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METHYLDOPA 125MG TABLETS

Active substance(s): METHYLDOPA / METHYLDOPA / METHYLDOPA

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Job No: 000000

P L 06464/1432/3/4 GB 724-9816-APIL

Name: Methyldopa 125, 250, 500 mg tablets

C/Date: 24.04.17 Ver: 08 Barcode:
Update: 25.04.17 27.04.17 26.06.17 27.06.17

Special instructions:

Laetus: 000

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Size: 160 x 450 mm

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Arial 9pt.
Miles Gray Road,
Basildon, Essex.
SS14 3FR
© 2017

GB 724-9816-APIL

Package leaflet: Information for the user

Methyldopa

125 mg, 250 mg & 500 mg 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. 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

1. What Methyldopa Tablets are
and what they are used for
The name of your medicine is Methyldopa
125 mg, 250 mg or 500 mg Tablets (referred to
as Methyldopa Tablets throughout this leaflet).
Methyldopa Tablets contain the active
ingredient methyldopa, which belongs to a
group of medicines called antihypertensives,
which lower blood pressure.
Methyldopa Tablets are used for the treatment
of hypertension (high blood pressure).

2. What you need to know before
you take Methyldopa Tablets
Do not take this medicine








if you are allergic to methyldopa or any of
the other ingredients of this medicine
(listed in section 6)
if you have ever had liver disease
if you have ever had depression
if you have been taking a type of medicine
called a monoamine oxidase inhibitor
(MAOI)
if you have high blood pressure due to a
tumour near your kidney called
'phaeochromocytoma' or 'paraganglioma'
If you have porphyria (a rare, inherited
blood disorder).

If you are unsure if any of the above apply to
you, please talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Methyldopa Tablets
• if you have a blood disorder called
haemolytic anaemia
• if you have liver problems
• If you have jaundice (yellowing of the skin
and eyes)
• if you have a fever
• If you have abnormal movements
(involuntary).
Check with your doctor while taking this
medicine if you are going to have:
• dialysis
• an operation
• a blood transfusion.
Other medicines and Methyldopa Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including any medicines obtained
without a prescription, as some medicines 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’ (MAO inhibitor) used to treat
depression.
It is especially important to talk to your doctor
or pharmacist if you are taking any of the
following:
• alprostadil used to treat erectile
dysfunction
• NSAIDs (non-steroidal anti-inflammatory
drugs) which are used to relieve pain
• medicines used to treat anxiety or
insomnia (e.g. diazepam, temazepam)
• antihypertensive medicines such as
beta-blockers or calcium-channel blockers
or diuretics (also known as `water tablets')
used to treat high blood pressure (e.g.
propranolol, nifedipine, verapamil or
furosemide)
• corticosteroids (e.g. prednisolone,
hydrocortisone)
• medicines to treat Parkinson's disease
such as levodopa or entacapone

Type: A

Note:
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moxisylyte, used to treat Raynaud's
syndrome
muscle relaxants such as baclofen,
tizanidine
nitrates (e.g. glycerol trinitrate “GTN”,
isosorbide dinitrate/mononitrate)
combined oral contraceptive (“the pill”) or
hormone replacement therapy (HRT)
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
sympathomimetics medicines used mainly
for coughs and colds (e.g. ephedrine or
salbutamol)
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 Tablets.
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 Tablets with alcohol
You are advised not to drink alcohol while
taking Methyldopa Tablets. Discuss this with
your doctor if you have any questions.
Laboratory tests
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 that you are taking
methyldopa if you are having a blood or urine
test, as this medicine may affect the results of
certain laboratory tests.
Rarely, in patients taking methyldopa, urine
may darken when it is exposed to air after
voiding.
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 for advice
before taking this medicine.
Driving and using machines
You may feel drowsy or light-headed
while taking Methyldopa Tablets.
If this happens do not drive or use
any tools or machines.

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.
You should take this medicine by mouth and
exactly as advised by your doctor or
pharmacist. The amount you take each day
will depend on your condition. It is important to
continue taking Methyldopa Tablets for as long
as your doctor has prescribed. Do not take
more or less than your doctor has prescribed.
The breakline is not intended for breaking
the tablet.
Recommended dose
Adults
• The usual 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 usual 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 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.
If you take more Methyldopa Tablets than
you should
If you realise that you have taken more
Methyldopa Tablets than your doctor has
recommended (or if someone else has taken
some of your Methyldopa Tablets), contact
your doctor right away. If you cannot contact
your doctor, go to your nearest hospital
casualty department and take the pack with
you.

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If you forget to take Methyldopa Tablets
If you forget to take a dose, just take the next
dose at the usual time. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Methyldopa Tablets
Do not stop taking Methyldopa Tablets without
talking to your doctor.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
unwanted 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)
• 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
• having movements you cannot control
The following reactions have also been
reported:
Blood:
• 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
Bells' Palsy (weakness or paralysis of the
muscles on one side of the face)
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
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
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:
o a decrease in blood cell production
o an increase in some white blood cells
o abnormal levels of prolactin
Methyldopa Tablets 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
or pharmacist. 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 store above 25°C.
Container (125 mg): Keep the container tightly
closed and store in the original container.
Blister pack (250 mg and 500 mg): Store in the
original package.
Do not use this medicine after the expiry date
that is stated on the carton, label or blister after
EXP. The expiry date refers to the last day of
that month.
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
Each film-coated tablet contains 125 mg,
250 mg or 500 mg of the active ingredient
methyldopa (anhydrous).
The other ingredients are anhydrous citric acid,
povidone, sodium starch glycollate, stearic
acid, magnesium stearate, microcrystalline
cellulose, hydroxypropylmethylcellulose,
Opaspray Yellow M-1F-6047B solids (which
includes titanium dioxide (E171), yellow iron
oxide (E172) and Quinoline yellow (E104)).
What Methyldopa Tablets look like and
contents of the pack
Methyldopa 125 mg Tablets are yellow, round,
film coated tablets, embossed with “MT/125”
separated by a breakline.
Methyldopa 250 mg Tablets are yellow, round,
film coated tablets, embossed with “MT/250”
separated by a breakline.
Methyldopa 500 mg Tablets are yellow, round,
film coated tablets, embossed with “MT/500”
separated by a breakline.
Methyldopa 125 mg Tablets are packed in
containers of 56 tablets.
Methyldopa 250 mg Tablets and Methyldopa
500 mg Tablets are available as blister packs
of 56 tablets.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder
Sovereign Medical, Sovereign House
Miles Gray Road, Basildon, Essex
SS14 3FR, UK
Manufacturer
Waymade Plc, Sovereign House
Miles Gray Road, Basildon, Essex
SS14 3FR, UK
This leaflet was last revised in July 2017
PL 06464/1432
PL 06464/1433
PL 06464/1434

Methyldopa 125 mg Tablets
Methyldopa 250 mg Tablets
Methyldopa 500 mg Tablets

To request a copy of this
leaflet in Braille, large print or
audio format, contact the
licence holder at the above
address or telephone:
01268 535200 (select option
Medical Information) / e-mail:
info@waymade.co.uk

GB 724-9816-APIL

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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