CAPOZIDE

Treatment of essential arterial hypertension.

This fixed-dose combination is indicated in patients whose blood pressure is not sufficiently controlled by captopril alone or hydrochlorothiazide alone.

Frequency is defined using the following convention: very frequent (≥ 1/10); frequent (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000) and unknown (the frequency cannot be estimated from the available data).

Related to captopril

Adverse effects reported during treatment with captopril and/or ACE inhibitors include the following effects:

Hematological and lymphatic system disorders

· Very rare: neutropenia/agranulocytosis (see section 4.4), pancytopenia particularly in patients with impaired renal function (see section 4.4), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, autoimmune diseases and/or positive antinuclear antibodies.

Metabolism and nutrition disorders

· Uncommon: anorexia.

· Very rare: hyperkalaemia, hypoglycaemia (see section 4.4).

Psychiatric disorders

· Frequent: sleep disorders.

· Very rare: confusion, depression.

Nervous system disorders

· Frequent: altered taste, dizzy sensations.

· Uncommon: headache, paresthesia.

· Rare: somnolence.

· Very rare: cerebrovascular incidents, including stroke, cerebrovascular insufficiency and syncope.

Eye disorders

· Very rare: blurred vision.

Cardiac disorders

· Uncommon: tachycardia or tachyarrhythmia, angina, palpitations.

· Very rare: cardiac arrest, cardiogenic shock.

Vascular disorders

· Uncommon: hypotension (see section 4.4), Raynaud's syndrome, flush, pallor.

Respiratory, thoracic and mediastinal disorders

· Common: dry and irritative, non-productive cough (see section 4.4) and dyspnoea.

· Very rare: bronchospasm, rhinitis, allergic alveolitis/eosinophilic pneumonia.

Gastrointestinal disorders

· Common: nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth, gastrointestinal ulcer.

· Rare: stomatitis/aphthous ulceration, intestinal angioedema (see section 4.4).

· Very rare: glossitis, pancreatitis.

Hepatobiliary disorders

· Very rare: hepatic function disorders, cholestasis (including jaundice), hepatitis including necrosis, elevations of hepatic enzymes and bilirubin.

Skin and subcutaneous tissue disorders

· Common: pruritus, rash and alopecia.

· Uncommon: angioedema (see section 4.4).

· Very rare: urticaria, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, pemphigoid reactions, erythroderma and exfoliative dermatitis.

Musculoskeletal and systemic disorders

· Very rare: myalgia, arthralgia.

Renal and urinary disorders

· Rare: renal function disorders including renal failure, polyuria, oliguria, increased urinary frequency.

· Very rare: nephrotic syndrome.

Reproductive system and breast disorders

· Very rare: impotence, gynaecomastia.

General disorders and administration site conditions

· Uncommon: chest pain, fatigue, malaise.

· Very rare: fever.

Investigations

· Very rare: proteinuria, eosinophilia, hyperkalaemia, hyponatraemia, increased serum urea, creatinine and bilirubin, decreased haemoglobin, haematocrit, leucocytes, platelets, positive antinuclear antibodies, increased sedimentation rate.

Related to hydrochlorothiazide

Infections and infestations

· Sialadenitis.

Blood disorders and lymphatic system disorders

· Leucopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia, bone marrow aplasia.

Metabolism and nutrition disorders

· Anorexia, hyperglycaemia, glycosuria, hyperuricaemia, electrolyte imbalance (notably hyponatraemia and hypokalaemia), increase in cholesterol and triglycerides.

Psychiatric disorders

· Agitation, depression, sleep disorders.

Nervous system disorders

· Loss of appetite, paresthesia, sensation of empty head.

Eye disorders

· Choroidal effusion (undetermined frequency), xanthopsia, transient blurred vision, acute myopia, acute angle-closure glaucoma.

Ear and labyrinth disorders

· Vertigo.

Cardiac disorders

· Orthostatic hypotension, cardiac arrhythmia.

Vascular disorders

· Necrotizing angiitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders

· Respiratory distress (notably inflammatory pneumopathy and pulmonary oedema), acute respiratory distress syndrome (ARDS) (see section 4.4) (very rare).

Gastrointestinal disorders

· Gastric irritation, diarrhoea, constipation, pancreatitis.

Hepatobiliary disorders

· Jaundice (jaundice due to intrahepatic cholestasis).

Skin and subcutaneous tissue disorders

· Photosensitization reaction, rash, disseminated lupus erythematosus-type reaction, reactivation of disseminated lupus erythematosus, urticaria, anaphylactic reaction, toxic epidermal necrolysis.

Benign, malignant and unspecified tumours (including cysts and polyps) (frequency unknown)

· Non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma).

Musculoskeletal and systemic disorders

· Muscle spasm.

Renal and urinary disorders

· Impaired renal function, interstitial nephritis.

General disorders and administration site conditions

· Fever, weakness.

Description of certain adverse effects

Non-melanoma skin cancer

Based on available data from epidemiological studies, a cumulative dose-dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization is important. It allows for continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www. signalement-sante.gouv.fr