Leaflet: information for the user

Lacimen 4 mg film-coated tablets

lacidipine

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Lacimen belongs to a group of medications called “calcium channel blockers” that act by dilating blood vessels.

Lacimen isa medication used to treat high blood pressure (hypertension).

Do not take Lacimen:

• if you areallergic(hypersensitive) to lacidipine or to any of the other componentsofthis medication (listed in section 6)
• if you have a heart disease calledaortic stenosis. This is a narrowing of a heart valve that reduces the amount of blood that leaves.

• If you think you are affected by any of these situations,do not take this medicationuntil you consult with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lacimen:

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

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

Children and adolescents

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

Taking Lacimen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Some medications may affect the way Lacimen works or make it more likely that you will experience adverse effects. Additionally, this medication may alter the effects of other medications. Among these medications are:

• medications to treat high blood pressure (anti-hypertensives), such as diuretics (increase urine elimination), beta-blockers (reduce the amount of work the heart does) or IECAs (produce vasodilation) as they may lower blood pressure too much
• medications to treat epilepsy (e.g. phenytoin, carbamazepine, and barbiturates)
• some medications to treat fungal infections (e.g. itraconazole)
• some antibiotics (e.g. rifampicin)
• cimetidine (medication to treat stomach ulcers)
• ciclosporin (used to prevent organ transplant rejection or to treat certain autoimmune diseases)
• corticosteroids or tetracosactide.

• Inform your doctor or pharmacistif you are taking any of these medications.

Taking Lacimen with food and drinks

Do not take grapefruit juice while taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor before using this medication.

Your doctor will assess whether the benefits associated with the use of this medication outweigh its potential risks before taking this medication.

No information is available on the safety of this medication in pregnant women.

The components of this medication may pass into breast milk.

Driving and operating machinery

Lacimen may cause dizziness. Do not drive or operate machineryunless you are sure you will not feel these effects.

Lacimen contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Lacimen. Do not interrupt treatment without consulting your doctor first. Remember to take your medication.

Initial recommended dose 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 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 every day, preferably in the morning , with or without food. The tablets should be swallowed with water and should not be chewed.

The medication packaging features a calendar that will help you know if you have taken your daily dose.

If you estimate that the action of this medication is too strong or too weak, inform 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 medication than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420. However, if the amount ingested is significant, you should go to your doctor or the emergency service of the nearest hospital. Bring this leaflet with you.

If you forgot to take Lacimen

Do not take a double dose to compensate for the missed doses. If you forgot to take the dose corresponding to a day, take your normal Lacimen dose the next day at the usual time.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

• tremors
• depression.

Inform your doctor or pharmacist if any of the side effects become severe or problematic, or if you observe any side effects not included in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 86°F (30°C).

Store in the original packaging to protect it from light.

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

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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Lacimen

• The active principle is lacidipine.
• The other components (excipients) are:
• • Core:monohydrate lactose, anhydrous lactose, povidone K-30, andmagnesium stearate

• Coating film:Opadry white OY-S-7335containing: hypromellose (E464) and titanium dioxide (E171)orOpadry white YS-1-18043containing hypromellose (E464), titanium dioxide (E171),PEG400, and polisorbate 80.

Appearance of the product and content of the container

They are white, oval-shaped tablets with a breaking notch on both faces. The tablets are marked with “GS” on one face and “3MS” on the other.

They are presented in a child-resistant blister, containing 28 tablets inside a cardboard box.

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 - Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

09400 - Aranda de Duero (Burgos)

Last review date of this leaflet:June 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/