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Package leaflet: Information for the user Lecalpin 10 mg Film-coated Tablets Lecalpin 20 mg Film-coated Tablets Lercanidipine hydrochloride

Read all of this leaflet carefully before Taking Lecalpin with certain other medicines you start using this medicine because it (see below), may alter the effect of these contains important information for you. medicines or of Lecalpin. • Keep this leaflet. You may need to read it again. It is especially important for your doctor to • If you have any further questions, ask your know if you are already being treated with any of the following medicines: doctor or pharmacist. •  or (medicines for • This medicine has been prescribed for you epilepsy) only. Do not pass it on to others. It may •  (a medicine to treat tuberculosis) harm them, even if their signs of illness are • midazolam (a medicine that helps you sleep) the same as yours. • cimetidine, more than 800 mg (a medicine • If you get any side effects, talk to your for ulcers, indigestion, or heartburn) doctor or pharmacist. This includes any •  (a medicine to treat a heart problem) possible side effects not listed in this •  or (medicines for leaflet. See section 4. allergies) •  or (medicines to treat a fast heart beat) What is in this leaflet: • metoprolol (a medicine to treat high blood 1 What Lecalpin is and what it is used pressure) for • simvastatin (a medicine for high 2 What you need to know before you value) take Lecalpin Lecalpin with food, drink and 3 How to take Lecalpin You must not eat grapefruit or drink grapefruit 4 Possible side effects juice as this may increase the effect of 5 How to store Lecalpin Lecalpin. 6 Contents of the pack and other information If you use alcohol together with Lecalpin you may experience dizziness/fainting, tiredness or weakness. This is because the medicine 1 What Lecalpin is and what it is used may lower your blood pressure considerably for together with alcohol.

Lecalpin belongs to a group of medicines Pregnancy and breast-feeding called blockers that block the Ask your doctor for advice before taking any entry of calcium into the muscle cells of the medicine. heart and the blood vessels that carry blood away from the heart (the arteries). It is the If you are pregnant or breast-feeding, think entry of calcium into these cells that causes you may be pregnant or are planning to have the heart to contract and arteries to narrow. a baby, ask your doctor for advice before By blocking the entry of calcium, calcium taking this medicine. channel blockers decrease contraction of the heart and dilate (widen) the arteries, and the Do not use if you are pregnant, or if you wish blood pressure is reduced. to become pregnant or if you are a woman in childbearing age and do not use any Lecalpin has been prescribed to you to treat contraceptive method. your high blood pressure, also known as hypertension. Do not use if you are breast-feeding. Driving and using machines 2 What you need to know before you Lecalpin has a negligible influence on the ability to drive or use machines. However, side take Lecalpin effects such as dizziness, weakness, tiredness and rarely sleepiness may occur. You should Do not take Lecalpin be careful until you know how you react to • if you are allergic to lercanidipine or any of Lecalpin. the other ingredients of this medicine (listed in section 6) Lecalpin contains lactose monohydrate • if you have had allergic reactions to If you have been told by your doctor that you medicines that are closely related to Lecalpin have an intolerance to some sugars, contact tablets (such as , , your doctor before taking this medicine. , , or ) • if you are suffering from certain heart 3 How to take Lecalpin diseases: - uncontrolled cardiac failure - an obstruction to flow of blood from the Always take this medicine exactly as your heart doctor has told you. Check with your doctor or - unstable (angina at rest or pharmacist if you are not sure. progressively increasing) - if you have had a heart attack less than one The recommended dose is one Lecalpin 10 month ago mg film-coated tablet daily at the same time • if you have severe liver or kidney problems each day, preferably in the morning at least 15 • If you are taking drugs that are inhibitors of minutes before breakfast, because a high fat CYP3A4 isoenzyme: meal significantly increases your blood levels - antifungal medicines (such as of the medicine. or ) Your doctor may decide to increase your dose - macrolide antibiotics (such as to one Lecalpin 20 mg film-coated tablet daily, or troleandomycin) if needed. - antivirals (such as ritonavir) • at the same time as another drug called The tablets should preferably be swallowed or cyclosporine whole with 1/2 glass of water. The score line is • with grapefruit or grapefruit juice only there to help you break the tablet if you • if you are pregnant, or if you wish to have difficulty swallowing it whole. become pregnant or if you are a woman in child-bearing age and do not use any Use in children and adolescents contraceptive method Lecalpin is not recommended for use in • if you are breast-feeding children and adolescents below 18 years.

Warnings and precautions If you take more Lecalpin than you Talk to your doctor before taking Lecalpin should • if you have a heart condition known as Immediately contact a doctor, the nearest sick sinus syndrome, and do not have a hospital casualty department or the centre for pacemaker poison information for advice. • if you suffer from chest pain (angina pectoris), Lercandipine may in very rare cases Exceeding the correct dosage may cause cause increased frequency of attacks that blood pressure to become too low, and the may last longer and become more severe. heart to beat irregularly or faster. It may also Heart attacks have been reported in isolated lead to unconsciousness. cases • if you have problems with your liver or If you forget to take Lecalpin kidney, or you are on . If you forget to take your tablet, take it as soon as you remember, unless it is almost time for Other medicines and Lecalpin your next dose. Then go on as before. Do not Tell your doctor or pharmacist if you are take a double dose to make up for a forgotten taking, have recently taken or might take dose. any other medicines, including medicines obtained without a prescription. If you stop taking Lecalpin If you stop taking Lecalpin your blood pressure may increase again. Please consult your doctor before stopping the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Lercanidipine 10 mg & 20 mg Film-coated Tablets PIL - Ireland

approved for print/date Item number: BBBA4694 Colours Non Printing Colours 1. Black 1. Originator: RH Dimensions: 190 x 600 2. 2. Origination Date: 30-04-19 Min Body Text Size: 12pt Revision Date: 07-05-19 Supplier: Teva Bulgaria Dupnitsa 3. 3. Revised By: RH 4. 5. Proof Round Technical Date sent: 30-04-19 6. 02 Approval Date received: 02-05-19 [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 4 Possible side effects Pack sizes: Blisters (Al/PVC/PVDC): Like all medicines, this medicine can cause Lecalpin 10 mg film-coated tablets: 14, 20, 28, side effects, although not everybody gets 30, 50, 56, 60, 90, 98, 100 tablets them. Lecalpin 20 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 tablets The frequencies of side effects have been listed below according to the following Bottles: definitions: Lecalpin 10 mg film-coated tablets: 100 tablets Very common: may affect more than 1 in 10 people Lecalpin 20 mg film-coated tablets: 100 Common: may affect up to 1 in 10 people tablets Uncommon: may affect up to 1 in 100 people Not all pack sizes may be marketed. Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people Marketing Authorisation Holder Not known: frequency cannot be estimated Accord Healthcare Ireland Ltd, from the available data Euro House, Euro Business Park, Uncommon: Headache, dizziness, faster Little Island, heartbeats, awareness of the beating of the Cork T45 K857, heart, (transient episodic redness of Ireland the face and neck), ankle swelling. Manufacturer Rare: Sleepiness, weakness, tiredness, Actavis ehf. nausea, vomiting, diarrhoea, abdominal pain, Reykjavikurvegur 78, 220 Hafnarfjordur, indigestion, rash, muscle pain, passage of Iceland large amounts of urine, angina pectoris. And/or Very rare, not known: Decrease in blood pressure which may lead to fainting, allergic Actavis Ltd, reaction, swelling of gums, increase in liver BLB 016 Bulebel Industrial Estate, Zejtun ZTN enzyme blood test values, fall in blood 3000, Malta pressure which can cause dizziness, light- headedness or fainting, increase in the usual And/or number of times one urinates, chest pain and heart attack. Balkanpharma – Dupnitsa AD 3 Samokovsko Schosse Str., Dupnitsa 2600, Reporting of side effects Bulgaria If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. This medicinal product is authorised in You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, the Member States of the EEA under the IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 following names: 1 6762517. Website: www.hpra.ie; E-mail: medsafety@ Ireland Lecalpin 10mg Film-coated hpra.ie. Tablets By reporting side effects you can help provide  Lecalpin 20mg Film-coated more information on the safety of this Tablets medicine. United Kingdom Lercanidipine hydrochloride 10mg film-coated Tablets Lercanidipine hydrochloride 5 How to store Lecalpin 20mg film-coated Tablets This leaflet was last revised in May 2019 Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.

Storage conditions: Al/PVC/PVDC blister: Do not store above 30°C. Store in the original package to protect from moisture. HDPE bottles: Store in the original package. Keep the bottle tightly closed to protect from moisture.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Lecalpin contains • The active substance is lercanidipine hydrochloride. One 10 mg film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4 mg lercanidipine. One 20 mg film-coated tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.8 mg lercanidipine. • The other ingredients are: Tablet core: stearate, povidone, sodium starch glycolate (Type A), lactose monohydrate, microcrystalline cellulose. Film-coating 10 mg tablets: Macrogol, polyvinyl alcohol (partly hydrolysed), talc, titanium dioxide (E 171), yellow iron oxide (E 172). Film-coating 20 mg tablets: Macrogol, polyvinyl alcohol (partly hydrolysed), talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).

What Lecalpin looks like and contents of the pack Lecalpin 10 mg tablets are yellow, round, biconvex 6.5 mm film-coated tablets, scored on one side, and marked ‘L’ on the other side.

Lecalpin 20 mg tablets are pink, round, biconvex 8.5 mm film-coated tablets, scored on one side, and marked ‘L’ on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

BBBA4694

Lercanidipine 10 mg & 20 mg Film-coated Tablets PIL - Ireland

approved for print/date Item number: BBBA4694 Colours Non Printing Colours 1. Black 1. Originator: RH Dimensions: 190 x 600 2. 2. Origination Date: 30-04-19 Min Body Text Size: 12pt Revision Date: 07-05-19 Supplier: Teva Bulgaria Dupnitsa 3. 3. Revised By: RH 4. 5. Proof Round Technical Date sent: 30-04-19 6. 02 Approval Date received: 02-05-19 [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017