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PROPYLTHIOURACIL 50MG TABLETS

Active substance(s): PROPYLTHIOURACIL

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for alternative UK supply
PACKAGE LEAFLET
INFORMATION FOR THE USER

Taking other medicines
Taking another medicine while you are taking Propylthiouracil Tablets can
affect how it or the other medicine works. Please inform your doctor or
pharmacist if you are taking or have recently taken any other medicines
or herbal products, including those you may have bought yourself
without a prescription.

Propylthiouracil 50mg Tablets
(Propylthiouracil)

Please check with your doctor if you are taking any of the following
(or any other medication):
• 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
• Radio-iodine, used to treat an overactive thyroid gland.

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If you have any doubts about whether you should take this medicine then
discuss matters with your doctor before taking it.

Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should
not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
The name of your medicine is Propylthiouracil 50mg Tablets. In the rest of
this leaflet it is called Propylthiouracil Tablets.
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

Pregnancy and breast-feeding
You should let your doctor know if you are pregnant or trying to become
pregnant before taking Propylthiouracil Tablets. Propylthiouracil Tablets
may be taken during pregnancy but it may affect your unborn child’s
thyroid gland. If you need to take Propylthiouracil Tablets during
pregnancy, you should be given the lowest effective dose and your
thyroid function should be checked every four to six weeks.
You should inform your doctor if you are breast-feeding or wish to start
breast-feeding whilst taking Propylthiouracil Tablets. If you need to take
Propylthiouracil Tablets whilst you are breast-feeding, you should be
given the lowest effective dose and the infant’s development and thyroid
function should be monitored.
Driving and operating machines
Propylthiouracil Tablets are not known to affect the ability to drive or
operate machinery.
Important information for patients who have an intolerance to
some sugars
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product,
as it contains lactose.

1. WHAT PROPYLTHIOURACIL TABLETS ARE
AND WHAT THEY ARE USED FOR
The active ingredient in Propylthiouracil Tablets is propylthiouracil, which
belongs to a group of medicines called antithyroid drugs. These
medicines work by reducing the production of a hormone called
thyroxine by the thyroid gland (a gland located beneath the voice box in
the throat that produces thyroid hormone and helps to regulate growth
and metabolism).
Propylthiouracil Tablets are used in the treatment and management of an
overactive thyroid gland (hyperthyroidism).

2. BEFORE YOU TAKE PROPYLTHIOURACIL
TABLETS

3. HOW TO TAKE PROPYLTHIOURACIL TABLETS
Your doctor will decide the dose which is best for you. Always follow
your doctor's instructions completely and also follow any special
instructions or warnings which appear on the label which the pharmacist
has put on the package. If you do not understand, or are in any doubt,
ask your doctor or pharmacist.
Unless instructed differently, take your tablets with a glass of water.
Adults and the elderly
The usual adult starting dose for Propylthiouracil Tablets is 300 to 600mg
once a day, or in divided doses, until your condition is controlled.

Do not take Propylthiouracil Tablets if you:
• are severely allergic to propylthiouracil or any of the other
ingredients of Propylthiouracil Tablets (see section 6 'What
Propylthiouracil Tablets contain' for a full list of ingredients).
• have a rare hereditary condition affecting the way your body
handles some sugars

When your condition has been controlled (usually after one to two
months) the dose is reduced to 50 to 150mg daily and continued for one
to two years.

If any of the above apply to you, you should not take Propylthiouracil
Tablets.

Children aged six to ten years of age
In children aged six to ten years, the usual starting dose is 50 to 150mg
once daily or in divided doses.

Propylthiouracil Tablets are not recommended for use in children
under six years of age.

Propylthiouracil Tablets are not recommended for use in children
under six 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.
• 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

Children over ten years of age
In children over ten years, the usual starting dose is 150 to 300mg once
daily or in divided doses.
If you have kidney or liver disease
If you have kidney or liver disease your doctor will reduce your dose
according to your condition.
Laboratory tests
Your doctor will normally arrange for you to have regular blood tests to
ensure Propythiouracil Tablets are working properly.

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Propylthiouracil 50mg - 56 Tablets
Wockhardt UK
FP3413
UK alternative
(w)210 x (h)290mm
8.5pt. (5% condensed)
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Non-Regulatory

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.
Too high a dose over a period of time can cause a swelling of your
thyroid (at the front of your neck) and your thyroid gland may become
underactive in which case you may feel tired or cold or put on weight.
If you miss a dose of Propylthiouracil Tablets
If you forget to take a dose, take another 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.

also report side effects directly via the national reporting systems listed
below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta:
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help
provide more information on the safety of
this medicine.

Stopping Taking Propylthiouracil Tablets
You should continue to take Propylthiouracil Tablets for as long as your
doctor tells you. Do not stop taking the medicine without talking to your
doctor first.

5. HOW TO STORE
PROPYLTHIOURACIL
TABLETS

4. POSSIBLE SIDE EFFECTS

Keep out of the reach and sight of children.

Like many medicines Propylthiouracil Tablets may cause side effects in
some patients, although not everybody gets them.
You should contact your doctor immediately if you develop any of the
following side effects affecting your blood or liver, or if you think you have
any type of infection:
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.
Your doctor should check your blood if you develop an infection or if you
are about to undergo surgery. You may need to stop your tablets if you
have any blood problems.
Symptoms of hepatitis (inflammation of your liver), liver failure or
other forms of liver damage (some of which can cause death):
• loss of appetite
• itching
• pain on the right side of your stomach
• jaundice (yellowing of the skin and whites of the eyes)
• a brain disease, which may affect your ability to think
You should contact your doctor immediately if you develop any of the
above side effects
You should also contact your doctor immediately if you develop an
allergic reaction, the symptoms of which are as follows:
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 the loins (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
Other less serious side effects include:
• feeling sick or being sick
• stomach upsets
• taste disturbance
• headaches
• hearing impairment
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can

Do not take this medicine if the expiry date on the label has passed.
The expiry date refers to the last day of that month.
Propylthiouracil Tablets should not be taken if they show signs of
deterioration such as discoloration.
Do not store above 25°C.
Store in the original container or package in order to protect from light
and moisture.
Do not transfer the tablets to another container.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Propylthiouracil Tablets contain
The active ingredient in Propylthiouracil Tablets is propylthiouracil.
The tablets are available in one strength of 50mg.
The other ingredients in your tablets are lactose, maize starch,
pregelatinised maize starch, magnesium stearate and sodium starch
glycollate.
What Propylthiouracil Tablets look like and contents of the pack
Propylthiouracil Tablets are white, circular tablets, rounded on both sides,
with a breakline on one side and CP on the other.
Propylthiouracil Tablets are available in polypropylene or polyethylene
(plastic) tablet containers of 56 or 100 tablets.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Reference number

Propylthiouracil 50mg Tablets

29831/0179

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 09/2015.

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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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