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

Meva Tablets/Mebeverine Tablets 135 mg:
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.
Paediatric 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.
Meva 135 mg Tablets:
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.
If symptoms persist for more than 2 weeks, consult your doctor.
Warning: Do not exceed the stated dose.
Paediatric 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 coated 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). 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).

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, face oedema, exanthema.

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.
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, without affecting normal gut motility. The exact mechanism of
action is not known, but multiple mechanisms, such as a decrease in ion channel
permeabilities, blockade of noradrenaline reuptake, a local anesthetic effect, changes in
water absorption as well as weak anti-muscarinergic and phosphodiesterase inhibitory effect
might contribute to the local effect of mebeverine on the gastrointestinal tract. Systemic
side-effects as seen with typical anti-cholinergics are absent.

Clinical efficacy and safety
All formulations of mebeverine were generally safe and well tolerated in the recommended
dose regimen.
Paediatric population
The safety and efficacy of the product has only been evaluated in adults.

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 Cmax of
DMAC for the coated tablets with 135 mg is 1670 ng/ml and tmax is 1 h.
Elimination:
Mebeverine is not excreted as such, but metabolised 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).

Paediatric population
The safety and efficacy of the product has only been evaluated in adults.

Effects in repeat-dose toxicity studies, after oral and parenteral doses, were indicative of
central nervous involvement with behavioural 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.

Lactose Anhydrous
Microcrystalline Cellulose (PH102)
Povidone K29/32
Maize Starch
Croscarmellose Sodium
Colloidal Silicon Dioxide (Aerosil 200)
Magnesium Stearate
Coating material:
Opadry white(03H28604)
Propylene Glycol
Purified Water

Not applicable.

Do not Store above 30°C.

Immediate Container: Alu-PVC/PVDC Blister.
30 (3 X 10) Tablets are packed in outer carton along with PIL.

No special requirements.
Any unused product or waste material should be disposed of in accordance with local
requirements.