LERCANIDIPINE SANDOZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lercanidipine Sandoz10 mg film-coated tablets EFG

Lercanidipine Sandoz20 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Lercanidipine is used to treat high blood pressure, also known as arterial hypertension, in adults over 18 years old (it is not recommended for children and adolescents under 18 years of age).

2. What you need to know before you take Lercanidipine Sandoz

Do not take Lercanidipine Sandoz:

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

• untreated heart failure,
• obstruction of blood flow from the heart,
• unstable angina (crushing chest pain at rest or progressive angina),
• within the first month after having a heart attack,
• • if you have severe liver problems,
  • if you have severe kidney problems or are on dialysis treatment
  • if you are taking medicines that inhibit liver metabolism, such as:

• antifungal medicines (e.g. ketoconazole or itraconazole),
• macrolide antibiotics (e.g. erythromycin, troleandomycin or clarithromycin),
• antivirals (e.g. ritonavir),
• if you are taking other medicines called cyclosporin (used after a transplant to prevent organ rejection),
• • 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 contraceptive methods (for more information, see section Pregnancy, breastfeeding and fertility).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lercanidipine:

• if you have certain heart diseases 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 take any other medicines.

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

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

Taking Lercanidipine Sandoz with food, drinks and alcohol

• Fatty meals significantly increase the concentration of the medicine in the blood (see section 3).

• Alcohol may increase 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, breastfeeding and fertility

Do not take lercanidipine if you are pregnant or breastfeeding, or if you wish to become pregnant or are of childbearing age and not using contraceptive methods.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Be cautious as dizziness, weakness, fatigue and rarely somnolence may occur. Do not drive or use machines until you know how lercanidipine affects you.

Lercanidipine Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Lercanidipine Sandoz

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Adults

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

Your doctor will indicate, if necessary, to increase the dose to one 20 mg Lercanidipine tablet per day.

The tablets should be swallowed whole with a little water. The score line is only for ease of breaking and does not divide the tablet into equal doses.

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

Elderly

No dose adjustment is required. However, they may require special care at the start of treatment.

Patients with kidney or liver problems

Special care is needed at the start of treatment in these patients and an increase in dose to 20 mg per day should be done with caution.

Use in children and adolescents

This medicine should 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 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 medical attention immediately and, if possible, take your tablets and/or 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 have forgotten to take your tablet, simply omit the forgotten dose and take the next one when it is due.

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

If you stop taking Lercanidipine Sandoz

If you stop taking lercanidipine, your blood pressure will rise again. Consult your doctor before stopping treatment with this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these side effects can be serious:

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

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

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

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

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

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

Other possible side effects:

Common (may affect up to 1 in 10 people)

Headache, increased heart rate, palpitations (heartbeats or acceleration), 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, production of large amounts of urine, weakness or fatigue.

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

Somnolence, discomfort, diarrhea, blisters, increased urination, chest pain.

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

Gingival inflammation, changes in liver function (detected in blood tests); cloudy liquid (when dialysis is performed through a tube inside the abdomen).

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 via 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 Sandoz

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 carton, after EXP. The expiry date is the last day of the month stated.

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

Keep in the original package to protect from moisture.

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

Keep in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. 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 10 mg Lercanidipine Sandoz film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.

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

• The other ingredients are:

Core of the tablet:magnesium stearate, povidone, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose.

Lercanidipine Sandoz 10 mg:

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

Lercanidipine Sandoz 20 mg:

Coating:macrogol, partially hydrolyzed polyvinyl alcohol, 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, scored 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, scored on one side and marked with “L” on the other.

The score line is only for ease of breaking and does not divide the tablet 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 authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area 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 last revision of this leaflet:June 2020.

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/