Do not take CARDASA 100 mg tablets
- If you are allergic to acetylsalicylic acid, other salicylates or any of the other ingredients of this medicine (listed in section 6).
- If you have ever reacted with hypersensitivity (allergy, asthma attacks) to certain medicines against pain, for example acetylsalicylic acid (ASA) at higher doses, or non-steroidal anti-inflammatory drugs (NSAIDs).
- If you have ever had an ulcer or bleeding problem (including perforation) in your stomach or small intestine which was caused by treatment with a non-steroidal anti-inflammatory drug (NSAID) against pain, fever or inflammation.
- If you currently have or have ever had an ulcer or bleeding/perforation in your stomach or small intestine.
- If you ever had the problem of your blood not clotting properly, for instance because you suffer from bleeding tendency or haemophilia (an inherited disorder of the blood) or have a reduced number of platelets in your blood (thrombocytopenia).
- If you have severe liver problems.
- If you have severe kidney problems.
- If you have severe heart problems (heart failure).
- If you have to take 15 mg per week or more of methotrexate (a medicine for the treatment of certain types of cancer or rheumatic disease).
- If you are taking medicines against blood clotting (oral anti-coagulants, so-called ‘blood thinners’) or ASA at high doses.
- During the last 3 months of pregnancy (see also section 2 Pregnancy, breastfeeding and fertility).
- If you suffer from oxaluria (a condition frequently causing formation of renal stones).
Warnings and precautions
Talk to your doctor or pharmacist before taking CARDASA 100 mg tablets:
- If you are hypersensitive to other medicines against pain (analgesics, anti-inflammatory medicines or medicines used to treat rheumatic disorders), or if you suffer from other allergies.
- If you have a history of high blood pressure or heart failure. In association with high-dose acetylsalicylic acid treatment, there have been reports of fluid retention in body tissue and swelling (oedema).
- If you are concomitantly treated with medicines against blood clots (anticoagulants).
- If you have or have ever had gastrointestinal ulcers, including chronic or repeatedly recurring ulcers, or gastrointestinal bleeding.
- If your liver function is impaired.
- Before surgical procedures (even smaller procedures such as tooth extraction). The risk of bleeding may increase. Please tell your doctor or dentist that you are taking CARDASA 100 mg tablets.
- If you are planning to take ibuprofen (a medicine against pain), as it may weaken the effect of CARDASA 100 mg tablets. You should talk to your doctor before taking CARDASA 100 mg tablets.
- If your kidney function or your cardiovascular system is impaired (problems of the vessels in your kidneys, heart failure, deficiency in the amount of blood in the body, major operations, sepsis (pus in the blood or tissue), or serious bleeding events), as ASA may increase the risk of an impairment of kidney function and acute kidney failure.
Please also talk to your doctor or pharmacist before taking CARDASA 100 mg tablets:
- If you are pregnant, think you are pregnant or are planning to have a baby.
- If you are breastfeeding.
- If you are taking other medicines additionally, particularly medicines containing ASA or medicines against pain or rheumatism.
- If you also suffer from other diseases or allergies.
Hypersensitivity/allergic reactions
CARDASA 100 mg tablets may induce bronchial spasms, asthma attacks or other hypersensitivity reactions of the respiratory tract. The risk for these reactions is increased if you are asthmatic, have hay fever, nasal polyps or chronic respiratory diseases. The same applies to patients with allergies to other substances (for instance with skin reactions, itching, or hives).
Gastrointestinal problems
Severe – even life-threatening – bleeding, ulcers and/or perforation may occur at any time during treatment, also if you have not had any complaints or problems in the digestive tract before. You should therefore carefully watch out for any symptoms or complaints in your stomach or intestines while taking CARDASA 100 mg tablets. The risk increases with higher doses, in elderly persons, those with a history of gastric ulcers (particularly if they were complicated by bleeding or perforation), and in patients concomitantly treated with other medicines which may increase the risk for ulcers or bleeding, for instance corticosteroids, blood-thinners, certain medicines against depression (selective serotonin re-uptake inhibitors – SSRIs) or other medicines against platelet aggregation. If any of the above applies to you, your doctor may consider it necessary to reduce your dose of CARDASA 100 mg tablets and prescribe an additional medicine to protect your stomach. Please report any unusual symptom in your digestive tract (particularly signs of bleeding) to your doctor immediately, especially in the early stages of treatment. If you experience bleeding or ulcers in the stomach or intestines, treatment with CARDASA 100 mg tablets must be stopped immediately.
Possible symptoms and signs of gastrointestinal complications
Pain in your stomach, vomiting blood, vomiting that looks like coffee grounds, black stools. If any of these occur, stop taking CARDASA 100 mg tablets right away and contact a doctor immediately.
Bleeding tendency
ASA inhibits the clotting of blood cells (platelets) even at relatively low doses. This causes an increased bleeding risk during and after operations (including minor surgery such as tooth extractions), which may continue for several days after stopping to take the medicine. In rare to very rare cases severe bleeding, for example in the brain, has been reported, particularly in patients with uncontrolled high blood pressure and/or concomitant treatment with other medicines preventing the clotting of blood. In exceptional cases, these bleeding events may be life-threatening.
Gout attack
CARDASA 100 mg tablets reduces uric acid excretion and can thus increase the level of uric acid in the blood. This may trigger gout attacks in predisposed patients.
Kidney damage
If ASA is taken over prolonged periods at high doses (against pain), this may lead to lasting kidney damage (nephropathy), which can progress to renal failure. This risk is especially high if you take over-the-counter pain medication in addition to the treatment prescribed by your doctor.
Laboratory tests
If you have to take CARDASA 100 mg tablets for a prolonged period, your doctor will ask you to have certain blood tests done (for instance liver function, kidney function, blood count, coagulation).
Glucose-6-phosphate dehydrogenase deficiency
In some people with so-called glucose-6-phosphate dehydrogenase deficiency (a metabolic disease), high doses of ASA could cause decay of red blood cells. If a patient with glucose-6-phosphate dehydrogenase deficiency needs to take CARDASA 100 mg tablets, this has to be done under strict medical supervision.
Fertility
CARDASA may affect fertility in women (see section 2 Pregnancy, breastfeeding and fertility).
Children and adolescents
In very rare cases so-called Reye’s syndrome (a severe, life-threatening disease affecting the brain and the liver) has been reported in children and adolescents during treatment with acetylsalicylic acid, especially when it was used for treating fever or chicken pox. There may be a relationship with ASA, and the syndrome can also occur in young adults. Medicines containing acetylsalicylic acid such as CARDASA 100 mg tablets should therefore be administered to children younger than 12 years and adolescents only if specifically prescribed by a doctor and only if other treatments have not proved effective. If continued vomiting, impaired consciousness and/or abnormal behaviour occurs (possibly after temporary improvement of the patient’s general state), treatment with CARDASA 100 mg tablets must be stopped immediately and you must seek medical assistance. As a precaution it is recommended that CARDASA 100 mg tablets should not be taken for at least 6 weeks following a vaccination against chicken pox.
