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Amlodipine Tablets 10mg

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S1447 LEAFLET Amlodipine 20130227

PATIENT INFORMATION LEAFLET AMLODIPINE TABLETS 10mg (amlodipine besilate)

Your medicine is known as Amlodipine Tablets 10mg but will be referred to as Amlodipine throughout the following patient information leaflet.

Information for other strength of Amlodipine (Amlodipine Tablets 5mg) also may be present in this leaflet.

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 get 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 which belongs to a group of medicines called calcium antagonists.

Amlodipine is used to treat high blood pressure (hypertension) or 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 your medicine 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. Your medicine does not provide immediate relief of chest pain from angina.

2. BEFORE YOU TAKE AMLODIPINE

Do not take Amlodipine

•    if you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of your medicine listed in section 6, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing.

•    If you have severe low blood pressure (hypotension).

•    If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).

•    If you suffer from heart failure after a heart attack.

Take special care with Amlodipine

You should inform your doctor if you have or have had any of the following conditions:

•    Recent heart attack

•    Heart failure

•    Severe increase in blood pressure (Hypertensive crisis)

•    Liver disease

•    You are elderly and your dose needs to be increased Use in children and adolescents

Amlodipine has not been studied in children under the age of 6 years. Amlodipine should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).

For more information, talk to your doctor.

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.

Amlodipine may affect or be affected by other medicines, such as:

•    ketoconazole, itraconazole (anti-fungal medicines)

•    ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)

•    rifampicin, erythromycin, clarithromycin (antibiotics)

•    hypericum perforatum (St. John's Wort)

•    verapamil, diltiazem (heart medicines)

•    dantrolene (infusion for severe body temperature abnormalities)

•    simvastatin (a cholesterol lowering medicine)

Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Taking Amlodipine with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine.

Pregnancy

The safety of amlodipine in human pregnancy has not been established.

If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine.

Breast-feeding

It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine.

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

Driving and using machines

Amlodipine may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Important information about some of the ingredients of Amlodipine

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially ‘sodium-free'.

3. HOW TO TAKE AMLODIPINE

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

The usual initial dose is Amlodipine 5 mg once daily. The dose can be increased to Amlodipine 10 mg once daily.

Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not take Amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day.

The maximum recommended dose is 5 mg a day. Amlodipine 5 mg tablets can be divided into halves to provide a 2.5 mg dose.

It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Amlodipine than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipine tablets.

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 a double dose to make up for a missed dose.

If you stop taking Amlodipine

Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.

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

4. POSSIBLE SIDE EFFECTS

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

Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine.

•    Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing

•    Swelling of eyelids, face or lips

•    Swelling of the tongue and throat which causes great difficulty breathing

•    Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions

•    Heart attack, abnormal heart beat

•    Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

The following common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common: affects 1 to 10 users in 100

•    Headache, dizziness, sleepiness (especially at the beginning of treatment)

•    Palpitations (awareness of your heart beat), flushing

•    Abdominal pain, feeling sick (nausea)

•    Ankle swelling (oedema), tiredness

Other side-effects that have been reported include the following list. If any of these get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: affects 1 to 10 users in 1,000

•    Mood changes, anxiety, depression, sleeplessness

•    Trembling, taste abnormalities, fainting, weakness

•    Numbness or tingling sensation in your limbs; loss of pain sensation

•    Visual disturbances, double vision, ringing in the ears

•    Low blood pressure

•    Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)

•    Altered bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (being sick)

•    Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration

•    Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine

•    Inability to obtain an erection; discomfort or enlargement of the breasts in men

•    Weakness, pain, feeling unwell

•    Joint or muscle pain, muscle cramps, back pain

•    Weight increase or decrease

Very rare: affects less than 1 user in 10,000

•    Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage)

•    Excess sugar in blood (hyperglycaemia)

•    A disorder of the nerves which can cause weakness, tingling or numbness

•    Cough, swelling of the gums

•    Abdominal bloating (gastritis)

•    Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests

•    Increased muscle tension

•    Inflammation of blood vessels, often with skin rash

•    Sensitivity to light

•    Disorders combining rigidity, tremor, and/or movement disorders

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

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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 contains

•    Each Amlodipine 10mg Tablet contains 10mg of the active ingredient, amlodipine (as the besilate).

•    Amlodipine Tablets also contain anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

What Amlodipine looks like and contents of the pack

•    Amlodipine Tablets are octagonal white tablets marked ‘Pfizer' on one side and ‘AML 10' with a breakline on the other.

•    Amlodipine is available as blister packs of 14 & 28 tablets Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1Dx.

Manufacturer

This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse, 35 89257 Illertissen, Germany.

|POM|    PL No. 19488/1447

Leaflet revision date: 27 February 2013

S1447 LEAFLET Amlodipine 20130227

Rare: affects 1 to 10 users in 10,000 • Confusion