patient information leaflet budenofalk 2mg rectal foam

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before you start to take your medicine.

It contains important information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all of your medicine. You may want to read it again.

What is in your medicine?

The name of this medicine is Budenofalk® 2mg rectal foam. The active ingredient is budesonide and each actuation of foam contains 2 mg budesonide. The foam also contains cetyl alcohol, emulsifying wax, purified water, disodium edetate, macrogol stearyl ether, propylene glycol, sorbic acid, citric acid monohydrate and n-butane, isobutane and propane as propellants.

Each can of Budenofalk® 2mg rectal foam contains 1.2 grams of foam, sufficient for 14 applications.

What your medicine is used for

Your medicine contains a type of steroid which reduces inflammation. Budenofalk® 2mg rectal foam may be used to treat distal ulcerative colitis which is an inflammation of the colon limited to the rectum (back passage) and the lower part of the colon (sigmoid colon).

Before taking your medicine

You should not take this medicine if:

You are allergic to budesonide or any of the ingredients.
You have a serious liver disease.

If you answer yes to any of the following questions, tell your doctor or pharmacist

Do you have, or have you ever had, tuberculosis, high blood pressure, diabetes, brittle bones (osteoporosis), stomach ulcers, glaucoma, cataracts or liver problems?
If you know or think you may have any sort of infection.
Has anyone in your family ever had diabetes or glaucoma?
Are you taking digoxin, water tablets, ketoconazole, ritonavir, itraconazole, clarithromycin, carbamazepine or rifampicin?
Are you taking any other medication (including any medicines you have bought without a prescription) which your doctor does not know about?
Are you pregnant, trying to become pregnant or think you may be pregnant?
Are you breast-feeding?

Please try to avoid contact with people who have chicken pox, shingles or measles. This is particularly important if you do not think you have had this illness yourself. If you think you may have been exposed to any of these illnesses, tell your doctor as soon as possible. Please tell your doctor if you are about to go abroad and need a vaccination whilst you are taking this medicine.

How to take your medicine

It is important to take your medicine as directed by your doctor.

The label will tell you how much to take and how often. If it does not or you are unsure, ask your doctor or pharmacist.

This medicine is not recommended for children.

The usual dose is one administration a day either in the morning or in the evening.
The best results are achieved if the bowel is emptied before using Budenofalk® 2mg rectal foam.
This medicine should not be swallowed.
Try to avoid drinking grapefruit juice while on your medicine as this may affect the levels of the active ingredient in your blood.

Picture of the spray can:

The applicator and its protective cap are in a special rail. Please hold the rail firmly and pull the applicator out sharply. The protective cap remains inside the rail.

Preparing to use the foam:

Push applicator firmly onto spout of the spray can.

Mix contents by shaking of spray can for about 15 seconds.

Before first use, remove safety tab from under the pump dome.

Twist the dome on top of the canister until the semi-circular gap underneath it is in line with the nozzle. The spray can is now ready for use.

Using the foam:

	Place your forefinger on the top of pump dome and turn spray can upside down. Note that spray can will only work properly when held with the pump dome pointing down as vertically as possible.
	Insert the applicator into the rectum as far as comfortable. The easiest way to use Budenofalk® 2mg rectal foam is to keep one foot on the floor and raise the other foot onto a firm surface such as a chair or stool. To administer a dose of Budenofalk® 2mg rectal foam, push down fully the pump dome once and release it very slowly. The applicator should be held in position for 10 –15 seconds before being withdrawn from the rectum, as the foam still expands a little and would otherwise drop out of the applicator.
	After administering the foam, remove the applicator and dispose of it as domestic waste; using the plastic bag provided. Use a new applicator for another administration. In order to prevent the inadvertent loss of foam from the spray can between applications turn the pump dome around so that the semi-circular gap faces the opposite direction to the nozzle.

Keep taking your medicine until your doctor tells you to stop, even if you start to feel better.
Your doctor will not normally want you to take this medicine for more than 8 weeks.
If you go into hospital, or visit a dentist or another doctor, tell them you are taking Budenofalk® 2mg rectal foam.

What to do if you forget to take your medicine

If you forget to take your medicine, take a dose as soon as you remember and then continue with the next dose as instructed on the label. Do not take more than one administration of foam per day.

What to do if you take too much foam

If you accidentally take too much of your medicine, do not worry, but contact your doctor or local hospital casualty department as soon as possible. Take this medicine with you.

After taking your medicine

Like all medicines, Budenofalk® 2mg rectal foam may occasionally cause unwanted effects in some people.

Most of these effects are not serious.

This medicine contains a type of steroid, so you might experience unwanted effects typical of steroids. They may include:

Skin rashes, acne, itchy skin, development of marks and bleeding within the skin, delayed wound healing.
Tiredness, muscle weakness, brittle bones, wasting of bones and cartilage.
Roundness of the face, weight gain, fluid retention, increased risk of high blood sugar, increased risk of infections, blood clots and high blood pressure.
Heartburn, stomach complaints such as ulcers, pancreatitis and constipation.
Blurred vision (e.g. glaucoma and cataract).
Heavy or irregular periods in women, growth retardation in children, male hair growth patterns in women, impotence.
Nervous system disorders including headaches, which may or may not be associated with blurred vision or vomiting and mood changes, such as depression, irritability or euphoria.

Most of these unwanted effects were noted after long-term use of oral steroids and so these effects will be less with Budenofalk® 2mg rectal foam.

If you experience these or any other undesirable effects, then tell your doctor or pharmacist as soon as possible.

This medicine contains sorbic acid, propylene glycol and cetyl alcohol which may cause local skin reactions or irritation (e.g. contact dermatitis).

How to store your medicine

Store the cans of foam in a place where they cannot be seen or reached by children, your medicine could harm them.
Do not store above 25 °C.
Do not refrigerate or freeze.
This is a pressurized container, containing 6.5 % by mass of inflammable propellant. It should be kept away from any flames or sparks, including cigarettes.
It should be protected from direct sunlight and must not be pierced or burned even when empty.
Actuated containers must be used up within 4 weeks.
Check the expiry date on the carton or can and do not use the foam if this date has been passed.
If your doctor decides to stop treatment, return any left over foam to the pharmacist. Only keep it if the doctor tells you to.

This leaflet provides a summary of the information available on your medicine. This information applies only to Budenofalk® 2mg rectal foam. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.

Medicine: budenofalk 2mg rectal foam