ZANIDIP 10MG FILM-COATED TABLETS

Active substance: LERCANIDIPINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning and precautions

Zanidip® 10mg

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 preexisting angina.
If you have problems with your liver or kidneys or you are on
dialysis.

film-coated tablets

(lercanidipine hydrochloride)
The name of your medicine is Zanidip 10mg film-coated tablets
but will be referred to as Zanidip throughout the remainder of
this leaflet. Please note that this leaflet also contain information
about other strength Zanidip 20mg Film-coated Tablets.

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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

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
Content of the pack and other information

1. WHAT ZANIDIP IS AND WHAT IT IS USED
FOR
Zanidip, lercanidipine hydrochloride, 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).

2. 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 tablets.
If You have had allergic reactions to drugs closely related to
Zanidip tablets (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
cyclosporine (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, Breast-feeding and fertility for more information).

You must tell your doctor if you think you are (or might become)
pregnant or breast-feeding (see pregnancy, breast-feeding and
fertility section).

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 tablets since it may increase the effect of Zanidip
tablets.
• Please do not take Zanidip tablets with grapefruit or grapefruit
juice.

PREGNANCY, BREAST-FEEDING AND FERTILITY
Zanidip should not be used if you are pregnant or breastfeeding, think you may be pregnant or 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 and 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 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 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 10mg 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 20mg 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 20mg should be approached with caution.
If you have any further questions on the use of this medicine
ask your doctor or pharmacist.

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the 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.

5. HOW TO STORE ZANIDIP

IF YOU TAKE MORE ZANIDIP THAN YOU SHOULD

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH
OF CHILDREN

Do not exceed the prescribed dose

Store in original pack.

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.

Do not use tablets after the expiry date, which is marked on
both the outer carton and on each blister strip of tablets.

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.

4. POSSIBLE SIDE EFFECTS

Remember: this medicine has been prescribed for you.
Do not give it to anyone else under any circumstances.

6. CONTENT OF TH EPACK AND OTHER
INFORMATION
WHAT ZANIDIP CONTAINS
Each film-coated tablets contains 10mg lercanidipine
hydrochloride.
Zanidip 10mg tablets also contain lactose, microcrystalline
cellulose, sodium starch glycolate, povidone K30, magnesium
stearate, hypromellose, talc, titanium dioxide (E171), macrogol
6000, ferric oxide (E172).

WHAT ZANIDIP LOOKS LIKE AND CONTENTS OF THE
PACK
Zanidip tablets are film-coated, yellow, circular tablets with a
score line on one side and plain on the other.
Zanidip is available in blister packs of 50 or 100 tablets.

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

Manufactured by: Recordati Industria Chimica e

Some side effects can be serious:
If you experience any of these side effects tell your doctor
straight away.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK

Rare (affecting less than 1 out of 1000 patients): angina
pectoris (chest pain due to lack of blood to your heart).

Zanidip 10mg Tablets - PL No: 18799/1795

Farmaceutica S.p.A. - Via Matteo, Civitali, 1 - 20148 Milan, Italy

Zanidip is a registered trademark of Recordati
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.

Leaflet date: 05.11.2014

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lercanidipine hydrochloride® 10mg
film-coated tablets
The name of your medicine is Lercanidipine hydrochloride
10mg Tablets but will be referred to as Lercanipidine
hydrochloride throughout the remainder of this leaflet. Please
note that this leaflet also contain information about other
strength Lercanipidine hydrochloride 20mg Film-coated Tablets.

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.

What is in this leaflet:
1. What Lercanidipine hydrochloride is and what it is
used for
2. What you need to know Before you take
Lercanidipine hydrochloride
3. How to take Lercanidipine hydrochloride
4. Possible side effects
5. How to store Lercanidipine hydrochloride
6. Content of the pack and other information

1. 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).

2. 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 tablets.
If You have had allergic reactions to drugs closely related to
Lercanidipine hydrochloride tablets (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
cyclosporine (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, 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 preexisting angina.
If you have problems with your liver or kidneys or you are on
dialysis.
You must tell your doctor if you think you are (or might become)
pregnant or breast-feeding (see pregnancy, breast-feeding and
fertility section).

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 tablets since it may increase the
effect of Lercanidipine hydrochloride tablets.
• Please do not take Lercanidipine hydrochloride tablets 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 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 and 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 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
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 10mg 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 20mg
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 20mg should be approached with caution.
If you have any further questions on the use of this medicine
ask your doctor or pharmacist.

IF YOU TAKE MORE LERCANIDIPINE HYDROCHLORIDE
THAN YOU SHOULD
Do not exceed the prescribed dose

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the 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.

5. HOW TO STORE LERCANIDIPINE
HYDROCHLORIDE
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH
OF CHILDREN
Store in original pack.
Do not use tablets after the expiry date, which is marked on
both the outer carton and on each blister strip of tablets.

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.

Remember: this medicine has been prescribed for you.
Do not give it to anyone else under any circumstances.

IF YOU FORGET TO TAKE LERCANIDIPINE
HYDROCHLORIDE

Each film-coated tablets contains 10mg 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.

Lercanidipine hydrochloride 10mg tablets also contain lactose,
microcrystalline cellulose, sodium starch glycolate, povidone
K30, magnesium stearate, hypromellose, talc, titanium dioxide
(E171), macrogol 6000, ferric oxide (E172).

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

6. CONTENT OF THE PACK AND OTHER
INFORMATION
WHAT LERCANIDIPINE HYDROCHLORIDE CONTAINS

WHAT LERCANIDIPINE HYDROCHLORIDE LOOKS LIKE
AND CONTENTS OF THE PACK
Lercanidipine hydrochloride tablets are film-coated, yellow,
circular tablets with a score line on one side and plain on the
other.
Lercanidipine hydrochloride tablets are available in blister packs
of 50 or 100 tablets.

Manufactured by: Recordati Industria Chimica e
Farmaceutica S.p.A. - Via Matteo, Civitali, 1 - 20148 Milan, Italy

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 hydrochloride belongs, you
may experience increased frequency, duration or severity of
these attacks. Isolated cases of heart attack may be observed.

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 Tablets
- PL No: 18799/1795
Leaflet date: 05.11.2014

POM

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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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