Colazide 750mg Capsules

Document: leaflet MAH BRAND_PLPI 18799-1294 change

Package Leaflet: Information for the user Colazide 750mg capsules

(balsalzide disodium)

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 or pharmacist.

- 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 or pharmacist. This includes any possible side effects not listed in this leaflet. 'See section 4.'

- The name of your medicine is Colazide 750mg capsules but will be referred as Colazide throughout this leaflet.

What is in this leaflet

1. What Colazide is and what it is used for

2. What you need to know before you take Colazide

3. How to take Colazide

4. Possible side effects

5. How to store Colazide

6. Contents of the pack and other information

1. What Colazide is and what it is used for

Colazide is used for the treatment of ulcerative colitis (ulceration of the large intestine). It may also be used to keep the disease under control by preventing further episodes. It works as an anti-inflammatory agent.

This medicine contains balsalazide disodium as the active ingredient.

2. What you need to know before you take Colazide Do not take Colazide:

- if you are allergic to balsalazide or any of the other ingredients of this medicine (listed in section 6)

- if you are allergic (hypersensitive) to mesalazine, aspirin or other salicylates

- if you have a severe liver disease

- if you have a moderate to severe kidney disease

- if you are pregnant or breast feeding Colazide is not recommended for use in children.

Warnings and precautions

- asthma

- any blood disorders

- a mild kidney disorder

- a confirmed liver disease

- an active ulcer

If any of these apply to you, talk to your doctor or pharmacist before taking Colazide.

Tests on your liver, kidney and blood

Before you start treatment with Colazide you will have a blood and urine test to check how well your kidneys are working and what your blood is doing.

During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine samples periodically during your treatment.

Children

Colazide is not recommended in children.

Other medicines and Colazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular digoxin (used to treat heart problems), methotrexate (used as treatment for some autoimmune diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus, some inflammatory bowel diseases (Chron's disease) and some types of cancer, among other diseases), azathioprine (used to prevent rejection following organ transplantation, and to treat rheumatoid arthritis, some inflammatory bowel diseases (Chron's disease and ulcerative colitis) and multiple sclerosis among other diseases) and 6-mercaptopurine

(used to treat leukaemia and inflammatory bowel diseases such as Chron's disease and ulcerative colitis).

Colazide with food

Colazide should be taken preferably with or after food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Colazide during pregnancy or while breast-feeding.

Driving and using machines

There is no evidence of any effect of Colazide on your ability to drive or use machines.

3. How to take Colazide

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and elderly patients:

Treatment of ulcerative colitis:

The recommended dose is 3 capsules three times daily to be taken with or after food. Swallow the capsules whole, with a glass of water if necessary. Treatment may be given for a maximum of 12 weeks. Your doctor may also give you steroids at the same time as Colazide.

Maintenance treatment to prevent further episodes:

The starting dose is 2 capsules twice daily (3g daily) to be taken with or after food. Swallow the capsules whole, with a glass of water if necessary. Your doctor may adjust your treatment based on your response to the medicine.

There may be an additional benefit with a dose up to 6g daily. Whilst taking this medicine ensure you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidneys.

During your treatment with Colazide your doctor will carry out blood and urine tests.

Children:

Colazide is not recommended for use in children.

If you take more Colazide than you should

If you think you have taken too many capsules contact your doctor or pharmacist. Take any remaining capsules and the packaging with you.

PL 18799/1294 POM

If you forget to take Colazide

If you forget to take a dose at the right time, take it as soon as possible after food.

If you miss a dose completely, do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediate medical attention must be sought if you experience:

• a severe allergic reaction including swelling of the face, tongue, throat and lips

• unusual bleeding, bruising, rash, fever, sore throat or excessive tiredness.

A blood count will be performed and the drug stopped immediately if there is suspicion of a blood disorder.

Other side effects that may occur with Colazide are:

• rash,

• diarrhoea, stomach pain, nausea,vomiting, headache,

• gallstones,worsening of ulcerative colitis,

• problems with the blood,

• difficulty breathing, cough, fever,

• abnormal sensation or function (such a weakness or numbness), joint pains, muscle ache,

• hair loss,

• hypersensitivity.

Problems with the kidneys including renal malfunction have been reported. Symptoms may include:

• blood or any other changes in your urine,

• rash, fever,

• loin or joint pain,

• fluid retention,

• decreased urine.

Inflammation of the heart, liver and pancreas have been reported. Symptoms of these are:

• Inflammation of the heart: chest pain, palpitations, breathlessness and fatigue.

• Inflammation of the liver: flu like symptoms,jaundice (yellowing of the skin and whites of the eyes) and abdominal pain.

• Inflammation of the pancreas: abdominal pain, nausea and vomiting.

Systemic lupus erythematosus (SLE) like syndrome

has been reported. Symptoms are:

• inflammation of the joints, connective tissue, tendons and organs such as the heart, lungs, kidneys or skin.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Colazide

Do not use after the expiry (Exp) date shown on the carton and bottle. The date refers to the last day of that month

Keep out of the sight and reach of children.

Remember to return any unused medicine to 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.

If your medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.

6. Contents of the pack and other information What Colazide contains

Each capsule contains 750mg of balsalazide disodium corresponding to 612.8mg of balsalazide and 262.5mg of mesalazine.

Also contains magnesium stearate, colloidal anhydrous silica, gelatin, shellac, titanium dioxide (E171) black iron oxide (E172) and indigo carmine (E132).

What Colazide looks like and contents of the pack

Colazide are hard gelatin capsules with a white body and blue which come in packs of 112 capsules.

Colazide is converted in the large intestine to mesalazine, which lessens and prevents inflammation, soreness and ulcers of the lower bowel that occur in ulcerative colitis.

Manufactured by: A Menarini industrie Sud s.r.l., Via campo di pile, 67100 I'Aquila, italy.

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

Colazide 750mg capsules;

Leaflet date: 16.10.2015

Colazide is a Registered Trademark Of Shire Pharmaceuticals Group Plc

Package Leaflet: Information for the user Balsalazide 750mg capsules

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 or pharmacist.

- 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 or pharmacist. This includes any possible side effects not listed in this leaflet. 'See section 4.'

- The name of your medicine is Balsalazide 750mg capsules but will be referred as Balsalazide throughout this leaflet.

What is in this leaflet

1. What Balsalazide is and what it is used for

2. What you need to know before you take Balsalazide

3. How to take Balsalazide

4. Possible side effects

5. How to store Balsalazide

6. Contents of the pack and other information

1. What Balsalazide is and what it is used for

Balsalazide is used for the treatment of ulcerative colitis (ulceration of the large intestine). It may also be used to keep the disease under control by preventing further episodes. It works as an anti-inflammatory agent.

This medicine contains balsalazide disodium as the active ingredient.

2. What you need to know before you take Balsalazide

Do not take Balsalazide:

- if you are allergic to balsalazide or any of the other ingredients of this medicine (listed in section 6)

- if you are allergic (hypersensitive) to mesalazine, aspirin or other salicylates

- if you have a severe liver disease

- if you have a moderate to severe kidney disease

- if you are pregnant or breast feeding Balsalazide is not recommended for use in children.

Warnings and precautions

- asthma

- any blood disorders

- a mild kidney disorder

- a confirmed liver disease

- an active ulcer

If any of these apply to you, talk to your doctor or pharmacist before taking Balsalazide.

Tests on your liver, kidney and blood

Before you start treatment with Balsalazide you will have a blood and urine test to check how well your kidneys are working and what your blood is doing.

During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine samples periodically during your treatment.

Children

Balsalazide is not recommended in children.

Other medicines and Balsalazide

Balsalazide with food

Balsalazide should be taken preferably with or after food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Balsalazide during pregnancy or while breast-feeding.

Driving and using machines

There is no evidence of any effect of Balsalazide on your ability to drive or use machines.

3. How to take Balsalazide

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and elderly patients:

Treatment of ulcerative colitis:

Maintenance treatment to prevent further episodes:

During your treatment with Balsalazide your doctor will carry out blood and urine tests.

Children:

Balsalazide is not recommended for use in children.

If you take more Balsalazide than you should

If you think you have taken too many capsules contact your doctor or pharmacist. Take any remaining capsules and the packaging with you.

If you forget to take Balsalazide

If you forget to take a dose at the right time, take it as soon as possible after food.

If you miss a dose completely, do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediate medical attention must be sought if you experience:

• a severe allergic reaction including swelling of the face, tongue, throat and lips

• unusual bleeding, bruising, rash, fever, sore throat or excessive tiredness.

A blood count will be performed and the drug stopped immediately if there is suspicion of a blood disorder.

Other side effects that may occur with Balsalazide are:

• rash,

• diarrhoea, stomach pain, nausea,vomiting, headache,

• gallstones,worsening of ulcerative colitis,

• problems with the blood,

• difficulty breathing, cough, fever,

• abnormal sensation or function (such a weakness or numbness), joint pains, muscle ache,

• hair loss,

• hypersensitivity.

Problems with the kidneys including renal malfunction have been reported. Symptoms may include:

• blood or any other changes in your urine,

• rash, fever,

• loin or joint pain,

• fluid retention,

• decreased urine.

Inflammation of the heart, liver and pancreas have been reported. Symptoms of these are:

• Inflammation of the heart: chest pain, palpitations, breathlessness and fatigue.

• Inflammation of the liver: flu like symptoms,jaundice (yellowing of the skin and whites of the eyes) and abdominal pain.

• Inflammation of the pancreas: abdominal pain, nausea and vomiting.

Systemic lupus erythematosus (SLE) like syndrome

has been reported. Symptoms are:

• inflammation of the joints, connective tissue, tendons and organs such as the heart, lungs, kidneys or skin.

Reporting of side effects

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Balsalazide

Do not use after the expiry (Exp) date shown on the carton and bottle. The date refers to the last day of that month

Keep out of the sight and reach of children.

Remember to return any unused medicine to 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.

If your medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.

6. Contents of the pack and other information What Balsalazide contains

Each capsule contains 750mg of balsalazide disodium corresponding to 612.8mg of balsalazide and 262.5mg of mesalazine.

Also contains magnesium stearate, colloidal anhydrous silica, gelatin, shellac, titanium dioxide (E171) black iron oxide (E172) and indigo carmine (E132).

What Balsalazide looks like and contents of the pack

Balsalazide are hard gelatin capsules with a white body and blue which come in packs of 112 capsules. Balsalazide is converted in the large intestine to mesalazine, which lessens and prevents inflammation, soreness and ulcers of the lower bowel that occur in ulcerative colitis.

Manufactured by: A Menarini industrie Sud s.r.l., Via campo di pile, 67100 I'Aquila, italy.

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

Balsalazide 750mg capsules;

Leaflet date: 16.10.2015

PL 18799/1294 POM