Medicinal Products

PERINDOPRIL ARGI AMLOD SERVIER 5mg / 5mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Amlodipine
laboratory: Servier

Compressed
Box of 1 Pill box of 30
All forms

Indication

PERINDOPRIL ARGININE-AMLODIPINE SERVIER 5mg / 5mg tablet is indicated for the treatment of essential hypertension and / or stable coronary artery disease, as a substitute, in patients already controlled with perindopril and amlodipine taken simultaneously at the same dose .

Dosage Perindopril ARGI AMLOD SERVIER 5 mg / 5 mg Tablet Box of 1 Pill box of 30

Oral way.

One tablet a day in one dose, preferably in the morning and before the meal.

Fixed-dose combination is not appropriate for initial therapy.

If a change in dosage is necessary, the dose of PERINDOPRIL ARGININE-AMLODIPINE SERVIER 5 mg / 5 mg tablet may be modified or an individual adjustment of the free combination may be considered.

Patients with renal impairment and the elderly (see sections Warnings and Precautions and Pharmacokinetic Properties )

The elimination of perindoprilat is diminished in the elderly and the renal failure. Therefore, regular medical monitoring should include periodic monitoring of creatinine and potassium.

PERINDOPRIL ARGININE-AMLODIPINE SERVIER 5mg / 5mg tablet can be administered in patients with Clcr (60ml / min, but is not recommended in patients with a Clcr <60ml / min) In these patients, an individual adaptation monocomponents is recommended.

Changes in plasma concentrations of amlodipine are not correlated with the degree of renal impairment.

Hepatic impairment (see sections Warnings and precautions for use and Pharmacokinetic properties )

The need for dose adjustment in patients with hepatic impairment has not been established, however PERINDOPRIL ARGININE-AMLODIPINE SERVIER 5 mg / 5 mg, tablet should be administered with caution.

Child and teenager

PERINDOPRIL ARGININE-AMLODIPINE SERVIER 5 mg / 5 mg tablets should not be used in children and adolescents because the efficacy and safety of perindopril and amlodipine, alone or in combination, have not been established.

Against indications

Perindopril-related

Hypersensitivity to perindopril or any other IEC

· History of angioedema associated with taking an ACE,

· Hereditary or idiopathic angioedema,

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Linked to amlodipine

· Severe hypotension,

· Hypersensitivity to amlodipine or any other dihydropyridine,

· State of shock, including cardiogenic shock,

· Obstruction in the left ventricular ejection system (eg, high degree of aortic stenosis),

· Unstable angina (except Prinzmetal angina),

· Heart failure after acute myocardial infarction (during the first 28 days).

Related to PERINDOPRIL ARGININE-AMLODIPINE SERVIER

All contraindications relating to each of the monocomponents, mentioned above, must also apply to the fixed combination PERINDOPRIL ARGININE-AMLODIPINE SERVIER 5 mg / 5 mg, tablet.

· Hypersensitivity to any of the excipients.

Side effects Perindopril Argi Amlod Servier

The following adverse reactions have been observed during treatment with perindopril or amlodipine taken separately and are classified according to the MedDRA system organ classification and according to their frequency:

Very common ((≥1 / 10), frequent ((≥1 / 100, <1/10), uncommon ((≥1 / 1000, <1/100), rare ((≥1 / 10, 000, <1) / 1000), very rare (<1 / 10, 000), unknown (can not be estimated from the available data).

MedDRA
System Organ

Side effects

Frequency

amlodipine

perindopril

Blood and lymphatic system disorders

Leukopenia / neutropenia (see section Warnings and precautions for use )

Very rare

Very rare

Agranulocytosis or pancytopenia (see Warnings and precautions for use )

-

Very rare

Thrombocytopenia (see section Warnings and precautions for use )

Very rare

Very rare

Hemolytic anemia in patients with congenital G-6PDH deficiency (see Warnings and precautions for use )

-

Very rare

Decreased hemoglobin and hematocrit

-

Very rare

Immune system disorders

Allergic reaction: Urticaria

Very rare

Rare

Metabolism and nutrition disorders

hyperglycemia

Very rare

-

Weight gain

Rare

-

Weightloss

Rare

-

Hypoglycaemia (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction )

Unknown

Psychiatric disorders

Insomnia

Rare

-

Mood changing

Rare

Rare

Sleeping troubles

-

Rare

Nervous system disorders

Drowsiness

Frequent

-

Dizziness

Frequent

Frequent

headaches

Frequent

Frequent

tremors

Rare

-

Hypoaesthesia

Rare

-

paresthesia

Rare

Frequent

hypertonia

Very rare

-

Peripheral neuropathy

Very rare

-

Dizziness

-

Frequent

Confusion

-

Very rare

Eye disorders

Vision disorders

Rare

Frequent

Ear and labyrinth disorders

tinnitus

Rare

Frequent

Cardiac disorders

palpitations

Frequent

-

Syncope

Rare

-

Angina pain

Rare

-

angor

-

Very rare

Myocardial infarction, probably secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section )

Very rare

Very rare

Arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)

Very rare

Very rare

Vascular disorders

Flush

Frequent

-

Hypotension (and effects related to hypotension)

Rare

Frequent

Stroke, probably secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section )

-

Very rare

vasculitis

Very rare

Unknown

Respiratory, thoracic and mediastinal disorders

Dyspnea

Rare

Frequent

rhinitis

Rare

Very rare

Cough

Very rare

Frequent

bronchospasm

-

Rare

Eosinophilic pneumonia

-

Very rare

Gastrointestinal disorders

Gingival hyperplasia

Very rare

-

Abdominal pain, nausea

Frequent

Frequent

vomiting

Rare

Frequent

Dyspepsia

Rare

Frequent

Intestinal transit disorders

Rare

-

Dry mouth

Rare

Rare

dysgeusia

-

Frequent

Deformation of taste

Rare

-

Diarrhea, constipation

-

Frequent

pancreatitis

Very rare

Very rare

Gastritis

Very rare

-

Hepatobiliary disorders

Hepatitis, cholestatic jaundice

Very rare

-

Cytolytic or cholestatic hepatitis (see section Warnings and precautions for use )

-

Very rare

Skin and subcutaneous tissue disorders

Angioedema

Very rare

-

Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx (see Warnings and Precautions for Use section )

-

Rare

Erythema multiforme

Very rare

Very rare

Alopecia

Rare

-

purpura

Rare

-

Discoloration of the skin

Rare

-

Increased sweating

Rare

-

sweating

-

Rare

itching

Rare

Frequent

rash

Rare

Frequent

Stevens-Johnson Syndrome

Very rare

-

Muscle, connective tissue and bone disorders

Arthralgia, myalgia

Rare

-

Muscle cramps

Rare

Frequent

Back pain

Rare

-

Renal and urinary disorders

Micturition disorders, nocturia, increased urinary frequency

Rare

-

Renal failure

-

Rare

Acute renal failure

-

Very rare

Disorders of the reproductive organs and breast

Incapacity

Rare

Rare

gynecomastia

Rare

-

General disorders and administration site conditions

Edema, peripheral edema

Frequent

-

Tired

Frequent

-

Chest pain

Rare

-

Asthenia

Rare

Frequent

pains

Rare

-

Discomfort

Rare

-

Biological parameters

Elevation of liver enzymes: ALT, AST (mainly related to cholestasis)

Very rare

-

Elevation of serum bilirubin and liver enzymes

-

Rare

Increased blood urea and serum creatinine, kyperkalemia (see Warnings and precautions for use )

-

Unknown

Additional information related to amlodipine

Exceptional cases of extrapyramidal syndromes have been reported during treatment with calcium channel blockers.

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