Package Leaflet: Information for the User

Lacipil 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Lacipil belongs to a group of medications known as “calcium channel blockers” that work by widening (dilating) blood vessels.

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

Do not take Lacipil:

• if you areallergic(hypersensitive) to lacidipine or to any of the other componentsofthis medication (listed in section 6)
• if you have a heart condition 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 Lacipil:

• 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 allergies.

• 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 Lacipil with other medications

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

Some medications may affect the way Lacipil 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 (cause relaxation of blood vessels) as they may lower blood pressure too much when taken together
• 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 Lacipil 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

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

Lacipil 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 Lacipil. Do not interrupt treatment without consulting your doctor first. Remember to take your medication.

Initial recommended dose is 2 milligrams of lacidipine (half a Lacipil tablet) once a day.

After some time (3-4 weeks), it may be necessary to increase the dose to 4 milligrams (one Lacipil 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 presents 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 Lacipil than you should

It is likely that you will 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 Lacipil

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 dose of Lacipil 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 of 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 Medicinal Products 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 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 Lacipil

• The active ingredient is lacidipine.
• The other components (excipients) are:

• Core:lactose monohydrate, lactose anhydrous, povidone K-30, andmagnesium stearate.
• Covering film:Opadry white OY-S-7335which contains: hypromellose (E464) and titanium dioxide (E171)uOpadry white YS-1-18043which contains hypromellose (E464), titanium dioxide (E171),PEG400, and polisorbate 80.

Appearance of the product and content of the packaging

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.

SThey 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/