Source: European Medicines Agency (EU)
Should be administered with caution in patients with mild hepatic impairment, since the antihypertensive effect may be increased (see section 4.2 “Posology and method of administration”).
A reduction of the dose is required in elderly patients due to the slowing down of the metabolic processes (see section 4.2 “Posology and method of administration”).
Manidipine should be administered with caution in patients with left ventricular failure, in patients who have left ventricular outflow tract obstruction, isolated right heart failure or sick sinus syndrome (with no pacemaker).
Since there are no study results available on patients with stable coronary disease, caution should be taken with these patients due to the possibility of increased coronary risk (see section 4.8 “Undesirable effects”).
This medicinal product should not be administered to patients with hereditary problems of intolerance to galactose, Lapp lactase deficiency or glucose-galactose malabsorption.
As occurs with other dihydropyridine calcium channel blockers, it is probable that manidipine metabolism is catalysed by the cytochrome P450 3A4. Caution should be exercised when Manidipine RKG is administered with drugs which inhibit the CYP 3A4 enzyme, such as ketoconazole, itraconazole, or with drugs which induce CYP 3A4, such as phenytoin, carbamazepine, phenobarbital and rifampicin and posology of manidipine should be adjusted if needed.
Other antihypertensive drugs: The antihypertensive effect of manidipine can be increased by the concomitant administration of diuretics, betablockers and, in general, any other antihypertensive drugs.
Alcohol: As for all vasodilatory antihypertensives, caution is mandatory if alcohol is consumed concomitantly, as this can enhance their effects.
Grapefruit juice: Grapefruit juice seems to inhibit the metabolism of dihydropyridines, with a resulting increase in its systemic bioavailability and its hypotensive effect. Manidipine must therefore not be administered with grapefruit juice.
Oral hypoglycaemics: No interactions with oral hypoglycaemic agents have been noticed.
Amifostine: Increased risk of the antihypertensive effect.
Tricyclic antidepressant/antipsychotics: Increased antihypertensive effect and increased risk of orthostatic hypotension.
Baclofen: Potentation of antihypertensive effect. Monitoring of blood pressure and renal function, and dose adaptation of the antihypertensive if necessary.
Corticosteroids, tetracosactide: Reduction of antihypertensive effect (salt and water retention due to corticosteroids).
Alpha-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin): Increased antihypertensive effect and increased risk of orthostatic hypotension.
No clinical data are available about the use of this medicinal product by pregnant women. Studies with manidipine on laboratory animals do not provide sufficient results on foetal development (see section 5.3 “Preclinical safety data”). Since other medicinal products in the dihydropyridine family have been shown to be teratogenic in animal species, and since the potential clinical risk is not known, manidipine should not be used during pregnancy.
Manidipine and its metabolites are excreted in large quantities in rat milk. It is not known whether or not manidipine is excreted in human milk.
The use of manidipine must be avoided during lactation. If manidipine treatment is necessary, breast-feeding must be discontinued.
Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been reported in some patients treated by channel blockers.
Since dizziness may be experienced due to a reduced blood pressure, patients should be advised to take care while driving and operating machinery.
A number of undesirable effects have been observed during treatment with Manidipine RKG and other dihydropyridines, with the following frequencies: 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, including isolated cases.
The common adverse effects are dose-dependent and usually disappear later on during treatment.
Uncommon: reversible increases in SGPT, SGOT, LDH, gamma-GT, alkaline phosphatase, BUN and serum creatinine
Common: palpitations, oedema
Uncommon: tachycardia
Rare: chest pain, angina
Very rare: myocardial stroke and, in isolated cases, patients with pre-existent angina may experience increased frequency, duration and severity of these accidents.
Common: headache, dizziness and vertigo
Uncommon: paresthesia
Rare: somnolence and drowsiness
Unknown: extrapyramidal syndrome has been reported with some calcium inhibitors
Uncommon: dyspnea
Uncommon: nausea, vomiting, constipation, dry mouth, digestive disorders
Rare: stomach ache, abdominal pain
Very rare: gingivitis and gingival hyperplasia, which generally disappeared with the withdrawal of the drug and need careful dental care.
Uncommon: rash, eczema
Rare: erythema, itching
Common: hot flushes
Uncommon: hypotension
Rare: hypertension
Uncommon: asthenia
Rare: irritability
Not applicable.
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