MEBAGEN SR 200/MG CAP 30/CAP

Indications

Approved Uses

Symptomatic treatment of irritable bowel syndrome (IBS) and other functional gastrointestinal disorders associated with abdominal pain, cramps, and intestinal spasm.

Off-Label Uses

Not routinely recommended off‑label; occasionally used in practice for other functional GI spasm syndromes, but evidence is limited and should be clinician-directed.

Dosage & Administration

Dosing by Condition

Adults (IBS/functional GI spasm): 200 mg sustained‑release capsule orally twice daily (morning and evening), preferably ~20 minutes before meals.

Initial Dose

One 200mg capsule twice daily.

Maintenance Dose

200mg SR capsule twice daily (400mg/day total)

Maximum Dose

400mg per day (as 200mg twice daily).

Children's Dosage

Not recommended for children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

How to Take

Swallow the sustained‑release capsule whole with water; do not crush, chew, or open; take preferably about 20 minutes before meals (e.g., morning and evening).

Side Effects

Common Side Effects

Generally uncommon; may include nausea/dyspepsia, dizziness or headache, and hypersensitivity reactions such as skin rash/urticaria (rarely angioedema).

Side Effect Frequency

Hypersensitivity reactions (rash, urticaria, angioedema, anaphylaxis) are rare; other adverse effects are generally uncommon and not consistently reported as ‘common’ at 1-10%.

Safety & Warnings

Contraindications

Hypersensitivity to mebeverine hydrochloride or to any excipient.

Age Restriction

Not recommended under 18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant drug interactions are known/expected.

Interaction Severity

No clinically significant drug-drug interactions are well documented; routine interaction screening is still advised.

Special Populations

Children

Not recommended for children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

Storage & Patient Advice

Stopping the Medicine

May be stopped when symptoms resolve; no taper is required.

Monitoring Requirements

No routine monitoring required.

Pharmacology

Mechanism of Action

Musculotropic antispasmodic that directly relaxes gastrointestinal smooth muscle (antispasmodic effect) with minimal effect on normal motility; the precise molecular mechanism is not fully established (proposed effects include modulation of smooth‑muscle ion fluxes).

Duration of Effect

Approximately 12 hours per SR dose (supports twice‑daily dosing).

Half-Life

Parent mebeverine has a short apparent half‑life (about 1-2 hours); the main metabolite (DMAC) has an elimination half‑life around 2.5 hours (reported ~2.45 h).

Product Information

Available Dosage Forms

For this SFDA-registered product: sustained‑release oral capsule (200 mg) in blister pack of 30 capsules.

Composition per Dose

Each sustained-release capsule: 200mg mebeverine hydrochloride

Generic Availability

Yes

Gi Condition

IBS

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