LACIDIPINE Film-coated tablet Ref.[8327] Active ingredients: Lacidipine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Dr. Reddys Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

Therapeutic indications

Lacidipine is indicated in adults for the treatment of hypertension either alone or in combination with other antihypertensive agents, including β-adrenoceptor antagonists, diuretics, and ACE-inhibitors.

Posology and method of administration

Posology

Adults

The treatment of hypertension should be adapted to the severity of the condition, and according to the individual response.

The recommended initial dose is 2 mg once daily. The dose may be increased to 4 mg (and then, if necessary, to 6 mg) after adequate time has been allowed for the full pharmacological effect to occur. In practice, this should not be less than 3 to 4 weeks. Daily doses above 6 mg have not been shown to be significantly more effective.

Lacidipine should be taken at the same time each day, preferably in the morning.

Treatment with Lacidipine may be continued indefinitely.

Patients with hepatic impairment

Lacidipine is metabolised primarily by the liver and therefore in patients with hepatic impairment, the bioavailability of Lacidipine may be increased and the hypotensive effect enhanced. These patients should be carefully monitored, and in severe cases, a dose reduction may be necessary.

Patients with kidney disease

As Lacidipine is not cleared by the kidneys, the dose does not require modification in patients with kidney disease.

Paediatric population

The safety and efficacy of Lacidipine in children and adolescents aged below 18 have not been established. No data are available.

Method of administration

For oral administration.

Overdose

Symptoms

There have been no recorded cases of Lacidipine overdosage. The expected symptoms could comprise prolonged peripheral vasodilation associated with hypotension and tachycardia. Bradycardia or prolonged AV conduction could occur.

Therapy

There is no specific antidote. Standard general measures for monitoring cardiac function and appropriate supportive and therapeutic measures should be used.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

Nature and contents of container

Alu/Alu blisters (OPA/Alu/PVC-Alu).

Pack sizes: 28

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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