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ZANIDIP 10 MG FILM-COATED TABLETS

Active substance: LERCANIDIPINE HYDROCHLORIDE

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MOCK-UP
GUEST (cliente)

ZANIDIP
10 mg and 20 mg tablets

LEAFLET (f.ill.)

RECORDATI Pharmaceuticals
SIZES (dimensioni)

150 x 304,80

CODE (codice)

UK
PROOF-READING (revisione)

X

XXXXXXXX

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

ISSUE DATE (data creazione f.ill.)

13/11/2013
3 COLOURS
(3 colori)

COUNTRY (nazione)

336

BLACK

Warm Red

APPROVED TEXT

1031

LINEA GAMMA 3

FRONT (fronte)

NAME:

APPROVED WITH CORRECTIONS

P 300

393

1031

1a BOZZA (13/11/2013)

DATE:

PELLICOLA DI PROPRIETÀ RECORDATI S.p.A.

VIETATA LA MANOMISSIONE

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 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.

1. What Zanidip is and what it is used for
2. What you need to know before you take
Zanidip
3. How to take Zanidip
4. Possible side effects
5. How to store Zanidip
6. 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:
• 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:
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
• If you have severe liver or kidney problems.
• If 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)
• If 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, breast-feeding and fertility for more
information).

Warning and precautions
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 pre-existing
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 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 breast-feeding,
think you may be pregnant 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, 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 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 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 10 mg 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
XXXXXXXX

XXXX X

SENSO SVOLGIMENTO BOBINA

What is in this leaflet:

RENDERE DOPO LA STAMPA

MOCK-UP
GUEST (cliente)

ZANIDIP
10 mg and 20 mg tablets

LEAFLET (f.ill.)

RECORDATI Pharmaceuticals
SIZES (dimensioni)

150 x 304,80

13/11/2013
BLACK

CODE (codice)

UK
PROOF-READING (revisione)

X

XXXXXXXX

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

ISSUE DATE (data creazione f.ill.)

3 COLOURS
(3 colori)

COUNTRY (nazione)

336

Warm Red

APPROVED TEXT

LINEA GAMMA 3

BACK (retro)

P 300

1031

NAME:

APPROVED WITH CORRECTIONS

393

1031

1a BOZZA (13/11/2013)

DATE:

PELLICOLA DI PROPRIETÀ RECORDATI S.p.A.

VIETATA LA MANOMISSIONE

blood levels of the drug. Your doctor may advise you to increase
the dose to one Zanidip 20 mg 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 20 mg 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 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
Like all medicines, this medicine 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.

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

5. How to store Zanidip
Keep this medicine out of the sight and reach of children
Do not use Zanidip after the expiry date, which is stated on the
label, carton and on blister after EXP. The expiry date refers to
the last day of that month.
Store in the original package in order to protect from light
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Zanidip contains
The active substance is lercanidipine hydrochloride.
Each film-coated tablet contains 10 mg lercanidipine
hydrochloride (equivalent to 9.4 mg lercanidipine) or 20 mg
lercanidipine hydrochloride (equivalent to 18.8 mg
lercanidipine).
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate, povidone K30, magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171),
macrogol 6000, ferric oxide (E172).

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

Rare (affecting less than 1 out of 1,000 patients): angina
pectoris (chest pain due to lack of blood to your heart)

Marketing Authorization Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali 1 - 20148 Milan, Italy

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)

Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali 1 - 20148 Milan, Italy

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.

This medicinal product is authorised in the Member States of
the EEA under the following names:

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.

Corifeo
Zanedip
Zanicor
Lerdip

Zanidip

Austria, Belgium, Denmark, Finland, Greece,
Luxemburg, Spain, Sweden, United Kingdom
Germany
Italy,
Portugal
The Netherlands

This leaflet was last revised in 11/2013
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.

XXXXXXXX

XXXX X

SENSO SVOLGIMENTO BOBINA

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.

RENDERE DOPO LA STAMPA

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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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