DUSPAMEN 135/MG TAB 30/TAB

Indications

Approved Uses

Symptomatic treatment of irritable bowel syndrome (IBS) and other functional gastrointestinal spasm/irritable colon conditions (e.g., spastic/irritable colon, mucous/spastic colitis) where abdominal pain and cramps are prominent.

Off-Label Uses

Not routinely recommended; evidence for uses such as functional dyspepsia is limited and not guideline-standard compared with its established role in IBS/functional bowel spasm.

Dosage & Administration

Dosing by Condition

IBS/functional GI spasm (immediate‑release 135 mg tablet): 135 mg three times daily, preferably ~20 minutes before meals; if using 200 mg modified‑release capsules (where available): 200 mg twice daily.

Initial Dose

One 135mg tablet three times daily.

Maintenance Dose

One 135mg tablet three times daily. Dosage may be gradually reduced after several weeks when the desired effect has been obtained.

Maximum Dose

405mg per day (135mg three times daily)

Children's Dosage

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

How to Take

Swallow the 135 mg film‑coated tablet whole with water; take about 20 minutes before meals; do not chew or crush.

Side Effects

Common Side Effects

Generally uncommon; most reported are hypersensitivity reactions (rash, urticaria, angioedema) and occasional dizziness or headache; GI effects such as nausea/constipation can occur but are not prominent.

Side Effect Frequency

Adverse effects are generally uncommon; most notable are hypersensitivity reactions (rash, urticaria, angioedema, anaphylaxis-rare). GI or CNS effects (e.g., nausea, dizziness, headache) may occur but are not typically listed as common in many product informations.

Safety & Warnings

Contraindications

Hypersensitivity to mebeverine hydrochloride or to any excipients.

Age Restriction

Not recommended for children under 18 years due to insufficient data

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant drug interactions are known/expected; can be used with common analgesics (e.g., paracetamol/ibuprofen). Avoid duplicating therapy with other antispasmodics/IBS medicines unless advised by a clinician.

Interaction Severity

No clinically significant drug-drug interactions are well documented for mebeverine in routine practice.

Food Interaction

No clinically significant food interaction, but it is recommended to take doses about 20 minutes before meals for best symptom control.

Alcohol Interaction

Safe

Special Populations

Breastfeeding

Consult Doctor

Children

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

Elderly

Standard adult dosing. No dosage adjustment is deemed necessary.

Kidney Impairment

No dose adjustment recommended; use caution in severe renal impairment due to limited data.

Liver Impairment

No dose adjustment recommended; use caution in severe hepatic impairment due to limited data.

Storage & Patient Advice

Storage Conditions

Store below 30°C; keep in the original blister/package to protect the tablets; keep out of reach of children.

Missed Dose

Take the missed dose when remembered unless it is close to the next scheduled dose; then skip and resume the regular schedule-do not double doses.

Stopping the Medicine

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

Overdose

Symptoms: CNS excitation (e.g., agitation, tremor, convulsions) and possible cardiovascular effects in large overdose. Management: symptomatic/supportive care; consider gastric decontamination (e.g., lavage/activated charcoal) if early; no specific antidote; seek urgent medical attention.

Pharmacology

Mechanism of Action

Musculotropic antispasmodic that directly relaxes gastrointestinal smooth muscle and reduces spasm with minimal effect on normal motility; proposed mechanisms include effects on ion channels and smooth‑muscle excitability (exact mechanism not fully defined).

Duration of Effect

Immediate‑release 135 mg tablets provide symptom control for roughly the dosing interval (about 6-8 hours), hence three times daily dosing.

Half-Life

Half‑life is best described for metabolites (not the parent); reported metabolite half‑lives are approximately ~2 hours (range about 1-3 hours depending on study/assay).

Bioavailability

Rapid absorption with extensive first‑pass metabolism; systemic exposure to unchanged (parent) mebeverine is very low (parent bioavailability is low/limited).

Metabolism

Extensively metabolized by ester hydrolysis (esterases) during first pass to mebeverine alcohol and corresponding acid metabolites (e.g., veratric/veratrylmandelic acid derivatives); CYP450 involvement is not considered clinically significant.

Protein Binding

Unknown / not reliably established in standard labeling for routine clinical use.

Product Information

Available Dosage Forms

For this SFDA product: film‑coated tablet (oral). Other mebeverine products may exist as modified‑release capsules, but an oral suspension is not a standard/typical registered form.

Composition per Dose

Each film-coated tablet: 135mg mebeverine hydrochloride

Generic Availability

Yes

Gi Condition

IBS

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