Leaflet: Information for the user

ZANIDIP 10 mg film-coated tablets

ZANIDIP 20 mg film-coated tablets

Lercanidipine hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Zanidip and what it is used for

2.What you need to know before taking Zanidip

3.How to take Zanidip

4.Possible side effects

5.Storage of Zanidip

6.Contents of the pack and additional information

Zanidip, lercanidipine hydrochloride, belongs to a group of medicines called calcium channel blockers (of the dihydropyridines group) that lower blood pressure.

Zanidip is used for the treatment of high blood pressure, also known as hypertension in adults aged 18 years and older (not recommended for children under 18 years of age).

Do not take Zanidip

-If you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medication (listed in section 6).

--If you have heart conditions such as: heart blockage, uncontrolled heart failure, unstable angina (chest discomfort at rest or progressively increasing) and during the first month after a myocardial infarction.

-If you have severe liver problems.

-If you have severe kidney problems or are undergoing dialysis.

-If you are taking certain medications that inhibit liver metabolism such as: antifungals (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin), antivirals (such as ritonavir).

-If you are taking other medications containing ciclosporina (used after a transplant to prevent organ rejection).

-With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zanidip:

-If you have a heart problem.

-If you have liver or kidney problems.

You must inform your doctor if you think you are pregnant (you may become pregnant) or are breastfeeding (see section on pregnancy, breastfeeding and fertility).

Children and adolescents

The safety and efficacy of Zanidip have not been demonstrated in children under 18 years.

Other medications and Zanidip

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. This is because combining Zanidip with other medications may alter the effect of Zanidip or the other medication or increase the frequency of certain adverse effects (see section 2 “Do not take Zanidip”).

Specifically, inform your doctor or pharmacist if you are taking any of the following medications:

-phenytoin, phenobarbital or carbamazepine (medications for treating epilepsy)

-rifampicin (medication for treating tuberculosis)

-astemizol or terfenadine (medications for allergies)

-amiodarone, quinidine or sotalol (medications for treating arrhythmias)

-midazolam (medication for helping you sleep)

-digoxin (medication for treating heart problems)

-beta-blockers such as metoprolol (a medication for treating high blood pressure, heart failure and abnormal heart rhythm)

-cimetidine (more than 800 mg, a medication for ulcers, indigestion or heartburn)

-simvastatin (a medication for lowering blood cholesterol levels)

-other medications for treating high blood pressure

Taking Zanidip with food, drinks and alcohol

-Fatty meals significantly increase the concentration of the medication in the blood (see section 3).

-Alcohol may increase the effect of Zanidip. Do not consume alcohol during treatment with Zanidip.

-Zanidip should not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 “Do not take Zanidip”.

Pregnancy, breastfeeding and fertility

Zanidip is not recommended for pregnant women and should not be taken during breastfeeding. There are no data on the use of Zanidip in pregnant women and during breastfeeding. If you are pregnant or breastfeeding, if you are not using an effective contraceptive method, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

If you experience dizziness, weakness or numbness when taking this medication, do not drive vehicles or operate machinery.

Zanidip contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

ZANIDIP contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:The usual recommended dose is one 10 mg tablet daily at the same time every day, preferably in the mornings and at least 15 minutes before breakfast. Your doctor may increase your dose to one 20 mg tablet daily if necessary (see section 2 “Taking Zanidip with food, drinks, and alcohol”).

Zanidip 10 mg: the groove is only to facilitate the division of the tablet and improve its ingestion,but not to divide the same into two equal doses.

Zanidip 20 mg: the tablet can be divided into equal doses.

The tablets should be taken whole with a little water.

Use in children:This medication should not be given to children under 18 years old.

Older population:No dose adjustment is required. However, they may require special care at the start of treatment.

Patients with kidney or liver problems:Special care is needed at the start of treatment in these patients and an increase in dose to 20 mg daily should be done with caution.

If you take more Zanidip than you should

Do not take more doses than prescribed.

If you have taken more Zanidip tablets than you should, consult your doctor immediately, go directly to the hospital or call the Toxicology Information Service, phone (91) 562 04 20. Bring the packaging with you.

Taking a dose higher than the correct dose may cause excessive lowering of blood pressure and irregular and faster heartbeats.

If you forget to take Zanidip

If you forget to take your tablet, do not take the missed dose. Then, continue the next day as your doctor indicated.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Zanidip

If you stop taking Zanidip, your blood pressure will increase again. Consult your doctor before interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The following side effects may occur when taking this medicine:

Some of these side effects may be serious.

If you experience any of these side effects, consult your doctor.

Rare(may affect up to 1 in 1,000 patients):angina pectoris (chest tightness due to lack of blood to the heart), allergic reactions (with symptoms such as itching, hives, and urticaria) and fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks with medicines in the group to which Zanidip belongs. Isolated cases of heart attacks have been observed.

Other possible side effects

Frequent(may affect up to 1 in 10 patients):headache, increased heart rate or palpitations (strong or rapid heartbeats), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Occasional(may affect up to 1 in 100 patients):dizziness, low blood pressure, heartburn, discomfort, stomach pain, skin rash, itching, muscle pain, increased urine production, weakness or fatigue.

Rare(may affect up to 1 in 1,000 patients):drowsiness, vomiting, diarrhea, urticaria, increased urination frequency, chest pain.

Unknown frequency(cannot be estimated from available data):swelling of the gums, changes in liver function (detected in blood tests), cloudy fluid (during hemodialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat that may cause breathing or swallowing difficulties.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national notification system:Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date, which appears on the blister and on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect the medication from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Zanidip:

• The active ingredient is lercanidipine hydrochloride. Each 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: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate.

Covering: hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).

Appearance of the product and contents of the packaging

Zanidip 10 mg are coated tablets with a yellow film, 6.5 mm in diameter, circular, biconvex, and scored on one of their faces.

Zanidip 20 mg are coated tablets with a pink film, 8.5 mm in diameter, circular, biconvex, and scored on one of their faces.

Zanidip 10 mg is available in packaging of 7, 14, 28, 35, 50, 56, 98, and 100 tablets. Not all packaging may be marketed.

Zanidip 20 mg is available in packaging of 7, 14, 28, 35, 42, 50, 56, 98, and 100 tablets. Not all packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza). Spain.

Responsible for manufacturing:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan (Italy)

This medicine is authorized in the member states of the European Economic Area with the following names:

Zanidip: Austria, Belgium, Denmark, Finland, Greece, Luxembourg, Spain, Sweden, and the United Kingdom.

Corifeo: Germany.

Zanedip: Italy.

Zanicor: Portugal.

Lerdip: Netherlands.

Date of the last review of this leaflet: June 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/