• 75 mg paracetamol

• Hard fat

BEN-U-RON paracetamol suppository, suppositories for kids, babes Indication / application

• The preparation is a pain reliever and antipyretic drug.
• Areas of application: For the symptomatic treatment of mild to moderately severe pain and fever.
• For use in babies weighing 3 kg or more.

BEN-U-RON paracetamol suppository, suppositories for kids, babes dosage

• The preparation is suitable for the treatment of newborns and babies weighing 3 kg or more. Please ask your pediatrician for advice before using the medicine.
• Always use the preparation exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• The drug is dosed depending on body weight and age, 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 dosage interval depends on the symptoms and the maximum total daily dose. There should be at least a 6 hour interval between applications.
• Unless otherwise prescribed by your doctor, the usual dose is:
  • Age: younger than 3 months; Body weight: 3 - 4 kg
    • First dose: 1 suppository (75 mg paracetamol)
    • Maintenance dose: 1 suppository (75 mg paracetamol) every 8 - 12 hours
    • maximum daily dose (24 hours): 2 suppositories (150 mg paracetamol)
  • Age: younger than 3 months; Body weight: 4 - 5 kg
    • First dose: 1 suppository (75 mg paracetamol)
    • Maintenance dose: 1 suppository (75 mg paracetamol) every 6 - 8 hours
    • maximum daily dose (24 hours): 3 suppositories (225 mg paracetamol)
  • Age: older than 3 months; Body weight: 4 kg
    • First dose: 1 suppository (75 mg paracetamol)
    • Maintenance dose: 1 suppository (75 mg paracetamol) every 6 - 8 hours
    • maximum daily dose (24 hours): 3 suppositories (225 mg paracetamol)
  • Age: older than 3 months; Body weight: 5 - 6 kg
    • First dose: 1 suppository (75 mg paracetamol)
    • Maintenance dose: 1 suppository (75 mg paracetamol) every 6 hours
    • maximum daily dose (24 hours): 4 suppositories (300 mg paracetamol)
  • The maximum daily dose (24 hours) must not be exceeded under any circumstances and the time interval until the next suppository is used must at least correspond to the intervals specified under the maintenance dose.
• Special patient groups
  • Liver dysfunction and slight impairment of kidney function
    • In patients with impaired liver or kidney function or with Gilbert's syndrome, the dose must be reduced or the dose interval extended. In these cases, talk to the doctor before using it on your child.
  • Severe renal impairment
    • In severe renal impairment (creatinine clearance <10 ml / min), a dose interval of at least 8 hours must be observed. In this case, talk to the doctor before using it on your child.

• Duration of application
  • If treatment is required after 72 hours, a doctor should be sought for advice. Infants up to 3 months of age, and especially premature and newborn babies, must be monitored with particular care and it may be necessary to seek advice from the doctor earlier.
  • 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 give your child more than you should
  • The first signs of an overdose are nausea, vomiting and severe abdominal pain.
  • In this case, contact a doctor immediately - even if the symptoms have temporarily subsided - who will take the necessary measures.

• If you forget to use it
  • Do not use a double dose to make up for a forgotten dose.

• If you have any further questions on the use of the medicinal product, please ask your doctor or pharmacist.

BEN-U-RON paracetamol suppository, suppositories for kids, babes way

• The suppositories are for rectal use. If possible, they are inserted deep into the anus after a bowel movement. To improve the lubricity, warm the suppository in your hand or immerse it briefly in hot water.

BEN-U-RON paracetamol suppository, suppositories for kids, babes Side effects

• Like all medicines, the medicine can have side effects, but not every person treated will experience them.
• The frequency of side effects is based on the following categories:
  • Very common: affects more than 1 in 10 people
  • Common: affects 1 to 10 users in 100
  • Uncommon: affects 1 to 10 users in 1,000
  • Rare: affects 1 to 10 users in 10,000
  • Very rare: less than 1 user in 10,000
  • Not known: frequency cannot be estimated from the available data.
• possible side effects
  • Liver and biliary diseases
    • Rare: increase in certain liver enzymes (serum transaminases - may indicate possible liver damage).
  • Blood and lymphatic system disorders
    • Very rare: changes in the blood count such as a reduced number of blood platelets (thrombocytopenia) or a problem with the production of white blood cells in the bone marrow (agranulocytosis). This will be determined by a blood test.
  • Immune system disorders
    • Very rare: Difficulty breathing or wheezing (bronchospasm - analgesic asthma) in sensitive people, allergic reactions (hypersensitivity reactions) in the form of a simple skin rash or hives up to a shock reaction.
• Please inform your doctor or pharmacist if any of the listed side effects gets serious or if you notice any side effects that are not listed.

BEN-U-RON paracetamol suppository, suppositories for kids, babes Interactions

• When using the preparation with other drugs:
  • Please inform your doctor or pharmacist if your child is taking / using or has recently taken / used any other medication, including medicines obtained without a prescription.
  • Using the drug increases the risk of side effects of:
    • Medicines that accelerate the breakdown in the liver [e.g. B. Anti-epilepsy agents (including phenobarbital carbamazepine, phenytoin), and rifampicin (a tuberculosis drug)] - This can lead to liver damage.
    • Chloramphenicol (antibiotic)
    • Zidovudine (antiviral medicine). If paracetamol and zidovudine are used at the same time, the tendency to reduce white blood cells is increased.

BEN-U-RON paracetamol suppository, suppositories for kids, babes Contraindications

• The drug must not be used
  • if your child is allergic (hypersensitive) to paracetamol or another component of the preparation
  • if your child has severe hepatic impairment (Child-Pugh> / = 9)

BEN-U-RON paracetamol suppository, suppositories for kids, babes pregnancy and breast feeding period

• This chapter is not relevant for the preparation, as the suppositories are used in newborns and infants weighing 3 kg or more. However, the information is important for the active ingredient paracetamol.
• Ask your doctor or pharmacist for advice before taking / using any medicine.
• pregnancy
  • Paracetamol should not be taken over long periods of time, in high doses or in combination with other medicinal products during pregnancy, as the safety of its use in these cases has not been proven.
• Breastfeeding
  • Paracetamol passes into breast milk. Since no adverse consequences for the infant have become known to date, interruption of breastfeeding will generally not be necessary.

BEN-U-RON paracetamol suppository, suppositories for kids, babes Patient information

• Special care is needed when using the drug if your child
  • suffers from liver problems (e.g. liver inflammation),
  • has a damaged kidney,
  • Sufferers from the rare hereditary metabolic disorder Gilbert's syndrome (also known as Meulengracht's disease), which is accompanied by an increased level of bilirubin in the blood.
• In these cases, only use the preparation after consulting your doctor.
• General remark
  • Long-term, high-dose, improper use of painkillers can lead to headaches that should not be treated with increased doses of the drug. In general, the habitual use of painkillers, especially when combining several pain relievers, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).