LERCANIDIPINE HCL 10MG FILM-COATED TABLETS
Active substance: LERCANIDIPINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER Lercanidipine HCl 10 mg film-coated tablets Lercanidipine HCl 20 mg film-coated tablets lercanidipine hydrochloride Read all of this leaflet carefully before you start taking using this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Lercanidipine HCl is and what it is used for 2. Before you take Lercanidipine HCl 3. How to take Lercanidipine HCl 4. Possible side effects 5. How to store Lercanidipine HCl 6. Further information
1.
WHAT LERCANIDIPINE HCl IS AND WHAT IT IS USED FOR
Lercanidipine HCl belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Lercanidipine HCl is used to treat high blood pressure also known as hypertension in adults over the age of 18 years (it is not recommended for children under 18 years old).
2.
BEFORE YOU TAKE LERCANIDIPINE HCl
DO NOT TAKE LERCANIDIPINE HCl AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Lercanidipine HCl tablets You have had allergic reactions to drugs closely related to Lercanidipine HCl tablets ( such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) If you are suffering from certain heart diseases: o Untreated heart failure o Obstruction to flow of blood from the heart o Unstable angina (angina at rest or progressively increasing) o Within one month of heart attack You have severe liver or kidney problems You are taking drugs that are inhibitors of CYP3A4 isoenzyme: o Antifungal medicines (such as ketoconazole or itraconazole) o Macrolide antibiotics (such as erythromycin or troleandomycin) o Antivirals (such as ritonavir) You are taking another drug called ciclosporin or cyclosporin (used after transplants to prevent organ rejection) With grapefruit or grapefruit juice Do not use if you are pregnant or breastfeeding (see section Pregnancy and Breastfeeding for more information). TAKE SPECIAL CARE WITH LERCANIDIPINE HCl AND TELL YOUR DOCTOR IF: You have certain other heart conditions which have not been treated by insertion of a pacemaker or have
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pre-existing angina You have problems with your liver or kidneys or you are on dialysis USING OTHER MEDICINES Please tell your doctor or pharmacist if: You are taking or have recently taken any other medicines, including medicines obtained without a prescription You are taking beta-blockers e.g. metoprolol, diuretics (water tablets) or ACE-inhibitors (medicines to treat high blood pressure) You are taking cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn) You are taking digoxin (a medicine to treat a heart problem) You are taking midazolam (a medicine that helps you sleep) You are taking rifampicin (a medicine to treat tubercolosis) You are taking astemizole or terfenadine (medicines for allergies) You are taking amiodarone or quinidine (medicines to treat a fast heart beat) You are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual. Some medicines should not be taken at the same time as Lercanidipine HCl. See section 2 Do not take Lercanidipine HCl and tell your doctor if: for a list of these. TAKING LERCANIDIPINE HCl WITH FOOD AND DRINK Patients should not consume alcohol during treatment with Lercanidipine HCl tablets since it may increase the effect of Lercanidipine HCl tablets. Patients should not take grapefruit or grapefruit juice PREGNANCY AND BREAST FEEDING Do not use Lercanidipine HCl if you are pregnant or breast-feeding, or you wish to become pregnant or if you are not using any contraceptive method If you are taking Lercanidipine HCl and think that you may be pregnant, consult your doctor DRIVING AND USING MACHINES Caution should be exercised because of the possibility of dizziness, weakness and tiredness. Do not drive or use machines until you know how Lercanidipine HCl affects you. INFORMATION ABOUT SOME INGREDIENTS OF LERCANIDIPINE HCl: If you have been told by your doctor that you have an intolerance to some sugars, e.g. intolerance to lactose, galactosaemia or glucose/galactose malabsorption syndrome, contact your doctor before taking this medicinal product, as the tablets contain lactose
3.
HOW TO TAKE LERCANIDIPINE HCl
Always take Lercanidipine HCl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Adults: The usual dose is 10 mg film-coated tablet daily at the same time each day, preferably in the morning at least 15 minutes before breakfast, because a high fat meal significantly increases blood levels of the drug. Your doctor may advise you to increase the dose to one Lercanidipine HCl 20 mg film-coated tablet daily, if needed. The tablets should preferably be swallowed whole with some water. Elderly: No adjustment of the daily dose is required. However, special care should be exercised in starting treatment Patients with liver or kidney problems: special care is needed in starting treatment in these patients and an increase in daily dose to 20 mg should be approached with caution.
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Children: This medicine should not be used in children under 18 years of age. If you have any further questions on the use of this product ask your doctor. IF YOU TAKE MORE LERCANIDIPINE HCl THAN YOU SHOULD Do not exceed the prescribed dose If you take more than the prescribed dose or in the event of overdose, seek medical advice immediately and, if possible, take your tablets and/or the container with you. 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 FORGET TO TAKE LERCANIDIPINE HCl If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose. IF YOU STOP TAKING LERCANIDIPINE HCl If you stop taking Lercanidipine HCl 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 product, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS Like all medicines, Lercanidipine HCl can cause side effects, although not everybody gets them. Some side effects can be serious: If you experience any of these side effects tell your doctor straight away. Rare (affecting less than 1 out of 1000 patients): angina pectoris (chest pain due to lack of blood to your heart) Very rare (affecting less than 1 out of 10,000 patients): chest pain, fall in blood pressure, fainting and allergic reactions (symptoms include itching, rash, hives) If you suffer from pre-existing angina pectoris, with the group of medicines to which Lercanidipine HCl belongs, you may experience increased frequency, duration or severity of these attacks. Isolated cases of heart attack may be observed. Other possible side effects: Uncommon (affecting less than 1 out of 100 patients): headache, dizziness, faster heart beats, palpitations (heart pounding or racing), sudden reddening of the face, neck or upper chest,, ankle swelling. Rare (affecting less than 1 out of 1000 patients): sleepiness, feeling sick, vomiting, heartburn, stomach pain, diarrhoea; skin rash, muscle pain, passage of large amounts of urine, tiredness. Very rare (affecting less than 1 out of 10,000 patients): swelling of gums, changes in liver function (detected by blood tests), increase in the usual number of times one urinates.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
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5. HOW TO STORE LERCANIDIPINE HCl Keep out of the reach and sight of children Do not use Lercanidipine HCl after the expiry date, which is stated on the label, carton and on blister. The expiry date refers to the last day of that month. Store in the original package in order to protect from light and moisture. The original package should be kept in a dry place. Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
6.
FURTHER INFORMATION
WHAT LERCANIDIPINE HCl CONTAINS The active substance is: lercanidipine hydrochloride 10 mg which is equivalent to 9.4 mg of lercanidipine or lercanidipine hydrochloride 20 mg which is equivalent to 18.8 mg of lercanidipine. The other ingredients are: Core tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate Film coating : hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172). WHAT LERCANIDIPINE HCl LOOKS LIKE AND CONTENTS OF THE PACK Lercanidipine HCl 10 mg: yellow, circular, biconvex, film coated tablet scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Lercanidipine HCl 20 mg: pink , circular, biconvex, film coated tablet scored on one side Lercanidipine HCl is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - 20148 Milan, Italy This leaflet was last approved in 02/2012
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1.
WHAT LERCANIDIPINE HCl IS AND WHAT IT IS USED FOR
Lercanidipine HCl belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Lercanidipine HCl is used to treat high blood pressure also known as hypertension in adults over the age of 18 years (it is not recommended for children under 18 years old).
2.
BEFORE YOU TAKE LERCANIDIPINE HCl
DO NOT TAKE LERCANIDIPINE HCl AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Lercanidipine HCl tablets You have had allergic reactions to drugs closely related to Lercanidipine HCl tablets ( such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) If you are suffering from certain heart diseases: o Untreated heart failure o Obstruction to flow of blood from the heart o Unstable angina (angina at rest or progressively increasing) o Within one month of heart attack You have severe liver or kidney problems You are taking drugs that are inhibitors of CYP3A4 isoenzyme: o Antifungal medicines (such as ketoconazole or itraconazole) o Macrolide antibiotics (such as erythromycin or troleandomycin) o Antivirals (such as ritonavir) You are taking another drug called ciclosporin or cyclosporin (used after transplants to prevent organ rejection) With grapefruit or grapefruit juice Do not use if you are pregnant or breastfeeding (see section Pregnancy and Breastfeeding for more information). TAKE SPECIAL CARE WITH LERCANIDIPINE HCl AND TELL YOUR DOCTOR IF: You have certain other heart conditions which have not been treated by insertion of a pacemaker or have
1
pre-existing angina You have problems with your liver or kidneys or you are on dialysis USING OTHER MEDICINES Please tell your doctor or pharmacist if: You are taking or have recently taken any other medicines, including medicines obtained without a prescription You are taking beta-blockers e.g. metoprolol, diuretics (water tablets) or ACE-inhibitors (medicines to treat high blood pressure) You are taking cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn) You are taking digoxin (a medicine to treat a heart problem) You are taking midazolam (a medicine that helps you sleep) You are taking rifampicin (a medicine to treat tubercolosis) You are taking astemizole or terfenadine (medicines for allergies) You are taking amiodarone or quinidine (medicines to treat a fast heart beat) You are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual. Some medicines should not be taken at the same time as Lercanidipine HCl. See section 2 Do not take Lercanidipine HCl and tell your doctor if: for a list of these. TAKING LERCANIDIPINE HCl WITH FOOD AND DRINK Patients should not consume alcohol during treatment with Lercanidipine HCl tablets since it may increase the effect of Lercanidipine HCl tablets. Patients should not take grapefruit or grapefruit juice PREGNANCY AND BREAST FEEDING Do not use Lercanidipine HCl if you are pregnant or breast-feeding, or you wish to become pregnant or if you are not using any contraceptive method If you are taking Lercanidipine HCl and think that you may be pregnant, consult your doctor DRIVING AND USING MACHINES Caution should be exercised because of the possibility of dizziness, weakness and tiredness. Do not drive or use machines until you know how Lercanidipine HCl affects you. INFORMATION ABOUT SOME INGREDIENTS OF LERCANIDIPINE HCl: If you have been told by your doctor that you have an intolerance to some sugars, e.g. intolerance to lactose, galactosaemia or glucose/galactose malabsorption syndrome, contact your doctor before taking this medicinal product, as the tablets contain lactose
3.
HOW TO TAKE LERCANIDIPINE HCl
Always take Lercanidipine HCl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Adults: The usual dose is 10 mg film-coated tablet daily at the same time each day, preferably in the morning at least 15 minutes before breakfast, because a high fat meal significantly increases blood levels of the drug. Your doctor may advise you to increase the dose to one Lercanidipine HCl 20 mg film-coated tablet daily, if needed. The tablets should preferably be swallowed whole with some water. Elderly: No adjustment of the daily dose is required. However, special care should be exercised in starting treatment Patients with liver or kidney problems: special care is needed in starting treatment in these patients and an increase in daily dose to 20 mg should be approached with caution.
2
Children: This medicine should not be used in children under 18 years of age. If you have any further questions on the use of this product ask your doctor. IF YOU TAKE MORE LERCANIDIPINE HCl THAN YOU SHOULD Do not exceed the prescribed dose If you take more than the prescribed dose or in the event of overdose, seek medical advice immediately and, if possible, take your tablets and/or the container with you. 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 FORGET TO TAKE LERCANIDIPINE HCl If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose. IF YOU STOP TAKING LERCANIDIPINE HCl If you stop taking Lercanidipine HCl 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 product, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS Like all medicines, Lercanidipine HCl can cause side effects, although not everybody gets them. Some side effects can be serious: If you experience any of these side effects tell your doctor straight away. Rare (affecting less than 1 out of 1000 patients): angina pectoris (chest pain due to lack of blood to your heart) Very rare (affecting less than 1 out of 10,000 patients): chest pain, fall in blood pressure, fainting and allergic reactions (symptoms include itching, rash, hives) If you suffer from pre-existing angina pectoris, with the group of medicines to which Lercanidipine HCl belongs, you may experience increased frequency, duration or severity of these attacks. Isolated cases of heart attack may be observed. Other possible side effects: Uncommon (affecting less than 1 out of 100 patients): headache, dizziness, faster heart beats, palpitations (heart pounding or racing), sudden reddening of the face, neck or upper chest,, ankle swelling. Rare (affecting less than 1 out of 1000 patients): sleepiness, feeling sick, vomiting, heartburn, stomach pain, diarrhoea; skin rash, muscle pain, passage of large amounts of urine, tiredness. Very rare (affecting less than 1 out of 10,000 patients): swelling of gums, changes in liver function (detected by blood tests), increase in the usual number of times one urinates.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
3
5. HOW TO STORE LERCANIDIPINE HCl Keep out of the reach and sight of children Do not use Lercanidipine HCl after the expiry date, which is stated on the label, carton and on blister. The expiry date refers to the last day of that month. Store in the original package in order to protect from light and moisture. The original package should be kept in a dry place. Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
6.
FURTHER INFORMATION
WHAT LERCANIDIPINE HCl CONTAINS The active substance is: lercanidipine hydrochloride 10 mg which is equivalent to 9.4 mg of lercanidipine or lercanidipine hydrochloride 20 mg which is equivalent to 18.8 mg of lercanidipine. The other ingredients are: Core tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate Film coating : hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172). WHAT LERCANIDIPINE HCl LOOKS LIKE AND CONTENTS OF THE PACK Lercanidipine HCl 10 mg: yellow, circular, biconvex, film coated tablet scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Lercanidipine HCl 20 mg: pink , circular, biconvex, film coated tablet scored on one side Lercanidipine HCl is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - 20148 Milan, Italy This leaflet was last approved in 02/2012
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
