Lacidipine 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lacidipine

Available from:

Zentiva Pharma UK Ltd

ATC code:

C08CA09

INN (International Name):

Lacidipine

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5060222601343

Summary of Product characteristics

OBJECT 1
LACIDIPINE 4 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 20-Nov-2017 | Creo Pharma
Limited
1. Name of the medicinal product
Lacidipine 4 mg film-coated tablets
2. Qualitative and quantitative composition
Lacidipine 4 mg film-coated tablets
Each film-coated tablet contains lacidipine 4 mg.
Excipient with known effect: lactose anhydrous 274 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Lacidipine 4 mg film-coated tablets
White, oval [13 mm × 7.4 mm], biconvex, film-coated tablets with
score line on one side.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Lacidipine is indicated for the treatment of hypertension either alone
or in combination with other
antihypertensive agents, including ß-adrenoceptor antagonists,
diuretics, and ACE-inhibitors.
4.2 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 tablets 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 saf