Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Propylthiouracil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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 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).
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 using machinery 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.
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.
2. BEFORE YOU TAKE PROPYLTHIOURACIL TABLETS Do not take Propylthiouracil Tablets if you:
Unless instructed differently, take your tablets with a glass of water.
If any of the above apply to you, you should not take Propylthiouracil Tablets. 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:
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. 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. Propylthiouracil Tablets are not recommended for use in children under six years of age. 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. 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. 106778/6
pg 1/2 ARTWORK CHECK BOX PRODUCT : COMPONENT : CUSTOMER : FP CODE : DIMENSIONS : PHARMACODE : MIN. FONT SIZE : FILE NAME : SOFTWARE : TYPEFACES : REQUEST RECEIVED ON : PROOF REVISION :
Propylthiouracil 50mg – 56 & 100 Tablets Leaflet Wockhardt UK – (w) 210mm x (h) 290mm – 9 pt. Propylthiouracil_50mg_WUK Lit_106778-6.ai Adobe Illustrator CS5 Myriad Pro Regular / Bold 19th January, 2026
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Changes in detail: • New regulatory text Process Black
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Non-Regulatory
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. 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 your forgotten tablet.
Do not store above 25°C.
Like many medicines Propylthiouracil Tablets may cause side effects in some patients, although not everybody gets them.
Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container.
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:
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.
Symptoms of a serious problem affecting your blood:
Propylthiouracil Tablets should not be taken if they show signs of deterioration such as discoloration.
6. FURTHER INFORMATION What Propylthiouracil Tablets contain The active ingredient in Propylthiouracil Tablets is propylthiouracil. The tablets are available in one strength of 50mg.
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.
The other ingredients in your tablets are lactose, maize starch, pregelatinised maize starch, magnesium stearate and sodium starch glycollate.
Symptoms of hepatitis (inflammation of your liver), liver failure or other forms of liver damage (some of which can cause death):
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.
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:
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 01/2026
106778/6 Code: PB/Drugs/1802-OSP
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PROPYLTHIOURACIL TABLETS Keep out of the sight and reach of children.
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.
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 50mg Tablets comes as tablet containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Propylthiouracil 50mg Tablets is propylthiouracil.
Medicines with the same active substance, strength and form include: Propylthiouracil 50 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Propylthiouracil 50mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Hyperthyroidism
Adults and elderly:
Initially 300 to 600mg daily, once daily or in divided doses until the patient becomes euthyroid.
When the condition is controlled (usually after 1-2 months), the dose is reduced to 50 to 150mg daily and continued for 1-2 years.
In renal impairment:
GFR 10 to 50ml/min, 75% dose
GFR < 10ml/min, 50% dose
In hepatic disease:
Reduced dose
Children under 6 years:
Not recommended
Children 6-10 years:
Initially 50 to 150mg once daily or in divided doses
Children over 10 years:
Initially 150 to 300mg once daily or in divided doses
Previous severe hypersensitivity reaction e.g. agranulocytosis, hepatitis, vasculitis, nephritis.
Owing to the presence of Lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Because of the risk of agranulocytosis it is advised that patients should be warned to report to their doctor in the event of a sore throat, fever, mouth ulcers, bruising, malaise, non-specific illness or other symptoms of infection immediately. A full blood count should be performed and treatment should be discontinued immediately if there is clinical or laboratory evidence of neutropenia.
Propylthiouracil may cause hypothrombinaemia and bleeding so prothrombin time should be monitored during therapy, especially prior to surgery.
Some cases of severe hepatic reactions, both in adults and children, including fatal cases and cases requiring a liver transplant have been reported with propylthiouracil. Time to onset has varied but in a majority of cases the liver reaction occurred within 6 months. If significant hepatic enzyme abnormalities develop during treatment with propylthiouracil the drug should be discontinued immediately (see 4.8).
Propylthiouracil should be used with caution in patients with renal impairment or hepatic disease (see 4.2 Posology and Method of Administration). Patients should be advised of the symptoms of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc) and told to report them immediately. The occurrence of hepatic necrosis may have fatal consequences (see section 4.8, Undesirable effects).
Drug induced changes in thyroid status may affect the dosage requirements for theophylline, digoxin or beta-blockers. The doses of theophylline, digoxin or beta-blockers may need to be reduced as thyroid function returns to normal.
Pre-treatment with propylthiouracil may reduce the effectiveness of radio-iodine (131I) therapy for hyperthyroidism. This is supported by four studies one of which, a randomised study in 80 patients, showed an approximate halving of cure rate one year after 131I therapy in patients pre-treated with propylthiouracil.
Women of childbearing potential
Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy.
Pregnancy
Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and foetal complications.
Propylthiouracil is able to cross the human placenta and in high doses may cause foetal goitre and hypothyroidism.
Some epidemiological studies indicate that propylthiouracil use during pregnancy is associated with a slight increased risk of congenital malformations in comparison to women without hyperthyroidism, while others do not support this association. However, the risk appears to be comparable in magnitude to that observed in women with untreated overt hyperthyroidism.
Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy. Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones. If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended.
Lactation
Propylthiouracil also transfers to breast milk but this does not preclude breast-feeding. Neonatal development and infant thyroid function should be closely monitored. The lowest effective dose should be used.
None known.
Blood and lymphatic system: Reversible leucopenia. Rarely, agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia. A rare complication of therapy is a tendency to haemorrhage associated with hypoprothrombinaemia which may be controlled by the administration of phytomenadione.
Ear and labyrinth disorders: Rarely, hearing impairment may occur with propylthiouracil. The impairment usually becomes less marked after withdrawal of the drug.
Gastrointestinal: Nausea, gastrointestinal disturbances, taste perversion. Rarely vomiting.
General: Fever.
Hepatobiliary: Jaundice (usually cholestatic), hepatic necrosis (sometimes with fatal consequences), encephalopathy. More commonly, asymptomatic liver function test abnormalities (increased serum bilirubin, Alanine transaminase and / or alkaline phosphatase concentrations), which are reversible on dose reduction or discontinuation of treatment, may occur with propylthiouracil.
Frequency unknown: Hepatitis, hepatic failure.
Immune system: Interstitial pneumonitis, alveolar haemorrhage, lymphadenopathy, arthritis, nephritis, vasculitis and lupus erythematosus-like syndromes have occurred in some patients taking thiourea antithyroid drugs. An immune mechanism has been proposed. There have also been rare reports of acute glomerulonephritis. Hypersensitivity reactions may also be associated with the development of antineutrophil cytoplasmic antibodies (ANCA).
Musculoskeletal: Myopathy, arthralgia,
Nervous system: Headache.
Skin: Mild papular skin rashes, pruritus, urticaria, alopecia, cutaneous vasculitis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Goitre and hypothyroidism may be induced by repeated over dosage. Single overdose is not dangerous. Overdose may manifest as vomiting, epigastric distress, headache, fever, arthralgia, pruritus, and pancytopenia.
Treatment
The treatment of propylthiouracil overdose should aim to minimise the amount of drug absorbed into the circulation. Treatment should involve liberal use of oral fluids. Activated charcoal may also be employed. General symptomatic and supportive measures should then be instituted. A full blood analysis should be considered because of the slight risk of haematological complications and appropriate therapy given if bone marrow depression develops.
There is no specific antidote for propylthiouracil.
Ask anything about Propylthiouracil 50mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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