LACIPIL 4 mg FILM-COATED TABLETS

2. What you need to know before taking Lacipil

Do not take Lacipil:

• if you are allergic (hypersensitive) to lacidipine or any of the other components of this medication (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 medication until you consult 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 rate or other cardiac 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 Lacipil with Other Medications

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

Some medications may affect how Lacipil works or make it more likely for you to experience side effects. Additionally, this medication may alter the effects of other medications. These medications include:

• medications for treating high blood pressure (antihypertensives), such as diuretics (increase urine elimination), beta-blockers (reduce the amount of work the heart does), or ACE inhibitors (cause relaxation of blood vessels), as they can lower blood pressure too much when taken together
• medications for treating epilepsy (e.g., phenytoin, carbamazepine, and barbiturates)
• some medications for treating fungal infections (e.g., itraconazole)
• some antibiotics (e.g., rifampicin)
• cimetidine (medication for treating stomach ulcers)
• cyclosporine (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 medications.

Taking Lacipil with Food and Drinks

Do not take grapefruit juice while being treated with this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

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

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

The components of this medication may pass into breast milk.

Driving and Using Machines

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

Lacipil Contains Lactose

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

3. How to Take Lacipil

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

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

The initial doserecommended 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 not chewed.

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

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

If you take more Lacipil 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 Toxicology Information Service, phone: 91 5620420. However, if the amount ingested is significant, you should go to the doctor or the emergency service of the nearest hospital. Bring this package leaflet with you.

If you forget to take Lacipil

Do not take a double dose to make up for forgotten doses. If you forgot to take the dose for one 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

• tremors
• depression.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lacipil

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

Do not store above 30°C.

Keep 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 medication.

The unused half-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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacipil

• The active ingredient is lacidipine.
• The other components (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 of the Product and Package Contents

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

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

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

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

28760 - Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

09400 Aranda de Duero (Burgos)

Date of the Last Revision of this Package Leaflet:June 2016

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/