EFFERALGAN 1000MG GRANULES IN SACHET X8 CAPPUCCINO FLAVOUR

Indications

Efferalgan 1g cappuccino granules in sachet is indicated for the symptomatic treatment of mild to moderate pain and/or fever

Dosage

The recommended daily dose of paracetamol is 3000 milligrams (mg) per day, or 3 sachets. However, in case of more severe pain, the maximum dosage may be increased to 4000 mg per day, i.e. 4 sachets per day.

• Method and route of administration

Oral use only. Please take the granules directly into the mouth, on the tongue, then swallow without water.

• Frequency of administration

Regular dosing avoids fluctuations in pain or fever:
In adults and adolescents, dosing should be at least 4 hours apart.

Special Patient Groups

The lowest possible effective daily dose should be considered, not to exceed 60 mg per kg per day (not to exceed 3000 mg per day), in the following situations:

Adults and adolescents under 50 kg
Hepatic insufficiency (liver disease) (mild to moderate)

Chronic alcoholism
Dehydration

Chronic malnutrition

Gilbert's syndrome

No dosage adjustment is necessary in elderly patients

• Duration of Treatment

As with any pain medication (analgesic), the duration of treatment should be as short as possible and appropriate to the symptoms.

The duration of treatment is limited to :

5 days in case of pain and 3 days in case of fever

Precautions for use

Talk to your doctor or pharmacist before taking Efferalgan 1g cappuccino granules in a sachet

• if you weigh less than 50 kg
• in case of mild or moderate hepatic insufficiency (liver disease)
• in case of chronic alcoholism
• if you have severe renal insufficiency (serious kidney disease)
• if you have Gilbert's syndrome (familial non-hemolytic jaundice)
• if you are taking other medicines that have an effect on the liver at the same time as Efferalgan 1g cappuccino granules in a sachet
• if you have glucose-6phosphate dehydrogenase deficiency
• if you have haemolytic anaemia (abnormal decrease in the number of red blood cells and haemoglobin)
• if you are chronically malnourished (low liver glutathione stores) - if you are dehydrated (excessive loss of body water)
• if you have acute viral hepatitis or if this disease is diagnosed while you are taking Efferalgan 1g cappuccino granules in a sachet. Talk to your doctor as he or she may stop the treatment with Efferalgan 1g cappuccino granules in sachet.

Before starting treatment with this medicine, check that you are not taking other medicines containing paracetamol.

Do not continue treatment without consulting your doctor:

• if the pain persists for more than 5 days or if the fever persists for more than 3 days;
• if the medication does not seem to be effective enough;
• if any other health problem occurs.

If in doubt, do not hesitate to consult your doctor or pharmacist.

Children and adolescents

When a child is treated with paracetamol, the combination of another fever-reducing medication is justified only if it is ineffective. Any combination with more than one drug should be initiated and supervised by a physician.

The use of Efferalgan 1g cappuccino granules in sachet is reserved for adults and adolescents weighing 50 kg or more (over 12 years)

Pregnancy and breastfeeding

• Pregnancy

In case of pregnancy, Efferalgan 1g cappuccino granules in sachet should be used only after careful consideration of the benefits and risks. In this case, the recommended dose and duration of treatment must be strictly observed.

During pregnancy, paracetamol should not be taken for long periods, in high doses or in combination with other drugs

• Breastfeeding

Efferalgan 1g cappuccino granules in sachet can be used at recommended doses during breastfeeding

Contraindications

Never take Efferalgan 1g cappuccino granules in a sachet:

• if you are allergic to paracetamol or any of the other components contained in this medicine, mentioned in section 6.
• if you have severe liver disease (liver failure or progressive decompensated liver disease)

Undesirable effects

Like all medicines, this medicine may cause side effects, but they do not always occur in everyone.

The following side effects may occur:

Rare: may occur in up to 1 in 1,000 people

• Anemia, non-hemolytic anemia
• Bone marrow aplasia, a disease caused by a decrease in the production of blood cells, thrombocytopenia, leukopenia and neutropenia (decrease in the number of certain blood cells)
• Edema (abnormal accumulation of fluid in the body)
• Acute and chronic pancreatitis
• Hemorrhage (blood loss), abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice
• Pruritus, rash, sweating, purpura (red or purple spots on the skin), angioedema (rapid swelling of different layers of the skin), urticaria (itchy, pale red blisters on the skin)
• Nephropathy and tubular disorders (kidney disease).

Paracetamol is widely used and reports of adverse reactions are rare and usually associated with overdose.

Nephrotoxicity (kidney toxicity) is uncommon and has not been reported at recommended doses, except with prolonged administration

Composition

• Active ingredients

Each sachet contains 1000 mg paracetamol

Packaging

Efferalgan 1g cappuccino granules in sachet comes in sachets, in boxes of 8.

If your symptoms persist, consult your doctor.