Vitatab MV

Pronunciation: muhl-tee-VYE-ta-mins/MIN-er-als/FOE-lik AS-id
Generic Name: Multivitamins with Minerals/Folic Acid
Brand Name: Examples include Glutofac-ZX and Folpace Rx

Vitatab MV is used for:

Treating or preventing low levels of vitamins, folic acid, or minerals. It may also be used for other conditions as determined by your doctor.

Vitatab MV is a vitamin, folic acid, and mineral supplement. It works by providing extra vitamins, minerals, and folic acid to the body when you need more than what you get in your diet.

Do NOT use Vitatab MV if:

• you are allergic to any ingredient in Vitatab MV


• you have decreased liver or kidney function

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vitatab MV:

Some medical conditions may interact with Vitatab MV. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of bowel problems (eg, a bowel blockage), a certain eye problem (Leber optic atrophy), certain blood disorders (eg, megaloblastic anemia, pernicious anemia), high blood calcium levels, kidney problems, kidney stones, liver problems, sarcoidosis, or parathyroid gland problems

Some MEDICINES MAY INTERACT with Vitatab MV. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) or fluorouracil because the risk of their side effects may be increased by Vitatab MV


• Hydantoins (eg, phenytoin) or penicillamine because their effectiveness may be decreased by Vitatab MV


• Many other prescription and nonprescription medicines (eg, used for infections, heart problems, high blood pressure, immune system suppression, cancer, low blood platelets, osteoporosis, thyroid problems, bladder problems, Parkinson disease, psoriasis, swelling, other conditions) may interact with Vitatab MV. This may increase the risk of side effects or decrease the effectiveness of your other medicines. Ask your doctor or pharmacist if any medicines you take may interact with Vitatab MV and how to take them with Vitatab MV

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vitatab MV may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vitatab MV:

Use Vitatab MV as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Vitatab MV by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Vitatab MV with a full glass of water (8 oz/240 mL).


• If you miss a dose of Vitatab MV, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vitatab MV.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Vitatab MV unless your doctor tells you to.


• Tell your doctor or dentist that you take Vitatab MV before you receive any medical or dental care, emergency care, or surgery.


• Vitatab MV has many vitamins (eg, pyridoxine [vitamin B₆], cyanocobalamin [vitamin B₁₂], ascorbic acid [vitamin C], vitamin E), minerals (eg, zinc), and folic acid in it. Before you start any medicine, check the label to see if it has any vitamins, minerals, or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Vitatab MV while you are pregnant. Vitatab MV is found in breast milk. If you are or will be breast-feeding while you take Vitatab MV, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vitatab MV:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Vitatab MV. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased coordination; numbness or tingling of the skin; severe drowsiness, headaches, or nausea; severe or persistent constipation or diarrhea.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Vitatab MV side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bone pain; confusion; dark urine; diarrhea; fever; lower back or side pain; mental or mood changes; nausea, vomiting, or stomach cramps; sluggishness; unexplained skin or mouth sores; yellowing of the skin or eyes.

Proper storage of Vitatab MV:

Store Vitatab MV at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vitatab MV out of the reach of children and away from pets.

General information:

• If you have any questions about Vitatab MV, please talk with your doctor, pharmacist, or other health care provider.


• Vitatab MV is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vitatab MV. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Vitatab MV resources

• Vitatab MV Side Effects (in more detail)
• Vitatab MV Use in Pregnancy & Breastfeeding
• Vitatab MV Drug Interactions
• Vitatab MV Support Group
• 0 Reviews for Vitatab MV - Add your own review/rating

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• Vitamin/Mineral Supplementation and Deficiency

zinc sulfate

Generic Name: zinc sulfate (ZINK SUL fate)

Brand names: Orazinc 110, Orazinc 220, Verazinc, Zinc-220, Zincate, Zinca-pak, Mar-Zinc, Zinc CR, Micro-Zn, Zinc 50 mg Pink

What is zinc sulfate?

Zinc is a naturally occurring mineral. Zinc is important for growth and for the development and health of body tissues.

Zinc sulfate is used to treat and to prevent zinc deficiency.

Zinc sulfate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about zinc sulfate?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc sulfate can make certain antibiotics less effective. Tell your doctor about all other medications you are using before you start taking zinc sulfate.

What should I discuss with my healthcare provider before taking zinc sulfate?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

It is not known whether zinc sulfate will harm an unborn baby. Do not take zinc sulfate without telling your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zinc sulfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take zinc sulfate?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take zinc sulfate with a full glass of water. Take zinc sulfate with food if it upsets your stomach.

Your healthcare provider may occasionally change your dose to make sure you get the best results from zinc sulfate. The recommended dietary allowance of zinc sulfate increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, severe vomiting, dehydration, and restlessness.

What should I avoid while taking zinc sulfate?

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc sulfate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  nausea; or

  
  


• 
  

  upset stomach.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect zinc sulfate?

The following drugs can interact with or be made less effective by zinc sulfate. Tell your doctor if you are using any of these:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  methyltestosterone (Android, Methitest, Oreton);

  
  


• 
  

  penicillamine (Cuprimine, Depen);

  
  


• 
  

  risedronate (Actonel);

  
  


• 
  

  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others.

  
  

This list is not complete and other drugs may interact with zinc sulfate. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More zinc sulfate resources

• Zinc sulfate Use in Pregnancy & Breastfeeding
• Drug Images
• Zinc sulfate Drug Interactions
• Zinc sulfate Support Group
• 1 Review for Zinc sulfate - Add your own review/rating

• Zinc Sulfate MedFacts Consumer Leaflet (Wolters Kluwer)


• Zinc Sulfate Professional Patient Advice (Wolters Kluwer)


• Orazinc 110 Advanced Consumer (Micromedex) - Includes Dosage Information

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• Vitamin/Mineral Supplementation and Deficiency

Where can I get more information?

• Your pharmacist can provide more information about zinc sulfate.

Teslac

Pronunciation: TES-toe-LAK-tone
Generic Name: Testolactone
Brand Name: Teslac

Teslac is used for:

Treating certain types of breast cancer in women who have been through menopause or whose ovaries no longer function. It may also be used for other conditions as determined by your doctor.

Teslac is an antineoplastic that is related to testosterone (male sex hormone) but has not been shown to have the masculine effects of testosterone. It works by blocking the production of estrogen, which helps prevent the growth of breast cancers that are activated by estrogen. It may also prevent tumor cells from being activated by other hormones.

Do NOT use Teslac if:

• you are allergic to any ingredient in Teslac


• you are a man with breast cancer


• you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Teslac:

Some medical conditions may interact with Teslac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart disease (eg, ischemic heart disease), kidney disease, or liver problems


• if you have high levels of calcium in your blood

Some MEDICINES MAY INTERACT with Teslac. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of side effects such as bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Teslac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Teslac:

Use Teslac as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Teslac by mouth with or without food.


• If nausea, vomiting, or loss of appetite occur, check with your doctor or pharmacist for ways to lessen these effects.


• Continue to use Teslac even if you feel well. Do not miss any doses.


• If you miss a dose of Teslac, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Teslac.

Important safety information:

• Lab tests, including calcium blood levels, may be performed while you use Teslac. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Teslac with caution in the ELDERLY; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: Do not use Teslac if you are pregnant. If you think you may be pregnant, contact your doctor immediately. It is not known if Teslac is found in breast milk. If you are or will be breast-feeding while you use Teslac, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Teslac:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; aches of the legs and arms; general body discomfort; hair loss; loss of appetite; nausea; redness of the tongue; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; increased thirst or urination; severe drowsiness; severe muscle weakness; swelling of the hands or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Teslac side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Teslac:

Store Teslac at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Teslac out of the reach of children and away from pets.

General information:

• If you have any questions about Teslac, please talk with your doctor, pharmacist, or other health care provider.


• Teslac is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Teslac. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Teslac resources

• Teslac Side Effects (in more detail)
• Teslac Use in Pregnancy & Breastfeeding
• Drug Images
• Teslac Drug Interactions
• Teslac Support Group
• 0 Reviews for Teslac - Add your own review/rating

• Teslac Prescribing Information (FDA)


• Teslac Concise Consumer Information (Cerner Multum)


• Teslac Advanced Consumer (Micromedex) - Includes Dosage Information

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• Breast Cancer, Palliative

Etrivex 500 micrograms / g Shampoo

1. Name Of The Medicinal Product

Etrivex500 micrograms/g shampoo

2. Qualitative And Quantitative Composition

One gram of shampoo contains 500 micrograms of clobetasol propionate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Shampoo.

Viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.

4. Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of moderate scalp psoriasis in adults.

4.2 Posology And Method Of Administration

For cutaneous use on the scalp only.

Etrivex 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to around a half tablespoon (around 7.5 ml) per application is sufficient to cover all the scalp. Etrivex 500 micrograms/g shampoo should be then kept in place without covering for 15 minutes before rinsing. Hands should be washed carefully after application. After 15 minutes, the product must be rinsed with water and / or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.

The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.

Repeated courses of Etrivex 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.

Paediatric population

The experience in the paediatric population is limited. Etrivex 500 micrograms/g shampoo is not recommended for use in children and adolescents below 18 years of age. It is contraindicated in children under 2 years of age (see sections 4.3 and 4.4).

4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients

- Skin areas affected by bacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by lues).

- Etrivex 500 micrograms/g shampoo must not be applied to the eye (risk of glaucoma) or to ulcerous wounds.

- Children under 2 years of age

4.4 Special Warnings And Precautions For Use

Topical corticosteroids should be used with caution for a number of reasons including post treatment rebound relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalised pustular psoriasis in case of intensive and prolonged topical use. In very rare cases, hypersensitivity to corticosteroids can be observed. This can be suspected in case of resistance to treatment.

In general, long-term continuous therapy with corticosteroids, use of occlusive mobcaps or treatment of children can lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of HPA axis suppression. Such systemic effects disappear when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children. If Etrivex 500 micrograms/g shampoo is required for use in children and adolescents below 18 years of age, it is recommended that the treatment should be reviewed weekly.

Etrivex 500 micrograms/g shampoo is only intended for the treatment of scalp psoriasis and should not be used to treat other skin areas. In particular, Etrivex 500 micrograms/g shampoo is not recommended for use in the face, eyelids, intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangectasia or cortico-induced dermatitis.

If Etrivex 500 micrograms/g shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of topical clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Etrivex 500 micrograms/g shampoo should not be used during pregnancy unless clearly necessary.

Lactation

Systemically administered corticosteroids pass into breast milk. Damage to the infant is not reported to date. Nevertheless, as there are no adequate data on the possible milk transfer of topical clobetasol propionate and its biological or clinical repercussions, Etrivex 500 micrograms/g shampoo should not be prescribed to breastfeeding women unless clearly indicated.

4.7 Effects On Ability To Drive And Use Machines

As a topical corticosteroid, Etrivex 500 micrograms/g shampoo has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

During clinical development of Etrivex 500 micrograms/g shampoo, in a total of 558 patients receiving Etrivex 500 micrograms/g shampoo, the most commonly reported adverse drug reaction was skin discomfort.Its incidence was about 5%. Most adverse events were rated as mild to moderate and they were not affected by race or gender. Clinical signs of irritation wereuncommon (0.5%). No serious drug-related adverse events were reported during any of the clinical trials.

If signs of local intolerance appear, application should be suspended until they disappear. If signs of hypersensitivity appear, application should be stopped immediately.

The table below reports the adverse reactions related to treatment by body system and by absolute frequency:

Body System	Incidence	Adverse reactions
Skin and subcutaneous tissue disorders             Eye disorders	Common (   Uncommon (         Common (	Skin discomfort Acne/folliculitis   Local signs of irritation Pruritus Urticaria Telangiectasia Skin atrophy   Eye stinging/burning

As a class attribution, prolonged use of topical corticosteroids, treatment of extensive areas or use of large amounts can result in sufficient systemic absorption to produce the features of hypercortisolism (Cushing syndrome) or of Hypothalamus-Pituitary-Adrenal (HPA) axis suppression. Should HPA axis suppression occur, it is likely to be transient with a rapid return to normal values.However, as Etrivex 500 micrograms/g shampoo is to be kept in place for only 15 minutes before rinsing, systemic absorption is seldom observed (see section 5.2) and therefore, the risk of appearance of HPA axis suppression is very low compared to non rinsed potent corticosteroids products. No HPA axis suppression has been observed during clinical trials with Etrivex 500 micrograms/g shampoo.

Prolonged and/or intensive treatment with potent corticosteroid preparations may cause local atrophic changes, such as local skin atrophy, striae, telangiectasia, erythema, purpura, contact dermatitis. When applied to the face, very potent corticosteroids can induce perioral dermatitis, skin atrophy or worsen rosacea. During development of Etrivex 500 micrograms/g shampoo, skin atrophy was assessed using ultrasound measurement of skin thickness in a specific clinical trial involving 13 patients. After 4 weeks of treatment with Etrivex 500 micrograms/g shampoo, no skin thinning was observed.

There are reports of pigmentation changes, acne, pustular eruptions and hypertrichosis with topical corticosteroids.

4.9 Overdose

Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under medical supervision.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Corticosteroids, Very Potent (Group IV)

ATC code: D07AD01

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical corticosteroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.

5.2 Pharmacokinetic Properties

In vitro liberation –penetration studies on human skin showed that only a small percentage (0.1 %) of the applied dose of Etrivex Shampoo can be found in the epidermis (including the stratum corneum) when applied for 15 minutes and then rinsed. The very low topical absorption of clobetasol propionate from Etrivex Shampoo when applied according to the recommended clinical use (15 minutes before rinse off) resulted in negligible systemic exposure in animal studies and in clinical trials. Available clinical data revealed that only 1 of 141 subjects had a quantifiable clobetasol propionate plasma concentration (0.43 ng/ml).

The present pharmacokinetic data indicate that systemic effects following clinical treatment with Etrivex Shampoo are highly unlikely due to the low systemic bioavailability of clobetasol propionate.

5.3 Preclinical Safety Data

Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single, repeated dose toxicity and genotoxicity. The carcinogenicity of clobetasol has not been studied.

In rabbits, Etrivex Shampoo was slightly irritating to the skin and eyes, but no delayed-type hypersensitivity was seen on guinea pigs' skin.

In developmental toxicity studies in the rabbit and the mouse, clobetasol propionate was shown to be teratogenic when administered subcutaneously at low doses. In a topical embryotoxicity study of clobetasol in the rat, foetal immaturity and skeletal and visceral malformations were observed at relatively low dosage levels. In addition to malformations, studies in animals exposed to high systemic levels of glucocorticoids during pregnancy have also shown other effects on the offspring, such as intrauterine growth retardation.

The clinical relevance of the effects of clobetasol and other corticosteroids in developmental animal studies is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol

Coco alkyl dimethyl betaine

Sodium laurethsulfate

Polyquaternium-10

Sodium citrate

Citric acid monohydrate

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

Shelf life after first opening: 4 weeks

6.4 Special Precautions For Storage

Store in the original container

6.5 Nature And Contents Of Container

The product is packaged in high density polyethylene (HDPE) bottles of 60 ml or 125 ml fitted with polypropylene snap closures. The HDPE bottle of 30 ml is fitted with polypropylene screw closure.

Bottles contain 30 ml, 60 ml or 125 ml of shampoo.

1 g of shampoo corresponds to 1 millilitre of shampoo.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

8. Marketing Authorisation Number(S)

PL 10590/0052

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

January 2007

Fluocinolone Ear Drops

Dosage Form: otic oil
Fluocinolone Acetonide Oil 0.01%

Ear Drops

For Otic Use Only-

Not for Ophthalmic Use

DESCRIPTION

Fluocinolone Acetonide Oil 0.01% Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α) - 6,9 - difluoro - 11,21 - dihydroxy - 16,17[(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide is C24 H30 F2O6 anhydrous. It has the following structural formula:

Fluocinolone acetonide in Fluocinolone Acetonide Oil 0.01% has a molecular weight of 452.49. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Fluocinolone Acetonide Oil 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF.

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone Acetonide Oil 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.

CLINICAL STUDIES

Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of fluocinolone acetonide oil 0.01% twice daily, after 7 days of treatment, showed Fluocinolone Acetonide Oil 0.01% to be superior to placebo in clearing the signs and symptoms of eczematous external otitis.

Clinical safety studies were conducted on the same formulation of fluocinolone acetonide oil 0.01%, marketed as Fluocinolone Acetonide 0.01% Topical Oil. Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 mcg/dL; normal: cortisol > 7mcg/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 mcg/dL).

A clinical study was conducted to assess the safety of Fluocinolone Acetonide 0.01% Topical Oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing peanut oil NF, Fluocinolone Acetonide 0.01% Topical Oil and histamine/saline controls on the 13 individuals. These subjects were also treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Fluocinolone Acetonide 0.01% Topical Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Fluocinolone Acetonide 0.01% Topical Oil use. Importantly, the bulk peanut oil NF, used in fluocinolone acetonide oil is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

INDICATIONS AND USAGE

Fluocinolone Acetonide Oil 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.

CONTRAINDICATIONS

Fluocinolone Acetonide Oil 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF (See PRECAUTIONS).

PRECAUTIONS

General:

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric use)

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic testing.

If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, fluocinolone acetonide oil 0.01% should be discontinued immediately and appropriate therapy instituted.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinolone acetonide oil 0.01% should be discontinued until the infection has been adequately controlled.

Fluocinolone acetonide oil 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Oil 0.01% for peanut-sensitive individuals.

Information for Patients:

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external ear use only. Do not use occlusive dressings.

2. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.

3. This medication should not be used for any disorder other than that for which it was prescribed.

4. Patients should promptly report to their physician any worsening of their skin condition.

5. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests:

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment of fertility:

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide oil 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide oil 0.01%. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).

Pregnancy:

Teratogenic effects:

Pregnancy category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide oil 0.01%. Therefore, fluocinolone acetonide oil 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide oil 0.01% is administered to a nursing woman.

Pediatric Use:

Fluocinolone acetonide oil 0.01% may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis.

Fluocinolone acetonide oil 0.01% is not recommended for use on the face (See ADVERSE REACTIONS section).

Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS).

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Fluocinolone acetonide oil 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Oil 0.01% for peanut-sensitive individuals.

ADVERSE REACTIONS

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE

Topically applied fluocinolone acetonide oil 0.01% can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil 0.01% into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

HOW SUPPLIED

Fluocinolone Acetonide Oil 0.01% Ear Drops is supplied in 1 fluid ounce bottles with a net contents of 20 mL (Dropper Included) (NDC # 65162-702-94).

Keep tightly closed. Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86°F) [See USP Controlled Room Temperature]

Caution: Rx only

Manufactured by:

Amneal Pharmaceuticals

Branchburg, NJ 08876

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 09-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLUOCINOLONE ACETONIDE  fluocinolone acetonide  oil

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-702 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 0.11 mg  in 20 mL

Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL   ISOPROPYL MYRISTATE   LIGHT MINERAL OIL   OLETH-2   PEANUT OIL

Product Characteristics Color YELLOW Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-702-94 1 BOTTLE In 1 CARTON contains a BOTTLE 1 20 mL In 1 BOTTLE This package is contained within the CARTON (65162-702-94)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091306	10/17/2011

Labeler - Amneal Pharmaceuticals, LLC (123797875)

Registrant - Identi Pharmaceuticals LLC (832355189)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals, LLC		963900878	MANUFACTURE, ANALYSIS

Revised: 11/2011Amneal Pharmaceuticals, LLC

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• Eczema

Helidac Therapy Pack

Pronunciation: BIZ-muth SUB-sa-LIS-i-late/MET-roe-NYE-da-zole/TET-ra-SYE-kleen
Generic Name: Bismuth Subsalicylate/Metronidazole/Tetracycline
Brand Name: Helidac

Helidac Therapy Pack should only be used to treat ulcers of the small intestine (duodenal ulcers) associated with H. pylori infection.

Helidac Therapy Pack is used for:

Treating H. pylori infection associated with ulcers. It is used with an H₂ blocker (eg, ranitidine).

Helidac Therapy Pack is an antimicrobial combination. It works by killing sensitive bacteria.

Do NOT use Helidac Therapy Pack if:

• you are allergic to any ingredient in Helidac Therapy Pack or to salicylates (eg, aspirin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen)


• you are pregnant or breast-feeding


• you are a child or teenager and have a viral infection (eg, flu, chickenpox, shingles)


• you have kidney problems, liver problems, or bleeding or blood clotting problems (eg, hemophilia, von Willebrand disease)


• you are taking acitretin, busulfan, an ergot alkaloid (eg, ergotamine), an HIV protease inhibitor oral solution (eg, amprenavir), isotretinoin, methoxyflurane, a penicillin antibiotic (eg, amoxicillin), ranolazine, or disulfiram, or if you have taken disulfiram within the past 14 days


• you drink alcohol

Before using Helidac Therapy Pack:

Some medical conditions may interact with Helidac Therapy Pack. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of blood problems (eg, anemia, low white blood cell levels, unusual bleeding or bruising)


• if you have a seizure disorder (eg, epilepsy), nerve or brain problems, a viral infection (eg, flu, shingles), inflammation of the stomach, peptic ulcers, Crohn disease, dehydration problems, or lupus

Some MEDICINES MAY INTERACT with Helidac Therapy Pack. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin or isotretinoin because the risk of high pressure in the brain may be increased


• Methoxyflurane because serious, even fatal kidney problems may occur


• Amiodarone, busulfan, disulfiram, or an HIV protease inhibitor oral solution (eg, amprenavir) because irregular heartbeat; serious liver, lung, or bladder problems; severe mood or mental problems; or stomach cramps, nausea, vomiting, headaches, and flushing may occur


• Barbiturates (eg, phenobarbital), cimetidine, hydantoins (eg, phenytoin), or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Helidac Therapy Pack's effectiveness


• Anticoagulants (eg, warfarin), cyclosporine, digoxin, ergot alkaloids (eg, ergotamine), lithium, macrolide immunosuppressants (eg, sirolimus), medicines for diabetes (eg, glipizide), methotrexate, ranolazine, salicylates (eg, aspirin), or valproic acid because the risk of their side effects may be increased by Helidac Therapy Pack


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), atovaquone, hormonal contraceptives (eg, birth control pills, patches), penicillin antibiotics (eg, amoxicillin), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Helidac Therapy Pack

This may not be a complete list of all interactions that may occur. Ask your health care provider if Helidac Therapy Pack may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Helidac Therapy Pack:

Use Helidac Therapy Pack as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Helidac Therapy Pack. Talk to your pharmacist if you have questions about this information.


• Each dose of Helidac Therapy Pack is made up of 2 pink chewable tablets, one white tablet, and one orange and white capsule. Each blister card contains 4 doses (enough doses for 1 day).


• Take a dose of Helidac Therapy Pack 4 times a day, at mealtimes and at bedtime, unless your doctor tells you otherwise.


• To take a dose of Helidac Therapy Pack, thoroughly chew 2 pink tablets and swallow. Afterward, take 1 white tablet and 1 orange and white capsule with a full glass of water (8 oz/240 mL). Swallow the tablet and capsule whole. Do not break, crush, or chew before swallowing.


• Drinking extra fluids while you are taking Helidac Therapy Pack is recommended. Be sure to do this especially with the bedtime dose. Check with your doctor for instructions.


• Do not take an antacid that has aluminum, calcium, or magnesium in it, or a product that has iron or zinc in it within 2 hours of Helidac Therapy Pack.


• Do not eat or drink dairy products within 2 hours of Helidac Therapy Pack.


• To clear up your infection completely, take Helidac Therapy Pack for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Helidac Therapy Pack, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 4 doses of Helidac Therapy Pack, contact your doctor.

Ask your health care provider any questions you may have about the proper use of Helidac Therapy Pack.

Important safety information:

• Helidac Therapy Pack may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Helidac Therapy Pack with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using Helidac Therapy Pack and for at least 1 day after you have stopped taking Helidac Therapy Pack. Stomach cramps, nausea, vomiting, headaches, and flushing may occur.


• Helidac Therapy Pack combination should only be used to treat H. Pylori infection associated with ulcers. It is not effective for treating viral infections (eg, the common cold).


• Be sure to use Helidac Therapy Pack for the full course of treatment. If you do not, the medicine may not clear up your infection completely. This could cause your ulcer to recur.


• Long-term or repeated use of Helidac Therapy Pack may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Helidac Therapy Pack for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Helidac Therapy Pack may have an aspirin-like medicine in it. Aspirin has been linked to a serious illness called Reye syndrome. Do not give Helidac Therapy Pack to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• If you are taking aspirin for some other condition and you develop ringing in the ear, contact your doctor.


• Do not receive a live vaccine (eg, typhoid) while you are taking Helidac Therapy Pack. Talk with your doctor before you receive any vaccine.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Helidac Therapy Pack. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Helidac Therapy Pack may temporarily discolor or darken the tongue or stools. This is normal and not a cause for concern.


• Helidac Therapy Pack may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Helidac Therapy Pack. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Helidac Therapy Pack may interfere with certain lab tests, including x-ray, blood, liver function, and triglyceride tests. Be sure your doctor and lab personnel know you are taking Helidac Therapy Pack.


• Use Helidac Therapy Pack with caution in the ELDERLY; they may be more sensitive to its effects.


• Helidac Therapy Pack should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• Use of tetracycline in CHILDREN younger than 8 years old may cause serious tooth problems, including softening of the tooth enamel and permanent yellow, gray, or brown discoloration of the teeth.


• PREGNANCY and BREAST-FEEDING: Do not use Helidac Therapy Pack if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while taking it. If you think you may be pregnant, contact your doctor right away. Helidac Therapy Pack is found in breast milk. Do not breast-feed while taking Helidac Therapy Pack.

Possible side effects of Helidac Therapy Pack:

Every medicine can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; darkening of the tongue or stools; diarrhea; dizziness; headache; indigestion; loss of appetite; metallic taste; nausea; stomach pain; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, hairy tongue or sore tongue; bloody stools; blurred vision, vision loss, or other vision changes; dark urine; depression; increased or decreased urination; loss of coordination; numbness, tingling, or burning of the arms, hands, legs or feet; pale stools; red, swollen, peeling, or blistered skin; ringing in the ears; seizures; severe diarrhea; severe or persistent headache, dizziness, or stomach pain/cramps; signs of infection (eg, fever, chills, or persistent sore throat); sore mouth; speech problems; stiff neck; unusual bruising or bleeding; vaginal odor or discharge; white patches in the mouth or on the tongue; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Helidac side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; fast heartbeat; high fever; rapid breathing; ringing in the ears; severe or persistent diarrhea, nausea, or vomiting; unusual tiredness or fatigue.

Proper storage of Helidac Therapy Pack:

Store Helidac Therapy Pack at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Helidac Therapy Pack out of the reach of children and away from pets.

General information:

• If you have any questions about Helidac Therapy Pack, please talk with your doctor, pharmacist, or other health care provider.


• Helidac Therapy Pack is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Helidac Therapy Pack. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Helidac resources

• Helidac Side Effects (in more detail)
• Helidac Use in Pregnancy & Breastfeeding
• Helidac Drug Interactions
• Helidac Support Group
• 1 Review for Helidac - Add your own review/rating

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