Mevulak MR Capsule

(Mebeverine HCI)

QUALITATIVE AND QUANTITATIVE COMPOSITION
Mevulak MR 200mg Capsule
Each capsule contains:
Mebeverine hydrochloride modified release pellets MS
eq to Mebeverine hydrochloride
PHARMACEUTICAL FORM
Capsule
CLINICAL PARTICULARS

THERAPEUTIC INDICATIONS

200mg
For the symptomatic relief of irritable bowel syndrome.tiktok live earn money

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

One capsule of 200mg twice daily, to be given one in the moming and one in the evening. Paediatric Population: Not recommended for use in children and adolescents below 18, due to insufficient data on saff If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s Special Population: No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, m Method of administration:
Adults (including the elderly): The capsules should be swallowed with a sufficient amount of water (at least 100mi wa is intended to ensure a prolonged release mechanism.tiktok live apk

CONTRAINDICATIONS

Hypersensitivity to the active substance.tiktok live

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltese ins INTERACTION WITH

OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

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 hydrochlori

FERTILITY, PREGNANCY AND LACTATION

Fertility

There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of m Pregnancy: There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies Mebeverine is not recommended during pregnancy.

Breastfeeding

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

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

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

UNDESIRABLE EFFECTS

The following adverse reactions have been reported spontaneously during post marketing user precise frequency can 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.

OVERDOSE

Theoretically CNS excitability may occur in cases of overdose. In cases where mehevent 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.

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMIC PROPERTIES

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

PHARMACOKINETIC PROPERTIES

Absorption

Mebeverine hydrochloride is rapidly and completely absorbed after oral administration of tablets. The modified release formulation permits a twice daily dosing
scheme.

Distribution

No significant accumulation occurs after multiple doses.

Biotransformation

Mebeverine hydrochloride is mainly metabolised by esterases, initially splitting the ester bonds into veratric acid and mebeverine alcohol. The main metabolite in plasma is demethylated carboxylic acid. The steady state elimination half-life of demethylated carboxylic acid is 5.77h. During multiple dosing (200mg b.id.) the Cmax of demethylated carboxylic acid is 804ng/ml and Tmax is about 3 hours. The relative bioavailability of the modified release capsule appears to be optimal with a mean ratio
of 97%

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 and partly as the demethylated carboxylic acid. Paediatric population: The safety and efficacy of the product has only been evaluated in adults.

SHELF LIFE

See expiry on the pack.
AVAILABILITY