Efferalgan 150 mg suppositories – for pain and fever in children weighing 8 to 12 kg

Efferalgan 150 mg suppositories contain 150 mg of paracetamol per suppository. Paracetamol is an analgesic and antipyretic – it relieves pain and lowers fever.

According to the approved leaflet, this strength is intended only for children weighing 8 to 12 kg (about 6 to 24 months), to relieve mild to moderate pain and/or fever – for example in flu-like illness, headache, toothache or muscle pain.

When is an Efferalgan 150 mg suppository given to a child and how is it dosed correctly?

Key facts about the medicine

What is the Efferalgan 150 mg suppository used for?

Efferalgan 150 mg suppositories are used for symptomatic treatment of mild to moderate pain and/or fever, in conditions such as headache, flu-like illness, toothache and muscle pain.

This strength is intended only for children weighing 8 to 12 kg (about 6 to 24 months). Other paracetamol strengths exist for children of other weights – ask a doctor or pharmacist.

How is it used and dosed?

The recommended daily dose of paracetamol is about 60 mg/kg per day, divided into 4 single doses of about 15 mg/kg every 6 hours.

• Route: rectal; suppositories must not be broken.
• Because of the risk of rectal irritation, do not give more than 4 times a day; rectal use should be switched to oral as soon as possible.
• Give doses at regular intervals, day and night, ideally every 6 hours.
• The total paracetamol dose must not exceed 60 mg/kg per day.
• If the child's temperature is above 38.5 °C, the leaflet also advises removing excess clothing, giving plenty of fluids and not keeping the child in an overheated room.
• Duration: no longer than 3 days without asking a doctor or pharmacist.

Special patient groups

• Children 8–12 kg: the only target group for this strength.
• Impaired kidney function: at least 6 hours between doses (creatinine clearance above 10 mL/min) or 8 hours (below 10 mL/min).
• Liver disease, Gilbert's syndrome, chronic eating disorder or dehydration: the daily dose must not exceed 60 mg/kg; medical advice is needed.

Contraindications – when the medicine must not be used

• hypersensitivity to paracetamol or the excipients; allergy to peanuts or soya (the medicine contains soya lecithin)
• serious liver disease (severe hepatocellular insufficiency or acute liver decompensation)
• current or recent inflammation of the rectum or anus, bleeding from the lower bowel

Precautions and warnings

• Make sure the child is not receiving another paracetamol-containing medicine (prescription or non-prescription) to avoid overdose.
• The risk of local irritation increases with longer treatment, shorter intervals and higher doses; suppositories are not recommended in diarrhoea.
• Paracetamol can cause serious skin reactions (AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis) – stop treatment permanently at the first sign of a rash.
• In children, another antipyretic is combined with paracetamol only on a doctor's decision and under supervision.
• Caution is needed with liver or kidney disease, Gilbert's syndrome, G6PD deficiency, eating disorders, dehydration; in acute viral hepatitis the doctor may stop treatment.

Interactions with other medicines, alcohol and food

• oral anticoagulants (vitamin K antagonists): at high doses paracetamol may increase their effect; INR monitoring is needed
• flucloxacillin: increased risk of metabolic acidosis, especially with severe kidney impairment, sepsis or malnutrition
• laboratory tests: paracetamol may affect blood sugar and uric acid measurements – tell the doctor

Pregnancy and breastfeeding

The medicine is intended for children, so this section refers to paracetamol in general: according to the summary of product characteristics, paracetamol is used in pregnancy only if clinically necessary, at the lowest effective dose and for the shortest time. At therapeutic doses it can be used during breastfeeding.

Driving and using machines

Paracetamol has no or negligible influence on the ability to drive and use machines.

Possible side effects

• Rare: skin rash or redness, allergic reactions (sudden swelling of the face or neck, sudden weakness with a drop in blood pressure) – stop the medicine immediately, tell the doctor and never use paracetamol-containing medicines again.
• Rare: severe skin reactions – same action.
• Very rare: blood count changes (low white blood cells or platelets, which may lead to nose or gum bleeding), liver disease.
• Reported: diarrhoea, abdominal pain, raised liver enzymes, increased or decreased INR.
• Due to the dosage form: irritation of the rectum or anus.

Suspected side effects can be reported to your doctor, pharmacist or the Medicines and Medical Devices Agency of Serbia (ALIMS).

Overdose, missed dose and stopping treatment

• Overdose: symptoms (nausea, vomiting, loss of appetite, sweating, marked pallor, abdominal pain) usually appear within the first 24 hours; liver damage may develop later. Seek medical help immediately, even if the child seems well.
• Missed dose: do not give a double dose; give the next dose keeping to the interval.
• Stopping: the medicine is given only while pain or fever lasts; if complaints last longer than 3 days or the child gets worse, a medical examination is needed.

Composition, packaging and manufacturer

• One suppository contains 150 mg of paracetamol.
• Excipient: hard fat with additives (contains soya lecithin).
• Pack: PVC/PE blister of 5 suppositories; carton with 2 blisters (10 suppositories) and a patient leaflet.
• Marketing authorisation holder: Amicus SRB d.o.o., Belgrade (licence 515-01-01044-22-001 of 9 January 2023).
• Manufacturer: UPSA SAS, Agen, or UPSA SAS, Le Passage, France (the manufacturer of the specific batch is stated on the pack).

Storage

• Store below 30 °C.
• Shelf life: 3 years.
• Keep out of the sight and reach of children; do not use after the expiry date on the pack.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Which children is the Efferalgan 150 mg suppository for?

For children weighing 8 to 12 kg, which roughly corresponds to 6 to 24 months of age. The dose is always based on body weight, not on age alone.

How often is Efferalgan 150 mg given?

One suppository is ideally given every 6 hours (the minimum interval is 4 hours), with no more than 4 suppositories in 24 hours.

When should you switch from 80 mg to 150 mg?

The strength is chosen by body weight: 80 mg is for children of 4 to 6 kg and 150 mg for children of 8 to 12 kg. Doses are not transferred between strengths – check the choice with a doctor or pharmacist.

For how many days can it be given without a doctor?

No longer than 3 days without asking a doctor or pharmacist. If pain or fever lasts longer, the child should be examined by a doctor.

Related information

For additional care and support with fever, see also the Digital thermometers category – products in this category do not replace the medicine you have been prescribed.

Sources

• ALIMS – Patient leaflet Efferalgan®, 150 mg, suppositories (licence 515-01-01044-22-001, 9 January 2023)
• ALIMS – Summary of product characteristics Efferalgan®, 150 mg, suppositories (revised January 2023)
• ALIMS – List of medicines dispensed without a prescription (dispensing status)

Sources checked on: 23 October 2026.