SUMMARY CMI

HYDROXYCARBAMIDE MEDSURGE CAPSULES

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Hydroxycarbamide Medsurge?

Hydroxycarbamide Medsurge capsules contain the active ingredient hydroxycarbamide (hydroxyurea). Hydroxycarbamide Medsurge is used to treat various types of cancers such as, leukemia and cancer of the ovary.

For more information, see Section 1. Why am I using Hydroxycarbamide Medsurge? in the full CMI.

2. What should I know before I use Hydroxycarbamide Medsurge?

Do not use if you have ever had an allergic reaction to Hydroxycarbamide Medsurge or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Hydroxycarbamide Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Hydroxycarbamide Medsurge and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Hydroxycarbamide Medsurge?

• Hydroxycarbamide Medsurge capsules may be given to you at the hospital or surgery, or you may take them yourself at home
• Swallow Hydroxycarbamide Medsurge capsules with a glass of water
• Hydroxycarbamide Medsurge is taken as a single dose and can be taken each day, or once every three days, at about the same time each day.

More instructions can be found in Section 4. How do I use Hydroxycarbamide Medsurge? in the full CMI.

5. What should I know while using Hydroxycarbamide Medsurge?

For more information, see Section 5. What should I know while using Hydroxycarbamide Medsurge? in the full CMI.

6. Are there any side effects?

If you get any of the following side effects, tell your doctor immediately or go to Accident and Emergency at your nearest hospital: chills, fever, fast heartbeat, wheezing or coughing, difficulty breathing, dizziness, flushing, sweating and swelling of the face, tongue or other parts of the body. Tell your doctor or nurse as soon as possible if you notice any of the following: nausea, vomiting, diarrhoea, stomach pain or discomfort, constipation. High fever (greater than 39°C) that requires hospitalization, feeling tired or sleepy, fever, high temperature, chills. Discolouration or ulcers on the skin, decay of the skin or nails, nail discolouration. Fever, severe chills. Pain in lungs or difficulty breathing, coughing. Sore mouth, tiredness, headaches, being short of breath, dizziness, convulsions. Joint pain, and/or swelling especially in the hands or feet, skin rashes, made worse by being in the sun, sores in the mouth or nose. Itching of the skin, joint aches, blisters that look like hives on the upper body, legs, arms, palms, hands, or feet and may involve the face or lips. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

HYDROXYCARBAMIDE MEDSURGE CAPSULES

Active ingredient(s): Hydroxycarbamide (hydroxyurea)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Hydroxycarbamide Medsurge. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Hydroxycarbamide Medsurge.

Where to find information in this leaflet:

1. Why am I using Hydroxycarbamide Medsurge?
2. What should I know before I use Hydroxycarbamide Medsurge?
3. What if I am taking other medicines?
4. How do I use Hydroxycarbamide Medsurge?
5. What should I know while using Hydroxycarbamide Medsurge?
6. Are there any side effects?
7. Product details

1. Why am I using Hydroxycarbamide Medsurge?

Hydroxycarbamide Medsurge contains the active ingredient hydroxyurea, an anti-cancer medicine. It interferes with the replication of cells and causes cell death, particularly in cancer cells.

Hydroxycarbamide Medsurge is used to treat various types of cancers such as, leukemia and cancer of the ovary.

Hydroxycarbamide Medsurge may be used alone or in combination with other treatments for cancer. Your doctor will inform you if this is necessary.

Hydroxycarbamide Medsurge is not recommended for use in children as its safety and effectiveness in patients under 18 years of age has not been established.

2. What should I know before I use Hydroxycarbamide Medsurge?

Warnings

Do not use Hydroxycarbamide Medsurge if:

• you are allergic to hydroxyurea, or any of the ingredients listed at the end of this leaflet
• always check the ingredients to make sure you can use this medicine.
• you have marked depression of white blood cells (bone marrow depression) or red blood cells (severe anaemia). Your doctor will be able to advise whether Hydroxycarbamide Medsurge is appropriate in this situation.
• you are pregnant or intend to become pregnant
• the packaging shows signs of tampering

Check with your doctor if you have or have had any medical conditions, especially the following:

• liver or kidney problems
• any condition which reduces your blood cell “counts” such as white cells (leukopenia), neutrophils (neutropenia) or platelets (thrombocytopenia).
• infection or high temperature. Your doctor may decide to delay your treatment until the infection has gone.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?

Pregnancy and breast feeding

Tell your doctor and do not take Hydroxycarbamide Medsurge if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Hydroxycarbamide Medsurge passes into breast milk. Therefore, there is a possibility that the breast-fed baby may be affected.

Tell your doctor if you are a sexually active man.

Hydroxycarbamide Medsurge may cause birth defects if either the male or female is using it at the time of conception. Men who take Hydroxycarbamide Medsurge are advised to use a condom to avoid pregnancy in their partner.

Women who take Hydroxycarbamide Medsurge are advised to use birth control during therapy and for at least 6 months after therapy.

If you have not told your doctor about any of the above, or not sure whether you should have Hydroxycarbamide Medsurge, talk to your doctor.

3. What if I am taking other medicines?

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

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

• Vaccinations. Hydroxycarbamide Medsurge may suppress the body's normal defence mechanisms and result in a more severe than normal reaction with the virus.
• Some other medicines that are used to treat other forms of cancer
• Medicines used to treat gout.
• Medicines used to treat HIV infection including Videx^® (didanosine) and Zerit^® (stavudine)

These medicines may be affected by Hydroxycarbamide Medsurge or affect how well it works. You may need different amounts of your medicine, or you may need to have different medicines. Your doctor will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Hydroxycarbamide Medsurge.

4. How do I take Hydroxycarbamide Medsurge?

How much to take

Your doctor will decide what dose you will receive. Your dose of Hydroxycarbamide Medsurge capsules is worked out based on your body weight and height, the type of cancer you have, and other medicines you are taking. The dose that worked out for you may be different to the dose for another patient.

Hydroxycarbamide Medsurge may be given alone or together with other anti-cancer treatments or drugs.

Ask your doctor if you want to know more about the dose of Hydroxycarbamide Medsurge you receive.

How to take Hydroxycarbamide Medsurge

Hydroxycarbamide Medsurge capsules may be given to you at the hospital or surgery, or you may take them yourself at home.

Swallow Hydroxycarbamide Medsurge capsules with a glass of water.

Or if you have problems with swallowing the capsules, you can empty the capsule contents into a glass of water, stir and drink it straight away. Some of the materials present in the capsule may float to the surface of the water.

When to take Hydroxycarbamide Medsurge

Hydroxycarbamide Medsurge is taken as a single dose and can be taken each day, or once every three days. Your doctor will decide how you should take the capsules and will explain this to you.

Take Hydroxycarbamide Medsurge at about the same time each day that you are to take it.

Hydroxycarbamide Medsurge may or may not be given at the same time as other anti-cancer treatments or agents.

How long it is given

• Several courses of Hydroxycarbamide Medsurge therapy may be needed depending on your response to treatment.
• Additional treatment may not be repeated until your blood cell numbers return to acceptable levels and any side effects have been controlled.

Do not stop taking Hydroxycarbamide Medsurge unless your doctor tells you to - even if you feel better.

If you forget to take Hydroxycarbamide Medsurge

If it is almost time for 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 you missed.

This may increase the chance of you getting an unwanted side effect.

If you take too much Hydroxycarbamide Medsurge

If you are in hospital Hydroxycarbamide Medsurge will be given to you by the hospital staff, so it is most unlikely that too many capsules would be given. However, if an overdose should be given, your doctor will give you the appropriate treatment.

If you are taking Hydroxycarbamide Medsurge at home and think that you or someone else may have taken too many Hydroxycarbamide Medsurge capsules, you should immediately:

• phone the Poisons Information Centre (by calling 13 11 26),
• or contact your doctor,
• or go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of overdose may include acute skin inflammation, soreness, discoloration of the skin, fluid retention associated with the hands & feet followed by scaling of the skin in these areas, soreness & inflammation of the mouth.

5. What should I know while using Hydroxycarbamide Medsurge?

Things you should do

Be sure to keep all your doctor's appointments and follow-up appointments in order to get the best effect from your treatments, and so your progress can be checked.

Remind any doctor, dentist, nurse or pharmacist you visit that you are having Hydroxycarbamide Medsurge.

Avoid exposing your skin to sunlight. Use appropriate clothing, a hat, and sunscreen if you must go in the sun. Check your skin regularly for any changes. If you notice any changes, tell your doctor.

You must maintain an adequate fluid intake.

Tell your doctor, dentist or pharmacist straight away that you are taking Hydroxycarbamide Medsurge if you:

• are about to be started on any new medicine.
• plan to have surgery that needs a general anaesthetic.

Hydroxycarbamide Medsurge can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding. The following precautions should be taken to reduce your risk if infection or bleeding:

• avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate.
• be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work.
• be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters.
• avoid contact sports or other situations where you may bruise or get injured.

Things you should not do

• give Hydroxycarbamide Medsurge to anyone else, even if they have the same condition as you.
• Take Hydroxycarbamide Medsurge to treat any other complaints unless your doctor tells you to.
• stop taking Hydroxycarbamide Medsurge, or lower the dose, without checking with your doctor.

If you empty the contents of the capsules into water for swallowing, do not allow the powder to come into contact with your skin. Also avoid inhaling the contents when opening the capsules. If the powder is accidentally spilled, you should wipe up the powder using a damp paper towel and the paper towel should be disposed of immediately. You should also dispose of the empty capsules immediately after taking your required dosage.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Hydroxycarbamide Medsurge affects you.

As with other medicines used to treat cancer, Hydroxycarbamide Medsurge may cause dizziness, light-headedness or tiredness in some people. Make sure you know how you react to Hydroxycarbamide Medsurge before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.

Looking after your medicine

• Hydroxycarbamide Medsurge capsules should be stored below 25°C in a cool dry place.
• The container must be tightly closed.

Follow the instructions on the label on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight where the temperature stays below 25°C; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on windowsills.

Keep it where young children cannot reach it.

Pay particular attention to this when you are opening the capsules to dissolve the contents in water.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date. If you take this medicine after the expiry date has passed, it may not work as well.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are having Hydroxycarbamide Medsurge.

Like other medicines that treat cancer, Hydroxycarbamide Medsurge may have unwanted side effects, some of which may be serious. You may need medical treatment if you get some of the side effects.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

If you are receiving radiation treatment with Hydroxycarbamide Medsurge, or are taking other medications as well as Hydroxycarbamide Medsurge, the side effects listed above may occur more frequently or be more severe.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

The benefits and side effects of Hydroxycarbamide Medsurge may take some time to occur. Therefore, even after you have finished your Hydroxycarbamide Medsurge treatment you should tell your doctor immediately if you notice any of the side effects listed above.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Hydroxycarbamide Medsurge contains

Do not take this medicine if you are allergic to any of these ingredients.

What Hydroxycarbamide Medsurge looks like

Hydroxycarbamide Medsurge 500 mg capsules are Size 0 hard gelatin capsules with an opaque pink body and an opaque light green cap containing a white to off-white powder.

They are supplied in PVC/PCTFE(Aclar)/Al blister packs of 100 (AUST R 313761).

Who distributes Hydroxycarbamide Medsurge

Medsurge Healthcare Pty Ltd
Unit 1&2, 6-7 Gilda Court
Mulgrave, Victoria 3170
Telephone: 1300 788 261
Website: www.medsurgehc.com

This leaflet was prepared in June 2023.

Published by MIMS September 2023

Notes

Distributed by Medsurge Healthcare Pty Ltd

1 Name of Medicine

Hydroxycarbamide (hydroxyurea).

2 Qualitative and Quantitative Composition

Hydroxycarbamide (hydroxyurea) is an antineoplastic agent, available for oral use as capsules containing 500 mg per capsule.

Excipients with known effect.

3 Pharmaceutical Form

Hard capsules containing 500 mg hydroxycarbamide (hydroxyurea); size 0 hard gelatin capsules with an opaque pink body and an opaque light green cap containing a white to off white homogeneous powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Significant tumour response to hydroxycarbamide (hydroxyurea) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent, metastatic, or inoperable carcinoma of the ovary.

4.2 Dose and Method of Administration

Because of the rarity in children of chronic myelocytic leukaemia, carcinoma of the ovary, and carcinomas of the head and neck, dosage regimens have not been established.
All dosage should be based on the patient's actual or ideal weight, whichever is less.

Note.

Solid tumours.

Intermittent therapy.

Continuous therapy.

Concomitant therapy with irradiation (carcinoma of the head and neck).

Resistant chronic myelocytic leukaemia.

Continuous therapy.

Renal insufficiency.

Hepatic insufficiency.

4.3 Contraindications

Hydroxycarbamide (hydroxyurea) is contraindicated in patients with marked bone marrow depression, i.e. leucopoenia (< 2500 WBC/mm³), thrombocytopenia (< 100,000/mm³), or severe anaemia.
A previous hypersensitivity to hydroxycarbamide (hydroxyurea) or any other component of its formulation.

4.4 Special Warnings and Precautions for Use

Concurrent use of hydroxycarbamide (hydroxyurea) and other myelosuppressive agents or radiation therapy may increase the likelihood of bone marrow depression as other adverse events.
Treatment with hydroxycarbamide (hydroxyurea) should not be initiated if bone marrow function is markedly depressed (see Section 4.3 Contraindications). Bone marrow suppression may occur, and leucopoenia is generally its first and most common manifestation. Thrombocytopenia and anaemia occur less often, and are seldom seen without a preceding leucopoenia. However, the recovery from myelosuppression is rapid when therapy is interrupted. It should be borne in mind that bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents; hydroxycarbamide (hydroxyurea) should be used cautiously in such patients.
Patients who have received irradiation therapy in the past may have an exacerbation of post irradiation erythema.
Cases of haemolytic anaemia in patients treated with hydroxycarbamide for myeloproliferative diseases have been reported (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients who develop persistent anaemia should have laboratory tests evaluated for haemolysis. In the setting of confirmed diagnosis of haemolytic anaemia, hydroxycarbamide (hydroxyurea) should be discontinued.
Fatal and nonfatal pancreatitis have occurred in HIV-infected patients during therapy with hydroxycarbamide (hydroxyurea) and didanosine, with or without stavudine. Hepatotoxicity and hepatic failure resulting in death have been reported during post-marketing surveillance in HIV-infected patients treated with hydroxycarbamide (hydroxyurea) and other antiretroviral agents. Fatal hepatic events were reported most often in patients treated with the combination of hydroxycarbamide (hydroxyurea), didanosine, and stavudine. This combination should be avoided. Peripheral neuropathy, which was severe in some cases, has been reported in HIV-infected patients receiving hydroxycarbamide (hydroxyurea) in combination with antiretroviral agents, including didanosine, with or without stavudine.
Interstitial lung disease including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis have been reported in patients treated for myeloproliferative neoplasm and may be associated with fatal outcome. Patients developing pyrexia, cough, dyspnea, or other respiratory symptoms should be closely monitored, investigated and treated. Promptly discontinue hydroxycarbamide (hydroxyurea) and treat with corticosteroids to resolve the pulmonary events (see Section 4.8 Adverse Effects (Undesirable Effects)).
Severe anaemia must be corrected with whole blood replacement before initiating therapy with hydroxycarbamide (hydroxyurea).
Erythrocytic abnormalities: megaloblastic erythropoiesis, which is self-limiting, is often seen early in the course of hydroxycarbamide (hydroxyurea) therapy. The morphologic change resembles pernicious anaemia, but it is not related to vitamin B₁₂ or folic acid deficiency. The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended. Hydroxycarbamide (hydroxyurea) may also delay plasma iron clearance and reduce the rate of iron utilisation by erythrocytes, but it does not appear to alter the erythrocyte survival time.
Elderly patients may be more sensitive to the effects of hydroxycarbamide (hydroxyurea), and may require a lower dosage regimen.
In patients receiving long-term therapy with hydroxycarbamide (hydroxyurea) for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemia has been reported. It is unknown whether this leukemogenic effect is secondary to hydroxycarbamide (hydroxyurea) or associated with the patients' underlying disease.
Therapy with hydroxycarbamide (hydroxyurea) requires close supervision. The complete status of the blood, including bone marrow examination, if indicated, as well as kidney function and liver function should be determined prior to, and repeatedly during, treatment. The determination of the haemoglobin level, total leucocyte counts, and platelet counts should be performed at least once a week throughout the course of hydroxycarbamide (hydroxyurea) therapy.
If the white blood cell count decreases to less than 2500/mm³, or the platelet count to less than 100,000/mm³, therapy should be interrupted until the values rise significantly toward normal levels. Anaemia, if it occurs, should be managed with whole blood replacement, without interrupting hydroxycarbamide (hydroxyurea) therapy.
Since hydroxycarbamide (hydroxyurea) may cause drowsiness and other neurologic effects alertness may be impaired in driving or in operating machinery.
Patients should be advised to maintain adequate fluid intake. Patients should consult with their physician or pharmacist regarding missed doses.
Hydroxycarbamide (hydroxyurea) is not indicated for the treatment of HIV-infection; however, if HIV-infected patients are treated with hydroxycarbamide (hydroxyurea), and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis and hepatotoxicity is recommended. Patients who develop signs and symptoms of pancreatitis or hepatotoxicity should permanently discontinue therapy with hydroxycarbamide (hydroxyurea) (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
Cutaneous vasculitic toxicities including vasculitic ulcerations and gangrene have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide (hydroxyurea). These vasculitic toxicities were reported most often in patients with a history of or currently receiving interferon therapy. Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxycarbamide (hydroxyurea) should be discontinued if cutaneous vasculitic ulcerations develop and alternative cytoreductive agents should be initiated as indicated.

Interference with continuous glucose monitoring systems.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent use of hydroxycarbamide (hydroxyurea) and other myelosuppressive agents or radiation therapy may increase the likelihood of bone marrow depression or other adverse events (see Section 4.4 Special Warnings and Precautions for Use).

Vaccinations.

Other interactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions have been primarily bone marrow depression (leucopoenia, anaemia, and occasionally thrombocytopenia), haemolytic anaemia and less frequently gastrointestinal symptoms (stomatitis, anorexia, nausea, vomiting, diarrhoea, and constipation), and dermatological reactions such as maculopapular rash, facial erythema, peripheral erythema, hyperpigmentation, erythema, atrophy of skin and nails, nail pigmentation, skin ulceration, dermatomyositis-like skin changes, scaling, cutaneous lupus erythematosus and violet papules have been observed. Skin cancer has also been reported rarely. Dysuria and alopecia occur very rarely.
Large doses may produce moderate drowsiness. Neurological disturbances have occurred extremely rarely and were limited to headache, dizziness, disorientation, hallucinations and convulsions.
Hydroxycarbamide (hydroxyurea) occasionally may cause temporary impairment of renal tubular function accompanied by elevations in serum uric acid, BUN, and creatinine levels. Abnormal BSP retention has been reported.
Fever, chills, malaise, asthenia, azoospermia, oligospermia, cholestasis, hepatitis, tumour lysis syndrome, and elevation of hepatic enzymes have also been reported.
Adverse reactions observed with combined hydroxycarbamide (hydroxyurea) and irradiation therapy are similar to those reported with the use of hydroxycarbamide (hydroxyurea) alone. These effects primarily include bone marrow depression (anaemia and leucopoenia) and gastric irritation. Almost all patients receiving an adequate course of combined hydroxycarbamide (hydroxyurea) and irradiation therapy will demonstrate concurrent leucopoenia. Platelet depression (less than 100,000 cells/mm³) has occurred rarely and only in the presence of marked leucopoenia. Gastric distress has also been reported with irradiation alone and in combination with hydroxycarbamide (hydroxyurea) therapy.

Musculoskeletal and connective tissue disorders.

Hypersensitivity.

Drug-induced fever.

Respiratory.

Reporting suspected adverse effects.

4.9 Overdose

Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide (hydroxyurea) at dosages several times the therapeutic dose. Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, severe generalized hyperpigmentation of skin, and stomatitis have also been observed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, citric acid, dibasic sodium phosphate, magnesium stearate. Capsule contains gelatin, titanium dioxide, sodium lauryl sulfate and capsule colourants (Erythrosine, Indigo carmine and, Quinoline yellow).

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 25°C.

6.5 Nature and Contents of Container

Blister: PVC/Aclar film, sealed with aluminium foil in pack 30, 100.
Not all presentations may be marketed.

6.6 Special Precautions for Disposal

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

Guidelines for proper handling and disposal of anticancer drugs.

6.7 Physicochemical Properties

Hydroxycarbamide (hydroxyurea) is an essentially tasteless, white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes