Patient leaflet - Budesonide CR 3 mg capsules
1. What Budesonide Capsules are and what they are used for
Budesonide Capsules contain the active substance budesonide. This belongs to a group of medicines called ‘corticosteroids’. These are used to reduce inflammation.
Crohn’s disease: Budesonide Capsules are used to treat an inflammation of the small bowel and the first part of the large bowel.
Microscopic colitis: Budesonide 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 Capsules
Do not take Budesonide Capsules:
- If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
- If you have an infection.
Do not take Budesonide Capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Budesonide Capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking Budesonide Capsules if: • You have ever had tuberculosis (TB).
- You have ever had high blood pressure.
- You have diabetes.
- You have ever had brittle bones.
- You have ever had stomach ulcers.
- You have ever had glaucoma (increased pressure in the eye) or cataracts. • A member of your family has ever had diabetes or glaucoma. • You have ever had liver problems.
- 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 Capsules.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Budesonide 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 Capsules can affect the way some medicines work and some medicines can have an effect on Budesonide Capsules.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Steroid medicines, such as prednisolone or dexamethasone. • Colestyramine, used to reduce cholesterol levels or reduce itching caused by liver problems.
Ketoconazole or itraconazole, used to treat infections caused by a fungus. • Medicines that contain oestrogen, such as hormone replacement therapy
(HRT) and some oral contraceptives.
- HIV protease inhibitors (such as ritonavir, cobicistat and nelfinivir). • Carbamazepine (used to treat epilepsy and fits).
Some medicines may increase the effects of Budesonide 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 Capsules with food and drink
Do not drink grapefruit juice while you are taking Budesonide Capsules. 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 Capsules are not likely to affect you being able to drive or use any machines.
Budesonide Capsules contain sucrose
Budesonide 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.
Budesonide Capsules contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially sodium-free.
3. How to take Budesonide 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 and when to take them.
Swallow the capsules whole with a glass of water.
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 Capsules 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).
Use in children
Budesonide Capsules are not recommended for children.
Additional information about taking Budesonide Capsules
If you are about to have an operation or during times of stress, please tell the doctor that you take Budesonide Capsules. The doctor may ask you to take steroid tablets as well, particularly if you have been taking a high dose of Budesonide Capsules, or a similar medicine, for a long time. • Try to avoid people who have chicken pox or measles while you are taking
Budesonide Capsules. Talk to your doctor if you think you may have caught chicken pox or measles while taking this medicine.
MKP_PIL Budesonide Caps GB
If you take more Budesonide Capsules than you should
If you take more Budesonide Capsules than you should, talk to a doctor or pharmacist straight away.
If you forget to take Budesonide Capsules
- If you forget to take a dose of Budesonide Capsules, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Budesonide Capsules
Do not stop taking Budesonide Capsules without talking to your doctor first. If you stop taking your capsules suddenly it may make you ill.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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)
- Heartburn.
- Muscle cramps.
- Pounding heart beat (palpitations).
- Rash or itchy skin.
- Heavy or irregular periods in women.
- Low levels of potassium in the blood which may cause muscle weakness, thirst or ‘pins and needles’.
- Cushingoid features such as a rounded face, acne, weight gain and bruising more easily.
- Behavioural changes such as feeling nervous, difficulty sleeping, mood swings and depression.
Uncommon (may affect up to 1 in 100 people)
- Shaking.
- Unintentional movements or extreme restlessness possibly accompanied by muscle spasms or twitching.
- Anxiety.
Rare (may affect up to 1 in 1000 people)
- Aggression.
- Clouding of the eye’s natural lens including the back of the lens. • Skin discoloration resulting from bleeding beneath the skin. • Glaucoma (increased pressure in the eye)
- Blurred vision
Very Rare (may affect up to 1 in 10,000 people)
- A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
- A slowing of the rate of growth in children and adolescents.
Not known (frequency cannot be estimated from the available data)
- Allergic reaction which can cause swelling of the face, particularly eyelids, lips, tongue or throat (angioedema).
Medicines like Budesonide Capsules (corticosteroids) can affect the normal production of steroid hormones in your body. The effects include: • Changes in bone mineral density (thinning of the bones). • Glaucoma (increased pressure in the eye).
- A slowing of the rate of growth of children and adolescents. • 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 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 Website: www.mhra.gov.uk/yellowcard or search for 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 Capsules
Keep this medicine out of the sight and reach of children. • 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.
- Do not store above 30°C.
- Replace the cap firmly after use.
- 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 Capsules contain
The active ingredient is budesonide. Each capsule contains 3 mg of budesonide.
The other ingredients are ethyl cellulose, tributyl acetylcitrate, methacrylic acid copolymer, triethylcitrate, Antifoam M, polysorbate 80, talc, sucrose (see section 2), maize starch, gelatine, titanium dioxide (E 171) and iron oxide (E 172).
What Budesonide Capsules look like and contents of the pack
Budesonide Capsules are pink and grey. They come in a white plastic container fitted with a cap containing a desiccant. They are available in pack sizes of 50 or 100 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Budesonide CR 3 mg Capsules is held by Tillotts Pharma UK Ltd., Wellingore Hall, Wellingore, Lincolnshire, UK LN5 0HX, Tel: +44 1522 813500, e-mail: ukinfo@tillotts.com.
Budesonide CR 3 mg Capsules are manufactured by
Astrea Fontaine SAS, Rue des Prés Potets, 21121 Fontaine-les-Dijon, France
Tillotts Pharma GmbH, Warmbacher Str. 80, 79618 Rheinfelden, Germany
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Product name Budesonide CR 3 mg Capsules
Reference number 36633/0012
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in March 2023.
GI 14 0035