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PROPYLTHIOURACIL 50MG TABLETS

Active substance(s): PROPYLTHIOURACIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PROPYLTHIOURACIL 50 MG TABLETS
(Propylthiouracil)

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, pharmacist or nurse
• This medicine has been prescribed for
you only. Do not pass it on to others as 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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4
• Propylthiouracil 50 mg Tablets are called
‘Propylthiouracil Tablets’ in this leaflet
What is in this leaflet
1. What Propylthiouracil Tablets are and
what they are used for
2. What you need to know before you take
Propylthiouracil Tablets
3. How to take Propylthiouracil Tablets
4. Possible side effects
5. How to store Propylthiouracil Tablets
6. Contents of the pack and other
information

1. What Propylthiouracil Tablets
are and what they are used for
Propylthiouracil Tablets contains the active
substance propylthiouracil.
Propylthiouracil is used to treat
hyperthyroidism in adults (including the
elderly) and in children and adolescents
aged 6 to 18 years.
Hyperthyroidism is a condition where the
thyroid gland is overactive and makes too
much thyroid hormone called thyroxine.
Thyroxine helps to regulate the body's
growth and metabolism.
This medicine helps restore thyroxine levels
in your bloodstream to normal levels: it
may take several weeks for this to happen.
Hence it is important to keep taking the
medicine every day.

2. What you need to know before
you take Propylthiouracil
Tablets
Do not take Propylthiouracil Tablets:
• if you are allergic to propylthiouracil or
any of the other ingredients in this
medicine (listed in section 6)
• if you have ever had a severe allergic
reaction to propylthiouracil, including a
reduced white blood cell count, liver
problems, inflamed blood vessels and
kidney problems
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Propylthiouracil:
• if you are prone to getting infections
• if you have or have ever had liver or
kidney problems
• if you have a rare hereditary condition
such as galactose intolerance, the Lapp
lactase deficiency or are unable to absorb
glucose-galactose you should not take
this medicine
Talk to your doctor or pharmacist
immediately if during treatment you suffer
from:
• a sore throat, fever, mouth ulcers or other
symptoms of infection because
propylthiouracil may affect your body’s
ability to fight an infection.
• liver problems or the side effects of liver
problems such as anorexia, itching or
pain in the upper part of your stomach on
the right side.
• kidney problems.
Your doctor will arrange for you to have
regular blood tests to make sure that the
medicine is working properly.
Check with your doctor if any of the
following applies to you:
• Some cases of severe liver reactions,
including cases with fatal outcome or
requiring liver transplant, have been

reported in both children and adults
treated with propylthiouracil. You should
inform your doctor immediately if you
develop symptoms of liver disease, such
as nausea, feeling sick, diarrhoea, yellow
discolouration of the skin or eyes, dark
urine, pale stools, bleeding easily, itching
or chills.
• If you have liver or kidney problems
If any of the above applies to you, you
should speak to your doctor before taking
propylthiouracil tablets.
Other medicines and Propylthiouracil
Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including:
• Theophylline, a drug used to treat asthma
• Digoxin, used to treat problems with the
rhythm of your heart
• Beta-blockers, used to treat high blood
pressure
Propylthiouracil can affect how these
medicines or other medicines work. Your
doctor may need to change how much of
these medicines you need to take.
You should not take Propylthiouracil
Tablets before you have radio-iodine (131I)
therapy for an overactive thyroid gland
(hyperthyroidism) because it can reduce the
effectiveness of radio-iodine (131I) therapy.
Pregnancy, breast‐feeding and fertility
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.
Pregnancy
Propylthiouracil Tablets may be taken
during pregnancy but it may affect your
unborn baby. If you need to take
Propylthiouracil Tablets during pregnancy,
you should be given the lowest possible
dose and your thyroid function should be
tested every four to six weeks.
Breast-feeding
You should tell your doctor if you are
breast‐feeding or wish to start
breast‐feeding whilst taking
Propylthiouracil Tablets. Propylthiouracil
passes into breast milk and may affect your
child’s development. If you need to take
Propylthiouracil Tablets whilst you are
breast‐feeding, you should be given the
lowest possible dose and your baby’s
development should be closely monitored.
Fertility
If you suffer from hyperthyroidism this may
affect your fertility. Taking Propylthiouracil
Tablets can restore your fertility to normal
levels.
Driving and using machines
Propylthiouracil Tablets should not affect
your ability to drive or use machines.
Propylthiouracil Tablets contain lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to take Propylthiouracil
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. The dose will be on the
pharmacist’s label. It should tell you how
many tablets to take and how often. Also
follow any special instructions or warnings
which appear on the pharmacist’s label.
You can take Propylthiouracil Tablets with
or without food. Swallow the tablets whole
with a drink of water. Unless your doctor
has told you otherwise, try to take the
tablets at the same time each day. This will
help you to remember to take them.
Adults, including the elderly
The recommended starting dose is 300 to
600 mg daily (6 to 12 tablets), taken as

recommended by your doctor. When your
condition has been controlled (usually after
one to two months) the dose is usually
reduced to 50 to 150 mg daily (1 to 3
tablets) and continued for one to two years.
Use in children and adolescents
Children aged over ten years
The recommended starting dose is 150 to
300 mg daily (3 to 6 tablets), taken as
recommended by your doctor.
Children aged six to ten years
The recommended starting dose is 50 to
150 mg daily (1 to 3 tablets), taken as
recommended by your doctor.
Children under six years
Do not give this medicine to children
under six years because it is unlikely to
be safe.
Kidney or liver disease
If you have kidney or liver disease your
doctor will reduce your dose according to
your condition.
If you take more Propylthiouracil
Tablets than you should
If you accidentally take too many tablets
contact your doctor or pharmacist or
nearest hospital casualty department
immediately. Take this leaflet and any
remaining tablets with you to show the
doctor or pharmacist.
Signs that you have taken too many tablets
include being sick, stomach pain, headache,
fever, joint pain, itching, being pale,
tiredness, frequent infections, unusual
bleeding or unexplained bruising.
If you take too high a dose over a period of
time this can cause a swelling of your
thyroid gland (at the front of your neck).
Your thyroid gland may become
underactive, in which case you may feel
tired or cold or put on weight.
If you forget to take Propylthiouracil
Tablets
If you forget to take a dose, take it as soon
as you remember. If it is almost time for
your next dose, then do not take the missed
dose at all. Do not take a double dose to
make up for a forgotten tablet.
If you stop taking Propylthiouracil
Tablets
You should continue to take your medicine
for as long as your doctor tells you. Do not
stop taking the medicine without talking to
your doctor first.
If you have any further questions on the use
of this medicine, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, particularly when treatment is
first started, although not everybody gets
them.
Stop taking Propylthiouracil Tablets and
contact your doctor or the nearest
hospital accident and emergency
department immediately if you
experience any of these side effects whilst
taking Propylthiouracil Tablets:
Symptoms of an allergic reaction:
• difficulty in breathing
• cough
• swelling of your lymph glands (glands
situated around the body which protect
against the spread of infection)
• arthritis (painful joints)
• pain in your lower back or other
symptoms of kidney problems
• inflammation of your blood vessels (of
the skin)
• a rash across the bridge of your nose and
across your cheeks
Symptoms of liver problems, including
inflammation of your liver (hepatitis),
liver failure or other forms of liver
damage (some of which can cause
death):
• yellowing of the skin and whites of the
eyes (jaundice)
• pain on the right side of your stomach
• itching
• loss of appetite
• a brain disease which may affect your
ability to think
Some cases of severe liver reactions,
including cases with fatal outcome or
requiring liver transplant, have been
reported in both children and adults treated
with propylthiouracil.
Symptoms of kidney problems, including
kidney inflammation (nephritis):
• blood in the urine
• bruises and blood spots
• breathlessness
• coughing

• swelling of your lymph glands (glands
situated around the body which protect
against the spread of infection)
• swelling of the blood vessels in your skin
• pain in your lower back
Symptoms of a serious problem
affecting your blood:
• sore throat
• fever
• mouth ulcers
• unusual bleeding or unexplained
bruising
• unusual tiredness or weakness
• feeling generally unwell
You should contact your doctor
immediately if you develop any of these
side effects.
Other less serious side effects include:
• feeling sick or being sick
• stomach upsets
• taste disturbance
• headaches
• hearing loss
• mild skin rashes
• itching or reddening of the skin
• hair loss
• pain or stiffness of your muscles or
joints
• abnormal results of liver function tests
If any of these side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
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 national reporting systems
below.
United Kingdom: Yellow card scheme:
www.mhra.gov.uk/yellowcard
Ireland: via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL – Dublin 2. Tel:
+353 1 6764971 Fax: +353 1 6762517.
Website: www.hpra.ie
Email: medsafety@hpra.ie
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Propylthiouracil
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 outer carton,
bottle label or blister pack after EXP. The
expiry date refers to the last day of that
month.
Store in the original package in order to
protect from light.
Do not use this medicine if you notice
visible signs of deterioration such as
discoloration.
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 Propylthiouracil Tablets contains
The active substance is propylthiouracil.
Each tablet contains 50 mg of
propylthiouracil.
The other ingredients are lactose
monohydrate, acacia (spray-dried),
croscarmellose sodium, sodium
laurilsulfate and magnesium stearate.
What Propylthiouracil Tablets look like
and contents of the pack
Propylthiouracil Tablets are white, circular,
biconvex tablets of approximately 6.5 mm
by 3 mm.
Propylthiouracil Tablets are available in
plastic (polypropylene) bottles of 100
tablets and blister packs of 28 tablets or 56
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Halewood Chemicals Ltd, The Mill,
Horton Road, Stanwell Moor, Staines,
Middlesex, TW19 6BJ, UK.
Manufacturer: Surepharm Services
Limited, Unit 2B Bretby Business Park,
Ashby Road East, Bretby, Burton on Trent,
Staffordshire, DE15 0YZ, UK.
This leaflet was last revised in January
2018
PL 00042/0205
PA 1888-2-1

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