Lercanidipino Tarbis 10 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 you should not give it to other people, 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 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 side 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 the blood outflow from the heart,
  • uncontrolled heart failure,
  • unstable angina (chest discomfort at rest or progressively worsening),
  • during the first month after suffering a myocardial infarction.

• If you have severe liver problems.

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

• If you are taking certain hepatic metabolism inhibitors such as:

  • antifungal agents (such as ketoconazole or itraconazol),
  • macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin),
  • antiviral agents (such as ritonavir).

• If you are taking other medicines containing cyclosporine (used after organ transplantation to prevent organ rejection).

• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 (or could become pregnant) or if you are breastfeeding (see section on pregnancy, breastfeeding and fertility).

Children and adolescents

The safety and efficacy of Lercanidipine 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 combining Lercanidipine with other medicines may alter the effect of Lercanidipine or the other medicine, or may increase the frequency of certain adverse effects (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 used 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.
• 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

Lercanidipine is not recommended during pregnancy and must 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, if you think you may be pregnant, or if you 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 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 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Lercanidipine Tarbis

Follow exactly the instructions for use of this medicine as given by your doctor. 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 20 mg tablet of Lercanidipine 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 population: Daily dose adjustment is not required. However, special care may be needed at the start of treatment.

Patients with kidney or liver problems: Special care is required at the beginning of treatment, and an increase in dose to 20 mg daily should be done with caution.

If you take more Lercanidipine Tarbis than you should

Do not take more than the prescribed dose. In case of overdose or accidental ingestion, consult 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 an excessive drop in 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 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 experiences 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 (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 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):

• drowsiness
• vomiting
• diarrhea
• hives
• increased frequency of urination
• chest pain.

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

• gum swelling
• changes in liver function (detected in blood tests)
• cloudy fluid (when undergoing 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to 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 coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 10.139 mg of lercanidipine hydrochloride hemihydrate).

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

Other components:

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

Coating: Polyvinyl alcohol, partially hydrolysed (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 only 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 only to facilitate tablet splitting and swallowing, but not for dividing into equal doses.

Lercanidipine Tarbis is available in blisters of 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 authorised in the Member States of the European Economic Area 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 review 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/