DIPENTUM CAPSULES 250MG
Active substance: OLSALAZINE SODIUM
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RECTO 1/2
TOP
RECTO 2/2
Artwork Studiochecksandapproves technical accuracyandpre-press suitabilityof thisartworkonly. Ensuretheartworkhas been thoroughly checked fortextual accuracy and hasbeenapprovedassuch!
Patient Information Leaflet
Olsalazine sodium
Note:
Techn. Colours
techn. info
Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Strae 10 4 0789 Monheim, Germany
1.What Dipentum is for Dipentum belongs to a group of medicines called aminosalicylates. Dipentum works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation. Dipentum is used to treat an inflammation of your large intestine (colon) called ulcerative colitis. It is used for short-term (acute) attacks (called flare-ups), and at a lower dose to maintain the improvement (maintenance treatment) and keep away further flare-ups. If untreated, a severe attack of ulcerative colitis may cause death due to dehydration and bursting of the colon (peritonitis). 2.Before you take Dipentum Do not take if: You are allergic to olsalazine sodium or any of the other ingredients of Dipentum (see section 6) You have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirin-containing products, including those bought over the counter) You have severe kidney disease You are a child under 12. If any of the above apply to you talk to your doctor or pharmacist. Take special care Before you start taking Dipentum your doctor will do a blood test . This will be repeated every three months for the first year, every six months for the next four years and then once a year. This is to see how well your liver and kidneys are functioning. You should also check for signs of worsening of allergies such as asthma. Tell your doctor immediately if you develop unexplained bruising or bleeding accompanied with fever, dizziness, sore throat and mouth ulcers. You could have developed a blood disorder. Tell your doctor if you are taking any of the following medicines: Aspirin or any other aspirin-containing medicines or salicylates Other drugs to treat ulcerative colitis Blood thinning agents such as warfarin or heparin or heparinoids Drugs that treat irritable bowel syndrome and cancer such as thioguanine and 6 mercaptopurine If you have recently had chickenpox
CIA70264B_MU1 / UK
Dipentum Cap 250
In this leaflet: 1.What Dipentum is for 2.Before you take Dipentum 3.How to take Dipentum 4.Possible side effects 5.How to store Dipentum 6.Further information.
Print Colours
black
cut
Read all of this leaflet carefully before you start taking 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. In this leaflet, Dipentum 250mg Capsules will be called Dipentum.
Id.-No. / Countr.
Modific. Date
Product Name
external Id.-No.
If you take more Dipentum than you should Do not take more Dipentum than you should. If you have taken too much, immediately go to the nearest hospital casualty department or your doctor. Take your tablets and this leaflet with you. Signs of taking too much Dipentum include nausea, vomiting and diarrhoea. If you forget to take Dipentum If you forget a dose take the next one as usual. Do not take a double dose to make up for a missed dose. If you stop taking Dipentum Do not stop taking Dipentum without first talking to your doctor even if your symptoms have improved. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4.Possible side effects Like all medicines Dipentum can cause side effects, although not everybody gets them. Seek immediate medical help if you have any of the following symptoms (the frequency of these side effects is unknown): Swelling of face lips, tongue or throat which may cause difficulty in swallowing/breathing Blood disorders (reduced number of blood cells) where you could have the following symptoms: bruise or bleed easily, have a persistent sore throat, mouth ulcers, dizziness and feeling tired and feverish Pancreatitis where you could have the following symptoms: severe stomach pain, fever, feeling sick/being sick Liver disease where you could have the following symptoms: feeling sick/being sick, loss of appetite, feeling generally unwell, itching and the whites of the eyes may become yellow. Other possible side effects: Common (affects less than 1 in 10 people):
Technical information: Head-to-Toe Layout (Circular) RECTO 1/2 FRONT BACK
RECTO 2/2
CIA70264B_MU1_GI_ROC_Dipentum_UK.indd 1
Edition No.
18.01.13 10:38
Creation Date
Amended by
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Operator
Maintenance treatment Once the flare-up is controlled your doctor may gradually reduce your dose to two capsules twice a day (two in the morning, two in the evening at the end of a meal). This is to prevent further flare-ups You may remain on this treatment, provided it remains effective, for a long period of time.
15.01.2013
Horschel
Horschel
2 x 27
18.01.2013
p/n CIA60342
3. How to take Dipentum Always use Dipentum exactly as your doctor has told you. Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist. Remember: Your medicine should always be taken after food Adults, children over 12 and the elderly Acute flare-ups The usual starting dose is two capsules twice a day (two in the morning, two in the evening at the end of a meal). Your doctor may increase your dose until your condition improves. You must not take more than twelve capsules a day or more than four capsules at a time If a flare-up is severe you are likely to be given additional medicines.
Date
Artwork Information
8 Pt
Linespacing
250 mg Capsules
Taking Dipentum with food and drink Always take Dipentum with a glass of water after food. Pregnancy and breast-feeding If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor before taking Dipentum. Driving and using machines If you experience dizziness and/or blurred vision whilst taking Dipentum do not drive or use machinery.
Remarks: Slash Code: R-1+6+7-D; ATTENTION: Mock-Up! No techn. approval by Rochester!
Technical Changes
Fontsize Bodytext
Artwork Studio
Dispatched to
PT Approval
03
VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
Approver
Manufacturing Site
VERSO 2/2
VERSO 1/2
Operator
8,5 Pt
vaccination (taking Dipentum may cause a greater risk of Reyes syndrome; a life threatening condition) Any other medicine, including medicines obtained without a prescription.
AW CIA70264B_MU1 PT# CIA60342
VERSO 1/2
Headache Diarrhoea. It does not usually last very long, but taking your medicine at the end of a meal helps to reduce diarrhoea. Feeling sick Rash Joint pain Uncommon (affects less than 1 in 100 people): Fever Being sick Indigestion Raised liver enzymes (tests your doctor may perform will show changed liver function) Itching and/or hives, a nettle-like rash Unusual hair loss Light sensitivity. Increased heart rate Shortness of breath Muscle pain Pins and needles Depression Dizziness The frequency of the following side effects is unknown: Altered breakdown of blood cells in the liver which could result in jaundice (yellowing of skin/eyes) Stomach pain Inflammation of heart muscle Awareness of your heartbeat Inflammation of sac around heart muscle Pain in passing urine or blood in the urine Difficulty in breathing Blurred vision Loss of touch sensation/numbness If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5.How to store Dipentum Keep out of the reach and sight of children. Do not use Dipentum after the expiry date on the carton. The expiry date refers to the last day of that month. Store in a dry place. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. 6.Further information What Dipentum contains The active substance is Olsalazine Sodium 250 mg. The other ingredients are: Capsule contents: Magnesium stearate Capsule shell: Gelatin, caramel (E150) and titanium dioxide (E171) Printing ink: Shellac, iron oxide black (E172) and propylene glycol. What Dipentum looks like Dipentum are beige colour and marked Dipentum 250 mg. Dipentum comes in plastic bottles containing 112 capsules. Marketing Authorisation Holder and Manufacturer UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK. This leaflet was last updated on January 2013. If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Limited, 208 Bath Road, Slough, Berkshire SL1 3WE, UK.
TOP
VERSO 2/2
Artwork Studiochecksandapproves technical accuracyandpre-press suitabilityof thisartworkonly. Ensuretheartworkhas been thoroughly checked fortextual accuracy and hasbeenapprovedassuch! VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
Approver
Manufacturing Site
8,5 Pt
Techn. Colours
techn. info
Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Strae 10 4 0789 Monheim, Germany
Print Colours
CIA70264B_MU1 / UK
Dipentum Cap 250
black
cut
Remarks: ATTENTION: Mock-Up! No techn. approval by Rochester! Horschel
Note:
Date
Artwork Information
8 Pt Technical Changes Fontsize Bodytext Dispatched to PT Approval
Artwork Studio
Linespacing
Operator
15.01.2013
Horschel
2 x 27
18.01.2013 Modific. Date
p/n CIA60342
Id.-No. / Countr.
Product Name
external Id.-No.
Technical information: Head-to-Toe Layout (Circular) RECTO 1/2 FRONT BACK
RECTO 2/2
p/n CIA60342
AW CIA70264B_MU1
CIA70264B_MU1_GI_ROC_Dipentum_UK.indd 2
Edition No.
18.01.13 10:38
Creation Date
Amended by
Dimensions
Operator
03
VERSO 2/2 VERSO 1/2
TOP
RECTO 2/2
Artwork Studiochecksandapproves technical accuracyandpre-press suitabilityof thisartworkonly. Ensuretheartworkhas been thoroughly checked fortextual accuracy and hasbeenapprovedassuch!
Patient Information Leaflet
Olsalazine sodium
Note:
Techn. Colours
techn. info
Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Strae 10 4 0789 Monheim, Germany
1.What Dipentum is for Dipentum belongs to a group of medicines called aminosalicylates. Dipentum works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation. Dipentum is used to treat an inflammation of your large intestine (colon) called ulcerative colitis. It is used for short-term (acute) attacks (called flare-ups), and at a lower dose to maintain the improvement (maintenance treatment) and keep away further flare-ups. If untreated, a severe attack of ulcerative colitis may cause death due to dehydration and bursting of the colon (peritonitis). 2.Before you take Dipentum Do not take if: You are allergic to olsalazine sodium or any of the other ingredients of Dipentum (see section 6) You have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirin-containing products, including those bought over the counter) You have severe kidney disease You are a child under 12. If any of the above apply to you talk to your doctor or pharmacist. Take special care Before you start taking Dipentum your doctor will do a blood test . This will be repeated every three months for the first year, every six months for the next four years and then once a year. This is to see how well your liver and kidneys are functioning. You should also check for signs of worsening of allergies such as asthma. Tell your doctor immediately if you develop unexplained bruising or bleeding accompanied with fever, dizziness, sore throat and mouth ulcers. You could have developed a blood disorder. Tell your doctor if you are taking any of the following medicines: Aspirin or any other aspirin-containing medicines or salicylates Other drugs to treat ulcerative colitis Blood thinning agents such as warfarin or heparin or heparinoids Drugs that treat irritable bowel syndrome and cancer such as thioguanine and 6 mercaptopurine If you have recently had chickenpox
CIA70264B_MU1 / UK
Dipentum Cap 250
In this leaflet: 1.What Dipentum is for 2.Before you take Dipentum 3.How to take Dipentum 4.Possible side effects 5.How to store Dipentum 6.Further information.
Print Colours
black
cut
Read all of this leaflet carefully before you start taking 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. In this leaflet, Dipentum 250mg Capsules will be called Dipentum.
Id.-No. / Countr.
Modific. Date
Product Name
external Id.-No.
If you take more Dipentum than you should Do not take more Dipentum than you should. If you have taken too much, immediately go to the nearest hospital casualty department or your doctor. Take your tablets and this leaflet with you. Signs of taking too much Dipentum include nausea, vomiting and diarrhoea. If you forget to take Dipentum If you forget a dose take the next one as usual. Do not take a double dose to make up for a missed dose. If you stop taking Dipentum Do not stop taking Dipentum without first talking to your doctor even if your symptoms have improved. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4.Possible side effects Like all medicines Dipentum can cause side effects, although not everybody gets them. Seek immediate medical help if you have any of the following symptoms (the frequency of these side effects is unknown): Swelling of face lips, tongue or throat which may cause difficulty in swallowing/breathing Blood disorders (reduced number of blood cells) where you could have the following symptoms: bruise or bleed easily, have a persistent sore throat, mouth ulcers, dizziness and feeling tired and feverish Pancreatitis where you could have the following symptoms: severe stomach pain, fever, feeling sick/being sick Liver disease where you could have the following symptoms: feeling sick/being sick, loss of appetite, feeling generally unwell, itching and the whites of the eyes may become yellow. Other possible side effects: Common (affects less than 1 in 10 people):
Technical information: Head-to-Toe Layout (Circular) RECTO 1/2 FRONT BACK
RECTO 2/2
CIA70264B_MU1_GI_ROC_Dipentum_UK.indd 1
Edition No.
18.01.13 10:38
Creation Date
Amended by
Dimensions
Operator
Maintenance treatment Once the flare-up is controlled your doctor may gradually reduce your dose to two capsules twice a day (two in the morning, two in the evening at the end of a meal). This is to prevent further flare-ups You may remain on this treatment, provided it remains effective, for a long period of time.
15.01.2013
Horschel
Horschel
2 x 27
18.01.2013
p/n CIA60342
3. How to take Dipentum Always use Dipentum exactly as your doctor has told you. Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist. Remember: Your medicine should always be taken after food Adults, children over 12 and the elderly Acute flare-ups The usual starting dose is two capsules twice a day (two in the morning, two in the evening at the end of a meal). Your doctor may increase your dose until your condition improves. You must not take more than twelve capsules a day or more than four capsules at a time If a flare-up is severe you are likely to be given additional medicines.
Date
Artwork Information
8 Pt
Linespacing
250 mg Capsules
Taking Dipentum with food and drink Always take Dipentum with a glass of water after food. Pregnancy and breast-feeding If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor before taking Dipentum. Driving and using machines If you experience dizziness and/or blurred vision whilst taking Dipentum do not drive or use machinery.
Remarks: Slash Code: R-1+6+7-D; ATTENTION: Mock-Up! No techn. approval by Rochester!
Technical Changes
Fontsize Bodytext
Artwork Studio
Dispatched to
PT Approval
03
VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
Approver
Manufacturing Site
VERSO 2/2
VERSO 1/2
Operator
8,5 Pt
vaccination (taking Dipentum may cause a greater risk of Reyes syndrome; a life threatening condition) Any other medicine, including medicines obtained without a prescription.
AW CIA70264B_MU1 PT# CIA60342
VERSO 1/2
Headache Diarrhoea. It does not usually last very long, but taking your medicine at the end of a meal helps to reduce diarrhoea. Feeling sick Rash Joint pain Uncommon (affects less than 1 in 100 people): Fever Being sick Indigestion Raised liver enzymes (tests your doctor may perform will show changed liver function) Itching and/or hives, a nettle-like rash Unusual hair loss Light sensitivity. Increased heart rate Shortness of breath Muscle pain Pins and needles Depression Dizziness The frequency of the following side effects is unknown: Altered breakdown of blood cells in the liver which could result in jaundice (yellowing of skin/eyes) Stomach pain Inflammation of heart muscle Awareness of your heartbeat Inflammation of sac around heart muscle Pain in passing urine or blood in the urine Difficulty in breathing Blurred vision Loss of touch sensation/numbness If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5.How to store Dipentum Keep out of the reach and sight of children. Do not use Dipentum after the expiry date on the carton. The expiry date refers to the last day of that month. Store in a dry place. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. 6.Further information What Dipentum contains The active substance is Olsalazine Sodium 250 mg. The other ingredients are: Capsule contents: Magnesium stearate Capsule shell: Gelatin, caramel (E150) and titanium dioxide (E171) Printing ink: Shellac, iron oxide black (E172) and propylene glycol. What Dipentum looks like Dipentum are beige colour and marked Dipentum 250 mg. Dipentum comes in plastic bottles containing 112 capsules. Marketing Authorisation Holder and Manufacturer UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK. This leaflet was last updated on January 2013. If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Limited, 208 Bath Road, Slough, Berkshire SL1 3WE, UK.
TOP
VERSO 2/2
Artwork Studiochecksandapproves technical accuracyandpre-press suitabilityof thisartworkonly. Ensuretheartworkhas been thoroughly checked fortextual accuracy and hasbeenapprovedassuch! VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
Approver
Manufacturing Site
8,5 Pt
Techn. Colours
techn. info
Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Strae 10 4 0789 Monheim, Germany
Print Colours
CIA70264B_MU1 / UK
Dipentum Cap 250
black
cut
Remarks: ATTENTION: Mock-Up! No techn. approval by Rochester! Horschel
Note:
Date
Artwork Information
8 Pt Technical Changes Fontsize Bodytext Dispatched to PT Approval
Artwork Studio
Linespacing
Operator
15.01.2013
Horschel
2 x 27
18.01.2013 Modific. Date
p/n CIA60342
Id.-No. / Countr.
Product Name
external Id.-No.
Technical information: Head-to-Toe Layout (Circular) RECTO 1/2 FRONT BACK
RECTO 2/2
p/n CIA60342
AW CIA70264B_MU1
CIA70264B_MU1_GI_ROC_Dipentum_UK.indd 2
Edition No.
18.01.13 10:38
Creation Date
Amended by
Dimensions
Operator
03
VERSO 2/2 VERSO 1/2
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.
