Lacidipine Mylan Pharma

Package leaflet: Information for the patient

Lacidipine Mylan Pharma 2 mg, 4 mg and 6 mg film-coated tablets

Lacidipine
Generic Medicine
Please read all of 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 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 yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lacidipine Mylan Pharma is and what it is used for

Lacidipine Mylan Pharma tablets contain the active substance lacidipine, which belongs to a group of
medicines called "calcium channel blockers". Lacidipine Mylan Pharma promotes relaxation of the
blood vessels, causing them to widen. This helps blood to flow more easily and lowers blood pressure.
When taken regularly as prescribed by your doctor, Lacidipine Mylan Pharma will help to lower
blood pressure (in the treatment of hypertension).

2. What you need to know before taking Lacidipine Mylan Pharma

Do not take Lacidipine Mylan Pharma:

• If you are allergic to lacidipine, to other calcium channel blocker medicines, or to any of the other ingredients of this medicine (listed in section 6)
• If you have the 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 previous month.

Do not take Lacidipine Mylan Pharma if you are in any of the above conditions. If in
doubt, consult your doctor or pharmacist before taking this medicine.
You must stop taking Lacidipine Mylan Pharma if you experience chest pain (angina), weak pulse, rapid pulse, rapid shallow breathing, low blood pressure, cold and clammy skin, blue lips, or dizziness, fainting, weakness, or nausea.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lacidipine Mylan Pharma:

• If you have an irregular heartbeat or any other heart problem
• If you have or have had liver problems.

If you undergo blood tests, inform the staff performing the blood draw that you are taking this
medicine. This is because Lacidipine Mylan Pharma may affect the results of liver function tests.
Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as it is not
recommended for this age group.
Other medicines and Lacidipine Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine. Lacidipine Mylan Pharma may affect the action of certain medicines. Likewise, other medicines may influence the mechanism of action of Lacidipine Mylan Pharma.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines for treating high blood pressure: such as beta-blockers (e.g. atenolol, propranolol), diuretics (called “water tablets” e.g. bendroflumethiazide, furosemide), and ACE inhibitors (e.g. enalapril, ramipril)
• ciclosporin, a medicine used to prevent organ transplant rejection
• rifampicin, a medicine used to treat tuberculosis
• itraconazole, a medicine used to treat fungal infections
• medicines for controlling heart rhythm (called “antiarrhythmics” e.g. disopyramide, flecainide, amiodarone)
• medicines for treating depression called “tricyclic antidepressants” (e.g. clomipramine, imipramine)
• antibiotics, medicines used to treat infections (e.g. erythromycin)
• antihistamines, medicines used to treat hay fever or other allergies (e.g. terfenadine)
• cimetidine, a medicine used to treat stomach problems
• tetracosactide, a medicine used to test adrenal gland function
• corticosteroids, a group of medicines used to reduce inflammation (e.g. prednisone, hydrocortisone).

Lacidipine Mylan Pharma with food and drink
Do not consume grapefruit or grapefruit juice while taking this medicine.
Pregnancy and breastfeeding
There are insufficient data on the use of lacidipine in pregnant women. Problems such as difficulty in conception, miscarriages, or difficult deliveries may occur.
Lacidipine is excreted in breast milk. Lacidipine Mylan Pharma is not recommended unless your doctor considers that the benefit to you outweighs the risks to the infant.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine may cause dizziness. If you experience this side effect, do not drive or operate machinery.
Lacidipine Mylan Pharma contains lactose
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Lacidipine Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults
It is important to take the correct number of tablets at the correct time of day.

• The recommended starting dose is 2 mg every morning.
• 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.
• Swallow the tablets whole with water.
• Do not take the medicine with grapefruit juice.

The 4 mg tablet may be divided into two equal doses.
Patients with liver problems
Your doctor may decide to prescribe a lower dose if you have severe liver problems.
If you take more Lacidipine Mylan Pharma than you should
If you take more of this medicine than prescribed, consult a doctor or go immediately
to the nearest hospital emergency department. You may experience low blood pressure or changes in
your heartbeat.
Take the medicine pack with you, even if it no longer contains tablets.
If you forget to take Lacidipine Mylan Pharma
If you forget a morning dose, take it as soon as you remember on the same day. However, if you remember
only the next day, take your normal dose that morning. Do not take a double dose to make up for the
forgotten dose.
If you stop taking Lacidipine Mylan Pharma
If you are thinking about stopping or have stopped treatment with Lacidipine Mylan Pharma, speak to your doctor or
pharmacist.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately or go to the nearest hospital Emergency Department if you notice any of the following serious side effects – you may need urgent medical treatment:

• chest pain or a sensation of pressure in the chest, including worsening chest pain. These may be signs of angina, which is more likely to occur when you first start taking this medicine or if you already have heart problems;
• severe allergic reactions such as rapid swelling of the face, mouth, lips, tongue or throat, which may cause difficulty breathing or swallowing.

Other possible side effects include:
Common (may affect up to 1 in 10 people)

• dizziness
• headache
• fast or irregular heartbeat, which you may feel as pounding in your chest (also known as palpitations)
• flushing
• swelling (fluid retention), particularly in the ankles
• stomach upset
• feeling unwell (nausea)
• rash, redness, itching
• increased urine production
• feeling of weakness
• changes in liver blood test results.

Uncommon (may affect up to 1 in 100 people)

• low blood pressure, which may cause a feeling of faintness
• fainting
• bleeding, tightness or swelling of the gums.

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

• itchy rash (urticaria)
• muscle cramps. Very rare (may affect up to 1 in 10,000 people)
• tremor
• depression.

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

5. How to store Lacidipine Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Remove the tablet from the blister only when ready to take the medicine.
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 Mylan Pharma contains
The active substance is lacidipine. Each film-coated tablet contains 2 mg, 4 mg or 6 mg.
The other components are monohydrate lactose (see section 2 “Lacidipina Mylan Pharma contains lactose”), povidone, crospovidone and magnesium stearate. The coating film contains hypromellose, titanium dioxide (E171) and macrogol.
Description of the appearance of Lacidipina Mylan Pharma and contents of the pack

The 2 mg tablets are film-coated, round and white in colour. The logo is engraved on one side and “225” on the other side.

The 4 mg tablets are film-coated, oval and white in colour. The logo is engraved on one side and “2” and “24” separated by a breakline on the other side.

The 6 mg tablets are film-coated, oval and white in colour. The logo is engraved on one side and “226” on the other side.
Lacidipina Mylan Pharma is available in blister packs containing 14 or 28 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturer responsible for batch release
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
Dr. Reddy’s Laboratories (UK) Ltd., Beverley, East Yorkshire, United Kingdom
This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Lacidipina Mylan Pharma
Poland: Lapimyl
United Kingdom: Lacidipine 2 mg, 4 mg & 6 mg Film-coated Tablets