Zanedip

Package leaflet: Information for the user

ZANEDIP 10 mg film-coated tablets, 20 mg film-coated tablets

lercanidipine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

1. What Zanedip is and what it is used for
2. What you need to know before taking Zanedip
3. How to take Zanedip
4. Possible side effects
5. How to store Zanedip
6. Contents of the pack and other information

1. What Zanedip is and what it is used for

Zanedip, lercanidipine hydrochloride, belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives) that reduce blood pressure.
Zanedip is used for the treatment of high blood pressure, also known as hypertension, in adults over 18 years of age (it is not recommended for children under 18 years of age).

2. What you should know before taking Zanedip

Do not take Zanedip

• If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any of the other ingredients of Zanedip tablets.
• If you have certain heart conditions such as: obstruction of blood flow from the heart, uncontrolled heart failure, unstable angina (chest pain occurring at rest or progressively worsening), or a heart attack that occurred less than one month ago.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking medicines that are inhibitors of hepatic metabolism such as:
  - antifungal agents (e.g. ketoconazole or itraconazole)
  - macrolide antibiotics (e.g. erythromycin, troleandomycin or clarithromycin)
  - antiviral agents (e.g. ritonavir).
• If you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zanedip:

• If you have heart problems.
• If you have liver or kidney problems.

You must inform your doctor if you think you are (or could become) pregnant or if you are breastfeeding (see section
Pregnancy, breastfeeding and fertility).
Children and adolescents
The safety and efficacy of Zanedip in children up to 18 years of age have not been established.
Other medicines and Zanedip
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This is because when Zanedip is taken together with other medicines, the effect of Zanedip or
the other medicine may be altered, or certain side effects may occur more frequently
(see also section 2 Do not take Zanedip).
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (medicines for the treatment of allergies)
• amiodarone, quinidine or sotalol (medicines for the treatment of tachycardia)
• midazolam (a medicine that helps you sleep)
• digoxin (a medicine for the treatment of heart problems)
• beta-blockers, e.g. metoprolol (a medicine for the treatment of high blood pressure, heart failure and heart rhythm disorders)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine to lower blood cholesterol)
• other medicines for the treatment of high blood pressure
• .

Zanedip with food, drinks and alcohol

• A high-fat meal significantly increases blood levels of the medicine (see section 3).
• Alcohol may enhance the effect of Zanedip. Do not consume alcohol during treatment with Zanedip.
• Zanedip must not be taken with grapefruit or grapefruit juice (as they may increase its hypotensive effect) (See section 2 - Do not take Zanedip).

Pregnancy, breastfeeding and fertility
Zanedip is not recommended during pregnancy and must not be used during breastfeeding. There are no data on the use of Zanedip in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using any contraceptive method, think you could be pregnant, or if you are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience dizziness, weakness or drowsiness with this medicine, do not drive or operate machinery.
Zanedip contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Zanedip

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults: The recommended dose is 10 mg once daily, taken at the same time each day, preferably in the morning at least 15 minutes before breakfast. If necessary, your doctor may advise you to increase the dose to Zanedip 20 mg once daily (see section 2, Zanedip with food, drinks and alcohol).
The tablets should preferably be swallowed whole with some water.
Use in children: This medicine must not be used in children under 18 years of age.
Elderly patients: No adjustment of the daily dose is required. However, particular caution is needed at the start of treatment.
Patients with liver or kidney problems: Particular care is required at the beginning of treatment in these patients, and increasing the daily dose to 20 mg should be carefully considered.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you take more Zanedip than you should
Do not exceed the prescribed dose.
If you have taken more than the prescribed amount, consult your doctor or go to hospital immediately. Take the packaging with you.
Taking more than the correct dose may cause excessive lowering of blood pressure and your heart may beat irregularly or faster.
If you forget to take Zanedip
If you forget to take a tablet, simply skip the missed dose and continue with your next scheduled dose the following day.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Zanedip
If you stop taking Zanedip, your blood pressure may rise again. Consult your doctor before stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:
Some side effects can be serious.
If you experience any of the following side effects, contact your doctor immediately.
Rare (may affect up to 1 in 1,000 people): angina pectoris (e.g. chest tightness caused by inadequate blood supply to the heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks with the group of medicines to which Zanedip belongs. Isolated cases of myocardial infarction may be observed.
Other possible side effects:
Common (may affect up to 1 in 10 people): headache, fast heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (flushing), ankle swelling.
Uncommon (may affect up to 1 in 100 people): dizziness, drop in blood pressure, heartburn, nausea, stomach discomfort, skin rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from available data): gum swelling, changes in liver function (detected by blood tests), cloudy fluid (when performing dialysis through a catheter in the abdomen), swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zanedip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Zanedip contains
The active substance is lercanidipine hydrochloride.
Each film-coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine) or
20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylamidone, povidone
K30, magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).

Description of the appearance of Zanedip and contents of the pack
Zanedip 10 mg: yellow, round, biconvex, film-coated tablet with a break line on one side. The break line on the tablet is intended to facilitate breaking for easier swallowing and is not intended for dividing the tablet into equal doses.
Zanedip 20 mg: pink, round, biconvex, film-coated tablet with a break line on one side.
ZANEDIP is available in packs containing 7, 14, 28, 35, 42, 50, 56, 98 and 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:
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milan (Italy).

This medicinal product is authorised in the European Economic Area countries under the following names:
Zanidip Austria, Belgium, Denmark, Finland, Greece,
Luxembourg, Spain, Sweden, United Kingdom
Corifeo Germany
Zanedip Italy
Zanicor Portugal
Lerdip Netherlands