Medicinal Products

AMLODIPINE QUALIMED 5 mg

Generic drug of Amlor
Therapeutic class: Cardiology and angiology
active ingredients: Amlodipine
laboratory: Qualimed

capsule
Box of 90
All forms

Indication

· Preventive treatment of angina attacks: effort angina, spontaneous angina (including Prinzmetal's angina).

· Hypertension.

Dosage AMLODIPINE QUALIMED 5 mg Capsule Box of 90

Hypertension:

the starting dose is one capsule (5 mg) once a day, which can be increased to 10 mg once daily in a single dose depending on the response to treatment.

Angina pectoris:

the starting dose is one capsule (5 mg) once a day, which can be increased to 10 mg once daily in a single dose depending on the response to treatment.

The maximum daily dose is 10 mg.

In the elderly

Amlodipine, used in similar doses in the elderly or the younger subject, is tolerated in the same way.

In patients with renal insufficiency

Treatment can be started at the usual recommended dosage. Changes in plasma concentrations are not correlated with the degree of renal failure. Amlodipine is not dialysable.

Amlodipine doses do not need to be adjusted when combined with thiazide diuretics, beta-blockers or angiotensin converting enzyme inhibitors.

In children aged 6 to 17 with hypertension:

For an antihypertensive effect, the recommended dose in children aged 6 to 17 years is 2.5 mg once daily (initiation dose), and may be increased to 5 mg once daily if the desired blood pressure was not reached after 4 weeks of treatment. Doses in excess of 5 mg daily have not been studied in the pediatric population (see sections Pharmacodynamic properties Pharmacodynamic properties and Pharmacokinetic properties Pharmacokinetic properties). In children less than 6 years old, the effect of amlodipine on blood pressure has not been studied.

Against indications

This medication should never be used in case of hypersensitivity to dihydropyridine or any of the excipients.

This medicine is generally not recommended for combination therapy with dantrolene (see section 4.5 ).

Adverse effects Amlodipine Qualimed

The most frequently reported adverse reactions are related to the vasodilator action of the product: headache, redness or sensation of warmth of the face.

Usually they appear during the first weeks of treatment and fade during prosecution.

As with other dihydropyridines, edema of the ankle and / or of the face may appear. Its appearance is more frequent at high doses.

We rarely observe:

· Cardiac effects: tachycardias, palpitations, syncope;

· Mucocutaneous effects: alopecia, increased sweating, allergic reaction including pruritus, rash and angioedema. As with other dihydropyridines, mild gingival enlargement has been reported in patients with severe gingivitis / periodontitis. Enlargement can be prevented or eliminated with careful oral hygiene;

· Digestive effects: abdominal pain, dyspepsia, dysgeusia, loss of appetite, nausea, diarrhea, constipation, dry mouth;

· Neuromuscular effects: muscle cramps, myalgia, arthralgia;

Hepatic effects: hepatitis, jaundice and elevated liver enzymes have been reported very rarely (the main cause in relation to cholestasis), including some cases severe enough to lead to hospitalization. They are reversible when the treatment is stopped.

· Pulmonary effects: dyspnoea;

· Genitourinary effects: pollakiuria, impotence as described under other antihypertensives, gynecomastia;

· Neuropsychic effects: asthenia, dizziness, sleep disturbances, paresthesia, tremors, visual disturbances, depressive disorders;

· General effect: discomfort;

· Blood effect: thrombocytopenia;

· Vascular effect: vasculitis.

As with other calcium antagonists, the following events have been reported rarely: anginal pain, myocardial infarction, arrhythmia. They may be related to pre-existing treatment pathology, and should be discussed for further treatment.

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