LERCANIDIPINE STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lercanidipine Stada 10 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.
• 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 Package Leaflet

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

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

Lercanidipine is a selective calcium channel blocker and belongs to a group of medicines called dihydropyridines. Selective calcium channel blockers reduce high blood pressure. They dilate (widen) the arteries, and consequently, the blood pressure drops.

Lercanidipine is used for:

• treatment of high blood pressure, from mild to moderate (essential hypertension).

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

Do not take Lercanidipine Stada

• if you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have had allergic reactions to medicines that are closely related to lercanidipine (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine, or lacidipine).
• if you are pregnant or breastfeeding, or if you may become pregnant (see section 2, Pregnancy and breastfeeding).
• if you have certain heart diseases:

• uncontrolled heart failure
• obstruction of blood flow out of the heart
• unstable angina (angina at rest or progressively increasing)
• if you have had a heart attack less than a month ago

• if you have severe liver or kidney problems
• if you are taking medicines or foods that may affect the effectiveness or adverse reactions of lercanidipine, such as:

• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin or troleandomycin)
• antivirals (such as ritonavir, a medicine for the treatment of AIDS)
• cyclosporin (a medicine used to prevent rejection after a transplant)
• with grapefruit or grapefruit juice

Warnings and precautions

Consult your doctor or pharmacist before starting to take lercanidipine, especially if you have or have had any of the following diseases or disorders:

• sick sinus syndrome (a heart disease that can cause the heart to beat too fast or too slow) if it has not been treated with a pacemaker
• left ventricular dysfunction (a heart disease in which one of the heart chambers cannot fill or pump blood properly)
• ischemic heart disease (in which the blood supply to the heart is insufficient)
• pre-existing angina pectoris (chest pain)
• moderate liver or kidney impairment

Other medicines and Lercanidipine Stada

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

Do nottake lercanidipine with any medicine that inhibits its metabolism and may therefore influence its effect and/or adverse effects. Your doctor knows which medicines these are. Among them are, for example:

• cyclosporin (a medicine used to prevent rejection after a transplant)
• ketoconazole and itraconazole (medicines for the treatment of fungal infections)
• ritonavir (a medicine for the treatment of AIDS)
• erythromycin or troleandomycin (antibiotics)

Some other medicines that are metabolized (activated or modified) by the enzyme CYP3A4 or that induce this enzyme may affect the concentration of lercanidipine in the blood. Therefore, consult your doctor if you are taking any other medicine.

The effect of lercanidipine is increased by:

• midazolam (a sedative)

• terfenadine or astemizole (antihistamines used for the treatment of hay fever and other allergies)
• amiodarone, quinidine (for the treatment of irregular heartbeats)
• cimetidine (for the treatment of certain stomach ulcers), if administered at high doses (>800 mg per day)

The effect of lercanidipine is reduced by:

• phenytoin, carbamazepine (anticonvulsant medicines for the treatment of epilepsy)
• rifampicin (an antibiotic)
• beta-blockers (medicines for the treatment of high blood pressure and heart disorders; e.g., metoprolol)

Lercanidipine increases the effect of:

• digoxin (for the treatment of heart disorders)
• simvastatin (a medicine for reducing cholesterol)

Taking Lercanidipine Stada with food, drinks, and alcohol

Always take lercanidipine at least 15 minutes before a meal (breakfast).

Consumption of alcohol may increase the effect and adverse reactions of lercanidipine. Therefore, you should not drink alcohol during treatment.

Grapefruit may increase the concentration of lercanidipine in the blood. You should not take grapefruit or grapefruit juice if you are being treated with lercanidipine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Lercanidipine should not be taken if you are pregnant. If you wish to become pregnant or think you may be pregnant, consult your doctor. Your treatment will be changed.

Breastfeeding

Lercanidipine should not be taken if you are breastfeeding. Lercanidipine may pass into breast milk. If you continue treatment with lercanidipine, you should stop breastfeeding.

Driving and using machines

Lercanidipine may cause dizziness, weakness, fatigue, and somnolence. If you are affected, do not drive or use machines.

Lercanidipine Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult 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 Stada

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

The whole or half tablet of lercanidipine should be swallowed complete with a glass of water, preferably in the morning, at least 15 minutes before breakfast.

Dose

Adults:

The normal dose is 10 mg once a day. Your doctor will decide if it is necessary to increase your dose to 20 mg per day.

Elderly patients

Generally, it is not necessary to adjust the dose in elderly patients.

Patients with liver or kidney impairment:

In liver or kidney impairment, the initial normal dose is 10 mg once a day. Your doctor will carefully increase your dose. If you have severe liver or kidney impairment, you should not take lercanidipine.

Use in children and adolescents:

The use of lercanidipine is not recommended in children and adolescents under 18 years due to insufficient safety and efficacy data.

If you take more Lercanidipine Stada than you should

If you take too many tablets, consult your doctor or the emergency department of the nearest hospital immediately. An overdose may cause a significant drop in blood pressure, and the heart may beat more slowly or more quickly. This can lead to loss of consciousness and other adverse effects. Other symptoms, described in section 4, Possible side effects, may be intensified in case of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Lercanidipine Stada

Do not take a double dose to make up for forgotten doses. Take the next dose as usual.

If you stop taking Lercanidipine Stada

Do not stop treatment with lercanidipine without consulting your doctor.

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.

The following side effects have been associated with lercanidipine:

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

• rapid heartbeat (tachycardia)
• awareness of heartbeat (palpitations)
• peripheral edema (fluid accumulation in the limbs, especially in the legs)
• headache
• dizziness
• flushing (redness of the skin, particularly of the face)

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

• angina pectoris (chest pain)
• some medicines similar to lercanidipine may cause precordial pain (pain in the front of the chest)
• somnolence
• nausea
• indigestion
• diarrhea
• abdominal pain
• vomiting
• polyuria (passing large amounts of urine)
• rash
• muscle pain
• weakness
• fatigue

Very rare(may affect up to 1 in 10,000 people):

• if you have angina pectoris, the symptoms may occur more frequently, last longer, or be more severe
• isolated cases of heart attack (myocardial infarction)
• fainting (syncope)
• increase in liver enzyme values (transaminases) in blood tests (usually reversible when treatment is discontinued)

• gum hypertrophy (gum overgrowth)
• increased frequency of urination
• hypotension (low blood pressure)
• chest pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Stada

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

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Stada

The active substance is lercanidipine.

One tablet contains 10 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate.

The other ingredients are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, hypromellose, colloidal anhydrous silica, magnesium stearate.

Coating with film: hypromellose, macrogol 8000, titanium dioxide (E-171), talc, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Lercanidipine Stada 10 mg film-coated tablets are yellow, round, biconvex, 6.5 mm, and scored.

The score line serves to facilitate breaking and swallowing but not to divide into equal doses.

Lercanidipine Stada is available in packs containing 10, 14, 28, 30, 50, 56, 84, 98, 100, 126, or 154 tablets in white opaque aluminum/PVC/PVDC blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse, 2-18

D-61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Eurogenerics N.V.

Heizel Esplanade B22

B-1020 Brussels

Belgium

or

Clonmel Healthcare Ltd.

Waterford Road

IRL-Clonmel

Co Tipperary

Ireland

or

LAMP SAN PROSPERO S.pA.

Via della Pace, 25/A

41030 San Prospero (Modena)

Co Tipperary

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

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

Date of last revision of this leaflet:June 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/