Lacidipine DOC Generici 4mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

L

Available from:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

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:

Authorised

Authorization date:

2015-04-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACIDIPINE DOC GENERICI 2 MG FILM-COATED TABLETS
LACIDIPINE DOC GENERICI 4 MG FILM-COATED TABLETS
LACIDIPINE DOC GENERICI 6 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 DOC Generici is and what it is used for
2.
What you need to know before you use Lacidipine DOC Generici
3.
How to use Lacidipine DOC Generici
4.
Possible side effects
5.
How to store Lacidipine DOC Generici
6.
Contents of the pack and other information
1.
WHAT LACIDIPINE DOC GENERICI IS AND WHAT IT IS USED FOR
Lacidipine DOC Generici contains a medicine called lacidipine. It
belongs to a group of medicines called
‘calcium channel blockers’. Lacidipine DOC Generici 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 DOC Generici 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 DOC GENERICI
DO NOT USE LACIDIPINE DOC GENERICI
•
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.
•
If you are pregnant or breastfeeding (see section ”Pregnancy

Summary of Product characteristics

09/18 aggiunta conf 28 cpr x 6 mg; var.07 IAIN A.3
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lacidipine DOC Generici 2 mg film-coated tablets
Lacidipine DOC Generici 4 mg film-coated tablets
Lacidipine DOC Generici 6 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacidipine DOC Generici 2 mg film-coated tablets
Each film-coated tablet contains lacidipine 2 mg.
Excipient with known effect: lactose 137 mg.
Lacidipine DOC Generici 4 mg film-coated tablets
Each film-coated tablet contains lacidipine 4 mg.
Excipient with known effect: lactose 274 mg.
Lacidipine DOC Generici 6 mg film-coated tablets
Each film-coated tablet contains lacidipine 6 mg.
Excipient with known effect: lactose 411 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Lacidipine DOC Generici 2 mg film-coated tablets
White, round, biconvex, film-coated tablets
Lacidipine DOC Generici 4 mg film-coated tablets
White, oval, biconvex, film-coated tablets with score line on one
side.
The tablet can be divided into two equal doses.
Lacidipine DOC Generici 6 mg film-coated tablets
White, oval, biconvex, film-coated tablets, debossed with “6 mg”
on one side.
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
Lacidipine is available in the following strengths:
•
Lacidipine, 2 mg, film-coated tablets
•
Lacidipine, 4 mg, film-coated tablets
•
Lacidipine, 6 mg, film-coated tablets
2
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 practic