Medicinal Products


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

Box of 30
All forms



Chronic stable angina

Vasospastic angina (Prinzmetal syndrome)

Dosage AMLODIPINE ALMUS 10 mg Capsule Box of 30



For hypertension and angina, the usual starting dose is 5 mg AMLODIPINE ALMUS once daily, which can be increased to a maximum dose of 10 mg depending on the patient's individual response.

In hypertensive patients, AMLODIPINE ALMUS has been used in combination with a thiazide diuretic, an alpha blocker, a beta-blocker or an angiotensin converting enzyme inhibitor. In angina, AMLODIPINE ALMUS may be used alone or in combination with other antianginal agents in patients with nitrate-refractory angina and / or adequate doses of beta-blockers.

No dose adjustment of AMLODIPINE ALMUS is necessary when coadministered with thiazide diuretics, beta-blockers and angiotensin converting enzyme inhibitors.

Special populations


AMLODIPINE ALMUS used at similar doses shows good equivalent tolerance in elderly patients and younger patients. Normal dosing regimens are recommended for elderly patients, but dosage increases should be made with caution (see Warnings and Precautions and Pharmacokinetic Properties sections).

Hepatic insufficiency

Dose recommendations have not been established in patients with mild to moderate hepatic impairment therefore the dose should be selected with caution and should start at the lowest effective dose (see sections Warnings and Precautions for Use). and pharmacokinetic properties ). The pharmacokinetic properties of amlodipine have not been studied in patients with severe hepatic impairment. Amlodipine should be started at the lowest dose and slowly increased in patients with severe hepatic impairment.

Renal failure

Changes in plasma concentrations of amlodipine are not correlated with the degree of renal impairment, so a usual dosage is recommended. Amlodipine is not dialysable.

Children and adolescents

Hypertensive children and adolescents from 6 to 17 years old.

The recommended oral antihypertensive dosage in children aged 6 to 17 years is 2.5 mg once daily as the initial dose, which can be increased to 5 mg once daily if the desired blood pressure is not reached after four weeks. Doses greater than 5 mg once daily have not been studied in pediatric patients (see sections Pharmacodynamic properties and Pharmacokinetic properties ).

A dosage of 2.5 mg amlodipine is not possible with this drug.

Children under 6 years old.

There is no data available.

Administration mode

Capsule for oral administration.

Against indications

Amlodipine is contraindicated in patients with:

· Hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients.

· Severe hypotension.

· Shock (including cardiogenic shock)

· Obstruction of the left ventricular outflow tract (eg, high degree of aortic stenosis).

· Hemodynamically unstable heart failure after acute myocardial infarction.

Adverse effects Amlodipine Almus

Summary of the security profile

The most common side effects reported during treatment are drowsiness, dizziness, headache, palpitations, flushing, abdominal pain, nausea, swollen ants, edema, and fatigue.

List of undesirable effects

The following adverse reactions have been observed and reported during treatment with amlodipine at the following frequencies: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to ≤ 1/100); rare (≥ 1/10 000 to ≤ 1/1 000); very rare (≤1 / 10, 000).

In each frequency group, the adverse effects are presented in order of decreasing severity.

Class of organ systems


Side effects

Blood and lymphatic system disorders

Very rare

Leukocytopenia, thrombocytopenia,

Immune system disorders

Very rare

Allergic reaction

Metabolism and nutrition disorders

Very rare


Psychiatric disorders


Insomnia, change of mood (including anxiety), depression



Nervous system disorders


Drowsiness, dizziness, headache (especially at the beginning of treatment)


Tremor, dysgeusia, syncope, hypoaesthesia, paresthesia

Very rare

Hypertonia, peripheral neuropathy

Eye disorders


Visual disorder (including, diplopia)

Affections of the ear and labyrinth



Heart conditions



Very rare

Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)

Vascular disorders





Very rare


Respiratory, thoracic and mediastinal disorders


Dyspnea, rhinitis

Very rare


Gastrointestinal disorders


Abdominal pain, nausea


Vomiting, dyspepsia, transit disorders (including diarrhea and constipation), dry mouth

Very rare

Pancreatitis, gastritis, gingival hyperplasia

Hepatobiliary disorders

Very rare

Hepatitis, jaundice, elevated liver enzymes *

Skin and subcutaneous tissue disorders


Alopecia, purpura, change of skin color, hyperhidrosis, pruritus, rash, exanthema

Very rare

Angioedema, erythema multiforme, urticaria, exfoliating dermatitis, Stevens-Johnson syndrome, angioedema, photosensitivity

Musculoskeletal, Connective Tissue and Bone Disorders


Edema of the ankles


Arthralgia, myalgia, muscle cramp, back pain

Renal and urinary disorders


Micturition disorder, nocturia, increased urinary frequency

Disorders of reproductive organs and breast


Impotence, gynecomastia

General disorders and administration site conditions


Edema, tiredness


Chest pain, asthenia, pain, discomfort



Increased weight, decreased weight

* Generally suggestive of cholestasis

Exceptional cases of extrapyramidal syndrome have been reported.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website:

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