POTABA

Posology One sachet containing 3 g Potassium para-aminobenzoate powder should be taken orally, four times daily. Paediatric population The safety of Potassium para-aminobenzoate 3 g powder in children aged 0 to 18 years has not been established.

No data are available. Method of administration For oral use. The contents of one sachet should be dissolved in cold water or fruit juice and taken orally with food.

The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with Potassium para-aminobenzoate 3 g powder treatment. g. transaminases, gamma-GT, ALP, LDH) Rare: hepatitis Not known: drug-induced liver injury, hepatic failure Skin and subcutaneous tissue disorders Uncommon: skin rash (exanthema, eczema, dermatitis, urticaria), pruritus Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS) General disorders and administration site conditions Common: pyrexia, chills Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Hypersensitivity reactions Potassium para-aminobenzoate 3 g powder must be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle pain, blisters, oral lesions, oedema and eosinophilia) and must not be restarted.

Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs) manifesting as drug reactions with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with Potassium para-aminobenzoate 3 g powder treatment.

At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of this reaction appear, Potassium para-aminobenzoate 3 g powder should be withdrawn immediately.

If the patient has developed DRESS with the use of Potassium para-aminobenzoate 3 g powder, treatment with Potassium para-aminobenzoate 3 g powder must not be restarted in this patient at any time. g. during fasting, anorexia, nausea).

This is to avoid the possible development of hypoglycaemia. 8). 5), Potassium para-aminobenzoate 3 g powder should be used with caution because of the risk of hyperkalaemia. Before start of treatment with Potassium para-aminobenzoate 3 g powder, an anamnestic survey of pre-existing hyperkalaemia risk factors including an initial serum potassium determination should be performed for all patients.

For patients with an increased risk of hyperkalaemia, serum potassium should be measured at least monthly or at closer intervals depending on risk assessment and monitoring requirements due to other risk factors. For patients with an increased initial serum potassium level, the underlying cause should be identified insofar as possible and serum potassium levels should be normalised before start of treatment with Potassium para- aminobenzoate 3 g powder.

Hypersensitivity to the active substance potassium para-aminobenzoate, para-substituted aromatic amines (e. g. 1. - Renal insufficiency (GFR < 45 ml/min). - Hyperkalaemia (each sachet contains 669 mg potassium). 5). - Severe liver damage.