DIAMOX SR

Posology Adults:

One or two 250mg capsules a day. Elderly Acetazolamide should be used with particular caution in elderly patients or those with potential obstruction in the urinary tract or with disorders rendering their electrolyte balance precarious or with liver dysfunction.

Renal Impairment In patients with moderate to severe renal impairment, the dose should not exceed 250mg per day or the dosage interval should be increased to every 12 hours.

Paediatric population Children:

This product is not intended for administration to children. There is no relevant use of Acetazolamide in the paediatric population. Method of administration Oral use. Capsules should be swallowed whole. Do not chew or crush.

Adverse reactions during short-term therapy are usually non-serious. Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.

System organ class Frequency Adverse reactions Blood and lymphatic system disorders Uncommon Thrombocytopenia, Leukopenia, Aplastic anaemia, Bone marrow depression, Pancytopenia Not Known Agranulocytosis Common Acidosis. The acidosis can usually be corrected by the administration of bicarbonate.

Uncommon Hypokalaemia, Metabolic acidosis Rare Appetite disorders, Hyponatraemia, Hyperglycaemia and hypoglycaemia may occasionally occur during long term therapy. Very rare Electrolyte imbalance Metabolism and nutrition disorders Not known Thirst Uncommon Depression Rare Confusion Psychiatric disorders Very Rare Irritability, reduced libido Very common Paraesthesia, Tingling of extremity Uncommon Dizziness Very rare Headache, Ataxia, Convulsions, Flaccid paralysis, Sensory disturbances Nervous system disorders Not known Excitement, Occasional instances of drowsiness Eye disorders Not known Transient myopia has been reported.

This condition invariably subsides upon diminution or discontinuation of the medication. Choroidal effusion, choroidal detachment Ear and labyrinth disorders Uncommon Impaired hearing and tinnitus Respiratory, thoracic and mediastinal disorders Not known Non-cardiogenic pulmonary oedema Uncommon Melaena, Nausea, Vomiting Rare Diarrhoea Gastrointestinal disorders Not known Taste disturbance Hepatobiliary disorders Rare Fulminant hepatic necrosis, Hepatitis or cholestatic jaundice Uncommon Urticaria, Rash (including Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis Rare Photosensitivity Very rare Thrombocytic purpura Skin and subcutaneous tissue disorders Not known acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Uncommon Osteomalacia with long-term phenytoin therapy Very common NephrolithiasisRenal and urinary disorders Common Haematuria Uncommon Crystalluria, Renal and ureteral colic, Renal lesions, Renal failure, nephrolithiasis, Calculus formation, Haematuria Very rare Renal tubular necrosis Not known Polyuria, Ureteral pain, Glycosuria General disorders and administration site conditions Very rare Flushing, Fever, Fatigue, Anaphylaxis Investigations Uncommon Abnormal liver function Injury, poisoning and procedural complications Not known Renal injury Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia. Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic agents in several indications.

A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Acetazolamide.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

When acetazolamide is prescribed for long-term therapy, special precautions are advisable. The patient should be cautioned to report any unusual skin rash. Prior to initiating therapy and at regular intervals during therapy monitoring of blood cell counts and electrolyte levels are recommended.

Fatalities have occurred, although rarely, due to severe reactions to sulphonamides including acetazolamide, such as Steven-Johnson syndrome and toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasias and anaphylaxis.

A precipitous drop in formed blood cell elements or the appearance of toxic skin manifestations should call for immediate cessation of acetazolamide therapy. Hypersensitivity reactions may recur if a sulphonamide or sulphonamide derivative is re-administered, irrespective of the route of administration.

If signs of hypersensitivity reactions or other serious reactions occur, acetazolamide must be discontinued. Acetazolamide treatment may cause electrolyte imbalances, including hyponatraemia and transient hypokalaemia, as well as metabolic acidosis.

1 Acetazolamide should not be used in patients hypersensitive to sulphonamides or other sulphonamide derivatives. Acetazolamide is contra-indicated in situations in which sodium and/or potassium blood levels are depressed, in cases of marked renal impairment and liver disease or dysfunction, suprarenal gland failure, and hyperchloremic acidosis.

Acetazolamide should not be used in patients with liver disease or impairment of liver function including cirrhosis as this may increase the risk of hepatic encephalopathy. Acetazolamide is contra-indicated in patients with hypokalemia and hyponatraemia.

Long-term administration of Acetazolamide is contra-indicated in patients with chronic non- congestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intra- ocular pressure.