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PREDNISOLONE 20 MG / DOSE RECTAL FOAM - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - PREDNISOLONE 20 MG / DOSE RECTAL FOAM

1. what prednisolone is and what it is used for

Prednisolone is a foam enema which is inserted into the rectum. Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.

This medicine is used to treat ulcerative colitis (inflammation of the bowels) and may be used

to treat proctitis (inflammation of the rectum).

2. what you need to know before you use prednisolone

Do not use Prednisolone:

  • If you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer from peritonitis (inflammation of the peritoneum -(abdominal lining)).
  • If you suffer from bowel problems such as obstruction, perforation or rectal/colonic fistulae (abnormal connection between internal organs) or if you have a possible infection.

If you think this may apply to you speak to your doctor.

Warnings and precautions

Talk to your doctor before using Prednisolone:

  • 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.
  • If you suffer from severe ulcerative colitis this medicine may not be suitable for you and you should talk to your doctor before using it.
  • The use of Prednisolone 20 mg/dose Rectal Foam may make diagnosing an infection more difficult, but your doctor should be aware of this.

This medicine is for application in the rectum only.

It is not advisable to use Prednisolone 20 mg/dose Rectal Foam for a long period of time, but your doctor will be aware of this.

Children and adolescents

This medicine is not recommended for use in children (i.e. those under 18 years old).

Other medicines and Prednisolone

You can use Prednisolone 20 mg/dose Rectal Foam whilst taking other medicines.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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

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.

Prednisolone contains cetostearyl alcohol and sorbic acid

This may cause local skin reactions (e.g. contact dermatitis).

3. how to use prednisolone

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

The recommended dose is:

One metered-dose of Prednisolone 20 mg/dose Rectal Foam should be inserted rectally, using one of the applicator nozzles provided, once or twice daily for 2 weeks. Your doctor may decide to extend the treatment for a further 2 weeks.

Administration

This medicine has been designed for your maximum comfort and ease of use. Read these instructions carefully before using Prednisolone for the first time.

If you find it difficult to use Prednisolone in a standing position an alternative is to administer while lying on your side with both legs bent up.

1.Shake well before use.

  • 2.When using for the first time remove and discard the small plastic safety tag from under the button.

  • 3.Carefully push an applicator nozzle onto the side arm of the canister. Line up semi-circular cut-out on cap with nozzle.

  • 4.The easiest way to use Prednisolone is to stand with one foot raised on a chair and gently insert the nozzle tip into your rectum. It may help if you smear the nozzle with lubricating jelly before insertion.


    canislet nozzle applicatoi nozzle


foam canister

safety tag

semi-circular cut-out dose button

5.Important: Holding the canister with the dose button pointing down, press the button on the canister firmly and release. Only press the button once otherwise you will exceed the recommended dose. Note: the canister will only work when held with the dose button pointing down. Foam is expelled when the button is released.

Dispose of the used nozzle in the plastic bag provided – the nozzles will not flush down toilets.

Disposal

The used nozzles should be disposed of in the plastic bag provided.

If you forget to use Prednisolone 20 mg/dose Rectal Foam Do not worry if you miss a dose of Prednisolone. Administer it as soon as you remember and then use your next dose at the usual time. Do not use more than 2 doses in one day.

If you use more Prednisolone than you should

Overdosage by this route is unlikely, but if someone else takes your medicine or it is used incorrectly take the canister to your doctor and ask for advice.

If you have any further questions on the use of this medicine, ask your doctor.

4. possible side effects

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

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 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store prednisolone

  • Keep out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton and canister. The expiry date refers to the last day of that month.
  • Pressurised container containing a flammable propellant.
  • Do not store above 25°C. Do not refrigerate.
  • Protect from sunlight and do not expose to temperatures above 50"C. Do not pierce or burn even after use. Do not spray on naked flame or any incandescent material.
  • Discard after 14 doses have been used.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

If your medicine becomes discoloured or shows signs of deterioration seek the advice of your pharmacist who will tell you what to do.

6. contents of the pack and other information

What Prednisolone contains

  • Each dose contains 20mg of prednisolone (as prednisolone metasulphobenzoate sodium).
  • Also includes cetomacrogol emulsifying wax, cetostearyl alcohol, oleyl alcohol, light liquid paraffin, phenoxyethanol, sorbic acid, polysorbate 20, disodium edetate, sodium hydroxide and purified wate. The propellant in Prednisolone contains butane 48.

What Prednisolone looks like and contents of the pack

Aluminium aerosol with a metering valve containing a white to pale cream coloured foam. Pack containing 1 aerosol, 14 disposable applicators and14 disposable plastic bags.

Manufactured by Pharmaserve (North West) Limited, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU, UK. Procured from within the EU and repackaged by Product Licence Holder Ennogen Healthcare Ltd, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS

PLGB 40739/0129 POM

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 01322 629220 to obtain the leaflet in a format suitable for you.

Leaflet date: 21 September 2021

Ref: PredF/UT1


Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Prednisolone rectal foam used for?

Prednisolone rectal foam is primarily used to reduce inflammation and treat certain conditions affecting the rectum and intestines, such as ulcerative colitis and proctitis.

How do I use Prednisolone rectal foam correctly?

To use Prednisolone rectal foam, shake the canister, then apply the recommended dose into the rectum using the attached applicator. Follow your doctor’s specific instructions for proper use.

Can I store Prednisolone rectal foam in the fridge?

No, it’s best to store Prednisolone rectal foam at room temperature away from direct sunlight and heat. Refrigeration may affect its effectiveness.

What should I do if I miss a dose of Prednisolone rectal foam?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

What are common side effects of using Prednisolone rectal foam?

Common side effects may include burning or itching in the rectal area, headache, or gastrointestinal discomfort. If you experience severe side effects like bleeding or severe abdominal pain, contact your doctor immediately.

Is Prednisolone rectal foam safe during pregnancy?

Consult your doctor before using Prednisolone rectal foam if you are pregnant or planning to become pregnant. They will help determine if the benefits outweigh any potential risks.

Can children use Prednisolone rectal foam?

Prednisolone rectal foam may be prescribed for children, but dosage and safety should be discussed with a pediatrician to ensure it is appropriate for their age and condition.

How long does it take for Prednisolone rectal foam to work?

Many patients start noticing improvements within a few days of starting treatment; however, full benefits may take longer, depending on individual response to therapy.

Are there any interactions with other medications when taking Prednisolone?

Yes, Prednisolone can interact with certain medications, including blood thinners and other corticosteroids. Always inform your doctor about all medications and supplements you are taking.

What should I avoid while using Prednisolone rectal foam?

Avoid using other topical treatments in the same area unless instructed by your doctor. Additionally, avoid alcohol as it can increase side effects.

Can I stop using Prednisolone suddenly?

Do not stop using Prednisolone abruptly without consulting your doctor, as this can lead to withdrawal symptoms or worsening of your condition.

Is it safe to use Prednisolone long term?

Long-term use of Prednisolone should be monitored by a healthcare provider due to potential side effects like increased risk of infections and hormonal imbalances.

Will using Prednisolone affect my ability to drive?

Generally, Prednisolone doesn’t directly affect driving ability; however, if you experience side effects like dizziness or blurred vision, avoid driving until these symptoms resolve.

Can I use over-the-counter products while on Prednisolone rectal foam?

Before using any over-the-counter products or supplements while using Prednisolone, consult your healthcare provider to ensure they do not interfere with your treatment.

What happens if I accidentally ingest Prednisolone rectal foam?

If accidentally ingested, seek immediate medical attention or contact poison control. Do not induce vomiting unless directed by a professional.

What lifestyle changes can help enhance the effectiveness of Prednisolone treatment?

Maintaining a healthy diet rich in anti-inflammatory foods, regular exercise, and managing stress can support your treatment with Prednisolone and improve overall health.

How do I know if my condition is improving while on this medication?

Improvement signs may include reduced pain or discomfort in the affected area, fewer flare-ups of symptoms, and overall better bowel function. Discuss progress with your doctor regularly.

Is there an alternative to Rectal Foam for treating my condition?

Yes, there are alternative treatments such as oral medications or enemas that may be recommended based on your specific condition. Consult your physician for options suitable for you.

Are there special dietary considerations while taking this medication?

While taking Prednisolone rectal foam, maintaining a balanced diet with limited salt intake can help manage potential side effects like fluid retention. Discuss any specific dietary needs with your doctor.