ZANIDIP 10 MG FILM-COATED TABLETS

Active substance: LERCANIDIPINE HYDROCHLORIDE

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1ª BOZZA (26/03/2013)
GUEST (cliente)

LEAFLET (f.ill.)

RECORDATI Pharmaceuticals
SIZES (dimensioni)

150 x 279,40

26/03/2013
BLACK

UK
PROOF-READING (revisione)

A

41912213

PHARMACODE (Laetus) INVERSE PHARMACODE WORK N. (n. lavoro)
(Laetus inverso)

GENERETED LEAFLET DATE (data creazione f.ill.)

3 COLOURS
(3 colori)

CODE (codice)

336

Warm Red

APPROVED TEXT

FRONT (fronte)

1031

LINEA GAMMA 3

NAME:

APPROVED WITH CORRECTIONS

P 300

393

DATE:

PELLICOLA DI PROPRIETÀ RECORDATI S.p.A.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Zanidip 10 mg film-coated tablets
Zanidip 20 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:

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 tablets
• 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:
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).

VIETATA LA MANOMISSIONE

RENDERE DOPO LA STAMPA

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 tablets since it may increase the effect of Zanidip
tablets
• 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. 41912213 A

1031

ZANIDIP
10 mg e 20 mg tablets

COUNTRY (nazione)

1ª BOZZA (26/03/2013)
GUEST (cliente)

LEAFLET (f.ill.)

RECORDATI Pharmaceuticals
SIZES (dimensioni)

150 x 279,40

UK
PROOF-READING (revisione)

A

41912213

PHARMACODE (Laetus) INVERSE PHARMACODE WORK N. (n. lavoro)
(Laetus inverso)

GENERETED LEAFLET DATE (data creazione f.ill.)

26/03/2013
3 COLOURS
(3 colori)

CODE (codice)

336

BLACK

Warm Red

APPROVED TEXT

BACK (retro)

1031

LINEA GAMMA 3

NAME:

APPROVED WITH CORRECTIONS

P 300

393

DATE:

PELLICOLA DI PROPRIETÀ RECORDATI S.p.A.

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.

VIETATA LA MANOMISSIONE

RENDERE DOPO LA STAMPA

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 ZANIDIP
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.

Keep out of the reach and sight of children
Do not use Zanidip 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
IF YOU FORGET TO TAKE ZANIDIP
WHAT ZANIDIP CONTAINS
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 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.

The active substance is: lercanidipine hydrochloride 10 mg
which is equivalent to 9.4 mg of lercanidipine or lercanidipine
hydrochloride 20 mg which is equivalent to 18.8 mg of
lercanidipine.
The other ingredients are:
Core tablet: lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate, povidone K30, magnesium stearate
Film coating: hypromellose, talc, titanium dioxide (E171),
macrogol 6000, and ferric oxide (E172).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zanidip 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 Zanidip belongs, you may experience
increased frequency, duration or severity of these attacks.
Isolated cases of heart attack may be observed.

WHAT ZANIDIP LOOKS LIKE AND CONTENTS OF
THE PACK
Zanidip 10 mg: yellow, circular, biconvex, film coated tablet
scored on one side. The score line is only to facilitate breaking
for ease of swallowing and not to divide into equal doses.
Zanidip 20 mg: pink, circular, biconvex, film coated tablet
scored on one side
Zanidip is available in blister packs of 7, 14, 28, 35, 42, 50, 56,
98, 100 tablets. Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo
Civitali 1 - 20148 Milan, Italy.
This leaflet was last revised in October 2008

41912213 A

1031

ZANIDIP
10 mg e 20 mg tablets

COUNTRY (nazione)

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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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