ZANIDIP 20MG TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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ZANIDIP® 20MG TABLETS
(lercanidipine hydrochloride)

Zanidip Tablets are available in the following strengths:
10mg and 20mg.

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Your medicine is available as Zanidip 20mg tablets but will be
referred to as Zanidip throughout the leaflet. Zanidip 10mg
will also be referred to in this leaflet.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
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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
Contents 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:
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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 to Zanidip (such as amlodipine, nicardipine,
felodipine, isradipine, nifedipine or lacidipine).

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If you are suffering from certain heart diseases:
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untreated heart failure
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obstruction to flow of blood from the heart
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unstable angina (angina at rest or progressively
increasing)
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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:
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antifungal medicines (such as ketoconazole or
itraconazole)
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macrolide antibiotics (such as erythromycin or
troleandomycin)
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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.

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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
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Please do not consume alcohol during treatment with
Zanidip since it may increase the effect of Zanidip.
Please do not take Zanidip with grapefruit or grapefruit
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.

Do not use if you are pregnant or breastfeeding (see section
Pregnancy, breast-feeding and fertility for more information).

Ask your doctor or pharmacist for advice before taking this
medicine.

Warning and precautions

Driving and using machines

Talk to your doctor or pharmacist before taking Zanidip:
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if you have certain other heart conditions which have
not been treated by insertion of a pacemaker or have
pre-existing angina.
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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 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:
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You are taking or have recently taken any other
medicines, including medicines obtained without a
prescription
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You are taking beta-blockers e.g. metoprolol, diuretics
(water tablets) or ACE-inhibitors (medicines to treat
high blood pressure)
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You are taking cimetidine (more than 800mg, a
medicine for ulcers, indigestion, or heartburn)
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You are taking digoxin (a medicine to treat a heart
problem)
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You are taking midazolam (a medicine that helps you
sleep)
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You are taking rifampicin (a medicine to treat
tuberculosis)

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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 monohydrate

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 monohydrate.

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.

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.

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.

Do not take a double dose to make up for a forgotten dose.

By reporting side effects you can help provide more
information on the safety of this medicine.

If you stop taking Zanidip

5. How to store 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.

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

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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)

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Store in the original package.
Keep out of the sight and reach of children.
Do not use the tablets after the expiry date, which is
shown on the carton and blister labels. The expiry date
refers to the last day of that month.
If your doctor tells you to stop using the medicine,
please take it back to the pharmacist for safe disposal.
Only keep the medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or
household waste. These measures will help to protect
the environment.
If the medicine become discoloured or shows any other
signs of deterioration, you should seek the advice of
pharmacist who will tell you what to do.

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.

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6. Contents of the pack and other
information
What Zanidip contains

Each film-coated tablet contains 20mg of the active ingredient
lercanidipine hydrochloride.
The following inactive ingredients are also included in
Zanidip: Lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate, povidone K30, magnesium stearate,
hypromellose, talc, titanium dioxide (E171), macrogol 6000,
and iron oxide (E172).

What Zanidip looks like and contents of the pack

Zanidip tablets are pink, circular, biconvex, film-coated
tablets which are plain on both sides. They are available in
blister packs of 30 tablets.

Manufacturer

Laboratoires BOUCHARA-RECORDATI,
92300 LEVALLOIS-PERRET, France
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster,
DN3 1QR.
PL No: 08929/0449

POM

Date of review of this leaflet: 16.06.16
Zanidip® is a registered trademark of Recordati Ireland
Limited.