Patient leaflet - BUDESONIDE 3 MG PROLONGED-RELEASE CAPSULES
1. what budesonide 3 mg prolonged-release capsules is and what it is used for
This medicine contains the active substance budesonide. This belongs to a group of medicines called ‘corticosteroids’. These are used to reduce inflammation.
Crohn’s disease: Budesonide 3 mg prolonged-release capsules are used to treat an inflammation of the small bowel and the first part of the large bowel.
Microscopic colitis: Budesonide 3 mg prolonged-release capsules are used to treat microscopic colitis (a disease with chronic inflammation of the large bowel which is typically with chronic watery diarrhoea).
2. what you need to know before you take budesonide 3 mg prolonged-release capsules do not take budesonide 3 mg prolonged-release capsules
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– if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
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– if you have an infection.
Do not take Budesonide 3 mg prolonged-release capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Budesonide 3 mg prolonged-release capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking Budesonide 3 mg prolonged-release capsules if:
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– You have ever had tuberculosis (TB).
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– You have ever had high blood pressure.
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– You have diabetes.
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– You have ever had brittle bones.
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– You have ever had stomach ulcers. You have ever had glaucoma (increased pressure in the eye) or cataracts.
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– A member of your family has ever had diabetes or glaucoma.
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– You have ever had liver problems.
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– You or a member of your family has ever had mental health problems. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Budesonide 3 mg prolonged-release capsules.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Budesonide 3 mg prolonged-release capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Budesonide 3 mg prolonged-release capsules can affect the way some medicines work and some medicines can have an effect on Budesonide 3 mg prolonged-release capsules.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
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– Steroid medicines, such as prednisolone or dexamethasone.
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– Colestyramine, used to reduce cholesterol levels or reduce itching caused by liver problems.
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– Ketoconazole or itraconazole, used to treat infections caused by a fungus.
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– Medicines that contain oestrogen, such as hormone replacement therapy (HRT) and some oral contraceptives.
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– HIV protease inhibitors (such as ritonavir, cobicistat and nelfinivir).
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– Carbamazepine (used to treat epilepsy and fits).
Some medicines may increase the effects of Budesonide 3 mg prolonged-release capsules and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Diagnostic tests for pituitary glands activity may show false low values due to suppression of the adrenal function.
Budesonide 3 mg prolonged-release capsules with food and drink
Do not drink grapefruit juice while you are taking Budesonide. It can affect the way the medicine works.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Budesonide 3 mg prolonged-release capsules are not likely to affect you being able to drive or use any machines.
Budesonide 3 mg prolonged-release capsules contain sucrose
Budesonide 3 mg prolonged-release capsules contain sucrose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. how to take budesonide 3 mg prolonged-release capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many capsules to take an when to take them.
For oral use. Capsules should be swallowed whole with water and should not be sucked, chewed or crushed.
Crohn’s disease:
The recommended dose for an attack of Crohn’s disease is 3 capsules in the morning before breakfast. Normally, you will take this number of capsules for up to 8 weeks. Your doctor will then gradually reduce the dose. The medicine will usually have its full effect within 2 to 4 weeks. Continue to take Budesonide as your doctor has told you, even if you start feeling better.
Microscopic colitis:
For treatment of active disease: Take 3 capsules once daily in the morning. When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy.
For the maintenance of remission: Take 2 capsules once daily in the morning (or the lowest effective dose).
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat. This may make it difficult to breathe.
The following side effects may happen with this medicine:
Common (may affect up to 1 in 10 people)
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– Heartburn.
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– Muscle cramps.
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– Pounding heart beat (palpitations).
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– Rash or itchy skin.
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– Heavy or irregular periods in women.
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– Low levels of potassium in the blood which may cause muscle weakness, thirst or ‘pins and needles’.
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– Cushingoid features such as a rounded face, acne, weight gain and bruising more easily.
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– Behavioural changes such as feeling nervous, difficulty sleeping, mood swings and depression.
Uncommon (may affect up to 1 in 100 people)
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– Shaking.
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– Unintentional movements or extreme restlessness possibly accompanied by muscle spasms or twitching.
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– Anxiety.
Rare (may affect up to 1 in 1000 people)
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– Aggression.
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– Clouding of the eye’s natural lens including the back of the lens.
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– Skin discoloration resulting from bleeding beneath the skin.
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– Glaucoma (increased pressure in the eye)
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– Blurred vision
Very Rare (may affect up to 1 in 10,000 people)
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– A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
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– A slowing of the rate of growth in children and adolescents.
Medicines like Budesonide 3 mg prolonged-release capsules (corticosteroids) can affect the normal production of steroid hormones in your body. The effects include:
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– Changes in bone mineral density (thinning of the bones).
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– Glaucoma (increased pressure in the eye).
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– A slowing of the rate of growth of children and adolescents.
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– An effect on the adrenal gland (a small gland near the kidney).
Most of the side effects mentioned in this list can also be expected with other glucocorticoids treatment.
Mental health problems can happen while taking steroids like Budesonide 3 mg prolonged-release capsules. Talk to a doctor if you (or someone taking this medicine), show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. Very rarely mental health problems have happened when high doses have been taken for a long time.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search the MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store budesonide 3 mg prolonged-release capsules
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original container in order to protect from light/moisture
Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.If your capsules become discoloured or show any other signs of deterioration please ask your doctor or pharmacist before taking your medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Budesonide 3 mg prolonged-release capsules contains
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– The active substance is budesonide.
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– The other ingredient(s) are:
Capsule content
Sugar spheres (Maize starch & Sucrose),
Ethylcellulose,
Polysorbate 80,
Methacrylic acid-methyl methacrylate copolymer (1:1),
Triethyl citrate,
Talc
Capsule shell
Black iron oxide E172 Red Iron Oxide E172 Titanium dioxide E171 Gelatin
What Budesonide 3 mg prolonged-release capsules looks like and contents of the pack
Swedish-orange opaque cap and light-grey opaque body with 2 parallel black lines hard gelatin prolonged release capsules size ‘1' (approximately 19.4 mm length), filled with white to off-white gastro-resistant prolonged-release pellets. Budesonide 3 mg prolonged-release capsules are available in packs containing 20, 45, 50, 60, 90 or 100 capsules in HDPE bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer Marketing Authorisation Holder
Medical Valley Invest AB Bradgardsvagen 28
23632 Hollviken Sweden
Manufacturer
Laboratorios Liconsa S.A. Calle Dulcinea s/n
Alcala de Henares 28805
Spain
This leaflet was last revised in 11/2021.
540 mm
Use in children
Budesonide 3 mg prolonged-release capsules are not recommended for children.
Additional information about taking Budesonide 3 mg prolonged-release capsules
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– If you are about to have an operation or during times of stress, please tell the doctor that you take Budesonide. The doctor may ask you to take steroid tablets as well, particularly if you have been taking a high dose of Budesonide, or a similar medicine, for a long time.
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– Try to avoid people who have chicken pox or measles while you are taking Budesonide. Talk to your doctor if you think you may have caught chicken pox or measles while taking this medicine.
7mm
If you take more Budesonide 3 mg prolonged-release capsules than you should
If you take more Budesonide 3 mg prolonged-release capsules than you should, talk to a doctor or pharmacist straight away.
If you forget to take Budesonide 3 mg prolonged-release capsules
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– If you forget to take a dose of Budesonide 3 mg prolonged-release capsules, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
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– Do not take a double dose to make up for a forgotten dose.
581145–01
126 mm
7mm
7mm
126 mm
7mm
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