Lacimen 4 mg film-coated tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Lacimen 4 mg Film-coated Tablets
lacidipine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to refer to it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Lacimen is and what it is used for
- What you need to know before taking Lacimen
- How to take Lacimen
- Possible side effects
- How to store Lacimen
- Contents of the pack and other information
1. What Lacimen is and what it is used for
Lacimen belongs to a group of medicines called "calcium channel blockers" which work by widening (dilating) blood vessels.
Lacimen is a medicine used to treat high blood pressure (hypertension).
2. What you need to know before taking Lacimen
Do not take Lacimen:
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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 situations apply to you, do not take this medicine until you have consulted your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Lacimen:
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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, to control your heart rhythm or other heart conditions, mental or mood disorders, to treat certain infections, or even allergic conditions.
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Inform your doctor if any of these situations apply to you.
Children and adolescents
Safety and efficacy have not been established in the paediatric population. No data are available.
Taking Lacimen 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 Lacimen works or make it more likely that you experience adverse effects. In addition, this medicine may alter the effects of other medicines. These include:
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medicines to treat 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 used to treat epilepsy (e.g. phenytoin, carbamazepine, and barbiturates)
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some medicines used to treat 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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ciclosporin (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 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 become pregnant, consult your doctor before using this medicine.
Your doctor will assess whether the benefits of taking this medicine outweigh any possible risks before prescribing it.
There is no information on the safety of this medicine in pregnant women.
Components of this medicine may pass into breast milk.
Driving and using machines
Lacimen may cause dizziness. Do not drive or operate machinery unless you are certain you are not affected by these effects.
Lacimen contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Lacimen
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine how long you should take Lacimen. Do not stop treatment without first consulting your doctor. Remember to take your medicine.
The recommended initial dose is 2 milligrams of lacidipine (half a Lacimen tablet) once daily.
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 daily. Your doctor may change your medication according to your needs and you should follow their instructions.
Take it 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 Lacimen than you should
You may experience low blood pressure and changes in your heart rate (beating faster or slower).
If you have taken more medicine than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 5620420. However, if the amount taken is significant, you must go to your doctor or the nearest hospital emergency department. Take this leaflet with you.
If you forget to take Lacimen
Do not take a double dose to make up for missed doses. If you forget to take a dose on a given day, take your normal dose of Lacimen 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 effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Common side effects May affect up to 1 in 10 people: |
Common side effects that may appear in blood tests:
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Uncommon side effects May affect up to 1 in 100 people: |
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Rare side effects May affect up to 1 in 1,000 people: |
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Very rare side 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 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 it from light.
Do not remove the tablets from the aluminum blister until you are ready to take the medicine.
The unused half tablet should be kept in the alveolar container inside the carton 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lacimen
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The active substance is lacidipine.
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The other components (excipients) are:
- Core: monohydrate lactose, dried lactose, povidone K-30, magnesium stearate
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Film coating: white Opadry OY-S-7335 containing: hypromellose (E464) and titanium dioxide (E171), or white Opadry YS-1-18043 containing hypromellose (E464), titanium dioxide (E171), PEG 400 and polysorbate 80.
Appearance of the medicine and contents of the pack
The tablets are white, oval-shaped, with a breakline 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
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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/