• 500 mg phenazone

• hard fat

indication

• This medicine is a remedy for migraine headaches and other pains.
• It is applied:
  • for the acute treatment of headaches from migraine attacks with and without aura,
  • for mild to moderate pain.

dosage

• Always use 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.
• Unless otherwise prescribed by the doctor, the recommended dose is:
  • Acute treatment of headaches from migraine attacks with and without aura
    • Adults and adolescents over 15 years of age take 2 tablets (equivalent to 1000 mg phenazone) for the acute treatment of headaches from migraine attacks with and without aura, possibly several times a day at intervals of 4 to 8 hours.
    • The maximum total daily dose should not exceed 8 tablets.
      For use in children and adolescents up to 15 years of age, there is insufficient knowledge to be able to give a general dosage recommendation for the acute treatment of headaches associated with migraine attacks.
  • Mild to moderate pain
    • Adults and adolescents over the age of 15 use 1 - 2 suppositories (equivalent to 500 mg - 1000 mg phenazone), possibly several times a day at intervals of 4 to 8 hours.
      • The maximum total daily dose should not exceed 8 suppositories.
    • Suppositories are not suitable for use in children and adolescents up to the age of 15 because of the size of the suppository due to the high active ingredient content.
    • The dose should be reduced in old age, in a reduced general condition and with limited creatinine clearance or liver function, since the excretion of the metabolites of the drug can be delayed. In these cases, the total daily dose should not exceed 3 suppositories (equivalent to 1500 mg phenazone).

• Duration of use:
  • Drugs containing phenazone should not be taken for more than 3-4 days without medical or dental advice.

• If you take more than you should
  • Signs of an overdose are tremors, seizures, blurred vision, skin rashes and loss of consciousness. If you experience these signs, contact a doctor immediately. If necessary, first aid measures must be taken. If unconscious, keep the airways clear.

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

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

way

• The suppositories are inserted deep into the anus after defecation if possible. To improve the lubricity, warm the suppository in your hand or briefly immerse it in hot water.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • The frequency of side effects is based on the following categories:
    • Very common more than 1 in 10 people treated
    • Often less than 1 in 10 but more than 1 in 100 people treated
    • Uncommonly less than 1 in 100 but more than 1 in 1000 people treated
    • Rarely less than 1 in 1000 but more than 1 in 10,000 people treated
    • Very rarely affects less than 1 in 10,000 people
    • Not known: frequency cannot be estimated from the available data
  • Possible side effects:
    • Skin and subcutaneous tissue disorders:
      • Uncommon: Skin changes with redness and itching, inflammation, rashes of various forms, nodules, blisters and hives.
      • Rarely: Swelling with accumulation of water, inflammation and swelling of the mucous membranes, especially in the throat, and skin rashes up to detachment and dissolution of the skin (fixed exanthema, urticaria, in particularly rare cases: maculopapular exanthema, erythema multiforme, erythema nodosum, angioneurotic edema and toxic epidermal necrolysis).
    • General disorders and administration site conditions:
      • Rare: Severe immediate allergic reaction with signs of shock.
    • Notice:
      • Shock is a very rare event. It can be expressed in varying degrees by the following warning signs: cold sweat, shortness of breath, dizziness, nausea, drowsiness. A feeling of trepidation in the heart area, rapid heart rate and drop in blood pressure can also occur. These symptoms can appear immediately or up to an hour after ingestion.
      • At the first sign of shock, call the nearest available doctor for help immediately!
      • Until his arrival, the patient's upper body should be flat and his legs elevated. To avoid chilling, the patient should be kept warm with a blanket.
      • In individual cases, blood count changes after application cannot be ruled out.
  • Countermeasures for side effects:
    • If severe side effects occur, the drug should no longer be taken; please contact your doctor immediately in this case.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed here.

interactions

• Taking the medicine with other medicines
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
  • If the medicine is taken at the same time as warfarin, the effect of warfarin is weakened by reducing the time it takes for blood to clot.
  • If the medicine is used for a long time with enzyme-inducing substances such as e.g. phenytoin, carbamazepine, barbiturates, spironolactone or rifampicin, the duration of action of phenazone may be shortened.
  • Used concomitantly with cimetidine and/or disulfiram and beta-blockers such as B. propranolol, with calcium antagonists such as verapamil or diltiazem, with antiarrhythmics such as amiodarone, with oral contraceptives or ketoconazole, the degradation and / or elimination of phenazone is slowed down. As with fever, there is the possibility of accumulation (increase in the concentration of phenazone in the blood).

Contraindications

• The medicine must not be taken
  • if you are allergic to phenazone, pyrazolones and phenylbutazone or any of the other ingredients,
  • if you have a genetically determined glucose-6-phosphate dehydrogenase deficiency (hereditary disease with a risk of dissolving the red blood cells),
  • in acute hepatic porphyria (hereditary disease with impaired formation of the red blood pigment),
  • during pregnancy and lactation.
  • The drug is not suitable for infants and children under the age of 12. Furthermore, there are no findings for this age group, which is why the preparation must not be used in these children.

pregnancy and breast feeding period

• 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.
• Since there is no experience with the use of the drug during pregnancy and the active substance passes into breast milk, the drug must not be used during pregnancy and breastfeeding.

patient notes

• Please talk to your doctor or pharmacist before taking this medicine.
• Patients in whom damage to the blood count has already been determined should only use the drug under medical supervision of the blood count.
• Patients with known allergies or certain diseases with a possible allergic cause (also in the past) are more prone to a shock reaction (sudden circulatory collapse). This particularly affects patients with:
  • Bronchial asthma (attacks of 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 foods, preservatives, alcoholic beverages as well
  • Allergy to fur or hair dyes.
• Patients with these diseases should only use the drug under medical supervision.
• In the elderly and in patients with acute liver damage, the dosage should be based on the lower recommended limit, because the effect of the drug is stronger and lasts longer in these patients.

• Ability to drive and use machines
  • There are no special features to consider.