Lercanidipine Tevagen 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lercanidipine Tevagen 10 mg film-coated tablets EFG

Lercanidipine Tevagen 20 mg film-coated tablets EFG

lercanidipine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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.

Leaflet Contents

1. What Lercanidipine Tevagen is and what it is used for
2. What you need to know before taking Lercanidipine Tevagen
3. How to take Lercanidipine Tevagen
4. Possible side effects
5. How to store Lercanidipine Tevagen
6. Contents of the pack and other information

1. What Lercanidipine Tevagen is and what it is used for

Lercanidipine belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives) that lower blood pressure.

Lercanidipine is used to treat high blood pressure, mild to moderate, 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 Lercanidipine Tevagen

Do not take Lercanidipine Tevagen

• If you are allergic (hypersensitive) to lercanidipine hydrochloride, to medicines closely related to lercanidipine (such as amlodipine, nicardipine, felodipino, isradipine, nifedipine or lacidipine), or to any of the other ingredients of this medicine (listed in section 6).

• If you have certain heart conditions:

• untreated heart failure.

• obstruction of blood flow from the heart.

• unstable angina (chest discomfort occurring at rest or progressively worsening).

• during the first month after a heart attack.

  • If you have severe liver problems.
  • If you have severe kidney problems or are undergoing dialysis.
  • If you are taking medicines that are inhibitors of hepatic 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 another medicine called cyclosporine (used, for example, after organ transplants to prevent organ rejection).

• With grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lercanidipine Tevagen if

• you have certain heart problems.
• you have liver or kidney problems.

You must inform your doctor if you think you are (or might be) pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Children and adolescents

The safety and efficacy of this medicine have not been established in children under 18 years of age.

Taking Lercanidipine Tevagen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because when lercanidipine is taken with other medicines, the effect of lercanidipine or of the other medicines may change, or the frequency of certain adverse effects may increase (see section 2 “Do not take Lercanidipine Tevagen”).

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

• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)

• rifampicin (a medicine used to treat tuberculosis)

• astemizole or terfenadine (medicines for allergies)

• amiodarone, quinidine or sotalol (medicines for treating tachycardia)

• midazolam (a medicine that helps you sleep)

• digoxin (a medicine for treating heart problems)

• beta-blockers, for example, metoprolol (a medicine used to treat high blood pressure, heart failure, and abnormal heart rhythm)

• cimetidine (more than 800 mg per day, a medicine for ulcers, indigestion or heartburn)

• simvastatin (a medicine that lowers blood cholesterol levels)

• other medicines for treating high blood pressure

• ketoconazole or itraconazole (antifungal medicines)

• erythromycin, troleandomycin or clarithromycin (macrolide antibiotics)

• ritonavir (antiviral)

• cyclosporine (a medicine that reduces the body's resistance to disease).

Taking Lercanidipine Tevagen with food, drinks and alcohol

• High-fat meals considerably increase the concentration of the medicine in the blood (see section 3 “How to take Lercanidipine Tevagen”).
• Alcohol may enhance the effect of lercanidipine. Do not consume alcohol during treatment with this medicine.
• This medicine must not be taken with grapefruit or grapefruit juice (as they may increase the hypotensive effect). See section “Do not take Lercanidipine Tevagen”.

Pregnancy, breastfeeding and fertility

It is not recommended to take this medicine during pregnancy, and it should not be taken while breastfeeding. There are no data on the use of lercanidipine in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using an effective contraceptive method, 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 drowsiness while taking this medicine, do not drive or operate machinery.

Lercanidipine Tevagen contains sodium

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

3. How to take Lercanidipine Tevagen

Follow exactly the instructions for use of this medicine provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Lercanidipine Tevagen 10 mg film-coated tablets

Adults: The recommended dose is 10 mg once daily, at the same time each day, preferably in the morning, at least 15 minutes before breakfast. If necessary, your doctor may advise you to increase the dose to 20 mg (see section 2 “Lercanidipine Tevagen with food, drinks and alcohol”).

The tablet should preferably be swallowed whole with a small amount of water.

Lercanidipine Tevagen 20 mg film-coated tablets

Adults: The recommended dose is 10 mg once daily, at the same time each day, preferably in the morning, at least 15 minutes before breakfast. A 10 mg dose is not possible with the tablets described in this leaflet. If necessary, your doctor may advise you to increase the dose to 20 mg daily (see section 2 “Lercanidipine Tevagen with food, drinks and alcohol”).

The tablet should preferably be swallowed whole with a small amount of water.

Elderly patients: No adjustment of the daily dose is required. However, special care should be taken when starting treatment.

Patients with kidney or liver problems: Special care is needed when starting treatment in these patients, and increasing the daily dose to 20 mg should be done with caution.

Use in children: This medicine must not be used in children and adolescents under 18 years of age.

If you take more Lercanidipine Tevagen than you should

Do not exceed the prescribed dose.

If you take more than the prescribed dose or in case of overdose, contact your doctor immediately, go directly to the hospital, or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested. Take the packaging with you.

Taking a higher dose than recommended may cause excessive lowering of blood pressure, and heartbeats may become irregular or faster.

If you forget to take Lercanidipine Tevagen

If you forget to take a dose, simply take the next tablet as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Lercanidipine Tevagen

If you stop taking Lercanidipine Tevagen, 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 will experience them. The following adverse effects may occur when taking this medicine:

Some adverse effects may be serious:

If you experience any of these adverse effects, inform your doctor immediately.

Rare (may affect up to 1 in 1,000 people): angina (e.g., chest tightness due to insufficient blood flow to the heart), allergic reactions (with symptoms such as itching, rash, and hives), fainting.

Patients with pre-existing angina may experience an increase in frequency, duration, or severity of angina attacks with medicines in the group to which Lercanidipine Tevagen belongs. Isolated cases of myocardial infarction have been observed.

Other possible adverse effects:

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

Uncommon (may affect up to 1 in 100 people): 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 people): drowsiness, vomiting, diarrhea, 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 (when undergoing peritoneal dialysis through 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, 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 Spanish System of Pharmacovigilance for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Tevagen

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 outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging, to protect from light.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Lercanidipino Tevagen

Lercanidipino Tevagen 10 mg film-coated tablets EFG

• The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
• The other components are:

Core:

Maize starch, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica, microcrystalline cellulose, poloxamer 188, sodium stearyl fumarate, macrogol 6000.

Coating:

Hypromellose (E-464), macrogol 6000, yellow iron oxide (E 172), titanium dioxide (E 171).

Lercanidipino Tevagen 20 mg film-coated tablets EFG

• The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other components are:

Core:

Microcrystalline cellulose, maize starch, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica, povidone K 30, sodium stearyl fumarate.

Coating:

Hypromellose (E-464), macrogol 6000, red iron oxide (E 172), titanium dioxide (E 171).

Appearance of Lercanidipino Tevagen and contents of the container

Lercanidipino Tevagen 10 mg film-coated tablets EFG

Lercanidipino Tevagen is presented as yellow, round, biconvex, film-coated tablets, 6.5 mm in diameter, with a score line on one side and smooth on the other. The score line is intended to facilitate breaking and swallowing, but not for dividing into equal doses.

Lercanidipino Tevagen 20 mg film-coated tablets EFG

Lercanidipino Tevagen is presented as pink, round, biconvex, film-coated tablets, 8.5 mm in diameter, with a score line on one side and smooth on the other. The score line is intended to facilitate breaking and swallowing, but not for dividing into equal doses.

Pack sizes: 14, 28, 30, 50 x1, 56, 98, 100 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid, Spain.

Manufacturer

Teva UK Ltd

Brampton Road, Hampden Park,

BN22 9AG Eastbourne, East Sussex

United Kingdom

or

Merckle GmbH,

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Lercanidipin-HCL Teva 10 mg Filmtabletten

Lercanidipin-HCL Teva 20 mg Filmtabletten

Spain: Lercanidipino Tevagen 10 mg comprimidos recubiertos con película EFG

Lercanidipino Tevagen 20 mg comprimidos recubiertos con película EFG

United Kingdom (Northern Ireland): Lercanidipine hydrochloride 10mg film-coated tablets

Lercanidipine hydrochloride 20mg film-coated tablets

Date of the most recent revision of this package leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.