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Lacidipine 4mg Film-Coated Tablets

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Package Leaflet: Information for the Patient

Lacidipine 2 mg, 4 mg Film-Coated Tablets

Lacidipine

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 further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Lacidipine is and what it is used for

2.    What you need to know before you take Lacidipine

3.    How to take Lacidipine

4.    Possible side effects

5.    How to store Lacidipine

6.    Contents of the pack and other information

1. What Lacidipine is and what it is used for

Lacidipine tablets contain a medicine called lacidipine. This belongs to a group of medicines called 'calcium channel blockers'. Lacidipine helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure.

Lacidipine tablets taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension).

2. What you need to know before you take Lacidipine

Do not take Lacidipine:

•    if you are pregnant, likely to get pregnant or are breast-feeding

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

•    if you have the heart problem 'aortic stenosis'.

This is a narrowing of a valve in your heart, which restricts blood flow

•    if you have had a heart attack within the last month.

Do not take Lacidipine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking the medicine.

You should stop taking Lacidipine if you get chest pain (angina) or a fast, weak pulse, rapid shallow breathing, low blood pressure, cold clammy skin, blue lips or feel dizzy, faint, weak or sick.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lacidipine:

•    if you have an uneven heart beat or any other heart problems

•    if you have or have ever had any liver problems.

If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Lacidipine can affect results relating to your liver.

Other medicines and Lacidipine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Lacidipine can affect the way some other medicines work. Also some other medicines can affect the way Lacidipine works.

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

•    medicines for high blood pressure

•    medicines to control your heart beat (called 'anti-arrhythmics')

•    medicines for depression called 'tricyclic antidepressants'

•    sleeping tablets or sedatives

•    antibiotics

•    antihistamines-used for hayfever and other allergies

•    cimetidine-used for stomach problems

•    tetracosactide and corticosteroids.

Lacidipine with food and drink

Do not take this medicine with grapefruit juice.

Pregnancy and breast-feeding

Do not take Lacidipine if you are pregnant, likely to get pregnant or are breast-feeding.

Driving and using machines

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

Lacidipine tablets contain lactose

If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

3. How to take Lacidipine

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

It is important to take the right number of tablets at the right time of day.

•    The usual starting dose is 2 mg every morning.

•    After 3-4 weeks this may be increased to 4 mg every morning.

•    If necessary, the dose may be increased again to 6 mg every morning which is the maximum daily dose.

•    Swallow the tablets whole with a drink of water.

•    Do not take with grapefruit juice.

The 4 mg tablet can be divided into equal doses.

If you take more Lacidipine than you should

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no tablets left.

If you forget to take Lacidipine

If you forget a dose in the morning, take it as soon as you remember it on the same day. However, if you remember the next day, take your normal dose on that morning. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

•    angina, this is a type of chest pain. This is uncommon in people taking Lacidipine and is more likely to occur when you start taking this medicine

•    allergic reactions, the signs may include: rapid swelling of the face, mouth and throat which may cause difficulty breathing.

The side effects described below have been experienced by people taking Lacidipine. They are listed as either common, uncommon, rare or very rare.

Common (may affect up to 1 in 10 people)

•    dizziness, headache, fast or uneven heart beat (also called palpitations), flushing, swelling particularly of the ankles. These side effects usually go away as treatment continues

•    fast heart beat

•    upset stomach, feeling sick (nausea)

•    rash, redness of the skin, itching

•    an increase in the amount of water (urine) that you pass

•    feeling weak

•    changes in results of blood tests relating to your liver

Uncommon (may affect up to 1 in 100 people)

•    chest pain (angina) including chest pain that is getting worse

•    low blood pressure for example feeling faint, fainting

•    swelling of the gums

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

•    rapid swelling of the face, mouth and throat which may cause difficulty breathing

•    nettle rash (urticaria)

•    muscle cramps

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

•    tremor

•    depression

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lacidipine

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

This medicine does not need any special temperature storage conditions.

The tablets should be kept in the original container to protect them from light. Do not remove any tablets from the foil until you are ready to take them.

Do not use this medicine after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lacidipine tablets contain

The active substance is lacidipine. Each tablet contains 2 mg or 4 mg.

The other ingredients are lactose monohydrate, povidone, crospovidone and magnesium stearate. The film coating contains hypromellose, titanium dioxide and macrogol 400.

What Lacidipine tablets look like and contents of the pack

The 2 mg tablets are film-coated, round and white in

colour. They have the logo * on one side and the code '225' on the other.

The 4 mg tablets are film-coated, oval and white in

colour. They have the logo ' on one side and the codes '2' and '24' separated by a break line on the other.

Lacidipine tablets are available in blister packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

This leaflet was last revised in 02/2014