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ALDOMET 500 MG FILM-COATED TABLETS

Active substance(s): METHYLDOPA

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Aldomet® 500 mg Film-coated
Tablets

2227
26.04.16[9]

(methyldopa)
PATIENT INFORMATION LEAFLET
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 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 or nurse. This
includes any possible side effects not listed in this leaflet. See Section 4.
Your medicine is available using the above name but will be referred to as
Aldomet throughout the leaflet.
What is in this leaflet:
1. What Aldomet is and what it is used for
2. What you need to know before you take Aldomet
3. How to take Aldomet
4. Possible side effects
5. How to store Aldomet
6. Contents of the pack and other information
1. WHAT ALDOMET IS AND WHAT IT IS USED FOR
Aldomet contains the active substance 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. WHAT YOU NEED TO KNOW 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’ or ‘paraganglioma’.
- been taking a type of medicine called a ‘monoamine oxidase inhibitor’
(MAO inhibitor)
- porphyria (a rare, inherited blood disorder)
Do not take Aldomet if any of the above applies to you. If you are not sure
talk to your doctor or pharmacist before taking Aldomet.
Take special care with Aldomet
Talk to your doctor before taking Aldomet if you have:
- a blood disorder called haemolytic anaemia
- liver problems
- jaundice (yellowing of the skin and eyes)
- fever
- any abnormal movements (involuntary)
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.
Rarely, in patients taking Aldomet urine may darken when it is exposed to
air after voiding.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before taking Aldomet.
Other medicines and Aldomet
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 (antihypertensives)
- 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 applies to you, talk to your doctor or
pharmacist before taking Aldomet.
Surgery
If you have to have surgery, including dental, that requires an anaesthetic,
you must inform the dentist or hospital that you are taking Aldomet tablets.
Aldomet with alcohol
You are advised not to drink alcohol while taking Aldomet tablets. Discuss
this with your doctor if you have any questions.
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.
Contact your doctor IMMEDIATELY if you notice any of the following side
effects as they are serious and require medical attention:
- an allergic reaction – symptoms such as shortness of breath, skin rash or
itching, hives, swelling of your lips, face or tongue, chills or
- fever or painful joints
- chest pain, slow heart rate, existing angina made worse, problems with
the electrical current in the heart (AV block)
- 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).

5. HOW TO STORE ALDOMET
Keep out of the sight and reach of children.

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
- your medicine may alter the numbers and types of your blood cells and
cause a rise in urea in the blood

Do not use Aldomet after the expiry date, which is stated on the carton. The
expiry date refers to the last day of that month.

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
- Parkinsonism – with symptoms such as tremor, a decrease in body
movements with an inability to move your muscles
- 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.
Reporting of side effects
If you get any side effects, please tell your doctor or pharmacist. 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.

o

Do not store above 25 C. Store in the original package in order to protect from
light.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Aldomet Tablets contain
The active ingredient in 'Aldomet' Tablets is methyldopa.
Each Aldomet 500 mg film-coated tablet contains methyldopa equivalent to
500mg anhydrous methyldopa.
Aldomet also contains: 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.
What Aldomet looks like and the contents of the pack
Aldomet 500 mg Film-Coated Tablets are yellow, round biconvex filmcoated tablets with ‘ALDOMET’ embossed on one side and ‘500’ on the
reverse.
Available in pack size of 30 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Iroko Products Limited, One Silk St, London, EC2Y 8HQ,
United Kingdom and procured from the EU by Product Licence holder: Star
Pharmaceuticals Ltd., 5, Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2227

Leaflet issue and Revision date (Ref): 26.04.16[9]
Aldomet is trademark of Iroko Pharmaceuticals, LLC

Methyldopa 500 mg Film-coated
Tablets

2227
26.04.16[9]

PATIENT INFORMATION LEAFLET
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 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 or nurse. This
includes any possible side effects not listed in this leaflet. See Section 4.
Your medicine is available using the above name but will be referred to as
Methyldopa throughout the leaflet.
What is in this leaflet:
1. What Methyldopa is and what it is used for
2. What you need to know before you take Methyldopa
3. How to take Methyldopa
4. Possible side effects
5. How to store Methyldopa
6. Contents of the pack and other information
1. WHAT METHYLDOPA IS AND WHAT IT IS USED FOR
Methyldopa contains the active substance 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 Methyldopa to treat high blood
pressure (hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLDOPA
Do not take Methyldopa 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’ or ‘paraganglioma’.
- been taking a type of medicine called a ‘monoamine oxidase inhibitor’
(MAO inhibitor)
- porphyria (a rare, inherited blood disorder)
Do not take Methyldopa if any of the above applies to you. If you are not
sure talk to your doctor or pharmacist before taking Methyldopa.
Take special care with Methyldopa
Talk to your doctor or pharmacist before taking Methyldopa if you have:
- a blood disorder called haemolytic anaemia
- liver problems
- jaundice (yellowing of the skin and eyes)
- fever
- any abnormal movements (involuntary)
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 Methyldopa
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 Methyldopa. Tell your doctor you are taking
Methyldopa if you have a laboratory test where a urine or blood sample is
taken. This is because Methyldopa may affect the results of some types of
tests.
Rarely, in patients taking Aldomet urine may darken when it is exposed to
air after voiding.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before taking Methyldopa.
Other medicines and Methyldopa
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 Methyldopa 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 Methyldopa
- other medicines for high blood pressure (antihypertensives)
- 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 applies to you, talk to your doctor or
pharmacist before taking Methyldopa.
Surgery
If you have to have surgery, including dental, that requires an anaesthetic,
you must inform the dentist or hospital that you are taking Aldomet tablets.
Methyldopa with alcohol
You are advised not to drink alcohol while taking Aldomet tablets. Discuss
this with your doctor if you have any questions.
Pregnancy and breast-feeding
You should check with your doctor before taking Methyldopa 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 Methyldopa. If this
happens do not drive or use any tools or machines.
3. HOW TO TAKE METHYLDOPA
Always take Methyldopa 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 Methyldopa for as long as
your doctor has prescribed. Do not take more or less than your doctor has
prescribed.
The usual doses of Methyldopa 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 Methyldopa than you should
If you take too many tablets by mistake, contact your doctor immediately or
seek medical attention.
If you forget to take Methyldopa
- 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 Methyldopa
Do not stop taking Methyldopa 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, Methyldopa can cause side effects, although not
everybody gets them.
Contact your doctor IMMEDIATELY if you notice any of the following side
effects as they are serious and require medical attention:
- an allergic reaction – symptoms such as shortness of breath, skin rash or
itching, hives, swelling of your lips, face or tongue, chills or
- fever or painful joints
- 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).

5. HOW TO STORE METHYLDOPA
Keep out of the sight and reach of children.

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
- your medicine may alter the numbers and types of your blood cells and
cause a rise in urea in the blood

Do not use Methyldopa after the expiry date, which is stated on the carton.
The expiry date refers to the last day of that month.

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
- Parkinsonism – with symptoms such as tremor, a decrease in body
movements with an inability to move your muscles
- 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 Methyldopa. Results could show:
- a decrease in blood cell production
- an increase in some white blood cells
- abnormal levels of prolactin
Methyldopa may also interfere with the interpretation of certain blood and
urine tests.
Reporting of side effects
If you get any side effects, please tell your doctor or pharmacist.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.

o

Do not store above 25 C. Store in the original package in order to protect from
light.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Methyldopa Tablets contain
The active ingredient in 'Methyldopa' Tablets is methyldopa.
Each Methyldopa 500 mg film-coated tablet contains methyldopa equivalent
to 500mg anhydrous methyldopa.
Methyldopa also contains: 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.
What Methyldopa looks like and the contents of the pack
Methyldopa 500 mg Film-Coated Tablets are yellow, round biconvex filmcoated tablets with ‘ALDOMET’ embossed on one side and ‘500’ on the
reverse.
Available in pack size of 30 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Iroko Products Limited, One Silk St, London, EC2Y 8HQ,
United Kingdom and procured from the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5, Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2227

Leaflet issue and Revision date (Ref): 26.04.16[9]

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.

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