ANALGISER Tablet Ref.[28102] Active ingredients: Paracetamol

• Analgiser should be administered with caution to patients with renal and/or hepatic insufficiency.
• Dosage should not be continued for more than 3 days without consultation of your doctor. Prolonged use without medical supervision may be harmful.
• Patients should never exceed the recommended dosage.
• Do not take any other paracetamol-containing products during the therapy with Analgiser
• Not to be given to children under 6 years without medical advice.
• Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of delayed, serious liver damage. The note should be stated on the label and leaflet.
• The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Drug interactions:

• Anti-coagulants (e.g. warfarin): paracetamol may inhibit the metabolism of warfarin or may interfere with formation of clotting factors. Thus, there is the increased risk of bleeding. Occasional doses have no significant effect.
• Oral contraceptives increase the rate of clearance of paracetamol.
• Barbiturates, anticonvulsants, tricyclic antidepressants may increase the hepatotoxic effect of paracetamol, particularly in case of overdosage.
• The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.
• Plasma concentration of Chloramphenicol may be increased with concomitant use.
• Absorption of paracetamol is reduced by cholestyramine. Cholestyramine should not be taken within one hour if maximal analgesia is required.

Other interactions:

• Ethanol: In chronic alcoholics, excessive therapeutic doses or overdoses of paracetamol are more likely to cause hepatotoxicity than in non-alcoholic patients. Chronic alcoholics should avoid the use of paracetamol.

Pregnancy

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidimiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Breast-feeding

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Analgiser does not affect the ability of patients to drive or use machinery.

If Analgiser is taken in the recommended therapeutic doses side effects are rare.

Side-effects are usually mild and occur with the folowing frequency:Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Blood and lymphatic system disorders

Very rare: there have been reports of blood dyscrasias including thrombocytopenia, methaemoglobinaemia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Immune system disorders

Rare: other allergic reactions occasionally.

Skin and subcutaneous tissue disorders

Rare: skin rashes.

Very rare: Very rare cases of serious skin reactions have been reported.

Hepatobiliary disorders

Very rare: Also, there are isolated reports of liver damage.

Most reports of adverse reactions due to paracetamol are related to drug overdose.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None known.