PACKAGE LEAFLET: INFORMATION FOR THE USER Amlostin 5mg Tablets Amlostin 10mg Tablets

Amlodipine maleate

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 Amlostin Tablets are and what are they used for?

2.    Before you take Amlostin Tablets

3.    How to take Amlostin Tablets

4.    Possible side-effects

5.    How to store Amlostin Tablets

6.    Further information

1.    WHAT AMLOSTIN TABLETS ARE AND WHAT ARE THEY USED FOR?

Amlostin contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists.

Amlostin 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 Amlostin 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 AMLOSTIN TABLETS Do not take Amlostin Tablets:

•    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 Amlostin Tablets:

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

Amlostin has not been studied in children under the age of 6 years. Amlostin 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 other medicines, including medicines obtained without a prescription.

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

•    verapamil, diltiazem (heart medicines)

•    ketoconazole, itraconazole (anti-fungal medicines)

•    erythromycin, rifampicine, clarithromycin (antibiotics)

•    hypericum perforatum (St. John’s Wort)

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

•    dantrolene (infusion for severe body temperature abnormalities)

•    simvastatin (used to reduce elevated cholesterol levels in the blood).

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

Taking Amlostin with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlostin. 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 Amlostin.

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 Amlostin.

Breast-feeding

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

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

Driving and using machines

Amlostin 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 Amlostin Tablets

Amlostin contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    HOW TO TAKE AMLOSTIN TABLETS

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 5mg Amlostin once daily. The dose can be increased to 10mg Amlostin 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 Amlostin with grapefruit juice.

Use in children and adolescents

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

Amlodipine 2.5mg is not currently available and the 2.5mg dose cannot be obtained with Amlostin 5mg tablets 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 Amlostin Tablets than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, light-headed, 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 Amlostin tablets.

If you forget to take Amlostin Tablets:

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 Amlostin 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, Amlostin 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 heartbeat

•    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 heartbeat), 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.

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.

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 AMLOSTIN TABLETS

Keep out of the reach and sight of children.

Do not use your medicine after the expiry date which is stated on the pack after 'EXP'. The expiry date refers to the last day of that month.

Do not store above 25°C.

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 Amlostin Tablets contain Amlostin 5mg Tablets

•    The active substance is amlodipine (in the form of amlodipine maleate); each tablet contains an amount of amlodipine maleate corresponding to 5mg amlodipine.

•    The other ingredients are: lactose monohydrate, povidone K30, povidone K90, microcrystalline cellulose (E460), crospovidone, sodium stearyl fumarate.

Amlostin 10mg Tablets

•    The active substance is amlodipine (in the form of amlodipine maleate); each tablet contains an amount of amlodipine maleate corresponding to 10mg amlodipine

•    The other ingredients are: lactose monohydrate, povidone K30, povidone K90, microcrystalline cellulose (E460), crospovidone, sodium stearyl fumarate.

What Amlostin Tablets look like and contents of the pack

Amlostin 5mg Tablets:

Amlostin 5mg Tablets are white, round tablets.

The tablets are packed in cartons containing aluminium-aluminium blister packs with 10, 20, 28, 30, 50, 98,100 and 300 (10 x 30) tablets.

Amlostin 10mg Tablets:

Amlostin 10mg Tablets are white, round tablets with a break score on both sides. The tablets can be divided into equal halves.

The tablets are packed in cartons containing aluminium-aluminium blister packs with 10, 20, 28, 30, 50, 98 and 100 tablets.

Not all pack sizes may be marketed.

POM

PL 06831/0106    Amlostin 5mg Tablets

PL 06831/0107    Amlostin 10mg Tablets

Marketing Authorisation Holder:

Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, UK. Manufacturer:

Pharmathen S.A., 6 Dervenskion Street 153 51, Pallini Attikis, Greece.

This leaflet was last approved in 10th February 2012.