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Manufacturers: Sun Pharmaceutical Industries Ltd (India)
Active ingredients
- Mebeverine
Disease class
- Dyspepsia
- Irritable bowel syndrome
- Functional bowel disorder, unspecified
- Other specified gallbladder diseases
- Other and unspecified abdominal pain
- Intestinal atony
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Antispasmodic
- Myotropic
Pharmacological group
- Myotropic antispasmodics
Niaspam capsule
Instructions for medical use of the drug
Description of pharmacological action
Blocks fast sodium channels of the myocyte cell membrane and disrupts the entry of Na+ ions into the cell, blocks the entry of Ca2+ ions through slow channels, slows down the processes of membrane depolarization and prevents muscle fiber contraction.
Indications for use
In adults: spasm of the gastrointestinal tract (including those caused by organic disease), intestinal colic, biliary colic; irritable bowel syndrome (symptomatic treatment of pain and cramping, as well as intestinal disorders and discomfort). In children over 12 years of age: functional gastrointestinal disorders accompanied by abdominal pain.
Release form
extended-release capsules 200 mg; strip 10, cardboard pack 3;
Pharmacodynamics
Blocks fast sodium channels of the myocyte cell membrane and disrupts the entry of Na+ ions into the cell, blocks the entry of Ca2+ ions through slow channels, slows down the processes of membrane depolarization and prevents muscle fiber contraction. Directly relaxes smooth muscles, mainly the gastrointestinal tract. Eliminates spasm, does not have a significant effect on normal intestinal motility. Does not have anticholinergic effect.
Pharmacokinetics
After oral administration, it is not detectable in plasma, because undergoes presystemic hydrolysis in the liver with the formation of 3,4-dimethoxybenzoic acid (veratric acid) and mebeverine alcohol. It is excreted primarily in the urine exclusively in the form of metabolites - veratric acid and mebeverine alcohol (including partly in the form of the corresponding carboxylic acid, partly in the form of demethylated carboxylic acid), and is determined in small quantities in bile. It is completely eliminated within 24 hours after taking a single dose. Does not accumulate.
Use during pregnancy
During pregnancy, it is possible if the expected effect of therapy exceeds the potential risk to the fetus. When used in therapeutic doses, mebeverine does not pass into breast milk.
Contraindications for use
Hypersensitivity.
Side effects
Dizziness (in some cases), diarrhea or constipation; allergic reactions (urticaria, angioedema, facial swelling and exanthema).
Directions for use and doses
Orally, without chewing, 20 minutes before meals, with water, adults and children over 12 years of age are prescribed 200 mg 2 times a day.
Overdose
Symptoms: central nervous system stimulation. Treatment: removal of unabsorbed drug from the gastrointestinal tract (gastric lavage, administration of activated charcoal), symptomatic and supportive therapy. A specific antidote is unknown.
Precautions for use
Due to the possibility of developing dizziness during treatment, special care must be taken when driving vehicles, operating machines and mechanisms.
Storage conditions
List B: In a dry place, protected from light, at a temperature not exceeding 25 °C.
Best before date
24 months
ATX classification:
A Digestive tract and metabolism
A03 Drugs for the treatment of functional disorders of the gastrointestinal tract
A03A Drugs used for intestinal dysfunction
A03AA Synthetic anticholinergics - esters with a tertiary amino group
A03AA04 Mebeverine
Composition and release form
The main active ingredient included in the drug is mebeverine hydrochloride. 1 capsule contains 200 mg of the main component.
Additional substances:
- microcrystalline cellulose;
- hydrogenated vegetable oil;
- purified talc;
- magnesium stearate;
- colloidal silicon dioxide.
The drug is available in the form of tablets (capsules), the contents of which are white or close to white powder. The presence of small lumps and compactions is acceptable.
Similar drugs:
- Duspatalin Oral tablets
- Duspatalin Capsule
- Nomigren Oral tablets
- Spasmol Tablets
- Drotaverine Solution for intravenous and intramuscular administration
- Driptan Oral tablets
- Cystrin Oral tablets
- Drotaverine Aerosol
- Spasmol Solution for injection
** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Niaspam, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Niaspam is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
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Indications and contraindications
The instructions for use of the drug indicate the following indications:
- irritable bowel syndrome (diarrhea, alternating constipation and diarrhea, pain in the lower abdomen, increased gas formation);
- spastic discomfort in the abdomen that occurs against the background of an organic disease of the gastrointestinal tract;
- dyspepsia due to diverticulitis, enteritis, inflammatory processes in the digestive tract;
- disruption of the liver and bile ducts, which is accompanied by pain or spasms.
The drug helps to cope with pain symptoms of any intensity and has virtually no contraindications. The exception is individual intolerance to the components included in the composition, children and adolescents under 18 years of age.
special instructions
Studies regarding the possibility of treatment with the drug during pregnancy have not been conducted. For this reason, the medicine Niaspam is not prescribed to this category of people.
There is also insufficient information on the level of penetration of components into breast milk. It is better to stop breastfeeding during the period of therapy. Lactation is restored after stopping the medication.
The specific effects of the drug on fertility in women and men have not been examined. Appropriate animal studies have proven that there are no adverse effects of the main active ingredient (mebeverine).
Tests have been conducted on animals regarding the possibility of Niaspam therapy and taking alcoholic beverages together. Based on the results, it was concluded that there are no specific reactions during the interaction of mebeverine and ethanol.
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While taking the drug Niaspam, you can drive vehicles and moving machinery. Numerous reviews indicate the absence of a negative effect on concentration, although no special studies have been conducted on this issue.
Storage of the drug Niaspam is recommended at temperatures up to +25°C. It is allowed to take capsules for 2 years from the date of production. To avoid overdose and poisoning, the medication should be stored in its original packaging, out of the reach of children.
Comparison of Niaspam with Duspatalin
Only a doctor can determine which is better, Niaspam or Duspatalin for a particular patient, taking into account the primary disease and the state of general health.
Medicines contain a similar active ingredient - mebeverine hydrochloride, contained in one tablet in the same volume (200 mg). The difference is in the manufacturer: Niaspam is produced in India, Duspatalin - in France.
Despite the same composition, the production technology of medicines is different:
- the drug Duspatalin is rich in mebeverine microspheres, which are covered with two layers: the outer one is resistant to acid, the inner one consists of a prolonged action agent;
- Niaspam is formulated from a hot melt with the addition of a hydrophobic material (wax), by encapsulating granules and forming modified release capsules.
Taking into account the production technology, we can conclude that the clinical effect of Niaspam is somewhat different from the therapeutic effect of Duspatalin:
- The drug produced in France (Duspatalin) is highly effective in cases of impaired motor function of the duodenum and has a selective effect on the sphincter of Oddi. Despite this, the drug has little effect on intestinal motor function, especially in the lower sections.
- The drug produced in India (Niaspam) has virtually no effect on the sphincter of Oddi and the motor function of the biliary tract, but is effective in relation to the motor function of the intestine, restoring the coordination of contraction of its upper and lower sections.
The drug Niaspam is an effective remedy used in the treatment of diseases of the gastrointestinal tract as a method of relieving pain and spasms. Therefore, in combination with taking pills, etiotropic therapy aimed at eliminating the causative factor is indicated.
Side symptoms and overdose
The drug is well tolerated by the body and rarely causes negative reactions after oral administration. In exceptional cases, it is possible to develop symptoms characteristic of an allergic picture:
- itching, burning, hyperemia of the skin;
- rashes, urticaria on the epidermis (more often on the stomach and arms);
- angioedema of the face.
If you accidentally take the drug in a dosage that exceeds the permissible volume, the excitability of the central nervous system increases. Other symptoms of overdose are neurological in nature and may be associated with the cardiovascular system (in the form of increased heart rate, bradycardia, etc.).
No cases of anaphylactic shock or death were recorded.
The instructions indicate that in case of an overdose of Niaspam, symptomatic therapy is carried out. Gastric lavage measures are effective if no more than 1 hour has passed after taking an increased dose of the drug. To do this, take a large amount of liquid (up to 1 liter), press on the root of the tongue, inducing vomiting.
A specific antidote to eliminate the consequences of an overdose has not been developed.
Instructions for use
The medicine Niaspam is prescribed for oral administration. The tablets are drunk whole, without chewing, with plenty of liquid (about 100 ml).
The limitation on chewing the capsule before swallowing may be explained by the fact that its shell promotes prolonged release of the drug.
The daily dosage of the drug is 2 capsules, divided into 2 doses. Take the tablets 20-30 minutes before meals, in the morning and evening. The permissible period of drug therapy is determined by the doctor individually.
If you manage to miss a pill, doubling the next dose is not required. Also, correction of the daily volume is not necessary if renal or liver failure develops.
