MANIDIPINE Tablet
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Manidipine 10 mg tablets. Manidipine 20 mg tablets.
Qualitative and quantitative composition
Manidipine dihydrochloride 10 mg Excipients: lactose monohydrate 66.40 mg Manidipine dihydrochloride 20 mg Excipients: lactose monohydrate 132.80 mg For a full list of excipients, see Section 6.1.
Pharmaceutical form
Tablet. The 10 mg tablets are round convex, yellow coloured, with midline score line. The 20 mg tablets are oval convex, yellow coloured, with midline score line. The score line is only to facilitate breaking ...
Therapeutic indications
Mild to moderate essential hypertension.
Posology and method of administration
The recommended starting dose is 10 mg once a day. If, after 2-4 weeks of treatment, the anti-hypertensive effect is insufficient, it is advisable to increase the dosage to the usual maintenance dose of ...
Contraindications
Hypersensitivity to the active substance, manidipine, or to other dihydropyridines or to any of the excipients. Children. Unstable angina or within 4 weeks of a myocardial stroke. Untreated congestive ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
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 ...
Fertility, pregnancy and lactation
Pregnancy 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 ...
Effects on ability to drive and use machines
Since dizziness may be experienced due to a reduced blood pressure, patients should be advised to take care while driving and operating machinery.
Undesirable effects
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 ...
Overdose
No case of overdose is known. As occurs with other dihydropyridines, it is expected that an overdose would cause excessive peripheral vasodilatation with severe hypotension and reflex tachycardia. In this ...
Pharmacodynamic properties
Pharmacotherapeutic group: selective calcium channel blockers, with mainly vascular effects ATC code: C08CA11 Manidipine is a dihydropyridine calcium channel blocker with anti-hypertensive activity and ...
Pharmacokinetic properties
After oral administration, maximum plasma concentration is achieved in 2-3.5 hours. Manidipine undergoes first-pass metabolism. Binding to plasma proteins is 99%. The medicinal product is widely distributed ...
Preclinical safety data
The results of repeated dose toxicity studies have shown only toxic signs linked to the exacerbation of the pharmacological effects. The toxicological profile of manidipine on reproduction has not been ...
List of excipients
Lactose monohydrate Maize starch Low-substituted hydroxypropylcellulose Hydroxypropylcellulose Magnesium stearate Riboflavin
Incompatibilities
Not applicable.
Shelf life
24 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC blister sealed with Al/PVDC. 10 and 20 mg: 14, 28, 30, 56, 84, 90, 98, 112 tablets. Not all pack sizes may be marketed
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
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