Prospect: information for the patient

Lercanidipine Sandoz10 mg film-coated tablets EFG

Lercanidipine Sandoz20 mg film-coated tablets EFG

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 should 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 Sandoz and how it is used

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

3. How to take Lercanidipine Sandoz

4. Possible adverse effects

5. Storage of Lercanidipine Sandoz

6. Contents of the package and additional information

Lercanidipino Sandoz, lercanidipino hydrochloride, belongs to a group of medicines called calcium channel blockers (of the dihydropyridines group) that lower blood pressure.

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

Do not take Lercanidipino Sandoz:

• untreated heart failure,
• obstruction of blood flow to the heart,
• unstable angina (crushing chest pain at rest or progressive angina),
• 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 medications that inhibit hepatic metabolism, such as:

• antifungal medications (e.g., ketoconazol or itraconazol),
• macrolide antibiotics (e.g., erythromycin, troleandomycin, or clarithromycin),
• antivirals (e.g., ritonavir),
• if you are taking other medications called ciclosporina (used after a transplant to prevent organ rejection),
• • with grapefruit or grapefruit juice.

Do not take this medication if you are pregnant or breastfeeding, or if you wish to become pregnant or are of childbearing age and not using contraception (for more information, see the Pregnancy, breastfeeding, and fertility section).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lercanidipino:

Children and adolescents

The safety and efficacy of lercanidipino have not been demonstrated in children and adolescents under 18 years old.

Taking Lercanidipino Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is especially important to inform your doctor if you are being treated with any of the following medications:

• beta-blockers, e.g., metoprolol (a medication for treating high blood pressure, heart failure, and abnormal heart rhythm),
• other medications that affect blood pressure (alpha-blockers for treating high blood pressure, enlarged prostate, antidepressants, and antipsychotics for treating mental disorders),
• cimetidine, more than 800 mg (a medication for ulcers, indigestion, or stomach acid),
• simvastatina (a medication for lowering blood cholesterol),
• digoxina (a medication for treating certain heart problems),
• midazolam (a medication to help you sleep),
• rifampicina (a medication for treating tuberculosis),
• astemizol or terfenadine (medications for allergies),
• amiodarona, quinidina, or sotalol (medications for lowering heart rate),
• phenytoin, phenobarbital, or carbamazepine (medications for treating epilepsy).

Taking Lercanidipino Sandoz with food, drinks, and alcohol

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

-Alcohol can increase the effect of this medication. Do not consume alcohol during treatment with this medication.

-Do not take this medication with grapefruit or grapefruit juice (this can increase the hypotensive effect). See the “Do not take Lercanidipino Sandoz” section.

Pregnancy, breastfeeding, and fertility

Do not take lercanidipino if you are pregnant or breastfeeding, not using contraception, think you may be pregnant, or intend to become pregnant.

Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Be cautious as there may be cases of dizziness, weakness, fatigue, and rarely somnolence. Do not drive or operate machinery until you know how lercanidipino affects you.

Lercanidipino Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

Adults

The recommended dose is one Lercanidipine 10 mg tablet per day, taken always at the same time every day, preferably in the mornings, at least 15 minutes before breakfast, since a meal rich in fats significantly increases the blood levels of this medication.

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

The tablets should be swallowed whole with a little water. The groove is only for breaking and facilitating swallowing, but not for dividing into equal doses.

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

Advanced age

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

Patients with kidney or liver problems

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

Use in children and adolescents

This medication should not be given to children and adolescents under 18 years old.

If you take more Lercanidipine Sandoz than you should

Do not take more doses than prescribed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

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

Exceeding the recommended dose may cause blood pressure to drop too low and the heart rate to be irregular or faster, you may feel dizzy or have a headache.

If you forgot to take Lercanidipine Sandoz

If you forgot to take your tablet, simply omit the missed dose and take the next one when it is due.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Lercanidipine Sandoz

If you interrupt the treatment with lercanidipine, your blood pressure will increase again. Consult your doctor before stopping the medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Some of these 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):

Crushing chest pain (angina), fainting, and allergic reactions (with symptoms that include itching, hives, and urticaria, difficulty breathing or swelling, dizziness).

If you have pre-existing angina, with medications in the group to which lercanidipine belongs, you may experience an increase in 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:

Frequent (may affect up to 1 in 10 people)

Headache, increased heart rate, palpitations (heartbeats or acceleration), flushing (e.g., on the face), swelling of the ankles.

Poorly frequent(may affect up to 1 in 100 people):

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

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

Drowsiness, discomfort, diarrhea,blistering, increased frequency of urination, chest pain.

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

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

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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Aluminum/PVC blister: Do not store at a temperature above25°C.

Store in the original packaging to protect it from moisture.

Aluminum/PVDC blister: Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lercanidipino Sandoz

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

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

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

Lercanidipino Sandoz 10 mg:

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

Lercanidipino Sandoz 20 mg:

Coating: macrogol, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).

Appearance of the product and contents of the package

Lercanidipino Sandoz 10 mg: yellow film-coated tablets, round, biconvex, 6.5 mm in diameter, scored on one side and marked with “L” on the other.

Lercanidipino Sandoz 20 mg: pink film-coated tablets, round, biconvex, 8.5 mm in diameter, scored on one side and marked with “L” on the other.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Pack sizes:

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

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: June 2020.

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/