Cortiment 9 Mg Prolonged Release Tablets
Package leaflet: Information for the user
Cortiment®
Prolonged release tablets Budesonide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Cortiment is and what it is used for
2. What you need to know before you take Cortiment
3. How to take Cortiment
4. Possible side effects
5. How to store Cortiment
6. Contents of the pack and other information
1. What Cortiment is and what it is used for
Cortiment tablets contain a medicinal product called budesonide. This belongs to a category of medicinal products called ‘corticosteroids'. These are used to reduce inflammation.
Cortiment tablets are used for adults for the treatment of inflammation of the large intestine (colon) and the rectum. This is called ulcerative colitis.
2. What you need to know before you take Cortiment
Do not take Cortiment
If you are allergic to budesonide or one of the other ingredients of this medicine (listed in section 6).
Cortiment 9 mg tablets contain lecithin which is a derivate from soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
Warnings and precautions
Talk to your doctor before taking Cortiment:
• if you have an infection, such as a virus infection, a bacterial infection or a fungal infection;
• if you have ever had tuberculosis (TBC);
• if you have ever had high blood pressure;
• if you have diabetes;
• if you ever had brittle bones;
• if you ever had a stomach ulcer;
• if you ever had elevated eyeball pressure (glaucoma) or grey cataract;
• if a family member has ever had diabetes or elevated eyeball pressure (glaucoma);
• if you ever had liver problems;
• if you or a family member ever had problems with mental health;
• if you are scheduled to undergo surgery soon or are going through a stressful period.
While taking Cortiment tablets, try to avoid people with measles or chicken pox. Inform your doctor if you think you have been infected with chicken pox or measles while taking this medicine.
If you have any doubts about whether one of the above applies to you, contact your doctor before you take Cortiment tablets.
Other medicines and Cortiment
Tell your doctor if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines or herbal medicines. This is necessary because Cortiment tablets affect how some medicines work and some medicines may affect how Cortiment works.
Tell your doctor if you are taking, have recently taken or might take one of the following medicines:
• steroids, such as prednisolone or dexamethasone;
• cholestyramine, which is used to lower cholesterol levels or treat itching caused by liver problems, antacids;
• ketoconazole or itraconazole, which are substances used to treat fungal infections;
• medicines that contain oestrogens, such as hormone replacement therapy (HRT) and some oral contraceptives;
• cardiac glycosides and diuretics.
• HIV protease inhibitors (such as ritonavir and nelfinavir)
• Carbamazepine, which is used for treatment of epilepsy.
Cortiment with food, drink and alcohol
Do not drink grapefruit juice when taking Cortiment tablets. This may affect the working of the medicine.
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 for advice before taking this medicine.
Driving and using machines
It is unlikely that Cortiment will affect your ability to drive and use machines. Care is required because this type of medicine may sometimes cause dizziness or fatigue.
Cortiment contains lactose
Cortiment tablets contain lactose, 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 Cortiment
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
• The recommended dose is one tablet in the morning before or with breakfast.
• Swallow the tablet whole with a glass of water, the tablet must not be broken, crushed or chewed.
• Usually you will take this medicine daily for a maximum of eight weeks. Your doctor may then gradually lower the number of times you take the medicine.
• Keep taking Cortiment tablets as your doctor has told you, even if you start feeling better.
Additional information when taking Cortiment tablets
If you will undergo surgery soon or are going through a stressful period, the doctor may ask you to take steroid tablets. This is particularly true if you have been taking high doses of Cortiment tablets or a similar medicine for a long time.
Use in children
Cortiment tablets are not recommended for use in children.
If you take more Cortiment than you should
If you take more Cortiment tablets than you should, inform your doctor immediately.
If you forget to take Cortiment
• If you forget to take a Cortiment tablet, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten tablet.
If you stop taking Cortiment
Do not stop taking Cortiment tablets without discussing it with your doctor first. If you suddenly stop taking the medicine, you may become ill.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction, contact your doctor immediately. Signs may include hives or swelling of the face, lips, mouth, tongue and throat. This can make it difficult to breathe.
The following side effects may occur when taking Cortiment. If one of the side effects becomes serious or you develop a side effect not listed in the leaflet, consult your doctor.
Common (may affect up to 1 in 10 people)
• Reflux
• Muscle cramps and stomach pain
• Heart palpitations
• Blurred vision
• Skin rash or itchiness
• Heavy or irregular menstruation in women
• Low potassium levels in the blood, which can cause muscle weakness or fatigue, thirst or a tingling sensation
• Cushing-like symptoms, such as a round face, acne, weight gain and a tendency to bruise easily
• Nausea or headache
• Reduced response to an infection
• Change in behaviour, such as nervousness, insomnia or mood swings
Uncommon (may affect up to 1 in 100 people)
• Somnolence
• Diarrhoea
• Bloated abdomen, abdominal pain
• Stomach complaints or indigestion
• Pain in your limbs
• Swelling in your legs
• Tremor
Very rare (may affect up to 1 in 10,000 people)
• A serious allergic reaction (called anaphylaxis) which can lead to breathing difficulties and shock
• Slowed growth in children under the age of 18 years.
Medicines like Cortiment tablets (corticosteroids) may affect the normal production of steroid hormones in your body. The effects include:
• changes to bone mineral density (brittle bones);
• glaucoma (high eyeball pressure);
• effect on the adrenal gland (small gland near the kidney).
Psychological problems may develop when taking steroids like Cortiment. Discuss it with your doctor if you (or someone who uses this medicine) have (has) symptoms of psychological problems. This is particularly important if you are depressed and may be thinking about committing suicide. In very rare cases, psychological problems have developed when high doses were taken for a long time.
Do not worry about this list of possible side effects. You may not get any of these side effects.
If you have a lot of trouble with one of these side effects, or get a side effect not listed in this leaflet, contact your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any side effects not listed in this leaflet. You can also report side effects directly (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace, IRL Dublin 2
Tel: +353 1 6764971 Fax: +353 1 6762517.
Website: www.hpra.ie E-mail: medsafety@hpra.ie
5. How to store Cortiment
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 carton and on the blister pack after EXP. This lists a month and year. The expiry date refers to the last day of that month.
Store below 30°C.
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 Cortiment contains
• The active substance in this medicine is budesonide. Each tablet contains 9 mg of budesonide.
• The other ingredients (excipients) in this medicine are: tablet core: stearic acid (E570), lecithin (E322), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), lactose monohydrate, silica colloidal hydrated (E551), magnesium stearate (E470b)
film coating: methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), talcum powder (E553b), titanium dioxide (E171), triethyl citrate
What Cortiment looks like and contents of the pack
Cortiment is supplied in white to off-white, round, double convex tablets with a film coating, and ‘MX9' engraved on one side of the tablet. The tablets are supplied in blister packs with aluminium press-through foil in a cardboard carton.
This medicine is available in packs of 10, 20, 30, 50, 60 or 80 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder UK
Ferring Pharmaceuticals Ltd.
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK PL 03194/0113
Ireland
Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland.
PA 1009/XX/XXX
Manufacturer
Cosmo S.p.A.
Via C. Colombo 1,
20020 Lainate,
Milan,
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
Cortiment: Netherlands, Cyprus, Czech Republic,
Estonia, Greece, Ireland, Italy, Lithuania, Romania, Slovakia, Spain, UK
CortimentMMX: Austria, Bulgaria, Croatia, Finland,
Germany, Hungary, Iceland, Malta, Norway, Poland, Portugal.
Budesonide Ferring: Belgium, Latvia, Luxembourg. Budezonid Ferring: Slovenia
This leaflet was last revised in: October 2014.