DAPSONE

Dapsone 25, 100 mg tablet Consumer Medicine Information What Dapsone is used for? Dapsone is used to treat leprosy (Hansens disease) and to help control a skin problem called dermatitis and a fungal disease called Actinomycotic mycetoma. When it is used to treat leprosy, Dapsone may be given with one or more other medicines. Mechanism of action: Dapsone (DAP-sone), a sulfone, belongs to the family of medicines called anti-infectives. Dapsone works by killing the bacteria or fungi causing your infection or by stopping its growth. Dapsone will not work against infections caused by viruses such as colds or the flu. Dapsone is available only with a doctor's prescription. There is no evidence that Dapsone is addictive. Before taking Dapsone When you must not take it? When you must not be given it? Do not take/use Dapsone if:

If you are not sure whether you should start taking Dapsone, contact your doctor. Before you start to take it Before you are given it Tell your doctor if: 1. you have any type of allergic reaction to sulpha drugs (sulfonamide medicines): You may have an increased chance of being allergic to Dapsone if you are allergic to sulpha drugs. you have any allergies to: any other medicines any other substances, such as foods, preservatives or dyes. Pregnancy and breast feeding: you are pregnant, or intend to become pregnant. The use of Dapsone during pregnancy should be avoided. Dapsone may affect your developing baby if you take it during pregnancy. you are breastfeeding or intend to breastfeed. Dapsone passes into breast milk and may affect your baby. Dapsone may cause blood problems in nursing babies. Therefore, breast feeding may need to be stopped because of the risks to the baby. if you have or have had any medical conditions, including: anemia, or liver or kidney disease If you have not told your doctor about any of the above, tell them before you take/are given dapsone. Taking other medicines Tell your doctor if you are taking any other medicines, including medicines that you buy without a

2.

3.

4.

you have ever had an allergic reaction to Dapsone or any other sulpha drugs or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, which is always present, fever, jaundice, and eosinophilia. Tampering and Expiry Date Warnings: Do not use Dapsone if the packaging is torn or shows signs of tampering.

5.

prescription from your pharmacy (over-the-counter products), supermarket or health food shop. Some medicines may interfere with Dapsone. These include:

Amprenavir Didanosin Rifampicin Clofazimine Probenecid Trimethoprim Cimetidine Pyrimethamine These medicines may be affected by Dapsone, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you. When you are taking Dapsone, it is especially important that your healthcare professional knows if you are taking any of the above. Talk to your doctor about the need for an additional method of contraception while taking Dapsone. Some medicines may decrease the effectiveness of some birth control pills, although this has not been shown with Dapsone. Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Dapsone. How to take Dapsone? Take Dapsone with a full glass of water or another liquid, with or after food. Tablets should be taken whole and small doses should be made up from 25 mg tablets. Do not split the tablet. How long to take it?

Keep taking your Dapsone for as long as your doctor tells you to. Remember it may take a number of months for Dapsone to work. Do not stop taking Dapsone even if you begin to feel better. For best effect Dapsone must be taken regularly. Do not take a double dose to make up for the dose that you missed. If you have trouble remembering to take your tablets, ask your pharmacist for some hints. If you take too much (overdose) Immediately telephone your doctor or Poisons Information Centre (13 11 26) for advice or go to the Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too much Dapsone. Do this even if there are no signs of discomfort or poisoning. While you are using Dapsone Things you must do If the symptoms of your infection do not improve within 2 to 3 months, or if they become worse, tell your doctor. If you become pregnant while you are taking Dapsone tell your doctor immediately. If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Dapsone. Your doctor may give you a schedule for regular blood tests. This schedule should be carefully followed If you have to test your urine for sugar while you are using/being given Dapsone, make sure your doctor knows which type of test you use. Dapsone may affect the results of some of these tests. If you have to have any blood tests tell your doctor you are taking/using/ Dapsone. Dapsone may affect the results of some blood tests.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Dapsone. Things you must not do Do not stop taking your tablets because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria/fungi 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. Do not give Dapsone to anyone else, even if they have the same condition as you. Do not use Dapsone to treat any other complaints unless your doctor tells you to. Things to be careful of Dapsone may make you dizzy. Be careful when driving a car or using machinery. Side effects Check with your doctor as soon as possible if you have any problems while taking Dapsone, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like other medicines, Dapsone can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention. While taking Dapsone If any of the following happen, stop taking Dapsone and tell your doctor immediately. These are very serious side effects. You may need urgent medical attention or hospitalisation

Fever, sore throat and difficulty in breathing Back, leg or stomach pains Itching, dryness, redness, scaling or peeling of the skin Loss of hair Mood or other mental changes Numbness, tingling, pain, burning or weakness in hands or feet; Unusual bleeding or bruising Tell your doctor if you notice any of the following and they worry you: These side effects are usually mild.

Nausea, vomiting; Loss of appetite; Headache; Nervousness; Dizziness Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects. Some people may get other side effects while taking/using/being given Dapsone. Do not be alarmed by this list of possible side effects. You may not experience any of them after using Dapsone. Storage Keep your tablets in the original pack until it is time to take them. Keep the pack in a cool dry place. Do not leave it in the car on a hot day. Do not store medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines. Store all medicines out of the reach of children such as in a locked cupboard. If your doctor tells you to stop taking Dapsone, ask your pharmacist what

Severe skin rash Muscle weakness, unusual tiredness or weakness Yellowing of skin or eyes Bluish finger nails, lips or skin

to do with any tablets that are left over. Store below 25C. Protect from light. What it looks like? Tablets, 25 mg and 100 mg (white, scored): 100s Ingredients Active. Dapsone. Inactive. Starch-maize, cellulosemicrocrystalline, magnesium stearate, silicon dioxide. Tablets do not contain alcohol, gluten, lactose, parabens, sugar, sulfite or tartrazine. Manufacturer / Distributor / Supplier Manufactured by: Jacobus Pharmaceutical Co. Inc. (USA) Supplied and distributed by: Link Medical Products Pty Ltd 5 Apollo Street, Warriewood, NSW 2102, Australia

Lamprene
clofazimine (kloe FA zi meen) Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about Lamprene. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Lamprene against the benefits it can provide you. If you have any concerns about this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Lamprene is used for Lamprene is used to treat leprosy (Hansen's disease) and is given together with other medicines for leprosy. Lamprene should never be used alone for the treatment of leprosy Multidrug therapy is necessary to prevent the bacteria that causes leprosy (called Hansen's bacillus or Mycobacterium leprae) from developing resistance to the treatment.

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. Lamprene is only available with a doctor's prescription. It is not addictive. Before you take Lamprene When you must not take it Do not take Lamprene if you are allergic (hypersensitive) to:

clofazimine (the active ingredient) peanuts or soya (since this medicinal product contains soybean oil) any of the other ingredients of Lamprene 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. If any of these apply to you, do not take Lamprene and tell your doctor. If you think you may be allergic, ask your doctor for advice. Do not take Lamprene after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist. Before you start to take it Tell your doctor if you have any of the following medical conditions:

liver or kidney problems continuous or frequent abdominal pain, diarrhoea, or vomiting.

Your doctor will take these into account before and during your treatment with Lamprene. Tell your doctor if you are pregnant or intend to become pregnant. If possible, Lamprene should be stopped at least 3 months before an intended pregnancy. You should only use Lamprene during pregnancy if your doctor advises you to do so. The active substance in Lamprene crosses the placenta. This medicine may affect your developing baby if you take it while you are pregnant, especially during the first 3 months. The baby may also develop a red to brownish-black discolouration of the skin. This is reversible but it may last a long time. Tell your doctor if you wish to breastfeed while you are taking Lamprene. The active ingredient passes into breast milk and your baby's skin may become discoloured. Mothers taking Lamprene should not breast feed unless advised by the doctor. Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives. Your doctor will want to know if you are prone to allergies. If you have not told your doctor or pharmacist about any of these things, tell him/her before you have Lamprene. Taking other medicines Tell your doctor or pharmacist if you are taking:

Isoniazid, a medicine used to prevent or treat tuberculosis any other medicines, including ones that you buy without a prescription from a pharmacy, supermarket or health food store. If you have not told your doctor about any of these things, tell

him/her before you start taking Lamprene. How to take Lamprene Follow all directions given to you by your doctor and pharmacist carefully. These instructions may differ from the information contained in this leaflet. Lamprene works best when there is a constant amount of the active substance in the blood. Do not miss any doses. This will help to keep the amount of the active in your bloodstream constant. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. How much to take Adults usually take one 50 mg capsule of Lamprene each day plus one extra dose of 300 mg under supervision once a month. Dapsone and rifampicin will also be taken according to your doctor's instructions. Children receive lower doses according to their body weight. Do not exceed the recommended dose. When to take Lamprene Take Lamprene capsules during meals or with milk to prevent a stomach upset. How long to take it Continue taking Lamprene for as long as your doctor tells you to. This may be for as long as two years. If you want your leprosy to clear up completely, you must take this medicine for the whole treatment period, even if you feel better after a few months. If you stop taking Lamprene too soon, your symptoms may return. If you forget to take it If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for the one that you missed. This may increase the chance of you getting an unwanted side effect. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints. If you take too much (Overdose) Immediately telephone your doctor or the Poisons Information Center (telephone number 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Lamprene. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy. Medical treatment may be necessary. Some symptoms of an overdose may include:

dizziness headache nausea (feeling sick) vomiting stomach pains diarrhoea reduction in urine passed discolouration of the skin and urine. Show the pack of Lamprene to any medical staff that may be attending to you/the affected patient. While you are taking Lamprene Things you must do If you become pregnant while taking Lamprene, tell your doctor. Your doctor can discuss with you the risks of taking it while you are pregnant. If skin discoloration causes you to become depressed while taking this medicine, discuss this with your doctor. Sometimes during treatment,

people become depressed because of the skin discolouration that Lamprene can cause. The active substance of Lamprene is red and this may discolour your skin and hair within a few weeks after you start taking it. This reddish to dark brown discoloration will go away when you stop taking Lamprene, though it may take several months or years to clear up completely. When you are outdoors, wear protective clothing and use at least a 15+ sunscreen. Lamprene may cause your skin to be more sensitive to sunlight than it normally is. Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If your skin appears to be burning more readily, tell your doctor. Remind your doctor and pharmacist that you are taking Lamprene if you are about to be started on any new medicine. Tell any other doctor, dentist or pharmacist who treats you that you are taking Lamprene. Things you must not do Do not use a sunlamp. Do not take this medicine to treat any other complaints unless your doctor tells you to. Do not give this medicine to anyone else, even if their condition seems similar to yours. Things to be careful of Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Lamprene affects you. In some people, this medicine can cause:

headache tiredness dizziness dimness of vision or eyesight problems.

Make sure you know how it affects you before you drive a car, operate machinery, or do anything else that could be dangerous or requires your attention. Side effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Lamprene, even if you do not think it is connected with the medicine. Like all medicines, Lamprene can cause side effects, although not everybody gets them. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following rare but serious side effects:

severe pains in the stomach or abdomen yellowing of the skin or eyes fever or chills chest and left shoulder pain bloody or persistent diarrhoea nausea, loss of appetite vomiting, especially blood or material that looks like coffee grounds bleeding from the back passage, black sticky bowel motions (stools) flaking or peeling skin blurred or cloudy vision Tell your doctor or pharmacist if you notice any of the following and they worry you:

reversible red to brownish-black discolouration of the skin, eyes and hair, especially if you are lightskinned discoloured sweat, tears, saliva, semen, breast milk, urine and bowel motions; note that once the medicine is stopped, the discolouration will disappear but it may take several months or years for skin colour to return to normal dry, burning, itching, or irritated eyes dimness of vision dry, itchy or scaly skin acne or skin rash stomach pain or discomfort gastrointestinal disorders (nausea, i.e. feeling sick, vomiting, or diarrhoea) mild abdominal pain loss of appetite weight loss headache tiredness dizziness depression increased sensitivity of the skin when exposed to sunlight or the symptoms of sunburn (such as redness, itching, swelling, blistering) which may happen more quickly than normal swollen glands in the neck, armpit or groin signs of raised blood sugar levels, such as: - lethargy - thirst - passing large amounts of urine - blurred vision Tell your doctor if you notice anything else that is making you unwell. Other side effects not listed above may happen in some people. Ask your doctor or pharmacist to answer any questions you may have. After taking Lamprene

Storage Keep your medicine in the original container until it is time to take it. Store the capsules in a cool dry place where the temperature stays below 25 degrees C. Do not store Lamprene or any other medicine in the bathroom, near a sink, or on a window sill. This medicine will keep well if it is stored cool and dry. Do not store this medicine in the car. Heat and dampness can destroy some medicines. Keep the medicine 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 if the expiry date has passed, ask your pharmacist what to do with any capsules you have left over. Product description What it looks like Lamprene soft gelatin capsules are plain, round, brown capsules with no markings. The colour of the capsules may appear irregular or mottled. This is because the active ingredient consists of reddish-brown particles suspended in a dark brown oil-wax base. Lamprene is available in containers of 100 capsules. Ingredients Active ingredient: Lamprene capsules contain 50 mg of clofazimine as the active ingredient. Inactive ingredients: Lamprene capsules also contain:

rapeseed oil lecithin (E 322) wax blend composed of beeswax (E 901) and vegetable oils sodium ethylparaben (E 215) sodium propylparaben (E 217) ethyl vanillin gelatin glycerin (E 422) iron oxide black CI77499 (E 172) iron oxide red CI77491 (E 172) Sponsor Lamprene is supplied in Australia by: NOVARTIS Pharmaceuticals Australia Pty Limited ABN 18 004 244 160 54 Waterloo Road North Ryde NSW 2113 Telephone: 1 800 671 203 = Registered Trademark This leaflet was prepared in January 2009

acetanisole butylated hydroxytoluene (E320) citric acid (E 330) propylene glycol (E 1520)

Oresol
General Information: An expectorant that also has some muscle relaxing action. It is used in many cough preparations. Pharmacology: Oresol is an expectorant which increases the output of phlegm (sputum) and bronchial secretions by reducing adhesiveness and surface tension. The increased flow of less viscous secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent. By reducing the viscosity and adhesiveness of secretions, guaifenesin increases the efficacy of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway. Oresol Interactions The use of codeine may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics or other drugs that produce CNS depression. Serious toxicity may result if dextromethorphan is coadministered with monoamine oxidase inhibitors (MAOIs). The use of dextromethorphan hydrobromide may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics or other drugs that produce CNS depression.

Oresol Contraindications Hypersensitivity to any of the ingredients. The use of dextromethorphan-containing products are contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs). Oresol Indication: Used to assist the expectoration of phlegm from the airways in acute respiratory tract infections. Mechanism of Action: Oresol may act as an irritant to gastric vagal receptors, and recruit efferent parasympathetic reflexes that cause glandular exocytosis of a less viscous mucus mixture. Cough may be provoked. This combination may flush tenacious, congealed mucopurulent material from obstructed small airways and lead to a temporary improvement in dyspnea or the work of breathing. Food Interactions: Take with a full glass of water. Take without regard to meals. Generic Name: Guaifenesin Drug Category: Expectorants Absorption: Rapidly absorbed from the GI tract Toxicity (Overdose): LD50 1510 mg/kg (rat, oral) Protein Binding: Not Available Biotransformation: Rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite. Half Life: 1 hour Dosage Forms of Oresol: Liquid Oral Syrup Oral