Leaflet: Information for the User

Lercanidipine Tevagen 10 mg Film-Coated Tablets

Lercanidipine Tevagen 20 mg Film-Coated Tablets

Lercanidipine Hydrochloride

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Lercanidipine Tevagen

3. How to take Lercanidipine Tevagen

4. Possible side effects

5. Storage of Lercanidipine Tevagen

6. Contents of the pack and additional information

Lercanidipino Tevagen belongs to a group of medications called calcium channel blockers (dihydropyridine derivatives). Lercanidipino Tevagen is used to treat mild to moderatehigh blood pressure.

Do not take Lercanidipino Tevagen

• if you areallergic(hypersensitive) to lercanidipino hydrochloride or toany of the other componentsof this medication (listed in section 6)
• if you have hadallergic reactionswhen taking medications related to Lercanidipino Tevagen (such as amlodipino, nicardipino, felodipino, isradipino, nifedipino, or lacidipino).
• if you haveheart disease:

• Untreated heart failure.
• Obstruction of blood flow to the heart.
• Unstable angina (angina at rest or that increases progressively).
• During the first month after a heart attack.

• if you haveserious kidney or liver problems.
• if you are takingmedicinesthat are inhibitors of the isoenzyme CYP3A4:

• Antifungals (such as ketoconazole or itraconazole).
• Macrolide antibiotics (such as erythromycin or troleandomycin).
• Antivirals (such as ritonavir).

• if you are taking another medication called ciclosporina (used, for example, after transplants, to prevent organ rejection).
• if you are taking grapefruit or grapefruit juice.

Do not use if you arepregnantorbreastfeeding(for more information, see the Pregnancy and breastfeeding section).

Warnings and precautions

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

• You have certain heart problems (sinus node disease) and do not have a pacemaker, or if you have pre-existing angina.
• You have problems with your liver or kidneys, or if you are on dialysis.

Children and adolescents

Lercanidipino Tevagen should not be used in children and adolescents under 18 years old.

Taking Lercanidipino Tevagen with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor or pharmacist if:

• You are takingbeta-blockers, such as metoprolol,diuretics(medicines to increase urine elimination)or ACE inhibitors(medicines to treat hypertension).
• You are takingcimetidine(more than 800 mg per day, a medicine for ulcers, indigestion, or heartburn).
• You are takingdigoxin(a medicine to treat heart problems).
• You are takingmidazolam(a medicine to help you sleep).
• You are takingrifampicin(a medicine to treat tuberculosis).
• You are takingastemizol or terfenadine(medicines for allergies).
• You are takingamiodarone or quinidine(medicines to treat arrhythmia).
• You are takingphenytoin or carbamazepine(medicines for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual.
• You are takingantifungals(such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin or troleandomycin), or antivirals (such as ritonavir). The effect of Lercanidipino Tevagen may be increased. Therefore, simultaneous administration should be avoided (see “Do not take Lercanidipino Tevagen”).
• You are takingciclosporina(a medicine that reduces the body's resistance to diseases). The effect of Lercanidipino Tevagen and ciclosporina may be increased. Therefore, simultaneous administration should be avoided (see “Do not take Lercanidipino Tevagen”).
• You are takingsimvastatin(a medicine that reduces cholesterol levels). Lercanidipino Tevagen should be taken in the morning, and simvastatin, at night.

Taking Lercanidipino Tevagen with food, drinks, and alcohol

• Patientsshould not consume alcoholduring treatment with Lercanidipino Tevagen, as it may increase the effect of Lercanidipino Tevagen.

• Patientsshould not consume grapefruit or grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Lercanidipino Tevagen if you are pregnant or breastfeeding, if you want to become pregnant, or if you do not use any contraceptive method.

Driving and operating machinery

Be cautious, as there is a possibility of dizziness, weakness, and fatigue. Do not drive or operate machinery until you know how Lercanidipino Tevagen affects you.

Lercanidipino Tevagen contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Lercanidipine Tevagen 10 mg film-coated tablets

Adults:The recommended dose is one daily tablet of Lercanidipine Tevagen 10 mg (corresponding to 10 mg of lercanidipine hydrochloride), taken always at the same time each day, preferably in the morning, atleast 15 minutes before breakfast, since ahigh-fat meal significantly increases the blood levels of the active principle. If necessary, your doctor may advise you to increase the dose to two daily tablets of Lercanidipine Tevagen (corresponding to 20 mg of lercanidipine hydrochloride).

The tablet should be taken with a sufficient amount of liquid (for example, a glass of water).

Lercanidipine Tevagen 20 mg film-coated tablets

Adults:The recommended dose is 10mg of lercanidipine hydrochloride daily, taken always at the same time each day, preferably in the morning, atleast 15 minutes before breakfast, since ahigh-fat meal significantly increases the blood levels of the active principle. The dose of 10 mg is not possible with the tablets in this leaflet. If necessary, your doctor may advise you to increase the dose to one daily tablet of Lercanidipine Tevagen 20 mg (corresponding to 20mg of lercanidipine hydrochloride).

The tablet should be taken with a sufficient amount of liquid (for example, a glass of water).

Older adults:No dose adjustment is required. However, special care should be taken when starting treatment.

Patients with kidney or liver problems:Special care should be taken when starting treatment in these patients, and a daily dose increase to 20 mg should be done with caution.

Use in children and adolescents:This medication should not be used in children and adolescents under 18 years old.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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, seek immediate medical attention and, if possible, bring your tablets or the packaging with you or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A dose higher than recommended may cause blood pressure to drop too low, and heartbeats to become irregular or faster. It may also cause vomiting or loss of consciousness.

If you forgot to take Lercanidipine Tevagen

If you forgot to take a dose, limit yourself to taking the next tablet as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lercanidipine Tevagen

If you interrupt the administration of Lercanidipine Tevagen, your blood pressure will increase again. Consult your doctor before interrupting treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Some adverse effects can be severe:

Inform your doctor immediately if you experience any of these adverse effects.

Rare (may affect up to 1 in 1,000 people):

Angina pectoris (chest pain due to lack of blood flow to the heart).

Very rare (may affect up to 1 in 10,000 people):

Chest pain, decreased blood pressure, dizziness, and allergic reactions (symptoms include itching, skin rash, hives).

If you have previously experienced angina pectoris attacks, treatment with medications in the group to which Lercanidipino Tevagen belongs may cause an increase in the frequency, duration, or severity of these attacks. Isolated cases of myocardial infarction may be observed.

Other possible adverse effects:

Infrequent (may affect up to 1 in 100 people):

Headache, dizziness, tachycardia, palpitations (increased heart rate), sudden redness of the face, neck, or upper face, swelling of the ankles.

Rare (may affect up to 1 in 1,000 people):

Drowsiness, nausea, vomiting, chest burning, stomach pain, diarrhea; skin rash, muscle pain, large amounts of urine, fatigue.

Very rare (may affect up to 1 in 10,000 people):

Swelling of the gums, changes in liver function (detected by blood tests), increased frequency of urination.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need.This will help protect the environment.

Composition of Lercanidipine Tevagen

Lercanidipine Tevagen 10 mg film-coated tablets EFG

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

Core:

Maize starch, sodium starch glycolate (potato), anhydrous colloidal silica, microcrystalline cellulose, poloxamer 188, sodium fumarate estearate, macrogol 6000.

Coating:

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

Lercanidipine Tevagen 20 mg film-coated tablets EFG

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

Core:

Microcrystalline cellulose, maize starch, sodium starch glycolate (potato), anhydrous colloidal silica, povidone K 30, sodium fumarate estearate.

Coating:

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

Appearance of Lercanidipine Tevagen and packaging contents

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 notch on one face and smooth on the other face. The notch serves to break and facilitate swallowing but not to divide 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 notch on one face and smooth on the other face. The notch serves to break and facilitate swallowing but not to divide into equal doses.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

Manufacturer

Merckle GmbH,

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren,

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Lercanidipin-HCL Teva 10 mg Filmtabletten

Lercanidipin-HCL Teva 20 mg Filmtabletten

Spain:Lercanidipine Tevagen 10 mg film-coated tablets EFG

Lercanidipine Tevagen 20 mg film-coated tablets EFG

United Kingdom: Lercanidipine hydrochloride 10mg film-coated tablets

Lercanidipine hydrochloride 20mg film-coated tablets

Last review date of thisleaflet: October 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.