Clinical medicine profile
Hyoscine-N-butylbromide / Paracetamol
Non-opioid analgesic / antipyretic
- Route
- ORAL / RECTAL / IV
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
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A traceable source link is not attached to this profile. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [Hyoscine-N-butylbromide] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid. [Paracetamol] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid.
Precautions
- Do not exceed 4 g/day in adults (lower in malnutrition, alcohol, elderly, liver disease — often ≤2–3 g).
- Account for combination products (cold remedies).
- Overdose is a medical emergency (NAC protocol).
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Adult: 1-2 tab TID up to 6 tabs daily [for less than days]
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.
Use, effects & interactions
Indications
- Paroxysmal and spastic pain in GIT, GUT and biliary disorders Clinical selection for Hyoscine-N-butylbromide / Paracetamol should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Non-opioid analgesic / antipyretic.
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- GI disturbances, staggering, skin rashes, conjunctivitis, retrosternal pain.
- Anticholinergic side effects: dry mouth/skin, difficult in swallowing, visual disturbances, flushings, and drowsiness.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Hyoscine-N-butylbromide, Paracetamol.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Combination product.
Read complete mechanism
Combination product. Component mechanism (Hyoscine-N-butylbromide): Anticholinergic agent. Paracetamol inhibits central prostaglandin synthesis via effects on cyclo-oxygenase pathways (including COX-2 preferential central effects) and may engage serotonergic descending pathways. Antipyretic effect via hypothalamic heat-regulating centre. Minimal peripheral anti-inflammatory action.
30–60 minutes oral
4–6 hours
ORAL / RECTAL / IV
(glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted.
~2–3 h; prolonged in liver disease/overdose.
Pregnancy, lactation & diet
[Hyoscine-N-butylbromide] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration. [Paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration.
Compatible with breastfeeding at standard doses.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| UNIGAN TABS 500 | Not recorded | 10MG * 100S | KES 2,199.71Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.