Imprida HCT

Posology The recommended dose of Imprida HCT is one tablet per day, to be taken preferably in the morning. Before switching to Imprida HCT patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Imprida HCT should be based on the doses of the individual components of the combination at the time of switching.

The maximum recommended dose of Imprida HCT is 10 mg/320 mg/25 mg. 2). 2). 3). Medicinal product no longer authorised 3 Heart failure and coronary artery disease There is limited experience with the use of Imprida HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.

Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Imprida HCT, 10 mg/320 mg/25 mg. Elderly (age 65 years or over) Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Imprida HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.

Paediatric population There is no relevant use of Imprida HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension. Method of administration Imprida HCT can be taken with or without food.

The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.

The safety profile of Imprida HCT presented below is based on clinical studies performed with Imprida HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide. Information on Imprida HCT The safety of Imprida HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.

Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy. 7%). In the 8-week controlled clinical study, no significant new or unexpected adverse reactions were observed with triple therapy treatment compared to the known effects of the monotherapy or dual therapy components.

In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Imprida HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents. The presence of valsartan in the triple combination attenuated the hypokalaemic effect of hydrochlorothiazide.

The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Imprida HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually. 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, not known (cannot be estimated from the available data).

MedDRA System Organ Class Adverse reactions Frequency Imprida HCT Amlodipine Valsartan HCT Blood and lymphatic system disorders Agranulocytosis, bone marrow depression -- -- -- Very rare Decrease in haemoglobin and in haematocrit -- -- Not known -- Haemolytic anaemia -- -- -- Very rare Leukopenia -- Very rare -- Very rare Neutropenia -- -- Not known -- Thrombocytopenia, sometimes with purpura -- Very rare Not known Rare Aplastic anaemia -- -- -- Not knownMedicinal product no longer authorised 13 Immune system disorders Hypersensitivity -- Very rare Not known Very rare Metabolism and nutrition disorders Anorexia Uncommon -- -- -- Hypercalcaemia Uncommon -- -- Rare Hyperglycaemia -- Very rare -- Rare Hyperlipidaemia Uncommon -- -- -- Hyperuricaemia Uncommon -- -- Common Hypochloraemic alkalosis -- -- -- Very rare Hypokalaemia Common -- -- Very common Hypomagnesaemia -- -- -- Common Hyponatraemia Uncommon -- -- Common Worsening of diabetic metabolic state -- -- -- Rare Psychiatric disorders Depression -- -- -- Rare Insomnia/sleep disturbances Uncommon Uncommon -- Rare Mood swings -- Uncommon -- Nervous system disorders Coordination abnormal Uncommon -- -- -- Dizziness Common Common -- Rare Dizziness postural, dizziness exertional Uncommon -- -- -- Dysgeusia Uncommon Uncommon -- -- Extrapyramidal syndrome -- Not known -- -- Headache Common Common -- Rare Hypertonia -- Very rare -- -- Lethargy Uncommon -- -- -- Paraesthesia Uncommon Uncommon -- Rare Peripheral neuropathy, neuropathy Uncommon Very rare -- -- Somnolence Uncommon Common -- -- Syncope Uncommon Uncommon -- -- Tremor -- Uncommon -- -- Eye disorders Acute angle-closure glaucoma -- -- -- Not known Visual impairment Uncommon Uncommon -- Rare Ear and labyrinth disorders Tinnitus -- Uncommon -- -- Vertigo Uncommon -- Uncommon -- Cardiac disorders Palpitations -- Common -- -- Tachycardia Uncommon -- -- -- Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation) -- Very rare -- Rare Myocardial infarction -- Very rare -- -- Vascular disorders Flushing -- Common -- -- Hypotension Common Uncommon -- -- Orthostatic hypotension Uncommon -- -- Common Phlebitis, thrombophlebitis Uncommon -- -- -- Vasculitis -- Very rare Not known --Medicinal product no longer authorised 14 Respiratory, thoracic and mediastinal disorders Cough Uncommon Very rare Uncommon -- Dyspnoea Uncommon Uncommon -- -- Respiratory distress, pulmonary oedema, pneumonitis -- -- -- Very rare Rhinitis -- Uncommon -- -- Throat irritation Uncommon -- -- -- Gastrointestinal disorders Abdominal discomfort, abdominal pain upper Uncommon Common Uncommon Rare Breath odour Uncommon -- -- -- Change of bowel habit -- Uncommon -- -- Constipation -- -- -- Rare Decreased appetite -- -- -- Common Diarrhoea Uncommon Uncommon -- Rare Dry mouth Uncommon Uncommon -- -- Dyspepsia Common Uncommon -- -- Gastritis -- Very rare -- -- Gingival hyperplasia -- Very rare -- -- Nausea Uncommon Common -- Common Pancreatitis -- Very rare -- Very rare Vomiting Uncommon Uncommon -- Common Hepatobiliary disorders Hepatic enzyme elevation, including increase of serum bilirubin -- Very rare Not known -- Hepatitis -- Very rare -- -- Intrahepatic cholestasis, jaundice -- Very rare -- Rare Skin and subcutaneous tissue disorders Alopecia -- Uncommon -- Angioedema -- Very rare Not known -- Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus -- -- -- Very rare Erythema multiforme -- Very rare -- Not known Exanthema -- Uncommon -- -- Hyperhidrosis Uncommon Uncommon -- -- Photosensitivity reaction* -- -- -- Rare Pruritus Uncommon Uncommon Not known -- Purpura -- Uncommon -- Rare Rash -- Uncommon Not known Common Skin discoloration -- Uncommon -- -- Urticaria and other forms of rash -- Very rare -- Common Vasculitis necrotising and toxic epidermal necrolysis -- -- -- Very rare Musculoskeletal and connective tissue disorders Arthralgia -- Uncommon -- -- Back pain Uncommon Uncommon -- -- Joint swelling Uncommon -- -- -- Muscle spasm Uncommon Uncommon -- Not known Muscular weakness Uncommon -- -- -- Myalgia Uncommon Uncommon Not known -- Pain in extremity Uncommon -- -- --Medicinal product no longer authorised 15 Renal and urinary disorders Elevation of serum creatinine Uncommon -- Not known -- Micturition disorder Uncommon […]

2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension. In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Imprida HCT.

Imprida HCT should be used only after correction of any pre-existing sodium and/or volume depletion. If excessive hypotension occurs with Imprida HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.

Treatment can be continued once blood pressure has been stabilised. Serum electrolyte changes Amlodipine/valsartan/hydrochlorothiazide In the controlled trial of Imprida HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.

In other patients, one or the other effect may be dominant. Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. ) is not recommended. Monitoring of potassium should be undertaken as appropriate.

Hydrochlorothiazide Treatment with Imprida HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia. Thiazide diuretics can precipitate new onset hypokalaemia or exacerbate pre- existing hypokalaemia.

Thiazide diuretics should be administered with caution in patients with conditions involving enhanced potassium loss, for example salt-losing nephropathies and prerenal (cardiogenic) impairment of kidney function. If hypokalaemia develops during hydrochlorothiazide therapy, Imprida HCT should be discontinued until stable correction of the potassium balance.

Thiazide diuretics can precipitate new onset hyponatraemia and hypochloroaemic alkalosis or exacerbate pre-existing hyponatraemia. Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed.

 Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients. 6).  Hepatic impairment, biliary cirrhosis or cholestasis. 73 m2), anuria and patients undergoing dialysis.

 Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.