Lercanidipine Viatris 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lercanidipine Viatris 10 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.

  1. 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 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.

Contents of the leaflet

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

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

Lercanidipine Viatris belongs to a group of medicines called calcium channel blockers, which block the entry of calcium into the muscle cells of the heart and blood vessels carrying blood away from the heart (the arteries). The entry of calcium into these cells causes the heart to contract and the arteries to narrow. By blocking calcium entry, calcium channel blockers reduce the heart's contraction and dilate (widen) the arteries, thereby lowering blood pressure. It is not recommended for children under 18 years of age.

Lercanidipine Viatris has been prescribed for the treatment of your high blood pressure, also known as hypertension.

2. What you need to know before taking Lercanidipine Viatris

Do not take Lercanidipine Viatris

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

• If you have heart conditions such as:

  • Untreated heart failure.
  • Obstruction of the heart's outflow tract.
  • Unstable angina (angina at rest or progressively worsening).
  • During the first month after having had 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 are inhibitors of hepatic metabolism such as:

  • Antifungal medicines (such as ketoconazole or itraconazole).
  • Macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin).
  • Antiviral medicines (such as ritonavir).
  • Medicines containing cyclosporine (used after organ transplant to prevent organ rejection).
  • Grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lercanidipine Viatris:

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

You must inform your doctor if you think you may be pregnant (you 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 Viatris

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

Taking lercanidipine with certain medicines may alter the effect of these medicines or of lercanidipine.

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

• Phenytoin, phenobarbital or carbamazepine (medicines used to treat epilepsy).
• Rifampicin (a medicine used to treat tuberculosis).
• Midazolam (a medicine to help you sleep).
• Cimetidine, more than 800 mg (a medicine for ulcers, indigestion or heartburn).
• Digoxin (a medicine used to treat certain heart problems).
• Terfenadine or astemizole (medicines for allergies).
• Amiodarone, quinidine or sotalol (medicines used to treat heart rhythm disorders).
• Medicines known as beta-blockers, for example, metoprolol (a medicine used to treat high blood pressure).
• Simvastatin (a medicine used to lower blood cholesterol levels).
• Other medicines used to treat high blood pressure.

Taking Lercanidipine Viatris with food, drinks and alcohol

• High-fat meals considerably increase the concentration of the medicine in the blood (see section 3).
• Do not consume alcohol during treatment with lercanidipine, as it may enhance the effect of lercanidipine.
• Do not take grapefruit or grapefruit juice, as it may increase the effect of lercanidipine.

Pregnancy and breastfeeding

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

Lercanidipine has negligible influence on the ability to drive or use machinery. However, adverse effects such as dizziness, weakness, fatigue, and rarely, somnolence, may occur. Exercise caution until you know how you tolerate lercanidipine.

Lercanidipine Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 Viatris

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

Adults

The recommended dose is one 10 mg tablet daily, taken at the same time each day, preferably in the morning, at least 15 minutes before breakfast, since a high-fat meal significantly increases the levels of the medicine in the blood. Your doctor may decide to increase your dose to one 20 mg tablet daily, if necessary.

The tablets should preferably be swallowed whole with half a glass of water. The tablet's score line is intended only for breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into equal doses.

Elderly patients

No adjustment of the daily dose is required. However, special caution should be taken when starting treatment.

Patients with liver or kidney problems

Special caution should be taken when starting treatment. Your doctor may decide to adjust your dose.

Use in children and adolescents

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

If you take more Lercanidipine Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest emergency department, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Taking more than the recommended dose may cause an excessive drop in your blood pressure and may make your heart rate irregular or faster. It may also cause loss of consciousness.

If you forget to take Lercanidipine Viatris

If you forget to take your tablet, take it as soon as you remember, unless it is almost time for your next dose. Then continue as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lercanidipine Viatris

If you stop taking lercanidipine, your blood pressure may 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.

Some adverse effects can be serious. If you experience any of the following, contact your doctor immediately or go to the nearest hospital emergency department:

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

• Allergic reactions (with symptoms such as itching, skin rash, and hives)
• Chest pain, often radiating to the arms or neck, and sometimes to the shoulders and back, due to insufficient blood flow to the heart (angina pectoris)
• Fainting

If you have angina pectoris, lercanidipine may very rarely cause an increased frequency of attacks, which may last longer and be more severe. Isolated cases of heart attacks have been observed.

Other adverse effects:

Frequent (may affect up to 1 in 10 people)

• Headache
• Rapid heartbeat
• Awareness of heartbeats (palpitations)
• Flushing (temporary redness of the face, neck, or upper chest)
• Swelling of the ankles

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Feeling of weakness or fatigue
• Decreased blood pressure
• Heartburn
• Stomach pain
• Malaise
• Skin rash
• Itching
• Muscle pain
• Increased amount of urine

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

• Drowsiness
• Vomiting
• Diarrhea
• Hives
• Increased frequency of urination
• Chest pain

Frequency not known (cannot be estimated from available data)

• Increased liver enzyme values in blood tests
• Inflammation of the gums
• Cloudy fluid (when performing dialysis through a tube into 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 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 Viatris

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

Do not use Lercanidipine Viatris after the expiry date which is stated on the label, carton or bottle after CAD or EXP. The expiry date is the last day of the month indicated.

Blister packs: Do not store above 25°C. Keep in the original container to protect from moisture.

Bottles: Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Unused or expired medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Viatris

The active substance is lercanidipine hydrochloride.

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

The other components are: magnesium stearate, povidone, sodium starch glycolate (potato, type A), lactose monohydrate, microcrystalline cellulose.

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

Appearance of the product and contents of the pack

Lercanidipine Viatris are yellow, round, biconvex, film-coated tablets 6.5 mm in diameter, scored on one side and marked with an 'L' on the other side.

The score line is intended only to facilitate tablet splitting and swallowing, but not to divide the tablet into equal doses.

Available in blisters containing 14, 20, 28, 30, 50, 56, 98, 100 tablets.

Available in bottles containing 14, 25, 28, 30, 50, 56, 84, 90, 98, 100, 112 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Actavis Ltd.
BLB015-016 Bulebel Industrial Estate, Zejtun ZTN3000
Malta

Or

Coripharma ehf.
Reykjavikurvegur 76-78, IS-220 Hafnarfjörður
Iceland

Or

Balkanpharma – Dupnitsa AD
3 Samokovsko Str.
Dupnitsa 2600
Bulgaria

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Spain: Lercanidipino Viatris 10 mg film-coated tablets EFG
Italy: Lercanidipina Mylan Italia
Netherlands: Lercanidipine HCl Viatris 10 mg, filmomhulde tabletten
Portugal: Lercanidipina Mylan 10 mg comprimido revestido por pelicula
United Kingdom: Lercanidipine 10 mg Film-Coated Tablets

Date of the most recent review of this leaflet: November 2021

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