Lercanidipine Sandoz 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lercanidipine Sandoz 10 mg film-coated tablets EFG

Lercanidipine Sandoz 20 mg film-coated tablets EFG

lercanidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 yours, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Lercanidipino Sandoz is and what it is used for

Lercanidipino Sandoz, containing lercanidipine hydrochloride, belongs to a group of medicines called calcium channel blockers (dihydropyridine group) that lower blood pressure.

Lercanidipino is used for the treatment of high blood pressure, also known as hypertension, in adults over 18 years of age (it is not recommended for children and adolescents under 18 years of age).

2. What you need to know before taking Lercanidipine Sandoz

Do not take Lercanidipine Sandoz:

• if you are allergic to lercanidipine or to any of the other ingredients of this medicine (listed in section 6),

• if you have any of the following heart conditions:

  • untreated heart failure,
  • obstruction of blood flow from the heart,
  • unstable angina (crushing chest pain at rest or progressive angina),
  • during the first month after having 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 inhibit hepatic metabolism, such as:

  • antifungal medicines (e.g., ketoconazole or itraconazol),
  • macrolide antibiotics (e.g., erythromycin, troleandomycin or clarithromycin),
  • antiviral medicines (e.g., ritonavir),
  • if you are taking other medicines called cyclosporine (used after transplantation to prevent organ rejection),

• together with grapefruit or grapefruit juice.

Do not take this medicine if you are pregnant or breastfeeding, or if you wish to become pregnant or are of childbearing age and not using contraception (for further information see section Pregnancy, breast-feeding and fertility).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take lercanidipine:

• if you have certain heart conditions and have not been treated with a pacemaker, or if you have pre-existing angina (crushing chest pain),
• if you have liver or kidney problems.

Children and adolescents

The safety and efficacy of lercanidipine have not been established in children and adolescents under 18 years of age.

Taking Lercanidipine Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you tell your doctor if you are taking any of the following medicines:

• beta-blockers, e.g., metoprolol (a medicine used to treat high blood pressure, heart failure, and irregular heartbeat),
• other medicines affecting blood pressure (alpha-blockers for treating high blood pressure, enlarged prostate, tricyclic antidepressants and neuroleptics used to treat mental disorders),
• cimetidine, more than 800 mg (a medicine for ulcers, indigestion or stomach acidity),
• simvastatin (a medicine to lower blood cholesterol),
• digoxin (a medicine to treat certain heart problems),
• midazolam (a medicine to help you sleep),
• rifampicin (a medicine used to treat tuberculosis),
• astemizole or terfenadine (medicines for allergies),
• amiodarone, quinidine or sotalol (medicines to reduce heart rate),
• phenytoin, phenobarbital or carbamazepine (medicines used to treat epilepsy).

Taking Lercanidipine Sandoz with food, drinks and alcohol

• High-fat meals considerably increase the concentration of the medicine in the blood (see section 3).

• Alcohol may enhance the effect of this medicine. Do not consume alcohol during treatment with this medicine.

• Do not take this medicine with grapefruit or grapefruit juice (this may increase the hypotensive effect). See section "Do not take Lercanidipine Sandoz".

Pregnancy, breast-feeding and fertility

Do not take lercanidipine if you are pregnant or breast-feeding, not using a contraceptive method, think you may be pregnant, or plan to become pregnant.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Use caution, as dizziness, weakness, fatigue, and rarely drowsiness may occur. Do not drive or operate machinery until you know how lercanidipine affects you.

Lercanidipine Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Lercanidipine Sandoz

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

Adults

The recommended dose is one tablet of Lercanidipine 10 mg once daily, taken at the same time each day, preferably in the morning, at least 15 minutes before breakfast, as a high-fat meal significantly increases blood levels of this medicine.

Your doctor may decide, if necessary, to increase the dose to one tablet of Lercanidipine 20 mg daily.

The tablets should be swallowed whole with a small amount of water. The tablet's score line is intended only for ease of splitting and swallowing, and not for dividing into equal doses.

The use of Lercanidipine is not recommended in children and adolescents under 18 years of age.

Elderly

No adjustment of the daily dose is required. However, special care may be needed when starting treatment.

Patients with kidney or liver problems

Special caution is required when starting treatment in these patients, and increasing the dose to 20 mg daily should be done cautiously.

Use in children and adolescents

This medicine must not be given to children and adolescents under 18 years of age.

If you take more Lercanidipine Sandoz than you should

Do not take more than the prescribed dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you take more than the prescribed dose or in case of overdose, seek immediate medical attention and, if possible, bring your tablets and/or the packaging with you.

Taking more than the recommended dose may cause your blood pressure to drop too low and your heart rate to become irregular or faster. You may feel dizzy or have a headache.

If you forget to take Lercanidipine Sandoz

If you forget to take your tablet, simply skip the missed dose and take the next one at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Lercanidipine Sandoz

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

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.

Some of these adverse effects can be serious:

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

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

Crushing chest pain (angina pectoris), fainting, and allergic reactions (with symptoms including itching, rash, hives, difficulty breathing, or swelling, dizziness).

If you have pre-existing angina pectoris, treatment with medicines of the group to which lercanidipine belongs may increase the frequency, duration, or severity of these attacks. Isolated cases of heart attacks have been observed.

Frequency not known (cannot be estimated from available data):

Swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Other possible adverse effects:

Common (may affect up to 1 in 10 people):

Headache, increased heart rate, palpitations (awareness of heartbeat or rapid heartbeat), flushing (e.g. in the face), swelling of the ankles.

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

Dizziness, low blood pressure, indigestion, discomfort, stomach pain, rash, itching, muscle pain, passing large amounts of urine, weakness or fatigue.

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

Drowsiness, discomfort, diarrhoea, blisters, increased frequency of urination, chest pain.

Frequency not known (cannot be estimated from available data):

Gingival inflammation, changes in liver function (detected in blood tests); cloudy fluid (when undergoing dialysis through a tube in the abdomen).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Sandoz

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Aluminium/PVC blister: Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Aluminium/PVDC blister: Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Medicines and their empty containers should be returned to a pharmacy’s SIGRE collection point. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Sandoz

• The active substance is lercanidipine hydrochloride.

Each Lercanidipine Sandoz 10 mg film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.

Each Lercanidipine Sandoz 20 mg film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.

• The other components are:

Tablet core: magnesium stearate, povidone, sodium carboxymethyl starch (type A), lactose monohydrate, microcrystalline cellulose.

Lercanidipine Sandoz 10 mg:

Coating: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E 171), yellow iron oxide (E 172).

Lercanidipine Sandoz 20 mg:

Coating: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the pack

Lercanidipine Sandoz 10 mg: yellow, round, biconvex, film-coated tablets, 6.5 mm in diameter, with a score line on one side and marked with "L" on the other.

Lercanidipine Sandoz 20 mg: pink, round, biconvex, film-coated tablets, 8.5 mm in diameter, with a score line on one side and marked with "L" on the other.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

Pack sizes:

Lercanidipine Sandoz 10 mg: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98 and 100 film-coated tablets.

Lercanidipine Sandoz 20 mg: 7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Otto von Guericke Allee 1
39179 Barleben
Germany

Or

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitza 2600
Bulgaria

Or

ACTAVIS LIMITED
BLB016 Bulebel Industrial Estate
Zejtun ZTN3000
Malta

Or

Lek Pharmaceuticals d.d.
Verovskova 57
SI-1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

Austria: Lercanidipin Sandoz 10 mg – Filmtabletten
Lercanidipin Sandoz 20 mg – Filmtabletten

Belgium: Lercanidipin Sandoz 10 mg filmomhulde tabletten
Lercanidipin Sandoz 20 mg filmomhulde tabletten

Denmark: Lercatio

Italy: Lercanidipina Sandoz

Netherlands: Lercanidipine HCl Sandoz 10 mg, filmomhulde tabletten
Lercanidipine HCl Sandoz 20 mg, filmomhulde tabletten

Portugal: Lercanidipina Sandoz

Date of the most recent review of this summary: June 2020.

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