Apiredol

Package leaflet: Information for the user

APIREDOL 100 mg/ml oral solution

Paracetamol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you to do.
• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
• Consult your doctor if you do not notice any improvement, or if you notice worsening of symptoms, or if fever persists for more than 3 days or pain for more than 3 days in children or 5 days in adults (2 days for sore throat).

Contents of this leaflet:

1. What Apiredol is and what it is used for
2. What you need to know before taking Apiredol
3. How to take Apiredol
4. Possible side effects
5. How to store Apiredol
6. Contents of the pack and other information

1. What Apiredol is and what it is used for

Apiredol 100 mg/ml oral solution belongs to a group of medicines called analgesics and antipyretics.
This medicine is used to reduce fever lasting less than 3 days and to relieve mild to moderate pain.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms, or if fever persists for more than 3 days or pain for more than 3 days in children or 5 days in adults (2 days for sore throat).

2. What you need to know before taking Apiredol

Do not take Apiredol

• If you/your child are allergic to paracetamol or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before taking Apiredol.
• Consult your doctor before administering this medicine to children under 3 years of age.
• Do not exceed the recommended doses indicated in section 3.
• Patients with kidney, heart, or lung diseases, and patients with anaemia (reduced haemoglobin in the blood, whether or not due to a reduction in red blood cells) or with low levels of an enzyme called glucose-6-phosphate dehydrogenase in the blood, should consult their doctor before taking this medicine.
• If you have liver disease (including Gilbert's syndrome), consult your doctor, as it may be necessary to reduce the dose and/or increase the interval between doses.
• In patients weighing less than 50 kg who suffer from anorexia, malnutrition, or dehydration, as this may increase the risk of liver toxicity.
• Consumption of alcoholic beverages may cause paracetamol to damage the liver.
• If you have high fever (>39 °C), consult your doctor before taking Apiredol.
• If pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat), or if fever lasts more than 3 days, worsens, or new symptoms appear, you must stop treatment and consult your doctor.
• During treatment with Apiredol, inform your doctor immediately if you suffer from serious conditions, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Other medicines and Apiredol
Inform your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines.
In particular, if you/your child are taking medicines containing any of the following active substances,
dose adjustment or discontinuation of these medicines may be necessary:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and oestrogen therapy
• Antiepileptic drugs (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculosis drugs (isoniazid, rifampicin)
• Barbiturates (used as hypnotics, sedatives, and for anticonvulsant treatment)
• Activated charcoal, used to treat diarrhoea or intestinal gas
• Cholestyramine (used to reduce cholesterol levels in the blood)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to relieve spasms and cramps in the stomach, intestine, and bladder (anticholinergic drugs)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol, used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
• Zidovudine (used in the treatment of patients with human immunodeficiency virus, which causes AIDS).
  Interference with laboratory tests: If you/your child need to undergo laboratory tests (e.g. blood tests, urine analysis, skin allergy tests, etc.), you must inform the doctor that you are taking this medicine, as it may alter test results.

Apiredol with food, drinks, and alcohol
Apiredol can be diluted with water, milk, or fruit juices. The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day) may damage the liver.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
If necessary, Apiredol can be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and to take it for the shortest possible duration. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Therapeutic doses of paracetamol can be used during pregnancy and breastfeeding.
Driving and using machines
No effects have been reported that could impair the ability to drive vehicles or operate machinery.
Apiredol contains Azorubine and sodium (from sodium saccharin).
This medicine may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e., essentially 'sodium-free'.

3. How to take Apiredol

Take this medicine exactly as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Apiredol is intended only for children weighing up to 32 kg (approximately from 0 months to 10 years of age). It is essential to follow the dosage based on the child's body weight and to select the correct dose in ml of the oral solution.

The approximate age based on body weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg per day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

In children under 3 years of age, administration of the oral solution in drops (4 mg/drop) is recommended, using the dropper (1) supplied in the 30 ml pack.

For children aged 3 years and older, administration of the oral solution in millilitres (ml) (100 mg/ml) is recommended, using the oral syringe (2) supplied in the 60 ml pack.

To administer 15 mg/kg every 6 hours, the instructions are as follows:

Child's weight Approximate age Volume in ml mg of paracetamol Equivalent in drops
Up to 4 kg from 0 to 3 months 0.6 ml 60 mg 15 drops
Up to 7 kg from 4 to 8 months 1.0 ml 100 mg 25 drops
Up to 8 kg from 9 to 11 months 1.2 ml 120 mg 30 drops
Up to 10.5 kg from 12 to 23 months 1.6 ml 160 mg 40 drops
Up to 13 kg from 2 to 3 years 2.0 ml 200 mg --
Up to 18.5 kg from 4 to 5 years 2.8 ml 280 mg --
Up to 24 kg from 6 to 8 years 3.6 ml 360 mg --
Up to 32 kg from 9 to 10 years 4.8 ml 480 mg

To calculate the dose directly, multiply the child's weight in kg by 0.15. The result is the number of ml of Apiredol to administer.

In children, this dose should be administered every 6 hours, including during the night.

If the desired effect is not achieved within 3–4 hours, the dose may be administered every 4 hours: in this case, administer 10 mg/kg.

For children weighing less than 7 kg (6 months), the use of suppositories should be considered, if available, except in cases where administration of this pharmaceutical form is not possible for clinical reasons (e.g., diarrhoea).

Never exceed the maximum daily dose of 60 mg/kg per day unless advised by a doctor.

For patients with hepatic or renal impairment, see section 2, Warnings and Precautions.

Administration of the medicine depends on the onset of pain and fever symptoms. When these symptoms disappear, the medicine should be discontinued.

Instructions for correct administration of the medicine

Apiredol is administered orally.

30 ml bottle with child-resistant dropper (2 ml):

1 and 2. – Hold the bottle firmly with one hand. With the other hand, grasp the cap using the thumb and index finger on the triangles marked “PRESS” (press).

3. – To open, press down on the triangle and unscrew the cap by turning it to the left (counterclockwise). Draw up the required amount using the dropper. The drops may be administered directly or diluted in water.

4. – To close, rotate the cap to the right (clockwise) until a “click” is heard.

Close the bottle tightly after each use.

60 ml bottle with child-resistant closure and 5 ml oral dosing syringe:

1. – Open the bottle following the instructions on the cap (on first opening, break the tamper-evident seal).

2. – Insert the oral syringe by pressing it into the perforated opening.

3. – Invert the bottle and draw up the required amount.

4. – Administer directly or diluted in water, milk, or fruit juice.

5. – The oral syringe should be washed with water after use.

Close the bottle tightly after each use.

If you take more Apiredol than you should

If you/your child has taken more paracetamol than recommended, contact your doctor or pharmacist immediately, stating the name of the medicine and the amount taken. It is helpful to bring the container and the package leaflet with you and show them to the doctor or pharmacist.

In case of overdose, you/your child should go to a medical centre as soon as possible, even if there are no symptoms. Symptoms of overdose may appear even after 3 days, even in cases of severe poisoning. Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

In adults, an overdose of paracetamol is considered after ingestion of more than 6 g taken at the same time; in children, after ingestion of more than 100 mg per kg of body weight. Treatment for overdose is most effective when initiated within 4 hours of taking the medicine.

Patients taking barbiturates or suffering from chronic alcoholism are at higher risk of paracetamol overdose.

In general, treatment in cases of overdose is symptomatic.

If you forget to take Apiredol

Do not take a double dose to make up for a forgotten dose.

If you/your child forgets to take a dose, take the next dose as soon as possible, then continue as usual. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.

If you stop taking Apiredol

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions to paracetamol are generally rare (affecting 1 to 10 users out of 10,000) or very rare (affecting less than 1 user out of 10,000).
Rare adverse reactions include malaise, hypotension, and increased levels of liver enzymes.
Very rarely, it may cause liver damage at high doses or with prolonged treatment. Hypoglycemia, cloudy urine, renal adverse effects, skin rash, urticaria, anaphylactic shock, and blood cell count abnormalities such as neutropenia and leucopenia may also occur very rarely.
Very rare cases of serious skin reactions have been reported.
Frequency not known (cannot be estimated from the available data): severe condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apiredol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.
Keep the bottle in the outer packaging. This medicine does not require any special storage temperature.
After first opening, keep the bottle in the outer packaging.
Once opened, the contents of the bottle must be used within a maximum of 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apiredol contains

• The active substance is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are: macrogol 600, glycerol, raspberry flavour, sodium saccharin (E-954), azorubine (carmoisine) (E-122) and purified water.

Description of the appearance of Apiredol and contents of the pack
Apiredol is a red, transparent oral solution, supplied in 30 ml and 60 ml plastic bottles.

• 30 ml bottle: transparent plastic bottle with a child-resistant dropper of 2 ml.
• 60 ml bottle: transparent plastic bottle with a child-resistant closure and an oral dosing syringe of 5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PharmExtracta S.p.A.
Via G. Natta 28
29010 Pontenure (PC)
Italy
Manufacturer
LABORATORIOS ERN, S.A.
C/ Gorgs Lladó, 188
Barberà del Vallès
08210 Barcelona
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Spain Apiredol 100 mg/ml oral solution
Germany Apiredol 100 mg/ml solution for oral use
France Apedital 100 mg/ml oral solution
Apedital 100 mg/ml oral solution in drops
Italy Apiredol
Poland Pedicetamol
Portugal Paracetamol Ern 100 mg/ml Oral Solution
Further sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): http://www.agenziafarmaco.it/.