Instructions for Duspatalin film-coated tablets 135 mg No. 15
Composition
active ingredient: mebeverine hydrochloride;
1 tablet contains mebeverine hydrochloride 135 mg;
excipients: lactose monohydrate; potato starch; povidone; talc; magnesium stearate;
shell: talc, sucrose, gelatin, acacia, carnauba wax.
Dosage form
Film-coated tablets.
Main physicochemical properties: round white tablet, coated with a sugar shell, with a diameter of 11 mm and a weight of 420 mg.
Pharmacotherapeutic group
Drugs for functional gastrointestinal disorders. Synthetic anticholinergics, esterified tertiary amines.
ATX code A03A A04.
Pharmacological properties
Pharmacodynamics
Mebeverine is a myotropic antispasmodic with a direct effect on the smooth muscles of the gastrointestinal tract. It eliminates spasms without inhibiting normal intestinal motility.
Pharmacokinetics
Absorption.
Mebeverine is rapidly and completely absorbed when taken orally as tablets.
Distribution.
No significant accumulation is observed after repeated use.
Biotransformation.
Mebeverine hydrochloride is mainly metabolized by esterases, which in the first stage of metabolism cleave ester bonds to form veratric acid and mebeverine alcohol.
In plasma, demethylcarboxylic acid (DMCA) is the main metabolite. The half-life of DMCA at steady state is 2.45 hours. With multiple administration, Cmax and tmax of DMCA are 1670 ng/ml and 1 hour, respectively.
Breeding.
Mebeverine is completely metabolized and is not excreted unchanged, 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) and demethylcarboxylic acids (DMCC).
Indication
Symptomatic relief of irritable bowel syndrome.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Interaction with other medicinal products and other types of interactions
Interaction studies have only been conducted with alcohol. In vitro and in vivo animal studies have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol.
Application features
Since Duspatalin® film-coated tablets contain lactose and sucrose, patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
You should not use the medicine without consulting your doctor before starting treatment if you have the following conditions for the first time:
- age from 40 years,
- intestinal bleeding,
- nausea or vomiting,
- paleness or feeling tired,
- severe constipation,
- fever,
- recent trip abroad,
- pregnancy or suspected pregnancy,
- abnormal vaginal bleeding or discharge,
- difficulty urinating or pain when urinating.
Consult your doctor if new symptoms develop, or if existing symptoms worsen, or if symptoms do not improve after more than 2 weeks of treatment.
Use during pregnancy or breastfeeding
Pregnancy
There are only very limited data from the use of mebeverine in pregnant women. Animal reproductive toxicity studies are insufficient. Mebeverine is not recommended for use during pregnancy.
Breast-feeding
It is not known whether mebeverine or its metabolites are excreted in human breast milk. The excretion of mebeverine in animal breast milk has not been studied. Duspatalin® should not be used during breastfeeding.
Fertility
There are no clinical data on the effects on male or female fertility; however, animal studies do not indicate a harmful effect of mebeverine on fertility.
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 or use machines.
Method of administration and doses
For oral use.
The tablets should be taken with a sufficient amount of water (at least 100 ml). It is not recommended to chew them due to the unpleasant taste.
The duration of use is unlimited.
If one or more doses are missed, the patient should take the next dose as scheduled. The missed dose(s) should not be taken in addition to the regular dose.
Adults (including elderly patients):
It is advisable to take 1 tablet 3 times a day, preferably 20 minutes before meals.
If symptoms persist for more than 2 weeks, you should consult a doctor.
Reservation:
Do not exceed the indicated dose.
No dosage studies have been conducted in the elderly or in patients with renal and/or hepatic impairment. Based on available post-marketing data, no specific risk has been identified in the elderly or in patients with renal and/or hepatic impairment. No dose adjustment is considered necessary in the elderly or in patients with renal and/or hepatic impairment.
Children
Due to insufficient data on safety and efficacy, the drug is not recommended for use in children and adolescents under 18 years of age.
Overdose
In case of overdose, excitation of the central nervous system may theoretically occur. In cases of overdose with mebeverine, symptoms were absent or mild and resolved quickly. The symptoms of overdose observed were of neurological and cardiovascular origin.
Specific antidote is unknown. Symptomatic treatment is recommended in case of overdose. Gastric lavage is recommended only in case of intoxication with several drugs, or in case the symptoms of overdose are diagnosed within 1 hour from the moment of taking the drug. Measures to reduce absorption are not necessary.
Adverse reactions
The following adverse reactions have been reported spontaneously during post-marketing use. The exact frequency cannot be estimated from the available data.
Allergic reactions, mainly involving the skin, and reactions not limited to the skin, have been observed.
Immune system disorders:
hypersensitivity (anaphylactic reactions).
Skin and subcutaneous tissue disorders:
urticaria, angioedema, facial swelling, rash.
Expiration date
5 years.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 30 °C.
Packaging
15 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Abbott Healthcare SAS/Abbott Healthcare SAS.
Location of the manufacturer and its business address
Mylan Laboratories SAS. Address: Route de Belleville, Lieu dit Maillard, 01400, Chatillon-sur-Chalaronne, France.
You can report an adverse event or quality complaint to Abbott by phone (24/7) or at:
Ukraine, 01032, Kyiv, 110 Zhylyanska St., 2nd floor, tel. +380 44 498 6080 (for Ukraine and other CIS countries).
