Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about RIMYCIN. 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 RIMYCIN against the benefits they expect it will have for you.

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

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

What Rimycin is used for

RIMYCIN is an antibiotic that is used in combination with other medicines to treat tuberculosis, also known as TB.

TB is a bacterial infection, which mainly affects the lungs, but it can also spread to other organs in the body.

RIMYCIN is also used to treat leprosy, a skin condition that has many forms.

RIMYCIN can also be used to prevent certain diseases occurring where you may be in contact with, or have had contact with, a person known to have the disease or is known to be able to pass it on to others.

Examples of such diseases are meningitis (a serious infectious disease involving inflammation of the membranes that cover the brain and spinal cord) which affects children and young adults, pneumonia, conjunctivitis and meningitis caused by Haemophilus influenzae, a bacterium in the respiratory tract.

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.

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

Before you take RIMYCIN

When you must not take it

Do not take RIMYCIN if you have an allergy to:

• any medicine containing rifampicin
• any of the ingredients listed at the end of this leaflet

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 take this medicine if you have jaundice (yellowing of the eyes and skin).

Do not take this medicine if you are taking combination saquinavir/ritonavir medications.

Do not breast-feed if you are taking this medicine. The active ingredient in RIMYCIN passes into breast milk and there is a possibility 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 using Rimycin, 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 any of the following medical conditions:

• any type of liver disease
• problems with bleeding or tendency to bruise easily
• diabetes
• have a history of lung inflammation (interstitial lung disease/pneumonitis)

Tell your doctor if you are currently taking any other antibiotics.

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

If you have not told your doctor about any of the above, tell them before you start taking RIMYCIN.

Urine, faeces, saliva, sputum, sweat, tears and teeth may be a red-orange, yellow or brown colour when you are taking RIMYCIN. Soft contact lenses may be permanently stained.

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 or health food shop.

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

• antacids, used for heartburn and indigestion
• atovaquone, used to treat a respiratory infection in acquired immune deficiency syndrome (AIDS)
• ketoconazole, used for fungal infections
• aspirin used as a pain killer or for preventing blood clots
• isoniazid, used for TB (tuberculosis)
• p-aminosalicylic acid (PAS)
• decreasing the clotting of the blood such as clopidogrel
• controlling and preventing seizures
• heart disease and high blood pressure such as enalapril
• breast cancer treatment or prevention
• sedation
• bacterial infections
• fungal infections
• inflammatory conditions
• contraception
• high blood cholesterol
• diabetes
• tuberculosis and leprosy
• malaria
• rejection of transplanted organs
• thyroid deficiency states
• pain
• nocturnal cramps
• breathing difficulties
• anxiety or depression
• treatment of certain mental illnesses
• treatment of HIV (Human Immunodeficiency Virus) infections
• nausea and vomiting

Some drugs should not be taken with RIMYCIN. These include:

• halothane, a general anaesthetic (a sleep-inducing drug)
• the combination of saquinavir and ritonavir, antiviral agents used to treat acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) infections
• daclatasvir, simeprevir, sofosbuvir and telaprevir, antiviral medicines used to treat Hepatitis C
• cefazolin and other cefalosporin antibiotics used to treat infection
• oral contraceptives
• dapsone (an antibiotic), it may cause methemoglobinemia (decrease in oxygen in your blood caused by changes in red blood cells)
• paracetamol, it can increase the risk of liver damage

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

How to take RIMYCIN

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 decide what dose and for how long you will take RIMYCIN for.

How to take it

Swallow the capsules whole with a glass of water.

When to take it

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.

RIMYCIN should be taken 30 minutes before or 2 hours after a meal.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

If you forget to take it

Take the dose 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.

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 (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much RIMYCIN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include nausea, vomiting, abdominal pain, itchy skin, headache, fatigue, dizziness, swelling and abnormal heart beating.

While you are using RIMYCIN

Things you must do

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

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

Take RIMYCIN exactly as your doctor has prescribed. Keep all of your doctor's appointments.

If you develop itching with swelling, a skin rash or have difficulty breathing, or if you turn yellow while you are taking RIMYCIN, stop taking it and tell your doctor immediately.

If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking RIMYCIN. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping RIMYCIN, tell your doctor.

If you get vaginal itching or discharge while taking or soon after stopping RIMYCIN, tell your doctor. This may mean you have a fungal infection called thrush. Sometimes the use of RIMYCIN allows fungi to grow and the above symptoms to occur. This medicine does not work against fungi.

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

If you are using oral contraceptives you should change to alternative methods of birth control while you are taking RIMYCIN.

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

If you develop a new or sudden worsening of shortness of breath, possibly with a dry cough or fever that is not responding to antibiotic treatment. These could be symptoms of lung inflammation (interstitial lung disease/pneumonitis) and can lead to serious breathing problems due to collection of fluid in the lungs and interfere with normal breathing which can lead to life threatening conditions.

Things you must not do

Do not take RIMYCIN 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 do not complete the full treatment as prescribed by your doctor, some of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.

Things to be careful of

Be careful driving or operating machinery until you know how RIMYCIN affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking RIMYCIN.

This medicine helps most people, 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.

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:

• yellow discolouration of skin or eyes
• heartburn, anorexia, nausea, vomiting, wind, cramps or diarrhoea
• drowsiness, fatigue, inability to concentrate or confusion
• mental problems
• problems with your period
• urine, faeces, saliva, sputum, sweat, tears and teeth may be coloured red-orange, yellow or brown. Soft contact lenses may be permanently stained.
• poor coordination, muscle weakness, pain in the fingers or toes, or numbness
• oral thrush - white, furry, sore tongue and mouth
• vaginal thrush - sore and itchy vagina and/or discharge
• conjunctivitis or visual disturbances
• menstrual disturbances

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

• red and/or itchy skin, blisters or pimples, bleeding, peeling or bruising of the skin
• itching, weakness, loss of appetite, nausea, vomiting, stomach or gut pain, yellowing of the eyes or skin or dark urine
• swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing
• shortness of breath and wheezing
• blood in the urine or any other urination disturbances
• severe bleeding or bruising more easily than normal
• fever, chills, headache or dizziness
• bone pain
• develop itching with swelling or skin rash or difficulty breathing, or if you turn yellow
• new or sudden worsening of shortness of breath, possibly with a cough or fever (interstitial lung disease/pneumonitis)

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.

After finishing RIMYCIN

Tell your doctor immediately if you notice any of the following side effects, especially if they occur several weeks after stopping treatment with RIMYCIN:

• severe abdominal cramps or stomach cramps
• watery and severe diarrhoea, which may also be bloody
• fever, in combination with one or both of the above

These are rare but serious side effects. You may have a serious condition affecting your bowel, which may need urgent medical attention. However, this side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

After using RIMYCIN

Storage

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

Keep your capsules in a cool dry place where the temperature stays below 25°C.

Do not store RIMYCIN 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

RIMYCIN comes in different 2 strengths:

• 150 mg capsules - size 3 hard gelatin capsule, maroon body with black cap
• 300 mg capsules - size 1 hard gelatin capsule with maroon body and cap

RIMYCIN comes in bottles of 10 and 100 capsules.

Ingredients

RIMYCIN contains the active ingredient rifampicin:

The capsules also contain the following inactive ingredients:

• lactose monohydrate
• ascorbic acid
• purified talc
• magnesium stearate
• colloidal anhydrous silica
• sodium lauryl sulfate
• gelatin
• erythrosine CI 45430 (127)
• brilliant blue FCF CI 42090 (133)
• titanium dioxide CI 77891 (171)

RIMYCIN 150 capsules also contain:

• iron oxide red CI 77491 (172)
• iron oxide yellow CI 77492 (172)

RIMYCIN contains galactose and sulfites. The capsules are gluten free.

Manufacturer

RIMYCIN is made in Australia by:

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

Australian registration numbers:

RIMYCIN 150 - AUST R 48230

RIMYCIN 300 - AUST R 48231

This leaflet was prepared in September 2021.

rimycin_cmi\Sep21/00

Published by MIMS November 2021

1 Name of Medicine

Rifampicin.

2 Qualitative and Quantitative Composition

Each Rimycin capsule contains 150 mg or 300 mg of rifampicin as the active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

Rimycin 150 capsules are a size 3 hard gelatin capsule, maroon body with black cap.
Rimycin 300 capsules are a size 1 hard gelatin capsule with maroon body and cap.

4 Clinical Particulars

4.1 Therapeutic Indications

Tuberculosis.

Leprosy.

Meningococcal disease.

Haemophilus influenzae.

Buruli ulcer.

4.2 Dose and Method of Administration

It is recommended that rifampicin be administered once daily, either 30 minutes before or two hours after a meal.

Pulmonary tuberculosis.

Adults.

Children.

Leprosy.

Adults.

Prophylaxis of meningococcal disease (see Section 4.1 Therapeutic Indications).

Adults.

Children over 5 years.

Prophylaxis for household contacts of patients with H. influenzae type B infection.

Buruli ulcer.

Other information.

4.3 Contraindications

Jaundice.
Known hypersensitivity to rifampicin or any of the rifamycins.
Rifampicin use is contraindicated when given concurrently with the combination of saquinavir/ritonavir (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Concomitant administration with lurasidone as it markedly decreases the exposure of lurasidone compared to the use of lurasidone alone (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Adults treated for tuberculosis with rifampicin should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count and a platelet count (or estimate). Baseline tests are unnecessary in children unless a complicating condition is known or clinically suspected.
Patients should be seen at least monthly during therapy and should be specifically questioned concerning symptoms associated with adverse reactions. All patients with abnormalities should have follow-up, including laboratory testing, if necessary. Routine laboratory monitoring for toxicity in people with normal baseline is generally not necessary.
Rifampicin has been observed to increase the requirement for anticoagulant drugs of the coumarin type. The cause of this phenomenon is unknown.
In patients receiving anticoagulants and rifampicin concurrently, it is recommended that the prothrombin time be performed daily or as frequently as necessary to establish and maintain the required dose of anticoagulant.
Urine, faeces, saliva, sputum, sweat, tears and teeth may be coloured red-orange, yellow or brown by rifampicin and its metabolites.
Soft contact lenses may be permanently stained. Individuals to be treated should be made aware of these possibilities in order to prevent undue anxiety.
Rifampicin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D. Isolated reports have associated porphyria exacerbation with rifampicin administration as a result of induction of delta amino levulinic acid synthetase.
Rifampicin may cause vitamin K dependent coagulopathy and severe bleeding (see Section 4.8 Adverse Effects (Undesirable Effects)). Monitoring of occurrence of coagulopathy is recommended for patients at particular bleeding risk. Supplemental vitamin K administration should be considered when appropriate (vitamin K deficiency, hypoprothrombinaemia).
Rifampicin is a well characterised and potent inducer of drug metabolising enzymes and transporters and might therefore decrease or increase concomitant drug exposure safety and efficacy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Therefore, patients should be advised not to take any other medication without medical advice.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics, including rifampicin. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
For the treatment of tuberculosis, rifampicin is usually administered on a daily basis. High doses of rifampicin (greater than 600 mg) given once or twice weekly have resulted in a high incidence of adverse reactions, including the "flu syndrome" (fever, chills and malaise), haematopoietic reactions (leucopenia, thrombocytopenia, or acute haemolytic anaemia), cutaneous, gastrointestinal and hepatic reactions, shortness of breath, shock and renal failure. Recent studies indicate that regimens using twice-weekly doses of rifampicin 600 mg plus isoniazid 15 mg/kg are much better tolerated. Intermittent therapy may be used if the patient cannot or will not self-administer drugs on a daily basis. Patients on intermittent therapy should be closely monitored for compliance and cautioned against intentional or accidental interruption of prescribed therapy because of the risk of serious adverse reactions (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Rifampicin should be used very carefully in patients with a known history of porphyria cutanea tarda or acute intermittent porphyria.
Rifampicin may precipitate acute renal crisis in patients with adrenal insufficiency. It may be necessary to increase the dose of adrenal steroids in patients with impaired adrenal function who are to receive rifampicin.

Hepatotoxicity.

Drug resistance.

Immunological reactions/anaphylaxis.

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

Severe bullous reactions.

Interstitial lung disease (ILD)/pneumonitis.

Paradoxical drug reaction.

Thrombotic microangiopathy.

Use in hepatic impairment.

Use in the elderly.

Paediatric use.

Use in premature and newborn infants.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

When rifampicin is given concomitantly with combination saquinavir/ritonavir, the potential for hepatotoxicity is increased. Therefore, concomitant use of rifampicin with saquinavir/ritonavir is contraindicated (see Section 4.3 Contraindications).
Concomitant antacid administration may reduce the absorption of rifampicin. Daily doses of rifampicin should be given at least one hour before the ingestion of antacids.
Concomitant use of paracetamol with rifampicin may increase the known risk of hepatotoxicity seen in relation to each drug.
Rifampicin is a well characterised and potent inducer of drug metabolising enzymes and transporters including cytochrome P450 enzymes 1A2, 2B6, 2C8, 2C9, 2C19, and 3A4, UDP-glucuronyltransferases (UGT), sulfotransferases, carboxylesterases, and transporters including P-glycoprotein (P-gp) and multidrug resistance-associated protein 2 (MRP2). Most drugs are substrates for one or more of these enzyme or transporter pathways, and these pathways may be induced by rifampicin simultaneously.
Therefore, rifampicin may accelerate the metabolism and reduce the activity of certain co-administered drugs, or increase the activity of a coadministered pro-drug (where metabolic activation is required) and has the potential to perpetuate clinically important drug-drug interactions against many drugs and across many drug classes. To maintain optimum therapeutic blood levels, dosages of drugs metabolised by these enzymes may require adjustment when starting or stopping concomitantly administered rifampicin.
Caution should be used when prescribing rifampicin with drugs metabolised by enzyme and transporters reported to be affected by rifampicin, including cytochrome P-450.
Examples of drugs metabolised by cytochrome P450 enzymes include: oral anticoagulants (e.g. warfarin), anticonvulsants (e.g. phenytoin), antiarrhythmics (e.g. disopyramide, mexiletine, quinidine, tocainide and propafenone), antioestrogens (e.g. tamoxifen, toremifene), antipsychotics (e.g. haloperidol), antifungals (e.g. fluconazole, itraconazole, ketoconazole, see below), caspofungin, antiretroviral drugs (e.g. zidovudine, saquinavir, indinavir, efavirenz), barbiturates, beta-blockers, benzodiazepines (e.g. diazepam), benzodiazepine-related drugs (e.g. zopiclone, zolpidem), calcium channel blockers (e.g. diltiazem, nifedipine, verapamil), chloramphenicol, clarithromycin, corticosteroids, cardiac glycoside preparations, clofibrate, systemic hormonal contraceptives (see below), dapsone, doxycycline, oestrogens, fluoroquinolones, gestrinone, oral hypoglycaemic agents (sulfonylureas), immunosuppressive agents (e.g. ciclosporin, tacrolimus), irinotecan, levothyroxine, narcotic analgesics, methadone, praziquantel, progestins, quinine, riluzole, selective 5-HT₃ receptor antagonists (e.g. ondansetron), statins metabolized by CYP 3A4, telithromycin, theophylline, thiazolidinediones (e.g. rosiglitazone), tricyclic antidepressants (e.g. amitriptyline, nortriptyline) and losartan. It may be necessary to adjust the dosage of these drugs if they are given concurrently with rifampicin.
Concurrent daily use of alcohol may result in increased incidence of rifampicin induced hepatotoxicity and increased metabolism of rifampicin; dosage adjustments of rifampicin may be necessary and patient monitoring for hepatotoxicity.
Concurrent use of hepatitis-C antiviral drugs (e.g. daclatasvir, simeprevir, sofosbuvir, telaprevir) and rifampicin should be avoided.
When atovaquone and rifampicin were taken concomitantly, decreased concentrations of atovaquone and increased concentrations of rifampicin were observed.
Concomitant use of ketoconazole and rifampicin has resulted in decreased serum concentrations of both drugs.
Concurrent use of rifampicin and enalapril has resulted in decreased concentrations of enalaprilat, the active metabolite of enalapril. Dosage adjustments should be made if indicated by the patient's clinical condition.
When rifampicin is taken with p-aminosalicylic acid (PAS), rifampicin levels in the serum may decrease. Therefore, the drugs should be taken at least 4 hours apart.
Rifampicin treatment reduces the systemic exposure of oral contraceptives. Patients using oral contraceptives should be advised to change to non-hormonal methods of birth control during rifampicin therapy. Diabetes may become more difficult to control in patients treated with rifampicin.
Rifampicin was shown to decrease mifepristone AUC by 6.3-fold and its metabolites 22-hydroxy mifepristone and N-demethyl mifepristone by 20-fold and 5.9-fold, respectively. Therefore, reduced efficacy can be expected when mifepristone is given concomitantly with a potent CYP inducer such as rifampicin.
Rifampicin has also been shown to increase the clearance of dapsone and the production of the hydroxylamine metabolite of dapsone which could increase the risk of methemoglobinemia.
Combined administration of either halothane or isoniazid and rifampicin may give rise to more frequent and marked disorders of liver function than treatment with rifampicin alone. The concomitant use of rifampicin and halothane should be avoided. Patients receiving both isoniazid and rifampicin should be monitored closely for hepatotoxicity.
The concomitant use of rifampicin with other antibiotics causing vitamin K dependent coagulopathy such as cefazolin (or other cephalosporins with N-methyl-thiotetrazole side chain) should be avoided as it may lead to severe coagulation disorders, which may result in fatal outcome (especially with high doses).
After two weeks of repeated administration of rifampicin, trough levels of caspofungin were 30% lower than in adult subjects who received caspofungin alone.
Rifampicin 600 mg was shown to decrease lurasidone AUC by 81%. Therefore, markedly reduced exposure of lurasidone can be expected when lurasidone is given concomitantly with a CYP3A4 inducer such as rifampicin (see Section 4.3 Contraindications).
Rifampicin strongly induces CYP2C19, resulting in both an increased level of clopidogrel active metabolite and platelet inhibition, which in particular might potentiate the risk of bleeding. As a precaution, concomitant use of clopidogrel and rifampicin should be discouraged.
Probenecid may increase rifampicin serum concentration and/or toxicity due to competition for hepatic uptake, however the effect on blood levels is inconsistent and concurrent use of probenecid to increase rifampicin serum concentration is not recommended.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Rifampicin may cause undesirable effects which may reduce the capacity for the completion of certain tasks. Patients should be informed of the potential for these undesirable effects and if they experience these symptoms, consideration should be given not to drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Gastrointestinal disturbances such as heartburn, epigastric distress, abdominal discomfort, anorexia, decreased appetite, nausea, vomiting, gas, cramps and diarrhoea have been noted in some patients. Pseudomembranous colitis has been reported (see Section 4.4 Special Warnings and Precautions for Use).
Headache, drowsiness, fatigue, menstrual disturbances (in women receiving long-term antituberculosis therapy with regimens containing rifampicin), post-partum haemorrhage, fetal-maternal haemorrhage, ataxia, dizziness, inability to concentrate, mental confusion, visual disturbances, muscular weakness, fever, pains in the extremities and generalised numbness have also been noted. Psychoses have been reported rarely.
Encountered occasionally have been flushing, pruritus, urticarial rash, allergic dermatitis, pemphigus, pemphigoid, acneiform lesions, sore mouth, sore tongue and exudative conjunctivitis. Rarely, hepatitis or a shock-like syndrome with hepatic involvement and abnormal liver function tests (e.g. elevations in serum bilirubin, bromosulfophthalein, alkaline phosphatase, serum transaminases) have also been observed. Elevations in blood bilirubin, aspartate aminotransferase and alanine aminotransferase have been commonly reported. An increase in blood creatinine and hepatic enzymes have also been reported. Cholestasis has also been reported.
Drug-induced liver injury (including fatal cases especially when used in combination with other antituberculosis drugs) has been reported.
Hypersensitivity reactions have been reported. Erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, acute generalised exanthematous pustulosis (AGEP) and vasculitis have been reported rarely.
Rifampicin can cause certain bodily fluids such as sputum, urine, sweat and tears to become red-orange, yellow or brown in colour (see Section 4.4 Special Warnings and Precautions for Use). Tooth discolouration (which may be permanent) has also been reported.
Thrombocytopenia with or without purpura may occur, usually associated with intermittent therapy, but is reversible if the drug is discontinued as soon as purpura occurs. Cerebral haemorrhage and fatalities have been reported when rifampicin administration has been continued or resumed after the appearance of purpura. Eosinophilia, leucopenia, oedema, muscle weakness and myopathy have been reported to occur in a small percentage of patients treated with rifampicin. Agranulocytosis has been reported very rarely. Disseminated intravascular coagulation has been rarely reported. Vitamin K dependent coagulation disorders and bleeding have been reported. Porphyria has been reported. Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uremic syndrome have been reported.
Elevations in BUN (blood urea nitrogen), serum urea and serum uric acid have occurred. Rarely, haemolysis, haemoglobinuria, haematuria, renal insufficiency or acute renal injury have been reported and are generally considered to be hypersensitivity reactions. These have usually occurred during intermittent therapy or when treatment was resumed following intentional or accidental interruption of a daily dosage regimen and were reversible when rifampicin was discontinued, and appropriate therapy instituted.
Rare reports of adrenal insufficiency have been observed in patients with compromised adrenal function.
Reactions usually occurring with intermittent dosage regimens and most probably of immunological origin include the following:
"Flu-like syndrome" consisting of episodes of fever, chills, headache, dizziness and bone pain appearing most commonly during the third to the sixth month of therapy. The frequency of the syndrome varies but may occur in up to 50% of patients given once weekly regimens with a dose of rifampicin of 25 mg/kg or more. These symptoms may be a prelude to more serious complications such as renal hypersensitivity reactions. It is preferable in such cases to change to daily medication.
Shortness of breath/dyspnoea and wheezing.
Anaphylaxis/anaphylactic reaction.
Decrease in blood pressure, and shock.
Haemolytic anaemia.
Paradoxical drug reaction: Recurrence or appearance of fresh symptoms, physical and radiological signs in a patient who had previously shown improvement with appropriate anti-tuberculosis treatment is called a paradoxical reaction, which is diagnosed after excluding poor compliance of the patient to treatment, drug resistance, side effects of antitubercular therapy, secondary bacterial/fungal infections.
Interstitial lung disease (including pneumonitis) has been reported.
Acute renal injury usually due to renal tubular necrosis or tubulointerstitial nephritis, but cortical necrosis has been reported.
During the treatment of leprosy with rifampicin, a lepromatous reaction may occur. Mild reactions do not require a cessation of rifampicin therapy; in other cases, corticosteroid therapy may be required, and withdrawal of rifampicin considered.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antimycobacterials, antibiotic. ATC code: J04AB02.

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

The capsules contain the following inactive excipients: ascorbic acid, brilliant blue FCF, colloidal anhydrous silica, erythrosine, gelatin, lactose monohydrate, magnesium stearate, purified talc, purified water, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain iron oxide yellow and iron oxide red.

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

Rimycin 150.

Rimycin 300.

Australian register of therapeutic goods (ARTG).

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes