Griseofulvin Tablets USP 375mg Taj Pharma

1. Name of the medicinal product

Griseofulvin Tablets USP 250mg Taj Pharma
Griseofulvin Tablets USP 375mg Taj Pharma
Griseofulvin Tablets USP 500mg Taj Pharma

2. Qualitative and quantitative composition
   

a) Griseofulvin Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Griseofulvin USP 250mg
Excipients: Q.S.

b) Griseofulvin Tablets USP 375mg Taj Pharma
Each film-coated tablet contains:
Griseofulvin USP 375mg
Excipients: Q.S.

c) Griseofulvin Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Griseofulvin USP 500mg
Excipients: Q.S.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet.

White to off white, round, biconvex film-coated tablet.

4. Clinical particulars

• Therapeutic indications

The treatment of fungal infections of the skin, scalp, hair, or nails (Tinea barbae, Tinea capitis, Tinea corporis, Tinea cruris, Tinea pedis, Tinea unguium) where topical therapy is considered inappropriate, or the infection has proven refractory to topical therapy.

Oral administration of Griseofulvin Taj Pharma for systemic therapy of fungal infections enables newly formed keratin of the skin, hair, and nails to resist fungal attack. As the new keratin extends, the old infected keratin is shed.

Prior to therapy, the type of fungi responsible should be identified. The use of Griseofulvin Taj Pharma is not justified in the treatment of minor or trivial infections that will respond to topical therapy.

Before prescribing Griseofulvin Taj Pharma Tablets, consideration should be given to national and/or local guidance on the appropriate use of antifungals.

• Posology and method of administration

General:

For oral administration.

Tablets should be swallowed whole with a glass of water. Griseofulvin Taj Pharma is recommended to be taken after a high fat meal, for increased absorption and minimising GI distress, see section 5.2.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tine pedis, yeasts and bacteria may be involved as well as fungi. Griseofulvin Taj Pharma will not eradicate the bacterial or candidial infections.

Adults

The usual adult dose is 500 mg to 1000 mg daily. The dose should not be less than 10 mg / Kg bodyweight / day. The dose may be administered as a single daily dose, or it may be administered twice daily.The twice daily dosing regimen may be more effective in those patients who respond poorly.

Hepatic impairment

Griseofulvin Taj Pharma is contraindicated in patients with severe hepatic impairment, see section 4.3.

For patients with moderate to mild hepatic impairment, no dosage adjustment is required. However Griseofulvin Taj Pharma may lead to further impairment of hepatic function, therefore regular monitoring of liver function is mandated, see section 4.4.

Renal impairment

No dosage adjustment is required in renally impaired patients; renal insufficiency does not lead to accumulation.

Elderly

No dosage adjustment is required in the elderly. Consideration should be given that such patients may also have a degree of hepatic impairment, see section 4.4.

Children

The dosage form, film-coated tablet, is only suitable for children of an age to swallow the tablet.

The usual dose in 10 mg / Kg bodyweight / day, in divided doses.

Duration of therapy

The duration of theapy depends upon the thickness of keratin at the site of infection, and the clinical response. The following duration of therapy are indicative:

Tinea corporis: 2-4 weeks

Tinea capitis: 4-8 weeks, in refractory cases, 8-12 weeks

Tinea pedis: 4-8 weeks

Tinea unguium: 6-12 months

Therapy should be continued for at least two weeks after all signs of infection have disappeared.

• Contraindications

Griseofulvin Taj Pharma is contraindicated in patients who have:

– Hypersensitivity to Griseofulvin Taj Pharma or to any of the excipients, see section 6.1

– Porphyria

– Severe hepatic impairment

– Systemic Lupus Erythematosus (SLE)

– Pregnancy, see section 4.6

– Breastfeeding, see section 4.6

• Special warnings and precautions for use

Griseofulvin Taj Pharma is reccomended after a high fat meal for increased absorption and minimising GI distress.

Griseofulvin Taj Pharma is contraindicated in patients with severe hepatic impairment, see section 4.3. In patients with minor to moderate hepatic impairment, Griseofulvin Taj Pharma may cause further deterioration of hepatic function. Therefore care should be exercised with such patients, and it is recommended to perform regular periodic liver function tests, see section 4.8.

Griseofulvin Taj Pharma is contraindicated in patients with Systemic Lupus Erythematosus (SLE), see section 4.3; Griseofulvin Taj Pharma has been reported to exacerbate the conditions, and care should be taken to exclude patients with pre-existing SLE from therapy.

Animal data, see section 5.3, indicates long term administration of high dose Griseofulvin Taj Pharma induces tumours in some species, but not others. The clinical relevance of this to man is unknown, but Griseofulvin Taj Pharma should not be used prophylactically.

Griseofulvin Taj Pharma is a liver microsomal enzyme inducer and thus may impair the effectiveness of oral contraceptives. Therefore in women of child bearing age using oral contraception, additional barrier methods of contraception must be used during therapy and for 4 weeks following therapy cessation, see sections 4.5 and 4.6.

Griseofulvin Taj Pharma causes chromosomal abnormalities in animals, see section 5.3. Therefore sexually active males should be cautioned to use an effective barrier method of contraception throughout therapy and for 6 months after therapy termination, see section 4.6.

A theoretical possibility of cross sensitivity in patients known to be allergic to penicillins exists, therefore caution should be exercised in administration of Griseofulvin Taj Pharma to such patients. It should be noted that such patients have been satisfactorily treated with Griseofulvin Taj Pharma without sequelae.

Patients should be cautioned to avoid excessive and unnecessary exposure to sunlight or U.V sources, including sunbeds, during Griseofulvin Taj Pharma therapy as photosensitivity reactions can occur, see section 4.8.

Consumption of alcohol in association with Griseofulvin Taj Pharma can result in an “Antabuse” type reaction, see section 4.5. Patients should be cautioned to avoid consumption of alcoholic beverages, and medicines containing alcohol, while undergoing Griseofulvin Taj Pharma therapy.

In patients undergoing long term Griseofulvin Taj Pharma therapy, i.e for tinea unguium, consideration should be given to periodic monitoring of blood chemistry, particularly for patients with pre-existing blood disorders, since Griseofulvin Taj Pharma may cause blood disorders, see section 4.8.

In common with any antibiotic, therapy with Griseofulvin Taj Pharma may result in the overgrowth of non-susceptible organisms, i.e bacteria or yeasts, or non-dermatophyte fungi, that are often cofactors in tinea infections, especially tinea pedis. Additional therapy is required to control or eradicate such organisms, as Griseofulvin Taj Pharma is ineffective.

Griseofulvin Taj Pharma is not effective in infections due to Candida albicans, Aspergillus sp., MMalassezia furfur (Pittyriasis versiclor) and Nocardia sp. It has no antibacterial effects.

• Interaction with other medicinal products and other forms of interaction

Medicinal Products:

Griseofulvin Taj Pharma may depress plasma levels, and therefore the efficacy, of concommitantly administered medicinal products that are metabolised by cytochrome P450 3A4.

Interactions of Griseofulvin Taj Pharma with other drugs:

Ciclosporin: concomittant administration may result in a reduction of ciclosporin plasma levels, necessitating a dosage adjustment. Plasma levels of ciclosporin should be monitored during grisefulvin therapy, and necessary dosage adjustments made.

Coumarin anticoagulants: the efficacy may be reduced, necessitating dosage adjustment. It is recommended that both prothrombin and INR are regularly monitored, for the duration of Griseofulvin Taj Pharma therapy, and for 8 days post therapy cessation.

Methadone: depression of methadone plasma levels may occur during Griseofulvin Taj Pharma therapy. Patients should be closely monitored for any loss of efficacy, or plasma levels of methadone be monitored, and corresponding dosage adjustments made.

Oral contraceptives: efficacy of oral contraception is reduced during Griseofulvin Taj Pharma therapy and for four weeks post therapy cessation. In view of the contraindication in pregnancy, see section 4.3, and of the possible sequelae of male patients fathering a child during therapy, all sexually active patients should use additional barrier contraception, such as condoms, throughout Griseofulvin Taj Pharma therapy, and for four weeks (female) and 6 months (male) post therapy cessation. See also sections 4.3, 4.4, 4.6, and 5.3 for additional information.

Interactions of other drugs with Griseofulvin Taj Pharma:

Concurrent administration of other medicinal products that induce metabolising enzymes may result in a reduction of Griseofulvin Taj Pharma blood plasma levels and thus efficacy. The following drugs are known to have this effect:

Barbiturates, such as phenobarbitone

Doxercalciferol

Phenylbutazone

Primidone

Other sedative and hypnotic drugs that induce metabolising enzymes.

Food: administration of Griseofulvin Taj Pharma after food, results in increased absorption, and thus higher plasma levels. This effect is enhanced if the meal contains high fat content. Administration after food is recommended, see section 4.2.

Alcohol: there are reports that Griseofulvin Taj Pharma enhances the central nervous system effects of alcohol. There are also reports that Griseofulvin Taj Pharma and alcohol use result in an “Antabuse” type reaction. Patients should be cautioned to avoid alcohol and all alcohol containing products while undergoing Griseofulvin Taj Pharma therapy, See also section 4.8.

• Pregnancy and lactation

Pregnancy:

There are case reports of human foetal abnormalities associated with Griseofulvin Taj Pharma.

There are no adequate and well controlled studies in man, and inadequate epidemiological data. Griseofulvin Taj Pharma has been shown to be teratogenic and embryotoxic in mice and rats. (see section 5.3).

Griseofulvin Taj Pharma is suspected to cause serious birth defects when administered during pregnancy.

Griseofulvin Taj Pharma is contraindicated (see section 4.3) in pregnancy.

Women of childbearing potential have to use effective contraception during (and up to 4 weeks after) treatment (see section 4.5) in respect of effect on oral contraceptives, and contraceptive precautions.

Male-mediated effects on pregnancy

Griseofulvin Taj Pharma has been shown to induce chromosomal aberrations in animal spermatocytes (see section 5.3).Therefore men should take effective contraceptive precautions, i.e barrier contraception, to avoid fathering children for the duration of Griseofulvin Taj Pharma therapy, and for 6 months post therapy cessation.

Lactation:

It is unknown if Griseofulvin Taj Pharma is excreted in breast milk, but the possibility does exist. There is inadequate data on the safety of Griseofulvin Taj Pharma in breast feeding, and the potential risk to the infant cannot be assessed, therefore Griseofulvin Taj Pharma is contraindicated in breast feeding (see section 4.3).

• Effects on ability to drive and use machines

Griseofulvin Taj Pharma has no or negligible influence on the ability to drive and use machines. However, it may cause drowsiness, confusion dizziness, and impaired co-ordination, see section 4.8. Patients should therefore be cautioned not to drive or operate machines until they are sure they are not affected.

• Undesirable effects

The following frequencies are used for the description of the occurrence of undesirable effects:

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Headache and gastric discomfort are the most common effects on starting treatment, but usually disappear as treatment is continued.

Blood and lymphatic system disorder:

Rare: leucopenia, neutropenia, anaemia-these usually resolve on therapy cessation

Nervous system disorders:

Common: headache

Uncommon: impaired co-ordination, peripheral neuropathy, confusion, dizziness, drowsiness, insomnia, irritability.

Gastrointestinal disorders:

Common: diarrhoea, vomiting, nausea, gastric discomfort

Uncommon: anorexia, taste sensation changes

Skin and subcutaneous tissue disorders:

Uncommon: toxic epidermal necrolysis, erethema multiforme, photosensitivity on exposure to intense natural or artifical sunlight.

Rare: precipitation of Systemic Lupus Eryhthematosus, bullous reactions including Lyell’s syndrome, urticarial reactions, skin rashes.

Hepatobiliary disorders:

Very rare: alteration in liver function tests, with elevation to more than three times upper normal limit, intrahepatic cholecstasis, hepatitis.

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.

• Overdose

No case of overdose has been reported.

Symptoms:

The likely symptoms of any overdose would be nausea, nomiting, headache, numbness and tingling, confusion, and vertigo. Urticaria or porphyria could occur.

Treatment:

There is no specific antidote to Griseofulvin Taj Pharma. Gastric lavage, or the induction of emesis may be of help, if ingestion is recent. Administration of activated charcoal may also be of use. Treatment should be symptomatic and supportive. Laboratory monitoring of haemopoetic, hepatic and nephritic parameters and electrolytes is recommended.

5. Pharmacological properties

• Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for systemic use

Griseofulvin Taj Pharma is an antifungal antibiotic that is active in vivo against common dermatophytes. The antifungal effect is manifested by binding to tubulin, at distinct binding sites, thus interferring with the microtubule function and causing inhibition of mitosis, and arresting cell division.

The inhibition of fungal mitosis leads to the production of multinucleate cells of characteristic morphology.

On entering the systemic circulation, Griseofulvin Taj Pharma binds to keratin in keratin precursor cells, thereby making them resistant to fungal infections. The drug only reaches the site of action when hair or skin is replaced by the keratin-Griseofulvin Taj Pharma complex.

Griseofulvin Taj Pharma then enters the dermatophyte through energy dependent transport processes and binds to the fungal microtubules, interferring with, and inhibiting mitosis, and the deposition of fungal cell walls.

Mycology:

Griseofulvin Taj Pharma has antifungal activity against the following dermatophytes, although there is species and strain variability in susceptibility.

Trichophyton rubrum, T. tonsurans, T. mentagrophytes, T. interdigitalis, T. verrucosum, T. megnini, T. gallinae, T. Crateriform, T. sulphureum and T. schoenleinii.

Microsporum audouinii, M. Canis, M. gypseum.

Epidermophyton floccosum.

Griseofulvin Taj Pharma has no activity against dermatophyte fungi of other genera, non-dermatophyte fungi, yeasts, gram positive bacteria, or gram negative bacteria. If any of these are cofactors in the pathology of infection, suitable additional therapy will be required for their eradication.

• Pharmacokinetic properties

Absorption:

The absorption of Griseofulvin Taj Pharma from the gastrointestinal tract is varaible and incomplete. On average, less than 50% of the oral dose is absorbed, but administration after a fatty meal, and a reduction in particle size will increase the rate and extent of the absorption.

Following oral administration there is a phase of rapid absorption, and thereafter a phase of slower prolonged absorption.

Peak plasma levels, 0.5 μg / ml-1.5 μg / ml after a 500 mg dose, and 1.5 μg / ml-3.0 μg / ml after a 1000 mg dose, are reached in 2-4 hours, and are maintained for some 10-20 hours.

Griseofulvin Taj Pharma exhibits linear pharmacokinetics.

Distribution:

The volume of distribution is about 0.7 L / Kg, and Griseofulvin Taj Pharma is ca 80 % bound to plasma proteins, predominantly serum albumin.

Griseofulvin Taj Pharma crosses the placenta, and may be excreted in breast milk. There is selective deposition of Griseofulvin Taj Pharma in newly formed keratin of hair, skin, and nails, which gradually moves to the surface of these appendages.

Metabolism:

Griseofulvin Taj Pharma undergoes metabolism to inactive metabolites, principally 6- desmethylGriseofulvin Taj Pharma, or its glucuronide conjugate.

Excretion:

The terminal plasma half life ranges from 9.5-21 hours, with considerable intersubject variability. The majority of the dose, as 6-desmethylGriseofulvin Taj Pharma or the glucuronide conjugate, and other metabolites is excreted in the urine, with less than 1% administered dose beinge excreted as unchanged Griseofulvin Taj Pharma. The remainder of the dose, principally as metabolites, is excreted in bile and faeces.

Renal insufficiency does not lead to accumulation.

• Preclinical safety data

Griseofulvin Taj Pharma can induce aneuploidy and meiotic delay in mouse oocytes following oral administration of high doses, i.e. 250mg/kg or greater. In addition, Griseofulvin Taj Pharma caused increases in numerical and structural chromosome aberrations in mouse spermatocytes at doses of 500mg/kg and above. Aneuploidy was observed at doses of 1500mg/kg.

Griseofulvin Taj Pharma administered to rats and mice during pregnancy has been associated with foetotoxicity and foetal malformations. Long-term administration of high doses of Griseofulvin Taj Pharma with food has been reported to induce hepatomas in mice and thyroid tumours in rats but not hamsters (see contraindications). The effects in mice may be due to a species specific effect on porphyrin metabolism.

6. Pharmaceutical particulars

• List of excipients

• Incompatibilities

Not applicable.

• Shelf life

Unopened container: 36 Months

Opened container: 6 Months

• Special precautions for storage

Do not store above 25°C.

• Nature and contents of container

Each film coated tablet contains active substance Griseofulvin Taj Pharma 250mg, 375mg and 500mg.

Polypropylene (PP) tablet container with linear low-density polyethylene (LLDPE) screw closure.

Pack Size:

Each Pack/Box contains 5, 10, 15, 20, 30, 50, 60, 80, 100, 120, 240, 360 and 500 film coated tablets.

Maximum pack size in each box 250, 360, 500 and 1000 film coated tablets.

Not all pack sizes may be marketed.

• Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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

Griseofulvin Tablets USP 375mg Taj Pharma

Package leaflet: Information for the user

Griseofulvin Tablets USP 375mg Taj Pharma

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

2. What Griseofulvin Taj Pharma is and what it is used for
3. Before you take Griseofulvin Taj Pharma
4. How to take Griseofulvin Taj Pharma
5. Possible side effects
6. How to store Griseofulvin Taj Pharma
7. Further information

1. WHAT GRISEOFULVIN IS AND WHAT IT IS USED FOR

Griseofulvin Taj Pharma 500mg Tablets, contain an anti-fungal agent called Griseofulvin Taj Pharma. Griseofulvin Taj Pharma kills the fungi that cause infections of the hair, skin, scalp, groin (“jock itch”), feet (“athlete’s foot”), and nails-ringworm. It does this by being incorporated in the skin, hair and nails, which takes the same time as they take to grow. This is why treatment lasts for a long time.

2. BEFORE YOU TAKE GRISEOFULVIN

Do not take Griseofulvin Taj Pharma

• if you are allergic (hypersensitive) to Griseofulvin Taj Pharma or any of the other ingredients of the tablets-(see section 2)
• if you suffer from a rare disease called porphyria
• if you suffer from a rare painful skin and tissue disease called Systemic Lupus Erythematosus, or SLE
• if you have severe liver disease
• if you are pregnant, or you think you might be pregnant, or you are planning to get pregnant
• if you are breastfeeding

If any of the above apply to you, do not take the tablets and go back to your doctor.

Take special care with Griseofulvin Taj Pharma

If any of the following points apply to you, you should discuss them with your doctor before starting to take Griseofulvin Taj Pharma.

• If you have liver disease, your doctor may want to check on you while taking this medicine
• If you have had an allergic (hypersensitivity) reaction previously to penicillin or to cephalosporins, both types of antibiotic. There is a possibility you may be sensitive to Griseofulvin Taj Pharma
• If you are relying on oral contraception, the “pill”, Griseofulvin Taj Pharma may prevent it working. All sexually active patients should use additional barrier contraception, such as condoms, throughout Griseofulvin Taj Pharma therapy, and for four weeks (female) and 6 months (male) after stopping the therapy
• If you are a man planning to father a child, Griseofulvin Taj Pharma may damage your sperm. You should not father a child while taking Griseofulvin Taj Pharma and for six months after you have stopped taking it. You and your partner should use additional contraceptive measures to prevent pregnancy during this period.
• If you suffer from a rare painful skin and tissue disease called Systemic Lupus Erythematosus, or SLE
• Alcoholic drinks, and anything containing alcohol, should be avoided while you are taking Griseofulvin Taj Pharma. Griseofulvin Taj Pharma may make the alcohol affect you more. Alcohol and Griseofulvin Taj Pharma may cause a disulfiram reaction-you will feel sick, may be sick, blush, have an irregular heart beat, and chest and / or abdominal pain.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Griseofulvin Taj Pharma. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.
• Griseofulvin Taj Pharma may result in the overgrowth of non-susceptible organisms, i.e bacteria or yeasts, or non-dermatophyte fungi, that are often cofactors in tinea infections, especially tinea pedis. Additional therapy is required to control or eradicate such organisms, as Griseofulvin Taj Pharma is ineffective.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking any of the following:

• ciclosporin, a medicine used after organ transplantation, it may not work as well
• any medicines to thin your blood, such as warfarin, your dose may need to be increased, and the doctor will want to check on you during treatment, and for 8 days after finishing treatment with Griseofulvin Taj Pharma
• methadone, used to treat addiction, or as a pain killer, the dose may need to be increased to maintain the same effect
• oral contraceptives-it may not work as well, and as you should not become pregnant during treatment with Griseofulvin Taj Pharma, you should use additional contraceptive measures, such as a condom
• barbiturates, such as phenobarbital, used to treat convulsions or as a sedative, it may prevent Griseofulvin Taj Pharma from being effective
• phenyl butazone, used to relieve pain or inflammation, it may prevent Griseofulvin Taj Pharma from being effective
• primidone, used to treat convulsions
• doxecalciferol, a vitamin D supplement
• medicines for sedation, or relief of anxiety, as they may prevent Griseofulvin Taj Pharma from being effective

Taking Griseofulvin Taj Pharma with food and drink

For the best effects, Griseofulvin Taj Pharma should be taken after a high fat meal. This helps to increase the absorption of Griseofulvin Taj Pharma into your body, so it can be effective against the infection and also reduce stomach discomfort.

Alcoholic drinks, and anything containing alcohol, should be avoided while you are taking Griseofulvin Taj Pharma. Griseofulvin Taj Pharma may make the alcohol affect you more. Alcohol and Griseofulvin Taj Pharma may cause a disulfiram reaction-you will feel sick, may be sick, blush, have an irregular heart beat, and chest and / or abdominal pain.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant, or think you might be pregnant-do not take Griseofulvin Taj Pharma -see your doctor. It may harm your baby.

If you are taking Griseofulvin Taj Pharma and you get pregnant-see your doctor immediately.

Griseofulvin Taj Pharma stops oral contraceptives working as effectively, so you should use additional contraception, such as a condom, while taking Griseofulvin Taj Pharma and for 4 weeks afterwards.

If you are breastfeeding-do not take Griseofulvin Taj Pharma -see your doctor.

Driving and using machines

Griseofulvin Taj Pharma may cause drowsiness, dizziness, confusion, and lack of co- ordination. You

should not drive or operate machinery until you are sure you are not affected.

3. HOW TO TAKE GRISEOFULVIN

Always take Griseofulvin Taj Pharma exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual adult dose is 500 mg to 1000 mg a day, given as either a single dose, or as two equal doses.

For children, the dose depends on the age and the weight of the child, and is usually 10mg / kilogram of body weight per day. The dose is usually given as two equal doses.

Make sure you follow the instructions of the doctor.

The length of time you have to take your medicine will be decided by your doctor. For ringworm infections of the hair or body, this could be 2-4 weeks, for infections of the scalp or feet it could be 4-8 weeks, and for infections of the nails, 6-12 months.

If you take more Griseofulvin Taj Pharma than you should

You should contact your doctor, or the nearest hospital at once, and follow their advice.

Remember to tell them how many extra tablets have been taken, and if you are taking any other medicines.

If you forget to take Griseofulvin Taj Pharma

If you forget to take a tablet, take it when you remember, and if it is not after a meal, drink a glass of milk.

If it is nearly time for your next tablet, do not take a double dose to make up for a forgotten tablet just carry on with your next dose as normal.

If you stop taking Griseofulvin Taj Pharma

Do not stop taking Griseofulvin Taj Pharma unless your doctor tells you to. You must keep taking it, even if you feel better, and the skin or nails or hair seem to be cured. You should keep taking it for at least 2 weeks after all signs of infection have gone. If you stop early, the infection may come back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Griseofulvin Taj Pharma can cause side effects, although not everybody gets them.

The most common effects are headache and stomach discomfort at the start of treatment, but these usually disappear on continuing treatment.

If you get any of the following side effects stop taking the medicine and see your doctor immediately.

• Sore, painful, swollen skin, and joints, butterfly rash (attack of Systemic Lupus Erythematous), severe skin reactions, including severe reddening of the skin, raised, itchy, painful skin rash
• Changes to your liver, with signs such as lower back pain, very pale urine, yellowing of the skin and / or the whites of the eyes
• Blistering and peeling of the skin, lumpy skin, with or without a weeping liquid, reddening and burning of the skin

If you get any of the following rare, or very rare side effects, see your doctor immediately

Rare, affecting more than 1 in 10,000 patients, but less than 1 in 1,000 patients

• Low numbers of certain types of blood cells, characterised by increased minor infections, sore throat, feeling tired and weak

Common, affecting more than 1 in 100 patients, but less than 1 in 10 patients

• Headache
• Diarrhoea, being sick, feeling sick, stomach discomfort

Uncommon, affecting more than 1 in 1000 patients, but less than 1 in 100 patients

• Lack of co-ordination, confusion, dizziness, drowsiness, sleeplessness, irritability, tingling and numbness in fingers and toes
• Anorexia, changes in taste sensation

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE GRISEOFULVIN

Keep out of the reach and sight of children.

Do not use Griseofulvin Taj Pharma after the expiry date which is stated on the label after Exp. The expiry date refers to the last day of that month.

To be used within 6 months after first opening the container.

Do not store above 25°C.

After opening the container, screw the cap back tightly after every use.

Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Griseofulvin Taj Pharma contains

• The active substance is Griseofulvin Taj Pharma 250mg, 375mg and 500mg in each tablet.
• The other ingredients are: maize starch, microcrystalline cellulose, sodium laurilsulphate, povidone, magnesium stearate, hypromellose, ethylcellulose, polysorbate 80, and propylene glycol.

What Griseofulvin Taj Pharma looks like and contents of the pack

Griseofulvin Taj Pharma 250mg, 375mg & 500mg Tablets are white to off white, round, biconvex film coated tablets.

Pack Size:

Each Pack/Box contains 5, 10, 15, 20, 30, 50, 60, 80, 100, 120, 240, 360 and 500 film coated tablets.

Maximum pack size in each box 250, 360, 500 and 1000 film coated tablets.

Not all pack sizes may be marketed.

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