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ZANIDIP NOVUM 8MG FILM-COATED TABLETS

Active substance(s): LERCANIDIPINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zanidip Novum 8 mg film-coated tablets
Zanidip Novum 16 mg 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
In this leaflet:

• 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.

1. What Zanidip Novum is and what it is used for
2. Before you take Zanidip Novum
3. How to take Zanidip Novum
4. Possible side effects
5. How to store Zanidip Novum
6. Further information

TAKING ZANIDIP NOVUM WITH FOOD AND DRINK

1. WHAT ZANIDIP NOVUM IS AND WHAT IT IS
USED FOR

PREGNANCY AND BREAST FEEDING

Zanidip Novum belongs to a group of medicines called Calcium
Channel Blockers (dihydropyridine derivatives). Zanidip Novum is
used to treat high blood pressure also known as hypertension .

2. BEFORE YOU TAKE ZANIDIP NOVUM

• Patients should not consume alcohol during treatment with
Zanidip Novum tablets since it may increase the effect of
Zanidip Novum tablets.
• Patients should not take grapefruit or grapefruit juice.

Do not use Zanidip Novum 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 Novum and think that you may be
pregnant, consult your doctor.

DO NOT TAKE ZANIDIP NOVUM AND TELL YOUR
DOCTOR IF:

DRIVING AND USING MACHINES

• You are allergic (hypersensitive) to lercanidipine hydrochloride
or to any other ingredients of Zanidip Novum tablets
• You have had allergic reactions to drugs closely related to
Zanidip Novum tablets (such as amlodipine, nicardipine,
felodipine, isradipine, nifedipine or lacidipine)
• 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

Caution should be exercised because of the possibility of
dizziness, weakness and tiredness. Do not drive or use machines
until you know how Zanidip Novum affects you.

Do not use if you are pregnant or breastfeeding (see section
Pregnancy and Breastfeeding for more information).

TAKE SPECIAL CARE WITH ZANIDIP NOVUM 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

INFORMATION ABOUT SOME INGREDIENTS OF
ZANIDIP NOVUM
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 NOVUM
Zanidip Novum 8 mg film-coated tablets are equivalent to
Zanidip 10 mg film-coated tablets.
Zanidip Novum 16 mg film-coated tablets are equivalent to
Zanidip 20 mg film-coated tablets.
Always take Zanidip Novum 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 one tablet of Zanidip Novum 8mg
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 tablet
of Zanidip Novum 16 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. XXXXXXXX A

Patients with liver or kidney problems: Special care is needed
in starting treatment in these patients and an increase in daily
dose to 16 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 NOVUM 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 NOVUM
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 tablet.

5. HOW TO STORE ZANIDIP NOVUM
Keep out of the reach and sight of children
Do not use Zanidip Novum after the expiry date, which is stated
on the label, carton and on blister. The expiry date refers to the
last day of that month.
Store in the original package in order to protect from light and
moisture. The original package should be kept in a dry place.
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 ZANIDIP NOVUM CONTAINS
- Each tablet of Zanidip Novum 8 mg contains as active
ingredient 7.55 mg of lercanidipine (present as lercanidipine
hydrochloride 8 mg) and is equivalent (i.e. gives the same
concentrations of active substance in blood) to a tablet of
Zanidip 10 mg.
- Each tablet of Zanidip Novum 16 mg contains as active
ingredient 15.10 mg of lercanidipine (present as lercanidipine
hydrochloride 16 mg) and is equivalent (i.e. gives the same
concentrations of active substance in blood) to a tablet of
Zanidip 20 mg.

IF YOU STOP TAKING ZANIDIP NOVUM
If you stop taking Zanidip Novum 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zanidip Novum 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 (affects 1 to 10 users in 10,000): angina pectoris (chest
pain due to lack of blood to your heart).
Very rare (affects less than 1 user in 10,000): 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 Novum 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 (affects 1 to 10 users in 1,000): headache, dizziness,
faster heart beats, palpitations (heart pounding or racing), sudden
reddening of the face, neck or upper chest, ankle swelling.
Rare (affects 1 to 10 users in 10,000): sleepiness, feeling sick,
vomiting, heartburn, stomach pain, diarrhoea, skin rash, muscle
pain, passage of large amounts of urine, tiredness.
Very rare (affects less than 1 user in 10,000): 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

The other ingredients are:
Core tablet: Lactose monohydrate, Microcrystalline cellulose,
Povidone, Sodium starch glycolate, Silica colloidal anhydrous,
Poloxamer 407, Magnesium stearate.
Film coating: Hypromellose, Talc, Titanium Dioxide (E171),
Macrogol 6000, Iron oxide (E172)

WHAT ZANIDIP NOVUM LOOKS LIKE AND
CONTENTS OF THE PACK
Zanidip Novum 8 mg: yellow, circular, biconvex, film-coated tablet.
Zanidip Novum 16 mg: pink, circular, biconvex, film-coated tablet.
Zanidip Novum is available in blister packs of 7, 14, 28, 35, 50,
56, 98, 100 tablets. Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo
Civitali 1 - 20148 Milan, Italy
Manufacturer
Pharmathen SA, 6 Dervenakion str., 153 51 Pallni Attiki, Greece
Or
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo
Civitali 1 - 20148 Milan, Italy
This medicinal product is authorised in the following Member
States of the EEA:
Austria
Belgium
Germany
Denmark
Greece
Spain
Finland
Italy
Luxemburg
Netherlands
Portugal
Sweden
United Kingdom
Date of last revision of the text: 02/2010
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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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