PARACETA 500 tablets, 20 pcs

Instructions for use for PARACETA 500 tablets, 20 pcs

Detailed instructions for PARACETA 500 tablets, 20 pcs

Field of use

• The preparation is a pain relieving, fever -lowering medicine (analgesic and antipyretics).
• The tablets are used for symptomatic treatment of light to moderately severe pain and/or of fever.

Active ingredients / ingredients / ingredients

500 mg paracetamol
Carboxymethylar, sodium salt auxiliary material (+)
Corn starch auxiliary substance (+)
Corn starch, pre -clerked auxiliary substance (+)
Povidon K30 auxiliary material (+)
Stearic acid auxiliary material (+)
Ethyl 4-hydroxybenzoat auxiliary substance (+)
Propyl 4-hydroxybenzoat auxiliary substance (+)

Contradictions

• The medicine must not be taken
  • if you are allergic to paracetamol or one of the other components of this medicine

dosage

• Always take this medicine exactly as described or exactly after the agreement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.
• Dosage
  • This medicine should be used in the lowest pain -controlling dose over the shortest possible period.
  • The dosage is based on the information in the following table. The specified number of tablets only applies to patients who do not receive any other paracetamol-containing medicines.
  • 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 or up to a maximum of 8 tablets per day (corresponding to 4000 mg paracetamol as a total dose of daily dose).
  • The maximum daily dose must not be exceeded.
  • The respective dosage interval depends on the symptoms and the maximum total daily dose. The time interval between two applications must be at least 6 hours.
  • Do not apply the preparation for more than 3 days without medical or dental advice.
  • Body weight or age
    • 17 - 25 kg (children: 4 - 8 years)
      • Single dose: ½ tablet (corresponding to 250 mg paracetamol)
      • Maximum daily dose (24 hours): 2 tablets (4 × ½ tablet) corresponding to 1000 mg paracetamol
    • 26 - 32 kg (children: 8 - 11 years)
      • Single dose: ½ tablet (corresponding to 250 mg paracetamol¹)
      • Maximum daily dose (24 hours): 2 tablets (4 × ½ tablet) corresponding to 1000 mg paracetamol²
    • 33 - 42 kg (children: 11 - 12 years)
      • Single dose: 1 tablet (corresponding to 500 mg paracetamol)
      • Maximum daily dose (24 hours): 4 tablets (4 × 1 tablet) corresponding to 2000 mg paracetamol
    • from 43 kg. Children and adolescents from the age of 12 and adults
      • Single dose: 1 - 2 tablets (corresponding to 500 - 1000 mg paracetamol)
      • Maximum daily dose (24 hours): 8 tablets corresponding to 4000 mg paracetamol
  • ¹ Other dosage forms may be more advantageous for this patient group, since they enable a maximum dosage of a maximum of 400 mg paracetamol.
    ² In exceptional cases, up to 3 tablets (6 × ½ tablet) can be used daily, in a dosage interval of at least 4 hours. H. Up to 1500 mg paracetamol daily.
  • Liver dutyin the number and slight restriction of kidney function
    • In patients with liver or kidney dysfunction as well as Gilbert-Meulengracht syndrome, the dose must be reduced or the distance between the individual doses must be extended. A daily overall dose of 4 tablets (2000 mg paracetamol) may not be exceeded without medical instruction.
  • Medium -heavy to severe restriction of kidney function
    • Unless otherwise prescribed, a reduction in the dose is recommended in patients with kidney dysfunction. The distance between the individual doses must be at least 6 hours.
    • In the case of severe kidney dysfunction (creatinine clearance < 10 ml/min), the distance between the individual doses must be at least 8 hours (see table).
    • Adult:
      • glomerular filtration rate: 10 - 50 ml/min
        • Dose: a maximum of 1 tablet* every 6 hours
      • glomerular filtration rate: < 10ml/min
        • Dose: a maximum of 1 tablet* every 8 hours
      • * corresponds to 500 mg paracetamol
  • Older patients
    • Experience has shown that no special dose adjustment is required. However, in weakened, immobilized older patients with limited liver or kidney function, a reduction in the dose or extension of the dosage interval can
      be required.
    • Without medical instruction, the daily total dose of 60 mg/kg body weight (up to a maximum of 4 tablets per day, corresponding to 2000 mg paracetamol) should not be exceeded if they
      • weigh less than 50 kg
      • suffer from chronic alcoholism
      • are affected by water withdrawal (dehydration)
      • are chronically malnourished
  • Children and adolescents with low body weight
    • Using tablets in children under 4 years or under 17 kg body weight is not recommended, since the dose strength is not suitable for this age group. However, suitable dose strengths or dosage forms are available for this age group.

 

• If you have taken/applied a larger amount than you should
  • The total dose of paracetamol is allowed for adults and adolescents from the age of 12 or from 43 kg body weight 4000 mg paracetamol (corresponding to 8 paracetamol 500 mg tablets) daily and for children 60 mg/kg per day.
  • With an overdose of paracetamol, complaints generally occur within 24 hours that include nausea, vomiting, loss of appetite, pallor and abdominal pain. There can also be severe liver damage.
  • If a larger amount of paracetamol has been taken than recommended, please call the next accessible doctor to help!

 

• If you have forgotten the intake
  • Do not take the double amount if you have forgotten the prior intake.

 

• If you have any further questions about the application of this medicine, please contact your doctor or pharmacist.
  
  

Taking

• The tablets are taken with sufficient liquid (e.g. a glass of water).

Patient information

• Warnings and Precautions
  • In order to prevent the risk of overdose, it should be ensured that other medicines that are used at the same time do not contain paracetamol.
  • Please speak to your doctor or pharmacist before taking the medicine
    • if you suffer from the impairment of the liver function (e.g. through liver inflammation, Gilbert-Meulengracht-Syndrome)
    • if you are chronically alcoholic
    • for kidney dysfunction (e.g. pre -damaged kidney)
    • when the use of medicines that affect the liver function
    • in the event of an inherited lack of the enzyme glucose-6-phosphate dehydrogenase, which can lead to severe anemia, also called favism
    • in hemolytic anemia (anemia due to a decay of the red blood cells)
    • in the event of a deficiency of the glutathione involved in the liver metabolism (e.gg, alcohol abuse)
    • in the event of a lack of liquid in the body (dehydration), e.g. B. due to small amount of drinking, diarrhea or vomiting
    • in chronic malnutrition
    • with a body weight of less than 50 kg
    • in higher age
  • Use the tablets for more than 3 days or in higher doses without medical or dental advice.
  • A crossing of the recommended dose, which also means the once taking the total daily dose, can lead to severe liver damage. In such a case, medical help should be consulted immediately.
  • If painkillers are not dosed for a long time, headaches can occur, which may not be treated by increased doses of the drug. Ask your doctor for advice if you often suffer from headache despite taking paracetamol!
  • When stopping abruptly, headaches and fatigue, muscle pain, nervousness and vegetative symptoms can occur after a long -dosed, non -determined use of painkillers. This deductible symptoms subside within a few days. Until then, the re -application of painkillers should be avoided and the use of the use is not carried out again without medical advice.
  • The habitual use of painkillers, especially when combining several pain relievers, can lead to permanent kidney damage with the risk of kidney failure (analgesics nephropathy).
  • Children and adolescents with low body weight
    • Use in children under 4 years or under 17 kg body weight is not recommended.

 

• Effects on laboratory tests
  • The urinary acid determination and blood sugar determination can be influenced.

 

• Wateriness and ability to operate machines
  • Paracetamol has no or negligible influence on the traffic and operating machines. Nevertheless, caution is always required after taking a pain reliever.

Pregnancy

• pregnancy
  • If you are pregnant or breastfeed, or if you suspect that you are pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this drug.
  • Paracetamol should only be taken after strict weighing up the benefit risk ratio during pregnancy.
  • You should not take paracetamol during pregnancy for a longer time, in high doses or in combination with other medicines, since the safety of the application is not proven for these cases.

• Breastfeeding
  • Paracetamol passes into breast milk. Since adverse consequences for the infant have not yet become known, an interruption of breastfeeding will generally not be necessary.

Hints

Do not apply longer for pain or fever without medical advice than specified in the package insert!

Manufacturer:  Zentiva Pharma GmbH, Linkstrasse 2, 10785 Berlin