NOVALGIN OBLONG TAB; metamizole, anti inflammatory agents .
ACTIVE-INGREDIENT OF NOVALGIN OBLONG TAB
One film coated tablet contains 500 mg metamizole sodium.
INDICATION OF NOVALGIN OBLONG TAB
Novalgin is used for treatment of : Severe life threatining fever. Cancer pain. Not used as a routine analgesic.
DOSAGE OF NOVALGIN OBLONG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Stick to the prescribed doses: Novalgin must be administered exactly as your doctor has told you. Please with your doctor or pharmacist if you are not sure. Unless your doctor tells you otherwise, the usual dose is: The dosage depends on the intensity of pain or fever and individual sensitivity to respond to Novalgin. Your doctor will tell you hoe to take Novalgin. Generally, his guidance is based on the following recommendations. Generally, the lowest dose sufficient to control pain and fever is elected. In case of fever in children, a dose of 10 mg per kilogram of body weight metamizole is generally sufficient. A significant effect can be expected 30 to 60 minutes after ingestion. For children and adolescents under 14 years of age, It is given as a single dose of 8 to 16 mg metamizole sodium 1 H2O per kilogram of body weight. Adults and adolescents over 15 years (> 53 kg) can take up to 1000 mg per single dose. In case of insufficient effect, the respective single dose, may be given up to four times a day, depending on the maximum daily dose. In case of 10-14 years (32-53 kg ) body weight : Single dose is 1 tablet Novalgin (equivalent to 500 mg metamizole sodium 1 H2O) : Maximum daily dose is up to 4 tablets Novalgin (equivalent to up to 2.000 mg of metamizole sodium 1 H2O). In case of Adults and adolescents over 15 years (>53 kg ) body weight : Single dose is 1-2 tablet Novalgin (equivalent to 500-1,000 mg metamizole sodium 1 H2O) : Maximum daily dose is up to 8 tablets Novalgin (equivalent to up to 4,000 mg of metamizole sodium 1 H2O). Elderly: In the elderly patients dose should be reduced, as the excretion of the metabolites of Novalgin may be delayed. With poor general condition and impaired creatinine clearance: In patients with poor general condition and impaired creatinine clearance the dose should be reduced as the excretion of the metabolites of Novalgin may be delayed. Impaired kidney or liver function: As elimination rate is decreased with renal or hepatic dysfunction, multiple high doses should be avoided. With short-term use, no dose reduction is required. Data on long-term use has not been established. Method of administration: The tablets should be swallowed whole with sufficient amount of liquid (eg a glass of water). Duration of treatment: The duration of treatment depends on the nature and severity of the disease and is determined by your doctor. It is recommended that Novalgin is not to be taken beyond 3 to 5 days without a prescription from a adoctor, a pharmacist, or a dentist.
OVER-DOSAGE OF NOVALGIN OBLONG TAB
If you take more Novalgin than you should: If you have taken large quantities of Novalgin, this can manifest in the form of nausea, vomiting, abdominal pain, renal impairment up to acute renal failure (eg, in the form of intersitial nephritis) and rarely dizziness, sleepiness (somnolence), unconsciousness, convulsions, hypotension including shock and cardiac arrhthmia (tachycardia). Please notify a doctor immediately of any suspected overdose, so he can take the appropriate counter measures. Note: At very high doses, the excretion of a harmless metabolite (Rubazonic acid) causes a red coloration of the urine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
CONTRA-INDICATION OF NOVALGIN OBLONG TAB
If you are hypersensitive (allergic) to metamizole or other pyrazolones (eg phenazon, propyphenazone) or pyrazolidines (eg, phenylbutazone, oxyphenbutazone) – including patients who e.g. had agranulocytosis after using theses substances, or any of the other ingredients of Novalgin tablets. With known analgesic intolerance (analgesic asthma syndrome, or analgesic intolerance of urticaria-angioedema type); such as patients who develop spasmodic narrowing of the lower airways (bronchospasm) or other hypersensitivity reaction to salicylates and paracetamol or other analgesics such as Diclofenac, Ibuprofen, Indomethacin and Naproxen. If you have impaired bone marrow functions (eg following treatment with cytostatic agents, which are given in cancer) or disorders of blood formation (the hematopoietic system). If you have hereditary glucose-6-phosphate dehydrogenase deficiency ( a rare metabolic disease), reason: Danger of lysis of red blood cells (hemolysis), In acute intermittent hepatic prophyria ( a rare metabolic disease); reason: risk of triggering an attack of porphyria, In the last trimester of pregnancy. Children under 10 years old.
STORAGE OF NOVALGIN OBLONG TAB
Do not use this medicine after the expiry date stated on the blister and carton after “EXP” The expiry date refers to the last day of the month. Store below 30 °C.
PACK OF NOVALGIN OBLONG TAB
Carton box of 1 strip containing 10 film coated tablets & inner insert.
NOVALGIN OBLONG TAB MANUFACTURED BY
Sanofi-aventis / Egypt s.a.e. Under license of safoni-aventis / Germany.