Prospect: information for the user

Lercanidipine ratiopharm 10 mg film-coated tabletsEFG

lercanidipine hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

2.What you need to know before starting to take Lercanidipine ratiopharm

3.How to take Lercanidipine ratiopharm

4.Possible adverse effects

5.Storage of Lercanidipine ratiopharm

6.Contents of the pack and additional information

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

Lercanidipinois used to treat mild to moderatehigh blood pressurealso known as hypertension in adults over 18 years old (not recommended for children under 18 years old).

Do not take Lercanidipino ratiopharm

• if you areallergicto lercanidipine hydrochloride, to closely related medications (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine, or lacidipine), or toany of the other components ofthis medication (listed in section 6).
• if you haveheart disease:
• • untreated heart failure,
  • obstruction of blood flow out of 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 takingmedicationsthat 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 medication called ciclosporina (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 10 mg 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 Lercanidipino ratiopharm have not been established inchildren up to 18 years.

Other medications and Lercanidipino ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because when lercanidipine is taken with other medications, the effect of lercanidipine or the other medications may change or could increase the frequency of certain adverse effects (see section 2 “Do not take Lercanidipino ratiopharm”).

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

• phenytoin, phenobarbital, or carbamazepine(epilepsy medications)
• rifampicin(a medication for treating tuberculosis)
• astemizol or terfenadine(allergy medications),
• amiodarone, quinidine, or sotalol(medications for treating arrhythmia),
• midazolam(a medication that helps you sleep),
• digoxin(a medication for treating heart problems),
• beta-blockers, for example,metoprolol(a medication for treating high blood pressure, heart failure, and abnormal heart rhythm),
• cimetidine(more than 800 mg per day, a medication for ulcers, indigestion, or heartburn),
• simvastatin(a medication that lowers blood cholesterol levels),
• other medications for treating high blood pressure
• ketoconazoleoritraconazole(antifungal medications),
• erythromycin,troleandomycinorclarithromycin(macrolide antibiotics),
• ritonavir(antiviral),
• ciclosporina(a medication that reduces the body's resistance to diseases).

Taking Lercanidipino ratiopharm with food, drinks, and alcohol

• Fatty meals significantly increase the concentration of the medication 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.

• Lercanidipino 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

It is not recommended to take Lercanidipino ratiopharm if you are pregnant 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 may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machines

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

Lercanidipino ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; 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 again.

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.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 dosage 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 20mg should be done with caution.

Use in children:This medication should not be used in children and adolescents 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 forgot to take Lercanidipine ratiopharm

If you forgot 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 the 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 medications, this medication may have adverse effects, although not everyone may experience them.The following adverse effects may occur when taking this medication:

Some adverse effects may 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 (e.g., chest tightness due to lack of blood in 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. 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 heartbeats (palpitations), sudden redness of the face, neck, or upper chest (flushing), swelling of the ankles.

Infrequent (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):sleepiness, nausea, vomiting, diarrhea,

urticaria, increased urine 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 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 Medicinal Products 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 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 SIGRE collection pointof 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 Lercanidipino ratiopharm

• The active ingredient is lercanidipine hydrochloride. Each film-coated tablet contains 10mg of lercanidipine hydrochloride, equivalent to 9.4mg of lercanidipine.

• The other components are:

Core:

Maize starch, sodium carboxymethyl starch type IA (potato), anhydrous colloidal silica, microcrystalline cellulose, poloxamer 188, stearate fumarate and sodium, macrogol 6000.

Coating:

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

Appearance of the product and contents of the package

Lercanidipino ratiopharm 10 mg is presented in the form of yellow, 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, 50, 56, 60, 98, 100 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

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 10 mg Filmtabletten

Austria:Lercanidipin-ratiopharm 10 mg Filmtabletten

Italy:LERCANIDIPINA RATIOPHARM Italia 10 mg COMPRESSE RIVESTITE CON FILM

Portugal:Lercanidipina ratiopharm

Spain:Lercanidipino ratiopharm 10 mg film-coated tablets EFG

Last review date of this leaflet:February 2022

For detailed information about this medicine, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/