EU-MED phenazone, against fever, pain, migraine attack tablets

• 500 mg phenazone

• Crospovidone
• Cellulose, microcrystalline
• talc

Indication / application

• The preparation is a drug against pain and fever from the group of pyrazolones.
• It is applied
  • for mild to moderately severe pain
  • if you have a fever
  • for the acute treatment of headaches in migraine attacks with and without aura.
• If you do not feel better or even worse after taking it, contact your doctor.

dosage

• Always take this medicine exactly as described or as your doctor, pharmacist or nurse has told you. Please ask your doctor, pharmacist or nurse if you are not sure.
• How and how often should you take the medicine?
  • Unless otherwise prescribed by your doctor, the usual dose is:
    • Adults and adolescents over 15 years
      • The single dose is 1 to 2 tablets.
      • This single dose can - if necessary - be taken at intervals of 4 to 8 hours up to 4 times a day.
      • The maximum total daily dose should not exceed 8 tablets. This corresponds to 4000 mg phenazone.
    • Children from 7 to 15 years of age
      • The single dose is ½ tablet.
      • This single dose can - if necessary - be taken at intervals of 4 to 8 hours up to 4 times a day.
      • The maximum total daily dose should not exceed 2 ½ tablets. This corresponds to 1250 mg phenazone.
    • Children under 7 years of age should not be treated with the medicine.
    • Special living conditions
      • The dose should be reduced in advanced age, with a reduced general condition and with impaired liver function, as the excretion of metabolic products can be delayed.
      • The single dose should therefore be limited to 1 tablet, which corresponds to 500 mg of the active ingredient phenazone.
      • The total daily dose should not exceed 4 tablets (equivalent to 2000 mg phenazone).

• How long can you take the preparation?
  • Medicines containing phenazone should not be taken for more than 3 to 4 days without medical or dental advice.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you take more than you should,
  • please notify a doctor. This can decide on any necessary measures. Symptoms of overdose may include abdominal pain, nausea, and vomiting. It can also cause tremors, seizures, blurred vision, skin rashes and loss of consciousness.
  • If you feel that you are not experiencing adequate pain relief, do not increase the dosage yourself, but talk to your doctor.

• If you forget to take a dose
  • do not take a double dose next time. Continue taking as prescribed by your doctor or as described in these dosage instructions.

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

way

• Please take the tablets with sufficient liquid, preferably with a glass of drinking water (200 ml).

Side effects

• Like all medicines, this medicine can have side effects, although not everybody gets them. When evaluating side effects, the following are placed:
  • 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
• possible side effects
  • Skin and subcutaneous tissue disorders:
    • Uncommon: skin changes with redness and itching, inflammation, rashes of various forms, nodules, vesicles and hives.
    • Rare: swelling with water retention; Rashes up to detachment and dissolution of the skin (fixed rash, urticaria, in particularly rare cases: maculopapular rash, erythema multiforme, erythema nodosum, angioneurotic edema and toxic epidermal necrolysis); Inflammation and swelling of the mucous membranes, especially in the throat.
  • Blood and immune system
    • Rare: Severe immediate allergic reaction with signs of shock.
    • Very rare: changes in the blood count
• If severe side effects occur, the drug should no longer be taken.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions

• What should be considered if you are taking other medicines at the same time?
  • Medicines can affect each other so that their effects are stronger or weaker than usual. Therefore, please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you plan to take any other medicines.
  • If the medicine is used for a long time with substances such as B. phenytoin, carbamazepine, barbiturates (drugs for sedation), spironolactone or rifampicin, the duration of action of the active ingredient phenazone may be shortened.
  • If the drug is used simultaneously with drugs containing the active ingredients cimetidine and / or disulfiram, as well as with propanolol (beta receptor blockers), with calcium antagonists such as verapamil or diltiazem, with antiarrhythmics (drugs against cardiac arrhythmias) such as amiodarone, or with oral drugs for contraception or ketone azole ( a medicine against fungal diseases), this leads to a slowing down of the breakdown and / or the excretion of phenazone. There is a possibility of an increase in the concentration of phenazone in the blood.
  • If the medicine is taken at the same time as warfarin (active substance used to thin the blood), the effects of warfarin are increased.
• What should be considered when taking with food and drink?
  • If possible, you should not drink alcohol during use.

Contraindications

• You must not take the medicine
  • if you are allergic to drugs of the active substance group pyrazolones or pyrazolidines (hypersensitivity e.g. to drugs containing metamizole, propyphenazone, phenazone or phenylbutazone).
  • if you are allergic to any of the other ingredients.
  • if you have genetically caused glucose-6-phosphate dehydrogenase deficiency (hereditary disease with the risk of red blood cells dissolving).
  • if you have acute hepatic porphyria (hereditary disease with impaired formation of the red blood pigment).
  • During pregnancy and breastfeeding.
• Since there is insufficient scientific evidence available for use in infants and children up to 7 years of age, use in this age group is generally not indicated.

pregnancy and breast feeding period

• Since there is no experience with its use during pregnancy and the active ingredient is excreted in breast milk, you must not take the drug during pregnancy or breastfeeding.

Patient information

• Warnings and Precautions
  • Talk to your doctor, pharmacist or nurse before taking the medicine.
    • if you have already been diagnosed with damage to your blood count. Then you should only take the preparation under medical supervision of the blood count.
    • if you suffer from allergies or certain illnesses with a possible allergic cause (including a history). You then tend to have a shock reaction (sudden circulatory failure) and are therefore only allowed to use the drug under medical supervision. This is particularly true for the following allergies and diseases:
      • Bronchial asthma (shortness of breath due to narrowing of the smallest airways) and chronic (long-lasting) inflammation of the airways
      • Pain and rheumatic drug allergy (analgesic intolerance) or allergy to other drugs
      • Allergy to food, preservatives, alcoholic beverages
      • Allergy to fur and hair dyes.
  • What should you watch out for with children?
    • Children under 7 years of age should not take the medicine.
  • What should be considered in the elderly?
    • The dose should be reduced in old age.

• Driving and using machines
  • If such side effects occur, the ability to react can be altered and the ability to actively drive and use machines can be impaired. This applies even more in combination with alcohol.