Package Insert: Information for the Patient

Lercanidipine Viatris10 mg Film-Coated Tablets EFG

lercanidipine hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• 1. If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you and should not be given to others, 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 package insert. See section 4.

Lercanidipino Viatrisbelongs to a group of medications called calcium channel blockers,which block the entry of calcium into heart muscle cells and blood vessels that carry blood away from the heart (arteries). The entry of calcium into these cells is what causes the heart to contract and arteries to constrict. By blocking the entry of calcium, calcium channel blockers decrease heart contraction and dilate (widen) arteries, thereby reducing blood pressure. It is not recommended for children under 18 years.

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

Do not take Lercanidipino Viatris

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

• Untreated heart failure.
• Obstruction of the heart's outflow.
• 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 medications that are inhibitors of hepatic metabolism such as:

• Fungal medications (such as ketoconazol or itraconazol).
• Macrolide antibiotics (such as erythromycin, troleandomycin, or claritromycin).
• Antivirals (such as ritonavir).
• If you are taking other medications containing ciclosporina (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 Lercanidipino Viatris:

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

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

Children and adolescents

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

Other medications and Lercanidipino Viatris

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

Taking lercanidipino with certain medications may alter the effect of these medications or lercanidipino.

It is of special importance that your doctor knows if you are being treated with any of the following medications:

• Phenitoína, phenobarbital, or carbamazepine (medications for treating epilepsy).
• Rifampicina (medication for treating tuberculosis).
• Midazolam (medication for helping you sleep).
• Cimetidina, more than 800 mg (medication for ulcers, indigestion, or heartburn).
• Digoxina (medication for treating certain heart problems).
• Terfenadina or astemizol (medications for allergies).
• Amiodarona, quinidina, or sotalol (medications for treating arrhythmias).
• Medications known as beta-blockers, for example, metoprolol (medication for treating high blood pressure).
• Simvastatina (a medication for lowering blood cholesterol levels).
• Orother medications for treating high blood pressure.

Taking Lercanidipino Viatris with food, drinks, and alcohol

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

Pregnancy and breastfeeding

It is not recommended to take lercanidipino if you are pregnant and should not be taken during breastfeeding. There are no data on the use of lercanidipino in pregnant women and during breastfeeding. If you are pregnant or breastfeeding, and not using an effective contraceptive method, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Lercanidipino has an insignificant influence on the ability to drive or operate machinery. However, side effects such as dizziness, weakness, fatigue, and, rarely, drowsiness may occur. Act with caution until you know how you tolerate lercanidipino.

Lercanidipino Viatris contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a problem with certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated 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 every day, preferably in the morning, at least 15 minutes before breakfast, as a fatty meal significantly increases the levels of the medication in the blood. Your doctor may decide to increase the dose to one 20 mg tablet daily if necessary.

It is recommended to swallow the tablets whole with half a glass of water. The groove is only for breaking the tablet if it is difficult to swallow it whole, but not for dividing it into equal doses.

Older patients

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

Patients with liver or kidney problems

Special care 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 old.

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 service or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Exceeding the recommended dose may cause a significant drop in your blood pressure and an irregular or faster heart rate. It may also cause loss of consciousness.

If you forget to take Lercanidipine Viatris

If you forget to take the 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 the missed doses.

If you interrupt treatment with Lercanidipine Viatris

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious. If you experience any of the following, inform 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 urticaria)
• Chest pain, often extending to the arms or neck, and sometimes to the shoulders and back, due to a lack of blood to the heart (angina pectoris).
• Loss of consciousness.

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

Other side effects:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Fast heart rate.
• Perception of heartbeats (palpitations).
• Flush (temporary redness of the face, neck, or upper chest).
• Swelling of the ankles.

Occasional (may affect up to 1 in 100 people)

• Dizziness.
• Sensation of weakness or fatigue.
• Decreased blood pressure.
• Heartburn.
• Abdominal pain.
• Discomfort.
• Rash on the skin.
• Itching.
• Muscle pain.
• Increased urine production.

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

• Drowsiness.
• Vomiting.
• Diarrhea.
• Urticaria.
• Increased frequency of urination.
• Chest pain.

Unknown frequency (cannot be estimated from available data)

• Increased levels of liver enzymes in blood tests.
• Inflammation of the gums.
• Cloudy urine (when performing a dialysis through a tube inside the abdomen),
• Swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Lercanidipine Viatris after the expiration date that appears on the label, container, or bottle after CAD or EXP. The expiration date is the last day of the month indicated.

Blister packs: Do not store above25°C. Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Lercanidipine Viatris Composition

The active ingredient 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 (type A), lactose monohydrate, microcrystalline cellulose.

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

Appearance of the product and contents of the package

Lercanidipine Viatris are yellow, round, biconvex tablets of 6.5 mm, film-coated, scored on one face and marked with a 'L' on the other face.

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

It is available in blisters 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.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate, Zejtun ZTN3000

Malta

Or

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

Island

Or

Balkanpharma – Dupnitsa AD

3 Samokovsko Str.

Dupnitsa 2600

Bulgaria

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainLercanidipine Viatris 10 mg film-coated tablets EFG

ItalyLercanidipina Mylan Italia

NetherlandsLercanidipine HCl Viatris 10 mg, filmomhulde tablets

PortugalLercanidipina Mylan10 mg film-coated tablet

United KingdomLercanidipine 10 mg Film-Coated Tablets

Last review date of this leaflet:November 2021

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