Zanidip 10 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
ZANIDIP 10 mg film-coated tablets
ZANIDIP 20 mg film-coated tablets
lercanidipine hydrochloride
Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Zanidip is and what it is used for
- What you need to know before taking Zanidip
- How to take Zanidip
- Possible side effects
- How to store Zanidip
- 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 group) that lower blood pressure.
Zanidip is used to treat 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 need to know before taking Zanidip
Do not take Zanidip
- If you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- If you have heart conditions such as: obstruction of the blood outflow from the heart, uncontrolled heart failure, unstable angina (chest discomfort at rest or progressively worsening), or 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: antifungal agents (e.g., ketoconazole or itraconazole), macrolide antibiotics (e.g., erythromycin, troleandomycin, or clarithromycin), antiviral agents (e.g., ritonavir).
- If you are taking other medications containing cyclosporine (used after organ transplantation to prevent organ rejection).
- With grapefruit or grapefruit juice.
Warnings and precautions
Talk to your doctor or pharmacist before starting Zanidip:
- If you have a heart condition.
- If you have liver or kidney problems.
You must inform your doctor if you think you are pregnant (or could become pregnant) or if you 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 medicines and Zanidip
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because combining Zanidip with other medicines may alter the effect of Zanidip or the other medicine, or may 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 medicines:
- Phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)
- Rifampicin (a medicine used to treat tuberculosis)
- Astemizole or terfenadine (medicines used to treat allergies)
- Amiodarone, quinidine, or sotalol (medicines used to treat heart rhythm disorders)
- Midazolam (a medicine used to help you sleep)
- Digoxin (a medicine used to treat heart problems)
- Beta-blockers such as metoprolol (a medicine used to treat high blood pressure, heart failure, and abnormal heart rhythm)
- Cimetidine (more than 800 mg, a medicine used for ulcers, indigestion, or heartburn)
- Simvastatin (a medicine used to lower blood cholesterol levels)
- Other medicines used to treat high blood pressure
Taking Zanidip with food, beverages, and alcohol
- High-fat meals significantly increase the concentration of the medicine in the blood (see section 3).
- Alcohol may enhance the effect of Zanidip. Do not consume alcohol during treatment with Zanidip.
- Zanidip must 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 during pregnancy and must not be taken during breastfeeding. There are no data on the use of Zanidip in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using an effective contraceptive method, if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience dizziness, weakness, or numbness while taking this medicine, do not drive or operate machinery.
Zanidip contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
ZANIDIP contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; therefore, it is essentially “sodium-free”.
3. How to take Zanidip
Follow exactly your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist again.
Adults: The usual recommended dose is one 10 mg tablet daily, taken at the same time each day, preferably in the morning and at least 15 minutes before breakfast. Your doctor may increase your dose to one Zanidip 20 mg tablet daily, if necessary (see section 2, “Taking Zanidip with food, drinks and alcohol”).
Zanidip 10 mg: The score line is only intended to facilitate tablet splitting and improve ease of swallowing, but not to divide the tablet into two equal doses.
Zanidip 20 mg: The tablet can be divided into equal doses.
The tablets should be swallowed whole with a little water.
Use in children: This medicine should not be given to children under 18 years of age.
Elderly population: No adjustment of the daily dose is required. However, special care may be needed at the beginning of treatment.
Patients with kidney or liver problems: Special care is required at the beginning of treatment. Increasing the dose to 20 mg daily should be done cautiously.
If you take more Zanidip than you should
Do not take more than the prescribed dose.
If you have taken more Zanidip tablets than you should, contact your doctor immediately, go directly to the hospital, or call the Toxicology Information Service at telephone number (91) 562 04 20. Take the packaging with you.
Taking a higher dose than the correct one may cause an excessive drop in blood pressure and make your heartbeat irregular and faster.
If you forget to take Zanidip
If you forget to take your tablet, do not take the missed dose. Instead, continue the next day as instructed by your doctor.
Do not take a double dose to make up for forgotten doses.
If you stop taking Zanidip
If you stop taking Zanidip, your blood pressure will rise again. Consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur when taking this medicine:
Some of these adverse effects can be serious.
If you experience any of these adverse effects, consult your doctor.
Rare (may affect up to 1 in 1,000 patients): angina pectoris (chest tightness due to insufficient blood flow to the heart), allergic reactions (with symptoms such as itching, rash, and urticaria), and fainting.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks when taking medicines from the class to which Zanidip belongs. Isolated cases of heart attacks have been observed.
Other possible adverse effects
Common (may affect up to 1 in 10 patients): headache, increased heart rate or palpitations (strong or rapid heartbeat), sudden redness 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 amount of urine, weakness or fatigue.
Rare (may affect up to 1 in 1,000 patients): somnolence, vomiting, diarrhea, urticaria, increased urinary frequency, chest pain.
Frequency not known (cannot be estimated from available data): swelling of the gums, changes in liver function (detected in blood tests), cloudy fluid (when performing peritoneal dialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system: Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Zanidip Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect the medicine from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Zanidip
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The active substance 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).
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The other components are:
Tablet core: 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 6.5 mm yellow, film-coated, round, biconvex tablets, scored on one side.
Zanidip 20 mg are 8.5 mm pink, film-coated, round, biconvex tablets, scored on one side.
Zanidip 10 mg is available in packs of 7, 14, 28, 35, 50, 56, 98, and 100 tablets. Not all pack sizes may be marketed.
Zanidip 20 mg is available in packs of 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:
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 medicinal product is authorised 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 most recent review of this leaflet: June 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/