SIBNAYAL

Posology Dosing is based on age and weight. When initiating alkalising therapy, the target starting daily dose indicated below for each age group should be used and incrementally titrated to obtain the optimal dose that provides adequate metabolic acidosis control based on plasma bicarbonate levels.

5 mEq/kg/day to optimal dose When switching from another alkalising therapy to Sibnayal, treatment should be initiated at the target dose used with the previous therapy (in mEq/kg/day) and titrated where necessary as described above.

The maximum dose, regardless of the age group, is either 10mEq/kg/day or a total daily dose of 336 mEq, whichever is lower. The total daily dose should be administered in two intakes. For each individual patient, the nearest dose to the target dose should be fixed by combining whole sachets of the two available strengths.

In case of vomiting within two hours after intake, the patient should take another dose. The use of this medicine requires medical supervision. Special populations Elderly No dose adjustment is required. 73m². 73m² Sibnayal should only be used if the potential benefits are considered to outweigh the potential risks.

See Table 1. 73m² Treatment of dRTA 45-59 • Plasma potassium levels in the normal ranges: A regular monitoring of renal function parameters and blood potassium levels is necessary at starting dose and after new dose increase or if any decrease of GFR.

4). • Elevated plasma potassium: Contraindicated ≤ 44 Contraindicated Hepatic impairment There is no need for specific target starting daily dose adjustment in patients with hepatic impairment. Paediatric population The safety and efficacy of Sibnayal in children below one year of age have not been established.

No data are available. Method of administration For oral use. The total daily dose is administered twice daily, typically twelve hours apart. Sibnayal must be taken orally, swallowed with a large glass of water. The full dose of granules per intake can be swallowed in several smaller portions if necessary, but the content of each sachet must be entirely taken.

Doses should be taken preferably during meals. , fruit puree, yoghurt). The Sibnayal soft food mixture must be used immediately and cannot be stored. The mixture should be swallowed without chewing. Care should be taken to ensure that Sibnayal is not retained in the mouth.

Summary of the safety profile The most frequently reported adverse reactions are abdominal pain (7 patients, 14%, very common), upper abdominal pain (in 4 patients, 8%, common) and gastro-intestinal pain (in 1 patient, 2%, common).

Nausea (in 1 patient, 2%, common) can be experienced at initiation of therapy. Tabulated list of adverse reactions The list of adverse reactions is based on the experience with Sibnayal in clinical trials. The frequency of adverse reactions is defined using the following convention: very common ( 1/10) ; common ( 1/100 to <1/10) ; uncommon ( 1/1000 to <1/100) ; rare ( 1/10000 to <1/1000) and very rare (<1/10000).

Gastrointestinal disorders: - abdominal pain as very common - abdominal pain upper, diarrhoea, dyspepsia, gastrointestinal disorder, gastrointestinal pain, nausea and vomiting as common. Description of selected adverse reactions Gastrointestinal disorders Gastro-intestinal pain, abdominal pain and upper abdominal pain were generally of mild or moderate intensity and resolved within 24 hours without the need to modify or stop the treatment.

All other gastrointestinal adverse reactions (dyspepsia, vomiting, diarrhoea) were also of mild or moderate intensity, and resolved within 1 to 3 days, without modification or interruption of treatment. Paediatric population In clinical trials, although numbers were small, the safety profile was comparable for adults and children.

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.

Hyperkalaemia and cardiotoxicity Sibnayal should be used with caution in patients who have conditions pre- disposing them to hyperkalaemia, such as renal impairment, or crush syndrome, as a further rise in plasma potassium may lead to cardiac arrest.

Close monitoring of plasma potassium in patients at risk is required at starting dose and after new dose increase or in case of worsening of pre-existing disease. Then frequency is according to physicians´s criteria, but at least twice a year.

5). Gastrointestinal disorders Sibnayal should be used with caution in patients having gastro-intestinal disorders as they could affect efficacy and safety, such as malabsorption, delayed gastric emptying, diarrhoea, nausea, vomiting.

In such cases the blood bicarbonate levels should be regularly monitored and dose adjusted to maintain within normal ranges. The matrix of the granules can be found in the stools, which does not affect the efficacy or safety of Sibnayal.

73m². 73m² Sibnayal should only be used if the potential benefits are considered to outweigh the potential risks. 2). Special care should be taken in elderly people in whom renal function can be decreased. Potassium contents Sibnayal 8 mEq contains 308 mg of potassium per sachet.

This is to be taken into consideration if the patient has a reduced kidney function or if the patient is on a controlled potassium diet. Sibnayal 24 mEq contains 924 mg of potassium per sachet. This is to be taken into consideration if the patient has a reduced kidney function or if the patient is on a controlled potassium diet.

1. 73m². Hyperkalaemia.