LACIDIPINA 4 mg Film-Coated Tablets

Зміст інструкції

1. lacidipina
   1. WHAT IS LACIDIPINA EG AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING LACIDIPINA EG
   3. HOW TO TAKE LACIDIPINA EG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LACIDIPINA EG
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Lacidipina EG 4 mg film-coated tablets
Lacidipina EG 6 mg film-coated tablets

lacidipina

Generic medicine

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lacidipina EG is and what it is used for
• 2. What you need to know before you take Lacidipina EG
• 3. How to take Lacidipina EG
• 4. Possible side effects
• 5. How to store Lacidipina EG
• 6. Contents of the pack and other information

1. WHAT IS LACIDIPINA EG AND WHAT IS IT USED FOR

Lacidipina EG contains the active substance lacidipine. The latter belongs to a group of
medicines called “calcium antagonists”. Lacidipina EG promotes the relaxation of blood vessels, in
such a way that these dilate. This allows blood to flow more easily and lowers
blood pressure.
Taken regularly as prescribed by your doctor, Lacidipina EG will help lower
blood pressure (in the treatment of hypertension).

2. WHAT YOU NEED TO KNOW BEFORE TAKING LACIDIPINA EG

Do not take Lacidipina EG:

• If you are allergic to the active substance, to other calcium-antagonist medicines, or to any other ingredient of this medicine (listed in section 6).
• If you suffer from the heart condition ‘aortic stenosis’. This is a narrowing of a heart valve, which results in a reduction of blood flow.
• If you have had a heart attack in the previous month and in case of severe heart failure.
• You must stop taking lacidipina in case of chest pain (angina) or weak pulse, rapid pulse, rapid shallow breathing, low blood pressure, cold clammy skin, blue lips, or dizziness, fainting, weakness or nausea. Do not take Lacidipina EG if you are in any of the conditions listed above. If in doubt, consult your doctor or pharmacist before taking Lacidipina EG.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lacidipina EG:

• If you have an irregular heartbeat or any other heart problems
• If you have, or have had, liver problems

Other medicines and Lacidipina EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines. These include herbal medicines. In fact, Lacidipina EG can affect the action of some medicines. Also, other
medicines can affect the mechanism of action of Lacidipina EG.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:

• medicines for the treatment of high blood pressure
• medicines for the treatment of fungal infections
• medicines for controlling the heartbeat (called ‘anti-arrhythmics’)
• medicines for the treatment of depression called ‘tricyclic antidepressants’
• antibiotics (e.g. rifampicin)
• medicines for the treatment of epilepsy
• cimetidine - used for stomach problems
• cyclosporine (i.e. immunosuppressant drugs given to transplant patients)
• steroids or tetracosactide (used for the treatment of inflammatory conditions such as asthma, ulcerative colitis or arthritis)

If you are going to have blood tests, tell the person performing the test that you are taking
this medicine. In fact, Lacidipina EG can affect the results relating to liver values.

Lacidipina EG with food, beverages and alcohol
You can take this medicine on an empty stomach or with food.
Consult your doctor if you can take alcohol while taking this medicine, as
alcohol can enhance the effects of Lacidipina EG.
Do not take this medicine with grapefruit juice.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
This medicine may impair male fertility.

Driving and operating machinery
This medicine can cause dizziness. If you experience this side effect, do not drive
vehicles or operate machinery that requires your attention.

Lacidipina EG contains lactose monohydrate.If your doctor has told you that you have
intolerance to some types of sugars or that you have difficulty digesting them, contact him before taking this
medicine.

3. HOW TO TAKE LACIDIPINA EG

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
It is important to take the right number of tablets at the right time of day.

• The recommended initial dose is 2 mg every morning.
• After 3-4 weeks, it is possible to increase the dose to 4 mg every morning.
• If necessary, the dose can be further increased to 6 mg every morning, which is the maximum daily dose.
• Take the tablets whole with some water.
• Do not take the medicine with grapefruit juice.

If you take more Lacidipina EG than you should
If you take a quantity of this medicine higher than you should, consult a doctor or go
immediately to hospital. Bring with you the package of the medicine, even if it no longer contains tablets.
Medical treatment may be necessary. It is likely that the effects of an overdose will cause
irregular heartbeat, short and rapid breathing, low blood pressure, cold damp skin or a feeling
of dizziness, fainting, weakness or nausea.

If you forget to take Lacidipina EG
If you forget a dose in the morning, take it as soon as you remember on the same day. However, if you remember the next day, take your normal dose that morning. Do not take a double dose to
make up for a missed dose.
If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following side effects:

• chest pain (angina), including worsening of chest pain;
• if you feel very unwell, with rapid heartbeat, sweating, shortness of breath and fainting. Common(may affect up to 1 in 10 people)
• Headache
• Dizziness
• Hot flushes
• Fast or irregular heartbeat (palpitations)
• Stomach upset or nausea
• Skin rash, redness, itching
• Increased urine production
• Feeling of weakness
• Swelling, particularly in the ankles,
• Changes in blood tests related to the liver

Uncommon(may affect up to 1 in 100 people)

• Low blood pressure, for example feeling faint, fainting
• Swelling of the gums

Rare(may affect up to 1 in 1,000 people)

• Angioedema (allergic reaction that causes swelling of the face)
• Itchy skin rash (urticaria)
• Muscle cramps

Very rare(may affect up to 1 in 10,000 people)

• Tremor
• Depression

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE LACIDIPINA EG

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the package and on the blister. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Lacidipina EG contains

• The active ingredient is lacidipine. Each tablet contains 4 mg or 6 mg of the active ingredient lacidipine.
• The other ingredients are lactose monohydrate, povidone and magnesium stearate. The film coating contains hypromellose and titanium dioxide.

Description of the appearance of Lacidipina EG and package contents
Lacidipina EG 4 mg film-coated tablets are white, ovoid, biconvex tablets with
a score line on both sides and with ‘4’ imprinted on one side. The tablets can be divided
into two equal doses.
They are available in blister packs of Aluminium/Aluminium containing 14, 28, 30 or 90 film-coated
tablets.
Lacidipina EG 6 mg film-coated tablets are white, ovoid, biconvex tablets with
‘6’ imprinted on one side.
They are available in blister packs of Aluminium/Aluminium containing 14, 28 film-coated
tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Manufacturers
Laboratories BTT
ZI de Krafft
67150 Erstein
France
Rivopharm UK Ltd.
30th Floor, 40 Bank Street
Canary Wharf
London E14 5NR
United Kingdom