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METHYLDOPA 500 MG TABLETS BP

Active substance(s): METHYLDOPA ANHYDROUS

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METHYLDOPA PIL :0046470814/02

160 X 297MM

9/3/14

1:01 PM

Page 1

Patient Information Leaflet

METHYLDOPA 250MG & 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).
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 is a member of group of medicines called
antihypertensive drugs or alpha adrenergic agonists.
Methyldopa is converted to a natural chemical in the
body which acts to lower blood pressure and is
thought to do this by acting on the brain mechanism
for controlling blood vessel size.
This medicine is used to treat mild, moderate or
severe high blood pressure (hypertension).

2. What you need to know before you take
Methyldopa

Do not take Methyldopa Tablets if you:
• are sensitive or allergic to methyldopa or any of the
ingredients of this tablet (listed in section-6)
• are suffering from depression
• have liver problems
• are being treated for high blood pressure due to a
tumour of the adrenal gland
• are on treatment with monoamino oxidase
inhibitors
Warnings and precautions
Talk to your doctor or pharmacist before taking these
tablets if you:
• are pregnant, planning to become pregnant or
breast feeding
• have angina
• had a stroke
• have kidney problems
• have a condition called porphyria
• are allergic to tartrazine
If you are to undergo dialysis you should inform your
doctor, as methyldopa is removed by dialysis.
If you are to undergo surgery, blood transfusion or
laboratory tests you should inform your doctor of
your treatment with methyldopa.

You may need to undergo liver function tests and
blood tests during the first 6 to 12 weeks of treatment,
during long-term treatment or if you develop an
unexplained fever.
If you are not sure or confused consult your doctor or
pharmacist.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. In
particular, tell your doctor if you are taking:
• other drugs that lower high blood pressure (eg:
clonidine, enalapril, hydralazine, diltiazem,
losartan, atenolol, nitrates etc)

• medicines called ‘tricyclic antidepressant’, used to



















treat depression and other mental disorders
(eg:amitriptyline, isocarboxazid, lithium,
chlorpromazine, thioridazine and haloperidol)
decongestants, which are used to clear blocked
nasal passages and sinuses (eg: ephedrine and
phenylpropanolamine)
muscle relaxants (eg: baclofen and tizandine)
aldesleukin, which is used to treat kidney cancer
levodopa and amantadine, which are used to treat
Parkinson’s disease (a condition causing tremors or
shaking of the limbs in an uncontrolled fashion)
corticosteroids used to treat inflammation
moxisylyte, which is used to treat Raynaud’s
syndrome (a condition affecting the small blood
vessels usually in the hands and feet)
oestrogens (used as a combined oral contraceptive
(‘the pill’) or hormone replacement therapy)
salbutamol, which is used in asthma and
bronchospasm
anti-emetics, which are used to relieve vomiting,
and nausea (eg: perphenazine)
medicines containing iron, such as multivitamins
with minerals
sympathomimetics (such as adrenaline. Other
adrenaline like medicines which are included in
most cough /cold remedies)
a group of medicines called “phenothaizines” such
as chlorpromazine
monoamines oxidase inhibitors used to treat
depression

If you are not sure, talk to your doctor or pharmacist
before taking these tablets.
Taking this medicine with food and drink
Avoid alcohol while taking these tablets as it may
increase the sedative effects of methyldopa.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or
are breast feeding ask your doctor or pharma- -cist for
advice before taking this medicine.
Driving and using machines
As this medicine may make you drowsy, you should
not drive or operate machinery until you know how
the drug affects you.
Methyldopa tablet contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine as it contains lactose.

3. How to take Methyldopa

Always take methyldopa exactly as your doctor has
told you. The pharmacists label should tell how much
to take and how often. 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 prescribes. Do not take more or less than your
doctor has prescribed. If you’re not sure ask your
doctor or pharmacist. You should swallow the tablet
with a glass of water.
Dosage
Adults: The usual initial dose is 250mg, two or three
times daily, for the first two days. If required, your
doctor may adjust this dose, by 250mg per day or at
intervals of at least two days.
The maximum daily dose is 3000mg.
Children: If methyldopa is prescribed for a child,
make sure that the tablets are taken as stated on the
label.
The dosage for children is worked out on the basis of
the child’s weight in kilograms. The initial dose is
usually 10mg per kg body weight daily, given in two

METHYLDOPA PIL :0046470814/02

160 X 297MM

or four doses. The number of tablets may be increased
or lowered at intervals if required, by your doctor.
The maximum daily dose for children is 65mg per kg
body weight or 3000mg, whichever is less.
Elderly: The initial dose should not exceed 250mg
daily. If required, your doctor may adjust this dose.
The maximum daily dose for elderly people is
2000mg.

If you take more tablets than you should
If you or anyone else has taken a large dose contact
your nearest hospital casualty department or doctor
immediately. Bring any remaining tablets with you to
show the doctor.
If you forget to take a dose
Do not worry just take your tablets as soon as you
remember, then go on as before. Do not take a double
dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Methyldopa 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 lightheadedness (particularly when standing up quickly)
• mental changes, including nightmares or depression
Nose and chest:
• nasal stuffiness
Stomach and gut:
• feeling sick, being sick, diarrhoea
• abdominal pain, feeling bloated
• constipation, excess wind
• 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

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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
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

Keep all medicines out of the sight and reach of
children
• Do not use the tablets after the expiry date stated
on the label after ‘EXP’. The expiry date refers to
the last day of that month.
• Do not store above 25˚C.
• Keep container tightly closed.
• Store in original container to protect from light.
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
Methyldopa tablets 250mg & 500mg:
• The active substance is methyldopa equivalent to
either 250mg of anhydrous methyldopa or 500mg
of anhydrous methyldopa.
• The other ingredients are lactose monohydrate,
Povidone , sodium starch glycollate, magnesium
stearate, hypromellose (E464), propylene glycol,
polyethylene glycol and the colour titanium dioxide
(E171), quinoline yellow aluminium lake (E104),
iron oxide yellow (E172) and sunset yellow
aluminium lake (E110).
See end of section 2 for further information on
lactose.
What Methyldopa tablets looks like and contents
of the pack
• Methyldopa 250mg tablets are yellow, circular,
film coated tablets embossed PV on one face and,
MD/250 on reverse.
• Methyldopa 500mg tablets are yellow, circular
film coated tablets embossed PV on one face and
MD/500 on the reverse.
• Methyldopa 250mg tablets are available in packs
containing “7, 14, 28, 56, 84, 100, 500 and 1000
tablets”
• Methyldopa 500mg tablets are available in packs
containing “7, 14, 28, 56, 84, 100, 500 and 1000
tablets”
Not all pack sizes may be marketed.
Marketing Authorization Holder
and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or audio
format or additional copies, please contact the licence
holder at the address (or telephone, fax) above.
PL 04556 / 0046 & 04556 / 0047
Reference: 0046470814/02

The leaflet was last revised in August 2014

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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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