ALDOMET TABLETS 250MG

Active substance: METHYLDOPA

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

ALDOMET® Film-coated Tablets 250mg
ALDOMET® Film-coated Tablets 500mg
(Methyldopa)
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 is and what it is used for
2. Before you take Aldomet
3 How to take Aldomet
4. Possible side effects
5. How to store Aldomet
6. Further information
1. What Aldomet is and what it is used for
Aldomet 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 to treat high blood pressure (hypertension).
2. Before you take Aldomet
Do not take Aldomet 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 if any of the above apply to you. If you are not sure talk to your doctor or pharmacist before taking
Aldomet.
Take special care with Aldomet
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
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. Tell your doctor you are taking Aldomet if you have a
laboratory test where a urine or blood sample is taken. This is because Aldomet 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.
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 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




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.
Pregnancy and breast-feeding
You should check with your doctor before taking Aldomet 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. If this happens do not drive or use any tools or machines.
3. How to take Aldomet
Always take Aldomet 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 for as long as your doctor has prescribed.
Do not take more or less than your doctor has prescribed.
The usual doses of Aldomet 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 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

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
Do not stop taking Aldomet without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Aldomet 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. Results
could show:

a decrease in blood cell production

an increase in some white blood cells

abnormal levels of prolactin

Aldomet 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
Keep out of the reach and sight of children.
Do not use the medicine past the expiry date which is stated on the side of the carton after ’Exp’. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Blisters: Store in the original package in order to protect from light.
Bottles: Keep the container tightly closed in order to protect from light.
If you have any medicine left over when your doctor tells you to stop using it, return it to the pharmacist.
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 Aldomet contains
Active substances
The active ingredient in Aldomet tablets is methyldopa.
Aldomet tablets are available in two different strengths containing methyldopa equivalent to either 250 mg anhydrous
methyldopa, or 500 mg anhydrous methyldopa.
Other ingredients
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.
What Aldomet looks like and contents of the pack
Aldomet is available as film-coated tablets which come in two different strengths. They are yellow-coloured, round tablets
containing methyldopa equivalent to either 250 mg anhydrous methyldopa, or 500 mg anhydrous methyldopa.
Aldomet Tablets 250 mg are available in packs of 60.
Aldomet Tablets 500 mg are available in packs of 30.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Aspen Europe GmbH, Industriestrasse 32-36, 0-23843 Bad Oldesloe, Germany.
Manufacturer:
Aspen Pharmacare, Aspen House, Aspen Park, 98 Armstrong Avenue, La Lucia Ridge, Durban, 4019, South Africa
Batch release sites:
RX Farma Limited, Unit 3 Colonial Way, Watford, Hertfordshire, WD24 4YR
Custom Pharmaceuticals Limited, Unit 2 Fairway Trading Estate, Moulsecoombe Way, Brighton, East Sussex
BN2 4PB
Aspen Pharma Trading Limited,12/13 Exchange Place, Custom House Docks, International Financial Services Centre,
Dublin 1,Ireland
The leaflet was last amended October 2010

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)