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METHYLDOPA TABLETS 500MG

Active substance(s): METHYLDOPA / METHYLDOPA / METHYLDOPA

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

090112/6

Colours Used

Customer

Ennogen

Black

Description

Methyldopa Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

10

Date

06-07-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methyldopa 125mg, 250mg and 500mg Tablets
(methyldopa)

Read all of this leaflet carefully before you start
It is particularly important that you tell your doctor
taking this medicine because it contains
or pharmacist if you are taking any of the following
important information for you.
before taking Methyldopa Tablets:
!
!
Keep this leaflet. You may need to read it
Other medicines for high blood pressure
again.
(antihypertensives)
!
!
If you have any further questions, ask your
Lithium - used to treat some types of
doctor or pharmacist.
depression
!
!
This medicine has been prescribed for you
Medicines called 'phenothiazines' such as
only. Do not pass it on to others. It may harm
chlorpromazine - used for mental illness and
them, even if their signs of illness are the same
sometimes feeling and being sick
!
as yours.
Medicines called 'tricyclic antidepressants' !
If you get any side effects, talk to your doctor or
used to treat depression
!
Cough and cold remedies that contain a
pharmacist. This includes any possible side
decongestant
effects not listed in this leaflet. See section 4.
!
Iron and supplements containing iron, such as
multivitamins with minerals
What is in this leaflet:
1. What Methyldopa Tablets are and what they
Surgery
are used for
If you have to have surgery, including dental, that
2. What you need to know before you take
requires an anaesthetic, you must tell the dentist or
Methyldopa Tablets
hospital that you are taking Methyldopa Tablets.
3. How to take Methyldopa Tablets
4. Possible side effects
Methyldopa Tablets with alcohol
5. How to store Methyldopa Tablets
You are advised not to drink alcohol while taking
6. Contents of the pack and other information
Methyldopa Tablets. Discuss this with your doctor if
1. WHAT METHYLDOPA TABLETS ARE AND
you have any questions.
WHAT THEY ARE USED FOR
Pregnancy and breast-feeding
You should check with your doctor before taking
Methyldopa Tablets contain the active ingredient
Methyldopa Tablets if you are or think you may be
methyldopa.
pregnant, if you are planning to become pregnant
Methyldopa belongs to a group of medicines called
or if you are breast-feeding.
'anti-hypertensive' agents.
These tablets are used to treat high blood pressure
Driving and using machines
(hypertension).
Methyldopa can make you feel sleepy. You should
2. WHAT YOU NEED TO KNOW BEFORE YOU
not drive, operate machinery or carry out other
TAKE METHYLDOPA TABLETS
activities requiring full alertness whilst taking this
medicine if you experience this effect.
Do not take Methyldopa Tablets if:
!
Methyldopa 125mg and 250mg Tablets contain
You are allergic to methyldopa or any of the
lactose
other ingredients of this medicine (listed in
If you have been told by your doctor that you have
section 6)
!
an intolerance to some sugars, contact your doctor
You have ever had liver disease
!
before taking this medicinal product.
You have phaeochromocytoma or
paraganglioma (a rare tumour of the adrenal
Methyldopa Tablets contain Tartrazine (E102)
gland which causes high blood pressure)
!
You suffer from depression
May cause allergic reactions.
!
You are taking monoamine oxidase inhibitors
3. HOW TO TAKE METHYLDOPA TABLETS
(MAOI)- a type of antidepressant
!
You have porphyria (a rare, inherited blood
disorder).
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
Warnings and precautions
if you are not sure.
Talk to your doctor or pharmacist before taking
Methyldopa Tablets if you have:
The tablets should be swallowed with water.
!
Liver problems
Adults:
!
A blood disorder called haemolytic anaemia
Usual dosage:
!
Jaundice (yellowing of the skin and eyes)
Starting dose is 250mg twice a day for 2 days.
!
Fever
This dose may be increased by your doctor by
!
Any abnormal movements (involuntary).
250-500mg daily, at intervals of at least 2 days.
Check with your doctor while taking this medicine if
This increase may continue until satisfactory
you are going to have:
control of your blood pressure is achieved.
!
Dialysis
Once control has been achieved, the daily dose
!
An operation
will be in the region of 500mg-2000mg.
!
A blood transfusion.
Elderly:
Tests you may have while taking Methyldopa
The starting dose may be lower.
Tablets
Your doctor will tell you exactly the dose to take
Your doctor may do blood tests to check how your
and how often to take it.
liver is working during the first 6-12 weeks. He or
she may use similar tests if you have a fever at any
Patients with kidney problems:
time while you are taking this medicine.
If you have problems with your kidneys, your
starting dose may be lower than the adult dose
above.
Tell your doctor you are taking this medicine if you
Your doctor will tell you exactly the dose to take
have a laboratory test where a urine or blood
sample is taken. This is because methyldopa may
and how often to take it.
affect the results of some types of tests.
If you are already taking other medicines for
high blood pressure (diuretics):
Rarely, in patients taking this medicine urine may
darken when it is exposed to air after voiding.
Your starting dose may be lower.
Your doctor will tell you exactly the dose to take
and how often to take it.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before taking
The medicine you are currently taking will be
Methyldopa tablets.
gradually withdrawn and the dose of Methyldopa
Tablets will be gradually increased.
Other medicines and Methyldopa Tablets
Tell your doctor or pharmacist if you are taking,
This increase in dose of Methyldopa Tablets will be
have recently taken or might take any other
adjusted upwards by 250mg to 500mg at 2 to 7
medicines, including medicines obtained without a
day intervals to maintain control of your blood
prescription as some drugs may affect each other's
pressure.
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.

If you take more Methyldopa Tablets than you
should
If you take an unintentional extra dose, this should
not be a problem. If you (or someone else) swallow

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

090112/6

Colours Used

Customer

Ennogen

Black

Description

Methyldopa Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

10

Date

06-07-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

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.

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.

If you forget to take Methyldopa 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. Do not take a double
dose to make up for a forgotten dose.

Psychiatric:
!
Mental changes, including nightmares
or depression
!
Delusions and paranoia - which will stop when
you stop taking this medicine.

If you stop taking Methyldopa 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.
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 side
effects, although not everybody gets them.

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.
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,
Contact your doctor IMMEDIATELY if you have
pharmacist or nurse. This includes any possible
any of the following side effects as they are
side effects not listed in this leaflet. You can also
serious and require medical attention:
report side effects directly via the Yellow Card
!
An allergic reaction symptoms such as
Scheme at: www.mhra.gov.uk/yellowcard.
shortness of breath, skin rash or itching, hives,
swelling of your lips, face or tongue, chills or
By reporting side effects you can help provide
fever or painful joints.
more information on the safety of this medicine.
!
Chest pain, slow heart rate, or existing angina
made worse, problems with the electrical
5. HOW TO STORE METHYLDOPA TABLETS
current in the heart (AV block)
!
Severe skin reactions (such as painful
Keep this medicine out of the sight and reach
reddening, followed by blistering and peeling of
of children.
layers of skin)
!
Liver problems, including jaundice and
Do not use this medicine after the expiry date
hepatitis - signs include yellowing of your skin
which is stated on the carton. The expiry date
and eyes, sometimes with a fever, pale stools
refers to the last day of that month.
and dark urine
Methyldopa 125mg Tablets: Store in a cool, dry
!
Pain in the gut and diarrhoea caused by
place and protect from light.
inflammation of the bowel (colitis)
Methyldopa 250mg and 500mg Tablets: Store
!
Severe pain in the gut and back caused by
below 25°C. Protect from light.
inflammation of the pancreas (pancreatitis).
Do not use this medicine if you notice visible signs
of deterioration.
The following reactions have also been reported.
Do not throw away any medicines via wastewater
The frequency of these is not known (frequency
or household waste. Ask your pharmacist how to
cannot be estimated from the available data).
throw away medicines you no longer use. These
measures will help protect the environment.
Blood:
!
Reduction in red blood cells (anaemia) this
can make your skin pale and make you weak
6. CONTENTS OF THE PACK AND OTHER
or breathless
INFORMATION
!
Abnormal blood test causing symptoms such
as pale skin, tiredness, fever and sore throat
What Methyldopa Tablets contain:
!
Bruising and prolonged bleeding after injury
Methyldopa 125mg Tablets contain 125mg of
!
Your medicine may alter the numbers and
methyldopa in each tablet
types of your blood cells and cause a rise in
Methyldopa 250mg Tablets contain 250mg of
urea in the blood.
methyldopa in each tablet
Methyldopa 500mg Tablets contain 500mg of
Nervous system:
methyldopa in each tablet
!
Feeling sleepy or tired - this may happen at the
start of treatment or when the dose is
increased, and usually goes away
The other ingredients are:
!
Headache or feeling weak this may happen at
Methyldopa 125mg and 250mg Tablets: lactose
the start of treatment and usually goes away
(see section 2), sodium calcium edetate, citric
!
Pins and needles
acid, ethyl cellulose, furcellaran, microcrystalline
!
Being unable to move part of your face
cellulose, magnesium stearate, hypromellose,
(paralysis)
povidone, castor oil and tartrazine (E102) (see
!
Having movements you cannot control
section 2) In addition methyldopa 125mg tablets
!
Parkinsonism with symptoms such as tremor,
contain talc.
a decrease in body movements with an inability
to move your muscles
Methyldopa 500mg Tablets:
!
Confusion
!
Frequent dizziness or fainting
Sodium calcium edetate, citric acid, sodium starch
!
Dizziness due to low blood pressure and lightglycolate, microcrystalline cellulose, ethyl
headedness (particularly when standing up
cellulose, isopropyl alcohol, magnesium stearate,
quickly).
colloidal silicon dioxide, polyvinyl alcohol (E1023),
talc (E553b), tartrazine (E102)(see section 2),
Nose and chest:
titanium dioxide (E171), lecithin (E322) and
!
Nasal stuffiness.
xanthan gum (E415).
Stomach and gut:
What Methyldopa Tablets look like and
!
Feeling sick (nausea)
contents of the pack
!
Being sick (vomiting)
Methyldopa 125mg and 250mg Tablets are yellow
!
Abdominal pain
coloured, round, biconvex, film coated tablets,
!
Feeling bloated
plain on both sides.
!
Constipation
!
Excess wind
Methyldopa 500mg Tablets are yellow coloured
!
Diarrhoea
capsule shaped .biconvex film coated tablets, plain
!
Dry mouth
on both sides with an approximate dimensions of
!
Sore or black tongue.
19.10mm X 8.60mm.
Skin and hair:
!
Skin rash or peeling skin.
Methyldopa Tablets are available in packs of 28,
30, 56, 60, 84, 90, 100, 112 and 250 tablets.
Joints and muscles:
Not all pack sizes may be marketed.
!
Painful and/or swollen joints
!
Muscle pains.
Marketing Authorisation Holder and
Manufacturer
Infections:
Ennogen Pharma Limited
!
Swelling of salivary glands.
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
General:
!
Water retention causing swelling and weight
gain
This leaflet was last amended in July 2017
!
Fever.

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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