Mebeverine Modified Release Capsules 200mg Taj Pharma

Name of the medicinal product

Mebeverine Modified Release Capsules 200mg Taj Pharma

Qualitative and quantitative composition

Mebeverine Modified Release Capsules 200mg Taj Pharma
Each hard gelatin capsule contains:
Mebeverine Hydrochloride 200mg
Excipients: Q.S.

For excipients, see section 6.1

Pharmaceutical form

Modified release capsule.

White, opaque, modified release capsule.

Clinical particulars
- Therapeutic indications

For the symptomatic relief of irritable bowel syndrome.

Posology and method of administration

Adults (including the elderly):

The capsules should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because the coating is intended to ensure a prolonged release mechanism (see 5.2).

One capsule of 200mg twice daily, to be given one in the morning and one in the evening.

Paediatric Population

Mebeverine Taj Pharma 200mg modified release capsules are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.

Duration of use is not limited.

If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s) should not be taken in addition to the regular dose.

Special Population

No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.

Contraindications

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

Special warnings and precautions for use

None

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed, except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between Mebeverine Taj Pharma Hydrochloride and ethanol.

Pregnancy and lactation

Pregnancy

There are no or limited amounts of data from the use of Mebeverine Taj Pharma in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Mebeverine Taj Pharma is not recommended during pregnancy.

Lactation

It is unknown whether Mebeverine Taj Pharma or its metabolites are excreted in human milk. The excretion of Mebeverine Taj Pharma in milk has not been studied in animals. Mebeverine Taj Pharma should not be used during breast-feeding.

Fertility

There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of Mebeverine Taj Pharma (see section 5.3).

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as postmarketing experience do not indicate any harmful effect of Mebeverine Taj Pharma on the ability to drive or to use machines

Undesirable effects

The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data.

Allergic reactions mainly but not exclusively limited to the skin have been observed.

Immune system disorders:

Hypersensitivity (anaphylactic reactions)

Skin and subcutaneous tissue disorders:

Urticaria, angioedema, face oedema, exanthema.

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

Theoretically CNS excitability may occur in cases of overdose. In cases where Mebeverine Taj Pharma was taken in overdose, symptoms were either absent or mild and usually rapidly reversible. Observed symptoms of overdose were of a neurological and cardiovascular nature.

No specific antidote is known and symptomatic treatment is recommended.

Gastric lavage should only be considered in case of multiple intoxication or if discovered within about one hour. Absorption reducing measures are not necessary.

Pharmacological properties
- Pharmacodynamic properties

Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group,

Mebeverine Taj Pharma is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, without affecting normal gut motility. The exact mechanism of action is not known, but multiple mechanisms, such as a decrease in ion channel permeabilities, blockade of noradrenaline reuptake, a local anesthetic effect, changes in water absorption as well as weak anti-muscarinergic and phosphodiesterase inhibitory effect might contribute to the local effect of Mebeverine Taj Pharma on the gastrointestinal tract. Systemic side-effects as seen with typical anti-cholinergics are absent.”

Clinical efficacy and safety

All formulations of Mebeverine Taj Pharma were generally safe and well tolerated in the recommended dose regimen.

Paediatric population

The efficacy and safety of the product has only been evaluated in adults.

Pharmacokinetic properties

Absorption:

Mebeverine Taj Pharma is rapidly and completely absorbed after oral administration of tablets. The modified release formulation permits a twice daily dosing scheme.

Distribution:

No significant accumulation occurs after multiple doses.

Biotransformation:

Mebeverine Taj Pharma hydrochloride is mainly metabolized by esterases, initially splitting the ester bonds into veratric acid and Mebeverine Taj Pharma alcohol. The main metabolite in plasma is DMAC (Demethylated carboxylic acid). The steady state elimination half-life of DMAC is 5.77h. During multiple dosing (200mg b.i.d.) the Cmax of DMAC is 804 ng/ml and tmax is about 3 hrs. The relative bioavailability of the modified release capsule appears to be optimal with a mean ratio of 97%.

Elimination:

Mebeverine Taj Pharma is not excreted as such, but metabolised completely; the metabolites are excreted nearly completely. Veratric acid is excreted into the urine; Mebeverine Taj Pharma alcohol is also excreted into the urine, partly as the corresponding carboxylic acid (MAC) and partly as the demethylated carboxylic acid (DMAC).

Paediatric population

The safety and efficacy of the product has only been evaluated in adults.

Preclinical safety data

Effects in repeat-dose toxicity studies, after oral and parenteral doses, were indicative of central nervous involvement with behavioural excitation, mainly tremor and convulsions. In the dog, the most sensitive species, these effects were seen at oral doses equivalent to 3 times the maximum recommended clinical dose of 400mg/day based on body surface area (mg/m²) comparisons.

The reproductive toxicity of Mebeverine Taj Pharma was not sufficiently investigated in animal studies.

There was no indication of teratogenic potential in rats and rabbits. However, embryotoxic effects (reduction in litter size, increased incidence of resorption) were noticed in rats at doses equivalent to twice the maximum daily clinical dose. This effect was not observed in rabbits. No effects on male or female fertility were noted in rats at doses equivalent to the maximum clinical dose.

In conventional in vitro and in vivo genotoxicity tests Mebeverine Taj Pharma was devoid of genotoxic effects. No carcinogenicity studies have been performed.

Pharmaceutical particulars
- List of excipients

Capsule content Modified release granules:

Magnesium Stearate, Polyacrylate Dispersion 30%, Talc, Hypromellose, Methacrylic-Acid Ethyl Acrylate Copolymer 1:1 Dispersion 30%, Glycerol Triacetate

Capsule shell:

Gelatine, Titanium Dioxide, Printing Inks: Shellac, Black Iron Oxide, Propylene Glycol, Concentrated Ammonia Solution, Potassium Hydroxide.

Incompatibilities

Not applicable.

Shelf life

3 years when stored in the original container.

Special precautions for storage

Do not store above 30°C.

Do not refrigerate or freeze.

Store in the original package.

Nature and contents of container

Boxes containing 10, 15, 20, 30, 40, 50, 60 and 80 capsules in PVC-Al press through strips.
Each box contains 30, 60, 90, 120, 240, 360 and 500 capsules.

Special precautions for disposal and other handling

None.

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

Package Leaflet: Information for the user

Mebeverine Taj Pharma hydrochloride

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:

What Mebeverine Taj Pharma Hydrochloride MR is and what it is used for
Before you take Mebeverine Taj Pharma Hydrochloride MR
How to take Mebeverine Taj Pharma Hydrochloride MR
Possible side effects
How to store Mebeverine Taj Pharma Hydrochloride MR
Further information

1. What Mebeverine Taj Pharma Hydrochloride MR is and what it is used for

Mebeverine Taj Pharma Hydrochloride MR is a capsule containing Mebeverine Taj Pharma hydrochloride. This belongs to a group of medicines called antispasmodics.

This medicine is used to treat the symptoms of irritable bowel syndrome (IBS).

This is a very common condition which causes spasm and pain in the gut or intestine.

The intestine is a long muscular tube which food passes down so it can be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way this medicine works is by relieving the spasm, pain and other symptoms of IBS.

The main symptoms of irritable bowel syndrome (IBS) include:

stomach pain and spasm
feeling bloated and having wind
having diarrhoea (with or without constipation)
small, hard, pellet-like or ribbon-like stools (faeces)

These symptoms may vary from person to person.

Talk to your doctor or pharmacist if these symptoms do not improve after a while, if you develop new symptoms, or you are concerned about your symptoms.

Your diet and lifestyle can also help to treat IBS:

How you restrict your diet depends on the way IBS affects you. If you find that certain foods bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but ask your doctor or pharmacist for more information.

Some people find that learning to relax can help to lessen their symptoms of IBS. You may find it helpful to set aside a few moments each day to relax and gently unwind.

Before you take Mebeverine Taj Pharma Hydrochloride MR

Do not take Mebeverine Taj Pharma Hydrochloride MR if:

You are allergic to Mebeverine Taj Pharma Hydrochloride or any of the other capsule ingredients (see section 6 for a list of ingredients)

If the above applies to you, do not take this medicine and talk to your doctor or pharmacist.

Take special care with Mebeverine Taj Pharma Hydrochloride MR

Check with your doctor or pharmacist before taking your medicine if:

You have developed new symptoms or your symptoms have become worse
You have liver or kidney problems.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.

Taking Mebeverine Taj Pharma Hydrochloride MR with food and drink

You can drink alcohol while you are taking Mebeverine Taj Pharma Hydrochloride MR.

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.

Pregnancy and breast-feeding

You should talk to your doctor or pharmacist before taking Mebeverine Taj Pharma Hydrochloride MR if you are pregnant or might become pregnant. There is only limited information about the safety of Mebeverine Taj Pharma for pregnant women. Your doctor may advise you to stop taking Mebeverine Taj Pharma Hydrochloride MR before you become pregnant or as soon as you know you are pregnant. Mebeverine Taj Pharma Hydrochloride MR should not be used during breast-feeding.

Driving and using machines

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

How to take Mebeverine Taj Pharma Hydrochloride MR

Always take Mebeverine Taj Pharma Hydrochloride MR as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Try to take the capsule 20 minutes before a meal – some people find their symptoms to be strongest after they have eaten.
Swallow the capsule whole with a drink of water. Do not chew the capsule.

How much Mebeverine Taj Pharma Hydrochloride MR to take

Adults (including the elderly)

The normal starting dose is one capsule twice a day.

Children

This medicine is not recommended for use in children.

If you take more Mebeverine Taj Pharma Hydrochloride MR than you should

If you or someone else takes too much Mebeverine Taj Pharma Hydrochloride MR (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Mebeverine Taj Pharma Hydrochloride MR

If you miss a capsule, take it when you remember. However, if it is nearly time for the next dose, skip the missed dose and carry on as normal with the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Mebeverine Taj Pharma Hydrochloride MR

Do not stop taking Mebeverine Taj Pharma Hydrochloride MR without talking to your doctor, even if you feel better.

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

Possible side effects

Most people will not have problems, but some may get some side effects (unwanted effects or reactions).

If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

Skin rash, red itchy skin

Reporting of suspected adverse reactions

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.

How to store Mebeverine Taj Pharma Hydrochloride MR

Keep out of the reach and sight of children.
Do not use the capsules after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.
Store Mebeverine Taj Pharma Hydrochloride MR in the original package.
Do not store above 30°C. Do not refrigerate or freeze.
Return any unused capsules to a pharmacist.
Medicines should not be disposed of via waste water or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Mebeverine Taj Pharma Hydrochloride MR contains

Each capsule contains 200 mg of Mebeverine Taj Pharma Hydrochloride in a modified release formulation.

The capsules also contain Magnesium Stearate, Polyacrylate Dispersion 30%, Talc, Hypromellose, Methacrylic Acid-Ethyl Acrylate Copolymer (1:1) Dispersion 30% And Glycerol Triacetate. The Capsule Shell Contains Gelatine and Titanium Dioxide. The printing Inks contain Shellac, Black Iron Oxide, Propylene Glycol, Concentrated Ammonia Solution and Potassium Hydroxide.

What Mebeverine Taj Pharma Hydrochloride MR looks like and the contents of the pack

Mebeverine Taj Pharma Hydrochloride MR Capsules are white, opaque.

Boxes containing 10, 15, 20, 30, 40, 50, 60 and 80 capsules in PVC-Al press through strips.
Each box contains 30, 60, 90, 120, 240, 360 and 500 capsules.

Not all pack sizes may be marketed.