- Name of the medicinal product
Mebeverine Hydrochloride Tablets USP 135mg Taj Pharma
- Qualitative and quantitative composition
Mebeverine Hydrochloride Tablets USP 135mg Taj Pharma
Each film sugar-coated tablets contains:
Mebeverine Hydrochloride USP 135mg
Excipients: Q.S.
Excipients with known effect: Lactose and Sucrose
For a full list of excipients, see section 6.1
- Pharmaceutical for
Film sugar coated Tablets
Round white sugar-coated tablets,
- Clinical particulars
- Therapeutic indications
For the symptomatic relief of Irritable Bowel Syndrome.
- Posology and method of administration
For oral use.
The coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because of the unpleasant taste.
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.
Adults (including the elderly):
One tablet three times a day, preferably 20 minutes before meals.
If symptoms persist for more than 2 weeks, consult your doctor.
Warning: Do not exceed the stated dose.
Paediatric Population
Mebeverine Taj Pharma 135 mg tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
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
Since Mebeverine Taj Pharma coated tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
If this is the first time you have had these symptoms, consult your doctor before using any treatment.
If any of the following apply, do not use Mebeverine Taj Pharma. It may not be the right treatment for you. See your doctor as soon as possible.
- you are aged 40 years or over
- you have passed blood form the bowel
- you are feeling sick or vomiting
- you are looking pale and feeling tired
- you are suffering from severe constipation
- you have a fever
- you have recently travelled abroad
- you are or may be pregnant
- you have abnormal vaginal bleeding or discharge
- you have difficulty or pain passing urine
Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.
- 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 safety and efficacy 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.
Distribution:
No significant accumulation occurs after multiple doses.
Biotransformation:
Mebeverine Taj Pharma hydrochloride is mainly metabolized by esterases, which split the ester bonds into veratric acid and Mebeverine Taj Pharma alcohol firstly.
The main metabolite in plasma is DMAC (demethylated carboxylic acid).
The steady state elimination half-life of DMAC is 2.45 h. During multiple dosing Cmax of DMAC for the coated tablets with 135 mg is 1670 ng/ml and tmax is 1 h.
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
Lactose, starch (potato), povidone, talc, magnesium stearate, sucrose, gelatin, acacia, carnauba wax.
- Incompatibilities
Not applicable.
- Shelf life
5 years.
- Special precautions for storage
Do not store above 30°C. Store in the original package.
- Nature and contents of container
Pack Size:
Boxes containing 10, 15, 84 or 100 tablets in blister strips.
Each box contains 10, 15, 84,100, 200, 300, 360 and 500
Not all pack size may be marketed.
- 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
Mebeverine Hydrochloride Tablets USP 135mg Taj Pharma
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mebeverine Hydrochloride 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 become 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 is and what it is used for
- Before you take Mebeverine Taj Pharma Hydrochloride
- How to take Mebeverine Taj Pharma Hydrochloride
- Possible side effects
- How to store Mebeverine Taj Pharma Hydrochloride
- Further information
1. What Mebeverine Taj Pharma Hydrochloride is and what it is used for
Mebeverine Taj Pharma Hydrochloride is a tablet 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 and pain.
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 if you develop new symptoms or if these symptoms continue for more than 2 weeks.
Your diet and lifestyle can also help treat IBS:
How you restrict your diet depends on the way IBS affects you. If you find that certain things bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but ask your 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
Do not take Mebeverine Taj Pharma Hydrochloride if:
- You are allergic to any of the tablet ingredients (see section 6 for a list of ingredients)
- You are younger than 18 years of age
If any of 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
See your doctor before using any IBS treatment if you:
- have not suffered from IBS before or
- have developed new symptoms or your symptoms have become worse
- have liver or kidney problems.
Talk to your doctor or pharmacist if any of the following applies to you:
- You are 40 years of age or over and your symptoms have changed or it has been some time since you last had IBS
- You have blood in your stools (faeces)
- You are feeling sick (nauseous) or are sick (vomiting)
- You are looking pale and feeling tired
- You have constipation
- You have a fever
- You have recently travelled abroad
- You are pregnant, or planning to become pregnant
- You are a woman and you have unusual bleeding or discharge from your vagina
- You have difficulty or pain when passing water (urinating)
Your doctor will tell you whether it is safe for you to start taking Mebeverine Taj Pharma Hydrochloride.
Taking Mebeverine Taj Pharma Hydrochloride with food and drink
You can drink alcohol while you are taking Mebeverine Taj Pharma Hydrochloride.
Taking other medicine
No interactions with other medicines are known.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking Mebeverine Taj Pharma Hydrochloride 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 before you become pregnant or as soon as you know you are pregnant. Mebeverine Taj Pharma Hydrochloride 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.
Important information about some of the ingredients of Mebeverine Taj Pharma Hydrochloride
This medicine contains lactose and sucrose (types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
- How to take Mebeverine Taj Pharma Hydrochloride
How to take Mebeverine Taj Pharma Hydrochloride
- Try to take the tablets 20 minutes before a meal — some people find their symptoms to be strongest after they have eaten.
- Swallow the tablets whole with water. Do not chew the tablets.
How much Mebeverine Taj Pharma Hydrochloride to take
Adults and the elderly:
- Take 1 tablet 3 times a day
- The number of tablets you take can be lowered if your symptoms improve
- Do not take more than 3 tablets per day.
Do not give Mebeverine Taj Pharma Hydrochloride to children or adolescents younger than 18 years.
How to stop taking Mebeverine Taj Pharma Hydrochloride
You can lower the dose if your symptoms get better.
If you take more Mebeverine Taj Pharma Hydrochloride than you should
If you or someone else takes too much Mebeverine Taj Pharma Hydrochloride (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
If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed. Do not 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.
- 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 tablets. 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 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.
- How to store Mebeverine Taj Pharma Hydrochloride
- Keep out of the reach and sight of children.
- You should lock this medicine in a cupboard or medicine cabinet.
- Do not use the tablets after the expiry date which is printed on the carton and blister pack.
- Do not store your tablets above 30°C and keep them in the original container.
If your doctor stops your treatment, return any unused tablets to a pharmacist.
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.
- Further information
What Mebeverine Taj Pharma Hydrochloride contains
Each tablet contains 135 mg Mebeverine Taj Pharma Hydrochloride
The tablets also contain lactose, starch (potato), povidone, talc, magnesium stearate, sucrose, gelatin, acacia and carnauba wax.
What Mebeverine Taj Pharma Hydrochloride looks like and contents of the pack
Mebeverine Taj Pharma Hydrochloride tablets are white, round and sugar coated with no markings.
Boxes containing 10, 15, 84 or 100 tablets in blister strips.
Each box contains 10, 15, 84,100, 200, 300, 360 and 500
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
