PATIENT INFORMATION LEAFLET ALDOMET® 250mg TABLETS/ METHYLDOPA 250mg TABLETS ALDOMET® 500mg TABLETS/ METHYLDOPA 500mg TABLETS

(methyldopa)

This medicine is available as any of the above names but will be referred to as Aldomet Tablets throughout the following:

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Aldomet Tablets are and what are they used for

2.    Before you take Aldomet Tablets

3.    How to take Aldomet Tablets

4.    Possible side effects

5.    How to store Aldomet Tablets

6.    Further information

1. WHAT ALDOMET TABLETS ARE AND WHAT ARE THEY USED FORl

Aldomet Tablets contains a medicine called methyldopa. This belongs to a group of medicines called ‘antihypertensives'.

Methyldopa is changed inside your body to a natural substance that lowers blood pressure. Your doctor has prescribed Aldomet Tablets to treat high blood pressure (hypertension).

2. BEFORE YOU TAKE ALDOMET TABLETS

Do not take Aldomet Tablets if you have:

•    ever had a bad reaction, such as an allergy to methyldopa, or to any of the other ingredients (listed in section 6)

•    ever had liver disease

•    ever had depression

•    high blood pressure due to a tumour near your kidney called ‘phaeochromocytoma'.

•    been taking a type of medicine called a ‘monoamine oxidase inhibitor' (MAO inhibitor)

Do not take Aldomet Tablets if any of the above apply to you. If you are not sure talk to your doctor or pharmacist before taking Aldomet Tablets.

Take special care with Aldomet Tablets

Check with your doctor before taking this medicine if you have:

•    or anyone in your family has an illness called ‘hepatic porphyria'

•    kidney problems

•    had a stroke

Check with your doctor while taking this medicine if you are going to have:

•    dialysis

•    an operation

•    a blood transfusion.

Tests you may have while taking Aldomet Tablets

Your doctor may do blood tests to check how your liver is working during the first 6 - 12 weeks. He or she may use similar tests if you have a fever at any time while you are taking Aldomet Tablets. Tell your doctor you are taking Aldomet Tablets if you have a laboratory test where a urine or blood sample is taken. This is because Aldomet Tablets may affect the results of some types of tests.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Aldomet Tablets. 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 as some drugs may affect each other's action. This includes herbal medicines.

Do not take Aldomet Tablets if you are taking a type of medicine called a ‘monoamine oxidase inhibitor' (MAO inhibitor) used to treat depression.

It is particularly important that you tell your doctor or pharmacist if you are taking any of the following before taking Aldomet Tablets

•    other medicines for high blood pressure

•    lithium - used to treat some types of depression

•    medicines called ‘phenothiazines' such as chlorpromazine - used for mental illness and sometimes feeling and being sick

•    medicines called ‘tricyclic antidepressants' - used to treat depression

•    cough and cold remedies that contain a decongestant

•    iron and supplements containing iron, such as multivitamins with minerals

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Aldomet Tablets. Pregnancy and breast-feeding

You should check with your doctor before taking Aldomet Tablets if you are or think you may be pregnant, if you are planning to become pregnant or if you are breast-feeding.

Driving and using machines

You may feel drowsy or light-headed while taking Aldomet Tablets. If this happens do not drive or use any tools or machines.

3. HOW TO TAKE ALDOMET TABLETS

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

Taking this medicine

You should take this medicine by mouth and exactly as advised by your doctor or pharmacist. The amount you take each day will depend upon your condition. It is very important to continue taking Aldomet Tablets for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.

The usual doses of Aldomet Tablets are:

Adults

•    The usual starting dose for the first two days is 250 mg two or three times a day.

•    Your doctor may then change your dose depending on how you respond.

•    You should not take more than 3000 mg in a day.

The elderly

•    The usual starting dose will not be more than 250 mg each day.

•    Your doctor may then slowly increase the dose.

•    You should not usually take more than 2000 mg in a day.

Children

The doctor will work out the number of tablets. The dose is based on the weight of the child.

•    The usual starting dose is 10 mg for each kg of body-weight each day.

•    This dose is taken in two to four doses during the day.

•    Your doctor may then change the dose, depending on how the child responds.

•    A child will not usually take more than 65 mg for each kg (or 3000 mg a day), whichever is less.

If you take more Aldomet Tablets than you should

If you take too many tablets by mistake, contact your doctor immediately or seek medical attention.

If you forget to take Aldomet Tablets

•    If you forget to take a dose, just carry on with the next dose as normal.

•    Do not take a double dose to make up for a forgotten dose.

If you stop taking Aldomet Tablets

Do not stop taking Aldomet Tablets without talking to your doctor.

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

. POSSIBLE SIDE EFFECTS

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

Tell your doctor as soon as possible, if you notice any of the following serious side effects such as:

•    chest pain, slow heart rate, or existing angina made worse

•    severe skin reactions (such as painful reddening, followed by blistering and peeling of layers of skin)

•    liver problems, including jaundice and hepatitis - signs include yellowing of your skin and eyes, sometimes with a fever, pale stools and dark urine

•    pain in the gut and diarrhoea caused by inflammation of the bowel (colitis)

•    severe pain in the gut and back caused by inflammation of the pancreas (pancreatitis).

The following reactions have also been reported:

Blood:

•    reduction in red blood cells (anaemia) - this can make your skin pale and make you weak or breathless

•    abnormal blood test causing symptoms such as pale skin, tiredness, fever and sore throat

•    bruising and prolonged bleeding after injury

Nervous system:

•    feeling sleepy or tired - this may happen at the start of treatment or when the dose is increased, and usually goes away

•    headache or feeling weak - this may happen at the start of treatment and usually goes away

•    pins and needles

•    being unable to move part of your face (paralysis)

•    having movements you cannot control

•    confusion

•    frequent dizziness or fainting

•    dizziness due to low blood pressure and light-headedness (particularly when standing up quickly)

Nose and chest:

•    nasal stuffiness

Stomach and gut:

•    feeling sick

•    being sick

•    abdominal pain

•    feeling bloated

•    constipation

•    excess wind

•    diarrhoea

•    dry mouth

•    sore or black tongue

Skin and hair:

•    skin rash or peeling skin

Joints and muscles:

•    painful and/or swollen joints

•    muscle pains

Infections:

•    swelling of salivary glands General:

•    water retention causing swelling and weight gain

•    fever

Sexual:

•    breast enlargement

•    breast development in men

•    loss of periods in women

•    abnormal production of milk

•    changes in sexual function such as impotence and not being able to ejaculate

•    decreased sex drive

Psychiatric:

•    mental changes, including nightmares or depression Laboratory tests:

•    your doctor may need to carry out simple blood tests during the first few months of therapy with Aldomet Tablets. Results could show:

•    a decrease in blood cell production

•    an increase in some white blood cells

•    abnormal levels of prolactin

•    Aldomet Tablets may also interfere with the interpretation of certain blood and urine tests

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 ALDOMET TABLETS

•    Keep out of the sight and reach of children

•    Do not store above 25°C. Store in the original package to protect from light.

•    Do not transfer your medicine into another container, as it might get mixed up.

•    If you have any medicine left over when your doctor tells you to stop using it, return it to the pharmacist.

•    Do not use the medicine past the expiry date, which is clearly marked on the pack.

•    If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist who will advise you what to do.

6. FURTHER INFORMATION

What is in your medicine?

The active ingredient in Aldomet Tablets is methyldopa.

Aldomet Tablets are available as film-coated tablets, which come in two different strengths.

Each Aldomet 250mg Tablets contains methyldopa equivalent to 250mg anhydrous methyldopa. They are yellow-coloured, circular, biconvex tablets and are debossed with ‘ALDOMET' on one side and ‘250' on the reverse.

Each Aldomet 500mg Tablets contains methyldopa equivalent to 500mg anhydrous methyldopa. They are yellow -coloured, circular, biconvex tablets and are debossed with 'ALDOMET' on one side and '500' on the reverse.

Aldomet Tablets contain: cellulose powder, anhydrous citric acid, colloidal anhydrous silica, ethylcellulose, guar gum, magnesium stearate, sodium calcium edetate, hypromellose, propylene glycol. quinoline yellow aluminium lake E104, red iron oxide E172, talc, titanium dioxide (E171).

Aldomet 250mg Tablets are available in blister packs of 60.

Aldomet 500mg Tablets are available in blister packs of 30 and 60.

|POM|    PL No 15814/0897 Aldomet 250mg Tablets/ Methyldopa 250mg Tablets

PL No 15814/0898 Aldomet 500mg Tablets/ Methyldopa 500mg Tablets Who makes your medicine?

Aldomet Tablets are made by Iroko Products Limited, One Silk Street, London EC2Y 8HQ and procured from within the EU and repackaged by the Product Licence Holder OPD Laboratories Limited., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.) 10.09.2013.

Aldomet is a registered trademark of Iroko Pharmaceuticals, LLC.