If you forget to use Budenofalk Rectal Foam

Do not take a larger than normal dose of Budenofalk Rectal Foam next time, but continue treatment at the prescribed dosage

If you stop using Budenofalk Rectal Foam

Do not stop using this product until you have talked to your doctor.

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

Like all medicines, Budenofalk Rectal Foam can cause side effects, although not everybody gets them.

The following effects have been reported:

If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately:

•    Infection

•    Headache

The following side effects have been reported:

Common side effects (that affect less than 1 in 10 patients):

•    Burning or pain in the rectum

Uncommon side effects (that affect less than 1 in 100 patients):

•    Anaemia or other changes to the blood

•    Headache, giddiness, disturbance of smell

•    Urinary tract infections

•    High blood pressure

•    Sleeplessness

•    Nausea, abdominal pain, dyspepsia, wind, tingling in the abdomen, anal fissure, mouth rash, urgent need to empty the bowels , haemorrhoids, rectal bleeding

•    Changes in liver function

•    Changes in pancreatic function, changes in adrenal hormones

•    Acne, increased sweating

•    Tiredness, increase in body weight.

•    An increase in appetite

When Budenofalk Rectal Foam is used, side effects may occur which are typical of the more active cortisone preparations (Cushing-like properties). The side effects listed below depend on the dose, the period of treatment, whether there has been prior or accompanying treatment with other cortisone preparations and on the individual sensitivity.

•    Increased risk of infection

•    Cushing Syndrome: Roundness of the face, weight gain, increased risk of high blood sugar, fluid retention, reduced growth in children

•    Irregular periods in women, male hair growth patterns in women, impotence

•    Mood changes such as depression, irritation or euphoria

•    Blurred vision (e.g. glaucoma and cataract)

•    Increased risk of blood clotting, disease of the blood vessels (associated with stopping steroid use after long term therapy)

•    Stomach complaints such as ulcers, pancreatitis and constipation

•    Muscle pain and bone weakness (osteoporosis), loss of bone and cartilage (aseptic bone necrosis)

•    Rash from hypersensitivity reactions (allergic exanthema), formation of red stripes (striations) and bleeding in the skin, delayed wound healing. Local skin reactions such as contact dermatitis may develop.

•    Isolated cases: increased brain pressure with possible additional swelling of the optic disk in adolescents

Most of these unwanted effects were noted after long-term use of oral steroids and so these effects will be less with Budenofalk Rectal Foam.

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 as follows:

Republic of Ireland:

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971

Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

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

Keep this medicine out of the sight and reach of children.

Do not use Budenofalk Rectal Foam after the expiry date which is stated on the carton and on the pressurised container. The expiry date refers to the last day of that month.

The contents of the container must be used within 4 weeks after first opening.

Do not store above 25 °C.

Do not refrigerate or freeze

The container is pressurised and contains flammable propellant. Do not expose to temperature higher than 50°C, protect from direct sunlight. Do not pierce or burn, even when empty.

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 to protect the environment.

What Budenofalk Rectal Foam contains

The active substance is budesonide. Each dose of foam contains 2 mg budesonide.

The other ingredients are cetyl alcohol, emulsifying wax, purified water, disodium edetate, macrogol stearyl ether, propylene glycol, citric acid monohydrate and n-butane, isobutane and propane as propellants.

What Budenofalk Rectal Foam looks like and contents of the pack

Budenofalk Rectal Foam is a white to pale white, creamy, firm foam and is presented in a pressurised container.

Budenofalk Rectal Foam is available in packs containing 1 pressurised container, 14 applicators and 14 plastic bags or in packs containing 2 pressurised containers, 28 applicators and 28 plastic bags, for the hygienic disposal of the applicators.

Each pressurised container contains at least 14 doses of 1.2 g rectal foam.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

DR. FALK PHARMA GmbH

Tel.: +49 (0)761/1514-0 Fax: +49(0)761/1514-321 E-Mail: zentrale@drfalkpharma.de

This medicinal product is authorised in the Member States of the EEA und the following names:

Denmark, Finland, Great Britain, Greece, Ireland, Luxembourg,

Romania and Sweden: Budenofalk* Austria: Budo-San*

Italy: Rafton*

Spain: Intestifalk*

This leaflet was last revised in 09/2014

Budenofalk® 2mg/dose Rectal Foam

Budesonide

Read all of this leaflet carefully before you start using 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.

What is in this leaflet:

1.    What Budenofalk Rectal Foam is and what it is used for

2.    What you need to know before you use Budenofalk Rectal Foam

3.    How to use Budenofalk Rectal Foam

4.    Possible side effects

5.    How to store Budenofalk Rectal Foam

6.    Contents of the pack and other information

GB-IE/09.14

Budenofalk Rectal Foam contains the active substance budesonide, a type of locally acting steroid used to treat inflammatory bowel disease.

Budenofalk Rectal Foam is used for the treatment of:

• Inflammation of the rectum (back passage) and the lower part of the colon (sigmoid colon), known by doctors as ulcerative colitis.

Do not use Budenofalk Rectal Foam

•    If you are or have been told you are allergic (hypersensitive) to budesonide or any of the other ingredients of Budenofalk Rectal Foam (listed in section 6)

•    If you have a serious liver disease (e.g. liver cirrhosis).

Warnings and precautions

Before you start using this medicine

you should tell your doctor:

•    If you know or have been told that you have tuberculosis, high blood pressure, fragile bones (osteoporosis)

•    If you or any of your family suffers with diabetes (diabetes mellitus), or glaucoma (increase in the pressure within the eye)

•    If you suffer with ulcers in the stomach or duodenum (peptic ulcer)

•    If you suffer with eye problems such as cataracts.

•    If you suffer with problems of your liver

Further precautions:

•    Tell your doctor if you have not yet had chickenpox or measles, or if you have come into contact with anybody who has chickenpox, shingles or measles.

•    If you know that you need to be vaccinated please speak to your doctor first.

•    If you know that you are due to have an operation please tell your doctor that you are using Budenofalk Rectal Foam.

•    If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk Rectal Foam, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor!

Other medicines and Budenofalk Rectal Foam

Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):

•    Medicines used to treat heart conditions (cardiac glycosides such as digoxin)

•    Diuretics (medicines used to treat excess fluid in your body)

•    Ketoconazole and itraconazole

(substances used to treat fungal infections)

•    Antibiotic drugs used to treat infections (such as clarithromycin)

•    Ritonavir (a substance used for treating HIV infections)

•    Carbamazepine (substance used for treating epilepsy)

•    Rifampicin (substance used against tuberculosis)

•    Contraceptive pill

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Budenofalk Rectal Foam and your doctor will be able to decide what is suitable for you.

Budenofalk Rectal Foam with food and drink

You should not drink grapefruit juice

during your treatment with Budenofalk Rectal Foam, as this can change the effects of Budenofalk Rectal Foam.

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.

It is important that you tell your doctor if you are, or think you may be pregnant, as you should only use Budenofalk Rectal Foam during pregnancy if your doctor tells you to.

You should only use Budenofalk Rectal Foam during breast-feeding if your doctor tells you to, as it is not known if budesonide passes into breast milk.

Driving and using machines

There are no effects on the ability to drive and use machines.

Budenofalk Rectal Foam contains cetyl alcohol and propylene glycol

This medicine contains cetyl alcohol and propylene glycol which can cause local skin reactions (e.g. contact dermatitis).

Always use Budenofalk Rectal Foam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration:

This medicine may only be used rectally, so it has to be inserted through the anus. It is not intended to be taken by mouth. Do not swallow.

Dosage:

Dose for adults over 18 years of age:

The usual dose is 1 spray actuation per day, either in the morning or to be taken at bedtime.

Emptying your bowels before using Budenofalk Rectal Foam produces the best results.

Use in children and adolescents:

Budenofalk Rectal Foam should not be used in children under 18 years of age, because there is very limited experience with Budenofalk Rectal Foam in this age group.

Picture of the spray can:

pump dome spout applicator spray can

The applicators are in a special rail. Please hold the rail firmly and pull the applicator out sharply.

Preparing to use the foam:

Push applicator firmly onto the spout of the spray can.

Shake the spray can for about 15 seconds to mix the contents.

Before the first use, remove the safety lock (plastic flap) from under the pump dome.

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

Using the foam:

Place your index finger on the top of pump dome and turn the can upside down. Please note that the spray can will only work properly when held with the pump dome pointing down as vertically as possible.

Insert the applicator into your rectum as far as t| possible. The best way to do this is to place one foot on a chair or stool. To administer a dose of Budenofalk Rectal Foam, push down fully the pump dome once and release it very slowly. Wait 10-15 seconds before withdrawing the applicator 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 household waste in 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 semicircular gap faces the opposite direction to the nozzle.

•    Please wash your hands and try not to empty your bowels until the next morning.

•    If you go to hospital or see another doctor or dentist tell them you are using this medicine.

Duration of treatment:

How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication.

Acute episodes of inflammatory bowel disease (ulcerative colitis) generally subside after 6-8 weeks.

If you think that the effect of Budenofalk Rectal Foam is too strong or too weak, talk to your doctor.

If you use more Budenofalk Rectal Foam than you should

Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too much Budenofalk Rectal Foam on one occasion, just take your next dose as prescribed. Do not use a smaller amount.