Duspatalin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DUSPATALIN® (DUSPATALIN®)

Composition:

Active substance: mebeverine hydrochloride;

One tablet contains mebeverine hydrochloride 135 mg;

Excipients: lactose monohydrate; potato starch; povidone; talc; magnesium stearate;

Coating: talc, sucrose, gelatin, acacia, carnauba wax.

Pharmaceutical form. Coated tablets.

Main physicochemical properties: white, round, sugar-coated tablet, approximately 11 mm in diameter and weighing approximately 420 mg.

Pharmacotherapeutic group. Drugs for functional gastrointestinal disorders. Synthetic anticholinergic agents, esterified tertiary amines. ATC code A03AA04.

Pharmacological properties.

Pharmacodynamics.

Mebeverine is a myotropic spasmolytic with a direct effect on the smooth musculature of the gastrointestinal tract. It relieves spasms without suppressing normal intestinal motility.

Pharmacokinetics.

Absorption.

Mebeverine is rapidly and completely absorbed after oral administration of tablets.

Distribution.

No significant accumulation is observed after repeated administration.

Biotransformation.

Mebeverine hydrochloride is mainly metabolized by esterases, which in the first stage of metabolism cleave the ester bonds, forming 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. After repeated administration, Cmax and tmax of DMCA are 1670 ng/mL and 1 hour, respectively.

Elimination.

Mebeverine is completely metabolized and is not excreted unchanged; its metabolites are almost entirely eliminated. Veratric acid is excreted in urine. Mebeverine alcohol is also excreted by the kidneys, partly as the corresponding carboxylic acid (CA) and partly as demethylcarboxylic acid (DMCA).

Clinical characteristics.

Indications.

Symptomatic relief of irritable bowel syndrome.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients listed in the section "Composition".

Interaction with other medicinal products and other forms of interactions.

Interaction studies have not been conducted, except for interaction with alcohol. In vitro and in vivo studies in animals have demonstrated absence of any interaction between mebeverine hydrochloride and ethanol.

Special precautions for use

Since the coated tablets of the drug Duspatalin® contain lactose and sucrose, patients with rare hereditary disorders such as galactose intolerance, fructose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome, or sucrase-isomaltase insufficiency should not take this medication.

Do not use the medicinal product without consulting a physician and contact your doctor as soon as possible in the following cases:

• age over 40 years,
• gastrointestinal bleeding,
• malaise or vomiting,
• pallor and fatigue,
• severe constipation,
• fever,
• recent travel abroad,
• pregnancy or suspicion of pregnancy,
• abnormal vaginal bleeding or discharge,
• difficult urination or pain during urination.

Consult your doctor if new symptoms occur, if existing symptoms worsen, or if there is no improvement after 2 weeks of treatment.

Use during pregnancy or breastfeeding

Pregnancy

There are only very limited data on the use of mebeverine in pregnant women. Reproductive toxicity studies in animals are insufficient. Mebeverine is not recommended during pregnancy.

Breastfeeding

It is unknown whether mebeverine or its metabolites are excreted in human breast milk. Excretion of mebeverine into animal breast milk has not been studied. Mebeverine should not be used during breastfeeding.

Fertility

There are no clinical data on the effect of mebeverine on male or female fertility; however, animal studies do not indicate any harmful effect of mebeverine on fertility.

Ability to influence reaction speed when driving or operating machinery

Studies on the influence of mebeverine on the ability to drive a vehicle or operate machinery have not been conducted. However, the pharmacodynamic and pharmacokinetic profile of the drug, as well as post-marketing experience, do not suggest any adverse effect of mebeverine on the ability to drive or operate machinery.

Dosage and Administration.

For oral use.

The tablets should be taken with sufficient amount of water (not less than 100 mL). Chewing is not recommended due to unpleasant taste.

Duration of use is not limited.

If one or more doses are missed, the patient should take the next dose as scheduled. Missed dose(s) should not be taken additionally to the regular dose.

Adults (including elderly patients).

Take 1 tablet three times daily, preferably 20 minutes before meals.

If symptoms persist for more than 2 weeks, consult a physician.

Warning.

Do not exceed the recommended dose.

Special populations.

Dosage studies in elderly patients and patients with impaired renal and/or hepatic function have not been conducted. However, based on available post-marketing data, no specific risk has been identified in elderly patients or in patients with impaired renal and/or hepatic function. Dose adjustment in elderly patients and in patients with impaired renal and/or hepatic function is not considered necessary.

Children.

Due to insufficient safety and efficacy data, the drug is not recommended for use in children and adolescents (under 18 years of age).

Overdose.

Symptoms. CNS stimulation is theoretically possible in case of overdose. In cases of mebeverine overdose, symptoms were either absent or mild and rapidly disappeared. Observed overdose symptoms were of neurological and cardiovascular origin.

Treatment. No specific antidote is known. Symptomatic treatment is recommended in case of overdose. Gastric lavage is recommended only in cases of intoxication with multiple drugs or if overdose symptoms are diagnosed within 1 hour after drug intake. Measures to reduce absorption are not necessary.

Side effects.

The adverse reactions listed below have been reported during post-marketing use. The exact frequency cannot be determined based on available data.

Allergic reactions, primarily affecting the skin, as well as systemic reactions not limited to skin manifestations, have been observed.

Immune system disorders:

hypersensitivity (anaphylactic reactions).

Skin and subcutaneous tissue disorders:

urticaria, angioneurotic edema, facial swelling, rash.

Shelf life. 3 years.

Storage conditions. Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 30 °C.

Packaging. 15 tablets per blister, 1 blister per cardboard box.

Dispensing category. Over-the-counter.

Manufacturer. Mylan Laboratories SAS.

Manufacturer's address.
Route de Belleville, Lieu dit Maillard, 01400, Chatillon-sur-Chalaronne, France.