Patient Information Leaflet: Information for the User

Lacirex 4 mg film-coated tablets, 6 mg film-coated tablets

lacidipine
Please read this leaflet carefully before taking 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lacirex is and what it is used for
What you need to know before taking Lacirex
How to take Lacirex
Possible side effects
How to store Lacirex
Contents of the pack and other information

1. What Lacirex is and what it is used for

Lacirex is used to treat high blood pressure (hypertension). It belongs to a class of medicines called "calcium channel blockers". Lacirex has the property of widening (dilating) blood vessels, thereby facilitating blood flow and lowering blood pressure.

2. What you should know before taking Lacirex

Do not take Lacirex:
if you are allergic to the active substance or to any of the other ingredients of this
medicine (listed in section 6).
if you have a heart condition called aortic stenosis. This condition is a
narrowing of the valve that allows blood to be pumped out of the heart.
If you think any of these conditions applies to you, do not take Lacirex until you have discussed it
with your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lacirex.
Before starting treatment with Lacirex, your doctor should know:
if you have heart problems
if you have liver disease

Other medicines and Lacirex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Some medicines may alter the activity of Lacirex, either reducing or increasing it and causing side effects.
Lacirex may also alter the activity of other medicines, including:
other medicines used to treat high blood pressure, such as furosemide, propranolol, or captopril
cimetidine (used to treat stomach ulcers)
cyclosporine (used to prevent organ transplant rejection or for certain autoimmune diseases).
Concomitant use of lacidipine and corticosteroids or tetracosactide may reduce the antihypertensive effect.
Talk to your doctor or pharmacist if you are taking any of these medicines.

Taking Lacirex with food and drinks
Do not drink grapefruit juice while taking Lacirex.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
There is no information available on the safety of using Lacirex during pregnancy. If you are pregnant or
think you may be pregnant, or if you are planning a pregnancy, do not take Lacirex without first
consulting your doctor. Your doctor will evaluate the risks and benefits of taking Lacirex for you and your baby.
The active substance and excipients of Lacirex may pass into breast milk. If you are breastfeeding, consult your doctor before starting treatment with Lacirex.

Driving and using machines
Lacirex may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.

Important information about some of the excipients in Lacirex
Lacirex contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Lacirex

How much to take
Always take Lacirex exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
The usual starting dose of Lacirex is 2 mg once daily in the morning.
Your doctor may decide to increase the dose to 4 or 6 mg once daily in the morning after
approximately 3–4 weeks of treatment.

How to take it
Swallow the tablet with some water.
It is preferable to take the medicine at the same time every day.
You may take Lacirex with or without food.

If you take more Lacirex than you should
If you take too many Lacirex tablets, a drop in blood pressure and a change in heart rate, which may increase or decrease, is very likely.
Contact your doctor or pharmacist for advice.

If you forget to take Lacirex
If you forget to take a dose, take the next one at the usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Lacirex
Take Lacirex for the length of time recommended by your doctor. Do not stop taking
Lacirex without consulting your doctor.
If you have any questions about using Lacirex, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lacirex can cause side effects, although not everyone experiences them.

Common side effects
These may affect up to 1 in 10 people:

irregular heartbeat (palpitations)
faster heartbeat (tachycardia)
fluid retention causing swelling
dizziness
frequent urination
headache
skin rashes (including redness of the skin and itching)
hot flushes
stomach discomfort
nausea
fatigue

Common side effects that may be observed in blood tests:

reversible increase in the level of an enzyme called alkaline phosphatase

Uncommon side effects
These may affect up to 1 in 100 people:

worsening of chest pain (worsening of pre-existing angina pectoris)
pallor
low blood pressure
bleeding, sore gums
fainting
hypotension

Rare side effects
These may affect up to 1 in 1,000 people:

severe allergic reactions with swelling of the face, tongue or throat, which may cause difficulty swallowing or breathing
itchy red rash on the skin

Very rare side effects
These may affect up to 1 in 10,000 people:

restlessness or tremor of the arms and legs
depression

If you experience any of these side effects
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacirex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original container to protect from light.
Do not remove the tablet from the blister until it is time to take it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lacirex contains
The active substance is lacidipine. Lacirex tablets are available in different strengths.
Each tablet contains:
4 mg of lacidipine
6 mg of lacidipine
The excipients are:
Lactose, povidone, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol (PEG)
400, polysorbate 80

Description of the appearance of Lacirex and pack sizes
Lacirex 4 mg tablets are white, oval-shaped, with a breakline on both sides and engraved with “GS” and “3MS” on one side. Pack size: 28 tablets.
Lacirex 6 mg tablets are white, oval-shaped, engraved with “GXCX3” on one side. Pack sizes: 14 and 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratori Guidotti S.p.A. – Via Livornese, 897 – Pisa – La Vettola
Under licence from GlaxoSmithKline S.p.A.

Manufacturer
Glaxo Wellcome S.A. – Avenida de Extremadura, 3 - Aranda de Duero - Burgos (Spain)
A. Menarini Manufacturing Logistics and Services srl - Via Campo di Pile, L’Aquila
Menarini – Von Heyden GmbH – Leipziger Strasse, 7-13 – Dresden (Germany)