Duspamen is indicated for the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis.

Duspamen is effectively used to treat the symptoms of these conditions, such as: colicky abdominal pain and cramps, persistent, non-specific diarrhea (with or without alternating constipation) and flatulence.

(See Section 5.2 Pharmacokinetic properties-Special patient population)

For oral use.

The coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because of the unpleasant taste.

Duration of use is not limited.

If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s) should not be taken in addition to the regular dose.

• Adults (including the elderly)

One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks, when the desired effect has been obtained, the dosage may be gradually reduced.

• Pediatric population

Mebeverine 135 mg tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.

• Special Population

No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.

Since Mebeverine tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

No interaction studies have been performed, except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol.

• Pregnancy

There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (See Section 5.3. Pre-clinical safety studies). Mebeverine is not recommended during pregnancy.

• Lactation

It is unknown whether mebeverine or its metabolites are excreted in human milk. The excretion of mebeverine in milk has not been studied in animals. Mebeverine should not be used during breast-feeding.

• Fertility

There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of mebeverine (See Section 5.3. Pre-clinical safety studies).

No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as postmarketing experience do not indicate any harmful effect of mebeverine on the ability to drive or to use machines.

The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data.

Allergic reactions mainly but not exclusively limited to the skin have been observed.

Immune system disorders
Hypersensitivity (anaphylactic reactions).

Skin and subcutaneous tissue disorders
Urticaria, angioedema, erythematous rash.

• Signs and symptoms

Theoretically CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible. Observed symptoms of overdose were of a neurological and cardiovascular nature.

• Treatment: No specific antidote is known and symptomatic treatment is recommended.

Gastric lavage should only be considered in case of multiple intoxication or if discovered within about one hour. Absorption reducing measures are not necessary.

Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC-Code: A03AA04.

Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.

• Absorption: Mebeverine is rapidly and completely absorbed after oral administration of tablets.
• Distribution: No significant accumulation occurs after multiple doses.
• Biotransformation: Mebeverine hydrochloride is mainly metabolized by esterases, which split the ester bonds into veratric acid and mebeverine alcohol firstly. The main metabolite in plasma is DMAC (demethylated carboxylic acid). The steady state elimination half-life of DMAC is 2.45 h. During multiple dosing C_max of DMAC for the coated tablets with 135 mg is 1670 ng/ml and t_max is 1 h.
• Elimination: Mebeverine is not excreted as such, but metabolized completely; the metabolites are excreted nearly completely. Veratric acid is excreted into the urine, mebeverine alcohol is also excreted into the urine, partly as the corresponding carboxylic acid (MAC) and partly as the demethylated carboxylic acid (DMAC).

During its development phase the entity mebeverine was extensively tested in several animal species in acute, (sub) chronic and reproduction investigations.

The oral LD50 ranged from 902 to 1995 mg/kg.

The main symptoms in the animals, after very high oral and parenteral doses, were indicative of central nervous involvement with behavioural excitation.

The dosages used in animal studies exceeded several times the dosages used for humans (40 mg/kg for animal dosing versus 6 mg/kg for humans).

No mutagenic or clastogenic effects were found in in vitro and in vivo studies with mebeverine.

• Starch 1500 pregelatinied;
• Lactose anhydrous;
• Povidone k-30;
• Magnesium sterate;
• Alcohol absolute;
• Opadry-OY-B-28920;
• Antifoam emulsion;
• Talc powder;
• Purified water.

Not applicable. 

Store below 25°C. 

PVC/PVDC clear/aluminum foil.

No special requirements.