Lacidipine Teva 4 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lacidipine Teva 4 mg film-coated tablets EFG

lacidipine

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Lacidipino Teva contains a medicine called lacidipine. It belongs to a group of medicines known as "calcium channel blockers". Lacidipino Teva helps relax blood vessels so they can widen. This allows blood to flow more easily and reduces blood pressure. When taken regularly as prescribed by your doctor, Lacidipino Teva helps lower your blood pressure (to treat hypertension).

2. What you need to know before starting to take Lacidipine Teva

Do not take Lacidipine Teva

• If you are allergic to lacidipine, to other calcium channel blockers, or to any of the other ingredients of this medicine (listed in section 6).
• If you have the serious heart condition called "aortic stenosis". This is a narrowing of a valve in your heart, which reduces blood flow.

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

Warnings and precautions

Talk to 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 within the last month or if you have chest pain (angina).

Children and adolescents

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

Taking Lacidipine Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines. This is because this medicine may affect how other medicines work. Other medicines may also affect how Lacidipine Teva works.

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

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

If you are having a blood test, inform the healthcare professional that you are taking this medicine. This is because Lacidipine Teva may affect test results related to your liver.

Taking Lacidipine Teva with food, drinks, and alcohol

You may take this medicine on an empty stomach or with food.

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

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

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

Lacidipine Teva contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Lacidipine Teva

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

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

Adults

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

Method of administration

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

If you take more Lacidipine Teva than you should

If you take more of this medicine than you should, consult your doctor, go immediately to hospital, or call the Toxicology Information Service at telephone number 91 562 04 20. Please take this leaflet, any remaining tablets, and the container to the hospital or doctor so they know which tablets you have taken. Medical treatment may be necessary.

An overdose may cause effects such as irregular heartbeat, rapid and irregular breathing, low blood pressure, cold and clammy skin, 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 dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

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

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

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

The following adverse effects have been reported:

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

• headache
• dizziness
• flushing
• fast (tachycardia) or irregular (palpitations) heartbeat
• stomach discomfort (nausea)
• pruritus
• increased amount of urine produced (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):

• urticaria
• muscle cramps

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

• tremor
• depression

Not known (frequency cannot be estimated from the available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Lacidipine Teva

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following CAD or EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Lacidipine Teva

The active substance is lacidipine.

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

The other components are:

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

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

Appearance of the product and contents of the container

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

The tablets are packed in aluminum blisters.

Lacidipine Teva tablets are available in blister packs containing 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, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer:

TEVA Pharmaceutical Works CO. LTD

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The 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 medicinal product is registered in the EEA Member States under 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

The Netherlands: Lacidipine 4 mg Teva, filmomhulde tabletten

Date of the most recent review of this leaflet: December 2022

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. 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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