Lercanidipino Tarbis 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lercanidipine Tarbis 10 mg film-coated tablets EFG

Lercanidipine Tarbis 20 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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

2. What you need to know before taking Lercanidipine Tarbis

Do not take Lercanidipine Tarbis

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

• If you have heart conditions such as:

• obstruction of blood flow from the heart,

• uncontrolled heart failure,

• unstable angina (chest discomfort at rest or progressively worsening),

• during the first month after having suffered a myocardial infarction.

• If you have severe liver problems.

• If you have severe kidney problems or are undergoing dialysis.

• If you are taking certain medications that inhibit 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 other medications containing cyclosporine (used after organ transplant to prevent organ rejection).

• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting Lercanidipine Tarbis:

• If you have a heart condition.
• If you have liver or kidney problems.

You must inform your doctor if you think you are pregnant (you may become pregnant) or if you are breastfeeding (see section on pregnancy, breastfeeding, and fertility).

Children and adolescents

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

Other medicines and Lercanidipine Tarbis

Inform 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 combined with other medicines, the effect of Lercanidipine or the other medicine may change, or the frequency of certain adverse effects may increase (see section 2 “Do not take Lercanidipine Tarbis”).

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

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy),
• rifampicin (a medicine used to treat tuberculosis),
• astemizole or terfenadine (medicines used for allergies),
• amiodarone, quinidine, or sotalol (medicines used to treat heart rhythm disorders),
• midazolam (a medicine to help you sleep),
• digoxin (a medicine used to treat heart problems),
• beta-blockers such as metoprolol (a medicine used to treat high blood pressure, heart failure, and abnormal heart rhythm),
• cimetidine (more than 800 mg, a medicine used for ulcers, indigestion, or heartburn),
• simvastatin (a medicine used to lower blood cholesterol levels),
• other medicines used to treat high blood pressure.

Taking Lercanidipine Tarbis 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 Lercanidipine. Do not consume alcohol during treatment with Lercanidipine Tarbis.
• Lercanidipine must not be taken with grapefruit or grapefruit juice, as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipine Tarbis”.

Pregnancy, breastfeeding, and fertility

It is not recommended to take Lercanidipine if you are pregnant, 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 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 while taking this medicine, do not drive or operate machinery.

Lercanidipine Tarbis contains lactose

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

Lercanidipine Tarbis contains sodium

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

3. How to take Lercanidipine Tarbis

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

Adults: The usual recommended dose is one 10 mg tablet daily, taken at the same time each day, preferably in the morning and at least 15 minutes before breakfast. Your doctor may increase your dose to one Lercanidipine 20 mg tablet daily, if necessary (see section 2 “Taking Lercanidipine Tarbis with food, drinks and alcohol”).

The tablets should be swallowed whole with a little water.

Use in children: This medicine must not be given to children under 18 years of age.

Elderly patients: Daily dose adjustment is not required. However, special caution may be needed when starting treatment.

Patients with kidney or liver problems: Special care is needed when starting treatment in these patients, and increasing the dose to 20 mg daily should be done cautiously.

If you take more Lercanidipine Tarbis than you should

Do not take more than the prescribed dose. In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Taking a higher dose than the correct dose may cause excessive lowering of blood pressure and make your heartbeat irregular and faster.

If you forget to take Lercanidipine Tarbis

If you forget to take your tablet, do not take the missed dose. Instead, continue taking the medicine the next day as directed by your doctor.

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

If you stop taking Lercanidipine Tarbis

If you stop taking Lercanidipine, your blood pressure will 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 will experience them. The following adverse effects may occur when taking this medicine:

Some of these adverse effects may be serious.

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

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

• angina pectoris (chest tightness due to insufficient blood flow to the heart)
• allergic reactions (with symptoms such as itching, rash, and urticaria)
• fainting.

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

Other possible adverse effects

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

• headache
• increased heart rate
• palpitations (strong or rapid heartbeat)
• sudden redness of the face
• neck or upper chest
• swelling of the ankles.

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

• dizziness
• drop in blood pressure
• heartburn
• malaise
• stomach pain
• skin rash
• itching
• muscle pain
• increased amount of urine
• weakness or fatigue

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

• somnolence
• vomiting
• diarrhea
• urticaria
• 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 (during peritoneal dialysis through a tube inside the abdomen)
• swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, nurse, 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 Tarbis

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 the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Tarbis

The active substance is lercanidipine hydrochloride.

Each film-coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 10.139 mg of lercanidipine hydrochloride hemihydrate).

Each film-coated tablet contains 20 mg of lercanidipine hydrochloride (equivalent to 20.278 mg of lercanidipine hydrochloride hemihydrate).

The other components are:

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

Coating: Partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172) (only for 10 mg), red iron oxide (E172).

Appearance of the product and contents of the pack:

Lercanidipine Tarbis 10 mg film-coated tablets EFG

Yellow, film-coated, round, biconvex tablets with a diameter of approximately 6.6 mm, marked with "3" and "4" on either side of the breakline on one side of the tablet and "HL" on the other side.

The breakline is intended solely to facilitate tablet splitting and swallowing, but not for dividing into equal doses.

Lercanidipine Tarbis 20 mg film-coated tablets EFG

Pink to peach-coloured, film-coated, round, biconvex tablets with a diameter of approximately 8.5 mm, marked with "3" and "5" on either side of the breakline on one side of the tablet and "HL" on the other side.

The breakline is intended solely to facilitate tablet splitting and swallowing, but not for dividing into equal doses.

Lercanidipine Tarbis is available in blister packs containing 28, 30, 50 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Lercanidipin Amarox 10 mg/20 mg Filmtabletten

Spain: Lercanidipino Tarbis 10 mg/20 mg comprimidos recubiertos con película EFG

The Netherlands: Lercanidipine HCl Amarox 10 mg/20 mg, filmomhulde tabletten

Date of the most recent revision of this leaflet: February 2023

Detailed and up-to-date 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/