Lercanidipine Teva-Ratiopharm 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lercanidipine Teva-ratiopharm 10 mg film-coated tablets EFG

lercanidipine hydrochloride

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Lercanidipine Teva-ratiopharm is and what it is 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 essential hypertension, also known as high blood pressure, in adults aged 18 years and over (it is not recommended for children under 18 years of age).

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

Do not take Lercanidipine Teva-ratiopharm

• if you are allergic to lercanidipine hydrochloride, to medicines closely related to lercanidipine (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine), or to any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart conditions:
  • untreated heart failure,
  • obstruction of blood flow out of the heart,
  • unstable angina (chest pain occurring at rest or progressively worsening),
  • 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 medicines that 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 cyclosporine (used, for example, after organ transplants to prevent organ rejection),
• with grapefruit or grapefruit juice.

Warnings and precautions

Talk to 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 be) pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Children and adolescents

The safety and efficacy of Lercanidipine Teva-ratiopharm have not been established in children up to 18 years of age.

Other medicines and Lercanidipine Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 adverse effects may increase (see section 2 “Do not take Lercanidipine Teva-ratiopharm”).

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

• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine used to treat 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, for example, metoprolol (a medicine used 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 blood cholesterol levels),
• other medicines for treating high blood pressure,
• ketoconazole or itraconazole (antifungal medicines),
• erythromycin, troleandomycin or clarithromycin (macrolide antibiotics),
• ritonavir (an antiviral),
• cyclosporine (a medicine that reduces the body’s resistance to disease).

Taking Lercanidipine Teva-ratiopharm with food, drinks and alcohol

• High-fat meals considerably increase the concentration of the medicine in the blood (see section 3 “How to take Lercanidipine Teva-ratiopharm”).

• Alcohol may enhance the effect of lercanidipine. Do not consume alcohol during treatment with Lercanidipine Teva-ratiopharm.

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

Pregnancy, breastfeeding and fertility

It is not recommended to take Lercanidipine Teva-ratiopharm during pregnancy and it should not be taken during breastfeeding. There are no data on the use of lercanidipine in pregnant or 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 using machines

If you experience dizziness, weakness or numbness while taking this medicine, do not drive or operate machinery.

Lercanidipine Teva-ratiopharm contains sodium

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

3. How to take Lercanidipine Teva-ratiopharm

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults: The recommended dose is 10 mg once 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 once daily (see section 2 “Taking Lercanidipine Teva-ratiopharm with food, drinks, and alcohol”).

The tablet should preferably be swallowed whole with a little water.

Elderly patients: No adjustment of the daily dose is required. However, special care should be taken when starting treatment.

Patients with kidney or liver problems: Special care is needed when starting treatment in these patients, and increasing 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 Teva-ratiopharm than you should

Do not exceed the prescribed dose.

If you take more than the prescribed dose or in case of overdose, contact your doctor immediately, go directly to the hospital, or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested). Take the packaging with you.

Taking a higher dose than recommended may cause an excessive drop in blood pressure and may make your heartbeat irregular or faster.

If you forget to take Lercanidipine Teva-ratiopharm

If you forget to take your dose, simply 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur when taking this medicine:

Some adverse effects may be serious:

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

Rare (may affect up to 1 in 1,000 people): angina (e.g., chest tightness due to insufficient blood flow to your 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 attacks when taking medicines belonging to the same group as lercanidipine. 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 heartbeat (palpitations), sudden redness 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 amount of urine, weakness or fatigue.

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

Frequency not known (cannot be estimated from available data): swelling of the gums, changes in liver function (detected in blood tests), cloudy fluid (when performing peritoneal dialysis through a tube in the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 outer packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This 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 components are:

Core:

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

Coating:

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

Appearance of the medicine and contents of the pack

Lercanidipine Teva-ratiopharm 10 mg is presented as yellow, round, biconvex, film-coated tablets, with a score line on one side and smooth on the other. The score line is intended to facilitate breaking the tablet and swallowing, but not for dividing into equal doses.

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

Only certain pack sizes may be marketed.

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 medicinal product is authorized in the European Economic Area member states 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 comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: February 2022

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. 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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