ZANIDIP 10MG FILM-COATED TABLETS

Active substance: LERCANIDIPINE HYDROCHLORIDE

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MOCK UP
PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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).

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).

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.

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.

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.

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.

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.

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.

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.

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

4. POSSIBLE SIDE EFFECTS

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).

WHAT ZANIDIP LOOKS LIKE AND CONTENTS OF THE
PACK

Like all medicines, Zanidip can cause side effects, although not
everybody gets them.

Zanidip are film-coated, yellow, circular, biconvex tablets
engraved with a score line on one side and plain on the other.

Some side effects can be serious:

Zanidip is available in calendar blister packs of 28 tablets.

If you experience any of these side effects tell your doctor
straight away.

Manufactured by: Recordati Industria Chimica e

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.

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.

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

POM

Leaflet date: 27.02.2013
Zanidip is a registered trademark of Recordati group of
companies

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.

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

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.

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

PREGNANCY AND BREAST-FEEDING

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).

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

DRIVING AND USING MACHINES

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).

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 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.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Lercanidipine 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 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.

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.

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).

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.

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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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