PARACETAMOL Dexcel 500 mg tablets, 20 pcs

Instructions for use for PARACETAMOL Dexcel 500 mg tablets, 20 pcs

Application Notes

Children from 4-8 years with a body weight of 17-25 kg	1/2 Tablet	1-4 times a day	6 hours apart, regardless of the meal
Children from 8-11 years with a body weight of 26-32 kg	1/2 Tablet	1-4 times daily (max. 3 per day)	6 hours apart, regardless of the meal
Children 11-12 years old weighing 33-43 kg	1 Tablet	1-4 times a day	6 hours apart, regardless of the meal
Adolescents from 12 years and adults over 43 kg body weight	1-2 Tablets	1-4 times a day	6 hours apart, regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient has an analgesic and fever-reducing effect. It also has low anti-inflammatory properties. It blocks the formation of certain messenger substances in the body, so-called prostaglandins. These are significantly involved in the development of pain, fever and inflammation.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - talk to your doctor or pharmacist about this:
- Impaired liver function (eg. B. by chronic alcohol abuse or liver inflammation)
- Impaired kidney function
- Gilbert's syndrome (Meulengracht's disease)
- Alcohol abuse
- Hereditary enzyme disorder (glucose-6-phosphate dehydrogenase deficiency)
- Anemia due to faster breakdown of red blood cells (haemolytic anemia)
- Glutathione deficiency
- Dehydration
- Malnutrition

What age group do you need to consider?
- Children under 4 years of age: The medicine should not normally be used in this group. There are preparations that are more suitable in terms of the strength of the active ingredient and/or dosage form.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: According to current knowledge, there are no indications that the drug should not be used during breast-feeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

Only side effects that have only occurred in exceptional cases so far are described for the drug.

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- In case of pain or fever, do not use longer than specified in the leaflet without medical advice!
- With long-term use of painkillers, headaches caused by the painkiller can occur. Talk to your doctor to prevent your headache from becoming chronic.
- The habitual use of painkillers can lead to permanent kidney damage. If several painkillers are combined, or if one painkiller contains several active ingredients, the risk increases.
- Attention: Regular or high alcohol consumption can lead to life-threatening conditions due to possible liver damage if the drug is also used.
- Be careful if you are allergic to painkillers!
- Be careful if you are allergic to binding agents (e.g. carboxymethyl cellulose with the E number E 466)!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

Detailed instructions for PARACETAMOL Dexcel 500 mg tablets, 20 pcs

Field of use

• The preparation is an analgesic, antipyretic (analgesic and antipyretic) drug.
• The tablets are used for the symptomatic treatment of mild to moderate pain and/or fever.

Active substances / ingredients / ingredients

500 mg paracetamol
Carmellose, sodium salt excipient (+)
Gelatin excipient (+)
Magnesium stearate excipient (+)
Corn starch excipient (+)

Contraindications

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

dosage

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Dosage
  • This drug should be used at the lowest pain-controlling dose for the shortest possible time.
  • The dosage is based on the information in the table below. The given number of tablets only applies to patients who are not receiving any other medicines containing paracetamol.
  • 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 daily dose).
  • The maximum daily dose must not be exceeded.
  • The respective dosing 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 use the preparation for more than 3 days without medical or dental advice.
  • Body weight or Old
    • 17 - 25 kg (children: 4 - 8 years)
      • Single dose: ½ tablet (equivalent to 250 mg paracetamol)
      • Maximum daily dose (24 hours): 2 tablets (4 × ½ tablet) equivalent to 1000 mg paracetamol
    • 26 - 32 kg (children: 8 - 11 years)
      • Single dose: ½ tablet (equivalent 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 (equivalent to 500 mg paracetamol)
      • Maximum daily dose (24 hours): 4 tablets (4 × 1 tablet) corresponding to 2000 mg paracetamol
    • from 43 kg. Children and young people from 12 years and adults
      • Single dose: 1 - 2 tablets (equivalent to 500 - 1000 mg paracetamol)
      • Maximum daily dose (24 hours): 8 tablets equivalent to 4000 mg paracetamol
  • ¹ Other dosage forms may be more advantageous for this group of patients, since they allow a more precise dosing of a maximum of 400 mg paracetamol.
    ² In exceptional cases, up to 3 tablets (6 × ½ tablet) daily can be used at intervals of at least 4 hours, i. H. up to 1500 mg paracetamol daily.
  • Hepatic dysfunction and slight impairment of kidney function
    • In patients with liver or kidney dysfunction and Gilbert-Meulengracht syndrome, the dose must be reduced or the interval between the individual doses increased. A total daily dose of 4 tablets (2000 mg paracetamol) must not be exceeded without medical advice.
  • Moderate to severe impairment of renal function
    • Unless otherwise directed, dose reduction is recommended in patients with renal impairment. The interval between each dose must be at least 6 hours.
    • In severe renal impairment (creatinine clearance < 10 ml/min), the interval between the individual doses must be at least 8 hours (see table).
    • Adult:
      • glomerular filtration rate: 10 - 50 ml/min
        • Dose: maximum 1 tablet* every 6 hours
      • glomerular filtration rate: < 10ml/min
        • Dose: maximum 1 tablet* every 8 hours
      • * corresponds to 500 mg paracetamol
  • Elderly patients
    • Experience has shown that no special dose adjustment is required. However, in debilitated, immobilized elderly patients with hepatic or renal impairment, the dose may be reduced or the dosing interval may be increased
      become necessary.
    • If you
      • weigh less than 50 kg
      • suffer from chronic alcoholism
      • are affected by water deprivation (dehydration)
      • are chronically malnourished
  • Children and adolescents with low body weight
    • It is not recommended to use the tablets in children under 4 years of age or under 17 kg body weight as the dosage strength is not suitable for this age group. However, suitable dose strengths and dosage forms are available for this age group.

• If you take/use more than you should
  • The total dose of paracetamol must not exceed 4000 mg paracetamol (equivalent to 8 paracetamol 500 mg tablets) daily for adults and adolescents from 12 years of age or from 43 kg body weight and 60 mg/kg per day for children.
  • Symptoms of paracetamol overdose include nausea, vomiting, loss of appetite, pallor, and abdominal pain, generally occurring within 24 hours. It can also lead to severe liver damage.
  • If a larger amount of paracetamol has been taken than recommended, please call the nearest available doctor for help immediately!

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

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
  
  

Revenue

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

Patient notes

• Warnings and Precautions
  • To prevent the risk of overdose, it should be ensured that other drugs used at the same time do not contain paracetamol.
  • Please talk to your doctor or pharmacist before taking this medicine
    • if you suffer from impaired liver function (e.g. due to liver inflammation, Gilbert-Meulengracht syndrome)
    • if you are chronically alcoholic
    • in kidney dysfunction (e.g. previously damaged kidneys)
    • with the simultaneous use of drugs that adversely affect liver function
    • in hereditary deficiency of the enzyme glucose-6-phosphate dehydrogenase, which can lead to severe anemia, also called favism
    • if you have haemolytic anemia (anemia due to the breakdown of red blood cells)
    • if there is a deficiency of the protein glutathione involved in liver metabolism (e.g. malnutrition, alcohol abuse)
    • if there is a lack of fluid in the body (dehydration), e.g. B. by drinking too little, diarrhea or vomiting
    • in chronic malnutrition
    • with a body weight of less than 50 kg
    • in old age
  • Do not use the tablets for longer than 3 days or in higher doses without medical or dental advice.
  • Exceeding the recommended dose, which also means taking the total daily dose once, can lead to severe liver damage. In such a case, medical help should be sought immediately.
  • Long-term, high-dose, non-intended use of painkillers can cause headaches that must not be treated with increased doses of the drug. Ask your doctor for advice if you often suffer from headaches despite taking paracetamol!
  • Headaches, tiredness, muscle pain, nervousness and vegetative symptoms can occur if painkillers are stopped abruptly after prolonged, high-dose, improper use of painkillers. These withdrawal symptoms disappear within a few days. Until then, painkillers should not be used again and should not be used again without medical advice.
  • 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).
  • 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 uric acid determination as well as the blood sugar determination can be influenced.

• Ability to drive and use machines
  • Paracetamol has no or negligible influence on the ability to drive and use machines. Nevertheless, caution is always required after taking a painkiller.

Pregnancy

• pregnancy
  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • Paracetamol should only be taken during pregnancy after careful consideration of the risk-benefit ratio.
  • You should not take paracetamol for a long time, in high doses or in combination with other drugs during pregnancy, as the safety of use in these cases has not been proven.

• lactation
  • Paracetamol passes into breast milk. Since adverse consequences for the infant have not yet become known, it will not usually be necessary to interrupt breastfeeding.

Hints

In case of pain or fever, do not use longer than specified in the leaflet without medical advice!

Manufacturer: Dexcel Pharma GmbH, Carl-Zeiss-Strasse 2, 63755 Alzenau