ZANIDIP 10MG FILM-COATED TABLETS
Active substance: LERCANIDIPINE HYDROCHLORIDE
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MOCK UP
PACKAGE LEAFLET: INFORMATION FOR THE USER 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.
Zanidip 10mg
Film-Coated Tablets
(lercanidipine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. The name of your medicine is Zanidip 10mg Film-Coated Tablets but will be referred to as Zanidip throughout this leaflet. Please note that this leaflet also contains information about the other strength: Zanidip 20mg Film-Coated Tablets.
In this leaflet:
1. What Zanidip is and what it is used for 2. Before you take Zanidip 3. How to take Zanidip 4. Possible side effects 5. How to store Zanidip 6. Further information
TAKING ZANIDIP WITH FOOD AND DRINK
Patients should not consume alcohol during treatment with Zanidip since it may increase the effect of Zanidip Patients should not take grapefruit or grapefruit juice.
PREGNANCY AND BREAST FEEDING
Do not use Zanidip 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 Zanidip and think that you may be pregnant, consult your doctor.
1. WHAT ZANIDIP IS AND WHAT IT IS USED FOR
Zanidip belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Zanidip 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).
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 Zanidip affects you.
2. BEFORE YOU TAKE ZANIDIP
DO NOT TAKE ZANIDIP AND TELL YOUR DOCTOR IF:
You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip You have had allergic reactions to drugs closely related to Zanidip (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).
INFORMATION ABOUT SOME INGREDIENTS OF ZANIDIP:
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 ZANIDIP
Always take Zanidip 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 Zanidip 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. 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.
TAKE SPECIAL CARE WITH ZANIDIP AND TELL YOUR DOCTOR IF:
You have certain other heart conditions or you have a pacemaker or have pre-existing angina You have problems with your liver or kidneys or you are on dialysis.
IF YOU TAKE MORE ZANIDIP 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.
5. HOW TO STORE ZANIDIP
Keep out of the sight and reach of children. Do not take tablets after the expiry date which is stated on the carton and blister label after Exp. The expiry date refers to the last day of that month. Store in the original package. If the tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist. 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.
IF YOU FORGET TO TAKE ZANIDIP
If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose.
6. FURTHER INFORMATION
IF YOU STOP TAKING ZANIDIP
If you stop taking Zanidip 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. A translation of the days of the week as they appear on the blister strip is as follows: Italian: LUN MAR MER GIO VEN SAB DOM English: MON TUE WED THU FRI SAT SUN
WHAT ZANIDIP CONTAINS
Each film-coated tablet contains 10mg lercanidipine hydrochloride as an active substance equivalent to 9.4mg lercanidipine. Tablet core contains: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, povidone K30, magnesium stearate. Tablet coating contains: hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zanidip can cause side effects, although not everybody gets them.
WHAT ZANIDIP LOOKS LIKE AND CONTENTS OF THE PACK
Zanidip are film-coated, yellow, circular, biconvex tablets engraved with a score line on one side and plain on the other. Zanidip is available in calendar blister packs of 28 tablets.
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 Zanidip belongs, you may experience increased frequency, duration or severity of these attacks. Isolated cases of heart attack may be observed.
Manufactured by: Recordati Industria Chimica e
Farmaceutica S.p.A. - Via Matteo Civitali, 1 - 20148 Milan, Italy Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Zanidip 10mg Film-Coated Tablets, PL No: 18799/2187 Leaflet date: 27.02.2013 Zanidip is a registered trademark of Recordati group of companies POM
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lercanidipine hydrochloride 10mg Film-Coated Tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. The name of your medicine is Lercanidipine hydrochloride10mg Film-Coated Tablets but it will be referred to as Lercanipidine throughout this leaflet. Please note that this leaflet also contains information about the other strength: Lercanidipine hydrochloride 20mg Film-Coated Tablets.
TAKE SPECIAL CARE WITH LERCANIDIPINE AND TELL YOUR DOCTOR IF:
You have certain other heart conditions or you have a pacemaker or have 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.
In this leaflet:
1. What Lercanidipine is and what it is used for 2. Before you take Lercanidipine 3. How to take Lercanidipine 4. Possible side effects 5. How to store Lercanidipine 6. Further information
TAKING LERCANIDIPINE WITH FOOD AND DRINK
Patients should not consume alcohol during treatment with Lercanidipine since it may increase the effect of Lercanidipine Patients should not take grapefruit or grapefruit juice.
1. WHAT LERCANIDIPINE IS AND WHAT IT IS USED FOR
Lercanidipine belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Lercanidipine 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).
PREGNANCY AND BREAST-FEEDING
Do not use Lercanidipine 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 and think that you may be pregnant, consult your doctor.
2. BEFORE YOU TAKE LERCANIDIPINE
DO NOT TAKE LERCANIDIPINE AND TELL YOUR DOCTOR IF:
You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Lercanidipine You have had allergic reactions to drugs closely related to Lercanidipine (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 breast-feeding (see section Pregnancy and Breast-feeding for more information).
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 affects you.
INFORMATION ABOUT SOME INGREDIENTS OF LERCANIDIPINE:
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
Always take Lercanidipine 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 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. 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 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.
5. HOW TO STORE LERCANIDIPINE
Keep out of the sight and reach of children. Do not take your tablets after the expiry date which is stated on the carton/blister label after Exp. The expiry date refers to the last day of that month. Store in the original package. If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist. 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.
IF YOU TAKE MORE LERCANIDIPINE 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.
6. FURTHER INFORMATION
WHAT LERCANIDIPINE CONTAINS
Each film-coated tablet contains 10mg lercanidipine hydrochloride as an active substance equivalent to 9.4mg lercanidipine. Tablet core contains: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, povidone K30, magnesium stearate. Tablet coating contains: hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
IF YOU FORGET TO TAKE LERCANIDIPINE
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
If you stop taking Lercanidipine 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. A translation of the days of the week as they appear on the blister strip is as follows: Italian: LUN MAR MER GIO VEN SAB DOM English: MON TUE WED THU FRI SAT SUN
WHAT LERCANIDIPINE LOOKS LIKE AND CONTENTS OF THE PACK
Lercanidipine are film-coated, yellow, circular, biconvex tablets engraved with a score line on one side and plain on the other. Lercanidipine is available in calendar blister packs of 28 tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lercanidipine can cause side effects, although not everybody gets them.
Manufactured by: Recordati Industria Chimica e
Farmaceutica S.p.A. - Via Matteo Civitali, 1 - 20148 Milan, Italy Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Lercanidipine hydrochloride 10mg Film-Coated Tablets PL No: 18799/2187 POM Leaflet date: 27.02.2013
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 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER 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.
Zanidip 10mg
Film-Coated Tablets
(lercanidipine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. The name of your medicine is Zanidip 10mg Film-Coated Tablets but will be referred to as Zanidip throughout this leaflet. Please note that this leaflet also contains information about the other strength: Zanidip 20mg Film-Coated Tablets.
In this leaflet:
1. What Zanidip is and what it is used for 2. Before you take Zanidip 3. How to take Zanidip 4. Possible side effects 5. How to store Zanidip 6. Further information
TAKING ZANIDIP WITH FOOD AND DRINK
Patients should not consume alcohol during treatment with Zanidip since it may increase the effect of Zanidip Patients should not take grapefruit or grapefruit juice.
PREGNANCY AND BREAST FEEDING
Do not use Zanidip 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 Zanidip and think that you may be pregnant, consult your doctor.
1. WHAT ZANIDIP IS AND WHAT IT IS USED FOR
Zanidip belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Zanidip 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).
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 Zanidip affects you.
2. BEFORE YOU TAKE ZANIDIP
DO NOT TAKE ZANIDIP AND TELL YOUR DOCTOR IF:
You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip You have had allergic reactions to drugs closely related to Zanidip (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).
INFORMATION ABOUT SOME INGREDIENTS OF ZANIDIP:
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 ZANIDIP
Always take Zanidip 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 Zanidip 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. 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.
TAKE SPECIAL CARE WITH ZANIDIP AND TELL YOUR DOCTOR IF:
You have certain other heart conditions or you have a pacemaker or have pre-existing angina You have problems with your liver or kidneys or you are on dialysis.
IF YOU TAKE MORE ZANIDIP 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.
5. HOW TO STORE ZANIDIP
Keep out of the sight and reach of children. Do not take tablets after the expiry date which is stated on the carton and blister label after Exp. The expiry date refers to the last day of that month. Store in the original package. If the tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist. 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.
IF YOU FORGET TO TAKE ZANIDIP
If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose.
6. FURTHER INFORMATION
IF YOU STOP TAKING ZANIDIP
If you stop taking Zanidip 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. A translation of the days of the week as they appear on the blister strip is as follows: Italian: LUN MAR MER GIO VEN SAB DOM English: MON TUE WED THU FRI SAT SUN
WHAT ZANIDIP CONTAINS
Each film-coated tablet contains 10mg lercanidipine hydrochloride as an active substance equivalent to 9.4mg lercanidipine. Tablet core contains: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, povidone K30, magnesium stearate. Tablet coating contains: hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zanidip can cause side effects, although not everybody gets them.
WHAT ZANIDIP LOOKS LIKE AND CONTENTS OF THE PACK
Zanidip are film-coated, yellow, circular, biconvex tablets engraved with a score line on one side and plain on the other. Zanidip is available in calendar blister packs of 28 tablets.
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 Zanidip belongs, you may experience increased frequency, duration or severity of these attacks. Isolated cases of heart attack may be observed.
Manufactured by: Recordati Industria Chimica e
Farmaceutica S.p.A. - Via Matteo Civitali, 1 - 20148 Milan, Italy Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Zanidip 10mg Film-Coated Tablets, PL No: 18799/2187 Leaflet date: 27.02.2013 Zanidip is a registered trademark of Recordati group of companies POM
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lercanidipine hydrochloride 10mg Film-Coated Tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. The name of your medicine is Lercanidipine hydrochloride10mg Film-Coated Tablets but it will be referred to as Lercanipidine throughout this leaflet. Please note that this leaflet also contains information about the other strength: Lercanidipine hydrochloride 20mg Film-Coated Tablets.
TAKE SPECIAL CARE WITH LERCANIDIPINE AND TELL YOUR DOCTOR IF:
You have certain other heart conditions or you have a pacemaker or have 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.
In this leaflet:
1. What Lercanidipine is and what it is used for 2. Before you take Lercanidipine 3. How to take Lercanidipine 4. Possible side effects 5. How to store Lercanidipine 6. Further information
TAKING LERCANIDIPINE WITH FOOD AND DRINK
Patients should not consume alcohol during treatment with Lercanidipine since it may increase the effect of Lercanidipine Patients should not take grapefruit or grapefruit juice.
1. WHAT LERCANIDIPINE IS AND WHAT IT IS USED FOR
Lercanidipine belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Lercanidipine 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).
PREGNANCY AND BREAST-FEEDING
Do not use Lercanidipine 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 and think that you may be pregnant, consult your doctor.
2. BEFORE YOU TAKE LERCANIDIPINE
DO NOT TAKE LERCANIDIPINE AND TELL YOUR DOCTOR IF:
You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Lercanidipine You have had allergic reactions to drugs closely related to Lercanidipine (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 breast-feeding (see section Pregnancy and Breast-feeding for more information).
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 affects you.
INFORMATION ABOUT SOME INGREDIENTS OF LERCANIDIPINE:
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
Always take Lercanidipine 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 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. 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 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.
5. HOW TO STORE LERCANIDIPINE
Keep out of the sight and reach of children. Do not take your tablets after the expiry date which is stated on the carton/blister label after Exp. The expiry date refers to the last day of that month. Store in the original package. If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist. 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.
IF YOU TAKE MORE LERCANIDIPINE 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.
6. FURTHER INFORMATION
WHAT LERCANIDIPINE CONTAINS
Each film-coated tablet contains 10mg lercanidipine hydrochloride as an active substance equivalent to 9.4mg lercanidipine. Tablet core contains: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, povidone K30, magnesium stearate. Tablet coating contains: hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
IF YOU FORGET TO TAKE LERCANIDIPINE
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
If you stop taking Lercanidipine 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. A translation of the days of the week as they appear on the blister strip is as follows: Italian: LUN MAR MER GIO VEN SAB DOM English: MON TUE WED THU FRI SAT SUN
WHAT LERCANIDIPINE LOOKS LIKE AND CONTENTS OF THE PACK
Lercanidipine are film-coated, yellow, circular, biconvex tablets engraved with a score line on one side and plain on the other. Lercanidipine is available in calendar blister packs of 28 tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lercanidipine can cause side effects, although not everybody gets them.
Manufactured by: Recordati Industria Chimica e
Farmaceutica S.p.A. - Via Matteo Civitali, 1 - 20148 Milan, Italy Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Lercanidipine hydrochloride 10mg Film-Coated Tablets PL No: 18799/2187 POM Leaflet date: 27.02.2013
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 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.
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.
