ENTOCORT ENEMA
Active substance: BUDESONIDE
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6082728-1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Entocort Enema
budesonide 0.02 mg/ml Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1.What EntocortEnema is and what it is used for 2.Before you use EntocortEnema 3.How to use EntocortEnema 4.Possible side effects 5.How to store EntocortEnema 6.Further information 1.What EntocortEnema is and what it is used for EntocortEnema contains a medicine called budesonide. This belongs to a group of medicines called corticosteroids. These are used to reduce inflammation. An enema is a liquid that is inserted into the back passage (rectum). EntocortEnema is used to treat inflammation and ulcers in the large intestine (colon) and rectum. This is known as ulcerative colitis. 2.Before you use EntocortEnema Do not use EntocortEnema if: You are allergic (hypersensitive) to budesonide or any of the other ingredients of EntocortEnema (listed in Section 6: Further information). Take special care with EntocortEnema Check with your doctor or pharmacist before using EntocortEnema if: You have recently had a bowel infection. You have ever had liver problems. You or a member of your family has ever had mental health problems. Taking other medicines Please tell your doctor or pharmacist before using EntocortEnema if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because EntocortEnema can affect the way some medicines work and some medicines can have an effect on EntocortEnema. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Steroid medicines, such as prednisolone or dexamethasone. 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 and nelfinavir). Carbamazepine (used to treat epilepsy and fits). Pregnancy and breast-feeding Talk to your doctor before using EntocortEnema if you are pregnant, may become pregnant or are breast-feeding. Driving and using tools and machines EntocortEnema is not likely to affect you being able to drive or use any tools or machines. Important information about some of the ingredients EntocortEnema contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), these may cause allergic reactions (possibly delayed). 3.How to use EntocortEnema Always use EntocortEnema exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. EntocortEnema should only be used in your back passage (rectum), as directed by your doctor. EntocortEnema is not recommended for use by children. When to use EntocortEnema and how long to use it for It is important to use each enema at the right time. Usually this will be once a day, just before bedtime. Normally, your treatment will last for 4 weeks. However, your doctor may decide that you need to use EntocortEnema for longer. Parts of the bottle Protective Cap To prepare your enema for use, you Nozzle need to be familiar with the following Tablet parts of the plastic bottle: Preparing EntocortEnema for use Bottle To prepare one enema, dissolve one tablet in one bottle of liquid. To do this, follow the instructions below: 1.Take one of the plastic bottles containing a 1 liquid. Unscrew the complete nozzle section and protective cap in one piece.
2.Take one of the tablets from its foil strip. Then drop it into the bottle.
2
3.Put the nozzle and protective cap back onto the bottle. Then screw them up until they are tight.
3
4. Shake the bottle well for at least 15seconds, or until you cannot see the tablet in the liquid any more.
4
5. The enema is now ready. Use it straight away. You will find it more comfortable to use EntocortEnema if you empty your bowels and bladder before using it. EntocortEnema can stain your bedclothes. It is best to protect your bedclothes with a plastic sheet in case any liquid is spilled. Inserting the enema into your back passage To insert the enema into your back passage, follow the instructions below: 1. Shake the bottle again. Then only take off the protective cap. This will reveal the nozzle. 2.Undress from the waist down, then lie down on your side. Choose whichever side is most comfortable. Try to lie down so that your bottom is slightly higher than the rest of your body. For example, you can raise the bottom of the bed onto blocks or place one or two pillows under your bottom. This will help to keep the liquid in your back passage.
362720-A01 14-01-13 6082728-1 AZL005/A 861 Entocort Enema 2mg Leaflet: Patient UK DR
Black
3.If you wish, hold the bottle using 3 one of the plastic bags. 4.Gently ease the nozzle into your back passage as far as is comfortable. 5.Squeeze the bottle, this will push most of the liquid into your back passage. However, you will not be able to empty the whole bottle. It has been designed to keep some liquid after being used. 6.Then remove the nozzle from your back passage. 7. If you used a plastic bag, remove it from 7 your hand by pulling it forward over the bottle. This will leave the bottle inside the bag, ready to be disposed of. 8.Now, roll over onto your stomach. Stay like this for 5 minutes to stop any liquid coming out of your back passage. 9. Then, find a comfortable position to sleep in that helps you to keep the liquid in your back passage for as long as possible. EntocortEnema is a retention enema. This means that the liquid is meant to be held in the back passage for as long as possible. The longer it is kept there the more time it has to work and the better the results should be. If you use more EntocortEnema than you should If you use more enemas than prescribed by your doctor, talk to a doctor or pharmacist straight away. If you forget to use EntocortEnema If you forget a dose of EntocortEnema, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose (two doses at the same time) to make up for a forgotten dose. If you stop using EntocortEnema Do not stop using EntocortEnema without talking to your doctor first. If you stop using your enema suddenly it may make you ill. 4.Possible side effects Like all medicines, EntocortEnema 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. Other possible side effects: Common (affects less than 1 in 10 people) Upset stomach or gut such as stomach pains, wind, diarrhoea, heartburn and feeling sick. Skin reactions such as lumpy rash and skin rash. Uncommon (affects less than 1 in 100 people) Feeling agitated. Difficulty sleeping. Rare (affects less than 1 in 1,000 people) An effect on the adrenal gland (a small gland near the kidney). Very rare (affects less than 1 in 10,000 people) A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock. Other side effects may include: Glaucoma (increased pressure in the eye). Medicines like EntocortEnema (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). Mental health problems can happen while taking steroids like EntocortEnema. 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. 5.How to store EntocortEnema Do not use your enemas after the expiry date shown on the bottle or foil. Keep your medicine in a safe place where children cannot reach or see it. Do not store this medicine above 30C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment. 6.Further information What EntocortEnema contains The active ingredient is budesonide. Each bottle provides a dose of approximately 2mg of budesonide at a concentration of 0.02mg of budesonide per ml of solution. The other ingredients are lactose anhydrous, polyvidone, riboflavine sodium phosphate, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, sodium chloride, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and water purified. What EntocortEnema looks like and contents of the pack EntocortEnema, once prepared, is a whitish yellow liquid. EntocortEnema comes in a box containing the following: 7 tablets wrapped in foil, inside a small box. 7 plastic bottles containing solution. 7 plastic bags to be used when giving the enema. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for EntocortEnema is held by AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK. EntocortEnema is manufactured by Takeda Nycomed AS, Solbaervegen 5, NO-2409 Elverum, Norway.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name EntocortEnema Reference number 17901/0123 This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: December 2012 AstraZeneca 2012 Entocort is a trade mark of the AstraZeneca group of companies. GI 12 0191
362720-A01 14-01-13 6082728-1 AZL005/A 861 Entocort Enema 2mg Leaflet: Patient UK DR
Black
PACKAGE LEAFLET: INFORMATION FOR THE USER
Entocort Enema
budesonide 0.02 mg/ml Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1.What EntocortEnema is and what it is used for 2.Before you use EntocortEnema 3.How to use EntocortEnema 4.Possible side effects 5.How to store EntocortEnema 6.Further information 1.What EntocortEnema is and what it is used for EntocortEnema contains a medicine called budesonide. This belongs to a group of medicines called corticosteroids. These are used to reduce inflammation. An enema is a liquid that is inserted into the back passage (rectum). EntocortEnema is used to treat inflammation and ulcers in the large intestine (colon) and rectum. This is known as ulcerative colitis. 2.Before you use EntocortEnema Do not use EntocortEnema if: You are allergic (hypersensitive) to budesonide or any of the other ingredients of EntocortEnema (listed in Section 6: Further information). Take special care with EntocortEnema Check with your doctor or pharmacist before using EntocortEnema if: You have recently had a bowel infection. You have ever had liver problems. You or a member of your family has ever had mental health problems. Taking other medicines Please tell your doctor or pharmacist before using EntocortEnema if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because EntocortEnema can affect the way some medicines work and some medicines can have an effect on EntocortEnema. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Steroid medicines, such as prednisolone or dexamethasone. 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 and nelfinavir). Carbamazepine (used to treat epilepsy and fits). Pregnancy and breast-feeding Talk to your doctor before using EntocortEnema if you are pregnant, may become pregnant or are breast-feeding. Driving and using tools and machines EntocortEnema is not likely to affect you being able to drive or use any tools or machines. Important information about some of the ingredients EntocortEnema contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), these may cause allergic reactions (possibly delayed). 3.How to use EntocortEnema Always use EntocortEnema exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. EntocortEnema should only be used in your back passage (rectum), as directed by your doctor. EntocortEnema is not recommended for use by children. When to use EntocortEnema and how long to use it for It is important to use each enema at the right time. Usually this will be once a day, just before bedtime. Normally, your treatment will last for 4 weeks. However, your doctor may decide that you need to use EntocortEnema for longer. Parts of the bottle Protective Cap To prepare your enema for use, you Nozzle need to be familiar with the following Tablet parts of the plastic bottle: Preparing EntocortEnema for use Bottle To prepare one enema, dissolve one tablet in one bottle of liquid. To do this, follow the instructions below: 1.Take one of the plastic bottles containing a 1 liquid. Unscrew the complete nozzle section and protective cap in one piece.
2.Take one of the tablets from its foil strip. Then drop it into the bottle.
2
3.Put the nozzle and protective cap back onto the bottle. Then screw them up until they are tight.
3
4. Shake the bottle well for at least 15seconds, or until you cannot see the tablet in the liquid any more.
4
5. The enema is now ready. Use it straight away. You will find it more comfortable to use EntocortEnema if you empty your bowels and bladder before using it. EntocortEnema can stain your bedclothes. It is best to protect your bedclothes with a plastic sheet in case any liquid is spilled. Inserting the enema into your back passage To insert the enema into your back passage, follow the instructions below: 1. Shake the bottle again. Then only take off the protective cap. This will reveal the nozzle. 2.Undress from the waist down, then lie down on your side. Choose whichever side is most comfortable. Try to lie down so that your bottom is slightly higher than the rest of your body. For example, you can raise the bottom of the bed onto blocks or place one or two pillows under your bottom. This will help to keep the liquid in your back passage.
362720-A01 14-01-13 6082728-1 AZL005/A 861 Entocort Enema 2mg Leaflet: Patient UK DR
Black
3.If you wish, hold the bottle using 3 one of the plastic bags. 4.Gently ease the nozzle into your back passage as far as is comfortable. 5.Squeeze the bottle, this will push most of the liquid into your back passage. However, you will not be able to empty the whole bottle. It has been designed to keep some liquid after being used. 6.Then remove the nozzle from your back passage. 7. If you used a plastic bag, remove it from 7 your hand by pulling it forward over the bottle. This will leave the bottle inside the bag, ready to be disposed of. 8.Now, roll over onto your stomach. Stay like this for 5 minutes to stop any liquid coming out of your back passage. 9. Then, find a comfortable position to sleep in that helps you to keep the liquid in your back passage for as long as possible. EntocortEnema is a retention enema. This means that the liquid is meant to be held in the back passage for as long as possible. The longer it is kept there the more time it has to work and the better the results should be. If you use more EntocortEnema than you should If you use more enemas than prescribed by your doctor, talk to a doctor or pharmacist straight away. If you forget to use EntocortEnema If you forget a dose of EntocortEnema, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose (two doses at the same time) to make up for a forgotten dose. If you stop using EntocortEnema Do not stop using EntocortEnema without talking to your doctor first. If you stop using your enema suddenly it may make you ill. 4.Possible side effects Like all medicines, EntocortEnema 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. Other possible side effects: Common (affects less than 1 in 10 people) Upset stomach or gut such as stomach pains, wind, diarrhoea, heartburn and feeling sick. Skin reactions such as lumpy rash and skin rash. Uncommon (affects less than 1 in 100 people) Feeling agitated. Difficulty sleeping. Rare (affects less than 1 in 1,000 people) An effect on the adrenal gland (a small gland near the kidney). Very rare (affects less than 1 in 10,000 people) A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock. Other side effects may include: Glaucoma (increased pressure in the eye). Medicines like EntocortEnema (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). Mental health problems can happen while taking steroids like EntocortEnema. 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. 5.How to store EntocortEnema Do not use your enemas after the expiry date shown on the bottle or foil. Keep your medicine in a safe place where children cannot reach or see it. Do not store this medicine above 30C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment. 6.Further information What EntocortEnema contains The active ingredient is budesonide. Each bottle provides a dose of approximately 2mg of budesonide at a concentration of 0.02mg of budesonide per ml of solution. The other ingredients are lactose anhydrous, polyvidone, riboflavine sodium phosphate, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, sodium chloride, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and water purified. What EntocortEnema looks like and contents of the pack EntocortEnema, once prepared, is a whitish yellow liquid. EntocortEnema comes in a box containing the following: 7 tablets wrapped in foil, inside a small box. 7 plastic bottles containing solution. 7 plastic bags to be used when giving the enema. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for EntocortEnema is held by AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK. EntocortEnema is manufactured by Takeda Nycomed AS, Solbaervegen 5, NO-2409 Elverum, Norway.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name EntocortEnema Reference number 17901/0123 This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: December 2012 AstraZeneca 2012 Entocort is a trade mark of the AstraZeneca group of companies. GI 12 0191
362720-A01 14-01-13 6082728-1 AZL005/A 861 Entocort Enema 2mg Leaflet: Patient UK DR
Black
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
