Adults and children over the age of 10 years
Symptomatic treatment of abdominal pain and cramps, bowel disturbances and intestinal discomfort
related to irritable bowel syndrome.
Treatment of gastro-intestinal spasm secondary to organ diseases.

For oral use.
The capsules must be taken with a sufficient quantity of water (at least 100 ml). They must not be
chewed because the coating is designed for a modified release mechanism (see section 5.2).
Adults and children over the age of 10 years
Twice daily 1 capsule of 200 mg, one in the morning and one in the evening.
There are no safety risks for a duration of use up to 1 year. However, when the desired effect has been
achieved after a few weeks, the dose may be reduced gradually.
If one or more doses have not been taken, the patient must continue with the next dose as prescribed; the
missed dose should not be taken on top of the usual dose.
Paediatric population
Duspatalin Retard should not be used in children below the age of 10 years because the safety and
efficacy have not been established in this group.
Elderly patients and patients with kidney and/or liver disorders
No dose studies have been performed in elderly patients and patients with kidney and/or liver disorders.

Not applicable.

As far as known, mebeverine has no interactions with other medicinal products.

Pregnancy
There are no or limited amount of data from the use of mebeverine in pregnant women. Animal studies
are insufficient with respect to reproductive toxicity (see section 5.3). Use of Duspatalin Retard is
advised against during pregnancy.
Breast-feeding
It is unknown whether mebeverine or one of its metabolites is excreted in human milk. Excretion of
mebeverine in breast milk has not been investigated in animals. Duspatalin Retard should not be used
during breast-feeding.
Fertility
No clinical data are available on the fertility in men or women; however, animal studies do not indicate
damaging effects from Duspatalin Retard (see section 5.3).

No studies have been carried out into the effect on the ability to drive and use machines. Neither the
pharmacodynamic and pharmacokinetic profiles, nor the post-marketing experience indicate an adverse
effect of mebeverine on the ability to drive and use machines.

The following undesirable effects have been reported spontaneously during post-marketing use. No
exact frequency can be determined from the available data.
The observed allergic reactions are mainly, but not exclusively, limited to the skin.
Skin and subcutaneous tissue disorders
Urticaria, angioedema, facial oedema, exanthem
Immune system disorders
Hypersensitivity (anaphylactic reactions)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions.

To report any side effect(s):
-National Pharmacovigilance Center (NPC)
o Fax: +966-1-205-7662
oCall NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
oToll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc

Very little is reported in the literature about symptoms after mebeverine overdose. In cases of
mebeverine overdose, the symptoms were either absent or mild and usually quickly reversible. Observed
overdose symptoms are of a neurological nature. There is no known specific antidote and symptomatic
treatment is recommended. Measures to decrease absorption are not necessary.

Pharmacotherapeutic group: synthetic anticholinergics, esters with tertiary amino group. ATC code:
A03AA04.
Mechanism of action and pharmacodynamic effects
Mebeverine is a musculotropic spasmolytic agent with a direct effect on the smooth muscles of the
gastrointestinal tract without affecting the normal intestinal motility. Because this effect is not brought
about via the autonomous nervous system, the typical anticholinergic adverse effects do not occur.

Absorption
Mebeverine is quickly and fully absorbed after oral administration of tablets. The formulation with
modified release allows for a twice daily dosage schedule.
Distribution
No significant accumulation occurs after multidosage use.
Biotransformation
Mebeverine hydrochloride is mainly metabolised by esterases, which first split ester compounds into
veratric acid and mebeverine alcohol. The main metabolite in plasma is DMAC (demethylated
carboxylic acid). The steady state elimination half life of DMAC is 5.77 hours. With multidosage use
(200 mg twice daily), the C max of DMAC is 804 ng/ml and the tmax is approximately 3 hours.
The relative biological availability of the modified-release capsule appears to be optimal with an average
ratio of 97%.

Elimination:

Mebeverine is not excreted as such but excreted fully metabolised; the metabolites are excreted almost
completely. Veratric acid is excreted in the urine; mebeverine alcohol is also excreted in the urine, partly
as the corresponding carboxylic acid (MAC) and partly as the demethylated carboxylic acid (DMAC).
Paediatric patients
No clinical investigations in children have taken place with any form of mebeverine.

Effects in repeat-dose studies after oral and parenteral doses were indicative of central nervous
involvement with behavioral excitation, mainly tremor and convulsions. In the dog, the most sensitive
species, these effects were seen at oral doses equivalent to 3 times the maximum recommended
clinical dose of 400mg/day based on body surface area (mg/m2) comparisons.
The reproductive toxicity of mebeverine was not sufficiently investigated in animal studies. There was
no indication of teratogenic potential in rats and rabbits. However, embryotoxic effects (reduction in
litter size, increased incidence of resorption) were noticed in rats at doses equivalent to twice the
maximum daily clinical dose. This effect was not observed in rabbits.
No effects on male or female fertility were noted in rats at doses equivalent to the maximum clinical
dose.
In conventional in vitro and in vivo genotoxicity tests mebeverine was devoid of genotoxic effects. No
carcinogenicity studies have been performed.

- Capsule granulate: Magnesium stearate, polyacrylate dispersion (copolymer of ethyl acrylate and
methyl methacrylate), talc, hypromellose, methacrylic acid – ethyl acrylate copolymer (1:1)
dispersion (containing sodium laurylsulphate and polysorbate 80), glycerol triacetate
- Capsule shell: Gelatine, titanium dioxide (E171), printing inks: shellac (E904), black iron oxide
(E172), soy lecithin (E322) and Antifoam DC.

Not applicable.

Do not store above 30° C
Do not refrigerate
Keep in the original package

Blister strips of 15 capsules, 2 strips per pack. The blister strips are made of Alu/Alu foil

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.