Medicinal Products

ADALATE 10 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Nifedipine
laboratory: Bayer Healthcare

Capsule
Box of 30
All forms

Indication

· Angor of Prinzmetal.

· Angor stable in combination with beta-blockers, when other anti-anginal therapies are contraindicated or insufficiently effective.

· Symptomatic treatment of Raynaud's phenomena.

Dosage ADALATE 10 mg Capsule Box of 30

Oral way. The capsule is swallowed without chewing with a little liquid.

· Angor

In Prinzmetal's angina, the recommended dosage is 1 capsule 4 times a day, including one at bedtime.

In stable angina, the usual dosage is 1 capsule 3 times daily, in combination with a beta-blocker administered at an effective dosage.

The maximum dosage is 60 mg / day.

· Phenomena of Raynaud : the usual dosage is 1 capsule 3 times a day.

It is recommended that treatment be initiated with caution in patients who may experience an overreaction to nifedipine.

If therapy is discontinued, doses should be reduced gradually.

The interval between 2 doses of ADALATE 10 mg should be at least 2 hours.

Special populations

Children and adolescents

The safety and efficacy of ADALATE 10 mg capsule have not been studied in children under 18 years of age. Currently available data on the use of nifedipine in arterial hypertension are described in section Pharmacodynamic properties .

Elderly patient

As the bioavailability of nifedipine is increased in the elderly, ADALATE 10 mg capsule should be administered with caution in this population.

Hepatic insufficiency

Due to its hepatic metabolism, nifedipine should be administered under supervision in patients with hepatic impairment. In addition, there are no clinical data in patients with severe hepatic impairment.

Renal failure

There are no clinical data in renally impaired patients. ADALATE 10 mg capsule should be administered with caution in these patients.

Against indications

This medicine should not be used in the following cases:

· Known hypersensitivity to nifedipine, or to any of the excipients,

· Myocardial infarction less than 1 month old,

· Unstable angina (see section Warnings and precautions for use ),

· Cardiovascular shock (see section Warnings and precautions for use ),

· In combination with diltiazem (see section Interactions with other medicinal products and other forms of interaction )

This medicine is generally not recommended during pregnancy or breastfeeding (see section Pregnancy and breastfeeding ).

Adalate side effects

The risk of hypotension and / or decompensation of heart failure should be given special attention.

The adverse events reported in the placebo-controlled studies evaluating the effect of nifedipine are presented below by CIOMS III frequency category (clinical trial database: nifedipine n = 2661; placebo n = 1, 486; as of February 22, 2006 and ACTION study: nifedipine n = 3825; placebo n = 3840).

Adverse events considered "frequent" were observed with an incidence of less than 3%, with the exception of edema (9.9%) and headache (3.9%).

The frequency of adverse reactions reported with products containing nifedipine is summarized in the table below. In each frequency group, side effects are presented in descending order of safety.

The frequencies are defined as follows:

· Frequent: ≥ 1/100 to <1/10

· Uncommon: ≥ 1/1000 to <1/100

· Rare: ≥ 1/10 000 to <1/1000

Adverse reactions identified only during post-marketing surveillance and for which the frequency can not be expressed are classified as "unknown frequency".

Class-organ system (MedDRA)

Frequent

Rare

Rare

Frequency unknown

Blood and lymphatic system disorders

agranulocytosis

leukopenia

Immune system disorders

Allergic reaction, Quincke's edema

itching

Urticaria

Skin rash

Anaphylactic / anaphylactoid reaction

Psychiatric disorders

Nervousness

Insomnia

Metabolism and nutrition disorders

hyperglycemia

Nervous system disorders

headaches

Dizziness

Ebony sensations

tremors

paresthesia

/ Dysesthesia

Extrapyramidal syndrome

Drowsiness

Eye disorders

Vision disorders (mainly blurred vision or decreased vision)

Eye pain

Heart conditions

tachycardia

palpitations

Chest pain (angina)

Vascular disorders

Edema

Vasodilatation

Hypotension

Syncope

Respiratory, thoracic and mediastinal disorders

Epistaxis

Dyspnea

Gastrointestinal disorders

Constipation

Gastrointestinal and abdominal pain

nausea

Dyspepsia

Flatulence

Oral dryness

Gingival hyperplasia

vomiting,

Esophagitis associated with gastroesophageal sphincter insufficiency

Hepatobiliary disorders

Transient increase in hepatic transaminases or bilirubin

icterus

Skin and subcutaneous tissue disorders

Erythema Purpura

Toxic epidermal necrolysis

Photosensitivity reaction

Musculoskeletal and systemic disorders

Muscle cramps

Inflammatory swelling of the joints

arthralgia

myalgia

Renal and urinary disorders

polyuria

Dysuria

Reproductive and breast disorders

Erectile dysfunction

General disorders and administration site conditions

Discomfort

Asthenia or Fatigue,

Chills

1 = potentially life-threatening

In dialysis patients with malignant hypertension and hypovolemia, vasodilation may result in significant blood pressure drop.

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. Healthcare 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: www.ansm.sante.fr

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