Non –Opioid analgesics and antipyretics
Paracetamol 500 mg- Diphenhydramine Hcl 25mg
20Tablets - 500Tablets
T34
534/2004
26/9/2004
Excipients | Povidone, Maize Starch, Sodium Starch Glycolate, Microcrystalline Cellulose, Magnesium Stearate, Red Colorant E127 |
Mechanism Of Action | Paracetamol is a clinically proven analgesic/antipyretic. Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating centre. Diphenhydramine HCl is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. |
INDICATIONS | Temporary relief of headaches, minor aches, and pains with accompanying sleeplessness |
CONTRAINDICATIONS | Hypersensitivity to any of the ingredients. -Paracetamol should not be used in patients with severe liver disease. -Do not use this product if you are being treated with monoamine oxidase inhibitors, or within two weeks of stopping treatment with these medications. -Do not take this product during pregnancy or whilst breast-feeding. |
Side EFFECTS | Paracetamol may cause allergic reactions in the form of a rash or blood disorders (including neutropenia, pancytopenia and leucopenia). These should disappear on stopping the treatment. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes. Diphenhydramine hydrochloride may cause sedation, disturbances affecting the stomach and intestines, headache, blurred vision, ringing in the ears, swings in mood, lack of appetite, difficulty in urination, dryness of mouth and tightness of chest and tingling, and heaviness and weakness of hands |
WARNINGS | Diphenhydramine hydrochloride should be given with care to patients with raised pressure in the eye (glaucoma) or difficulty in passing urine due to enlargement of the prostate gland. Elderly patients are more susceptible to the central nervous system depressant and lowering of blood pressure effects even at dose quantities effective for treatment. The warning signs of damage caused by ototoxic medicines may be masked by diphenhydramine. Taking more than the recommended dose of paracetamol may cause severe liver damage. Caution should be exercised when Kanawati Kanadol Night is given to patients suffering from liver or kidney disease. This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other agents which slow down the nervous system activity. Patients should be warned against taking charge of vehicles or machinery or performing potentially dangerous tasks where loss of concentration may lead to accidents. Do not take concurrent medication containing paracetamol. Do not use continuously for longer than 10 days without consulting your doctor. |
DRUG INTERACTIONS | Interactions between paracetamol and Phenobarbital, phenytoin, or tricyclic antidepressants may occur. Caution should be exercised when paracetamol is used with drugs affecting the liver. Other central nervous system depressants, such as alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers, if taken together, will increase the chance of sedation. Be careful when taking medicines containing tricyclic anti-depressants or atropine together |
Pregnancy And lactations | Do not take this product during pregnancy or whilst breast-feeding. |
Dosage And Administration | Adults and children over 16 years: 1-2 tablets at bedtime. Do not exceed the recommended dose. Not recommended for children under 16 years of age. |
OVERDOSE | If more than the recommended dose has been taken, speak to your doctor or take the patient to the nearest hospital immediately. At first (during the first 24 hours), a patient who has taken a large overdose of this medicine may be pale and nauseous and begin to vomit have a lack of appetite and stomach pain. Symptoms during the first two days of severe poisoning do not reflect the potential seriousness of the overdose. Liver kidney or heart damage may all the result from paracetamol overdose. Specialized treatment is essential as soon as possible. Treatment is supportive and related to symptoms |
Storage Conditions | Store below 25°C Protect from moisture and light Keep out of reach of children. |