Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Lercanidipine Market UK Language English Size 170 x 550 (PIL) Min. Font Size 10 Version No. 1 (Page 1 of 2) Keyline Date 05_09_20 (Lercanidipine (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

Your doctor may decide to increase Do not use this medicine after your dose to one Lercanidipine the expiry date, which is stated hydrochloride 20mg film-coated on the label, carton or bottle Lercanidipine hydrochloride tablet daily, if needed. after EXP. The expiry date refers 10mg and 20mg film-coated tablets to the last day of that month.

The tablets should preferably be Storage conditions Read all of this leaflet carefully before ●suf fer from chest pain (angina swallowed whole with 1/2 glass of Al/PVC/PVDC blister: Do not store above you start using this medicine because it pectoris), Lercandipine may in very water. The score line is only there to help 30°C. rare cases cause increased frequency of contains important information for you. you break the tablet if you have Store in the original package to protect attacks that may last longer and • Keep this leaflet. You may need to dif ficulty swallowing it whole. from moisture. read it again. become more severe. Heart attacks have been reported in isolated cases. • If you have any further questions, ask Use in children and adolescents Do not throw away any medicines via ●have problems with your liver or your doctor or pharmacist. Lercanidipine is not recommended for wastewater or household waste. Ask kidney, or you are on dialysis • This medicine has been prescribed for use in children and adolescents below your pharmacist how to throw away 18 years. medicines you no longer use. These you only. Do not pass it on to others. It Other medicines and Lercanidipine measures will help protect the may harm them, even if their signs of Please tell your doctor or pharmacist if you If you take more Lercanidipine than environment. illness are the same as yours. are taking, have recently taken or might you should • If you get any side ef fects, talk to take any other medicines, including Immediately contact a doctor, the nearest your doctor or pharmacist. This medicines obtained without a prescription. hospital casualty department or the includes any possible side ef fects not 6 Contents of the pack and other centre for poison information for advice. Taking Lercanidipine with certain other information listed in this leaflet. See section 4. Exceeding the correct dosage may cause medicines (see below), may alter the ef fect blood pressure to become too low, and of these medicines or of Lercanidipine. What Lercanidipine hydrochloride the heart to beat irregularly or faster. It contains What is in this leaflet: may also lead to unconsciousness. It is especially important for your doctor The active substance is lercanidipine 1 What Lercanidipine to know if you are already being treated hydrochloride. One 10mg film-coated If you forget to take Lercanidipine hydrochloride tablets are and with any of the following medicines: tablet contains 10mg lercanidipine If you forget to take your tablet, take it what they are used for ●phenytoin or carbamazepine hydrochloride, equivalent to 9.4mg as soon as you remember, unless it is 2 What you need to know before (medicines for epilepsy) lercanidipine. almost time for your next dose. Then go ●rifampicin (a medicine to treat One 20mg film-coated tablet contains you take on as before. Do not take a double dose tuberculosis) 20mg lercanidipine hydrochloride, 3 How to take to make up for a forgotten dose. midazolam (a medicine that helps you equivalent to 18.8mg lercanidipine. 4 Possible side e ects ● sleep) If you stop taking Lercanidipine 5 How to store ●cimetidine, more than 800mg (a The other ingredients are: Tablet core: If you stop taking Lercanidipine your 6 Contents of the pack and other medicine for ulcers, indigestion, or Magnesium stearate, povidone, sodium blood pressure may increase again. information heartburn) starch glycolate (Type A), lactose Please consult your doctor before ●digoxin (a medicine to treat a heart monohydrate, microcrystalline cellulose. stopping the treatment. problem) Film-coating 10mg tablets: Macrogol, ●terfenadine or astemizole (medicines polyvinyl alcohol (partly hydrolysed), 1 What Lercanidipine If you have any further questions on the for allergies) talc, titanium dioxide hydrochloride tablets are and use of this medicine, ask your doctor or ●amiodarone or quinidine (medicines to (E 171), yellow iron oxide (E 172). what they are used for pharmacist. treat a fast heart beat) Film-coating 20mg tablets: Macrogol, ●metoprolol (a medicine to treat high polyvinyl alcohol (partly hydrolysed), Lercanidipine belongs to a group of blood pressure) talc, titanium dioxide (E 171), yellow iron medicines called calcium channel ●simvastatin (a medicine for high 4 Possible side ef fects oxide (E 172), red iron oxide (E 172). blockers that block the entry of calcium cholesterol value) into the muscle cells of the heart and the Like all medicines, this medicine can What Lercanidipine hydrochloride blood vessels that carry blood away from Lercanidipine with food, drink and cause side ef fects, although not tablets looks like and contents of the the heart (the arteries). It is the entry of alcohol everybody gets them. pack calcium into these cells that causes the You must not eat grapefruit or drink Lercanidipine hydrochloride 10mg heart to contract and arteries to narrow. grapefruit juice as this may increase the The frequencies of side ef fect have been tablets are yellow coloured, round By blocking the entry of calcium, calcium ef fect of Lercanidipine. listed below according to the following shaped, biconvex, coated tablets channel blockers decrease contraction of definitions: debossed with “LT1” on one side and the heart and dilate (widen) the arteries, If you use alcohol together with breakline on the other side. The diameter and the blood pressure is reduced. Very common: may af fect more than 1 in Lercanidipine you may 10 people of tablet is approximately 6.5 mm. experience dizziness/fainting, Common: may af fect up to 1 in 10 Lercanidipine has been prescribed to tiredness or weakness. This is people Lercanidipine hydrochloride 20mg you to treat your high blood pressure, because the medicine may Uncommon: may af fect up to 1 in 100 tablets are pink coloured, round shaped, also known as hypertension. lower your blood pressure people biconvex coated tablets debossed with Rare: may af fect up to 1 in 1,000 considerably together with alcohol. people “LT2” on one side and breakline on the Very rare: may af fect up to 1 in other side. The diameter of tablet is 2 What you need to know before Pregnancy and breast-feeding 10,000 people approximately 8.5 mm. you take Ask your doctor for advice before taking Not known: frequency cannot be any medicine. estimated from the The score line is only to facilitate available data Do not take Lercanidipine if you: If you are pregnant or breast-feeding, breaking for ease of swallowing and not ●are allergic to lercanidipine or any of think you may be pregnant or are to divide into equal doses. Uncommon: Headache, dizziness, faster the other ingredients of this medicine planning to have a baby, ask your doctor heartbeats, awareness of the beating of (listed in section 6). for advice before taking this medicine. Pack sizes: the heart, flushing (transient episodic ●have had allergic reactions to Do not use if you are pregnant, or if you Blisters redness of the face and neck), ankle medicines that are closely related to wish to become pregnant or if you are a 28 tablets swelling. Lercanidipine hydrochloride tablets (such woman in childbearing age and do not as amlodipine, nicardipine, felodipine, use any contraceptive method. Marketing Authorisation Holder Rare: Sleepiness, weakness, tiredness, isradipine, nifedipine or lacidipine) Accord, Barnstaple, EX32 8NS, UK nausea, vomiting, diarrhoea, abdominal ●are suf fering from certain heart diseases: Do not use if you are breast-feeding. pain, indigestion, rash, muscle pain, • uncontrolled cardiac failure Manufacturers passage of large amounts of urine, • an obstruction to flow of blood from Driving and using machines Accord, Barnstaple, EX32 8NS, UK angina pectoris. the heart Lercanidipine has a negligible influence • unstable angina (angina at rest or on the ability to drive or use machines. LABORATORI FUNDACIÓ DAU, Very rare, not known: Decrease in blood progressively increasing) However, side ef fects such as dizziness, C/ C, 12-14 Pol. Ind. Zona pressure which may lead to fainting, • have had a heart attack less than one weakness, tiredness and rarely sleepiness Franca, Barcelona, 08040, allergic reaction, swelling of gums, month ago may occur. You should be careful until you Spain increase in liver enzyme blood test values, ●have severe liver or kidney problems know how you react to Lercanidipine. fall in blood pressure which can cause ●are taking drugs that are inhibitors of Accord Healthcare Limited dizziness, light-headedness or fainting, CYP3A4 isoenzyme: Lercanidipine contains lactose Sage house, 319 Pinner Road, Harrow, increase in the usual number of times one • antifungal medicines (such as monohydrate Middlesex, urinates, chest pain and heart attack. ketoconazole or Itraconazole) Lercanidipine contains lactose HA1 4HF, United Kingdom • macrolide antibiotics (such as monohydrate. If you have been told by Reporting of side ef fects erythromycin or troleandomycin) your doctor that you have an Accord Healthcare Polska Sp. z o.o., If you get any side eects, talk to your • antivirals (such as ritonavir) intolerance to some sugars, contact your Authorization holder address: doctor, pharmacist or nurse. This includes • at the same time as another drug doctor before taking this medicine. ul. Taśmowa 7 any possible side effects not listed in this called ciclosporin or cyclosporin Warszawa, Polska, leaflet. You can also report side ef fects • with grapefruit or grapefruit juice 02-677 Poland directly via the Yellow Card Scheme at: ●are pregnant, or if you wish to Manufacturing site address: 3 How to take Website: www.mhra.gov.uk/yellowcard or become pregnant or if you are a ul. Lutomierska 50, Pabianice, search for MHRA Yellow Card in the woman in child-bearing age and do 95-200, Poland Always take this medicine exactly as your Google Play or Apple App Store not use any contraceptive method doctor has told you. Check with your By reporting side effects you can help ●if you are breast-feeding This leaflet was last revised in doctor or pharmacist if you are not sure. provide more information on the safety December 2020. The recommended dose is one of this medicine. Warnings and precautions Lercanidipine hydrochloride 10 mg Talk to your doctor before taking film-coated tablet daily at the same time Lercanidipine hydrochloride tablets if you: each day, preferably in the morning at 5 How to store ●have a heart condition known as sick least 15 minutes before breakfast, sinus syndrome, and do not have a because a high fat meal significantly Keep this medicine out of the sight and pacemaker increases your blood levels of the reach of children. continued top of next column medicine. continued over page

Front Side

(6004365) Date: 10_09_20, 03_12_20, 17_12_20 Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Lercanidipine Market UK Language English Size 170 x 550 (PIL) Min. Font Size 10 Version No. 1 (Page 2 of 2) Keyline Date 05_09_20 (Lercanidipine (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

Your doctor may decide to increase Do not use this medicine after your dose to one Lercanidipine the expiry date, which is stated hydrochloride 20mg film-coated on the label, carton or bottle tablet daily, if needed. after EXP. The expiry date refers to the last day of that month.

The tablets should preferably be Storage conditions Read all of this leaflet carefully before ●suf fer from chest pain (angina swallowed whole with 1/2 glass of Al/PVC/PVDC blister: Do not store above you start using this medicine because it pectoris), Lercandipine may in very water. The score line is only there to help 30°C. rare cases cause increased frequency of contains important information for you. you break the tablet if you have Store in the original package to protect attacks that may last longer and • Keep this leaflet. You may need to dif ficulty swallowing it whole. from moisture. read it again. become more severe. Heart attacks have been reported in isolated cases. • If you have any further questions, ask Use in children and adolescents Do not throw away any medicines via ●have problems with your liver or your doctor or pharmacist. Lercanidipine is not recommended for wastewater or household waste. Ask kidney, or you are on dialysis • This medicine has been prescribed for use in children and adolescents below your pharmacist how to throw away 18 years. medicines you no longer use. These you only. Do not pass it on to others. It Other medicines and Lercanidipine measures will help protect the may harm them, even if their signs of Please tell your doctor or pharmacist if you If you take more Lercanidipine than environment. illness are the same as yours. are taking, have recently taken or might you should • If you get any side ef fects, talk to take any other medicines, including Immediately contact a doctor, the nearest your doctor or pharmacist. This medicines obtained without a prescription. hospital casualty department or the includes any possible side ef fects not 6 Contents of the pack and other centre for poison information for advice. Taking Lercanidipine with certain other information listed in this leaflet. See section 4. Exceeding the correct dosage may cause medicines (see below), may alter the ef fect blood pressure to become too low, and of these medicines or of Lercanidipine. What Lercanidipine hydrochloride the heart to beat irregularly or faster. It contains What is in this leaflet: may also lead to unconsciousness. It is especially important for your doctor The active substance is lercanidipine 1 What Lercanidipine to know if you are already being treated hydrochloride. One 10mg film-coated If you forget to take Lercanidipine hydrochloride tablets are and with any of the following medicines: tablet contains 10mg lercanidipine If you forget to take your tablet, take it what they are used for ●phenytoin or carbamazepine hydrochloride, equivalent to 9.4mg as soon as you remember, unless it is 2 What you need to know before (medicines for epilepsy) lercanidipine. almost time for your next dose. Then go ●rifampicin (a medicine to treat One 20mg film-coated tablet contains you take on as before. Do not take a double dose tuberculosis) 20mg lercanidipine hydrochloride, 3 How to take to make up for a forgotten dose. midazolam (a medicine that helps you equivalent to 18.8mg lercanidipine. 4 Possible side e ects ● sleep) If you stop taking Lercanidipine 5 How to store ●cimetidine, more than 800mg (a The other ingredients are: Tablet core: If you stop taking Lercanidipine your 6 Contents of the pack and other medicine for ulcers, indigestion, or Magnesium stearate, povidone, sodium blood pressure may increase again. information heartburn) starch glycolate (Type A), lactose Please consult your doctor before ●digoxin (a medicine to treat a heart monohydrate, microcrystalline cellulose. stopping the treatment. problem) Film-coating 10mg tablets: Macrogol, ●terfenadine or astemizole (medicines polyvinyl alcohol (partly hydrolysed), 1 What Lercanidipine If you have any further questions on the for allergies) talc, titanium dioxide hydrochloride tablets are and use of this medicine, ask your doctor or ●amiodarone or quinidine (medicines to (E 171), yellow iron oxide (E 172). what they are used for pharmacist. treat a fast heart beat) Film-coating 20mg tablets: Macrogol, ●metoprolol (a medicine to treat high polyvinyl alcohol (partly hydrolysed), Lercanidipine belongs to a group of blood pressure) talc, titanium dioxide (E 171), yellow iron medicines called calcium channel ●simvastatin (a medicine for high 4 Possible side ef fects oxide (E 172), red iron oxide (E 172). blockers that block the entry of calcium cholesterol value) into the muscle cells of the heart and the Like all medicines, this medicine can What Lercanidipine hydrochloride blood vessels that carry blood away from Lercanidipine with food, drink and cause side ef fects, although not tablets looks like and contents of the the heart (the arteries). It is the entry of alcohol everybody gets them. pack calcium into these cells that causes the You must not eat grapefruit or drink Lercanidipine hydrochloride 10mg heart to contract and arteries to narrow. grapefruit juice as this may increase the The frequencies of side ef fect have been tablets are yellow coloured, round By blocking the entry of calcium, calcium ef fect of Lercanidipine. listed below according to the following shaped, biconvex, coated tablets channel blockers decrease contraction of definitions: debossed with “LT1” on one side and the heart and dilate (widen) the arteries, If you use alcohol together with breakline on the other side. The diameter and the blood pressure is reduced. Very common: may af fect more than 1 in Lercanidipine you may 10 people of tablet is approximately 6.5 mm. experience dizziness/fainting, Common: may af fect up to 1 in 10 Lercanidipine has been prescribed to tiredness or weakness. This is people Lercanidipine hydrochloride 20mg you to treat your high blood pressure, because the medicine may Uncommon: may af fect up to 1 in 100 tablets are pink coloured, round shaped, also known as hypertension. lower your blood pressure people biconvex coated tablets debossed with Rare: may af fect up to 1 in 1,000 considerably together with alcohol. people “LT2” on one side and breakline on the Very rare: may af fect up to 1 in other side. The diameter of tablet is 2 What you need to know before Pregnancy and breast-feeding 10,000 people approximately 8.5 mm. you take Ask your doctor for advice before taking Not known: frequency cannot be any medicine. estimated from the The score line is only to facilitate available data Do not take Lercanidipine if you: If you are pregnant or breast-feeding, breaking for ease of swallowing and not ●are allergic to lercanidipine or any of think you may be pregnant or are to divide into equal doses. Uncommon: Headache, dizziness, faster the other ingredients of this medicine planning to have a baby, ask your doctor heartbeats, awareness of the beating of (listed in section 6). for advice before taking this medicine. Pack sizes: the heart, flushing (transient episodic ●have had allergic reactions to Do not use if you are pregnant, or if you Blisters redness of the face and neck), ankle medicines that are closely related to wish to become pregnant or if you are a 28 tablets swelling. Lercanidipine hydrochloride tablets (such woman in childbearing age and do not as amlodipine, nicardipine, felodipine, use any contraceptive method. Marketing Authorisation Holder Rare: Sleepiness, weakness, tiredness, isradipine, nifedipine or lacidipine) Accord, Barnstaple, EX32 8NS, UK nausea, vomiting, diarrhoea, abdominal ●are suf fering from certain heart diseases: Do not use if you are breast-feeding. pain, indigestion, rash, muscle pain, • uncontrolled cardiac failure Manufacturers passage of large amounts of urine, • an obstruction to flow of blood from Driving and using machines Accord, Barnstaple, EX32 8NS, UK angina pectoris. the heart Lercanidipine has a negligible influence • unstable angina (angina at rest or on the ability to drive or use machines. LABORATORI FUNDACIÓ DAU, Very rare, not known: Decrease in blood progressively increasing) However, side ef fects such as dizziness, C/ C, 12-14 Pol. Ind. Zona pressure which may lead to fainting, • have had a heart attack less than one weakness, tiredness and rarely sleepiness Franca, Barcelona, 08040, allergic reaction, swelling of gums, month ago may occur. You should be careful until you Spain increase in liver enzyme blood test values, ●have severe liver or kidney problems know how you react to Lercanidipine. fall in blood pressure which can cause ●are taking drugs that are inhibitors of Accord Healthcare Limited dizziness, light-headedness or fainting, CYP3A4 isoenzyme: Lercanidipine contains lactose Sage house, 319 Pinner Road, Harrow, increase in the usual number of times one • antifungal medicines (such as monohydrate Middlesex, urinates, chest pain and heart attack. ketoconazole or Itraconazole) Lercanidipine contains lactose HA1 4HF, United Kingdom • macrolide antibiotics (such as monohydrate. If you have been told by Reporting of side ef fects erythromycin or troleandomycin) your doctor that you have an Accord Healthcare Polska Sp. z o.o., If you get any side eects, talk to your • antivirals (such as ritonavir) intolerance to some sugars, contact your Authorization holder address: doctor, pharmacist or nurse. This includes • at the same time as another drug doctor before taking this medicine. ul. Taśmowa 7 any possible side effects not listed in this called ciclosporin or cyclosporin Warszawa, Polska, leaflet. You can also report side ef fects • with grapefruit or grapefruit juice 02-677 Poland directly via the Yellow Card Scheme at: ●are pregnant, or if you wish to Manufacturing site address: 3 How to take Website: www.mhra.gov.uk/yellowcard or become pregnant or if you are a ul. Lutomierska 50, Pabianice, search for MHRA Yellow Card in the woman in child-bearing age and do 95-200, Poland Always take this medicine exactly as your Google Play or Apple App Store not use any contraceptive method doctor has told you. Check with your By reporting side effects you can help ●if you are breast-feeding This leaflet was last revised in doctor or pharmacist if you are not sure. provide more information on the safety December 2020. The recommended dose is one of this medicine. Warnings and precautions Lercanidipine hydrochloride 10 mg Talk to your doctor before taking film-coated tablet daily at the same time Lercanidipine hydrochloride tablets if you: each day, preferably in the morning at 5 How to store ●have a heart condition known as sick least 15 minutes before breakfast, sinus syndrome, and do not have a because a high fat meal significantly Keep this medicine out of the sight and pacemaker increases your blood levels of the reach of children. INP113 medicine. continued top of next column 10 4745 0 6004365

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(6004365) Date: 10_09_20, 03_12_20, 17_12_20