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METHYLDOPA 125 MG TABLETS

Active substance(s): METHYLDOPA / METHYLDOPA / METHYLDOPA

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24 mm

180 mm

Package leaflet: Infomation for the patient

Methyldopa 125 mg Tablets
(Methyldopa)
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 your 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. This includes any possible side effects not
listed in this leaflet. See section 4.

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



This medicine contains Methyldopa which 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 Tablets
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.
Warnings and Precautions
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 Methyldopa 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:
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other 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

Methyldopa Insert
SAME SIZE ARTWORK
180 x 420 mm
Front




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 Methyldopa tablets.
Methyldopa with alcohol
You are advised not to drink alcohol with this
medicine. Discuss this with your doctor if you have
any questions.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist before taking this medicine.
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.
This medicine 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.

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 doses of Methyldopa are:
Adults
• 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.
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.
• The recommended 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.
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420 mm

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



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 an
overdose has been taken, there may be signs such
as excessive drowsiness, weakness, slow heart rate,
dizziness, light-headedness, painful infrequent bowel
movements, bloated feeling, wind, diarrhoea, feeling
or being sick.
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, this medicine can cause side
effects, although not everybody gets them.
Tell 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)
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
• 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

Methyldopa Insert
SAME SIZE ARTWORK
180 x 420 mm
Back

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
• 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
• breast development in men
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.

5. How to store Methyldopa tablets






Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton after ‘EXP’. This
expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original
package in order 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
• The active substance is methyldopa.
• The tablets also contain Citric Acid, Lactose,
Starch, Talc, Magnesium Stearate, Stearic Acid,
Hydroxy Propyl Methyl Cellulose, Polyethylene
Glycol, Titanium Dioxide (E171) and Yellow Iron
Oxide (E172).
What Methyldopa Tablets look like and contents
of the pack
• Methyldopa Tablets are Yellow, circular, bi-convex
film-coated tablets embossed with ‘125’ on one
side and ‘BL’ on the reverse.
• Methyldopa 125 mg Tablets are packed in blister
pack containing 56 tablets.
Marketing Authorisation Holder and
Manufacturer
Name and address:
Bristol Laboratories Limited
Unit-3, Canalside, Northbridge Road,
Berkhamsted, HP4 1EG, United Kingdom
Telephone:
0044(0) 1442200922
Fax:
0044(0) 1442873717
Email:
info@bristol-labs.co.uk
Methyldopa 125 mg Tablets; PL 17907/0461
This leaflet was last revised in September 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.

V14 29-09-2016 D0

IXXXXXX



420 mm

24 mm

180 mm

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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