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METHYLDOPA 250MG TABLETS BP

Active substance(s): METHYLDOPA / METHYLDOPA / METHYLDOPA

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30 mm

180 mm

Package leaflet: Information for the user

METHYLDOPA 250MG AND 500MG TABLETS
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 or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Methyldopa Tablets are and what they are used for
2. What you need to know before you take Methyldopa Tablets
3. How to take Methyldopa Tablets
4. Possible side effects
5. How to store Methyldopa Tablets
6. Contents of the pack and other information

The name of your medicine is Methyldopa 250mg or 500mg
Tablets. It contains the active ingredient called methyldopa.
Methyldopa belongs to a group of medicines called
antihypertensives, which lower blood pressure. Methyldopa
tablets are used to treat high blood pressure (hypertension). It
works by relaxing the blood vessels so that blood can flow more
easily through the body.

2. What you need to know before you take
Methyldopa Tablets
Do not take Methyldopa Tablets if you:
• are allergic to methyldopa or any of the other ingredients of
this medicine (listed in section 6)
• have liver disease
• suffer from depression
• are taking MAOIs (monoamine oxidase inhibitors) for
depression.
• have high blood pressure due to a tumour near your
kidney called ‘phaeochromocytoma’ or ‘paraganglioma’
• have porphyria (a rare, inherited blood disorder)

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking Methldopa.
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.
If you are not sure if any of the above apply 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 Methldopa tablets.
Pregnancy, breast-feeding and fertility
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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Methyldopa.

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.

Methyldopa with alcohol
You are advised not to drink alcohol while taking Methyldopa
tablets. Discuss this with your doctor if you have any questions.

Warnings and precautions:
Talk to your doctor or pharmacist before taking
Methyldopa tablets if you have:
• a blood disorder called haemolytic anaemia
• liver problems
• jaundice (yellowing of the skin and eyes)
• fever
• any abnormal movements (involuntary)

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.

Other medicines and Methyldopa Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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
• medicines used as muscle relaxants : tizanidine and baclofen
• medicines used to treat parkinson’s disease e.g entecapone
• steroids e.g prednisolone
• medicines to treat psychosis e.g. haloperidol
• medicines used to treat erectile dysfunction e.g alprostadil
• medicines to treat anxiety
• iron and supplements containing iron, such as multivitamins
with minerals

Methyldopa Insert
SAME SIZE ARTWORK
180 x 420 mm
Front

This medicinal product contains:
• lactose - if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.
• sunset yellow E110, which may cause allergic reactions.

3. How to take Methyldopa Tablets
Always take this medicine exactly as your doctor or pharmacist
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 recommended dose is:
Adults and children over 12 years:
• The recommended 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 recommended 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.
IXXXXXX

Check with your doctor while taking this medicine if you are
going to have
• dialysis
• an operation
• a blood transfusion

Important information about some of the ingredients of
Methyldopa Tablets

420 mm

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

30 mm

180 mm

If you forget to take Methyldopa Tablets
Do not take a double dose to make up for a forgotten dose. If you
forget to take a dose take it as soon as you remember it and then
take the next dose at the right time.
If you stop taking Methyldopa Tablets
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, this medicine can cause side effects, although
not everybody gets them.
Contact your doctor IMMEDIATELY if you have 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).
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
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 or 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

Methyldopa Insert
SAME SIZE ARTWORK
180 x 420 mm
Back

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
• delusions and paranoia - which will stop when you stop taking
this medicine
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, 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.
420 mm

If you take more Methyldopa Tablets than you should
If you take too many tablets by mistake, contact your doctor
immediately or seek medical attention.






5. How to store Methyldopa Tablets
• Keep this medicine out of the sight and reach of children.
• Do not use the medicine after 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.
• Container: Keep the container tightly closed.
• 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 Methyldopa Tablets contain
The active ingredient in your tablets is methyldopa.
• Each Methyldopa 250mg Tablet contains methyldopa equivalent
to 250mg of anhydrous methyldopa.
• Each Methyldopa 500mg Tablet contains methyldopa equivalent
to 500mg of anhydrous methyldopa.
The other ingredients are lactose monohydrate, povidone, sodium
starch glycolate, magnesium stearate, hydroxypropyl
methylcellulose, propylene glycol, polyethylene glycol, colours:
titanium dioxide (E171), quinoline yellow aluminium lake (E104),
iron oxide yellow (E172) and sunset yellow aluminium lake (E110).
What Methyldopa tablets look like and contents of the
pack
• Methyldopa 250mg Tablets are yellow, circular, normal convex
film-coated tablets embossed with ‘250’ on one side and ‘BL’
on the reverse
• Methyldopa 500mg Tablets are yellow, circular, normal convex
film-coated tablets embossed with ‘500’ on one side and ‘BL’
on the reverse
Pack sizes:
• 250mg tablets: Containers of 56, 84, 100, 500 and 1000 tablets
and blister pack of 56 tablets
• 500mg tablets: Containers of 56, 84, 100 and 500 and blister
pack of 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and Address: Bristol Laboratories Limited
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Methyldopa 250mg Tablets; PL 17907/0350
Methyldopa 500mg Tablets; PL 17907/0351
This leaflet was last revised in January 2017
To request a copy of this leaflet in Braille, large print or audio
format, please contact the licence holder at the address (or
telephone, fax, email) above.

V7 19-01-17 D1

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• 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.

Expand Transcript

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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