LACIDIPINE TEVA 4 mg FILM-COATED TABLETS

Introduction

Project: Information for the User

Lacidipine Teva 4 mg Film-Coated Tablets EFG

lacidipine

Read this entire leaflet carefully before starting to take this medication, as 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, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet:

1. What is Lacidipine Teva and what is it used for
2. What you need to know before taking Lacidipine Teva
3. How to take Lacidipine Teva
4. Possible side effects
5. Storage of Lacidipine Teva
6. Package contents and additional information

1. What is Lacidipine Teva and what is it used for

Lacidipine Teva contains a medication called lacidipine. This belongs to a group of drugs called "calcium channel blockers". Lacidipine Teva helps to relax blood vessels so that they are more dilated. This helps the blood to flow more easily and reduces blood pressure. Lacidipine Teva taken regularly as prescribed by your doctor helps to reduce your blood pressure (to treat hypertension).

2. What you need to know before taking Lacidipine Teva

Do not take Lacidipine Teva

• If you are allergic to lacidipine, other calcium channel blockers, or any of the other components of this medication (listed in section 6).
• If you have a severe heart problem "aortic stenosis". This is a narrowing of a heart valve, which reduces blood flow.

Do not take Lacidipine Teva if you have any of the above circumstances. If you are unsure, consult your doctor or pharmacist before taking Lacidipine Teva.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Lacidipine if:

• you have an irregular heartbeat or any other heart problem.
• you have or have had any liver problems.
• you have had a heart attack in the last month or if you have chest pains (angina).

Children and adolescents

Lacidipine Teva is not recommended for use in children and adolescents under 18 years of age.

Taking Lacidipine Teva with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This includes herbal medicines. This is because this medication may affect how other medications work. Other medications may also affect how Lacidipine Teva works.

In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• medications to increase blood pressure.
• medications to treat fungal infections.
• medications to control heart rhythm (called "antiarrhythmics").
• medications for depression called "tricyclic antidepressants".
• medications for allergies (e.g., terfenadine).
• antibiotics (e.g., rifampicin, erythromycin).
• some antipsychotics (medications for treating schizophrenia and other psychotic disorders).
• cimetidine - used for gastric disorders.
• cyclosporin (immunosuppressive agent used, e.g., for transplant recipients).
• corticosteroids or tetracosactide for the treatment of inflammatory bowel disease (IBD), Crohn's disease, arthritis, and osteoarthritis.

If you are going to have a blood test, inform that you are taking this medication. This is because Lacidipine Teva may affect the results related to your liver.

Taking Lacidipine Teva with food, drinks, and alcohol

You can take this medication on an empty stomach or with food.

Do not take this medication with grapefruit juice. Do not consume alcohol during treatment with this medication.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

You may feel dizzy while taking Lacidipine Teva. If this happens, do not drive or operate tools or machines.

Lacidipine Teva contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

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

3. How to take Lacidipine Teva

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

It is important to take the correct number of tablets at the same time.

Adults

• The recommended dose is 2 mg per day, preferably in the morning, with or without food.
• After 3-4 weeks, it may be increased to 4 mg every morning.
• If necessary, it may be increased again to 6 mg every morning, which is the maximum daily dose.

Method of administration

• Swallow the tablets whole with water.
• Take the tablets every day at the same time, preferably in the morning.
• Do not take them with grapefruit juice.
• The tablet can be divided into equal doses.

If you take more Lacidipine Teva than you should

If you take more of this medication than you should, consult your doctor, go directly to the hospital, or call the Toxicology Information Service, phone 91 562 04 20. Please bring this leaflet, any tablets, and the packaging to the hospital or doctor so they know which tablets you have taken. Medical treatment may be necessary.

An overdose can cause effects such as irregular heartbeat, rapid and irregular breathing, low blood pressure, cold and sweaty skin, feeling of dizziness or fainting, weakness, or illness.

If you forget to take Lacidipine Teva

If you forget to take a tablet, take it as soon as you remember on the same day. However, if it is almost time for the next tablet, you should skip the missed dose and take the next one normally. Do not take a double dose to make up for missed doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Tell your doctor immediately if you notice the following side effects:

• chest pain (angina), including worsening chest pain (uncommon: may affect up to 1 in 100 people).
• angioedema (allergic reaction that causes swelling of the face) (rare: may affect up to 1 in 1,000 people).

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

• headache.
• dizziness
• flushing
• rapid or irregular heartbeat (tachycardia or palpitations)
• stomach upset (nausea).
• itching
• increased urine production (polyuria)
• feeling of weakness (asthenia)
• swelling (edema), particularly in the ankles
• changes in blood test results related to the liver.

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

• low blood pressure (hypotension)
• fainting
• gum inflammation (gingival hyperplasia)

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

• hives
• muscle cramps

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

• tremors
• depression

Unknown (cannot be estimated from available data):

• tremors or tics, changes in muscle tone, and slow movement.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lacidipine Teva

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

Do not use this medication after the expiration date stated on the blister pack and carton after CAD or EXP. The expiration date is the last day of the month indicated.

Keep the blister pack in the carton to protect it from light.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Lacidipine Teva

The active ingredient is lacidipine.

Lacidipine Teva 4 mg film-coated tablets: Each tablet contains 4 mg of lacidipine.

The other ingredients are:

Core: povidone K-30, anhydrous lactose, sodium starch glycolate type A (derived from potato), magnesium stearate.

Coating: titanium dioxide (E-171), hypromellose (E-464), arabic gum (E-414), lactose monohydrate, talc (E553b).

Appearance of the product and package contents

Lacidipine Teva 4 mg film-coated tablets: white, oval, biconvex tablets, scored and marked with "4" and "LC" on one side and plain on the other.

The tablets are packaged in aluminum blisters.

Lacidipine Teva tablets are available in blisters of 14, 15, 28, 30, 56, 60, 84, 90, 98, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid.

Manufacturer:

TEVA Pharmaceutical Works CO. LTD

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80, 31-546 Krakow

Poland

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 747 70 Opava-Komarov

Czech Republic

This medication is registered in the EEA Member States with the following names:

Denmark: Lacidipin Teva

Slovenia: Lacidipin Teva 4 mg filmsko obložene tablete

Spain: Lacidipino Teva 4 mg comprimidos EFG

Italy: Lacidipina Teva 4 mg compresse rivestite con film

Netherlands: Lacidipine 4 mg Teva, filmomhulde tabletten

Date of the last revision of this leaflet:December 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73875/P_73875.html

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