Package Leaflet: Information for the User

Lercanidipine ratiopharm 20 mg Film-Coated Tablets

Lercanidipine hydrochloride

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

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

3.How to take Lercanidipine ratiopharm

4.Possible side effects

5.Storage of Lercanidipine ratiopharm

6. Contents of the pack and additional information

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

Lercanidipino is used to treatmild to moderate hypertensionalso known as hypertension in adults aged 18 years and older (not recommended for children under 18 years of age).

Do not take Lercanidipino ratiopharm

• if you areallergicto lercanidipine hydrochloride, to closely related medicines (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine, or lacidipine), or toany of the other ingredientsof this medicine (listed in section 6),
• if you haveheart disease:
• • 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 a heart attack,
• if you havesevere liver problems,
• if you havesevere kidney problems or are undergoing dialysis,
• if you are takingmedicinesthat 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 ciclosporin (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 Lercanidipino ratiopharm if:

• you have heart problems,
• you have problems with your liver or kidneys.

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

Children and adolescents

The safety and efficacy of lercanidipine ratiopharm have not been established inchildren up to 18 years.

Other medicines and Lercanidipino ratiopharm

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

This is because when lercanidipine is taken with other medicines, the effect of lercanidipine or of the other medicines may change or could increase the frequency of certain side effects (see section 2 “Do not take Lercanidipino ratiopharm”).

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

• phenytoin, phenobarbital, or carbamazepine(epilepsy medicines),
• rifampicin(a medicine to treat tuberculosis),
• astemizol or terfenadine(allergy medicines),
• amiodarone, quinidineorsotalol(medicines to treat arrhythmia),
• midazolam(a medicine that helps you sleep),
• digoxin(a medicine to treat heart problems),
• beta-blockers, for example,metoprolol(a medicine 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 cholesterol levels),
• other medicines to treat high blood pressure,
• ketoconazoleoritraconazole(antifungal medicines),
• erythromycin,troleandomycinorclarithromycin(macrolide antibiotics),
• ritonavir(antiviral),

ciclosporina(a medicine that reduces the body's resistance to diseases).

Taking Lercanidipino ratiopharm with food, drinks, and alcohol

• Fatty meals significantly increase the concentration of the medicine in the blood (see section 3 “How to take Lercanidipino ratiopharm”).
• Alcohol may increase the effect of lercanidipine. Do not consume alcohol during treatment with Lercanidipino ratiopharm.

• Lercanidipine ratiopharm should not be taken withgrapefruit or grapefruit juice(may increase the hypotensive effect. See section “Do not take Lercanidipino ratiopharm”).

Pregnancy, breastfeeding, and fertility

Lercanidipine ratiopharm is not recommended for use during pregnancy and should not be taken during breastfeeding. There are no data on the use of lercanidipine in pregnant women and breastfeeding women.If you are pregnant or breastfeeding,if you are not using an effective contraceptive method, think you might be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and operating machines

If you experience dizziness, weakness, or numbness when taking this medicine, do not drive vehicles or operate machines.

Lercanidipino ratiopharm contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

The tablet should be swallowed preferably whole with a little 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 increasing the daily dose to 20 mg should be done with caution.

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

If you take more Lercanidipine ratiopharm 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested). Bring the packaging with you.

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

If you forget to take Lercanidipine ratiopharm

If you forget to take your 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 ratiopharm

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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, inform your doctor immediately.

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

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks with medications in the group to which lercanidipine belongs. 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 redness of the face, neck, or upper chest (flushing), swelling of the ankles.

Lessfrequent (may affect up to 1 in 100 patients):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, nausea, vomiting, diarrhea,

urticaria, increased urination frequency, chest pain.

Unknown frequency (cannot be estimated from available data)):swelling of the gums, changes in liver function (detected in blood tests), cloudy liquid (during hemodialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigrepoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lercanidipine ratiopharm

• The active ingredient 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 (potato), anhydrous colloidal silica, povidone K 30, stearate fumarate, and sodium.

Coating:

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

Appearance of the product and contents of the package

Lercanidipine ratiopharm 20 mg is presented in the form of pink, round, biconvex, film-coated tablets 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.

Package sizes: 7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

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

Germany:Lercanidipin-ratiopharm 20 mg Filmtabletten

Austria:Lercanidipin-ratiopharm 20 mg Filmtabletten

Italy:LERCANIDIPINA RATIOPHARM Italia 20 mg COMPRESSE RIVESTITE CON FILM

Portugal:Lercanidipina ratiopharm

Spain:Lercanidipine ratiopharm 20 mg film-coated tablets EFG

Last review date of this leaflet:February 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/