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METHYLDOPA 500MG TABLETS BP

Active substance(s): 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 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
Methyldopa Tablets. See 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 the kidney
(phaeochromocytoma)

• iron supplements containing iron, such as multivitamins with
minerals
• medicines called ‘tricyclic antidepressants’ - used to treat
depression
Pregnancy, Breast-feeding and Fertility
Tell your doctor if you are pregnant, planning to become pregnant
or if you are breast-feeding. If you become pregnant while taking
methyldopa, call your doctor immediately. Ask your doctor or
pharmacist for advice before taking any medicine.
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.
Methyldopa with food, drink and alcohol
Avoid drinking alcohol while taking this medicine. Methyldopa can
add to the effects of alcohol. Your doctor may prescribe a low-salt
or low-sodium diet. Follow these directions carefully.

Warnings and precautions:
Check with your doctor or pharmacist before taking
methyldopa tablets if you
• or anyone in your family has an illness called ‘hepatic porphyria’
• kidney problems
• had a stroke

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.

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

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.

Other Medicines and Methyldopa Tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription. Especially:
• alprostadil used to treat erectile dysfunction
• NSAIDs (non-steroidal anti-inflammatory drugs) which are used
to relieve pain
• antihypertensive medicines used to treat high blood
pressure (e.g. propranolol, nifedipine, verapamil or ‘water
tablets’)
• medicines used to treat anxiety or insomnia (e.g. diazepam,
temazepam)
• combined oral contraceptive (“the pill”) or hormone
replacement therapy (HRT)
• medicines to treat Parkinson’s disease such as levodopa,
entacapone, Amantadine
• linezolid (used to treat some infections)
• lithium (used to treat depression and mental illness)
• MAOIs (mono-amine oxidase inhibitors) used to treat
depression (e.g. phenelzine)
• medicines to treat mental illness and sometimes feeling ill
and being sick (e.g. chlorpromazine and thioridazine)
• moxisylyte used to treat Raynaud’s syndrome
• muscle relaxants such as baclofen, tizanidine
• nitrates (e.g. glycerol trinitrate “GTN”, isosorbide dinitrate/
mononitrate)
• steroids (e.g. prednisolone, hydrocortisone)
• sympathomimetics medicines used mainly for coughs and
colds (e.g. ephedrine or salbutamol)
• medicines used to treat ulcers such as carbenoxolone

3. How to take Methyldopa Tablets

Methyldopa Insert
SAME SIZE ARTWORK
180 x 420 mm
Front

Important information about some of the ingredients of
Methyldopa Tablets

• 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.
• Swallow these tablets with water.
Doses:
Adults and children over 12 years:
The recommended initial dose is 250mg two or three times each
day, for two days. This dose may be increased at intervals of 2
days until an adequate response is achieved upto 3g each day.
Children under 12 years:
The recommended initial dose is 10mg/kg of bodyweight daily in
2-4 divided doses adjusted as required up to 65mg/kg or 3g each
day, whichever is less.
Elderly:
If you are elderly, the recommended dose initially is not exceeding
250mg each day (e.g. 125mg twice daily), increasing as required,
up to 2g each day.
Methyldopa may be given with, or instead of, other medicines to
lower blood pressure and the doses may need to be amended.
If you take more Methyldopa Tablets than you should
If you (or someone else) swallow a lot of the tablets at the same
time, or if you think a child may have swallowed any, contact your
nearest hospital casualty department or tell your doctor
IXXXXXX
immediately.

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 treatment early because an increase in blood
pressure may occur. Talk to your doctor before you stop taking
the tablets and follow their advice.

4. Possible side effects
Like all medicines, this medicine 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 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

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. 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.
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 Methyldopa Tablets
• Keep out of the sight and reach 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. 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
Sodium content per tablet:
• 250 mg tablet – 158 micrograms
• 500 mg tablet – 315 micrograms
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.

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

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 May 2016
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.

Laboratory tests:
• Your doctor may need to carry out simple blood tests during
V4 11-05-2016 D0

Methyldopa Insert
SAME SIZE ARTWORK
180 x 420 mm
Back

IXXXXXX

Infections:
• swelling of salivary glands

420 mm

Symptoms of an overdose include excessive drowsiness,
weakness, slow heart rate, low blood pressure, dizziness, lightheadedness, painful infrequent bowel movements, bloated feeling,
wind, diarrhoea, feeling or being sick.

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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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