Spark (mebeverin) hard capsules with prolonged release 200 mg. №30

Description

Spark (mebeverin) hard capsules with prolonged release 200 mg. №30

Composition

active substance: 1 capsule contains mebeverine hydrochloride, pellets in terms of mebeverine hydrochloride 200 mg;

excipients in the composition of pellets: spherical sugar, povidone, shellac, talc, methacrylate copolymer dispersion;

the composition of the capsule shell: gelatin, titanium dioxide (E 171).

Dosage form

Prolonged capsules are hard.

Main physical and chemical properties: hard gelatin capsules. The capsule body is transparent, the lid is white. The contents of the capsule are granules (pellets) of almost white color, spherical in shape.

Pharmacotherapeutic group

Remedies used in functional gastrointestinal disorders. Synthetic anticholinergics, esterified tertiary amines.
ATX code A0ZA A04.

Pharmacological properties

It is a myotropic antispasmodic agent. Has a direct effect on the smooth muscles of the gastrointestinal tract, without affecting the normal intestinal motility. Reduces the permeability of ion channels, blocks the reuptake of norepinephrine, has a local anesthetic effect, alters the absorption of water. It normalizes intestinal motility without causing relaxation of smooth muscle fibers of the gastrointestinal tract.

Indications:

• for the symptomatic treatment of spasms, pain, discomfort in the intestinal region associated with irritable bowel syndrome;
• for the symptomatic treatment of spasms of the gastrointestinal tract.

Contraindications:

• with an allergy to an active ingredient;
• with intolerance to auxiliary components;
• under the age of 18;
• during pregnancy, breastfeeding.

Application during pregnancy and lactation

There is not enough data on the use of the drug during pregnancy, so the use is not recommended.
There is insufficient information on the excretion of the active substance (mebeverine) or its metabolites in mother’s milk. During breastfeeding, the drug is not used. If necessary, taking trimebutine breastfeeding is stopped.
There are not enough clinical data on the effect of the active substance (mebeverine) on female and male fertility, however, animal studies have not demonstrated a harmful effect on reproductive function.

Method of administration and dosage

Spark is applied orally 20 minutes before meals. The capsule should not be chewed as the capsule shell provides a sustained release of the drug. Capsules must be taken with a sufficient volume of water (at least one hundred milliliters).
The standard dose is 200 mg twice a day (morning and evening).
The duration of admission is not limited.
If you miss one or more doses, the drug must be continued with the next dose. Missed doses do not need to be taken in addition to your usual dose.
Dosage studies in patients with renal / hepatic insufficiency, elderly patients have not been conducted. The available data did not identify risk factors in the treatment of these categories of patients, so a change in the dosage regimen is not required.

Overdose

Symptoms: increased excitability of the central nervous system, cardiovascular disorders.
In the described cases of overdose, the symptoms of intoxication were not observed or they were mild and quickly disappeared. Gastric lavage is advisable within 1 hour from the moment of taking the drug.
Treatment: symptomatic treatment is recommended.
If the dose is exceeded, signs of an overdose are detected, it is required to stop taking this drug, consult with your doctor.

Side effects

Allergic reactions: angioedema, urticaria, exanthema.
Dermatological disorders: itching, dermatitis.