PARACETAMOL AL 250 infant suppositories

Active ingredient: Paracetamol Indication:

• analgesic, antipyretic (analgesic and antipyretic)
• The preparation is used for the symptomatic treatment of
  • slight to moderate pain
  • Fever

Contraindication:

• The medicine must not be used
  • if you are allergic (hypersensitive) to paracetamol or any of the other ingredients
  • if you suffer from severe liver impairment

Dosage:

• Always use the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• The dosage depends on the following information. Paracetamol is dosed depending on body weight and age, usually with 10 to 15 mg/kg body weight as a single dose, up to a maximum of 60 mg/kg body weight as a total daily dose.
• The respective dosing interval depends on the symptoms and the maximum total daily dose. It should not be less than 6 hours.
• If symptoms persist for more than 3 days, a doctor should be consulted.
• Body weight or age: 13 kg - 16 kg; 2 - 4 years
  • Single dose in number of suppositories (corresponding paracetamol dose): 1 suppository (corresponding to 250 mg paracetamol)
  • Maximum daily dose (24 hours) in number of suppositories (corresponding paracetamol dose): 3 suppositories (corresponding to 750 mg paracetamol)
• Body weight or age: 17 kg - 25 kg; 4 - 8 years
  • Single dose in number of suppositories (corresponding paracetamol dose): 1 suppository (corresponding to 250 mg paracetamol)
  • Maximum daily dose (24 hours) in number of suppositories (corresponding paracetamol dose): 4 suppositories (corresponding to 1000 mg paracetamol)

• Duration of application
  • Do not use the medicine for more than 3 days without medical or dental advice.

• Special patient groups
  • Hepatic dysfunction and slight impairment of kidney function
    • In patients with liver or kidney dysfunction or Gilbert's syndrome, the dose must be reduced or the dose interval extended.
  • Patients with severe renal insufficiency
    • In the case of severe renal insufficiency (creatinine clearance < 10 ml/min), a dosing interval of at least 8 hours must be observed.
  • Elderly patients
    • No special dose adjustment is required.
  • Children
    • It is not recommended to use the medicine in children under the age of 2 years or under 13 kg body weight, as the dosage strength is not suitable for this group of patients. However, suitable dose strengths and dosage forms are available for this patient group.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you have used more than you should
  • Symptoms of overdose include nausea, vomiting, loss of appetite, pallor, and abdominal pain, generally occurring within 24 hours.
  • If more medicine has been used than recommended, call a doctor for help!

• If you forget to use it
  • Do not use a double dose if you forget the previous dose.

• If you have any further questions about using the medicine, ask your doctor or pharmacist.

Side effects:

• Like all medicines, this preparation can cause side effects, although not everyone gets them.
• When evaluating side effects, the following frequency information is used:
  • very often more than 1 treated person in 10
  • often 1 to 10 treated in 100
  • occasionally 1 to 10 treated in 1,000
  • rarely 1 to 10 treated in 10,000
  • very rarely less than 1 treated person in 10,000
  • not known frequency cannot be estimated from the available data
• Liver and biliary diseases
  • Rare: Slight increase in certain liver enzymes (serum transaminases).
• Immune system diseases
  • Very rare: Allergic reactions in the form of a simple skin rash or hives, swelling of the face, tongue and larynx (Quincke's edema) up to a shock reaction.
  • In the event of an allergic shock reaction, call the nearest doctor for help. In sensitive people, a narrowing of the airways (analgesic asthma) has been triggered.
• Diseases of the blood and lymphatic system
  • Very rare: Changes in the blood picture such as a reduced number of blood platelets (thrombocytopenia) or a severe reduction in the number of certain white blood cells (agranulocytosis).
• Please tell your doctor or pharmacist if any of the listed side effects gets serious, or if you notice any side effects that are not listed.

Patient information:

• Particular caution is required when using the drug
  • if you are a chronic alcoholic
  • if you suffer from impaired liver function (inflammation of the liver, Gilbert's syndrome)
  • with previously damaged kidneys
  • If your symptoms worsen or do not improve after 3 days, or if you have a high fever, you must see a doctor.
  • To prevent the risk of overdose, it should be ensured that other drugs used at the same time do not contain paracetamol.
  • Long-term, high-dose, non-intended use of painkillers can cause headaches that must not be treated with increased doses of the drug.
  • In general, the habitual use of painkillers, especially when several painkillers are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
  • Headaches, tiredness, muscle pain, nervousness and vegetative symptoms can occur if painkillers are stopped abruptly after long-term, high-dose, improper use of painkillers. The withdrawal symptoms subside within a few days. Until then, painkillers should not be used again and should not be used again without medical advice.
  • Do not use the preparation for a long time or in higher doses without medical or dental advice.

• Driving and using machines
  • The medicine has no influence on the ability to drive and use machines.
  • Nevertheless, caution is always required after using a painkiller.

Pregnancy:

• Ask your doctor or pharmacist for advice before taking/using any medicine.
• The preparation should only be used during pregnancy after careful consideration of the benefit-risk ratio. You should not use the medicine for long periods of time, in high doses or in combination with other medicines during pregnancy, as the safety of use in these cases has not been proven.
• Paracetamol passes into breast milk. Since adverse consequences for the infant have not yet become known, it is usually not necessary to interrupt breastfeeding.

Way:

• If possible, the medicine is inserted deep into the anus after a bowel movement. To improve lubricity, warm the suppositories in your hand or dip them briefly in warm water.

Interactions:

• When using the preparation with other medicines
  • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
  • Interactions are possible with:
    • probenecid (medicine for gout)
    • possible liver-damaging substances, e.g. B. Phenobarbital (sleeping pills), phenytoin, carbamazepine (medicines against epilepsy) and rifampicin (tuberculosis medicine). Under certain circumstances, liver damage can occur when used at the same time, even from otherwise harmless doses of the drug. The same applies to alcohol abuse.
    • Medicines for HIV infections (zidovudine): The tendency to reduce white blood cells (neutropenia) is increased. The preparation should therefore only be used at the same time as zidovudine on medical advice.
    • Anticoagulant medicines (oral anticoagulants, especially warfarin). Repeated use of paracetamol for more than a week increases the tendency to bleed. In this case, long-term use of paracetamol should only be carried out under medical supervision. Occasional use of paracetamol has no effect on bleeding tendency.
  • Effects of the use of the drug on laboratory studies
    • The uric acid determination and the blood sugar determination can be influenced.
  • When using the preparation together with food and drinks
    • The medicine must not be used or administered together with alcohol.