Nilvadipine

No clinical experience with Nilvadipine in pregnancy or lactation is present. Preclinical investigations have not yielded any indication of a damaging potential of the substance on the foetus. The class of dihydropyridines has shown the potential to prolong delivery and parturition, which was not observed with Nilvadipine. As a consequence, Nilvadipine could be used in pregnancy only if the benefit justifies the potential risk to the foetus.

The results of animal tests have shown that Nilvadipine (or its metabolites) is excreted in human milk. Therefore, breast feeding is not advised during use of Nilvadipine. Since there has yet been no experience gained regarding the possible effects of the substance on the suckling infant, the child should be weaned from the breast in cases in which treatment of the nursing mother with nilvadipine is regarded as necessary.

No studies on the effects on the ability to drive and use machines have been performed with Nilvadipine. However, caution should be exercised because dizziness may occur during antihypertensive treatment.

The management of hypertension with this drug requires regular checks by the physician. The occurrence of reactions, which may differ in severity from one person to another, may impair the patient’s ability to drive vehicles and to operate machinery. This precaution applies particularly at the beginning of therapy, or when dosage is changed, or with concurrent consumption of alcohol.

The frequency of adverse reactions is defined as follows: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Blood and the lymphatic system disorders

Rare: Anaemia

Very rare: Leukopenia, Thrombocytopenia

Metabolism and nutrition disorders

Rare: Appetite disorder

Nervous system disorders

Common: Headache, Dizziness

Rare: Tinnitus, Nervousness, Insomnia

Eye disorders

Rare: Increased intraocular pressure, Blurred vision

Ear and labyrinth disorders

Rare: Epistaxis, Dry mouth

Cardiac disorders

Uncommon: Tachycardia, Palpitations, Angina Pectoris

Very rare: Myocardial infarction

Vascular disorders

Common: Flushing

Uncommon: Hypotension, Hypertensive crisis

Respiratory, thoracic and mediastinal disorders

Rare: Dyspnoea

Gastrointestinal disorders

Uncommon: Nausea, Abdominal discomfort, Abdominal distension, Constipation, Diarrhoea

Rare: Vomiting, Increased weight, Decreased weight

Very rare: Gingival hyperplasia

Hepato-biliary disorders

Uncommon: Transaminases increased, Blood alkaline phosphatase increased

Skin and subcutaneous tissue disorders

Uncommon: Hypersensitivity reactions, Rash, Pruritus, Erythema

Rare: Paraesthesia

Very rare: Peripheral coldness, Alopecia

Musculoskeletal, connective tissue and bone disorders

Uncommon: Tremor, Myalgia, Arthralgia, Sensation of heaviness

Rare: Neck pain, Chest discomfort

Renal and urinary disorders

Rare: Pollakiuria

Reproductive system and breast disorders

Rare: Erectile dysfunction

Very rare: Gynaecomastia

General disorders and administration site conditions

Common: Peripheral oedema

Uncommon: Fatigue

Rare: Hyperhidrosis