Duspatalin Retard 200 hard capsules of prolonged action 200 mg 2 blisters of 15 pcs.

Adults and children aged 10 and over:

• symptomatic treatment of abdominal pain and cramps, intestinal disorders and discomfort in the intestinal area in irritable bowel syndrome;
• treatment of gastrointestinal spasms of secondary genesis caused by organic diseases.

• active ingredient: mebeverine hydrochloride;
• 1 capsule contains mebeverine hydrochloride 200 mg;
• excipients: magnesium stearate, methacrylate copolymer dispersion, talc, hypromellose, polyacrylate dispersion, glycerol triacetate;
• hard gelatin capsule (size No. 1): titanium dioxide (E 171), gelatin.

Hypersensitivity to the active substance or to any of the excipients of the drug.

The following adverse reactions have been reported spontaneously during post-marketing use. The frequency cannot be estimated from the available data.

Allergic reactions were observed predominantly, but not exclusively, on the skin.

Skin and subcutaneous tissue disorders: urticaria, angioedema, facial edema, rash.

Immune system disorders: hypersensitivity (anaphylactic reactions).

For oral use.

The capsules should be taken with sufficient water (at least 100 ml). It is not recommended to chew them as the capsule coating is designed to provide a prolonged release mechanism.

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 to the regular dose.

Use during pregnancy or breastfeeding

Duspatalin Retard 200 is not recommended for use during pregnancy.

Duspatalin Retard 200 should not be used during breastfeeding.

Children

Duspatalin Retard 200 should not be used in children under 3 years of age due to the lack of clinical data for this age group. Duspatalin® Retard 200, 200 mg capsules, should not be used in children aged 3 to 10 years due to the high content of the active substance.

Ability to influence reaction speed when driving vehicles or other mechanisms

No studies on the effects on the ability to drive and use machines have been conducted. The pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effects of mebeverine on the ability to drive and use machines.

Symptoms: Theoretically, central nervous system excitation is possible in case of overdose. In cases of overdose, symptoms were absent or mild and usually resolved quickly. The symptoms of overdose that were observed were of neurological or cardiovascular origin.

Treatment. Specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is recommended only in case of intoxication with multiple drugs, which is diagnosed within 1 hour from the moment of taking the drugs. Measures to reduce absorption are not necessary.

Interaction studies have not been conducted, except for the interaction with alcohol. In vitro and in vivo animal studies have demonstrated the absence of any interaction between Duspatalin Retard 200 and ethanol.

Store in the original packaging at a temperature not exceeding 25 °C.

Do not store at temperatures below 5 ° C. Keep out of the reach of children.