Zanidip 20 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 all of 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, 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) which lower blood pressure.
Zanidip 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 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 outflow of blood 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 (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin), antiviral agents (such as 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 taking 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 (could 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 medicines and Zanidip
Inform 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 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 rhythms)
- 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, drinks and alcohol
- High-fat meals considerably 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
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 or breastfeeding, if you are not using an effective contraceptive method, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience dizziness, weakness, or drowsiness 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; this is essentially “sodium-free”.
3. How to take Zanidip
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 tablet has a score line to facilitate splitting and ease of swallowing, but not for dividing the tablet into two equal doses.
Zanidip 20 mg: The tablet may be divided into equal doses.
The tablets should be swallowed whole with a little water.
Use in children: This medicine must not be given to children under 18 years of age.
Elderly population: A daily dose adjustment is not 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 with caution.
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 hospital, or call the Toxicology Information Service at telephone (91) 562 04 20. Take the packaging with you.
Taking a higher dose than recommended may cause an excessive drop in blood pressure and may 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 using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur when taking this medicine:
Some of these adverse effects may be serious.
If you experience any of these adverse effects, consult your doctor.
Rare (may affect up to 1 in 1,000 patients): angina (chest tightness due to reduced blood flow to the heart), allergic reactions (with symptoms such as itching, rash and hives), and fainting.
Patients with pre-existing angina may experience an increase in frequency, duration or severity of attacks when taking medicines from the group 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 frequency of urination, weakness or fatigue.
Rare (may affect up to 1 in 1,000 patients): drowsiness, vomiting, diarrhoea, hives, increased frequency of urination, 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 (during peritoneal dialysis using a tube inserted into the abdomen), swelling of the face, lips, tongue or throat that 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 Medicines: 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.
Store in the original packaging to protect the medicine from light.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at 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 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 medicinal product is authorized in the European Economic Area member states under the following names:
Zanidip: Austria, Belgium, Denmark, Finland, Greece, Luxembourg, Spain, Sweden and 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/