PATIENT INFORMATION LEAFLET

Prednisolone 20 mg/100 ml Rectal Solution (prednisolone sodium metasulphobenzoate)

Please read this leaflet carefully. It gives you a summary of the information about your medicine. If there is anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.

What is in Prednisolone 20 mg/100 ml Rectal Solution?

Prednisolone Rectal Solution is a single dose retention enema for application into the rectum. Each single dose, disposable enema contains a rectal solution of 20mg prednisolone, as prednisolone sodium metasulphobenzoate, in 100ml.

Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.

As well as the active ingredient, your medicine also contains disodium edetate, parahydroxyben­zoates (E214, E216, E218), and purified water.

Prednisolone Rectal Solution is supplied as a plastic bag containing the enema solution with an applicator nozzle and cap or alternatively with an extension tube attached to the nozzle (long-tube version) to enable easier self-administration.

The standard version is available in packs of 10 and the long tube version is available in packs of 7.

The Marketing Authorisation holder is

Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham

Business Village, Crabtree Road, Egham, Surrey TW20 8RB.

and the manufacturer is Forest Laboratories UK Ltd.,Bexley DA5 1NX.

What is Prednisolone Rectal Solution used for?

It is used to treat ulcerative colitis (inflammation of the bowels).

If you are not sure why you have been given this medicine ask your doctor or pharmacist (chemist).

Before Administering Prednisolone Rectal Solution

This medicine is suitable for adults and children over 12 years of age.

Do not administer to younger children. Do not use but tell your doctor if you are pregnant or breast feeding or suffering from peritonitis (inflammation of the walls of the abdominal cavity), anal sinus infection, fistulae (an unnatural connection between the bowel and other body organ or to outside the body), intestinal obstruction or perforation of the bowel.

Talk to your doctor before taking Prednisolone Rectal Solution, if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.

Parahydroxyben­zoates may cause allergic type reactions in sensitive patients. If this applies to you contact your doctor before using this medicine.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Prednisolone 20 mg/100 ml Rectal Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)

Side effects where the frequency is not known:

Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

Slow heart rate.

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:

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

How to administer Prednisolone Rectal Solution

This medicine is for rectal use only. The normal dose is one enema nightly for two to four weeks.

It may be administered at room temperature, or warmed in warm water before use. Holding the bag with the tube upwards, squeeze base of tube where it joins the bag. Remove cap and lubricate the nozzle. Lie in bed on your side with knees drawn up. Insert into rectum as far as the flange on the nozzle. Squeeze container gently until empty and discard bottle hygienically. Lie face downwards for a few minutes in order to retain thefluid before going to sleep in your usual position.

What if I miss a dose?

Do not worry if you miss your dose of Prednisolone Rectal Solution, if possible administer it as soon as you remember. Use your next dose at the usual time. Only use one dose per day.

After using your medicine

There are not normally problems after using this medicine but if any unwanted effects are noticed tell your doctor or pharmacist.

Storing your medicine

This medicine should be stored below 25°C and protected from light.

Do not use after the expiry date.

Date of last review of leaflet

PATIENT INFORMATION LEAFLET

Prednisolone 20 mg/100 ml Rectal Solution (prednisolone sodium metasulphobenzoate)

Please read this leaflet carefully. It gives you a summary of the information about your medicine. If there is anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.

What is in Prednisolone 20 mg/100 ml Rectal Solution?

Prednisolone Rectal Solution is a single dose retention enema for application into the rectum. Each enema bottle contains a rectal solution of 20mg prednisolone, as prednisolone sodium metasulphobenzoate, in 100ml.

Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.

As well as the active ingredient, your medicine also contains disodium edetate, parahydroxyben­zoates (E214, E216, E218), and purified water. Prednisolone Rectal Solution is supplied in a disposable plastic bottle. This ‘long tube’ version is supplied with a separate applicator which is screwed onto the bottle before use. This version may enable easier self-administration.

Long tube Prednisolone 20 mg/100 ml Rectal Solution is available in packs of 7 bottles with 7 screw-on applicators.

The Marketing Authorisation holder is

Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham

Business Village, Crabtree Road, Egham, Surrey TW20 8RB.

and the manufacturer is Forest Laboratories UK Ltd.,Bexley DA5 1NX.

What is Prednisolone Rectal Solution used for?

Prednisolone Rectal Solution is used to treat ulcerative colitis (inflammation of the bowels).

If you are not sure why you have been given this medicine ask your doctor or pharmacist (chemist).

Before Administering Prednisolone Rectal Solution

This medicine is suitable for adults and children over 12 years of age.

Do not administer to younger children. Do not use but tell your doctor if you are pregnant or breast feeding or suffering from peritonitis (inflammation of the walls of the abdominal cavity), anal sinus infection, fistulae (an unnatural connection between the bowel and other body organ or to outside the body), intestinal obstruction or perforation of the bowel.

Talk to your doctor before taking Prednisolone Rectal Solution, if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.

Parahydroxyben­zoates may cause allergic type reactions in sensitive patients. If this applies to you contact your doctor before using this medicine.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Prednisolone 20 mg/100 ml Rectal Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)

Side effects where the frequency is not known:

Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

Slow heart rate.

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:

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

How to administer Prednisolone Rectal Solution

This medicine is for rectal use only. The normal dose is one enema nightly for two to four weeks.

It may be administered at room temperature, or warmed in warm water before use. Holding the bottle upright, remove the cap and screw on the applicator nozzle firmly. Lubricate the nozzle. Lie in bed on your side with knees drawn up. Insert nozzle into rectum and squeeze the bottle gently until empty. Discard bottle hygienically. Lie face downwards for a few minutes in order to retain the fluid before going to sleep in your usual position.

What if I miss a dose?

Do not worry if you miss your dose of Prednisolone Rectal Solution, if possible administer it as soon as you remember. Use your next dose at the usual time. Only use one dose per day.

After using your medicine

There are not normally problems after using this medicine but if any unwanted effects are noticed tell your doctor or pharmacist.

Storing your medicine

Do not store above 25°C. In order to protect from light store the bottles in the carton. Do not use after the expiry date printed on the bottle and carton.

Date of last review of leaflet

March 2021

PATIENT INFORMATION LEAFLET

Prednisolone 20 mg/100 ml Rectal Solution (prednisolone sodium metasulphobenzoate)

Please read this leaflet carefully. It gives you a summary of the information about your medicine. If there is anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.

What is in Prednisolone 20 mg/100 ml Rectal Solution?

Prednisolone Rectal Solution is a single dose retention enema for application into the rectum. Each enema bottle contains a rectal solution of 20mg prednisolone, as prednisolone sodium metasulphobenzoate, in 100ml.

Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.

As well as the active ingredient, your medicine also contains disodium edetate, parahydroxyben­zoates (E214, E216, E218), and purified water. Prednisolone Rectal Solution is supplied in a disposable plastic bottle. This ‘long tube’ version is supplied with a separate applicator which is screwed onto the bottle before use. This version may enable easier self-administration.

Long tube Prednisolone 20 mg/100 ml Rectal Solution is available in packs of 7 bottles with 7 screw-on applicators.

The Marketing Authorisation holder is

Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham

Business Village, Crabtree Road, Egham, Surrey TW20 8RB.

and the manufacturer is Forest Laboratories UK Ltd.,Bexley DA5 1NX.

What is Prednisolone Rectal Solution used for?

Prednisolone Rectal Solution is used to treat ulcerative colitis (inflammation of the bowels).

If you are not sure why you have been given this medicine ask your doctor or pharmacist (chemist).

Before Administering Prednisolone Rectal Solution

This medicine is suitable for adults and children over 12 years of age.

Do not administer to younger children. Do not use but tell your doctor if you are pregnant or breast feeding or suffering from peritonitis (inflammation of the walls of the abdominal cavity), anal sinus infection, fistulae (an unnatural connection between the bowel and other body organ or to outside the body), intestinal obstruction or perforation of the bowel.

Talk to your doctor before taking Prednisolone Rectal Solution, if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.

Parahydroxyben­zoates may cause allergic type reactions in sensitive patients. If this applies to you contact your doctor before using this medicine.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Prednisolone 20 mg/100 ml Rectal Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)

Side effects where the frequency is not known:

Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

Slow heart rate.

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:

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

How to administer Prednisolone Rectal Solution

This medicine is for rectal use only. The normal dose is one enema nightly for two to four weeks.

It may be administered at room temperature, or warmed in warm water before use. Holding the bottle upright, remove the cap and screw on the applicator nozzle firmly. Lubricate the nozzle. Lie in bed on your side with knees drawn up. Insert nozzle into rectum and squeeze the bottle gently until empty. Discard bottle hygienically. Lie face downwards for a few minutes in order to retain the fluid before going to sleep in your usual position.

What if I miss a dose?

Do not worry if you miss your dose of Prednisolone Rectal Solution, if possible administer it as soon as you remember. Use your next dose at the usual time. Only use one dose per day.

After using your medicine

There are not normally problems after using this medicine but if any unwanted effects are noticed tell your doctor or pharmacist.

Storing your medicine

Do not store above 25°C. In order to protect from light store the bottles in the carton. Do not use after the expiry date printed on the bottle and carton.

Date of last review of leaflet

March 2021

102B/LBG/6–102B/LBT7/6

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