MANIDIPINE Tablet Ref.[8265] Active ingredients: Manidipine

Source: European Medicines Agency (EU) 

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 20 mg once a day.

Use in the elderly

Due to the metabolic slowing in elderly people, the recommended dose is 10 mg once a day. This dosage is sufficient for the majority of elderly patients.

The risk/benefit ratio of any dosage increase must be envisaged cautiously on a case-by-case basis.

Use in patients with impaired renal or liver function

In patients with mild to moderate renal impairment, caution should be taken in increasing the dose from 10 mg to 20 mg per day.

Due to manidipine’s extensive metabolism in the liver, dosage in patients with mild liver failure should not exceed 10 mg once a day (see section 4.3 “Contraindications”).

The tablets should be taken in the morning after breakfast with a little liquid, and without chewing.

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 case symptomatic treatment must be started without delay and measures taken to support cardiovascular function. Due to the prolonged duration of the pharmacological effects of manidipine, cardiovascular function must be monitored for at least 24 hours.

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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