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Active substance: amlodipine besilate

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 any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do 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 10 mg tablets is and what it Is used for

2.    Before you take Amlodipine 10 mg tablets

3.    How to take Amlodipine 10 mg tablets

4.    Possible side effects

5.    How to store Amlodipine 10 mg tablets

6.    Further Information

1.    WHAT AMLODIPINE 10 MG TABLETS IS AND WHAT IT IS USED FOR

Amlodipine belongs to a group of medicines called calcium antagonists.

Amlodipine 10 mg tablets are used to treat:

•    high blood pressure (hypertension)

•    a certain type of chest pain called angina, including a rare form called 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 the blood supply to the heart muscle. The heart muscle then receives more oxygen and this prevents chest pain. Amlodipine tablets do not provide immediate relief of chest pain from angina.

Amlodipine tablets are suitable for patients with heart failure and a history of high blood pressure or angina.

2.    BEFORE YOU TAKE AMLODIPINE 10 MG TABLETS Do NOT take Amlodipine 10 mg tablets:

•    if you are allergic (hypersensitive) to amlodipine. other calcium antagonists or any other ingredients of Amlodipine 10 mg tablets (see Section 6 - Further Information).

•    if you have heart problems such as cardiogenic shock, narrowing of the aortic heart valve (aortic stenosis) or new or changing chest pain (unstable angina).

•    if you are pregnant or breast feeding.

Take special care with Amlodipine 10 mg tablets:

•    if you have had a heart attack in the past month

•    if you have a sudden, severe rise in blood pressure that can lead to a stroke

•    if you have liver disease

•    if you are under 18 years of age

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 10 mg tablets with food or drink

Amlodipine 10 mg tablets are unlikely to affect or to be affected by normal eating or drinking.

Pregnancy and breast-feeding

Do not take Amlodipine 10 mg tablets if you are pregnant or breast-feeding your baby. If you are a woman with childbearing potential, you must use effective contraception. Ask your doctor or pharmacist for more information if you are unsure about this.

Driving and using machinery

Amlodipine 10 mg tablets may cause dizziness, headache, Tiredness or feeling sick. If you are affected in this way. you must be careful when driving or operating machinery.

Children

Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine 10 mg tablets has not been studied in children under the age of 6 years. For more information, talk to your doctor.

3.    HOW TO TAKE AMLODIPINE 10 MG TABLETS

Always take Amlodipine 10 mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose is 5 mg (half a tablet) of amlodipine once daily. This may be increased to 10 mg (one tablet) amlodipine daily.

Take your Amlodipine 10 mg tablets every day, preferably at the same time each day.

Swallow the tablets with a glass of water.

You must not stop taking the tablets because they will help you to remain well Make sure that you visit your doctor in plenty of time so that you do not run out of tablets.

For children (6-17 years old), the recommended usual starting dose is 2.S mg a day. The maximum recommended dose is S mg a day

for capsules or tablets without a break-line: Amlodipine 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg as these tablets are not manufactured to break into two equal halves

If you take more Amlodipine 10 mg tablets than you should

If you take too many tablets, tell your doctor immediately or go to your nearest hospital casualty department. You might fed flushed and have a strong and fast heart beat. You may get very low blood pressure, which can make you feel dizzy or faint. It Is dangerous to take several tablets at the same time.

If you forget to take Amlodipine 10 mg tablets

If you forget to take a tablet do not worry. Leave out the missed dose completely and take your next dose at the

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

Amlodipine 10 mg Tablets

4. POSSIBLE SIDE EFFECTS

Like all medicines. Amlodipine 10 mg tablets can cause side effects, although not everybody gets them.

The side effects are listed according to their frequencies.

Stop taking th« medicine and contact your doctor or a hospital immediately if you get:

•    symptoms or signs of an allergic reaction (sudden wheeziness or difficulty in breathing, swelling of the eyelids, face or lips, or rash or itching that affects the whole body)

•    fainting or dizziness

•    irregular or rapid heartbeat (arrythmia)

•    crushing pain in your chest that seems to go down your left arm (signs of a beginning heart attack)

•    unusual bruising and bleeding

Common side effects (occur in less than 1 in 10, but more than 1 in 100 patients treated)

•    headache

•    swelling (oedema), for example of the ankle

•    feeling tired

•    feeling sleepy

•    stomach (abdominal) pain

•    feeling sick (nausea)

•    flushing

•    a quicker or irregular heart beat (palpitations)

Tell your doctor If these effects cause you any problems or if they last for more than one week.

Uncommon side effects (occur in less than 1 in 100, but more than 1 in 1,000 patients treated)

•    itchy skin

•    hair loss

•    shortness of breath

•    back pain

•    chest pain

•    being sick (vomiting)

•    indigestion

•    muscle cramps

•    weakness

•    difficulty sleeping

•    altered bowel habit

•    muscle or joint pain

•    mood changes

•    increased need to urinate

•    changes in taste

•    dry mouth

•    loss of pain sensation

•    ringing in the ears

•    increased sweating

•    low blood pressure

•    skin rash

•    red or purplish patches on skin

•    general feeling of discomfort or lack of well-being

•    weight changes

•    inability to obtain an erection

•    enlarging of the male breasts

•    visual disturbances

•    increased sensitivity particularly on the skin

•    pins and needles

•    sneezing or runny nose

•    trembling (tremor)

Very rare side effects (occur in less than 1 in 10,000 patients treated)

•    raised. Itchy bumps on skin (hives)

•    abnormal blood tests for liver function

•    inflammation of the liver

•    yellowing of the skin

•    blood disorders

•    Inflammation of the nerves

•    inflammation of the blood vessels

•    excess sugar in blood

•    coughing

•    swelling or soreness of the gums

•    inflamed pancreas and stomach

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.

5.    HOW TO STORE AMLODIPINE 10 MG TABLETS

Keep out of the reach and sight of children.

Keep your medic me In a dry place.

Do not use Amlodipine 10 mg tablets after the expiry date which is stated on the label. 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 10 mg tablets contain

The active substance is amlodipine (as besilate).

One Amlodipine 10 mg tablet contains amlodipine besilate equivalent to 10 mg amlodipine.

The other ingredients are:

-    macrocrystalline cellulose

-    dibasic calcium phosphate anhydrous

-    sodium starch glycoltate.

-    magnesium stearate

What Amlodipine 10 mg tablets look like and contents of the pack

Amlodipine 10 mg tablets are white tablets. They are available in calendar packs of 28 tablets. Each pack contains two aluminium/PVC blister strips of 14 tablets.

07.012011 1021:52