Instructions Spark extended-release hard capsules 200 mg blister No. 30
Composition
active ingredient: 1 capsule contains mebeverine hydrochloride, pellets equivalent to mebeverine hydrochloride 200 mg;
excipients in the composition of pellets: spherical sugar, povidone, shellac, talc, methacrylate copolymer dispersion;
capsule shell composition: gelatin, titanium dioxide (E 171).
Dosage form
The extended-release capsules are hard.
Main physical and chemical properties: hard gelatin capsules. The capsule body is transparent, the cap is white. The contents of the capsule are granules (pellets) of almost white color, spherical shape.
Pharmacotherapeutic group
Drugs used in functional gastrointestinal disorders. Synthetic anticholinergics, esterified tertiary amines.
ATX code A03A A04.
Pharmacological properties
Pharmacodynamics.
Mechanism of action and pharmacodynamic effects.
Spark® is a myotropic antispasmodic with a selective effect on the smooth muscles of the digestive tract. It eliminates spasms without inhibiting normal intestinal motility. Since this action is not mediated by the autonomic nervous system, there are no typical anticholinergic side effects.
Clinical efficacy and safety.
Significant relief of core symptoms of irritable bowel syndrome (e.g., abdominal pain, bowel habits) has generally been observed in reference and baseline-controlled clinical trials.
All formulations of mebeverine were generally safe and well tolerated at the recommended dosage regimen.
Children.
Clinical studies of tablets and capsules have been conducted only in adults. Clinical efficacy and safety data from clinical studies, as well as post-marketing experience with mebeverine pamoate suspension in patients 3 years of age and older, demonstrate that mebeverine is an effective, safe, and well-tolerated drug.
Clinical trials of mebeverine suspension have shown it to be effective in reducing symptoms of irritable bowel syndrome in children. Further open-label, baseline-controlled trials of mebeverine suspension have confirmed its efficacy.
The dosage regimen of tablets and capsules is calculated based on the safety and tolerability of mebeverine.
Pharmacokinetics.
Absorption.
Mebeverine is rapidly and completely absorbed after oral administration in tablet form. Due to the prolonged release of the drug from the capsule, it can be taken twice a day.
Distribution.
With repeated use of mebeverine, no significant accumulation occurs.
Biotransformation.
Mebeverine hydrochloride is mainly metabolized by esterases, which in the first stage of metabolism cleave the ester bonds with the formation of veratric acid and mebeverine alcohol. In plasma, demethylcarboxylic acid (DMCA) is the main metabolite. The half-life of DMCA at steady state is 5.77 hours. With repeated use of capsules (200 mg 2 times a day), Cmax of DMCA was 804 ng/ml, and tmax was about 3 hours. The relative bioavailability of the prolonged-release capsules was optimal with an average ratio of 97%.
Breeding.
Mebeverine is not excreted unchanged, it is completely metabolized, and the metabolites are excreted almost completely. Veratric acid is excreted in the urine. Mebeverine alcohol is also excreted by the kidneys in the form of the corresponding carboxylic (CC) or demethylcarboxylic acids (DMCC).
Children.
Pharmacokinetic studies in children have not been conducted.
Indication
Adults and children aged 10 and over:
· symptomatic treatment of abdominal pain and spasms, intestinal disorders and discomfort in the intestinal area in irritable bowel syndrome;
· treatment of gastrointestinal spasms of secondary genesis caused by organic diseases.
Contraindication
Hypersensitivity to the active substance or to any of the inactive components of the drug.
Interaction with other drugs and other types of interactions.
Interaction studies with alcohol have been conducted. In vitro and in vivo animal studies have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol.
Use during pregnancy or breastfeeding
There are only very limited data from the use of mebeverine in pregnant women. Animal reproductive toxicity studies are insufficient. Mebeverine hydrochloride is not recommended for use during pregnancy.
It is not known whether mebeverine or its metabolites are excreted in human breast milk. The excretion of mebeverine in animal milk has not been studied. Spark® should not be used during breast-feeding.
There are no clinical data on the effects on male or female fertility, however, animal studies do not indicate harmful effects of mebeverine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effects on the ability to drive and use machines have not been conducted. The pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effects on the ability to drive and use machines.
Method of administration and doses
For oral use.
The capsules should be taken with sufficient water (at least 100 ml). Chewing is not recommended as the capsule coating is designed to provide prolonged release.
Adults and children over 10 years of age should take 1 capsule 2 times a day (morning and evening).
The duration of use is not limited. If one or more doses are missed, the patient should take the next dose as prescribed. The missed dose(s) should not be taken in addition.
Special populations.
No dosage studies have been conducted in the elderly, patients with renal and/or hepatic impairment. Based on available post-marketing data, no specific risk has been identified in the elderly, patients with renal and/or hepatic impairment. No dose adjustment is considered necessary for these patient groups.
Children
Used for children aged 10 and over.
Overdose
In case of overdose, central nervous system excitation may occur. In cases of mebeverine overdose, symptoms were absent or mild and resolved quickly. The symptoms of overdose observed were of neurological or cardiovascular origin. There is no specific antidote known. Symptomatic treatment is recommended. Gastric lavage is recommended only in case of intoxication with several drugs within 1 hour of taking the drugs. Measures to reduce absorption are not necessary.
Adverse reactions
Skin and subcutaneous tissue disorders: urticaria, angioedema, facial edema and rash.
Immune system disorders: hypersensitivity (anaphylactic reactions).
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister. 3 or 5 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 74.
