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PACKAGE LEAFLET: INFORMATION FOR THE USER

AMLODIPINE 5 MG TABLETS AMLODIPINE 10 MG TABLETS

Amlodipine Besilate

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, please ask your doctor or pharmacist.

•    The medicine has been prescribed for you only and 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.

What is in this leaflet:

1.    What Amlodipine is and what it is used for

2.    What you need to know before you take Amlodipine

3.    How to take Amlodipine

4.    Possible side effects

5.    How to store Amlodipine

6.    Contents of the pack and other information

1. What Amlodipine is and what it is used for

•    Amlodipine belongs to a group of medicines called calcium-channel blockers. 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.

•    If you have high blood pressure amlodipine works by relaxing blood vessels, so that blood passes through them more easily.

•    If you have angina, you may get chest pain when your heart cannot get enough blood. Amlodipine helps in preventing this by increasing blood supply to the heart. Amlodipine Tablets do not work immediately to stop chest pain from angina.

2. What you need to know before you take Amlodipine

Do not take Amlodipine if you:

•    are allergic to amlodipine or any other calcium channel blockers or any other ingredients of this medicine (these are listed in section 6). This may include itching, reddening of the skin or difficulty in breathing.

•    have any of the following conditions:

cardiogenic shock (a condition where your heart is unable to supply enough blood to the body) aortic stenosis (narrowing of the aortic heart valve)

•    suffer from heart failure after a heart attack

•    have severe low blood pressure (hypotension)

Warnings and Precautions

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

•    have suffered a recent heart attack or if your doctor has advised that you are in hypertensive crisis (severe increase in blood pressure).

•    have liver disease.

•    heart failure

•    you are elderly and your dose needs to be increased If any of the above apply to you, talk to your doctor.

Other medicines and Amlodipine

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

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.

Amlodpine 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 and Breast-feeding

•    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.

•    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.

Driving and using machines

•    Amlodipine tablets may cause dizziness, tiredness, give you headache or make you feel that you are about to be sick. If this happens to you do not drive or use machinery.

3. How to take Amlodipine

•    Always take amlodipine tablets exactly as prescribed by your doctor. You should check with your doctor or pharmacist if you are unsure.

•    Amlodipine tablets should be swallowed whole with a glass of water. Take the tablet(s) at the same time each day.

•    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.

Adults and Elderly:

•    The usual initial dose is 5mg amlodipine tablet once daily which may be increased to a maximum dose of 10mg depending on the individual patient’s response.

Children and Adolescents:

For children (6 -17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.

For 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.

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 Tablets 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.

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If you forget to take Amlodipine Tablets

•    Do not worry and take the next dose at the right time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amlodipine Tablets

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. STOP TAKING this medicine and see 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: may affect up to 1 in 10 people

•    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: may affect up to 1 in 100 people

•    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 discoloration

•    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: may affect up to 1 in 1,000 people

•    Confusion

Very rare: may affect up to 1 in 10,000 people

•    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 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. 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.

5. How to store Amlodipine

•    Keep this medicine out of the sight and reach of children

•    Do not use this medicine after expiry date stated on the pack. The expiry date refers to the last day of that month.

•    Blister Packs: Do not store above 25⁰C. Store in the original package.

Containers: Do not store above 25⁰C. Keep the container tightly closed.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. Contents of the pack and other information

What Amlodipine tablets contain

Active ingredient is Amlodipine (as besilate). Each tablet contains 5mg or 10mg of Amlodipine.

The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate, silica colloidal anhydrous and magnesium stearate.

What Amlodipine tablets look like and contents of pack

Amlodipine 5 mg tablets are white to off white, round, biconvex, uncoated tablets with ‘5’ embossing on one side.

Amlodipine 10 mg tablets are white to off white, round, biconvex, uncoated tablets with ‘10’ embossing on one side.

Amlodipine tablets come in blister packs of 28, 56, 84 tablets and containers of 100, 250, 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted,

HP4 1EG, UK

Telephone: 0044 (0) 1442 200922 Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

Amlodipine 5mg tablets; PL 17907/0085 Amlodipine 10mg tablets; PL 17907/0086

This leaflet was last revised in July 2014

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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