Lercanidipine Apotex, 10 mg- 20 mg film- coated tablets
Module 1.3 Product Information Version: 2014-11-26
Module 1.3.1 Package Leaflet Replaces : 2013-11-29
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lercanidipine Apotex 10 mg film- coated tablets Lercanidipine Apotex 20 mg film- coated tablets
lercanidipine hydrochloride
Read all of this leaflet carefully before you start using this medication because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects , talk to your doctor or pharmacist. This includs any possible side effects not listed in this leaflet. See section 4..
What is in this leaflet 1. What Lercanidipine is and what it is used for 2. What do you need to know before you take Lercanidipine 3. How to use Lercanidipine 4. Possible side effects 5. How to store Lercanidipine 6. Content of the packa and other information
1. What Lercanidipine Apotex is and what it is used for
Lercanidipine is a selective calcium channel blocker belonging to a group of medicines called dihydropyridines. Selective calcium channel blockers reduce high blood pressure. They work by relaxing and thus widening the blood vessels.
Lercanidipine is used to treat mild to moderate high blood pressure (essential hypertension).
2. What do you need to know before you take Lercanidipine Apotex
Do not take Lercanidipine Apotex if: you are allergic to lercandipine hydrochloride or to any dihyropyridine, or any of the other ingredients in this medicine (listed in Section 6). you are planning to become pregnant there is a chance you may become pregnant you are suffering from certain heart diseases: - uncontrolled cardiac failure - obstruction to flow of blood from the heart - unstable angina (angina at rest or progressively increasing) - have had a heart attack less than one month ago you have severe liver or kidney problems you are taking one of the following drugs/food: - antifungal medicines (such as ketoconazole or itraconazole) 1
- mocrolide antibiotics (such as erythromycin or troleandomycin) - antivirals (such as ritonavir, a medicine to treat AIDS) - ciclosporin (a medicine used to prevent rejection after a transplant) - grapefruit or grapefruit juice.
Do not use if you are pregnant or breast-feeding (see section Pregnancy , Breast-feeding and fertility for more information).
Warnings and precausions Talk to your doctor or pharmacist before taking Lercanidipine Apotex if you: have a condition known as sick sinus syndrome without the use of a pacemaker have any other heart conditions have angina pectoris. Lercanidipine may very rarely cause increased frequency of attacks that may last longer and become more severe. Myocardial infarction has been reported in isolated cases have mild to moderate kidney or liver problems are taking anticonvulsants like phenytoin, carbemazepine or rifampicin as these may reduce the effect of lercanidipine.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lercanidipine.
Tell your doctor if you get any of the following while taking the medicine: chest pains heart problems
Other medicines and Lercanidipine Apotex Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.
The effect of Lercanidipine is enhanced by: midazolam (a sedative) cyclosporin (a medicine used to prevent rejection after a transplant) ketoconazole or itraconazole (medicines to treat fungal infections) ritonavir (a medicine to treat AIDS) erythromycin or troleandomycin (antibiotics) terfenadine, astemizole (antihistamines used to treat hay fever and other allergies) amiodarone, quinidine (to treat an irregular heartbeat) cimetidine (to treat stomach ulcers), when given at high doses (> 800 mg per day)
The effect of Lercanidipine is reduced by: phenytoin, carbamazepine (some anticonvulsant medicines used to treat epilepsy) rifampicin (an antibiotic) Beta-blockers (medicines to treat high blood pressure and heart diseases; e.g. metoprolol)
Lercanidipine increases the effect of: digoxin (to treat heart diseases) simvastatin (a cholesterol-lowering medicine)
Lercanidipine Apotex with alcohol or grapefruit juice Do not drink alcohol or grapefruit juice while taking Lercanidipine
Pregnancy and breast-feeding Do not take Lercanidipine Apotex if: you are pregnant you are breast-feeding 2
there is a chance you may become pregnant while taking Lercanidipine Apotex.
If there is a chance you may become pregnant while taking Lercanidipine Apotex, you must use adequate birth control. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines This medicinal product has minor influence on the ability to drive and use machines . Lercanidipine may cause dizziness, feeling of weakness or tiredness. Do not drive or use machines until you know how Lercanidipine affects you. Ask your doctor or pharmacist if you are unsure.
Lercanidipine Apotex contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Lercanidipine Apotex
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking the medicine Swallow the tablets whole with a drink of water You should take Lercanidipine 15 minutes before food. It may take up to two weeks for an effect to take place.
How much to take The recommended dose is 10 mg each day. Depending on your response your doctor may increase the dose to 20 mg each day. There are two strengths available: 10 mg and 20 mg.
Patients with liver or kidney problems The recommended dose is 10 mg each day if you have mild to moderate liver or kidney problems. Depending upon your response, your doctor may increase the dose with caution to 20 mg each day.
Children and adolescents Lercanidipine should not be taken by children or young people under the age of 18.
If you take more Lercanidpine Apotex than you should Exceeding the correct dosage may cause blood pressure to become too low, and the heart to beat irregularly or faster. It may also lead to unconsciousness. If you take more Lercanidpine than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you.
If you forget to take Lercanidpine Apotex If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lercanidpine Apotex Do not stop taking Lercandipine without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
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Like all medicines, this medicine can cause side effects although not everybody gets them. The following side effects may happen with this medicine:
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment: chest pains heart problems
The following side effects may occur:
Uncommon (may affects up to 1 in 100 people): fast heartbeat (tachycardia) palpitations (feeling the heart beat) peripheral oedema (a build up of fluid in the extremities, especially the legs) headache dizziness flushing (redness of the skin, particularly of the face)
Rare (may affects up to 1 in 1,000 people): angina pectoris (chest pain) precordial pain (pain in the front of the chest) sleepiness (somnolence) feeling sick (nausea) indigestion diarrhoea stomach pain vomiting polyuria (passing large amounts of urine) skin rash muscle pain weakness tiredness (fatigue)
Very rare (may affects up to 1 in 10,000 people): if you already have angina pectoris, the symptoms may occur more often, last longer or be more severe isolated cases of heart attack (myocardial infarction) may occur increased liver enzyme levels (this is usually reversible when treatment is stopped) enlarged gums (gingival hypertrophy) urinary frequency (passing urine at shorter intervals than usual) hypotension (low blood pressure) chest pain fainting (syncope)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any other side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on safety of this medicine.
5. How to store Lercanidipine Apotex
Keep out of the sight and reach of children. 4
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30 °C. Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Content of th epack and other information
What Lercanidipine Apotex contains The active substance is lercanidipine hydrochloride.
What Lercanidipine Apotex looks like and contents of the pack Lercanidipine Apotex 10 mg film- coated tablets are yellow round, biconvex, film- coated tablets, with ‘APO’ engraved on one side and ‘score line’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. When the tablet has been divided, all parts should be taken closely together. Lercanidipine Apotex 20 mg film- coated tablets are pink, round, biconvex, film- coated tablets with ‘APO’ engraved on one side and ‘score line’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. When the tablet has been divided, all parts should be taken closely together. The tablets are available in blister pack sizes of 28, 56 and 98 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: <[To be completed nationally]>
Manufacturer: <[To be completed nationally]>
This leaflet was last approved in {MM/YYYY}.
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