Lerzam 20 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
LERZAM 10 mg film-coated tablets
LERZAM 20 mg film-coated tablets
lercanidipine hydrochloride
Read the entire leaflet carefully before starting to take 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Lerzam is and what it is used for
- What you need to know before taking Lerzam
- How to take Lerzam
- Possible side effects
- How to store Lerzam
- Contents of the pack and other information
1. What Lerzam is and what it is used for
Lerzam, lercanidipine hydrochloride, belongs to a group of medicines called calcium channel blockers (dihydropyridine group) that lower blood pressure.
Lerzam 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 Lerzam
Do not take Lerzam
- 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 suffering 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 Lerzam if:
- You have a heart condition.
- You have liver or kidney problems.
You must inform your doctor if you think you are pregnant (you could become pregnant) or if you are breastfeeding (see section on pregnancy, breastfeeding, and fertility).
Children and adolescents
The safety and efficacy of Lerzam have not been established in children under 18 years of age.
Other medicines and Lerzam
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because combining Lerzam with other medicines may alter the effect of Lerzam or of the other medicine, or may increase the frequency of certain adverse effects (see section 2 “Do not take Lerzam”).
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 for 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 irregular heartbeat)
- 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 Lerzam 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 Lerzam. Do not consume alcohol during treatment with Lerzam.
- Lerzam must not be taken with grapefruit or grapefruit juice, as it may increase the hypotensive effect. See section 2 “Do not take Lerzam”.
Pregnancy, breastfeeding, and fertility
It is not recommended that you take Lerzam if you are pregnant, and it should not be taken during breastfeeding. There are no data on the use of Lerzam in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using an effective method of contraception, think you might 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 numbness while taking this medicine, do not drive or operate machinery.
Lerzam contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Lerzam contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; thus, it is essentially “sodium-free”.
3. How to take Lerzam
Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Adults: The usual recommended dose is one 10 mg tablet daily 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 Lerzam 20 mg tablet daily, if necessary (see section 2 “Taking Lerzam with food, drinks and alcohol”).
Lerzam 10 mg: The score mark is only intended to facilitate tablet splitting and ease of swallowing, but not for dividing the tablet into two equal doses.
Lerzam 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: No adjustment of the daily dose is required. However, they may require special care at the beginning of treatment.
Patients with kidney or liver problems: Special care is required at the beginning of treatment in these patients, and an increase in dose to 20 mg daily should be done cautiously.
If you take more Lerzam than you should:
Do not take more than the prescribed dose.
If you have taken more Lerzam 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 container with you.
Taking a higher dose than the correct dose may cause an excessive drop in blood pressure and make your heartbeat irregular and faster.
If you forget to take Lerzam:
If you forget to take your tablet, do not take the missed dose. Instead, take the next dose the following day as directed by your doctor.
Do not take a double dose to make up for forgotten doses.
If you stop taking Lerzam:
If you stop taking Lerzam, 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 gets 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 (chest pain or tightness due to reduced blood flow to the heart), allergic reactions (with symptoms such as itching, rash, and urticaria), and fainting.
Patients with pre-existing angina may experience an increase in frequency, duration, or severity of attacks with medicines in the class to which Lerzam 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, 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 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 (when performing peritoneal dialysis through a tube in 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, consult 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. Storage of Lerzam
Keep this medicine out of the 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 will help protect the environment.
6. Contents of the pack and other information
Composition of Lerzam:
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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: monohydrate lactose, 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
Lerzam 10 mg are 6.5 mm yellow, film-coated, round, biconvex tablets, scored on one side.
Lerzam 20 mg are 8.5 mm pink, film-coated, round, biconvex tablets, scored on one side.
Lerzam 10 mg is available in packs of 7, 14, 28, 35, 50, 56, 98, and 100 tablets. Not all pack sizes may be marketed.
Lerzam 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)
Date of the most recent revision of this leaflet: June 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/