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METHYLDOPA TABLETS 250MG

Active substance(s): METHYLDOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Methyldopa 125mg, 250mg and 500mg tablets
(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 Methyldopa 125mg, 250mg and 500mg
tablets are and what they are used for
2. Before you take Methyldopa 125mg, 250mg
and 500mg tablets
3. How to take Methyldopa 125mg, 250mg and
500mg tablets
4. Possible side effects
5. How to store Methyldopa 125mg, 250mg and
500mg tablets
6. Further information
1. WHAT METHYLDOPA 125MG, 250MG AND
500MG TABLETS ARE AND WHAT THEY
ARE USED FOR
Methyldopa 125mg, 250mg and 500mg tablets
contain the active ingredient methyldopa.
Methyldopa belongs to a group of medicines called
'anti-hypertensive' agents.
These tablets are used to treat high blood pressure
(hypertension).
2. BEFORE YOU TAKE METHYLDOPA 125MG,
250MG AND 500MG
Do not take Methyldopa 125mg, 250mg and
500mg tablets if:
! You are sensitive to or have previously
experienced sensitivity to methyldopa or any of
the other ingredients in this medicine
! You have liver problems including hepatitis and
cirrhosis
! You have phaeochromocytoma (a rare tumour
of the adrenal gland which causes high blood
pressure)
! You suffer from depression
! You are taking monoamine oxidase inhibitors
(MAOI)- a type of antidepressant
Take special care with Methyldopa 125mg,
250mg and 500mg tablets:
Check with your doctor or pharmacist before using
your medicine if:
! You have kidney problems
! You suffer from a condition known as porphyria
! You are taking other medicines to lower your
blood pressure
! You have damaged or diseased blood vessels
in your brain
! You have a history of liver disease and/or liver
problems
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
tablets
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 this medicine.
Tell your doctor you are taking this medicine 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 applies to
you, talk to your doctor or pharmacist before taking
Methyldopa tablets.
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 Methyldopa tablets if you are taking a
type of medicine called a 'monoamine oxidase
inhibitor' (MAOI) 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 tablets:
! Other medicines for high blood pressure in
particular reserpine, also used to treat mental
illness, hydralazine and mebutamate also used
as a sedative
! 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
Pregnancy and breast-feeding
You should check with your doctor before taking
Methyldopa tablets 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
Methyldopa can make you feel sleepy. You should
not drive, operate machinery or carry out other
activities requiring full alertness whilst taking this
medicine if you experience this effect.
Important information about some of the
ingredients in this medicine
Methyldopa 125mg and 250mg tablets contain
lactose. If you have been told by your doctor that
you have an intolerance to some sugars, you
should talk to your doctor before taking this
medicine.
Methyldopa 125mg, 250mg and 500mg tablets
contain tartrazine (E102) which may cause an
allergic reaction.
3. HOW TO TAKE METHYLDOPA 125MG,
250MG AND 500MG TABLETS
Always take Methyldopa 125mg, 250mg and
500mg tablets exactly as your doctor has
instructed you. You should check with your doctor
or pharmacist if you are unsure.
The tablets should be swallowed with water.
Adults:
Usual dosage:
Starting dose is 250mg twice a day for 2 days.
This dose may be increased by your doctor by
250-500mg daily, at intervals of at least 2 days.
This increase may continue until satisfactory
control of your blood pressure is achieved.
Once control has been achieved, the daily dose
will be in the region of 500mg-2000mg.
Elderly:
The starting dose may be lower.
Your doctor will tell you exactly the dose to take
and how often to take it.
Patients with kidney problems:
If you have problems with your kidneys, your
starting dose may be lower than the adult dose
above.
Your doctor will tell you exactly the dose to take
and how often to take it.
If you are already taking other medicines for
high blood pressure (diuretics):
Your starting dose may be lower.
Your doctor will tell you exactly the dose to take
and how often to take it.
The medicine you are currently taking will be
gradually withdrawn and the dose of Methyldopa
tablets will be gradually increased.
This increase in dose of Methyldopa tablets will be
adjusted upwards by 250mg to 500mg at 2 to 7
day intervals to maintain control of your blood
pressure.
If you take more Methyldopa 125mg, 250mg
and 500mg tablets than you should
If you take an unintentional extra dose, this should
not be a problem. If you (or someone else) swallow
a lot of tablets altogether, or if you think a child has
swallowed one of the tablets, contact your nearest
accident and emergency department or doctor
immediately.

Symptoms of overdose include excessive
drowsiness, weakness, slow heart rate, low blood
pressure, dizziness, light-headedness, painful
infrequent bowel movements, feeling bloated,
wind, diarrhoea, feeling or being sick.
If you forget to take Methyldopa 125mg, 250mg
and 500mg tablets
If you forget to take a dose, take the missed dose
as soon as you remember. If your next dose is due
within 4 hours, skip the missed dose and take your
next dose at the usual time.
If you stop taking Methyldopa 125mg, 250mg
and 500mg tablets
Do not stop taking these tablets without talking to
your doctor. The dose needs to be gradually
reduced. If you stop taking these tablets you will
experience a rise in blood pressure and your
original symptoms will return.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Methyldopa Tablets can cause
side effects, although not everybody gets them.
You may feel dizzy or lightheaded when standing
up quickly or after exercising which is associated
with lowering of blood pressure although this is
less common than with some other
antihypertensive medicines.
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, 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).
Other unwanted effects which may occur while
taking Methyldopa Tablets are:
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

General:
! Water retention causing swelling and
weight gain
! Fever
Allergic:
! Inflammation of heart muscle or the
sac surrounding the heart, skin rash
which may be red and/or scaly, 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
! 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 tablets. Results could show:
! A decrease in blood cell production
! An increase in some white blood cells
! Abnormal levels of prolactin
! A positive result for antinuclear antibodies, LE
cells and rheumatoid factor
You may also notice that your urine may appear
darker after urination.
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 125MG,
250MG AND 500MG TABLETS
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date stated
on the label.
Methyldopa 125mg tablets: Store in a cool, dry
place and protect from light.
Methyldopa 250mg and 500mg tablets: Store
below 25°C. Protect from light.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste
water or household waste. Ask you pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.

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

Keep out of the reach and sight of children

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 lightheadedness (particularly when standing up
quickly)

What Methyldopa 125mg, 250mg and 500mg
tablets contain:
Methyldopa 125mg tablets contain 125mg of
methyldopa in each tablet
Methyldopa 250mg tablets contain 250mg of
methyldopa in each tablet
Methyldopa 500mg tablets contain 500mg of
methyldopa in each tablet

Nose and chest:
! Nasal stuffiness
Stomach and gut:
! Feeling sick (nausea)
! Being sick (vomiting)
! Abdominal pain
! Feeling bloated
! Constipation
! Excess wind
! Diarrhoea
! Dry mouth
! Sore or black tongue
Skin and hair:
! Skin rash or peeling skin

6. FURTHER INFORMATION

The other ingredients are: sodium calcium edetate,
citric acid, ethyl cellulose, furcellaran,
microcrystalline cellulose, magnesium stearate,
hypromellose, povidone, castor oil, tartrazine
(E102). The 125mg and 250mg tablets also
contain lactose. The 125mg and 500mg tablets
also contain talc and in addition the 500mg contain
colloidal silicon dioxide.
What Methyldopa 125mg, 250mg and 500mg
tablets look like and contents of the pack
Methyldopa Tablets 125mg, 250mg and 500mg
tablets are yellow, round slightly biconvex tablets
with a dividing groove.
Methyldopa 125mg, 250mg and 500mg tablets are
available in packs of 28, 30, 56, 60, 84, 90, 100,
112 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.

Joints and muscles:
! Painful and/or swollen joints
! Muscle pains

Manufacturer
Lagap Pharmaceuticals SA
Via San Gottardo 22, 6943 Vezia (LUGANO)
SWITZERLAND

Infections:
! Swelling of salivary glands

This leaflet was last amended in December
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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