ALKA-SELTZER XS

Alka-Seltzer XS is for oral ingestion after dissolution in water. It dissolves more quickly in warm water.

Adults:

Two tablets in water. This dose may be repeated every four hours up to four doses in 24 hours but the dosage should not be continued for more than three days without consulting a doctor. Do not exceed the stated dose. g. for Kawasaki’s disease).

Acetylsalicylic acid:

The listed adverse drug reactions are based on spontaneous reports, thus an organization according to CIOMS III categories of frequency is not possible. Blood and lymphatic system disorders Increased risk of bleeding (due to effect on platelet aggregation).

In the context of bleeding: haemorrhagic anaemia, iron deficiency anaemia with the respective laboratory and clinical signs and symptoms. In the context of glucose-6-phosphate dehydrogenase (G6PD) deficiency: haemolysis, haemolytic anaemia Immune system disorders Hypersensitivity, drug hypersensitivity, allergic edema and angioedema, anaphylactic reaction, anaphylactic shock with respective laboratory and clinical manifestations Nervous system disorders Cerebral and intracranial haemorrhage, dizziness Ear and labyrinth disorders Tinnitus Cardiac disorders In the context of severe allergic reactions: cardio-respiratory distress Vascular disorders Haemorrhage, operative haemorrhage, haematoma, muscle haemorrhage Respiratory, thoracic and mediastinal disorders Epistaxis, analgesic asthma syndrome, rhinitis, nasal congestion, bronchospasm Gastrointestinal disorders Dyspepsia, gastrointestinal pain, abdominal pain, gingival bleeding, gastrointestinal inflammation, gastrointestinal ulcer, gastrointestinal haemorrhage, gastrointestinal ulcer perforation with the respective laboratory and clinical signs and symptoms, nausea, diarrhoea, vomiting Hepatobiliary disorders Liver disorder, transaminases increased Skin and subcutaneous tissue disorders Rash, urticaria, pruritus, severe skin reactions Renal and urinary disorders Impaired renal function Injury, poisoning and procedural complications See overdose section Paracetamol: Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasis including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

g. g. renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major haemorrhagic events), since acetylsalicylic acid may further increase the risk of renal impairment, • patients with impaired hepatic function.

6) Acetylsalicylic acid may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions. Risk factors are pre-existing asthma, hay fever, nasal polyps, or chronic respiratory disease. g. cutaneous reactions, itching, urticaria) to other substances.

g. dental extractions). At low doses, acetylsalicylic acid reduces the excretion of uric acid. This can possibly trigger gout attacks in predisposed patients. There is a possible association between aspirin and Reye’s syndrome when given to children.

Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. g. Kawasaki’s disease). In patients suffering from severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, acetylsalicylic acid may induce haemolysis or haemolytic anaemia.

Factors that may increase the risk of haemolysis are high dosage, fever, or acute infections, for example. Alka-Seltzer XS contains paracetamol and so other paracetamol-containing preparations should be avoided. The maximum dose of paracetamol for adults is 4g daily.

Do not exceed the recommended dose. If symptoms persist consult your doctor. Keep out of the reach of children.

Leaflet warning:

Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

Label warning:

Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well. 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

g. g. asthma, rhinitis, urticaria) induced by the administration of salicylates, or substances with similar actions, notably non-steroidal anti-inflammatory drugs. • with active or a history of peptic ulcers. • with haemorrhagic diathesis such as haemophilia.

• with severe renal failure. • with severe hepatic failure. • with severe cardiac failure. 6). • who are breastfeeding. 5).