Package Insert: Information for the Patient

Lercanidipine Stada 20 mg Film-Coated Tablets

lercanidipine hydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lercanidipino is a selective calcium channel blocker and belongs to a group of medications called dihydropyridines. Selective calcium channel blockers reduce elevated blood pressure. They dilate (widen) the arteries and consequently blood pressure decreases.

Lercanidipino is used for:

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

Do not take Lercanidipino Stada

-uncontrolled heart failure

-obstruction of blood flow from the heart

-unstable angina (angina at rest or progressively increasing)

-if you have had a heart attack in the past month

-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)

-ciclosporin (a medicine used to prevent rejection after a transplant)

-grapefruit or grapefruit juice

Warnings and precautions

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

• Wolff-Parkinson-White syndrome (a heart disease that may make the heart beat too fast or too slow) if not treated with the implantation of a pacemaker
• left ventricular dysfunction (a heart disease in which one of the heart's chambers cannot fill or pump blood properly)
• ischaemic heart disease (in which the blood supply to the heart is insufficient)
• pre-existing angina (chest pain)
• mild to moderate liver or kidney impairment

Other medicines and Lercanidipino Stada

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

Do not take lercanidipine with any medicine that inhibits metabolism andthereby may affect the effect and/or side effects of lercanidipine. Your doctor knows which medicines are. Examples include:

• ciclosporin (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.

Lercanidipine's effect is increased by:

• midazolam (a sedative)

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

Lercanidipine's effect 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 conditions; e.g. metoprolol)

Lercanidipine increases the effect of:

• digoxin (to treat heart conditions)
• simvastatin (a medicine to reduce cholesterol)

Taking Lercanidipino Stada with food, drinks and alcohol

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

Consuming alcohol may increase the effect and side effects of lercanidipine. Therefore, do not drink alcohol during treatment.

Grapefruit may increase the concentration of lercanidipine in the blood. Do not take grapefruit or grapefruit juice if you are taking lercanidipine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend 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 the baby through breast milk. If you continue your treatment with lercanidipine, you must stop breastfeeding.

Driving and operating machinery

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

Lercanidipino Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The tablet can be divided into equal doses.

Keep the half tablet protected from light, for example, by returning the unused half to the blister pack, with the blister pack foil over the tablet and inside the case. Take this half dose at the next intake.

Dose

Adults:

The usual dose is 10 mg once a day. Your doctor will decide if you need to increase the dose to 20 mg a day.

Older patients

Generally, no dose adjustment is needed for older patients.

Patients with liver or kidney insufficiency

In liver or kidney insufficiency, the initial usual dose is 10 mg once a day. Your doctor will increase the dose carefully. If you have severe liver or kidney insufficiency, do not take lercanidipino.

Use in children and adolescents

Lercanidipino is not recommended for use in children and adolescents under 18 years due to insufficient safety and efficacy data available.

If you take more Lercanidipino Stada than you should

If you take too many tablets, consult your doctor or the nearest hospital emergency service immediately. An overdose can cause excessive lowering of blood pressure, and the heart may beat slower or faster. This can cause loss of consciousness and other adverse effects. Other symptoms, described in section 4, Possible adverse effects, may be intensified in case of overdose.

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

If you forget to take Lercanidipino Stada

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

If you interrupt treatment with Lercanidipino Stada

Do not stop treatment with lercanidipino without consulting your doctor.

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.

The following side effects have been associated with lercanidipine:

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

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

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

• angina pectoris (chest pain)
• some similar medicines to lercanidipine may cause precordial pain (pain in the front of the chest)
• drowsiness
• nausea
• indigestion
• diarrhea
• abdominal pain
• vomiting
• polyuria (urinating large amounts)
• eruption
• 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 often, last longer, or be more severe
• isolated cases of heart attacks (myocardial infarction)
• syncope (fainting)
• increased levels of liver enzymes (transaminases) in blood tests (usually reversible when treatment is stopped)

• gingival hypertrophy (swelling of the gums)
• increased frequency of urination
• hypotension (low blood pressure)
• chest pain

Reporting of 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

The halves of the tablets must be protected from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lercanidipine Stada

The active ingredient is lercanidipine

One tablet contains 20 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate.

The other components are:

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

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

Appearance of the product and contents of the package

Lercanidipine Stada 20 mg film-coated tablets are pink, round, biconvex, 8.1 mm in diameter, and scored.

The tablet can be divided into equal doses.

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

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse, 2-18

D-61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

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

Last reviewed date of this leaflet: June 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob .es/