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PROPYLTHIOURACIL TABLETS BP 50MG

Active substance(s): PROPYLTHIOURACIL

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Your tablets are called Propylthiouracil Tablets BP and they
are part of a group of drugs known as anti-thyroid drugs
which stop the body making too much thyroid hormone.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them
even if their symptoms seem to be 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.

(Propylthiouracil)

Patient Information Leaflet: PROPYLTHIOURACIL TABLETS BP 50 mg

What you need to know about Propylthiouracil Tablets
Please read this leaflet carefully before you start to take
your tablets. It contains important information. If you are
not sure about anything, or you want to know more, ask
your doctor or a pharmacist. Keep this leaflet safe, as you
may want to read it again.

In this leaflet:
1. What Propylthiouracil Tablets are and what they are used for
2. Before you take Propylthiouracil Tablets
3. How to take Propylthiouracil Tablets
4. Possible side effects
5. How to store Propylthiouracil Tablets
6. Further Information

1. What Propylthiouracil Tablets are and what
they are used for
The active ingredient in Propylthiouracil Tablets is
Propylthiouracil.
Propylthiouracil Tablets are used in the treatment of
hyperthyroidism. Hyperthyroidism is where an overactive
thyroid gland produces too much thyroid hormone. They
are also used to treat Graves’ disease, thyrotoxicosis and
thyrotoxic crisis (when levels of thyroid hormone are
dangerously high). Propylthiouracil Tablets may also be
given to lower very high levels of thyroid hormone before
surgery or radioactive iodine treatment. Children may be
given Propylthiouracil Tablets to delay the need for surgery
(or other treatment to remove part of an overactive thyroid
gland).

2. Before you take Propylthiouracil Tablets
Do not take Propylthiouracil Tablets if you:
• Think you may be allergic to Propylthiouracil or to any
of the other ingredients of Propylthiouracil Tablets.
(These are listed in section 6.);

Please tell your doctor before you start to take
Propylthiouracil Tablets if you:
• Have ever had an adverse reaction to Propylthiouracil or
to any of the other ingredients of Propylthiouracil
Tablets. (These are listed in section 6.);
• Are pregnant, may become pregnant or are breastfeeding;
• Have ever had any problems with your liver or kidneys;
• Are older than 40 years of age;
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.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your
doctor if you re taking any of the following:
• Are taking any mineral supplements in your diet which
may contain iodine;
• Are taking medicines which will reduce the number of
white blood cells in your body and hence lower your
resistance to infection. If you are not sure, you should
ask your doctor or pharmacist who will be able to give
you this information;
• Are taking medicines containing theophylline,
aminophylline or digoxin;

• Are taking other medicines including ones that you have
bought for yourself without a prescription.
These tablets contain Lactose and Sucrose. If you have been
told by your doctor that you have an intolerance to some
sugars contact your doctor before taking these tablets.
If you see another doctor or visit a hospital, remember to
tell them what medicines you are already taking.

3. How to take Propylthiouracil Tablets
You must take your tablets exactly as your doctor has told
you to. The dose will be on the pharmacist’s label. Check
the label carefully. It should tell you how many tablets to
take and how often. If you are not sure, ask your doctor or
pharmacist. Your doctor may want you to have regular
blood tests or other tests to check your condition and to
make sure that you are taking the right dose.
Swallow the tablets whole with water.
The following doses are intended as a guide:
ADULTS:
For management of hyperthyroidism and prior to surgery:
the starting dose is between 300mg and 600mg a day (6 to
12 tablets), taken as a single dose or in divided doses. This
may be gradually reduced to between 50mg and 150mg (1
to 3 tablets) daily as your condition improves.
In preparation for radioactive iodine therapy: The dose is as
above and should be taken for several weeks prior to
radioactive iodine therapy. Treatment should be stopped 2
to 4 days before iodine treatment.

For thyrotoxic crisis: The dose is 200mg (4 tablets) every 4
to 6 hours for the first 24 hours. This is then reduced as the
condition improves. Elderly patients will be given the adult
dose mentioned above. Patients with liver or kidney
problems may be given a lower dose.
CHILDREN:
Aged 6 to 10 years: The starting dose is 50mg to 150mg a
day (1 to 3 tablets).
Aged over 10 years: The starting dose is 150mg to 300mg a
day (3 to 6 tablets).
Neonates (babies less than 4 weeks old): The dose will be
worked out depending on the baby’s weight. The usual
daily dose is 5mg to 10mg for each kilogram of body
weight.
If you forget to take a dose at the right time, take it as soon
as you remember. Do not take two doses together. If it is
almost time to take the next dose, wait until then and then
carry on as before.
What to do if you take too many tablets: It is important
not to take too many tablets. Contact your nearest hospital
casualty department or a doctor for advice if you have
swallowed too many tablets or if you think a child has
swallowed any. Take this leaflet, and any tablets that you
still have to show the doctor.

4. Possible side effects
Like all medicines, Propylthiouracil Tablets can cause side
effects, although not everybody gets them.

Tell your doctor immediately if you get:
• A fever, sore throat, rashes or ulcers in your mouth and
throat, as this could be a sign that you are not making
any white blood cells to fight off infection. If this
happens your treatment should be stopped. However this
is a rare side effect and occurs most commonly within the
first two months of treatment and in patients over the
age of 40 who are taking larger doses.
• Fever, joint swelling and pain, muscle aches, blood in
urine, shortness of breath, rash.
Propylthiouracil may cause inflammation of the walls of
blood vessels which can be serious if not treated. This
can occur even if you have been taking propylthiouracil
for many years.
You should tell your doctor if you suffer from any of the
following for more than a few days:
• Rash;
• Itching;
• Hair loss;
• Skin colourations;
• Swelling (for example in the legs and feet);
• Being and feeling sick;
• Stomach upset;
• Loss of taste;
• Muscle or joint pain;
• Pins and needles and headache.
Possible side effects
Frequency unknown: Liver failure, liver inflammation.

Other rare side effects are:
• Anaemia, fever, weak and tender muscles, lupus-like
syndrome ( seen as a red, scaly rash on the nose and
cheeks and/or stiffness in the joints and malaise);
• Liver damage or inflammation, which can include
hepatitis, jaundice (yellow skin and whites of the eyes),
confusion, coma and death;
• Kidney inflammation (blood in the urine), bruises and
blood spots due to inflammation of the small blood
vessels in the skin, breathlessness and cough;
• Slow blood clotting, bleeding and bruising more easily
than usual.
If you feel unwell in any other way, tell your doctor as soon
as you can.
Your body may make less white blood cells than normal
which may make you more prone to picking up infections.
Levels will go back to normal when you stop taking your
treatment.

5. How to store Propylthiouracil Tablets
Store the tablets in their original pack away from direct
light. Store below 25ºC.
Keep all medicines out of the reach and sight of children.
Do not take the tablets after the expiry date which is
printed on the carton and label.
You should take any tablets that are out of date or which
you no longer need back to your pharmacist.

6. Further Information
There is one strength of Propylthiouracil Tablets, 50
milligrams (mg).
Propylthiouracil Tablets contain the active ingredient
Propylthiouracil. Each tablet contains Propylthiouracil BP
50 milligrams (mg) (active ingredient); and alginic acid,
maize starch, lactose, magnesium stearate and povidone 30
(other ingredients).
Propylthiouracil Tablets are white and come in packs of 56
or 100 tablets.
Marketing Authorisation Holder: RPH Pharmaceuticals
AB, Lagervägen 7, 136 50 Jordbro, Sweden
Manufacturer: Recipharm Ltd, Vale of Bardsley,
Ashton-under-Lyne, Lancashire, OL7 9RR, UK
Propylthiouracil Tablets are distributed by:
Focus Pharmaceuticals Ltd, Unit 5, Faraday Court, First
Avenue, Burton-upon-Trent, DE14 2WX
This leaflet was last approved in April 2012.
SIN 4664P
MAL 19940154A
If you would like any more information please contact
Medical Information on 0800 0329975
11000695

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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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