TEVA UK Ref: 231-30-62137-ZB LEA AMLODIPINE A/S TAB TUK <DEB Version: 4    03 June 2015

REG0059922

AMLODIPINE 5 mg and 10 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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.

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

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.

n 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 mmediate relief of chest pain from angina.

^ 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 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.

(antibiotics)

•    Hypericum Perforatum (St. John's Wort)

•    verapamil, diltiazem (heart medicines)

•    dantrolene (infusion for severe body temperature abnormalities).

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 is essentially 'sodium-free'.

HOW TO TAKE AMLODIPINE

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

Always take Amlodipine 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. Swallow the tablet with a glass 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 2.5 mg is not currently available. The 2.5 mg dose can be obtained with Amlodipine 5 mg tablets as these tablets can be divided into two equal doses.

Amlodipine 10 mg tablets can also be divided into equal doses.

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.

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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.

| 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 nclude 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.

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

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.

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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE AMLODIPINE

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original packaging. Keep the blister in the outer carton. Do not use Amlodipine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Do not take these tablets if there are any signs of discolouration or deterioration of the tablets.

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.

^ FURTHER INFORMATION

What Amlodipine contains:

•    The active ingredient is amlodipine (as besilate).

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

What Amlodipine looks like and contents of the pack:

•    Amlodipine 5 mg round white tablet,

8 mm in diameter. One side is slightly concave with a breakline and debossed 'A5'.The other side is slightly convex and plain and are available in pack sizes of 15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112 and 300 tablets.

•    Amlodipine 10 mg round white tablet,

11 mm in diameter. One side is slightly concave with a breakline and debossed 'A10'. The other side is slightly convex and plain and are available in pack sizes of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98,

100 and 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised: June 2015

PL 00289/0487-88

TTWTl

62137-ZB

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