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PROPYLTHIOURACIL 50MG TABLETS

Active substance(s): PROPYLTHIOURACIL / PROPYLTHIOURACIL / 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. 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 is called ‘Propylthiouracil Tablets’ in this leaflet.

What is in this leaflet
1.

What Propylthiouracil Tablets is and what it is 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 is and what it is used for

Propylthiouracil Tablets contains the active substance propylthiouracil. This is an antithyroid medicine
that reduces your body’s ability to make thyroxine, a body chemical (hormone) that is made by the
thyroid gland in your neck and helps to regulate growth and metabolism.
Propylthiouracil is used to treat hyperthyroidism: a condition where the thyroid gland is overactive and
makes too much thyroxine. Thyroxine is carried around the body in the bloodstream. It helps to keep
the body's functions (the metabolism) working at the correct pace. Many cells and tissues in the body
need thyroxine to keep them going correctly. If your thyroid gland makes too much thyroxine it can
cause many of your body's functions to speed up. As a result you may suffer from side effects such as
being restless all the time, feeling nervous, irritable, sleeping poorly and always being “on the go”,
shakey hands, losing weight, sweating, shortness of breath, feeling tired all the time, and other effects.
This medicine is used to treat an overactive thyroid gland (hyperthyroidism) in adults (including the
elderly) and in children and adolescents aged 6 to 18 years.
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 of 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 affecting the way your body handles some sugars

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.
Children
Do not give this medicine to children under 6 years of age because it is unlikely to be safe.
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 contains 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.
You can take Propylthiouracil Tablets with or without food. Swallow the tablets 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.
Propylthiouracil Tablets is not recommended for use in children under six years of age.
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 or 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 hepatitis (inflammation of your liver), 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

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 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 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 looks 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 12/2016

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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