Olsalazine Sodium 500mg Tablets
Dipentum® 500mg Tablets
(olsalazine sodium)
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.
Your medicine is known by the above name but will be referred to as Dipentum throughout this:
Patient Information Leaflet
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
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 vaccination (taking Dipentum may cause a greater risk of Reye's syndrome; a life threatening condition)
• Any other medicine, including medicines obtained without a prescription.
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.
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 tablets a day (one in the morning, one 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 six tablets a day or more than two tablets at a time.
• If a "flare-up" is severe you are likely to be given additional medicines.
Maintenance treatment
• Once the "flare-up" is controlled your doctor may gradually reduce your dose to one tablet twice a day (one in the morning, one 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.
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.
POM
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.
Information about the ingredients
This medicine contains small amounts of ethanol (alcohol), less than 100mg per tablet. 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):
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5) How to store Dipentum
• Keep out of the sight and reach of children.
• Do not use Dipentum after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in a dry place.
• Medicine 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. Each tablet contains 500mg olsalazine sodium.
The other ingredients are magnesium stearate, colloidal anhydrous silica, polyvidone K30 and crospovidone.
What Dipentum looks like and the contents of the pack
Dipentum are yellow capsule-shaped tablets marked with D500 on one side and a scored on the other side.
Dipentum comes in plastic bottles containing 60 tablets.
PL 10383/2171
Who makes and repackages your medicine?
Your medicine is manufactured by UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK, Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 21.04.2016
Dipentum® is a registered trademark of UCB Pharma Limited, UK.
Olsalazine sodium 500mg Tablets
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.
Your medicine is known by the above name but will be referred to as Olsalazine sodium Tablets throughout this:
Patient Information Leaflet
In this leaflet:
1) What Olsalazine sodium Tablet are for
2) Before you take Olsalazine sodium Tablets
3) How to take Olsalazine sodium Tablets
4) Possible side effects
5) How to store Olsalazine sodium Tablets
6) Further information
1) What Olsalazine sodium Tablets are for
Olsalazine sodium Tablets belongs to a group of medicines called aminosalicylates.
Olsalazine sodium Tablets works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation.
Olsalazine sodium Tablets 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 Olsalazine sodium Tablets Do not take if:
• You are allergic to olsalazine sodium or any of the other ingredients of Olsalazine sodium Tablets (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 Olsalazine sodium Tablets 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 vaccination (taking Olsalazine sodium Tablets may cause a greater risk of Reye's syndrome; a life threatening condition)
• Any other medicine, including medicines obtained without a prescription.
Taking Olsalazine sodium Tablets with food and drink
Always take Olsalazine Sodium Tablets 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 Olsalazine sodium Tablets.
Driving and using machines
If you experience dizziness and/or blurred vision whilst taking Olsalazine sodium Tablets do not drive or use machinery.
3) How to take Olsalazine sodium Tablets
Always use Olsalazine sodium Tablets 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 tablets a day (one in the morning, one 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 six tablets a day or more than two tablets at a time.
• If a "flare-up" is severe you are likely to be given additional medicines.
Maintenance treatment
• Once the "flare-up" is controlled your doctor may gradually reduce your dose to one tablet twice a day (one in the morning, one 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.
If you take more Olsalazine sodium Tablets than you should
Do not take more Olsalazine sodium Tablets 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 Olsalazine sodium Tablets include nausea, vomiting and diarrhoea.
POM
If you forget to take Olsalazine sodium Tablets
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 Olsalazine sodium Tablets
Do not stop taking Olsalazine sodium Tablets without first talking to your doctor even if your symptoms have improved.
Information about the ingredients
This medicine contains small amounts of ethanol (alcohol), less than 100mg per tablet. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4) Possible side effects
Like all medicines Olsalazine sodium Tablets 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 swal lowi ng/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):
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5) How to store Olsalazine sodium Tablets
• Keep out of the sight and reach of children.
• Do not use Olsalazine sodium Tablets after the expiry date stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in a dry place.
• Medicine should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6) Further information
What Olsalazine sodium Tablets contain
The active substance is olsalazine sodium. Each tablet contains 500mg olsalazine sodium.
The other ingredients are magnesium stearate, colloidal anhydrous silica, polyvidone K30 and crospovidone.
What Olsalazine sodium Tablets look like and the contents of the pack
Olsalazine sodium Tablets are yellow capsule-shaped marked with D500 on one side and a scored on the other side.
Olsalazine sodium Tablets come in plastic bottles containing 60 tablets.
PL 10383/2171
Who makes and repackages your medicine?
Your medicine is manufactured by UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK, Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.