Mebendazole Tablets 1000mg Taj Pharma

Mebendazole Tablets 1000mg Taj Pharma

1. Name of the medicinal product

Mebendazole Tablets 100mg
Mebendazole Tablets 500mg
Mebendazole Tablets 1000mg

2. Qualitative and quantitative composition

Each tablet contains
Mebendazole         100mg
Excipients                q.s

Each tablet contains
Mebendazole         500mg
Excipients                q.s

Each tablet contains
Mebendazole         1000mg
Excipients                q.s

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Tablet.

4. Clinical particulars

4.1 Therapeutic indications

For the treatment of Trichuris trichuria (whipworm), Enterobius vermicularis (pinworm or threadworm), Ascaris lumbricoides (roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed gastrointestinal infestations.

There is no evidence that Mebendazole Tablets are effective in the treatment of cysticercosis.

4.2 Posology and method of administration

Adults and children over 2 years:

For the control of trichuriasis, ascariasis and hookworm infections, one tablet twice a day for three consecutive days.

For the control of enterobiasis a single tablet is administered. It is highly recommended that a second tablet is taken after two weeks, if re-infection is suspected.

Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine.

Mebendazole oral suspension should be considered for patients such as young children who are unable to swallow the tablet.

Children under 2 years:

See section 4.4 Special warnings and precautions for use.

Method of Administration

Oral use.

4.3 Contraindications

Mebendazole is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.

4.4 Special warnings and precautions for use

Not recommended in the treatment of children under 2 years

There have been rare reports of reversible liver function disturbances, hepatitis and neutropenia described in patients who were treated with mebendazole at standard dosages for indicated conditions (see section 4.8 ‘Undesirable effects’). These events, along with glomerulonephritis and agranulocytosis, have also been reported with dosages substantially above those recommended and with treatment for prolonged periods of time.

A case-control study of a single outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible association with the concomitant use of metronidazole with mebendazole. Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided.

Convulsions in children, including in infants below 1 year of age, have been reported very rarely during post-marketing experience (see section 4.8 ‘Undesirable effects’). Because of the risk of convulsions, Mebendazole should not be used particularly in children below the age of 1 year. Mebendazole has not been extensively studied in children below the age of 2 years.

Mebendazole should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of the drug.

Concomitant use of mebendazole and metronidazole should be avoided (see section 4.4).

4.6 Fertility, pregnancy and lactaction

Pregnancy

Since Mebendazole is contraindicated in pregnancy, patients who think they are, or may be, pregnant should not take this preparation.

Breast-feeding

Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. Therefore, caution should be exercised when Mebendazole is administered to breast-feeding women.

4.7 Effects on ability to drive and use machines

Mebendazole has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Mebendazole based on the comprehensive assessment of the available adverse event information. A causal relationship with Mebendazole cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Mebendazole was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in ≥1% of Vermox-treated subjects.

ADRs identified from clinical trials and post-marketing experience with Mebendazole are included in Table 1. The displayed frequency categories use the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Table 1: Adverse Drug Reactions Reported in Clinical Trials and Post-marketing Experience for Vermox

^a ADR frequency data derived from Clinical Trials or Epidemiological Studies

^b ADRs not observed in clinical trials and frequency calculated based on 6276 patients exposed in clinical trials and epidemiological studies, divided by 3 (Frequency = 1/2092).

* Observed in higher and prolonged doses

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

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages (see section 4.8).

Signs and symptoms

In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.

Treatment

There is no specific antidote. Activated charcoal may be given if considered appropriate.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: anthelmintic for oral administration, benzimidazole derivatives; ATC code: P02CA01.

In vitro and in vivo work suggests that mebendazole blocks the uptake of glucose by adult and larval forms of helminths, in a selective and irreversible manner. Inhibition of glucose uptake appears to lead to endogenous depletion of glycogen stores within the helminth. Lack of glycogen leads to decreased formation of ATP and ultrastructural changes in the cells.

There is no evidence that Mebendazole is effective in the treatment of cysticercosis.

5.2 Pharmacokinetic properties

Absorption

Following oral administration, < 10% of the dose reaches the systemic circulation, due to incomplete absorption and pre-systemic metabolism (first-pass effect). The majority of an orally administered dose remains in the gastrointestinal tract. Maximum plasma concentrations are generally seen 2 to 4 hours after administration. Administration with a high fat meal increases the bioavailability of mebendazole, but the overall effect of food on the amount of drug remaining in the gastrointestinal tract is not expected to be substantial.

Distribution

The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that mebendazole penetrates areas outside the vascular space. This is supported by data in patients on chronic mebendazole therapy (e.g., 40mg/kg/day for 3-21 months) that show drug levels in tissue.

Metabolism

Orally administered mebendazole is extensively metabolised primarily by the liver. Plasma concentrations of its major metabolites (hydrolysed and reduced forms of mebendazole) are substantially higher than those of mebendazole. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma levels of mebendazole.

Elimination

Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation and are excreted in the urine and bile. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients.

Steady-state pharmacokinetics

During chronic dosing (e.g., 40mg/kg/day for 3-21 months), plasma concentrations of mebendazole and its major metabolites increase, resulting in approximately 3-fold higher exposure at steady-state compared to single dosing.

5.3 Preclinical safety data

In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats and mice throughout the period of organogenesis or as a single oral dose as low as 10mg/kg in rats (approximately 0.2-fold the maximum recommended human dose (MRHD)). Maternal toxicity was present at the highest of these doses. Dosing of hamsters and rabbits did not result in embryotoxicity or teratogenicity. Doses up to 40mg/kg in rats (0.8-fold the MRHD, based onmg/m²), given to males for 60 days and to females for 14 days prior to gestation, had no effect upon fetuses and offspring.

No mutagenic activity was observed with mebendazole in bacterial reverse mutation tests. Mebendazole was mutagenic when tested in the mouse lymphoma thymidine kinase assay and aneugenic in vitro in mammalian somatic cells. In the in vivo mouse micronucleus assay, orally administered mebendazole induced an increased frequency of micronucleated polychromatic erythrocytes with evidence suggestive of aneugenicity.

Mebendazole had no carcinogenic effects at doses as high as 40mg/kg/day when administered daily in the diet over 2 years in carcinogenicity tests in mice and rats (0.4 to 0.8-fold the MRHD, based onmg/m²).

6. Pharmaceutical particulars

6.1 List of excipients

Microcrystalline cellulose, Sodium starch glycolate, Talc, Maize starch, Sodium saccharin, Magnesium stearate, Cottonseed oil hydrogenated, Orange flavor, Colloidal anhydrous silica, Sodium laurilsulfate, Sunset yellow, Purified water*, 2-propanol*

* Not present in the final product.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions. .

6.5 Nature and contents of container

Blister strips of PVC genotherm glass clear aluminium foil coated on the inside with a heat seal lacquer.

Pack sizes: 1 and 6 tablet packs.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

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

Mebendazole Tablets 100mg, 500mg, 1000mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mebendazole 100mg, 500mg, 1000mg tablets

Mebendazole

Mebendazole is a registered trademark

Read all of this leaflet carefully before you start using 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 you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet

1. What Mebendazole tablets are and what they are used for
   2.Before you use Mebendazole tablets
   3. How to use Mebendazole tablets
   4. Possible side effects
   5. How to store Mebendazole tablets
   6. Further information
   7. Further advice regarding worms
2. What Mebendazole tablets are and what they are used for

The name of your medicine is Mebendazole 100mg tablets (referred to as Mebendazole tablets in this leaflet). Mebendazole tablets contain a medicine called mebendazole. It is one of a group of medicines called ‘anthelmintics’.

Mebendazole tablets are used to treat worm infections of the gut such as:

• threadworms (pinworms)
• other common worm infections (such as whipworm, roundworm, hookworm)

This medicine is for use in adults and children aged over 2 years.

You or your child has been advised to take Mebendazole tablets because you have a worm infection. Worms can infect anyone. It does not necessarily mean that your hygiene is poor.

2. Before you use Mebendazole tablets

Do not use Mebendazole tablets if:

• You are allergic to anything in Mebendazole tablets (listed in section 6 below)
• You are pregnant

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Mebendazole tablets.

Warnings and precautions

• Mebendazole tablets should not be given to children under 2 years of age
• Mebendazole should only be given to younger children if your doctor has specifically prescribed it. Your doctor will decide whether Mebendazole is suitable for your child. You must follow the doctor’s instructions carefully.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription, herbal medicines, dietary supplements or vitamins.

In particular tell your doctor or pharmacist if you are taking:

• Metronidazole – for certain infections
• Cimetidine – for excess stomach acidity

Talk to your doctor before using Mebendazole tablets if you are taking any of these medicines.

Pregnancy and breast-feeding

• Do not take Mebendazole tablets if you are pregnant, think you may be pregnant or might become pregnant
• Ask your doctor or pharmacist for advice if you are breast-feeding

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Mebendazole

This medicine contains 0.06mg of sunset yellow. This ingredient may cause allergic reactions.

3. How to use Mebendazole tablets

Always use Mebendazole tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth
• The dose will depend on which type of worm you have
• Crush the tablet before giving it to your child. Always supervise a child if they are taking this medicine
• Chew the tablets or swallow them whole
• You do not need to use a laxative or change your diet

How much you should take

Adults and children over 2 years old

For threadworms (pinworms):

• one tablet
  A single Mebendazole tablet will kill threadworms. Your doctor may tell you to take a second tablet after two weeks in case of re-infection.

For other common worm infections:

• one tablet two times a day (morning and evening) for three consecutive days or as directed by your doctor.

If you take more Mebendazole tablets than you should

If you take more Mebendazole tablets than you should, talk to a doctor or go to the nearest hospital casualty department straight away.

If you forget to take Mebendazole tablets

• Do not take the missed dose
• Take your next dose at the usual time, and then keep taking your medicine as your doctor has told you
• Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Mebendazole tablets can cause side effects, although not everybody gets them.

Stop using Mebendazole tablets and tell your doctor straight away if you notice or suspect the following serious side effects. You may need urgent medical treatment.

• Sudden swelling of your face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction
• Blistering of your skin, mouth, eyes and genitals
• Fits (convulsions)

Tell your doctor or pharmacist if you notice any of the following side effects:

Common (affects less than 1 in 10 people)

• Stomach pain

Uncommon (affects less than 1 in 100 people)

• Stomach discomfort
• Diarrhoea
• Wind
• Feeling sick (nausea) or being sick (vomiting)

Rare (affects less than 1 in 1,000 people)

• Rash
• Inflammation of the liver
• Changes in liver enzymes (shown in blood tests)
• Inflammation of the kidneys
• Reduction in white blood cells (shown in blood tests). You may get more infections
• Unusual hair loss
• Dizziness

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 Mebendazole tablets

• Keep out of the sight and reach of children
• Do not use Mebendazole tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month
• There are no special storage conditions
• Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Mebendazole tablets to your pharmacist

6. Further information

The active substance in Mebendazole tablets is mebendazole. The tablets contain 100mg of mebendazole.

The other ingredients are microcrystalline cellulose, sodium starch glycolate, talc, maize starch, sodium saccharin, magnesium stearate, cottonseed oil hydrogenated, orange flavour, colloidal anhydrous silica, sodium laurilsulfate, sunset yellow.

What Mebendazole tablets look like and contents of the pack

Mebendazole tablets are available in blister packs containing 6 tablets.

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