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PACKAGE LEAFLET: INFORMATION FOR THE USERS

AMLODIPINE

amlodipine

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or your pharmacist.

-    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Amlodipine is and what it is used for

2.    Before you take Amlodipine

3.    How to take Amlodipine

4.    Possible side effects

5.    How to store Amlodipine

6.    Further information

1.    WHAT AMLODIPINE IS AND WHAT IT IS USED FOR?

Amlodipine contains the active substance amlodipine. It is one of a group of medicines called calcium antagonists.

Your doctor has prescribed you Amlodipine for the reasons that

-    you have high blood pressure, or

-    you have a certain type of chest pain called angina, a rare form of which is Prinzmetal's or variant angina.

In patients with high blood pressure amlodipine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina amlodipine works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Amlodipine does not provide immediate relief of chest pain from angina, but helps prevent anginal attacks.

2.    BEFORE YOU TAKE AMLODIPINE Do not take Amlodipine

-    if you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of Amlodipine, or to any other calcium antagonists. (The symptoms of an allergic reaction may be itching, reddening of the skin or difficulty in breathing.),

-    if you have cardiogenic shock (your heart is unable to supply enough blood to the organs of your body),

-    if you have aortic stenosis (narrowing of the aortic heart valve),

-    if you have unstable angina (except Prinzmetal's angina),

-    if you are pregnant or breast feeding.

Take special care with Amlodipine

Before you take Amlodipine you should tell your doctor:

-    if you are suffering from heart failure (your heart has difficulty pumping blood around your body especially when you do exercises),

-    if you have had a heart attack recently (within the last month),

-    if you have had a severe increase in blood pressure (Hypertensive crisis),

-    if you have liver disease.

If any of these apply to you, tell your doctor before you start taking Amlodipine tablets.

Taking other medicines

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

Taking Amlodipine with food and drink

Grapefruit juice may interact with amlodipine increasing amlodipine levels in your blood. However this increase is too small and will not significantly alter your blood pressure or heart rate. Amlodipine tablets should be taken with a drink of water, with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take Amlodipine during pregnancy. Women of child-bearing potential should ensure that they use effective contraception.

Do not take Amlodipine if you are breast feeding or stop breast feeding if you are taking Amlodipine.

Driving and using machines

Amlodipine tablets may make you feel sick, tired, dizzy or give you a headache. If this happens, do not drive or use machines until the symptoms go away.

3.    HOW TO TAKE AMLODIPINE

Always take Amlodipine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly: the usual dose of Amlodipine is one tablet daily. Your doctor may start your Amlodipine treatment with one 5mg tablet daily, and then increase to one 10 mg tablet daily depending on your response to any dose increase. It is best to take Amlodipine at the same time each day with a drink of water.

If you have the impression that the effect of Amlodipine is too strong or too weak, talk to your doctor or pharmacist.

It is important to keep taking the tablets. Do not stop taking the tablets unless your doctor tells you to stop.

Do not wait until your tablets are finished before seeing your doctor. Your doctor may prescribe you more Amlodipine tablets.

Amlodipine tablets are not recommended for children.

If you take more Amlodipine than you should

If you take more tablets than you should, it may be dangerous. Contact your doctor immediately.

If you forget to take Amlodipine

Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take double dose to make up for a forgotten tablet.

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

4.    POSSIBLE SIDE EFFECTS

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

Allergic reactions may develop to any medicine. Although they are very rare, the symptoms can be severe.

If you experience any of the following symptoms after taking this medicine, you should contact your doctor immediately: sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body) or unusual bruising and bleeding caused by damage of a certain type of blood cells.

The following side effects have also been reported:

Common side effects (affecting less than 1 in 10 patientsI

•    Headache

•    Swelling (eg. of the ankles)

•    Tiredness

•    Dizziness

•    Feeling sick

•    Hot flushes

•    Sleepiness

•    A quick or irregular heartbeat (palpitations)

•    Stomach ache

Uncommon side effects (affecting less than 1 in 100 patientsI

•    Sleeplessness

•    Mood changes (eg depression, irritability, anxiety)

•    Trembling (tremor)

•    Taste abnormalities

•    Fainting

•    Sensation of pins and needles

•    Loss of pain sensation

•    Blurring and changes of vision

•    Ringing in the ears (tinnitus)

•    Low blood pressure

•    Shortness of breath

•    Runny nose (rhinitis)

•    Vomiting

•    Indigestion

•    Altered bowel habit

•    Dry mouth

•    Hair loss

•    Increased sweating

•    Itching

•    Skin rash or discolouration

•    Muscle or joint pain

•    Muscle cramps

•    Back pain

•    Increased need to urinate (especially at night)

•    Inability to obtain an erection

•    Enlargening of male breasts

•    Chest pain

•    Weakness

•    Pain

•    Feeling unwell

•    Weight increase or decrease

Very rare side effects (affecting less than 1 in 10,000 patientsI

•    Abnormalities of a certain type of blood cells (platelets) which may increase the risk of bleeding and bruising

•    Severe skin reactions (described above)

•    Rapid swelling of the skin around the mouth, throat, or in the hands

•    Excess sugar in the blood

•    Swelling or soreness in the gums

•    Cough

•    Inflammation of blood vessels

•    Nettle rash

•    Inflammed pancreas causing severe pain in the abdomen and back

•    Abdominal bloating (gastritis)

•    Inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes

•    Heart attack

•    Increased or irregular heart rate

•    Numbness, weakness, and/or burning pain in the arms or legs

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE AMLODIPINE

Keep out of the reach and sight of children.

Store in the original package.

Do not use Amlodipine tablets after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.

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 Amlodipine tablets contain

The active substance is amlodipine (as amlodipine besilate). Each tablet contains 5 mg or 10 mg of amlodipine.

The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate, anhydrous, sodium starch glycolate, magnesium stearate.

What Amlodipine tablets look like and the contents of the pack

Amlodipine 5 mg and 10 mg tablets: White or almost white, oblong tablets with an engraved mark ”5" or ”10" on one side and a breakline on the reverse side of 10 mg tablets.

Amlodipine comes in packs containing 28 tablets of 5 mg or 10 mg.

Marketing Authorisation Holder:

Gedeon Richter Plc.

1103 Budapest Gyomroi ut 19-21.

Hungary

Manufacturer responsible for batch release:

Gedeon Richter Plc.

1103 Budapest Gyomroi ut 19-21.

Hungary

For any information about this medicinalproduct, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last approved in 10/2009

© GEDEON RICHTER

nev	Amlodipine tbl utas angol
meret	148x300 mm
szin	P280 P200
keziratszam	K-5511-1.6
grafikus	MJuli
datum	2009.10.12.
javftva
modosftva
karakterszam	8 700
betumeret	8 pt