LERCANIDIPINE TEVAGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lercanidipine Tevagen 10 mg Film-Coated Tablets EFG

Lercanidipine Tevagen 20 mg Film-Coated Tablets EFG

lercanidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Lercanidipine is used to treat mild to moderate high blood pressurealso 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 you take 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, felodipine, isradipine, nifedipine or lacidipine) or to any of the other ingredientsof this medicine (listed in section 6).
• If you have certain heart diseases:

• untreated heart failure.
• obstruction of blood flow from the heart.
• unstable angina (chest pain that occurs at rest or that increases progressively).
• 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 medicinesthat are inhibitors of 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 another medicine called cyclosporin (which is used, for example, after transplants to prevent organ rejection).

• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lercanidipine Tevagen if

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

You should inform your doctor if you think you are (or might become) pregnant or are breast-feeding (see section “Pregnancy, breast-feeding 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 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 side effects may increase (see section 2 “Do not take Lercanidipine Tevagen”).

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

• phenytoin, phenobarbitalor carbamazepine(medicines for epilepsy)
• rifampicin(a medicine for treating tuberculosis)
• astemizoleor terfenadine(medicines for allergies)
• amiodarone, quinidineor 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 for treating 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

• ketoconazoleor itraconazole(antifungal medicines),
• erythromycin, troleandomycinor clarithromycin(macrolide antibiotics)
• ritonavir(antiviral)

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

Taking Lercanidipine Tevagen with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

It is not recommended to take this medicine if you are pregnant and it must not be taken during breast-feeding. There are no data on the use of lercanidipine in pregnant or breast-feeding women. If you are pregnant or breast-feeding, 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 numbness when taking this medicine, do not drive vehicles or use machines.

Lercanidipine Tevagen contains sodium

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

3. How to take Lercanidipine Tevagen

Follow exactly the instructions for administration of this medicine given 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 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 be swallowed preferably whole with a little water.

Lercanidipine Tevagen 20 mg Film-Coated Tablets

Adults:The recommended dose is 10 mg daily, at the same time each day, preferably in the morning, at least 15 minutes before breakfast. The 10 mg dose is not possible with the tablets of 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 be swallowed preferably whole with a little water.

Elderly:No dose adjustment is required. However, special care should be taken when initiating treatment.

Patients with kidney or liver problems:Special care is required when initiating treatment in these patients, and an increase in 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, consult your doctor immediately, go directly to the hospital or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. Bring the package with you.

Taking a dose higher than recommended may cause an excessive drop in blood pressure, and the heartbeats may become irregular or faster.

If you forget to take Lercanidipine Tevagen

If you forget to take a dose, just 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine:

Some side effects may be serious:

If you experience any of these side effects, tell your doctor immediately.

Rare (may affect up to 1 in 1,000 people): chest pain (e.g. chest tightness due to lack of blood in 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 these attacks with medicines of the group to which Lercanidipine Tevagen belongs. Isolated cases of myocardial infarction have been observed.

Other possible side effects:

Frequent (may affect up to 1 in 10 people): headache, increased heart rate, strong or rapid heartbeats (palpitations), sudden reddening 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 urine production, weakness or fatigue.

Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, hives, increased urination frequency, chest pain.

Frequency not known (cannot be estimated from the available data): gum swelling, changes in liver function (detected in blood tests), cloudy liquid (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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the blister and the carton after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicine to a pharmacy for proper disposal. If you have any doubts, ask your pharmacist how to dispose of packages and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Tevagen

Lercanidipine 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 ingredients are:

Core:

Corn starch, sodium carboxymethyl starch type A (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).

Lercanidipine 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 ingredients are:

Core:

Microcrystalline cellulose, corn starch, sodium carboxymethyl starch type A (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 Lercanidipine Tevagen and contents of the pack

Lercanidipine Tevagen 10 mg Film-Coated Tablets EFG

Lercanidipine Tevagen is presented in the form of yellow, round, biconvex film-coated tablets, 6.5 mm in diameter, with a score line on one face and smooth on the other face. The score line is for breaking and facilitating swallowing but not for dividing into equal doses.

Lercanidipine Tevagen 20 mg Film-Coated Tablets EFG

Lercanidipine Tevagen is presented in the form of pink, round, biconvex film-coated tablets, 8.5 mm in diameter, with a score line on one face and smooth on the other face. The score line is for breaking and facilitating swallowing but not for dividing into equal doses.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid.

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 medicine is authorised 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 last revision of this leaflet: December 2021

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