Package leaflet: Information for the user

Amolyte 5mg tablets Amolyte 10mg tablets

Amlodipine

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, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 Amolyte is and what it is used for

2.    What you need to know before you take Amolyte

3.    How to take Amolyte

4.    Possible side effects

5.    How to store Amolyte

6.    Contents of the pack and other information

1. What Amolyte is and what it is used for

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

Amolyte 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 Amolyte 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. What you need to know before you take <product name>

DO NOT takeAmolyte

•    If you are allergic to amlodipine or any of the other ingredients of this 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amolyte 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.

Children and adolescents

Amlodipine has not been studied in children under the age of 6 years. Amolyte 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.

Other medicines and Amolyte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Amolyte 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 (used to reduce elevated cholesterol levels in the blood)

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

Amolyte with food and drink

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

It is not known whether amlodipine is passed into breast milk.

Driving and using machines

Amolyte 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.

3. How to take Amolyte

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

The Amolyte 10 mg tablet can be divided into equal halves.

Your medicine can be taken 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 Amolyte 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 and the 2.5 mg dose cannot be obtained with Amolyte 5 mg 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 Amolyte 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 Amolyte tablets.

If you forget to take Amolyte

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 forgotten dose.

If you stop taking Amolyte

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, this medicine 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 (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 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 (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 you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. How to store AMOLYTE

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

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 Amolyte contains

The active substance is amlodipine (as besilate).

Amolyte 5mg tablets:

Each tablet contains 5 mg of amlodipine (as besilate)

•    The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium starch glycolate, magnesium stearate (E470b).

Amolyte 10mg tablets:

•    Each tablet contains 10 mg of amlodipine (as besilate)

•    The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium starch glycolate, magnesium stearate (E470b).

What Amolyte looks like and contents of the pack

Amolyte 5mg tablets:

Amolyte 5 mg tablets are white, round tablets.

Blister packs with 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 tablets.

Amolyte 10mg tablets:

Amolyte 10 mg tablets are white, round tablets with a break score on one side. The tablet can be divided into equal halves.

Blister packs with 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Amlodipin besilat STADA 5 mg Tabletten Amlodipin besilat STADA 10 mg Tabletten Amlodistad

Amlodipin AL 5 mg Tabletten

Amlodipin AL 10 mg Tabletten

Amlodipino STADA Genericos 5 mg comprimidos EFG

Amlodipino STADA Genericos 10 mg comprimidos EFG

Amlodipine Clonmel 5 mg tablets

Amlodipine Clonmel 10 mg tablets

Amlodipine CF 5 mg, tabletten

Amlodipine CF 10 mg, tabletten

Amlodistad

Amolyte 5 mg tablets

Amolyte 10 mg tablets

This leaflet was last revised in November 2014

Amolyte 5mg tablets Amolyte 10mg tablets

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