Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage.
In case of overdose, get medical help straight away. Quick medical attention is critical for adults as well as children even if signs or symptoms are not noticed.
Caution in patients with severely impaired liver or kidney function. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease. Chronic alcohol users should consult a doctor before use.
Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Paracetamol has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens- Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal.

Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain paracetamol. These reactions can occur with first-time use of paracetamol or at any time while it is being taken.

Anyone who develops a skin rash or reaction while using paracetamol should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with paracetamol should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers.

Health care professionals should be aware of this rare risk and consider paracetamol along with other drugs already known to have such an association, when assessing patients with potentially drug induced skin reactions.

Paracetamol can cause accidental poisoning in toddlers and infants. Paracetamol-containing products should be kept well out of reach of children.
Potentially fatal hepatotoxicity can result from paracetamol overdosage. However, in rare cases, hepatotoxicity has occurred in patients receiving high or excessive doses within therapeutic doses. Certain patients may be more susceptible to paracetamol hepatotoxicity, e.g., chronic alcoholics, patients with liver disease, or those who are malnourished or taking other drugs that induce hepatic enzymes.
Because of the risk of hepatotoxicity, patients should be cautioned against the inadvertent administration of excessive doses of paracetamol by using multiple paracetamol-containing products at once, such as cough and cold remedies, analgesics or arthritic formulations, antipyretics or products for relief of menstrual symptoms or muscle spasm. Administration of paracetamol to children may be especially prone to error due to the many concentrations and strengths of products available. To avoid dosing errors, all product labels should be checked carefully to ensure calculation of the amount of paracetamol to be given.
Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided.
Do not give this medicine with any other paracetamol-containing product.


Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol.
Close monitoring, including measurement urinary 5-oxoproline, is recommended.
Important information about some of the ingredients of this medicine The medicine contains the sweetener xylitol in an amount of 1.5 grams in every 5 ml syrup.
There may be a mild laxative effect. The caloric value is 2.4 kcal per 1 gram xylitol.
• The medicine contains colour red FDC No. 40, which may cause an allergic reaction.
• The medicine contains sodium in an amount of 5.86 mg in every 5 ml syrup. The medicine contains less than 1 mmol (23 mg) sodium in every 5 ml syrup and is therefore considered sodium-free.
• This medicine contains 625 mg propylene glycol in every 5 ml syrup. Consult the doctor or pharmacist before starting treatment: ○ If your child is under 5 years of age, particularly if your child is being treated with other medicines containing propylene glycol or alcohol.
○ Do not take this medicine if you suffer from liver or kidney disease. The doctor may ask you to undergo additional tests while taking this medicine.
6/5/24, 4:22 PM        Acamoli forte 50 mg/ml syr strawberry/tutti frutti flavour SK 07-2024 

○ Do not take the medicine if you are pregnant or breastfeeding, unless recommended by the doctor. The doctor may ask you to undergo additional tests while taking this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
No adverse effects known.