Lercanidipino Stada 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lercanidipino Stada 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.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may 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 Lercanidipino Stada is and what it is used for
2. What you need to know before taking Lercanidipino Stada
3. How to take Lercanidipino Stada
4. Possible side effects
5. How to store Lercanidipino Stada
6. Contents of the pack and other information

1. What Lercanidipine Stada is and what it is 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, thereby lowering blood pressure.

Lercanidipine is used for:

• treatment of mild to moderate elevated blood pressure (essential hypertension).

2. What you need to know before taking Lercanidipine Stada

DO NOT take Lercanidipine Stada

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

• if you have had allergic reactions to medicines closely related to lercanidipine (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)

• if you are pregnant or breastfeeding, or if you might become pregnant (see section 2, Pregnancy and breastfeeding)

• if you have certain heart conditions:

  • uncontrolled heart failure
  • obstruction of blood flow out of the heart
  • unstable angina (angina at rest or progressively worsening)
  • if you have had a heart attack within the last month

• 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 itraconazol)
  • macrolide antibiotics (such as erythromycin or troleandomycin)
  • antiviral medicines (such as ritonavir, a medicine used to treat AIDS)
  • cyclosporine (a medicine used to prevent transplant rejection)
  • grapefruit or grapefruit juice

Warnings and precautions

Talk to your doctor or pharmacist before taking lercanidipine, especially if you have or have had any of the following conditions or disorders:

• sick sinus syndrome (a heart condition that may cause the heart to beat too fast or too slow) if not treated with a pacemaker
• left ventricular dysfunction (a heart condition in which one of the heart chambers cannot fill or pump blood properly)
• ischemic heart disease (a condition in which 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 need to take any other medicines.

DO NOT take lercanidipine together with any medicine that inhibits metabolism and thus may affect the effect and/or adverse effects of lercanidipine. Your doctor knows which medicines these are. Examples include:

• cyclosporine (a medicine used to prevent transplant rejection)
• ketoconazole and itraconazole (medicines used to treat fungal infections)
• ritonavir (a medicine used to treat AIDS)
• erythromycin or troleandomycin (antibiotics)

Some other medicines that are metabolized (activated or modified) by the CYP3A4 enzyme or that induce this enzyme may affect the blood concentration of lercanidipine. 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 to treat hay fever and other allergies)

• amiodarone, quinidine (used to treat irregular heartbeats)

• cimetidine (used to treat certain stomach ulcers), when administered at high doses (>800 mg per day)

The effect of lercanidipine is reduced by:

• phenytoin, carbamazepine (anticonvulsant medicines used to treat epilepsy)
• rifampicin (an antibiotic)
• beta-blockers (medicines used to treat high blood pressure and heart disorders; e.g. metoprolol)

Lercanidipine increases the effect of:

• digoxin (used to treat heart disorders)
• simvastatin (a medicine used to lower 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 blood concentration of lercanidipine. You must not consume grapefruit or grapefruit juice while being treated with lercanidipine.

Pregnancy and breastfeeding

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

Pregnancy

Lercanidipine must not be taken during pregnancy. If you wish to become pregnant, or think you may be pregnant, consult your doctor. Your treatment will be changed.

Breastfeeding

Lercanidipine must not be taken while breastfeeding. Lercanidipine may pass into breast milk. If you continue treatment with lercanidipine, you must stop breastfeeding.

Driving and using machines

Lercanidipine may cause dizziness, weakness, fatigue and drowsiness. If you are affected, do not drive or operate machinery.

Lercanidipine Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of 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; this means it is essentially “sodium-free”.

3. How to take Lercanidipino Stada

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

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

Dosage

Adults:

The usual dose is 10 mg once daily. Your doctor will decide whether it is necessary to increase your dose to 20 mg per day.

Elderly patients:

In general, dose adjustment is not required in elderly patients.

Patients with liver or kidney impairment:

In liver or kidney impairment, the usual starting dose is 10 mg once daily. Your doctor will carefully increase your dose. If you have severe liver or kidney impairment, you must not take lercanidipine.

Use in children and adolescents:

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

If you take more Lercanidipino Stada than you should

If you take too many tablets, consult your doctor or the nearest hospital emergency department immediately. An overdose may cause excessive lowering of blood pressure, and the heart may beat more slowly or more rapidly. This may 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 at telephone number 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Lercanidipino Stada

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

If you stop taking Lercanidipino Stada

Do not stop treatment with lercanidipine without consulting your doctor.

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 have been associated with lercanidipine:

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

• fast heartbeat (tachycardia)
• awareness of heartbeat (palpitations)
• peripheral edema (fluid accumulation in the limbs, especially in the legs)
• headache
• dizziness
• flushing (skin redness, 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 part 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, symptoms may occur more frequently, last longer, or be more severe
• isolated cases of heart attacks (myocardial infarction)
• fainting (syncope)
• increased liver enzyme levels (transaminases) in blood tests (usually reversible when treatment is stopped)
• swelling of the gums (gingival hyperplasia)
• increased frequency of urination
• hypotension (low blood pressure)
• chest pain

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 can 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 Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:

Tablet core: lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, hypromellose, colloidal anhydrous silica, magnesium stearate.

Film coating: 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 in diameter, and scored.

The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide it into equal doses.

Lercanidipine Stada is available in packs containing 10, 14, 28, 30, 50, 56, 84, 98, 100, 126 or 154 tablets in opaque white 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)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

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

Date of last review of this leaflet: June 2020

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