LERCANIDIPINE VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lercanidipine Viatris10 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.
• 1. 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 Viatris and what is it used for
2. What you need to know before you take Lercanidipine Viatris
3. How to take Lercanidipine Viatris
4. Possible side effects
5. Storing Lercanidipine Viatris
6. Contents of the pack and other information

1. What is Lercanidipine Viatris and what is it 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 the blood vessels that carry blood out of the heart (the arteries). The entry of calcium into these cells is what causes the heart to contract and the arteries to narrow. By blocking the entry of calcium, calcium channel blockers reduce the contraction of the heart and dilate (widen) the arteries, thus reducing blood pressure. It is not recommended for children under 18 years of age.

Lercanidipine Viatris has been prescribed for you to treat your high blood pressure, also known as hypertension.

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

Do not take Lercanidipine Viatris

• If you are allergic to lercanidipine or any of the other ingredients of this medicine (listed in section 6).
• If you have heart diseases such as:

• Untreated heart failure.
• Obstruction of the outflow of blood from the heart.
• Unstable angina (angina at rest or progressively increasing).
• During the first month after having 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).
  • Antivirals (such as ritonavir).
  • If you are taking other medicines containing cyclosporin (used after a transplant to prevent organ rejection).
  • With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lercanidipine Viatris:

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

You should inform your doctor if you think you are pregnant (or might become pregnant) or are breast-feeding (see section on pregnancy, breast-feeding 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 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 for treating epilepsy).
• Rifampicin (a medicine for treating tuberculosis).
• Midazolam (a medicine to help you sleep).
• Cimetidine, more than 800 mg (a medicine for ulcers, indigestion or heartburn).
• Digoxin (a medicine for treating certain heart problems).
• Terfenadine or astemizole (medicines for allergies).
• Amiodarone, quinidine or sotalol (medicines for treating heart rhythm disorders).
• Medicines known as beta-blockers, for example metoprolol (a medicine for treating high blood pressure).
• Simvastatin (a medicine for lowering blood cholesterol levels).
• Other medicines for treating high blood pressure.

Taking Lercanidipine Viatris with food, drinks and alcohol

• Fatty meals significantly increase the concentration of the medicine in the blood (see section 3).
• Do notconsume alcohol during treatment with lercanidipine, as it may increase the effect of lercanidipine.
• Do not take grapefruit or grapefruit juice, as it may increase the effect of lercanidipine.

Pregnancy and breast-feeding

It is not recommended to take lercanidipine if you are pregnant and it should not be taken during breast-feeding. There are no data on the use of lercanidipine in pregnant or breast-feeding women. If you are pregnant or breast-feeding, 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 a negligible influence on the ability to drive or use machines. However, side effects such as dizziness, weakness, fatigue and, rarely, somnolence may occur. Act with caution until you know how lercanidipine affects you.

Lercanidipine Viatris 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 Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is one 10 mg tablet daily, 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 the medicine in the blood. Your doctor may decide to increase the dose to one 20 mg tablet daily, if necessary.

Preferably, swallow the tablets whole with half a glass of water. The score line is only to facilitate breaking the tablet for easier swallowing, but not to divide it into equal doses.

Elderly patients

No dose adjustment is required. However, special care should be taken when starting treatment.

Patient with liver or kidney problems

Special care should be taken when starting treatment. Your doctor may decide to adjust the dose.

Use in children and adolescents

The use of lercanidipine is not recommended 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, consult your doctor or pharmacist immediately, go to the nearest emergency department or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

Exceeding the appropriate dosage may cause an excessive drop in your blood pressure and your heart rate may become irregular or faster. It may also cause loss of consciousness.

If you forget to take Lercanidipine Viatris

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

If you stop taking Lercanidipine Viatris

If you stop taking lercanidipine, your blood pressure may increase again. Consult your doctor before stopping treatment.

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

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

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

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

Other side effects:

Common (may affect up to 1 in 10 people)

• Headache.
• Rapid heart rate.
• Perception 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.
• Decrease in blood pressure.
• Heartburn.
• Stomach pain.
• Discomfort.
• Skin rash.
• Itching.
• Muscle pain.
• Increased amount of urine.

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

• Somnolence.
• Vomiting.
• Diarrhea.
• Hives.
• Increased frequency of urination.
• Chest pain.

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

• Increased liver enzyme values in blood tests.
• Gingivitis.
• Turbid fluid (when performing dialysis through a tube into the abdomen),
• Swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 EXP. The expiry date is the last day of the month stated.

Blister packs: Do not store above 25°C. Store in the original package 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ingredients are: magnesium stearate, povidone, sodium starch glycolate (type A), lactose monohydrate, microcrystalline cellulose.

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

Appearance and packaging

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 only to facilitate breaking the tablet for easier swallowing, but not to divide it into equal doses.

It is available in blister packs containing 14, 20, 28, 30, 50, 56, 98, 100 tablets.

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

Not all 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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Lercanidipine 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 last revision of this leaflet:November 2021

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