Zanidip 10mg Film-Coated Tablets
Ref: 1625/301215/1/F
Zanidip®10mg film-coated Tablets
(lercanidipine hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Your medicine is called Zanidip 10mg film-coated Tablets but will be referred to as Zanidip throughout the rest of this leaflet. Please note that the leaflet also contains information about the other strength of medicine Zanidip 20mg film-coated Tablets.
What is in this leaflet:
^ What Zanidip is and what it is used for ^ What you need to know before you take Zanidip How to take Zanidip ^ Possible side effects How to store Zanidip
Contents of the pack and other information
^ What Zanidip is and what it is used for
Zanidip belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives) that lower blood pressure.
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).
What you need to know before you take Zanidip
Do not take Zanidip:
* If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip.
* If you have had allergic reactions to drugs closely related Zanidip (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
* If you are suffering from certain heart diseases:
- untreated heart failure
- obstruction to flow of blood from the heart
- unstable angina (angina at rest or progressively increasing)
- within one month of heart attack
* If you have severe liver or kidney problems.
* If you are taking drugs that are inhibitors of CYP3A4 isoenzyme:
- antifungal medicines (such as ketoconazole or itraconazole)
- macrolide antibiotics (such as erythromycin or troleandomycin)
- antivirals (such as ritonavir)
* If 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, breast-feeding and fertility for more information).
Warning and precautions
Talk to your doctor or pharmacist before taking Zanidip.
* if you have certain other heart conditions which have not been treated by insertion of a pacemaker or have pre-existing angina.
* if you have problems with your liver or kidneys or you are on dialysis.
Children and adolescents
The safety and efficacy of Zanidip in children aged up to 18 years have not been established.
No data are available.
Other medicines and Zanidip
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 with food, drink and alcohol
* Please do not consume alcohol during treatment with Zanidip since it may increase the effect of Zanidip.
* Please do not take Zanidip with grapefruit orgrapefruit juice.
Pregnancy, breast-feeding and fertility
Zanidip should not be used if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby or you are not using any contraceptive method.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Caution should be exercised because of the possibility of dizziness, weakness, tiredness and rarely sleepiness. Do not drive or use machines until you know how Zanidip affects you.
Zanidip contains lactose
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
How to take Zanidip
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: The recommended dose is 10 mg once 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 daily, if needed. The tablets should preferably be swallowed whole with some water.
Use in children: This medicine should not be used in children under 18 years of age.
Elderly patients: 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.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
(lercanidipine hydrochloride)
Patient Information Leaflet (continued)
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.
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 to make up for a forgotten dose.
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 medicine, ask your doctor or pharmacist.
3 Possible side effects
Like all medicines, this medicine 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 1,000 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.
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 1,000 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.
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Zanidip
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original package in order to protect from light.
Do not take this medicine after the expiry date shown on the packaging.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
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
Contents of the pack and other information
What Zanidip contains:
Each film-coated tablet contains 10mg of lercanidipine hydrochloride (equivalent to 9.4mg of lercanidipine).
Other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hypromellose, talc, titanium dioxide (E171), macrogol 6000 and iron oxide (E172).
What Zanidip looks like and contents of the pack
Zanidip are yellow, circular, biconvex tablets, scored on one side and plain on the other side.
Each pack contains 28 film-coated tablets.
Manufacturer and Licence Holder
Manufactured by Kwizda Pharma GmbH, 1160 Wien, Austria and is procured from within the Eu and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
|PQM| PL 15184/1625 Zanidip 10mg film-coated Tablets
Zanidip is a registered trademark of Recordati Ireland Limited.
Revision date: 30/12/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Your medicine is called Lercanidipine Hydrochloride 10mg film-coated Tablets but will be referred to as Lercanidipine Hydrochloride throughout the rest of this leaflet. Please note that the leaflet also contains information about the other strength of medicine Lercanidipine Hydrochloride 20mg film-coated Tablets.
What is in this leaflet:
What Lercanidipine Hydrochloride is and what it is used for [a What you need to know before you take Lercanidipine Hydrochloride How to take Lercanidipine Hydrochloride [4 Possible side effects
How to store Lercanidipine Hydrochloride Contents of the pack and other information
^ What Lercanidipine Hydrochloride is and what it is used for
Lercanidipine Hydrochloride belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives) that lower blood pressure. Lercanidipine Hydrochloride 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).
What you need to know before you take Lercanidipine Hydrochloride
Do not take Lercanidipine Hydrochloride:
* If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Lercanidipine Hydrochloride.
* If you have had allergic reactions to drugs closely related to Lercanidipine Hydrochloride (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
* If you are suffering from certain heart diseases:
- untreated heart failure
- obstruction to flow of blood from the heart
- unstable angina (angina at rest or progressively increasing)
- within one month of heart attack
* If you have severe liver or kidney problems.
* If you are taking drugs that are inhibitors of CYP3A4 isoenzyme:
- antifungal medicines (such as ketoconazole or itraconazole)
- macrolide antibiotics (such as erythromycin or troleandomycin)
- antivirals (such as ritonavir)
* If 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, breast-feeding and fertility for more information).
Warning and precautions
Talk to your doctor or pharmacist before taking Lercanidipine Hydrochloride.
* if you have certain other heart conditions which have not been treated by insertion of a pacemaker or have pre-existing angina.
* if you have problems with your liver or kidneys or you are on dialysis.
Children and adolescents
The safety and efficacy of Lercanidipine Hydrochloride in children aged up to 18 years have not been established.
No data are available.
Other medicines and Lercanidipine Hydrochloride
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.
Lercanidipine Hydrochloride with food, drink and alcohol
* Please do not consume alcohol during treatment with Lercanidipine Hydrochloride since it may increase the effect of Lercanidipine Hydrochloride.
* Please do not take Lercanidipine Hydrochloride with grapefruit or grapefruit juice.
Pregnancy, breast-feeding and fertility
Lercanidipine Hydrochloride should not be used if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby or you are not using any contraceptive method.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Caution should be exercised because of the possibility of dizziness, weakness, tiredness and rarely sleepiness. Do not drive or use machines until you know how Lercanidipine Hydrochloride affects you.
Lercanidipine Hydrochloride contains lactose
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
How to take Lercanidipine Hydrochloride
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: The recommended dose is 10 mg once 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 Hydrochloride 20 mg daily, if needed. The tablets should preferably be swallowed whole with some water.
Use in children: This medicine should not be used in children under 18 years of age.
Elderly patients: 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.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Patient Information Leaflet (continued)
If you take more Lercanidipine Hydrochloride 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 Hydrochloride
If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lercanidipine Hydrochloride
If you stop taking Lercanidipine Hydrochloride 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.
3 Possible side effects
Like all medicines, this medicine 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 1,000 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 Hydrochloride 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 1,000 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.
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Lercanidipine Hydrochloride
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original package in order to protect from light.
Do not take this medicine after the expiry date shown on the packaging.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
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
Contents of the pack and other information
What Lercanidipine Hydrochloride contains:
Each film-coated tablet contains 10mg of lercanidipine hydrochloride (equivalent to 9.4mg of lercanidipine).
Other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hypromellose, talc, titanium dioxide (E171), macrogol 6000 and iron oxide (E172).
What Lercanidipine Hydrochloride looks like and contents of the pack
Lercanidipine Hydrochloride are yellow, circular, biconvex tablets, scored on one side and plain on the other side.
Each pack contains 28 film-coated tablets.
Manufacturer and Licence Holder
Manufactured by Kwizda Pharma GmbH, 1160 Wien, Austria and is procured from within the Eu and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
|POM| PL 15184/1625 Lercanidipine Hydrochloride
10mg film-coated Tablets
Revision date: 30/12/15