URAPIDIL Prolonged-release capsule, hard Ref.[7679] Active ingredients: Urapidil

Therapeutic indications

Hypertension.

Posology and method of administration

Posology

The recommended starting dose is 30 mg urapidil twice daily.

For a faster blood pressure reduction, the treatment can be started with 60 mg urapidil twice daily

The dose can be adjusted to individual needs in steps. The dosage range for maintenance therapy is 60– 180 mg urapidil per day, with the total quantity split over two individual doses.

Treatment of blood pressure with this medicine requires regular medical follow-ups.

Patients with liver function disorders

In patients with liver function disorders, it may be necessary to reduce the dosage.

Patients with kidney function disorders

In patients with severe renal function disorders, it may be necessary to reduce the dosage.

Elderly

In elderly patients, antihypertensive agents must be administered with appropriate care and at the beginning in small doses.

Paediatric population

Safety and efficacy of urapidil in children aged 0-18 years have not been established.

No recommendation on a posology can be made.

Method of administration

For oral use.

It is recommended to take capsules with food in the morning and evening. Capsules must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.

Overdose

Symptoms

Symptoms of overdose are dizziness, orthostatic hypotension and collapse as well as fatigue and decreased reactivity.

Treatment of overdose

An excessive fall in blood pressure can be corrected by raising the legs and performing volume replacement. If these measures are not sufficient, vasoconstricting preparations can be slowly injected intravenously while monitoring the blood pressure. In very rare cases the administration of catecholamines (e.g. adrenaline, 0.5-1.0 mg diluted to 10 ml with isotonic sodium chloride solution) is necessary.

Shelf life

2 years.

Special precautions for storage

Keep the bottle tightly closed.

Nature and contents of container

Polypropylene bottle with polyethylene desiccant cap.

Box of 30, 50, 90 and 100 prolonged-release capsule, hard.

Not all pack size may be marketed.

Special precautions for disposal and other handling

No special requirements.

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