Package leaflet: Information for the user

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

lacidipine
Please read all of 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 they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

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

1. What Lacipil is and what it is used for
Lacipil is used to treat high blood pressure (hypertension). It belongs to a class of medicines called "calcium channel blockers". Lacipil has the property of widening (dilating) blood vessels, thereby improving blood flow and lowering blood pressure.

2. What you should know before taking Lacipil

Do not take Lacipil:

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 you may have either of these conditions, do not take Lacipil before speaking with your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lacipil.
Before starting treatment with Lacipil, your doctor should know:

if you have heart problems
if you have liver disease.

Other medicines and Lacipil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the activity of Lacipil, either reducing or increasing it and causing side effects. Lacipil may also affect the action of other medicines, including:

other medicines used to treat high blood pressure, such as furosemide, propranolol, or captopril
cimetidine (used to treat stomach ulcers)
ciclosporin (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 Lacipil with food and drink
Do not drink grapefruit juice while taking Lacipil.

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

Driving and using machines
Lacipil 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 Lacipil
Lacipil contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Lacipil

How much to take
Always take Lacipil 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 Lacipil is 2 mg once daily in the morning.
Your doctor may decide whether 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 a glass of water.
It is preferable to take the medicine at the same time each day.
You may take Lacipil with or without food.

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 rash (including skin redness and itching)
hot flushes
stomach discomfort
nausea
tiredness

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 (syncope)
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 in swallowing or breathing
itchy red rash on the skin (erythema)

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

restlessness or tremor in 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 effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione- avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacipil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Store in the original container to protect from light.
Do not remove the tablet from the blister pack 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 Lacipil contains
The active substance is lacidipine. Lacipil tablets are available in different strengths.
Each tablet contains:
4 mg of lacidipine
6 mg of lacidipine

The other components are:
lactose, povidone, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol (PEG) 400, polysorbate 80.

Description of the appearance of Lacipil and contents of the pack
Lacipil 4 mg tablets are white, oval-shaped, with a break line on both sides, marked "GS" on one side and "3MS" on the other. Pack size: 28 tablets.
Lacipil 6 mg tablets are white, oval-shaped, marked "GXCX3" on one side. Pack size: 14 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona
Manufacturer
Glaxo Wellcome S.A. – Avenida de Extremadura, 3 – Aranda de Duero – Burgos (Spain)
GlaxoSmithKline Manufacturing S.p.A. – Via A. Fleming, 2 – Verona (Italy)