LACIDIPINE EG

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lacidipine EG 4 mg film-coated tablets, 6 mg film-coated tablets

lacidipine
Equivalent medicine
Read this entire leaflet carefully before using 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lacidipine EG contains the active substance lacidipine. This belongs to a group of
medicines called "calcium antagonists". Lacidipine EG promotes the relaxation of blood vessels,
causing them to widen. This allows blood to flow more easily and lowers blood
pressure.
When taken regularly as prescribed by your doctor, Lacidipine EG helps to lower
blood pressure (in the treatment of hypertension).

2. WHAT YOU SHOULD KNOW BEFORE TAKING LACIDIPINE EG

Do not take Lacidipine EG:

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

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

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

Other medicines and Lacidipine EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal remedies. This is because Lacidipine EG may affect the action of certain medicines, and other medicines may affect how Lacidipine EG works.
In particular, inform 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 used to control heart rhythm (called 'antiarrhythmics')
• 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 medicines given to transplant patients)
• Steroids or tetracosactide (used to treat inflammatory conditions such as asthma, ulcerative colitis, or arthritis)

If you are undergoing blood tests, inform the person performing the test that you are taking this medicine, as Lacidipine EG may affect liver function test results.
Lacidipine EG with food, drinks, and alcohol
You may take this medicine on an empty stomach or with food.
Consult your doctor about whether you can drink alcohol while taking this medicine, as alcohol may enhance the effects of Lacidipine EG.
Do not take this medicine with grapefruit juice.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine may impair male fertility.
Driving and using machines
This medicine may cause dizziness. If you experience this side effect, do not drive or operate machinery requiring your attention.
Lacidipine EG contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars or difficulty digesting them, contact your doctor before taking this medicine.

3. HOW TO TAKE LACIDIPINE EG

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
It is important to take the correct number of tablets at the correct time of day.

• The recommended starting dose is 2 mg once daily in the morning.
• After 3–4 weeks, the dose may be increased to 4 mg once daily in the morning.
• If necessary, the dose may be further increased to 6 mg once daily in the morning, which is the maximum daily dose.
• Swallow the tablets whole with water.
• Do not take the medicine with grapefruit juice.

If you take more Lacidipine EG than you should
If you take more of this medicine than you should, consult a doctor or go to hospital immediately. Take the medicine pack with you, even if it no longer contains any tablets.
Medical treatment may be necessary. Overdose effects may include irregular heartbeat, short and rapid breathing, low blood pressure, cold and clammy skin, dizziness, fainting, weakness, or nausea.

If you forget to take Lacidipine EG
If you forget a dose in the morning, take it as soon as you remember on the same day. However, if you remember only the following day, take the usual dose that morning. Do not take a double dose to make up for the missed dose.

If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Contact your doctor immediately if you experience any of the following adverse reactions:

• 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
• Flushing
• Fast or irregular heartbeat (palpitations)
• Stomach discomfort or nausea
• Skin rash, redness, itching
• Increased urine production
• Feeling of weakness
• Swelling, particularly in the ankles
• Changes in liver function blood tests

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure, for example feeling faint, fainting
• Swollen gums

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

• Angioedema (allergic reaction causing 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 adverse reactions
If you get any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LACIDIPINE EG

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Lacidipina EG contains

• The active substance is lacidipine. Each tablet contains 4 mg or 6 mg of the active substance 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 contents of the pack
Lacidipina EG 4 mg film-coated tablets are white, oval, biconvex tablets with a score line on both sides and engraved with '4' on one side. The tablets can be divided into two equal doses.
They are available in aluminum/aluminum blister packs containing 14, 28, 30 or 90 film-coated tablets.
Lacidipina EG 6 mg film-coated tablets are white, oval, biconvex tablets engraved with '6' on one side.
They are available in aluminum/aluminum blister packs containing 14 or 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