LERCANIDIPINE TEVA-RATIOPHARM 10 mg FILM-COATED TABLETS

2. What you need to know before you take Lercanidipine Teva-ratiopharm

Do not take Lercanidipine Teva-ratiopharm

• if you are allergicto 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 suffer from certain heart diseases:
• • untreated heart failure,
  • obstruction of blood flow from the heart,
  • unstable angina (chest pain that occurs at rest or that progressively increases),
  • 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 medicinesthat are inhibitors of liver 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 (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 Teva-ratiopharm 10 mg if:

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

You must 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 Lercanidipine Teva-ratiopharm have notbeen established in children under 18 years of age.

Other medicines and Lercanidipine Teva-ratiopharm

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 Teva-ratiopharm”).

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

• phenytoin, phenobarbital or carbamazepine(medicines for epilepsy)
• rifampicin(a medicine for treating 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, such as metoprolol(a medicine for treating high blood pressure, heart failure and irregular 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),
• ciclosporin(a medicine that reduces the body's resistance to disease).

Taking Lercanidipine Teva-ratiopharm with food, drinks and alcohol

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

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

Pregnancy, breast-feeding and fertility

It is not recommended to take Lercanidipine Teva-ratiopharm if you are pregnant and it should 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 Teva-ratiopharm contains sodium

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

3. How to take Lercanidipine Teva-ratiopharm

Follow exactly the administration instructions of this medicine given 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 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 once a day (see section 2 “Taking Lercanidipine Teva-ratiopharm 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 starting treatment.

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

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

If you take more Lercanidipine Teva-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 Toxicology Information Service, phone: 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 Teva-ratiopharm

If you forget to take your 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 Teva-ratiopharm

If you stop taking lercanidipine, your blood pressure may rise again. Consult your doctor before stopping treatment.

If you have any further questions on the use of this product, 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 can be serious:

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

Rare (may affect up to 1 in 1,000 people): chest pain (e.g., chest pressure 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 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 (flush), 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, nausea, 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Teva-ratiopharm

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 on the carton after EXP. The expiry date is the last day of the month shown.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Teva-ratiopharm

• 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:

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

Coating:

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

Appearance and packaging of the product

Lercanidipine Teva-ratiopharm 10 mg is presented in the form of yellow, round, biconvex film-coated tablets with a score line on one side and a smooth surface on the other. The score line is to facilitate breaking and ease 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

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-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 Teva-ratiopharm 10 mg film-coated tablets EFG

Date of last revision of this leaflet:February 2022

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

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71698/P_71698.html

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