Budenofalk 3mg Capsules 90


Our Price $132.99
PBS $0.00
Concession $0.00
Safety Net $0.00

S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Any prescriptions from any other state cannot be filled and will be returned in the mail

Note: Private, PBS and our prices are available to the general public. Concession and Safety Net prices are only available to people with the appropriate concession or Safety Net cards. See Prescriptions for more details.


This prescription item requires a pre approved authority from the Government in order to get this item at the quoted price. Authority prescriptions need to be applied for by the doctor writing the script and can include reasons such as increased quantities due to dosage, increased repeats, use for a pre determined specified use, or the nature of the medication itself requiring specialist interaction. In the event that an authority is not granted on the script, the price will revert to the private price quoted for that item


This item contains more than one pack of a prescription product. Before this can be dispensed the doctor has to give approval. The prescription must be written for the total quantity or the prescription must be endorsed by your doctor "Regulation 24" otherwise we will be unable to dispense the increased amount. If you proceed with the order without approval, we will only send out one pack at the single pack price and refund the difference. Eg If your prescription is written out for 30 Tablets with 5 repeats and it does not have “Regulation 24 “ written on the script, the ONLY quantity we can dispense is 30 at one time. Further dispensing of this product could only occur after an appropriate length of time - usually 21 days but depends on dosage. In this example if you would like to obtain 180 Tablets then the doctor must endorse the prescription “Regulation 24” or the quantity must be written out for 180 and not 30. NB Conditions apply on the writing of a Regulation 24 prescription. Ask your doctor or pharmacist for details.

We can no longer accept signed authority forms from your doctor as permission to dispense more than one pack. Please contact our pharmacist for more information.

If you order this item as Private, NO PBS stickers will be issued. Once any prescription order has been sent the product cannot be returned for a refund even if your doctor changes your medication or you have an adverse reaction.

Budenofalk 3mg Capsules 90

Budenofalk 3mg Capsules 90

Product ID: 71659

Pharmacist Only Medicine

This product is a Pharmacist Only Medicine and requires pharmacist advice before we can dispatch this product. You must first place the order and then contact our pharmacists within 48 hours on 1300 367 283. The pharmacist will determine if this product is appropriate for you and if so, approve the order. In the event that you do not do this, the product will be deleted from your order and the balance of your order will be dispatched. This is not required if you have a doctor's prescription.



Consumer Medicine Information BUDENOFALK® enteric capsules Page 1 BUDENOFALK® ENTERIC CAPSULES Budesonide Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about BUDENOFALK enteric capsules. 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 BUDENOFALK enteric capsules against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What BUDENOFALK is used for BUDENOFALK enteric capsules contain the active ingredient, budesonide. Budesonide belongs to a group of medications called corticosteroids. BUDENOFALK enteric capsules are used to treat Crohn’s disease affecting the ileum and/or the ascending colon (inflammation of the last section of the small bowel and/or the first section of the large bowel) for 8 weeks. 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 not addictive. This medicine is not expected to affect your ability to drive a car or operate machinery. BUDENOFALK is only available on a doctor’s prescription. There is not enough information to recommend the use of this medicine for children or adolescents. Before you take BUDENOFALK When you must not take it Do not take BUDENOFALK if you have an allergy to:  any medicine containing budesonide  any of the ingredients listed at the end of this leaflet. Some 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. BUDENOFALK enteric capsules contain lactose and sucrose. This may cause a problem if you have an intolerance to some sugars. Do not take BUDENOFALK if you suffer from a severe liver disease (liver cirrhosis). Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking this medicine, talk to your doctor. Before you start to take it Consumer Medicine Information BUDENOFALK® enteric capsules Page 2 Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or wish to breastfeed. Your doctor will discuss the risks and benefits of taking BUDENOFALK if you are pregnant or breastfeeding. Tell your doctor if you have or have had any medical conditions, especially the following:  liver disease  lung disease  high blood pressure  diabetes, when the level of sugar in the blood is too high  disease which causes bones to become less dense, gradually making them weaker, more brittle and likely to break  ulcer in stomach or duodenum  glaucoma (high pressure in the eye)  cataracts  family history of diabetes or glaucoma  any infections  any stresses  intolerance to sugars  any other disease where use of steroids may have unwanted effects. If you have not told your doctor about any of the above, tell him/her before you start taking BUDENOFALK enteric capsules. Chicken pox, measles and shingles may become more severe when you take BUDENOFALK. Contact your doctor if you have been exposed to any of these infections. Taking other medicines Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and BUDENOFALK may interfere with each other. These include:  cardiac glycosides such as digoxin, medicines used to treat heart conditions  diuretics, medicines used to treat excess fluid in your body  ketoconazole and itraconazole, medicines used to treat fungal infections  antibiotics such as clarithromycin, medicines used to treat infections  ritonavir, medicine used to treat HIV infections  carbamazepine, medicine used to treat epilepsy  rifampicin, medicine used to treat tuberculosis  contraceptive pill  cholestyramine, medicine used to reduce cholesterol level  cimetidine, medicine used to reduce stomach acid. These medicines may be affected by BUDENOFALK or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Avoid drinking grapefruit juice while you are taking BUDENOFALK as this can alter its effects. Your doctor or pharmacist have more information on medicines to be careful with or avoid while taking this medicine. How to take BUDENOFALK Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. Consumer Medicine Information BUDENOFALK® enteric capsules Page 3 How much to take Adults and the elderly: One BUDENOFALK 3 mg enteric capsule three times a day (morning, midday and evening), or three BUDENOFALK 3 mg enteric capsules once daily in the morning. BUDENOFALK treatment should be terminated by gradual reduction of your dose over the last two weeks. The dosage should be reduced to two capsules daily (one in the morning and one in the evening) for one week. In the last week, only one capsule should be taken in the morning. Once you have started taking BUDENOFALK, do not stop taking it abruptly. How to take it Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. If you have difficulty swallowing the capsules, open the capsule and take the granules with plenty of liquid. Do not chew or crush the granules. When to take it Take BUDENOFALK enteric capsules about 30 minutes before a meal. Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. How long to take it BUDENOFALK enteric capsules may be used for up to 8 weeks for each episode of Crohn’s disease. If you forget to take it 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 that you missed. If you are not sure what to do, ask your doctor or pharmacist. 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 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 BUDENOFALK. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. While you are taking BUDENOFALK Things you must do If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking BUDENOFALK enteric capsules. Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine. If you are going to have surgery, tell the surgeon or anaesthetist that Consumer Medicine Information BUDENOFALK® enteric capsules Page 4 you are taking this medicine. It may affect other medicines used during surgery. If you become pregnant while taking this medicine, tell your doctor immediately. Things that you must not do Do not take BUDENOFALK enteric capsules to treat any 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 BUDENOFALK or change the dosage without checking with your doctor. Side effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking BUDENOFALK. Like all medicines, BUDENOFALK may have some 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 immediately if you notice any of the following:  signs or symptoms of an infection  headache Tell your doctor or pharmacist if you notice any of the following that are troublesome or ongoing:  abdominal pain  pain in the upper middle part of the abdomen  diarrhoea / soft stools  high blood pressure  acne  tiredness, general feeling of being ill. When BUDENOFALK is used, side effects may occur which are typical of the more active cortisone preparations (Cushing-like properties). The side effects listed below depend on the dose, the period of treatment, whether there has been prior or accompanying treatment with other cortisone preparations and on the individual sensitivity.  Cushing Syndrome: roundness of the face, weight gain, increased risk of high blood sugar, fluid retention, reduced growth  increased risk of infection  irregular periods in women, male hair growth patterns in women, impotence  mood changes such as depression, irritation or euphoria  blurred vision (e.g. glaucoma and cataract)  increased risk of blood clotting, disease of the blood vessels (associated with stopping steroid use after long term therapy)  stomach complaints, gastric ulcers, pancreatitis and constipation  muscle pain and bone weakness (osteoporosis), loss of bone and cartilage (aseptic bone necrosis)  rash from hypersensitivity reactions (allergic exanthema), formation of red stripes (striations) and bleeding in the skin, delayed wound healing, local skin reactions (such as contact dermatitis) Consumer Medicine Information BUDENOFALK® enteric capsules Page 5  isolated cases: increased brain pressure with possible additional swelling of the optic disk in adolescents. If any of the following happens, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:  allergic reaction including swelling of limbs, face, lips, mouth or throat which may cause difficulty swallowing or breathing. Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. After using BUDENOFALK Storage Keep BUDENOFALK enteric capsules in their original packaging until it is time to take them. Keep your capsules in a cool dry place where the temperature stays below 25C. Do not store BUDENOFALK 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-anda- half metres above the ground is a good place to store medicines. Disposal If your doctor tells you to stop taking BUDENOFALK or the expiry date has passed, ask your pharmacist what to do with any capsules that are left over. Product description What it looks like BUDENOFALK 3 mg enteric capsules are pink opaque capsules in blister packs. Ingredients Each BUDENOFALK enteric capsule contains 3 mg of the active ingredient, budesonide. Each BUDENOFALK enteric capsule also contains lactose, sugar spheres (sucrose), triethyl citrate, purified talc, povidone, methacrylic acid copolymer, ammonio methacrylate copolymer, gelatin, sodium lauryl sulphate, as well as the colourings titanium dioxide, iron oxide red, iron oxide black and erythrosine. BUDENOFALK 3 mg enteric capsules are available in packs of 90 capsules. Manufacturer/Supplier BUDENOFALK enteric capsules are made in Germany by: DR. FALK PHARMA GmbH Leinenweberstr. 5 79108 Freiburg Germany and are supplied in Australia by: Orphan Australia Pty Ltd (a member of the Aspen Australia group of companies) 34-36 Chandos Street St Leonards NSW 2065 This leaflet was prepared in July 2012. Australian Registration Number: BUDENOFALK enteric capsules 3 mg AUST R 179566 Consumer Medicine Information BUDENOFALK® enteric capsules Page 6 BUDENOFALK is a registered trademark of Dr. Falk Pharma GmbH, Germany, used under licence by Orphan Australia Pty Ltd
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