CLOPALVIX PLUS

DOSAGE AND ADMINISTRATION

Method of administration: 

CLOPALVIX PLUS for oral use, once a day, it may be given with or without food.

Posology

Adults and elderly: Use 1 tablet per day, do not use the drug for more than 12 months.

Paediatric population: Safety and efficacy of using the drug have not been established. There is a possible association between Reye´s syndrome when aspirin is given to children. Reye´s syndrome is a very rare disease which can be fatal. Not recommended for use in children.

CONTRAINDICATIONS

Hypersensitivity to clopidogrel, aspirin or to any of the excipients

Hepatic impairment, renal impairment.

Active pathological bleeding such as intracranial haemorrhage, gastrointestinal bleeding, or haemophilia

Peptic ulcer or erosive gastritis

Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) and and in patients with the syndrome of asthma with rhinitis and/or nasal polyps. Patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid may induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).

Breast-feeding and pregnancy

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine

 WARNINGS AND PRECAUTIONS

CLOPALVIX PLUS prolong bleeding time, and should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions, as follows:

If a patient is to undergo elective surgery and an anti-platelet effect is not desired, medicine should be discontinued 7 days prior to surgery.

This medicine should be used with extra caution in patients with a high risk of ophthalmic bleeding due to intraocular lesions, a history of peptic ulcer or gastroduodenal haemorrhage or minor upper gastrointestinal symptoms.. It is necessary to warn patients about the risk of gastrointestinal tumors and bleeding even if there are no previous symptoms.

Patients who have lesions with a propensity to bleed or taking medications that may increase damage to the gastrointestinal tract or intraocular.

Patients should be told about possible side effects and how to handle, slow blood clotting when using the drug. Patients should inform physicians and dentists that they are taking CLOPALVIX PLUS before any surgery is scheduled and before any new drug is taken

Caution is required in patients with a history of asthma or allergic disorders (as they are at increased risk of hypersensitivity reactions) or with gout (as low doses of aspirin increase urate concentrations

The hypoglycaemic effect of chlorpropamide may be enhanced by the concurrent administration of aspirin. Large doses of aspirin may have intrinsic hypoglycaemic activity when given to diabetic patients, but the effects on carbohydrate metabolism are complex and it may cause hyperglycaemia

Tinnitus is a premonitory sign of salicylism but may not be detected in patients with hearing loss.

Clopalvix plus should be discontinued 7 days prior to coronary bypass surgery

Use with caution in children

SHELF-LIFE 

36 months from the manufacturing date.