PRESENTATION
- Tablets 500 mg. Packs of 30 and 100 tablets.
- Oral syrup 120 mg/5ml. 60 ml and 100 ml bottles.
COMPOSITION
- Each tablet contains 500 mg of paracetamol.
- Each 5ml of syrup contains 120 mg of paracetamol.
Major excipients
- Tablet: Maize Starch, methylparaben, Sodium Starch Glycolate and Purified talc
- Syrup: Sugar, Ethanol 96%, Propylene Glycol, Methylparaben and Amaranth flavor
ACTION
Peripheral Analgesic / Antipyretic
This medicine is an:
analgesic: it soothes pain,
antipyretic: it reduces fever.
INDICATIONS
It is recommended in the short-term treatment of illnesses involving pain or fever such as headaches, flu-like conditions, toothache, stiffness, painful periods.
DOSAGE AND METHOD OF ADMINISTRATION
This medicine should not be used with other paracetamol containing products.
Do not exceed the stated dose.
Tablets
Dosage: Paracetamol tablets should only be taken by adults and children over 35 kg (12 years or over).
Adults and children over 35 kg (12 years or over):
The maximum daily dose is 4 g.
In practice: 1 or 2 tablets, to be repeated if necessary after 4 hours, without exceeding 8 tablets per day.Children 6–12 years:
Take one tablet every 4 to 6 hours as required.
Not more than 4 tablets to be taken every 24 hours
This medicine is not suitable for children under 6 years of age.
Mode of administration:
Oral route: The tablets must be swallowed whole with a large glass of water.
Space out the doses by at least:
- 4 hours in adults
- 4–6 hours in children
- 8 hours in subjects with renal impairment; if in doubt seek medical advice.
Systematic doses make it possible to avoid fluctuations in fever or pain.
Duration of treatment:
- 3 days in the case of fever
- 5 days in the case of pain
Syrup
| Weight (kg) | Age | Dosage |
|---|---|---|
| 4–7 | up to 6 months | 2.5 ml |
| 7–10 | 6 months to 1 year | 2.5–5 ml |
| 10–12 | 1 to 2 year | 5–7.5 ml |
| 12–16 | 2 to 4 year | 7.5–10 ml |
| 16–35 | 4–12 year | 10–20 ml |
Dosage: The recommended daily dose depends on the weight of your child. It is 60 mg/kg/day, preferably in 4 divided doses, i.e. 15 mg/kg every 6 hours.
As a guideline:
Doses to be repeated if necessary, preferably after 6 hours, or not less than 4 hours.
In case of doubt, consult your doctor.
Maximum duration of continued use without medical advice: 3 days
Method and route of administration:Oral route.
Drink undiluted, or diluted in a glass of water, milk or fruit juice.
CONTRA-INDICATIONS
This medicine must not be used in cases of known allergy to paracetamol.
If in doubt, you must ask your doctor or pharmacist for advice.
SPECIAL WARNINGS AND PRECAUTIONS
Warnings:
If fever persists for more than 3 days and the pain for more than 5 days or if these symptoms get worse or if a new complaint occurs, do not continue treatment without asking your doctor or pharmacist for advice.
In case of severe liver or kidney impairment, seek medical advice.
Do not exceed the stated dose.
Precautions:
Tablets should only be used in adults and in children over six years.
For younger children, the syrup should be used.
Do not alternate between aspirin and paracetamol containing medicines.
In order to avoid possible harmful interactions between several medicines, inform your doctor or pharmacist of any current treatment.
This medicine contains paracetamol. Other medicines also contain this substance. Do not combine them so as not to exceed the maximum recommended doses (see instructions for use and dosage)
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
PREGNANCY AND BREAST-FEEDING
Under normal conditions of use, paracetamol may be taken during pregnancy and breast feeding. However, as a precaution, before taking this medicine, always ask your doctor or pharmacist for advice
OVERDOSE
Paracetamol overdose may cause liver failure.
Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
Symptoms of paracetamol overdose in the first 24 hours:
nausea, vomiting, anorexia, pallor and abdominal pain.
Action to take in the case of overdose:
In case of accidental overdose, stop the treatment and consult your doctor immediately. Gastric lavage must be used to evacuate paracetamol. The treatment includes the administration of oral or intravenous N-acetylcysteine, if possible before the 10ᵗʰ hour. General supportive measures must be available.
SIDE EFFECTS
Like any active product, this medicine may, in certain people, cause inconvenient side-effects:
- In isolated cases, a rash or an allergic reaction may occur. Stop the treatment immediately and inform your doctor.
- Exceptionally, the level of certain elements in the blood (platelets) may be abnormally low and this becomes apparent through nosebleeds or bleeding from the gums.
- In patients sensitive to aspirin or other NSAIDs, aggravation of bronchospasm has been reported.
- Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.
- Sudden wheezing, uttering or tightness of the chest or collapse.
- Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
- Severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation).
Inform your doctor or pharmacist of any inconvenient side effects, especially ones which are not mentioned in this leaflet.
Most reports of adverse reactions to paracetamol relate to overdosage with the drug.
STORAGE
Do not use after the "Expiry" shown on the external packaging.
Store below 30°C.
This is a medicine. A medicine is unlike other products. A medicine is an active product. Medicines should not be abused. Use medicines as prescribed by your doctor.
Your pharmacist understands medicines: follow his advice. It is inadvisable to take many different medicines. You should only take those medicines which you need.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Not all presentations are available in every country. Further information is available upon request.
Manufactured by:
ERNEST CHEMISTS LIMITED
P.O. BOX 3345 Accra, Ghana.
Under licence from:
EXETER HEALTH LIMITED
Queens gate House, 48, Queen Street,
Exeter, Devon EX4 3SR, United Kingdom.
This leaflet was last revised on June 2021.