Lacidipine Doc Generici

Package leaflet: Information for the patient

LACIDIPINA DOC Generici 2 mg film-coated tablets, 4 mg film-coated tablets, 6 mg film-coated tablets

Lacidipine
Generic Medicine
Please read all of this leaflet carefully before you take 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LACIDIPINA DOC Generici is and what it is used for

LACIDIPINA DOC Generici contains a medicine called lacidipine. It belongs to a group of
medicines known as “calcium channel blockers”. LACIDIPINA DOC Generici helps relax blood
vessels so that they widen. This allows blood to flow more easily and reduces blood
pressure.
LACIDIPINA DOC Generici tablets, taken regularly as prescribed by your doctor, will help
lower your blood pressure (treat hypertension).

2. What you need to know before taking LACIDIPINE DOC Generics

Do not use LACIDIPINE DOC Generics

• 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 a heart condition called 'aortic stenosis'. This is a narrowing of a heart valve, which reduces blood flow.
• If you have had a heart attack within the last month.
• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• You must stop taking lacidipine if you experience chest pain (angina), or have rapid and weak heartbeat, rapid and shallow breathing, low blood pressure, cold and clammy skin, blue lips, or feel dizzy, lightheaded, weak, or nauseous.

Do not take LACIDIPINE DOC Generics if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking LACIDIPINE DOC Generics.

Warnings and precautions

Talk to your doctor or pharmacist before taking LACIDIPINE DOC Generics:

• if you have an irregular heartbeat or any other heart problems
• if you have or have ever had any liver problems.

Children and adolescents

LACIDIPINE DOC Generics is not recommended for use in children and adolescents under 18 years of age due to lack of experience regarding safety and efficacy in this age group.

Other medicines and LACIDIPINE DOC Generics

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines. This is because LACIDIPINE DOC Generics may affect how some other medicines work. Also, other medicines may affect how LACIDIPINE DOC Generics works.

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

• medicines for high blood pressure,
• medicines to control heart rhythm (called 'antiarrhythmics'),
• antidepressants called 'tricyclic antidepressants',
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole),
• antibiotics (e.g. rifampicin, erythromycin),
• sleeping pills or sedatives,
• medicines for psychiatric disorders,
• medicines used to treat epilepsy (seizures),
• antihistamines – used for hay fever or other allergies,
• cimetidine – used for stomach problems,
• cyclosporine (an immunosuppressant used in transplant patients),
• tetracosactide (used for diagnosis and treatment of adrenal cortex disorders),
• corticosteroids (used to treat inflammation, asthma, and certain skin conditions).

If you are due to have any blood tests, inform the person taking your blood sample that you are taking this medicine. This is because LACIDIPINE DOC Generics may alter liver-related test results.

LACIDIPINE DOC Generics with food, drinks and alcohol

LACIDIPINE DOC Generics can be taken with or without food.

Do not take this medicine with grapefruit juice.

Alcohol may increase the effect of this medicine. Caution is advised when consuming alcohol with LACIDIPINE DOC Generics.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take LACIDIPINE DOC Generics if you are pregnant, likely to become pregnant, or breastfeeding.

This medicine may reduce fertility in men.

Driving and using machines

You may feel dizzy while taking LACIDIPINE DOC Generics. If this happens, do not drive or operate tools or machinery.

LACIDIPINE DOC Generics contains lactose (milk sugar).

If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take LACIDIPINA DOC Generici

Take this medicine exactly as directed 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.

• The recommended starting dose is 2 mg every morning.
• After 3-4 weeks, this dose may be increased to 4 mg every morning.
• If necessary, the dose may be further increased to 6 mg every morning, which is the maximum daily dose.
• The tablets must not be removed from the blister pack until the time of administration.
• Swallow the tablets with a glass of water.
• Do not take the tablets with grapefruit juice.

LACIDIPINA DOC Generici 4 mg film-coated tablets
The tablet may be divided into two equal parts.
If, according to the recommended dosage, you need to take 2 mg of LACIDIPINA DOC Generici (i.e. half a 4 mg tablet), the unused half must be left in the blister and taken within 48 hours.

If you take more LACIDIPINA DOC Generici than you should
If you take more medicine than you should, contact your doctor or go immediately to the nearest hospital.
Take the package and the leaflet with you, even if no tablets are left.
Medical treatment may be necessary. Symptoms of overdose may include irregular heartbeat, rapid and shallow breathing, low blood pressure, cold and clammy skin, dizziness, fainting, weakness, or nausea.

If you forget to take LACIDIPINA DOC Generici
If you forget to take your morning dose, take it as soon as you remember during the same day. However, if you remember only the following day, take the normal dose that morning.
Do not take a double dose to make up for the missed dose.

If you stop taking LACIDIPINA DOC Generici
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking LACIDIPINA DOC Generici and contact your doctor immediately if you notice any of the
following serious side effects:

• chest pain (angina), including worsening chest pain,
• rapid swelling of the face, mouth and throat, which may cause difficulty breathing (angioedema),
• rapid and weak pulse, fast and shallow breathing, low blood pressure, cold and clammy skin, blue lips.

Side effects are categorized below according to their frequency:
Very common: may affect more than 1 in 10 people,
Common: may affect from 1 to 10 in 100 people,
Uncommon: may affect from 1 to 10 in 1,000 people,
Rare: may affect from 1 to 10 in 10,000 people,
Very rare: may affect less than 1 in 10,000 people,
Frequency not known: cannot be estimated from the available data.

Common:

• headache,
• dizziness,
• flushing (especially of the face),
• fast or irregular heartbeat (also known as palpitations),
• swelling (edema), particularly of the ankles. These side effects usually disappear with continued treatment,
• rapid heartbeat,
• upset stomach or feeling unwell (nausea),
• skin rash, redness of the skin, itching,
• increased volume of urine produced,
• feeling of weakness,
• changes in liver blood test results.

Uncommon:

• chest pain (angina), including worsening chest pain,
• fainting, low blood pressure, for example feeling faint,
• swollen gums.

Rare:

• angioedema (allergic reaction causing rapid swelling of the face, mouth and throat, which may cause difficulty breathing or swallowing),
• hives,
• depression,
• muscle cramps.

Very rare:

• tremor.

Frequency not known:

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

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

5. How to store LACIDIPINE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of this 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 DOC Generici contains
The active substance is lacidipine.
LACIDIPINA DOC Generici 2 mg film-coated tablets: each tablet contains 2 mg of lacidipine.
LACIDIPINA DOC Generici 4 mg film-coated tablets: each tablet contains 4 mg of lacidipine.
LACIDIPINA DOC Generici 6 mg film-coated tablets: each tablet contains 6 mg of lacidipine.
The other components are:
Core:
lactose, povidone, magnesium stearate;
Film coating: hypromellose, talc, propylene glycol, titanium dioxide (E171).

Description of the appearance of LACIDIPINA DOC Generici and contents of the pack
LACIDIPINA DOC Generici 2 mg film-coated tablets:
white, round, biconvex film-coated tablets.
LACIDIPINA DOC Generici 4 mg film-coated tablets:
white, oval, biconvex film-coated tablets with a break line on one side.
The tablet can be divided into two equal parts.
LACIDIPINA DOC Generici 6 mg film-coated tablets:
white, oval, biconvex film-coated tablets, engraved with “6 mg” on one side.

LACIDIPINA DOC Generici film-coated tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, placed in a cardboard carton with the package leaflet.

Pack sizes:
LACIDIPINA DOC Generici 2 mg film-coated tablets – 28 film-coated tablets.
LACIDIPINA DOC Generici 4 mg film-coated tablets – 28 film-coated tablets.
LACIDIPINA DOC Generici 6 mg film-coated tablets – 14 film-coated tablets.

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska 13
Poznań
60-198 Poland
Galenicum Health, S.L.
Avda. Cornellá 144
7th floor, 1st door, Building Lekla
Esplugues de Llobregat
08950 Barcelona
Spain
SAG Manufacturing SLU
Ctra. N-I, Km 36
28750 San Agustin de Guadalix
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Malta: Lacidipine DOC Generici
Italy: LACIDIPINA DOC Generici