SUMMARY CMI

MYCOBUTIN^® CAPSULES

Consumer Medicine Information (CMI) summary

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

1. Why am I taking Mycobutin?

Mycobutin contains the active ingredient rifabutin. Mycobutin is taken in combination with other medicines to treat mycobacterial infections e.g. tuberculosis (TB) or Mycobacteria avium-intracellulare complex (MAC). It may also be taken to prevent infections in patients with HIV disease. For more information, see Section 1. Why am I taking Mycobutin? in the full CMI.

2. What should I know before I take Mycobutin?

Do not take if you have ever had an allergic reaction to Mycobutin or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any problems with your liver or kidneys, 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 take Mycobutin? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Mycobutin 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 take Mycobutin?

Mycobutin capsules should be swallowed whole once a day. They may be taken at any time and do not need be taken with food. Follow the instructions provided by your doctor. Do not stop taking Mycobutin unless your doctor tells you to, even if you feel better. More instructions can be found in Section 4. How do I take Mycobutin? in the full CMI.

5. What should I know while taking Mycobutin?

For more information, see Section 5. What should I know while taking Mycobutin? in the full CMI.

6. Are there any side effects?

• Side effects may include nausea and vomiting, pain in joints and muscles, red-orange coloured urine and possibly discoloured skin or body secretions. More serious side effects include allergic reactions (shortness of breath, chest pain or rashes that may or may not be itchy, coughing and wheezing), diarrhoea, even after Mycobutin is stopped, skin rash with flu like symptoms, eye pain, redness or, blurry vision, unexpected bleeding or bruising and fever. 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

MYCOBUTIN^® CAPSULES

Active ingredient(s): Rifabutin

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I taking Mycobutin?

Mycobutin contains the active ingredient rifabutin. Mycobutin is an antibiotic, an agent taken to kill certain types of bacteria, known as mycobacteria.

Mycobutin is taken in combination with other medicines to treat mycobacterial infections e.g. tuberculosis (TB) or Mycobacteria avium-intracellulare complex (MAC). It may also be taken to prevent infections in patients with HIV disease.

Your doctor, however, may prescribe Mycobutin for another purpose. Ask your doctor if you have any questions about why Mycobutin has been prescribed for you.

Mycobutin can only be obtained on prescription from a doctor.

2. What should I know before I take Mycobutin?

Warnings

Do not take Mycobutin if:

1. You are allergic to rifabutin, other rifamycin antibiotics (e.g. rifampicin), or any of the ingredients listed at the end of this leaflet.
2. Always check the ingredients to make sure you can take this medicine.
3. You are taking treatments that include ritonavir or prolonged-release rilpivirine injections
4. The packaging is torn or shows signs of tampering
5. The expiry date printed on the pack has passed.

Do not give Mycobutin to children.

Check with your doctor if you:

• have any other medical conditions
• have or have had problems with your liver or kidneys
• take any medicines for any other condition
• are or may become pregnant during the time in which you are taking Mycobutin.
• are breastfeeding or intend to breast-feed

Your doctor may need to adjust your dose or your treatment in these situations.

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

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

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

Oral contraceptives may be affected by Mycobutin. Discuss with your doctor about using a different means of birth control during treatment with Mycobutin.

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 may interfere with Mycobutin and affect how it works.

• treatments for HIV, e.g. saquinavir, indinavir, ritonavir, amprenavir, fosamprenavir, lopinavir, nevirapine, bictegravir, doravirine, rilpivirine, elvitegravir/cobicistat
• anti-hepatitis C virus treatments, e.g. sofosbuvir
• anti-tuberculosis treatments, e.g. bedaquiline
• other antibiotics, e.g. clarithromycin, erythromycin, chloramphenicol, trimethoprim, atovaquone
• anti-fungal treatments, e.g. fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• oral contraceptives, e.g. ethinylestradiol/norethisterone
• oestrogens, e.g. in hormone replacement therapy (HRT)
• heart medicines
• medicines taken orally for diabetes
• epilepsy medicines, e.g. phenytoin
• sedatives, sleeping pills or medicines to treat anxiety
• corticosteroids (used to treat inflammatory diseases, such as skin disorders, asthma or rheumatoid arthritis, or as replacement therapy in adrenal disorders)
• tacrolimus (used to prevent organ transplant rejection)
• methadone or other opiates, such as morphine (used for severe pain or to treat drug dependence)
• cisapride (used to treat heartburn or stomach ulcers)
• warfarin (used after a heart attack or to treat blood clotting disorders)

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

4. How do I take Mycobutin?

How much to take

• The dose of Mycobutin depends on the infection for which you are being treated and the other medicines you are taking.
• The usual dose of Mycobutin will be 2 to 4 capsules per day (1-2 capsules per day for newly diagnosed pulmonary tuberculosis patients), but this may not always apply. Your doctor will decide your dose.
• Follow the instructions provided by your doctor. They may differ from the information contained in this leaflet.
• Do not stop taking Mycobutin unless your doctor tells you to, even if you feel better. You will usually need to take Mycobutin for a number of months.

If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. The bacteria may then continue to grow and multiply so that your infection may not clear completely, or it may return.

When to take Mycobutin

• Mycobutin capsules should be swallowed whole once a day. They may be taken at any time and may be taken with or without food.

If you forget to take Mycobutin

Mycobutin should be taken regularly around the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you take too much Mycobutin

If you think that you have taken too much Mycobutin, you may need urgent medical attention.

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.

An excessive dose may lead to severe side effects. You should inform your doctor as soon as possible.

5. What should I know while taking Mycobutin?

Things you should do

• Keep all appointments with your doctor and always discuss any problems you may be experiencing during your course of treatment with him/her.
• Mycobutin may affect the liver or reduce the body's ability to make red or white blood cells or platelets. Regular blood tests may be required.
• As part of your treatment, you may be given other medicines including other antibiotics. It is important to keep taking these medicines as well as Mycobutin unless you are told otherwise by your doctor or pharmacist.
• Tell your doctor immediately if you become pregnant while you are taking Mycobutin.
• If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after Mycobutin has been stopped.
  Diarrhoea may mean you have a serious condition affecting your bowel.
  Do not take any diarrhoea medicine without first checking with your doctor.
• Tell your doctor immediately if you have any pain, redness or blurry vision.
• Tell your doctor immediately if you have a moderate or severe skin rash or blisters often with flu-like symptoms

Remind any doctor or dentist you visit that you are taking Mycobutin.

Things you should not do

• Do not stop this medicine without advice from your doctor first.
• Mycobutin has been prescribed for you by your doctor. Do not give it to anyone else, even if they seem to have the same condition as you.
• Whilst you are taking Mycobutin, do not start taking any other medicines, prescription or not, without first telling your doctor or pharmacist.

Things to be careful of

• Oral contraceptives may be affected by Mycobutin. Discuss with your doctor about using a different means of birth control during treatment with Mycobutin.
• When taking Mycobutin, your urine (and possibly skin or body secretions) may become a red-orange colour.
• Contact lenses may be permanently stained. Therefore, it is better not to wear contact lenses, particularly soft contact lenses, during a treatment course of Mycobutin.

Driving or using machines

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

Drinking alcohol

No information available.

Looking after your medicine

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

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

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

Keep your capsules in their original packaging, including outer carton, until it is time to take them.

If you take the medicine out of the pack, it may not keep well.

Do not take this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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

6. Are there any 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.

Mycobutin, like all other medicines, may cause unwanted side effects. These are usually mild and disappear when you have completed the course.

Mycobutin is generally given together with other medications, so it is not always easy to identify which medicine may be causing the side effects that you may experience.

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

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.

Mycobutin can also cause changes in the levels of certain chemicals in your blood and can also increase or decrease the levels of red or white cells or platelets in your blood. This should be monitored by your doctor through regular blood tests.

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 Mycobutin contains

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

What Mycobutin looks like

Mycobutin capsules are opaque and red-brown in colour with the words "Pharmacia & Upjohn" and "Mycobutin" printed on them in white ink. They are supplied in blister packs of 30 capsules

AUST R 55038.

Who distributes Mycobutin

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in December 2023.

© Pfizer Australia Pty Ltd

Published by MIMS February 2024

1 Name of Medicine

Rifabutin.

2 Qualitative and Quantitative Composition

Mycobutin (rifabutin) is a wide spectrum, semi-synthetic ansamycin antibiotic particularly active on acid-fast bacilli, including atypical and multidrug-resistant mycobacteria.
Each Mycobutin capsule for oral administration contains 150 mg of rifabutin.

3 Pharmaceutical Form

The hard gelatin capsules are opaque and red-brown in colour with the words "Pharmacia & Upjohn" and "Mycobutin" imprinted on the capsule in white ink.

4 Clinical Particulars

4.1 Therapeutic Indications

Mycobutin is indicated for:
the prophylaxis of M. avium-intracellulare complex (MAC) infections in patients with advanced HIV infection (CD4 counts lower than 200/microlitre);
the treatment of infections caused by MAC and other atypical mycobacteria, including in immunocompromised patients;
the treatment of chronic multidrug resistant pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin sensitive M. tuberculosis strains;
the treatment of newly diagnosed pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin sensitive M. tuberculosis strains.
In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins.

4.2 Dose and Method of Administration

Dosage.

Mycobutin as a single agent.

Mycobutin in combination regimens.

4.3 Contraindications

Mycobutin is contraindicated in patients with a history of hypersensitivity to rifabutin or other rifamycins (e.g. rifampicin).
Due to insufficient clinical experience in children, Mycobutin should not be used in these patients.
Concomitant use of ritonavir and rifabutin is contraindicated.
Concomitant use with rilpivirine prolonged-release suspension for injection is contraindicated (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Mycobutin may impart a red-orange colour to the urine and possibly to skin and body secretions. Contact lenses, especially the soft variety, may be permanently stained.
In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins.
It is recommended that white blood cell and platelet counts and liver enzymes be monitored periodically during treatment because Mycobutin may be associated with neutropenia and more rarely thrombocytopenia.
Rifamycins have been associated with drug induced hepatic breakdown of vitamin K in pregnant women and their offspring (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
HIV protease inhibitors act as substrates or inhibitors of the CYP450 3A4 enzyme and have significant drug interactions with rifabutin. As a result, before concomitant use of these drugs, an overall assessment of the patient and their medication should be made (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Rifabutin is a CYP450 3A inducer. Therefore, co-administration with antiretroviral products including but not limited to bictegravir, elvitegravir, oral rilpivirine, or doravirine and anti-HCV products including but not limited to sofosbuvir (alone or in combination) is not recommended due to the expected decrease in plasma concentrations of the antiretrovirals and anti-HCV products which may lead to loss of virologic response and possible development of resistance (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). For further recommendations, please refer to the most recent prescribing information of the antiretrovirals or contact the specific manufacturer.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including rifabutin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
There have been reports of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) with anti-tuberculosis drugs (see Section 4.8 Adverse Effects (Undesirable Effects)). If patients develop a skin rash they should be monitored closely and suspect drug(s) discontinued if lesions progress. Identifying the specific drug is difficult, as multiple anti-tuberculosis drugs are prescribed in association concurrently. Specifically, for DRESS, a multi-system potential life-threatening SCAR, time to onset of the first symptoms may be prolonged. DRESS is a clinical diagnosis, and its clinical presentation remains the basis for decision making. An early withdrawal of the suspect drug is essential because of the syndrome's mortality and visceral involvement (e.g. liver, bone marrow or kidney).

Uveitis.

Malabsorption.

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

Although structurally similar to rifampicin, rifabutin appears to induce enzymes of the P450 system to a lesser extent.
Therefore, as rifabutin has been shown to induce the enzymes of the cytochrome P450 3A subfamily, treatment may affect the pharmacokinetic behaviour of drugs metabolised by the enzymes belonging to that subfamily (as is seen with rifampicin).
Rifabutin accelerates the metabolism of fluconazole, methadone, oral contraceptives, and phenytoin.
Rifabutin decreases the concentration of atovaquone, benzodiazepines, opiate analgesics, sulfamethoxazole, tacrolimus, and trimethoprim.
Rifabutin accelerates the metabolism and may decrease plasma concentrations of astemizole, calcium channel blockers, cisapride, clarithromycin, corticosteroids, ciclosporin, erythromycin, indinavir, itraconazole, ketoconazole, lidocaine, lovastatin, midazolam, nevirapine, oestrogens, quinidine, ritonavir, saquinavir, terfenadine, theophylline, triazolam, warfarin, and zidovudine.
Upward adjustment of the dosage of some of the drugs listed above may be required when administered with Mycobutin keeping in mind that some of the interactions show wide interindividual variability. The drugs normally subject to this include dapsone, narcotic analgesics (including methadone), anticoagulants, corticosteroids, cardiac glycoside preparations (although not digitalis), quinidine, oral hypoglycaemic agents and oral contraceptives. It is important to note that during Mycobutin therapy oral contraception may not be adequate and patients should be advised to use other forms of contraception.
There are insufficient data to assess whether dose adjustments are necessary when nevirapine and rifabutin are coadministered. Concomitant use of these drugs should be carefully monitored and the combination only used if clearly indicated.
When rifabutin is used concomitantly with clarithromycin, a decreased dose of rifabutin is recommended due to the increase in plasma concentrations of rifabutin (see Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use).
Other macrolide antibiotics may also inhibit metabolism of rifabutin.
When administered with indinavir, the dosage of rifabutin should be reduced by half.
Protease inhibitors act as substrates or inhibitors of CYP450 3A4 mediated metabolism. Therefore, due to significant drug-drug interactions between protease inhibitors and rifabutin, their concomitant use should be based on the overall assessment of the patient and a patient specific drug profile.
Other drugs such as ketoconazole, barbiturates, benzodiazepines, verapamil, β-blocking drugs, disopyramide, mexiletine, chloramphenicol and anticonvulsants, may also require consideration for potential dose adjustment during concomitant therapy, based on the known effects of rifampicin.
In contrast, no significant interactions may be expected with ethambutol, pyrazinamide, theophylline, sulfonamides and zalcitabine (DDC).
Although pharmacokinetic data have shown that Mycobutin, when given in combination with zidovudine, reduces the plasma levels of the latter, a large controlled clinical study has shown that these changes are of no clinical relevance.
Clinical studies have shown that Mycobutin does not affect the pharmacokinetics of didanosine (DDI), isoniazid (for the latter, see Section 4.8 Adverse Effects (Undesirable Effects), Blood and lymphatic system) and fluconazole. Fluconazole however increases rifabutin plasma levels. Zidovudine and DDI were shown not to affect the pharmacokinetics of rifabutin.
In addition, some drugs increase the concentration of rifabutin and these include the following: ciprofloxacin, clarithromycin, enoxacin, erythromycin, fluconazole, indinavir, itraconazole, ketoconazole, ritonavir, and saquinavir.
Major interactions in this category leading to a significant increase in side effects occur with clarithromycin, fluconazole, indinavir, ritonavir and, in particular, saquinavir.
Table 1 summarises the results and magnitude of the various drug interactions with rifabutin. The clinical relevance of these interactions and subsequent dose modifications should be judged in light of the population studied, severity of the disease, patient's drug profile and the likely impact on the risk/benefit ratio.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

There have been no reports of adverse effects of Mycobutin on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

The tolerability of Mycobutin in multiple drug regimens was assessed in long-term studies with daily dosages up to 600 mg in both immunocompetent and immunocompromised patients suffering from tuberculosis and nontuberculous mycobacteriosis.
Mycobutin was often given in these studies as part of a multidrug regimen, and it is not possible to define with certainty a drug-event relationship.
Treatment discontinuation was necessary in approximately 13% of patients with HIV infection and 5% of patients with tuberculosis in clinical trials, related to gastrointestinal symptoms, liver function test abnormalities and blood or lymphatic system disorders.
Adverse reactions identified through either clinical trials or postmarketing surveillance by system organ class (SOC) are listed below.
*Adverse reactions not observed in a clinical trial.
**Adverse reactions neither observed in the clinical trials nor in the spontaneous reporting for rifabutin and are mandated for the pharmacological class.

Blood and lymphatic system.

Immune system disorders.

Eye disorders.

Gastrointestinal disorders.

Hepatobiliary disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

General disorders and administration site condition.

Uveitis/corneal deposits.

Anti-tuberculosis drug SCARs.

Reporting suspected adverse effects.

4.9 Overdose

A specific toxic dose of rifabutin has not been established, although a syndrome of arthralgia/arthritis has been reported following daily monotherapy of 1 g or more. Other signs and symptoms of overdosage are likely to be similar to adverse effects from normal therapeutic doses.
There is no specific antidote. Treatment is symptomatic and supportive, including respiratory and cardiovascular function. Plasma rifabutin levels may confirm overdosage but are not clinically useful. Monitor complete blood count, liver enzyme levels and fluid-electrolyte status as indicated, and perform an ophthalmological examination if the patient exhibits ocular symptoms.
An aqueous slurry of activated charcoal may be administered after a potentially toxic ingestion, but it is most effective within one hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected.
Rifabutin is approximately 85% protein bound, is extensively distributed into various tissues and is not primarily excreted via the urinary route, therefore, neither haemodialysis nor forced diuresis are expected to be of any benefit.
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

In humans, rifabutin maximum plasma concentrations are reached around 2-4 hours after oral administration. The pharmacokinetics of rifabutin is linear after single dosing of 300, 450 and 600 mg to healthy volunteers. With these doses, C_max is in the range of 0.4-0.7 microgram/mL. Although systemic levels of rifabutin following multiple dosing decreased by 38%, its terminal half-life remained unchanged.
Rifabutin, due to its high lipophilicity, demonstrates a high propensity for distribution and intracellular tissue uptake. It is widely distributed in various animal organs with the exception of the brain. In particular, in human lung tissue the concentrations measured up to 24 hours after dosing are about 5-10 times higher than the plasma levels. Substantially higher intracellular tissue levels than those seen in plasma have been observed in both rat and man.
About 85% of the drug is bound to plasma proteins. Binding does not appear to be influenced by renal or hepatic dysfunction.
Renal and biliary clearance of unchanged drug each contribute approximately 5% to CL_s/F. About 30% of the dose is excreted in the faeces. Rifabutin and its metabolites are eliminated mainly by the urinary route. The t_1/2β of Mycobutin in humans is approximately 35-40 hours.
The bioavailability of rifabutin from the capsule dosage form, relative to a solution, was 85% in healthy adult volunteers. High fat meals slow the rate without influencing the extent of absorption from the capsule.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, silicon dioxide, iron oxide red, titanium dioxide, Opacode monogramming ink S-1-7085 White, TekPrint SB-0007P White Ink, gelatin.

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

Mycobutin is supplied as 150 mg capsules in:
PVC/Al blister packs of 30 (3 strips of 10 capsules);
Glass bottles of 30 - not 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.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes