BUDENOFALK 3mg
Gastro-resistant Capsules
BUDESONIDE
Please read this leaflet carefully before you start to take your medicine.
It contains important information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all of your medicine. You may want to read it again.
What is in your medicine?
Budenofalk 3mg comes in capsule form. Each gastro-resistant capsule contains 3mg of an active ingredient called budesonide.
The capsules also contain lactose monohydrate, sucrose, maize starch, triethyl citrate, talc, povidone and coating agents known as Eudragit.
The capsules are made of hard gelatin, purified water and sodium laurilsulfate. They are coloured with titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172) and erythrosine (E127).
Each box of Budenofalk 3mg contains either 10, 50, 90, 100 or 120 pink capsules in blister strips.
Marketing Authorisation Holder and Manufacturer:
Distributed by:
Bucks
What your medicine is used for
Your medicine contains a type of steroid which reduces inflammation. It may be used to treat Crohn’s disease, an inflammation which predominantly affects the last part of the small bowel and/or the first part of the large bowel but can affect other parts of the gastrointestinal tract.
Sometimes Crohn’s disease may include symptoms in the skin, eyes and joints. These symptoms are unlikely to respond to this medicine.
Budenofalk may also be used for the symptomatic relief of chronic diarrhoea due to collagenous colitis.
Before taking your medicine
You should not take this medicine if:
- You are allergic to budesonide or any of the ingredients listed above.
- You have a serious liver disease.
If you are pregnant, trying to become pregnant or think you may be pregnant, you should avoid taking this drug unless advised by your doctor.
It is not known if budesonide passes into breast milk, therefore you should not breast feed while on treatment.
If you answer yes to any of the following questions, tell your doctor or pharmacist.
- Do you have, or have you ever had, tuberculosis, high blood pressure, diabetes, brittle bones (osteoporosis), stomach ulcers, glaucoma, cataracts or liver problems?
- If you know or think you may have any sort of infection.
- Has anyone in your family ever had diabetes or glaucoma?
- Are you taking colestyramine, digoxin, water tablets, ketoconazole, ritonavir, itraconazole, clarithromycin, carbamazepine, rifampicin, cimetidine, oestrogens and oral contraceptives or antacids?
- Are you taking any other medication (including any medicines you have bought without a prescription) which your doctor does not know about?
Please try to avoid contact with people who have chicken pox, shingles or measles. This is particularly important if you do not think you have had this illness yourself. If you think you may have been exposed to any of these illnesses, tell your doctor as soon as possible. Please tell your doctor if you are about to go abroad and need a vaccination whilst you are taking this medicine.
The capsules contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product
How to take your medicine
It is important to take your medicine as directed by your doctor. The label will tell you how much to take and how often. If it does not or you are unsure, ask your doctor or pharmacist.
- The usual dose is one capsule three times a day (morning, midday and evening).
- Take the capsules about 30 minutes before a meal.
- Swallow the capsules whole with a glass of water (avoid taking with grapefruit juice).
- Do not chew the capsules.
This medicine is not recommended for children.
It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better. Your doctor will probably want to reduce your dose gradually, first from 3 to 2 capsules daily for one week, (one in the morning and one in the evening) and then only one capsule daily in the last week of treatment (taken in the morning).
Your doctor will not normally want you to take this medicine for more than 8 weeks.
If you go into hospital, or you visit a dentist or another doctor, tell them you are taking Budenofalk 3mg gastro-resistant capsules.
What to do if you forget to take your medicine
If you forget to take your capsules, take a dose as soon as you remember and then continue with the next dose as instructed on the label. Do not take more capsules in a day than you usually do.
What to do if you take too many capsules
If you accidentally take too many capsules, do not worry, but contact your doctor or local hospital casualty department as soon as possible. Take this medicine with you.
After taking your medicine
Like all medicines, Budenofalk 3mg gastro-resistant capsules may occasionally cause unwanted effects in some people. Most of these effects are not serious. This medicine contains a type of steroid, so you might experience unwanted effects typical of steroids. They may include:
- Skin rashes, acne, itchy skin, development of marks and bleeding within the skin, delayed wound healing.
- Tiredness, muscle weakness or pain, brittle bones, wasting of bones and cartilage.
- Roundness of the face, weight gain, fluid retention including leg edema, increased risk of high blood sugar, diabetes mellitus, increased risk of infections, blood clots and high blood pressure.
- Heartburn, stomach complaints such as ulcers, pancreatitis and constipation.
- Cataract, glaucoma.
- Heavy or irregular periods and male hair growth patterns in women, growth retardation in children, impotence.
- Nervous system disorders including headaches, which may or may not be associated with blurred vision or vomiting and mood changes, such as depression, irritability or euphoria.
If you experience these or any other undesirable effects, then tell your doctor or pharmacist as soon as possible.
How to store your medicine
- Do not store above 25°C.
- Do not take this medicine after the expiry date printed on the carton or blister strip.
- If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.
PL 08637/0002
PA 573/2/1
Keep this medicine in a safe place. Keep out of reach and sight of children.
REMEMBER: This medicine is for you. Never give it to anyone else. It may harm them, even if their problems seem to be the same as yours.
Leaflet revised: October 2006
Bucks
‘Budenofalk’ is a registered trademark, the property of Dr Falk Pharma GmbH
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