1. Clinical Overview
A fixed-dose combination analgesic-antispasmodic agent primarily indicated for the symptomatic relief of pain and discomfort associated with primary dysmenorrhea (menstrual cramps) and premenstrual syndrome (PMS). Paracetamol provides central analgesic and antipyretic effects, Pamabrom acts as a mild diuretic to reduce water retention and bloating, and Dicyclomine is an antispasmodic that relieves smooth muscle spasms in the uterus and gastrointestinal tract.
| Onset | Duration | Bioavailability |
|---|---|---|
| Paracetamol: 30-60 minutes; Dicyclomine: 1-2 hours; Pamabrom: 1-2 hours. | Paracetamol: 4-6 hours; Dicyclomine: 4-6 hours; Pamabrom: 4-6 hours. | Paracetamol: ~88% (oral); Dicyclomine: ~67% (oral); Pamabrom: Data not well established, but considered good. |
2. Mechanism of Action
The combination works synergistically: Paracetamol inhibits central cyclooxygenase (COX), particularly the COX-2 variant, and modulates the endogenous cannabinoid system, reducing prostaglandin synthesis in the CNS to elevate pain threshold. Dicyclomine is a competitive muscarinic acetylcholine receptor antagonist, directly relaxing smooth muscle in the uterus and GI tract via anticholinergic action, relieving spasm. Pamabrom is a xanthine derivative with mild diuretic properties, promoting renal excretion of sodium and water, thereby reducing premenstrual fluid retention, bloating, and breast tenderness.
3. Indications & Uses
- Primary Dysmenorrhea (Painful Menstrual Cramps)
- Symptomatic relief of Premenstrual Syndrome (PMS) including bloating and discomfort
4. Dosage & Administration
Adult Dosage: One tablet every 6-8 hours as needed for pain and cramps. Do not exceed 3 tablets in 24 hours. Should be taken with or after food.
Administration: Take with a full glass of water, preferably with or after meals to minimize gastric upset. Do not crush or chew. The tablet can be taken at the first sign of menstrual cramps and continued for 2-3 days as needed.
5. Side Effects
Common side effects may include:
- Dry mouth
- Drowsiness/sedation
- Dizziness
- Blurred vision
- Nausea
- Constipation
- Headache
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Alcohol (Chronic/heavy use) | Increased risk of paracetamol-induced hepatotoxicity due to CYP2E1 induction. | Major |
| Anticholinergics (e.g., Atropine, Trihexyphenidyl, TCAs, Antihistamines) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, confusion). | Major |
| Warfarin and other Coumarin Anticoagulants | Paracetamol may potentiate anticoagulant effect, increasing INR and bleeding risk, especially with doses >1.3g/day for >1 week. | Moderate |
| Metoclopramide, Domperidone | Dicyclomine may antagonize the prokinetic effect in the gut. | Moderate |
| Levodopa | Dicyclomine may reduce gastric emptying and absorption of levodopa. | Moderate |
| Digoxin | Anticholinergics may increase serum digoxin levels by decreasing gut motility. | Moderate |
| Other Hepatotoxic drugs (e.g., Isoniazid, Phenytoin, Carbamazepine, Rifampicin) | Increased risk of liver damage with paracetamol. | Major |
| Diuretics (e.g., Furosemide, Hydrochlorothiazide) | Additive diuretic effect with Pamabrom, increasing risk of dehydration and electrolyte imbalance. | Moderate |
7. Patient Counselling
- DO take with food or milk if stomach upset occurs.
- DO drink plenty of fluids while taking this medicine to maintain hydration, especially due to Pamabrom.
- DO inform your doctor about all other medications, including OTC drugs and herbal supplements.
- DO NOT exceed the recommended dose (3 tablets in 24 hours).
- DO NOT take with other products containing paracetamol.
- DO NOT consume alcohol while on this medication.
- DO NOT use for more than 3-5 days for pain without consulting a doctor.
8. Toxicology & Storage
Overdose: Paracetamol Overdose (>150 mg/kg): Stage 1 (0-24h): Nausea, vomiting, anorexia, malaise. Stage 2 (24-72h): Right upper quadrant pain, elevated LFTs. Stage 3 (72-96h): Peak hepatotoxicity, jaundice, coagulopathy, hepatic encephalopathy, potentially fatal liver necrosis. Dicyclomine Overdose: Exaggerated anticholinergic effects: severe dry mouth, dilated pupils, tachycardia, hyperthermia, CNS effects (restlessness, confusion, psychosis, seizures, respiratory depression). Pamabrom Overdose: Dehydration, electrolyte imbalance (hypokalemia, hyponatremia), weakness, arrhythmias.
Storage: Store below 30°C, in a cool, dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.