Document: leaflet MAH BRAND_PLPI 18799-2644 change

• leaflet MAH BRAND_PLPI 18799-2644
• leaflet MAH BRAND_PLPI 18799-2645

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Patient Information Leaflet

Dipentum® 250mg capsules

(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.

The name of your medicine is Dipentum 250mg capsules but will be referred to as Dipentum throughout this 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 breast-feeding, 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 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.

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.

If you take more Dipentum than you should

Do not take more Dipentum than you should. If you have taken too many, immediately go to the nearest hospital casualty department or your doctor. Take your capsules and this leaflet with you. Signs of taking too many 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):

•    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

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 after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the container tightly closed to protect from moisture.

If your capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Dipentum contains

The active ingredient in Dipentum is olsalazine sodium.

Each capsule contains 250mg olsalazine sodium.

The other ingredients are:

Capsule contents: Magnesium stearate (E572). Capsule shell: gelatin, titanium dioxide (E171) and caramel (E150).

Printing ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520) and potassium hydroxide.

What Dipentum looks like and contents of the pack

Dipentum are beige coloured capsules marked with 'Dipentum 250mg' in black ink.

Dipentum comes in plastic bottles containing 112 capsules.

Manufactured by: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Dipentum® 250mg capsules

Leaflet date: 05.10.2015

Olsalazine sodium 250mg capsules

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.

The name of your medicine is Olsalazine sodium 250mg capsules but will be referred to as Olsalazine sodium throughout this leaflet.

In this leaflet:

1.    What Olsalazine sodium is for

2.    Before you take Olsalazine sodium

3.    How to take Olsalazine sodium

4.    Possible side effects

5.    How to store Olsalazine sodium

6.    Further information.

1.    What Olsalazine sodium is for

Olsalazine sodium belongs to a group of medicines called aminosalicylates.

Olsalazine sodium works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation.

Olsalazine sodium 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 Do not take if:

•    You are allergic to olsalazine sodium or any of the other ingredients of Olsalazine sodium (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 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 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 with food and drink

Always take Olsalazine sodium with a glass of water after food.

Pregnancy and breast-feeding

If you are pregnant, or trying to become pregnant or breast-feeding, talk to your doctor before taking Olsalazine sodium.

Driving and using machines

If you experience dizziness and/or blurred vision whilst taking Olsalazine sodium do not drive or use machinery.

3. How to take Olsalazine sodium

Always use Olsalazine sodium 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.

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.

If you take more Olsalazine sodium than you should

Do not take more Olsalazine sodium than you should. If you have taken too many, immediately go to the nearest hospital casualty department or your doctor. Take your capsules and this leaflet with you. Signs of taking too many Olsalazine sodium include nausea, vomiting and diarrhoea.

If you forget to take Olsalazine sodium

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

Do not stop taking Olsalazine sodium 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 Olsalazine sodium 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

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

Keep out of the sight and reach of children.

Do not use after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the container tightly closed to protect from moisture.

If your capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Olsalazine sodium contains

The active ingredient in Olsalazine sodium is olsalazine sodium.

Each capsule contains 250mg olsalazine sodium.

The other ingredients are:

Capsule contents: Magnesium stearate (E572). Capsule shell: gelatin, titanium dioxide (E171) and caramel (E150).

Printing ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520) and potassium hydroxide.

What Olsalazine sodium looks like and contents of the pack

Olsalazine sodium are beige coloured capsules marked with 'Olsalazine sodium 250mg' in black ink.

Olsalazine sodium comes in plastic bottles containing 112 capsules.

Manufactured by: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Olsalazine sodium 250mg capsules

Leaflet date: 05.10.2015

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 heart beat

•    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