REMEDOL Oral suspension Ref.[50372] Active ingredients: Paracetamol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Remedol is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever.

4.2. Posology and method of administration

Posology

Age: 2-3 months Dose
1. Post-vaccination fever 2.5 ml

If necessary, after 4-6 hours, give a
second 2.5 ml dose
2. Other causes of Pain and Fever - if
your baby weighs over 4 kg and was born
after 37 weeks
• Do not give to babies less than 2 months of age.
• Do not give more than 2 doses.
• Leave at least 4 hours between doses.
• If further doses are needed, talk to your doctor or pharmacist.

Children aged 3 months-6 years:

Child’s Age How Much How often (in 24 hours)
3-6 months2.5 ml4 times
6-24 months5 ml4 times
2-4 years7.5 ml4 times
4-6 years10 ml4 times
• Do not give more than 4 doses in any 24 hour period.
• Leave at least 4 hours between doses.
• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

It is important to shake the bottle well before use.

The Elderly

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

Method of administration

Oral administration.

4.9. Overdose

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

a) Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.

Or

b) Regularly consumes ethanol in excess of recommended amounts.

Or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light.

6.5. Nature and contents of container

Amber glass bottle with a child resistant closure. A measuring spoon of 5 ml (graduated every 2.5 ml) is supplied with this pack. Pack-size of 100 ml oral suspension.

6.6. Special precautions for disposal and other handling

No special requirements.

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