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Lacidipine 4mg Tablets

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Package leaflet: Information for the user

LACIDIPINE 4mg 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 your pharmacist.

•    This medicine has been prescribed for you only 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 indudes any possible side effects not listed in this leaflet.

The name of your medicine is Lacidipine 4mg Tablets but it will be referred to as LACIDIPINE throughout most of the remainder of this leaflet.

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 contains 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, likelyto get pregnant or are breast-feeding

•    You are allergic (hypersensitive) to lacidipine, other calcium channel blocker medicines or any of the other ingredients ofthis medicine (listed in section 6)

•    You have the heart problem 'aortic stenosis'. This is a narrowing of a valve in your heart, which restricts blood flow

•    You have had a heart attack within the last month

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

•    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

Take special care with LACIDIPINE

Check with your doctor or pharmacist before taking LACIDIPINE if:

•    You have an uneven heart beat or any other heart problems

•    You have or have ever had any liver problems

Other medicines and LACIDIPINE

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medianes. 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 Tests

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.

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.

Important information about some of the ingredients of LACIDIPINE

LACIDIPINE contains 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. You should 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.

•    After3-4 weeks this maybe increased to 4 mg every morning.

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

•    Swallow the tablets whole with a drink ofwater.

•    Do not take with grapefruit juice.

This medicine comes in a calendar pack marked with the days of the week. This means you can easily check that you have taken the dose on each day.

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.

The translation of the days of the week as they appear on the blister strip is as follows:

LUN    MAR    MER    GIO    VEN    SAB    DOM

MON    TUE    WED    THU    FRI    SAT    SUN

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 common, uncommon, rare or very rare.

Common side effects

These 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 ofthe 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 side effects

These 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 side effects

These may affect up to 1 in 1000 people:

•    rapid swelling ofthe face, mouth and throatwhich may cause difficulty breathing.

•    nettle rash (urticaria)

•    muscle cramps

Very rare side effects

These 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store LACIDIPINE

Keep out of the sight and reach of children.

Do not store above 30°C.

Protect from light.

Store in the original container.

Do not use LACIDIPINE after the expiry date which is stated on the carton and blister after 'Exp'. The expiry date refers to the last date of the month.

If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further Information What LACIDIPINE contains

Each tablet contains either 4mg of lacidipine as the active ingredient. The other ingredients are lactose monohydrate, lactose spray-dried, povidone K30 and magnesium stearate. The film coating contains hypromellose and titanium dioxide (E171).

What LACIDIPINE looks like and contents of the pack

The 4mg tablets are white, oval, film-coated tablets engraved with a deep break-line on one face and a narrow break-line on the other.

LACIDIPINE tablets are available in blister packs of 28 tablets.

Manufactured by: GlaxoSmithKline S.p.A Officina Farmaceutica di S. Polo di Torrile, Parma, Italy.

Procured from within the EU and repackaged by the Parallel Import Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.

LACIDIPINE 4mg tablets

PL NO: 18799/0314    _

POM

Leaflet date: 30.01.2014    -

LACIDIPINE is a registered trademark of GlaxoSmithKline Pharmaceuticals.