LACIMEN 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lacimen 4 mg film-coated tablets

lacidipine

Read all of this leaflet carefully before you start taking 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lacimen and what is it used for
2. What you need to know before you take Lacimen
3. How to take Lacimen
4. Possible side effects
5. Storage of Lacimen
6. Contents of the pack and further information

1. What is Lacimen and what is it used for

Lacimen belongs to a group of medicines called "calcium channel blockers" that work by widening (dilating) blood vessels.

Lacimen is a medicine used to treat high blood pressure (hypertension).

2. What you need to know before you take Lacimen

Do not take Lacimen:

• if you are allergic (hypersensitive) to lacidipine or any of the other ingredients of this medicine (listed in section 6)
• if you have a heart disease called aortic stenosis. This is a narrowing of a heart valve that reduces the amount of blood that comes out.

• If you think you are affected by any of these situations, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lacimen:

• if you have or have had any heart problems
• if you have any liver problems
• if you are taking other medicines for the treatment of high blood pressure, to control heart rate or other heart disorders, mental or mood problems, to treat some infections, or even allergic problems.

• Tell your doctor if you are affected by any of these situations.

Children and adolescents

The safety and efficacy in the pediatric population have not been established. No data are available.

Taking Lacimen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect how Lacimen works or make it more likely that you will experience side effects. Additionally, this medicine may alter the effects of other medicines. These medicines include:

• medicines for treating high blood pressure (antihypertensives), such as diuretics (increase urine production), beta-blockers (reduce the amount of work the heart does), or ACE inhibitors (produce relaxation of blood vessels), as they can lower blood pressure too much when taken together
• medicines for treating epilepsy (e.g., phenytoin, carbamazepine, and barbiturates)
• some medicines for treating fungal infections (e.g., itraconazole)
• some antibiotics (e.g., rifampicin)
• cimetidine (medicine for treating stomach ulcers)
• cyclosporin (used to prevent organ rejection after transplantation or to treat certain autoimmune diseases)
• corticosteroids or tetracosactide.

• Tell your doctor or pharmacist if you are taking any of these medicines.

Taking Lacimen with food and drinks

Do not drink grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Your doctor will assess whether the benefits of using this medicine outweigh the potential risks before you take it.

There is no information on the safety of this medicine in pregnant women.

The components of this medicine may pass into breast milk.

Driving and using machines

Lacimen may cause dizziness. Do not drive or use machines unless you are sure you will not feel these effects.

Lacimen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Lacimen

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your doctor will tell you how long to take Lacimen. Do not stop treatment without consulting your doctor first. Remember to take your medicine.

The initial doserecommended is 2 milligrams of lacidipine (half a Lacimen tablet) once a day.

After some time(3-4 weeks), it may be necessary to increase the dose to 4 milligrams (one Lacimen tablet) or 6 mg (one and a half Lacimen tablets) once a day. Your doctor may change your medication according to your needs and you should follow their instructions.

It should be taken at the same time each day, preferably in the morning, with or without food. The tablets should be swallowed with water and not chewed.

The packaging of the medicine has a calendar that will help you know if you have taken your daily dose.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Lacimen than you should

You are likely to have low blood pressure and your heartbeats may change (beat faster or slower).

If you have taken more medicine than you should, talk to your doctor or pharmacist or the Toxicology Information Service, phone: 91 5620420. However, if the amount taken is significant, you should go to the doctor or the emergency department of the nearest hospital. Bring this leaflet with you.

If you forget to take Lacimen

Do not take a double dose to make up for forgotten doses. If you forget to take the dose for one day, take your normal dose of Lacimen the next day at the usual time.

If you have any further questions on 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.

• tremors
• depression.

Tell your doctor or pharmacist if any of the side effects get serious or troublesome, or if you notice any side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacimen

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Store in the original packaging to protect from light.

Do not remove the tablets from the aluminum blister pack until you are about to take this medicine.

The unused half of the tablet should be kept in the alveolar container inside the box and used within the next 48 hours.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lacimen

• The active substance is lacidipine.
• The other ingredients (excipients) are:
• • Core:lactose monohydrate, anhydrous lactose, povidone K-30, magnesium stearate

• Coating:Opadry white OY-S-7335which contains: hypromellose (E464) and titanium dioxide (E171) or Opadry white YS-1-18043which contains hypromellose (E464), titanium dioxide (E171), PEG 400, and polysorbate 80.

Appearance and packaging

They are white, oval tablets with a score line on both sides. The tablets are marked with "GS" on one side and "3MS" on the other.

They come in a child-resistant blister pack containing 28 tablets in a cardboard box.

Marketing Authorisation Holder:

GlaxoSmithKline, S.A.

P.T.M. C/Severo Ochoa, 2

28760 - Tres Cantos (Madrid)

Tel: +34 900 202 700

es-ci@gsk.com

Manufacturer:

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

09400 - Aranda de Duero (Burgos)

Date of last revision of this leaflet:June 2016

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/