ZANIDIP 10 mg FILM-COATED TABLETS

2. What you need to know before taking Zanidip

Do not take Zanidip

• If you are allergic to lercanidipine hydrochloride or any of the other components of this medication (listed in section 6).
• If you have heart diseases such as: obstruction of blood flow from the heart, uncontrolled heart failure, unstable angina (chest pain at rest or progressively increasing) and during the first month after suffering a heart attack.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking certain medications that inhibit hepatic 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 cyclosporine (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 should inform your doctor if you think you are pregnant (or 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 established in children under 18 years of age.

Other medications and Zanidip

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because when Zanidip is combined with other medications, the effect of Zanidip or the other medication may change or the frequency of certain side effects may increase (see section 2 "Do not take Zanidip").

In particular, 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)
• astemizole or terfenadine (medications for allergies)
• amiodarone, quinidine, or sotalol (medications for treating heart rhythm disorders)
• midazolam (medication to help 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 to lower 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

It is not recommended to take Zanidip if you are pregnant, and it should not be taken during breastfeeding. There are no data on the use of Zanidip in pregnant or breastfeeding women. If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and using machines

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

Zanidip contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

ZANIDIP contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Zanidip

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

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

Zanidip 10 mg: the score line is only to facilitate breaking the tablet and improving its ingestion, but not to divide it into two equal doses.

Zanidip 20 mg: the tablet can be divided into two 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 of age.

Elderly 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 required when starting treatment in these patients, and an increase in the dose to 20 mg per day 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, telephone (91) 562 04 20. Bring the packaging with you.

Taking a higher dose than the correct dose may cause an excessive drop in 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 make up for missed doses.

If you stop taking Zanidip

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. The following side effects may occur when taking this medication:

Some of these side effects can 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 pain due to lack of blood in the heart), allergic reactions (with symptoms such as itching, rash, and hives), and fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks with medications of 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 reddening of the face, neck, or upper chest, swelling of the ankles.

Uncommon (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, hives, increased urination frequency, chest pain.

Frequency not known (cannot be estimated from available data):gum swelling, changes in liver function (detected in blood tests), cloudy fluid (when performing hemodialysis through a tube into the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines:www.notificaRAM.es.

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

5. Storage of Zanidip

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 pack and carton after EXP. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

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:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate.

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

Appearance of the product and contents of the pack:

Zanidip 10 mg are film-coated tablets, 6.5 mm in size, yellow, circular, biconvex, and scored on one side.

Zanidip 20 mg are film-coated tablets, 8.5 mm in size, pink, circular, biconvex, and scored on one side.

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

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza), Spain.

Manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan (Italy)

This medication is authorized in the Member States of the European Economic Area under 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 revision of this leaflet:June 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/