Lacipil 4 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lacipil 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 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 other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Lacipil is and what it is used for
- What you need to know before taking Lacipil
- How to take Lacipil
- Possible side effects
- How to store Lacipil
- Contents of the pack and other information
1. What Lacipil is and what it is used for
Lacipil belongs to a group of medicines called "calcium channel blockers" which work by widening (dilating) blood vessels.
Lacipil is a medicine used to treat high blood pressure (hypertension).
2. What you need to know before taking Lacipil
Do not take Lacipil:
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if you are allergic (hypersensitive) to lacidipine or to any of the other components of this medicine (listed in section 6)
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if you have a heart condition called aortic stenosis. This is a narrowing of a heart valve that reduces the amount of blood flowing out.
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If you think any of these apply to you, do not take this medicine until you have consulted your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lacipil:
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if you have or have had any heart problems
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if you have any liver problems
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if you are taking other medicines for high blood pressure, for controlling heart rhythm or other heart conditions, mental or mood disorders, for treating certain infections, or even for allergic conditions.
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Inform your doctor if any of these situations apply to you.
Children and adolescents
The safety and efficacy in the paediatric population have not been established. No data are available.
Taking Lacipil with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may affect how Lacipil works or make it more likely that you will experience adverse effects. In addition, this medicine may alter the effects of other medicines. These include:
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medicines for treating high blood pressure (antihypertensives), such as diuretics (increase urine elimination), beta-blockers (reduce the workload of the heart), or ACE inhibitors (cause relaxation of blood vessels), as together they may lower blood pressure too much
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medicines for treating epilepsy (e.g. phenytoin, carbamazepine, and barbiturates)
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some medicines for treating fungal infections (e.g. itraconazole)
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some antibiotics (e.g. rifampicin)
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cimetidine (a medicine used to treat stomach ulcers)
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cyclosporine (used to prevent rejection of transplanted organs or to treat certain autoimmune diseases)
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corticosteroids or tetracosactide.
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Inform 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 this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Your doctor will assess whether the benefits of taking this medicine outweigh the potential risks before prescribing 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
Lacipil may cause dizziness. Do not drive or operate machinery unless you are certain you are not affected by this effect.
Lacipil contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Lacipil
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Your doctor will advise you on the duration of your treatment with Lacipil. Do not stop treatment without first consulting your doctor. Remember to take your medicine.
The recommended starting dose is 2 milligrams of lacidipine (half a Lacipil tablet) once daily.
After a period of 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 daily. 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 must not be chewed.
The medicine package includes a calendar to help you keep track of whether you have taken your daily dose.
If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.
If you take more Lacipil than you should
You may experience low blood pressure and your heartbeat may change (faster or slower).
If you have taken more medicine than you should, contact your doctor or pharmacist or the Toxicology Information Service immediately, telephone: 91 5620420. However, if the amount ingested is significant, you should go to the doctor or the nearest hospital emergency department. Bring this leaflet with you.
If you forget to take Lacipil
Do not take a double dose to make up for missed doses. If you forget to take your dose for one day, take your normal dose of Lacipil the next day at the usual time.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse effects May affect up to 1 in 10 people: |
Common adverse effects that may appear in blood tests:
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Uncommon adverse effects May affect up to 1 in 100 people: |
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Rare adverse effects May affect up to 1 in 1,000 people: |
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Very rare adverse effects May affect up to 1 in 10,000 people: |
- tremors
- depression.
Inform your doctor or pharmacist if any of the adverse effects become severe or troublesome, or if you notice any adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lacipil
Keep this medicine out of 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 ready to take the medicine.
Any unused half 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Lacipil
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The active substance is lacidipine.
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The other components (excipients) are:
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Core: monohydrate lactose, dried lactose, povidone K-30, magnesium stearate.
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Film coating: Opadry White OY-S-7335 containing: hypromellose (E464) and titanium dioxide (E171), or Opadry White YS-1-18043 containing hypromellose (E464), titanium dioxide (E171), PEG 400 and polysorbate 80.
Appearance of the product and contents of the pack
White, oval tablets with a break line on both sides. The tablets are marked with “GS” on one side and “3MS” on the other.
They are presented in child-resistant blisters 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
Manufacturer:
Glaxo Wellcome, S.A.
Avda. de Extremadura, 3
09400 Aranda de Duero (Burgos)
Date of the most recent review of this leaflet: June 2016
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/