Consumer medicine information

PTU 50 mg Tablets

Propylthiouracil

BRAND INFORMATION

Brand name

PTU

Active ingredient

Propylthiouracil

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using PTU 50 mg Tablets.

What is in this leaflet

This leaflet answers some common questions about PTU. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking PTU against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What PTU is used for

This medicine is used to treat an overactive thyroid gland. An overactive thyroid gland produces too much thyroid hormone, also known as hyperthyroidism. This medicine may also be used to treat symptoms of hyperthyroidism before surgery or radioactive iodine therapy.

This medicine belongs to a group of medicines called antithyroid medicines.

This medicine works by stopping thyroid hormone from forming. This medicine may take up to a week to reduce the symptoms of hyperthyroidism.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you take PTU

When you must not take it

Do not take PTU if you have an allergy to:

  • any medicine containing propylthiouracil
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines called thioamide derivatives.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not breast-feed if you are taking this medicine. The active ingredient in PTU passes into breast milk and there is a possibility that your baby may be affected.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had asthma.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking PTU.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

Some medicines and PTU may interfere with each other. These include:

  • medicines used to prevent blood clots or thin the blood, for example heparin, warfarin, aspirin
  • any medications which have a side effect called agranulocytosis, a lack of white blood cells. These include:
    - sulphonamide antibiotics
    - clozapine, a medicine used to treat schizophrenia
    - spironolactone, a medicine used to treat hypertension.

Ask your doctor for more information on medicines that cause this side effect.

These medicines may be affected by PTU or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take PTU

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how many tablets to take, and when to take them each day. This will depend on your condition, what other medicines you are taking, and how you respond to treatment with PTU.

When your condition has improved your doctor may put you on a lower dose long term to maintain your condition.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

PTU must be taken every day in equal doses at equal intervals during the day. If your doctor tells you to take 2 doses per day you would take each dose 12 hours apart. If your doctor tells you to take 4 doses per day you would take each dose 6 hours apart.

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

Continue taking your medicine for as long as your doctor tells you to. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is less than 6 hours for a twice daily dose or 3 hours for a four times daily dose before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 (Australia) for advice, or go to the Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much PTU. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

  • symptoms of agranulocytosis:
    - mouth ulcers
    - sore throat
    - frequent infections such as fever, chills
    - headache, tiredness and lethargy.
  • symptoms of hypothyroidism:
    - tiredness, lethargy
    - muscle weakness, cramps
    - feeling cold
    - a slow heart rate
    - dry, puffy, flaky skin
    - hair loss
    - a deep and husky voice
    - unusual weight gain
    - change in menstrual periods
    - listlessness
    - constipation
    - headache.

While you are using PTU

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking PTU.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests such as regular full blood counts, regular thyroid function tests and liver function tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take PTU to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Be careful driving or operating machinery until you know how PTU affects you. This medicine may cause dizziness and/or tiredness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or a chair, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PTU. This medicine helps most people with hyperthyroidism but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are a woman under 30 years of age you may have an increased chance of getting certain side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you (Those indicating need for medical attention only if they continue or are bothersome):

  • itching
  • dizziness
  • joint pain
  • loss of taste
  • nausea, vomiting, stomach pain
  • numbness or tingling of fingers, toes, or face
  • skin rash
  • change in skin or hair colour, loss of hair
  • sore, red, watery eyes.

The above list includes the side effects of your medicine that are usually mild and short-lived.

Tell your doctor as soon as possible if you notice the following symptoms of thyrotoxicosis (excess thyroid hormone):

  • diarrhoea
  • fever
  • irritability, listlessness, weakness
  • rapid or irregular heart beat
  • vomiting.

The above list includes side effects, which could mean the medicine is not working properly.

Tell your doctor as soon as possible if you notice any of the following:

  • yellowing of the eyes and skin
  • loss of hearing
  • swollen glands
  • unusual bleeding or bruising
  • increase or decrease in urination
  • backache
  • swelling of feet or lower legs symptoms of vasculitis:
    - painful joints
    - fever
    - skin rash or raised red lumps
    - wheezing or difficulty breathing
    - difficulty passing urine
  • hives
  • upper abdominal pain
  • tingling or pricking feeling.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:

  • symptoms of agranulocytosis, granulocytopenia and leucopenia (lack of white blood cells):
    - mouth ulcers
    - sore throat
    - frequent infections such as fever, chills
    - headache, tiredness and lethargy
  • symptoms of thrombocytopenia:
    - bleeding or bruising more easily than normal
  • symptoms of hypothyroidism:
    - tiredness, lethargy
    - muscle weakness, cramps
    - feeling cold
    - a slow heart rate
    - dry, puffy, flaky skin
    - hair loss
    - a deep and husky voice
    - unusual weight gain
    - change in menstrual periods
    - listlessness
    - constipation
    - headache
  • symptoms of hypersensitivity reactions: serious skin reactions and skin loss (Stevens Johnson syndrome and toxic epidermal necrolysis)
  • symptoms of hepatotoxicity:
    - discomfort in the upper stomach
    - fever
    - nausea and vomiting together with weight loss.
  • kidney disease
  • severe flaking or peeling of the skin
  • swelling of the lungs causing difficulty breathing
  • skin rash with red lumps.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

After using PTU

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store PTU or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

PTU tablets are round, white and biconvex. One side is debossed with “PRESTAB” while the other side is plain.

PTU tablets are available in an amber glass bottle containing 100 tablets.

Ingredients

Each PTU tablet contains 50 mg of propythiouracil as the active ingredient.

It also contains:

  • lactose monohydrate
  • maize starch
  • povidone
  • methylated spirit (removed in process)
  • sodium lauryl sulfate
  • magnesium stearate.

This medicine does not contain sucrose, gluten, tartrazine dyes or preservatives.

Supplier

PTU is supplied in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Ph: 1800 720 020

PTU™ 50 mg Tablets
100 tablets per bottle

AUST R 13319

Phebra Product Code- TAB001

Date of most recent amendment: Feb 2020

PTU, Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS May 2020

BRAND INFORMATION

Brand name

PTU

Active ingredient

Propylthiouracil

Schedule

S4

 

1 Name of Medicine

Propylthiouracil.

6.7 Physicochemical Properties

Chemical name: 1,2-dihydro-6- propyl-2- thioxopyrimidine-4-one.
The molecular weight of the compound is 170.2, the molecular formula is C7H10N2OS.

Chemical structure.


CAS number.

51-52-5.

2 Qualitative and Quantitative Composition

Propylthiouracil is a thioamide derivative which occurs as a white crystalline powder, odourless with a bitter taste, very slightly soluble in water, sparingly soluble in ethanol and soluble in solutions of alkali hydroxides or ammonia.
PTU 50 mg Tablets contain 50 mg of the active ingredient propylthiouracil.

Excipients with known effect.

Lactose monohydrate. The tablet is gluten free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

PTU 50 mg Tablets are white, round, biconvex and uncoated. One side is debossed 'PRESTAB' and other side is plain.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Category: Antithyroid.
Propylthiouracil blocks the peripheral conversion of thyroxine (T4) to triiodothyronine (T3) by inhibiting incorporation of iodide into tyrosine.
Propylthiouracil does not interfere with the action and the release of exogenous thyroid hormone. Clinical response, therefore, does not occur until circulating and colloid stored thyroid hormone is utilised, and as such depends in part on the amount of colloid in the gland. The rapid fall in serum triiodothyronine T3 concentration, before serum thyroxine (T4) levels fall, parallels a clinical improvement in the thyrotoxic patient, and is generally seen after the first week. The patient may become euthyroid after 4-6 weeks.
Propylthiouracil does not interfere with the effectiveness of thyroid hormones given by mouth or injection. Prolonged administration of propylthiouracil may result in hyperplasia of the thyroid gland due to pituitary thyrotrophic hyperactivity induced by diminished thyroxine secretion.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Propylthiouracil is rapidly absorbed.

Distribution.

Protein binding of propylthiouracil is approximately 75%.

Metabolism.

The drug is metabolized in the liver.

Excretion.

The half-life in plasma approximates 2 hours (in anuric patients T1/2 8.5 hours).
The drug is excreted in the bile (primary route) with approximately 30% being excreted in the urine as metabolites or whole drug.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Propylthiouracil is an antithyroid drug indicated for the total treatment of hyperthyroidism or in the treatment of the thyrotoxic patient prior to surgery or radioactive iodine therapy.

4.3 Contraindications

Patients who are known to be hypersensitive to propylthiouracil or related thioamide derivatives.

4.4 Special Warnings and Precautions for Use

In preparing patients for surgery, the administration of iodine is recommended concomitantly with propylthiouracil to decrease the vascularity and friability of the thyroid gland.
Although propylthiouracil is used for the total treatment of hyperthyroidism, duration of treatment necessary to produce a prolonged remission varies from 6 months to several years, with an average duration of one year. Remission has occurred in at least 50% of patients 6-12 months after cessation of medication.
In view of the fact that hypothyroid patients seem to have poor adrenergic nervous function, use with caution in patients with asthma.
Patients should be closely supervised during prolonged propylthiouracil therapy because of the likelihood of agranulocytosis. Patients should be warned to report immediately any evidence of illness, particularly sore throat, skin eruptions, fever, chills, headache, and malaise.
All patients receiving propylthiouracil should have regular full blood counts as well as close monitoring of liver and thyroid function tests (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).
Regular thyroid function tests are recommended in patient monitoring (recommended prior to initiation of therapy, at monthly intervals during stabilization, then every 2 to 3 months), viz free (unbound) serum thyroxine (T4) levels, total serum T4 levels, serum thyrotropin (TSH), total serum triiodothyronine (T3). Liver function tests are also recommended at periodic intervals during therapy.

Hepatotoxicity.

Propylthiouracil-related hepatotoxicity is a major but rare side effect. The frequency ranges from 0.1 percent to 0.2 percent and takes the form of an allergic hepatitis accompanied by laboratory evidence of hepatocellular injury. This includes markedly elevated amino-transferase levels and submassive or massive hepatic necrosis on biopsy. The danger of permanent hepatic damage should be kept in mind. The best way of preventing propylthiouracil hepatotoxicity is careful screening of patients considered for treatment.
Women less than 30 years of age have a higher incidence of propylthiouracil induced hepatotoxicity and the average duration of propylthiouracil therapy before the onset of hepatotoxicity is approximately three months. Monitoring hepatic enzymes on a monthly basis for the first six months of treatment has been suggested. Patients on propylthiouracil treatment should be counselled to report signs and symptoms of hepatotoxicity, such as upper abdominal discomfort, fever, nausea and vomiting together with weight-loss.
Hepatotoxicity resulting in liver failure, liver transplantation, or death, has been reported with propylthiouracil therapy in adults and children.

Agranulocytosis producing medications.

Concurrent use may increase the risk of agranulocytosis.

Use in the elderly.

No data available.

Paediatric use.

Propylthiouracil is not recommended for use in children except where carbimazole is not well-tolerated and surgery or radioactive iodine therapy are not appropriate therapies.

Effects on laboratory tests.

Prothrombin time, serum alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) levels may be increased.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Because propylthiouracil can cause hypoprothrombinemia, extreme caution is advised in patients receiving oral anticoagulants or heparin. Prothrombin times should be carefully monitored during therapy.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Propylthiouracil is Pregnancy Category C - Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Propylthiouracil freely crosses the placenta, and the safety of this product for use during pregnancy has not been fully established. Propylthiouracil may damage the foetal thyroid and produce foetal hypothyroidism and neonatal goitre, or cause congenital abnormalities in the neonate (vide infra).
Propylthiouracil is suggested for use prior to conception and in the first trimester of pregnancy where clinically appropriate due to the higher risk of congenital abnormalities with carbimazole during fetal organogenesis in the first trimester.
In administering propylthiouracil during pregnancy, careful consideration should be given to the dosage for individual patients to provide the required therapeutic effect compatible with minimum risk to the foetus from potential toxicity. The dose should be set as low as possible since there is evidence that neonatal goitre is less likely if the mother receives less than 100 mg of propylthiouracil per day. After control of thyrotoxicosis, the dose of propylthiouracil should be gradually decreased to 50 mg twice daily. If there is the slightest suspicion of hypothyroidism in the pregnant patient, the drug should be temporarily discontinued and thyroid hormone given.
Three cases of scalp defects in the offspring of mothers, and two siblings with aplasia cutis in one mother, who were on methimazole, a related thioamide derivative, have been reported.
Propylthiouracil is excreted in breast milk. Breastfeeding should be terminated prior to initiation of therapy.

4.8 Adverse Effects (Undesirable Effects)

Note.

Incidence of adverse effects is directly related to dosage.
The overall incidence of side effects with propylthiouracil is of the order of 3%.

Incidence more frequent.

Itching.

Incidence less frequent.

Inhibition of haemopoiesis (agranulocytosis, granulocytopenia, leucopenia, thrombocytopenia) is the most serious side effect. The incidence of agranulocytosis approaches 0.5%. Agranulocytosis usually occurs during the first two months of therapy and then the incidence gradually declines. Mild leucopenias occur more frequently, and approximately 10% of untreated hyperthyroid patients have leucocyte levels below 4.0 x 109/L. It should be noted that about 10% of patients with untreated hyperthyroidism have leucopenia (white blood cell count 4,000/mm3), often with relative granulocytopenia.
Dizziness, joint pain, loss of taste, nausea and vomiting (possible overdose), numbness or tingling of fingers, toes or face (peripheral neuropathy, possible overdose), skin rash (hypersensitivity). Note: may disappear spontaneously with continued treatment; appears to be dose related. Stomach pain.

Incidence rare.

Yellowing of eyes and skin (cholestatic jaundice), loss of hearing (ototoxicity), swollen lymph nodes (lymphadenopathy), unusual bleeding or bruising (hypoprothrombinemia, factor VII or proconvertin deficiency, thrombocytopaenia), unusual increase or decrease in urination, backache, swelling of feet or lower legs (nephritis). There have also been reports of serious hypersensitivity reactions (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis). Other adverse reactions include urticaria, epigastric distress and paraesthesia.
Darkening of skin, lightening of hair colour, loss of hair, sore, red, watery eyes (recurrent keratitis, conjunctival disorders).

Signs of overdosage or hypothyroidism.

Changes in menstrual periods, coldness, constipation, dry, puffy skin, headache, listlessness, muscle aches, sleepiness, tiredness, unusual weight gain, weakness.

Signs of thyrotoxicosis or inadequate therapy.

Diarrhoea, fever, irritability, listlessness, rapid or irregular heartbeat, vomiting, weakness.

Hepatotoxicity.

Propylthiouracil-related hepatotoxicity is a major but rare side effect. The frequency ranges from 0.1 percent to 0.2 percent and takes the form of an allergic hepatitis accompanied by laboratory evidence of hepatocellular injury. This includes markedly elevated amino-transferase levels and submassive or massive hepatic necrosis on biopsy. The danger of permanent hepatic damage should be kept in mind. The best way of preventing propylthiouracil hepatotoxicity is careful screening of patients considered for treatment.
Women less than 30 years of age have a higher incidence of propylthiouracil induced hepatotoxicity and the average duration of propylthiouracil therapy before the onset of hepatotoxicity is approximately three months. Monitoring hepatic enzymes on a monthly basis for the first six months of treatment has been suggested. Patients on propylthiouracil treatment should be counselled to report signs and symptoms of hepatotoxicity, such as upper abdominal discomfort, fever, nausea and vomiting together with weight-loss.
Severe adverse reactions include liver injury presenting as hepatitis, liver failure necessitating liver transplant or resulting in death. Nephritis, glomerulonephritis, interstitial pneumonitis, exfoliative dermatitis and erythema nodosum have also been reported.

Vasculitis.

Vasculitis is a rare complication of propylthiouracil therapy. Serological evidence consistent with lupus erythematosus develops in some patients, fulfilling the criteria for drug induced lupus. There are 32 cases of anti-neutrophil cytoplasmic antibody (ANCA)-positive vasculitis in association with anti-thyroid medication reported in the English literature. Approximately 90% of cases related to propylthiouracil. The clinical features of anti-thyroid drug induced ANCA positive vasculitis include renal involvement (67%), arthralgia (48%), fever (37%), skin involvement (30%), respiratory tract involvement (27%) and other manifestations (18%).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Propylthiouracil is administered orally, usually in 2 to 4 equal doses at 12 to 6 hourly intervals respectively.

Dosage in adults.

The usual initial controlling dose of propylthiouracil is 200-400 mg daily (range 100-1200 mg) in divided doses (three doses at eight-hour intervals or four doses at six-hour intervals) until the patient becomes euthyroid.
NB: Patients with severe hyperthyroidism may require up to 1,200 mg a day.

Maintenance dose.

50-800 mg daily in two to four divided doses.

Thyrotoxic crisis.

Concomitant with the administration of other agents, e.g. iodine, adrenergic blocking agents and general supportive measures, the recommended dose of propylthiouracil is 800-1200 mg daily in divided doses administered orally or by naso-gastric tube.

Dosage in children.

Propylthiouracil use should be avoided in children, except in rare circumstances in which alternative therapies are not appropriate options. In circumstances where PTU is used, careful titration with the advice of a specialist is recommended.

Initial.

Calculated on 50 mg/m2 of body surface three times a day.

6-10 years.

50 to 300 mg a day in two or three divided doses.

10 years and over.

150 to 600 mg a day divided into three doses at eight-hour intervals.

Maintenance dose.

50-100 mg daily as determined by response.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Agranulocytosis is the most serious adverse effect resulting from overdose and/or prolonged administration. Hypothyroidism may result from prolonged therapy (see Section 4.8 Adverse Effects (Undesirable Effects)).
General management of overdosage may consist of gastric lavage, observation, and symptomatic and supportive therapy.
Treatment is directed at the specific adverse effect e.g. in bone marrow depression, treatment by way of blood transfusion of fresh whole blood, antibiotics, and corticosteroids are used. Prothrombin deficiency associated with a haemorrhagic diathesis may be counteracted by phytomenadione.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients are lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and maize starch.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

PTU 50 mg Tablets are supplied in bottles containing 100 tablets.
AUST R 13319.
Phebra Product Code - TAB001.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes