THERAPEUTIC INDICATIONS

Severe pain, acute or chronic, e.g : in association with headache, toothache or tumours, and after injuries operations. Severe pain associated with smooth muscle spasms, acute or chronic, e.g. muscular spasm or colic affecting the gastrointestinal tract, the biliary passages, kidney or lower urinary tract. Not to be used in trivial complaints.

POSOLOGY AND METHOD OF ADMINISTRATION

Adults & adolescents ≥ 15 yrs: 1 tablet, up to 4 x 1 tab/day (do not chew). Syrup: 2-4 spoonfuls, up to 4x4 spoonfuls/day. Drops: 20-40 drops, up to 4x40 drops.

Children:

Do not prescribe for infants <3 months or <5 kg body weight unless there is compelling need. Should its administration be essential, a single dose of 1 drop and a daily dose of 1 drop twice daily must not be exceeded.

CONTRAINDICATIONS

Allergy to metamizol or to other pyrazolones (e.g. phenazone, propyphenazone) or to pyrazolidines (e.g. phenylbutazone, xyphenbutazone) including, previously experienced agranulocytosis to one of these substances; Impaired bone marrow function (e.g. following cytostatic treatment) or diseases of the haematopoietic system; Patients known to develop bronchospasm or other anaphylactoid reactions (e.g. urticaria, rhinitis, angioedema) to analgesics such as: salicylates, paracetamol, diclofenac, ibuprofen, indometacin, naproxen; Allergy to any of the excipients; Acute intermittent hepatic porphyria (risk of induction of porphyria attacks); Congenital glucose 6 phosphate dehydrogenase deficiency (risk of haemolysis); infants under 3 months of age or 5 kg body weight ; infants <3 months or <5 kg body weight; In infants between 3 and 11 months of age, NOVALGIN must not be injected by the IV route; Novalgin must not be given parenterally in patients with hypotension or unstable hemodynamic.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Agranulocytosis (immuno-allergic, rare but could be fatal). In the event of neutropenia, discontinue treatment and do complete blood count. Discontinue treatment in case of pancytopenia. Anaphylactic shock, use in caution in asthmatic or atopic patients. Parenteral administration is associated with a higher risk of anaphylactic reactions. Patients are at special risk for possibly severe anaphylactoid reactions: bronchial asthma, chronic urticarial, alcohol intolerance, intolerance to dyes (e.g. tartrazine) or to preservatives (e.g. benzoates). Life-threatening cutaneous reactions Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with the use of metamizole. Metamizol may cause isolated hypotensive reactions (dose-dependent and are more likely to occur following parenteral administration). Reverse hemodynamic in patients with pre-existing hypotension, with volume depletion or dehydration, or with circulatory instability or with incipient circulatory failure. Care should be taken in patients with high fever. Only used under close haemodynamic monitoring in patients in whom lowering of blood pressure must be avoided (e.g patients with severe coronary heart disease or stenoses of blood vessels supplying the brain). Avoid high doses in patients with renal or hepatic impairment.

INTERACTIONS

Reduction in serum cyclosporin concentration. Increasing the hematotoxicity of methotrexate. Reduction effect of aspirin. Reduction in bupropion blood concentrations. Interference with laboratory tests which use Trinder/Trinder-like reactions.

PREGNANCY AND LACTATION

Insufficient clinical data on the use of Novalgin during pregnancy. 1 st three months: use is not recommended, 2nd three month: use only after careful weighing of potential benefit and risk, 3rd three month: do not use. Metamizole metabolites are excreted into the breast milk, avoid breastfeeding during and for 48 hours after administration of Novalgin.

UNDESIRABLE EFFECTS

Anaphylactic/anaphylactoid reactions (very rare, but may be severe and life-threatening). Haematological reactions; rarely, leucopenia and, in very rare cases, agranulocytosis or thrombopenia may develop. Isolated hypotensive reactions. In very rare instances, especially in patients with a history of renal disease, acute worsening of renal function (acute renal failure), in some cases with oliguria, anuria or proteinuria may occur. Acute interstitial nephritis may occur in isolated cases. A red coloration has been sometimes observed in the urine. GI bleeding.

OVERDOSE

Sign and symptoms: Reactions such as nausea, vomiting, abdominal pain, impairment of renal function/acute renal failure (e.g. due to interstitial nephritis) and, more rarely, central nervous symptoms (dizziness, somnolence, coma, convulsions) and drop in blood pressure (sometimes progressing to shock) as well as cardiac arrhythmias (tachycardia) have been reported following acute overdose. After very high doses, the excretion of a harmless metabolite (rubazonic acid) may cause red discoloration of the urine. Management: No specific antidote for metamizol is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredients through measures for primary detoxification (e.g. gastric lavage) or those designed to reduce absorption (e.g. activated charcoal). The main metabolite (4N-methylaminoantipyrine) can be eliminated by haemodialysis, haemofiltration, haemoperfusion or plasma filtration. In the event of an overdose, medical aid is imperative. If the patient is not unconscious, attempts should be made to induce vomiting by rapidly drinking 3/4 to 1 litre of lukewarm salt water (1 - 2 table spoonfuls of salt in a glass of water) followed by mechanical stimulation of the posterior pharyngeal wall (e.g. with the handle of a spoon). Instead of salt solution, small children (1 to 6 years of age) should be made to drink warm fruit juice in amounts appropriate to their age.

PHARMACODYNAMIC PROPERTIES

ATC Code: N02BB02.

Pharmacological class: Other Analgesics and Antipyretics, Pyrazolones.

Presentation

Tablet : Dus, 10 blister @ 10 tablet ; Dus, 10 blister @ 50 tablet (DKL0121203604A1)

Syrup : Bottle of 60 ml (net content) (DKL0121202637A1)

More detailed Information on request: PT Aventis Pharma Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210 (021) 4892208 - 4895608

Date of revision: 1-Nov-18 (based on BPOM approval 24-Oct-18)

This information is intended for Health Care Professional only. See local product information for full details information