COLIFOAM 10% W/W RECTAL FOAM - patient leaflet, side effects, dosage

Colifoam 10% w/w Rectal Foam

(Hydrocortisone acetate)

Read all of this leaflet carefully before you start using 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 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,
• Throughout this leaflet Colifoam 10% w/w Rectal Foam is called Colifoam.

Important:

• Colifoam is a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to take it regularly to get the maximum benefit
• Don’t stop using this medicine without talking to your doctor – you may need to reduce the dose gradually
• Colifoam can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep using your medicine, but see your doctor straight away
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information)
• If you use it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.
• Keep away from people who have chickenpox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important for you.

In this leaflet:

• 1. What Colifoam is and what is it used for

• 2. What you need to know before you use Colifoam

• 3. How to use Colifoam

• 4. Possible side effects

• 5. How to store Colifoam

• 6. Contents of the pack and other information

1. what colifoam is and what it is used forcolifoam - benefit informationcolifoam belongs to a group of medicines called steroids. their full name is corticosteroids. these corticosteroids occur naturally in the body, and help to maintain health and well-being. boosting your body with extra corticosteroid (such as colifoam) is an effective way to treat various illnesses involving inflammation in the body. colifoam reduces this inflammation, which could otherwise go on making your condition worse. you must take this medicine regularly to get maximum benefit from it.

Colifoam is used to treat inflammation of the colon and rectum.

2. what you need to know before you use colifoam

Do not use Colifoam:

• If you are allergic to hydrocortisone acetate or any of the other ingredient in this medicine (listed in section 6)
• If you have bowel obstruction, abscess, perforation, recent intestinal anastomosis or extensive fistulae.
• If you are suffering from fungal or viral infection, tuberculosis or peritonitis.

If any of the above applies to you talk to your doctor or pharmacist.

Warnings and precautions:

Talk to your doctor or pharmacist before using Colifoam:

• If you have severe ulcerative disease
• If you are diabetic
• If you have myasthenia gravis
• If you have recently been vaccinated
• If you have severe cardiac and/or renal insufficiency
• If you have hypertension
• If you have glaucoma
• If you or anyone in your close family have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while using steroid medicines like Colifoam.
• If you have diseases of the bowel (rectum).

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Talk to your doctor or pharmacist before giving this medicine to children.

Other medicines and Colifoam

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

Some medicines may change the way Colifoam works. Talk to you doctor if you take any of the following medicines:

• Cardiac glycosides
• Potassium depleting agents (such as saluretic agents, amphotericin B)
• Antibiotics and/or ketoconazole
• Anti-diabetic medicines
• Medicines containing coumarin or its derivatives
• Salicylates or other NSAIDs (such as ibuprofen)
• Antiretroviral agents (such as ritonavir)
• Products containing cobicistat

Pregnancy and breast-feeding

If you are pregnantor breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Colifoam does not affect your ability to drive or use machinery.

3. how to use colifoam

Always use Colifoam 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 is not, or you are not sure, ask your doctor or pharmacist.

Remember:

• You need to use your medicine regularly to get the maximum benefit.
• Do not use for long periods in children or pregnant women.
• Treatment should be given carefully in cases of severe ulcerative disease.

The usual dose for adults including children and the elderly is one applicator of foam once or twice per day for two to three weeks and every second day thereafter, applied into the rectum.

For rectal use only. Do not swallow

• 1. Shake the canister vigorously for 30 seconds before each

use.

• 2. Withdraw the plunger until it stops at the catch Iine.

• 3. Hold the applicator upright and insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers.

  
  
  
  

• 4. Press down gently on the canister top with your fingers, so that the foam fills about % of the applicator body. Only a short press is needed to do this.

  
  

5. Wait for a few seconds until the foam stops expanding.

DO NOT fill the applicator in one go. Always release the canister top after a short press.

6. Repeat steps 4 & 5 above until the foam expands to just reach the ‘Fill’ Iine. This normally takes 2 to 4 short press/wait.

7. Stand with one leg raised on a chair, or lie down on your side. Hold the applicator as shown. Insert gently into the back passage and push the plunger fully into the applicator.

After using the applicator

• Always take the applicator apart and wash it thoroughly after use
• The canister top should also be removed and washed
• Replace the canister top with care. Make sure it is placed vertically on top of the canister, and not at an angle.

If you use more Colifoam than you should

If you use too much consult your doctor as soon as possible.

If you forget to use Colifoam

Do not use double the dose to make up for a forgotten dose. Simply take your next dose as planned.

If you stop using Colifoam

Do not stop using Colifoam without talking to your doctor. Your doctor may reduce your dose gradually.

Mental problems while using Colifoam

Mental health problems can happen while using steroids like Colifoam (see also section 4 Possible Side Effects).

• These illnesses can be serious
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

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

4. possible side effects

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

Serious effects: tell your doctor straight away Steroids can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines that contain steroids.

• Allergic reaction: the signs may include: breathing difficulties, skin rash (irritated, itchy or red skin) or swelling of the face, lips, tongue or throat. These can be serious.
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up and down Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other side effects

If you get any of the following, keep using the medicine but tell your doctor:

• Unexpected fattening of the face, neck and body
• Irregular periods
• Hair starts to grow on your face (women)
• Dusky complexion with purple patches
• Skin thinning
• Blisters on the skin
• Allergic reaction to the skin
• Increased risk of infection
• Burning sensation
• Anal pain or discomfort
• Itching
• Application site dryness
• Blurred vision (frequency not known).

Methylhydroxy­benzoate (E218) and propylhydroxy­benzoate (E216) may cause allergic reactions (possibly delayed).

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: 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 colifoam

Keep out of the reach and sight of children.

Do not use Colifoam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.

• Store in the original packaging
• Protect from sunlight.
• Do not expose to temperatures above 50°C.
• Store below 25°C.
• Do not refrigerate.
• Keep away from sources of ignition – No smoking.
• Do not spray on a naked flame or anything hot.
• Do not pierce or burn the container even after use. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

• 6. Further information
  
  What Colifoam contains:

  The active substance in Colifoam is hydrocortisone acetate (10% w/w).

The other ingredients are cetyl alcohol, emulsifying wax (contains cetostearyl alcohol), methyl parahydroxybenzoate (E218), polyoxyl (10); stearyl ether, propylene glycol, propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.

What Colifoam looks like

Colifoam is a white rectal foam contained in a pressurised canister.

Contents of the pack

Each pack contains a canister and an applicator. Each canister contains approximately 14 doses.

Marketing Authorisation Holder in the UK: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK

Manufacturer

Pharmasol Limited, North Way, Walworth Industrial Estate, Andover, SP10 5AZ, UK.

This leaflet was last approved in October 2018

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

Mylan Products Ltd.,

Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK

IQMylan

• Studio Oberlander GmbH Rubensstr. 33 60596 Frankfurt a. M. Germany Phone: +49 69 631520–85 Fax: –87 E-Mail: