Terbinafine Hydrochloride Cream 1% w/w Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Terbinafine Hydrochloride Cream 1% w/w Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains:
Terbinafine hydrochloride equivalent to
8.89 mg of Terbinafine……………………10mg
Excipients……………………………….q.s.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream

White or almost white cream, with a slight almond odour.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

The treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie itch/jock itch)

Fungal infections of the skin caused by dermatophytes such as species of Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

Infections of the skin caused by Candida (e.g. Candida albicans).

Pityriasis (tinea) versicolor caused by Pityrosporum orbiculare (Malassezia furfur).

4.2 Posology and method of administration

Posology

Adults and adolescents (>12 years of age)

Duration and frequency of treatment:

Terbinafine can be applied once or twice daily.

The likely duration of each treatment is as follows:

Tinea pedis: 1 week.

Tinea cruris and Tinea corporis: 1 to 2 weeks.

Cutaneous candida: 2 weeks.

Pityriasis versicolor: 2 weeks.

Relief of symptoms is usually obtained within a few days.

Irregular use or an inadequate treatment period increases the risk of the symptoms returning. If no improvement is obtained after 2 weeks, the diagnosis should be re-evaluated.

Elderly

There has been nothing to indicate that elderly patients require a different dosage or have a side effects profile different from younger patients.

Paediatric population

Terbinafine 1 % Cream is not recommended for children below 12 years of age due to insufficient data on safety. The experience in children is limited.

Method of administration

For cutaneous use.

The skin should be clean and dry. The cream should be applied in a thin layer on and around the affected skin and rubbed in gently. In cases of reddened and weeping infection (under the breasts, between the fingers, buttocks or in the groin) the skin may be covered with a sterile compress after application of the cream, especially at night.

4.3 Contraindications

Hypersensitivity to the active substance, terbinafine, or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Terbinafine 1 % Cream cream is for external use only.

Terbinafine 1 % Cream cream may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Terbinafine cream should be kept out of the reach of children.

In the event of allergic reaction, the cream should be removed and the treatment interrupted.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Candidiasis: It is not recommended to use acid pH soap. This provides favourable growth conditions for Candida spp.

Excipients

This medicine contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation. This medicine also contains cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

No drug interactions are known with the topical forms of terbinafine.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no clinical experience with terbinafine in pregnant women. Foetal toxicity studies conducted in animals suggest no adverse effects (see section 5.3). Terbinafine 1 % Cream should not be used during pregnancy unless clearly necessary.

Breast-feeding

Terbinafine is excreted into breast-milk. After topical use, only a low systemic exposure is expected (see section 5.2). Terbinafine 1 % Cream cream should not be used during breast-feeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.

Fertility

No effects of terbinafine on fertility have been seen in animal studies (see section 5.3).

4.7 Effects on ability to drive and use machines

Terbinafine 1 % Cream cream has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema, scab, etc. may occur at the site of application.

These harmless symptoms must be distinguished from hypersensitivity reactions including rash, which are reported in sporadic cases and require discontinuation of therapy.

In case of accidental contact with the eyes terbinafine may be irritating to the eyes.

In rare cases the underlying fungal infection may be aggravated.

Adverse reactions are listed below by system organ class and the frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

* Based on post-marketing experience.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

The low systemic absorption of topical terbinafine renders over dose extremely unlikely.

Symptoms

Accidental ingestion of one 30 g tube of terbinafine cream, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one terbinafine 250 mg tablet (adult oral unit dose).

Should a larger amount of terbinafine cream be inadvertently ingested, adverse effects similar to those observed with an over dose of terbinafine tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

Treatment

If accidentally ingested, the recommended treatment of over dose consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A E15)

Terbinafine is an allylamine that has a broad spectrum of antimycotic activity. It has an antimycotic effect on fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epdermophyton floccosum. At low concentrations terbinafine has a fungicidal effect against dermatophytes and moulds. Its activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane.

The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

5.2 Pharmacokinetic properties

Less than 5% of the dose is absorbed after topical application to humans: systemic exposure is thus very low.

5.3 Preclinical safety data

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100 mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.

In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69 mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.

During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were not associated with histological changes.

A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.

No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium hydroxide, Benzyl alcohol, Sorbitan monostearate, Cetyl palmitate, Cetyl alcohol, Cetostearyl alcohol, Polysorbate 60, Isopropyl myristate, Purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

4 years

Shelf life after opening 28 days

6.4 Special precautions for storage

Store in original container after first opening.

Do not freeze.

Keep the tube tightly closed.

6.5 Nature and contents of container

Collapsible aluminium tube with a polyethylene screw cap in pack sizes of 7.5 g, 15 g or 30 g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Not applicable

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

TERBINAFINE HYDROCHLORIDE CREAM
1%W/W
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Terbinafine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

WHAT IS IN THIS LEAFLET

1. What Terbinafine Cream is and what it is used for
2. What you need to know before you take Terbinafine Cream
3. How to use Terbinafine Cream
4. Possible side effects
5. How to store Terbinafine Cream
6. Contents of the pack and other information

   1. WHAT TERBINAFINE CREAM IS AND WHAT IT IS USED FOR

Terbinafine Cream is used to treat patients with fungal and certain yeast infections of the skin. It attacks and kills the fungus or yeast which is causing your infection.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Do NOT use Terbinafine Cream if you:

• are allergic (hypersensitive) to any of the ingredients in the product (see Section 6)
  The cream is NOT recommended for use on children.

Take special care with Terbinafine Cream

The cream is for external use only. Do not use on the face. Avoid contact with eyes. In case of accidental contact with eyes, rinse thoroughly with running water.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

Do not use the cream if you are pregnant or breastfeeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Terbinafine Cream is not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Terbinafine Cream

• cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis). For other ingredients see Section 6.

3. HOW TO USE TERBINAFINE CREAM

Adults
Your doctor will decide the right amount of Terbinafine Cream for you to use and will tell you for how long to use your medication.
Apply the cream once or twice a day, for one to two weeks, but this will depend upon the type and area of infection. Infections usually appear to improve within a few days of starting to use Terbinafine Cream, but may reappear if the cream is not applied regularly or is stopped too early.

Directions for use:
• Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin.
• Unscrew the cap then gently squeeze out a small amount of the cream onto your finger.
• Apply just enough cream to form a thin layer on the affected skin and surrounding areas.
• Rub in gently. When used between the toes, buttocks or on the groin, the treated area may be covered with a light, fresh gauze strip, especially at night.
• Replace the cap on the tube and wash your hands.

Even though you will not be using Terbinafine Cream during the second week for athlete’s foot, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.

Children
Use in children is NOT recommended, since there are no data to support use in this population.

If you accidently swallow Terbinafine Cream

Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some cream. Take any remaining medicine and this leaflet with you if possible. Symptoms of accidental ingestion include headache, nausea (feeling sick), dizziness and stomach pain.

If you forget to use Terbinafine Cream

If you miss an application, apply the cream as soon as possible then continue your treatment as before. If you only remember at the time of your next application, just apply the cream and carry on as normal. It is important to try to use the cream at the correct times as forgotten applications could risk the infection returning.

If you stop using Terbinafine Cream

Infections may come back if you do not use the cream regularly, or if you stop the treatment too early. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECT

Like all medicines, Terbinafine Cream can cause side effects, although not everybody gets them.
STOP using the cream and seek medical help immediately if you have any of the following very rare allergic reactions:

• difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic reaction).
  • severe itching of the skin, with a red rash or raised lumps, hives or blisters.

Common: (may affect up to 1 in 10 people): skin peeling, itching.

Uncommon: (may affect up to 1 in 100 people): skin lesions, scab, skin colour changes, redness, burning, pain and irritation at the site of application. These common and uncommon side effects are usually harmless and you can carry on using the cream.

Rare: (may affect up to 1 in 1000 people): eye irritation, dry skin, contact dermatitis, eczema, worsening of symptoms.

If any of these side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TERBINAFINE CREAM
   

Keep out of the sight and reach of children.
Keep the tube closed and in the carton.
Do not use this medicine after the expiry (EXP) date shown on the box and tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Terbinafine Cream contain
Each gram of cream contains:
Terbinafine hydrochloride equivalent to
8.89 mg of Terbinafine……………………10mg
Excipients……………………………….q.s.

The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

What Terbinafine Cream look like and contents of the pack
White The cream is a white cream, available in aluminium or laminate tubes of 15 g or 30 g. Not all pack sizes may be marketed.

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com