Lacidipine Galenicum Tablet, film coated 4mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

L

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC code:

C08CA09

INN (International Name):

Lacidipine 4 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

Lacidipine 4 mg

Prescription type:

POM

Therapeutic area:

CALCIUM CHANNEL BLOCKERS

Authorization status:

Withdrawn

Authorization date:

2017-06-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACIDIPINE GALENICUM 2 MG FILM-COATED TABLETS
LACIDIPINE GALENICUM 4 MG FILM-COATED TABLETS
Lacidipine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lacidipine tablets is and what it is used for
2.
What you need to know before you use Lacidipine tablets
3.
How to use Lacidipine tablets
4.
Possible side effects
5.
How to store Lacidipine tablets
6.
Contents of the pack and other information
1.
WHAT LACIDIPINE TABLETS IS AND WHAT IT IS USED FOR
Lacidipine tablets contains a medicine called lacidipine. This belongs
to a group of medicines called
‘calcium channel blockers’. Lacidipine tablets helps to relax your
blood vessels so that they get wider. This
helps the blood to flow more easily and lowers the blood pressure.
Lacidipine tablets taken regularly as prescribed by your doctor will
help to lower your blood pressure (to
treat hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LACIDIPINE TABLETS
DO NOT USE LACIDIPINE TABLETS

If you are pregnant, likely to get pregnant or are breast-feeding

If you are allergic to lacidipine, other calcium channel blocker
medicines or any of the other
ingredients of this medicine (listed in section 6)

If you have the heart problem ‘aortic stenosis’.This is a
narrowing of a valve in your heart, which
restricts blood flow

If you have had a heart attack within the last month
Do not take
Lacidipine tablets
if any of the above apply to you. If you are not sure, talk to your
doctor or
ph

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lacidipine Galenicum 2 mg film-coated tablets
Lacidipine Galenicum 4 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacidipine Galenicum 2 mg film-coated tablets
Each film-coated tablet contains lacidipine 2 mg.
Excipient with known effect: lactose anhydrous 137 mg.
Lacidipine Galenicum 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 Galenicum 2 mg film-coated tablets
White, round [diameter 8.1 mm], biconvex, film-coated tablets.
Lacidipine Galenicum 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.
2
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 c