Lacidipine Teva

Package Leaflet: Information for the User

Lacidipine Teva 2 mg film-coated tablets, 4 mg film-coated tablets

Generic medicine
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 Lacidipina Teva is and what it is used for

Lacidipina Teva contains a medicine called lacidipine. This substance belongs to a group of medicines called 'calcium antagonists'. Lacidipina Teva helps relax the blood vessels so that they widen. This allows blood to flow more easily and lowers blood pressure. When taken regularly as prescribed by your doctor, Lacidipina Teva tablets help lower 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, to other calcium antagonists, or to any of the excipients of this medicine (listed in section 6);
• if you have a serious heart condition called "aortic stenosis". This is the narrowing of a heart valve that restricts blood flow.

Do not take Lacidipine Teva if you are in any of the conditions described above. If you have any doubts, consult your doctor or pharmacist before taking Lacidipine Teva.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Lacidipine Teva 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
Administration of Lacidipine Teva is not recommended in children and adolescents under 18 years of age.
Other medicines and Lacidipine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines.
This is because Lacidipine Teva may affect how some medicines work. Likewise, some other medicines may affect how Lacidipine Teva works.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

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

If you are undergoing blood tests, inform the staff performing the blood draw that you are taking this medicine. This is because Lacidipine Teva may affect liver function test results.
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 Lacidipine Teva.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may experience dizziness when taking Lacidipine Teva. If this occurs, do not drive and avoid using tools or machinery.
Lacidipine Teva contains lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Lacidipine Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is important to take the correct number of tablets at the right time of 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 once daily in the morning.
• If necessary, the dose may be further increased to 6 mg once daily in the 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 this medicine with grapefruit juice.

Lacidipine Teva 4 mg: The tablet may be divided into equal parts.

If you take more Lacidipine Teva than you should
If you take more tablets than prescribed, inform your doctor or go to hospital immediately. Take this leaflet, any remaining tablets, and the container with you so that it is clear which tablets have been taken. Medical treatment may be necessary.
An overdose may cause effects such as irregular heartbeat, shortness of breath and rapid breathing, low blood pressure, cold and sweaty skin, or dizziness, fainting, weakness, or nausea.

If you forget to take Lacidipine Teva
If you forget to take a tablet, take it as soon as you remember, provided it is still the same day. However, if it is almost time for your next dose, skip the missed dose and take the next tablet at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately tell your doctor if you notice any of the following side effects:

• chest pain (angina), including worsening chest pain (uncommon: may affect up to 1 in 100 people)
• angioedema (an allergic reaction causing 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
• hot flushes
• fast (tachycardia) or irregular heartbeat (palpitations)
• stomach upset or nausea
• skin rash
• increased amount of urine produced (polyuria)
• feeling of weakness (asthenia)
• swelling (edema), especially of the ankles
• changes in blood test results related to liver values

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

• low blood pressure (hypotension)
• fainting
• swelling of the gums (gingival hyperplasia)

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

• hives (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 and changes in muscle tone and slowing of movements

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the carton after "Exp.". The expiry date refers to the last day of that month.
Keep the blister in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacidipina Teva contains
The active substance is lacidipine.
Lacidipina Teva 2 mg film-coated tablets: each tablet contains 2 mg of lacidipine.
Lacidipina Teva 4 mg film-coated tablets: each tablet contains 4 mg of lacidipine.
The other components are:
Tablet core: povidone K-30, lactose, sodium starch glycolate type A, magnesium stearate.
Film coating: titanium dioxide (E171), hypromellose (E464), arabic gum (E414), monohydrate lactose, talc (E553b). The 2 mg tablets contain yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Lacidipina Teva and pack contents
Lacidipina Teva 2 mg film-coated tablets: round, biconvex, film-coated tablets, beige in colour, marked with "2LC" on one side and smooth on the other.
Lacidipina Teva 4 mg film-coated tablets: oval, biconvex, film-coated tablets, white in colour, marked with "4", a break line and "LC" on one side and smooth on the other.
The tablets are packaged in aluminium blisters.
Lacidipina Teva 2 mg film-coated tablets are available in packs of 14, 15, 28, 30, 56, 60, 84, 90 and 98 tablets.
Lacidipina Teva 4 mg film-coated tablets are available in packs of 14, 15, 28, 30, 56, 60, 84, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
Pharmachemie BV
Swensweg 5, 2031 GA Haarlem (The Netherlands)
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80, 31-546 Krakow (Poland)
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, 747 70 Opava-Komarov (Czech Republic)

This medicinal product is authorised in the European Economic Area countries under the
following names:
Denmark: Lacidipin Teva
Spain: Lacidipino Teva 4 mg comprimidos EFG
Italy: Lacidipina Teva 2 mg, 4 mg compresse rivestite con film
The Netherlands: Lacidipine 2 mg, 4 mg Teva, filmohulde tabletten
Slovenia: Lacidipin Teva 4 mg filmsko obložene tablete