Carbasalate calcium Other names: Carbaspirin calcium

Low doses, up to 128 mg carbasalate calcium/day which is equivalent to 100 mg acetylsalicylic acid/day (1 tablet carbasalate calcium/day)

Clinical studies indicate that doses up to 100 mg acetylsalicylic acid/day for restricted obstetrical use, which require specialised monitoring, appear safe.

Doses of more than 128 mg up to 640 mg carbasalate calcium/day which is equivalent to 100-500 mg acetylsalicylic acid/day (more than 1 tablet carbasalate calcium/day)

There is insufficient clinical experience regarding the use of doses above 100 mg acetylsalicylic acid/day up to 500 mg acetylsalicylic acid/day. Therefore, the following recommendations for doses of 500 mg acetylsalicylic acid/day and above apply also for this dose range:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetyl salicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to:
• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, 128 mg carbasalate calcium/day which is equivalent to 100 mg acetylsalicylic acid/day and higher (more than 1 tablet carbasalate calcium/day) is contraindicated during the third trimester of pregnancy.

Acetyl salicylic acid is excreted into the maternal milk in small amounts. Since after incidental use no adverse effects were observed in the infant, 100 mg acetyl salicylic acid can be taken once during breastfeeding as indicated in the posology (not more than 1 tablet per day). With chronic use or intake of high doses, breast feeding should be stopped.

No studies on the effects on the ability to drive and use machines have been performed. On the basis of the pharmacodynamic profile and/or adverse reactions profile it is unlikely that carbasalate calcium affects the ability to drive and use machines.

The undesirable effects are often dose-dependent and are due to the pharmacological effect of acetyl salicylic acid. Most undesirable effects are usually associated with the gastrointestinal tract.

The frequencies of the adverse reactions below are defined as follows: 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).

Blood and lymphatic system disorders

Common: prolongation of the bleeding time. This effect can persist for several days after stopping the treatment and can give rise to haemorrhagic risks in the event of surgery or can lead to heavier menstruation.

Uncommon: intracranial bleeding, blood in urine

Rare: haemorrhagic syndrome (nosebleeds, bleeding gums, bloody vomiting and blood loss via the faeces, etc.)

Immune system disorders

Uncommon: urticaria, skin rash, angio-oedema, rhinitis, bronchial spasms

Very rare: anaphylactic shock, aggravation of the allergic symptoms of food allergy

Endocrine disorders

Very rare: hypoglycaemia.

Metabolism and nutrition disorders

Very rare: low-dose ASA can reduce the excretion of uric acid (which can lead to acute gout in pre-disposed patients).

Nervous system disorders

Rare: dizziness, headache, tinnitus. These are usually the first indications of overdose (see also section 4.9).

Gastrointestinal disorders

Very common: gastric complaints such as hyperacidity and nausea

Common: vomiting, gastritis, mild to moderate blood loss in the gastrointestinal tract, diarrhoea. With long-term or repeated use this blood loss can lead to anaemia.

Uncommon: gastric bleeding, gastric ulcers

Very rare: gastrointestinal perforation

Hepatobiliary disorders

Very rare including isolated reports: liver impairment

Skin and subcutaneous tissue disorders

Very rare: severe skin reactions (e.g. erythema exsudativum multiforme).

Renal and urinary disorders

Very rare: acute renal insufficiency, especially in patients with existing renal insufficiency, heart decompensation, nephrotic syndrome or concomitant treatment with diuretics.