Finished product reference

Belladonna Pb

Elixir · Oral · 19.4 µg/6.5 µg/103.7 µg/16.2 mg/5mL · 60 mL

List code
135
Pharmacologic class
Antimuscarinic antispasmodic with barbiturate sedative (belladonna alkaloids / phenobarbital)

What it is and how it works

Belladonna alkaloids (hyoscyamine, atropine, hyoscine) competitively block muscarinic receptors, reducing gastrointestinal smooth-muscle spasm and secretions. Phenobarbital adds mild sedation by enhancing GABA-A receptor-mediated inhibition.

Indications

Adjunctive treatment of irritable bowel syndrome and other functional gastrointestinal disorders with spasm, and as adjunct in peptic ulcer disease (historical use).

Dosage and administration (summary)

Oral: usually 1–2 tablets (or the equivalent volume of elixir) three to four times daily according to the product, adjusted to response.

Contraindications

Angle-closure glaucoma, obstructive uropathy (e.g. prostatic hypertrophy), obstructive gastrointestinal disease, paralytic ileus, severe ulcerative colitis or toxic megacolon, myasthenia gravis, acute intermittent porphyria and hypersensitivity to barbiturates.

Warnings and precautions

Antimuscarinic effects include dry mouth, blurred vision, tachycardia, urinary retention and heat intolerance; caution in the elderly, cardiac disease and hyperthyroidism. Phenobarbital causes drowsiness, may be habit-forming, potentiates alcohol and CNS depressants, and is a potent enzyme inducer reducing the efficacy of many drugs, including hormonal contraceptives and warfarin.

Pregnancy

Avoid in pregnancy; phenobarbital is associated with congenital malformations and neonatal withdrawal or bleeding.

Storage and supply

Store below 25 °C, protected from light and moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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