Document: leaflet MAH BRAND_PL 08637-0002 change

• leaflet MAH BRAND_PL 08637-0002
• leaflet MAH BRAND_PLPI 10383-2014
• leaflet MAH BRAND_PLPI 10383-2135

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PACKAGE LEAFLET:

INFORMATION FOR THE USER

Budenofalk® 3mg gastro-resistant capsules

Budesonide

Read all of this leaflet carefully before you start taking this

medicine. Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or your 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 3mg capsules are and what they are used for

2.    What you need to know before you take Budenofalk 3mg capsules

3.    How to take Budenofalk 3mg capsules

4.    Possible side effects

5.    How to store Budenofalk 3mg capsules

6.    Contents of the pack and other information

Budenofalk 3mg capsules contain the active substance budesonide, a type of locally acting steroid used to treat chronic inflammatory diseases of the intestine and the liver.

Budenofalk is used in the treatment of:

- Crohn's disease mild to moderate acute attacks of chronic inflammation of the intestine affecting the lower part of the small bowel (ileum) and/or upper part of the large bowel (the ascending colon).

Note: Budenofalk is not suitable for patients with Crohn's disease affecting the upper gastrointestinal tract. Sometimes this disease may cause symptoms outside the intestine (e.g. affecting the skin, eyes and joints) which are unlikely to respond to this medicine.

-    Acute episodes of collagenous colitis (a disease with chronic inflammation of the large bowel which is characterized by chronic watery diarrhoea).

-    Autoimmune hepatitis (a disease with chronic inflammation of the liver).

DO NOT take Budenofalk if you have:

-    an allergy (hypersensitivity) to budesonide or any of the other ingredients in this medicine (listed in section 6 and end of section 2)

-    a severe liver disease (liver cirrhosis)

Warnings and precautions

Before you start taking this medicine, tell your doctor if you have:

-    tuberculosis

-    high blood pressure

-    diabetes, or if diabetes has been diagnosed in your family

-    brittle bones (osteoporosis)

-    ulcers in the stomach or first part of the small intestine (peptic ulcer)

-    increased pressure in your eye (glaucoma) or eye problems such as clouding of the lens (cataracts) or if glaucoma has been diagnosed in your family

-    severe liver problems

Typical effects of cortisone preparations may occur which may

affect all parts of the body, particularly when you take Budenofalk at

high doses and for prolonged periods (see section 4. Possible side

effects).

Further precautions during treatment with Budenofalk:

-    Keep away from people who have chickenpox or herpes zoster (shingles), if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.

-    Tell your doctor if you have not yet had 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.

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

Budenofalk 3mg Gebrauchsinformation (Gl) fur GrolSbritannien-Irland Mat.-Nr.: Mock-up (Losan Pharma) Format: 420 x 200 mm Falk-Datumscode: GB-IE/03.16 Farbigkeit: (2/2) Schwarz + Pant. 644 Grammatur: 40g/m²    Laetuscode-Nr.: 118

Machart: vorgefalzt    SchriftgroSe: 9pt/ZAB: 10,5pt

Taking other medicines

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

-    Cardiac glycosides such as digoxin (medicines used to treat heart conditions)

-    Diuretics (to remove excess fluid from the body)

-    Ketoconazole or itraconazole (to treat fungal infections)

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

-    Ritonavir (for HIV infections)

-    Carbamazepine (used in the treatment of epilepsy)

-    Rifampicin (for treating tuberculosis)

-    Oestrogens or oral contraceptives

-    Cimetidine (used to inhibit the production of acid in the stomach)

If you take cholestyramine (for hypercholestrolemia and also used to treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk, take these medicines at least 2 hours apart.

Taking Budenofalk with food and drink

You should not drink grapefruit juice whilst you are taking this medicine as this can alter its effects.

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 for advice before taking this medicine. You should only take Budenofalk during pregnancy if your doctor tells you to. Do not breast-feed during treatment with Budenofalk as the drug may pass into breast milk.

Driving and using machines

Budenofalk is not expected to affect your ability to drive or operate machinery.

Budenofalk 3mg capsules contain sucrose and lactose.

Each capsule contains 240 mg sucrose and 12 mg lactose monohydrate - if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

Dosage

Crohn's disease Adults (over 18 years)

Take three capsules once daily in the morning or one capsule 3 times a day (morning, midday and evening), unless your doctor instructs you otherwise.

Collagenous colitis Adults (over 18 years)

Take three capsules once daily in the morning, unless your doctor instructs you otherwise.

Autoimmune hepatitis Adults (over 18 years)

Treatment of acute inflammation:

Take one capsule 3 times a day (morning, midday and evening), unless your doctor instructs you otherwise. Depending on the results of laboratory examinations, your doctor will decide how long you should take 3 capsules per day.

Maintenance treatment:

Take one capsule 2 times a day (morning and evening), unless your doctor instructs you otherwise. Depending on the results of laboratory examinations, your doctor will decide how long you should take 2 capsules per day.

Please note that in most cases your doctor will prescribe Budenofalk together with azathioprine, a medicine that works by reducing the body's immune response.

Use in children (all indications)

Budenofalk 3mg capsules should NOT be used in children under 12 years of age.

There is only limited experience with the use of this medicine in children older than 12 years of age.

Method of administration

Budenofalk 3mg capsules are for oral use only.

The capsules are to be swallowed whole, with a glass of water about I/2 hour before meals. Do not chew the capsules.

Duration of treatment

Your doctor will decide how long you are to continue the medication, depending on your condition.

Crohn's disease and collagenous colitis Your treatment should last about 8 weeks.

Autoimmune hepatitis

Depending on the results of examinations of your blood and liver tissue, your doctor will decide how long you should take this medicine and how many capsules per day you should take.

If you take more Budenofalk than you should

If you have taken too much medicine on one occasion, take your next dose as prescribed. Do not take a smaller amount. Contact a doctor if you are in doubt, so he or she can decide what to do; take the packet and this leaflet with you if possible.

If you forget to take Budenofalk

If you miss a dose, just continue your treatment at the prescribed dosage. Do not take a double dose to make up for the forgotten one.

If you stop taking Budenofalk

Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better.

Your doctor will probably want to reduce your dose gradually, first from three to two capsules for 1 week (one in the morning and one in the evening) and then only one capsule a day in the last week of treatment (taken in the morning).

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

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

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

-    Infection

-    Headache

-    Changes in behaviour or psychiatric effects for example depression, irritability and euphoria

The following side effects have also been reported:

Very rare (affecting less than 1 in 10,000 patients)

-    Cushing's syndrome - roundness of the face, weight gain, reduced glucose tolerance, high blood sugar, fluid retention, increased excretion of potassium (hypokaliemia), reduced growth in children, irregular periods in women, unwanted body hair in women, impotence, abnormal laboratory findings (reduced adrenal function), swelling of the legs (because of fluid retention, oedema)

-    increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents

-    constipation

-    muscle and joint pain and weakness, muscle twitching

-    brittle bones (osteoporosis)

-    tiredness, general feeling of being ill.

The following side effects are typical of steroid medication and may occur depending on your dose, period of treatment, whether you have had or are having treatment with other cortisone preparations, and your individual susceptibility. Most of the following side effects were noted after use of stronger steroids and so should be less frequent with Budenofalk 3mg capsules:

-    Cushing's Syndrome (for a description of typical symptoms, see above).

-    increased risk of infection.

-    mood changes such as depression, irritability or euphoria.

-    blurred vision (caused by increased pressure in the eye (glaucoma) or clouding of the lens (cataract)).

-    high blood pressure, increased risk of blood clotting, inflammation of the blood vessels (associated with stopping cortisone use after long term therapy).

-    stomach ache and complaints, nausea, vomiting (feeling sick), ulcers in the stomach and/or small intestine, inflammation of the pancreas.

-    rash from hypersensitivity reactions, red stripes on the skin, bleeding in the skin, acne, delayed wound healing, local skin reactions such as contact dermatitis.

-    bone and cartilage loss (aseptic bone necrosis).

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 national reporting system:

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.

This medicine does not require any special storage conditions.

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

Marketing Authorisation Holder and Manufacturer

DR. FALK PHARMA GmbH

Leinenweberstr. 5 79108 Freiburg Germany

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 under the following names:

Belgium, Bulgaria, Czech Republic, Denmark, Finland,

Germany, Great Britain, Greece, Plungary, Ireland, Latvia,

Lithuania, The Netherlands, Poland, Romania, Slovakia,

Slovenia, Sweden: Budenofalk®

Austria: Budo-San®

Portugal: Budo San®

Spain: Intestifalk®

France: MIKICORT®

Italy: Intesticort®

This leaflet was last approved in 04/2016.

What Budenofalk 3mg capsules contain

The active substance is budesonide. Each capsule with gastro-

resistant pellets contains 3 mg of budesonide.

The other ingredients are ammonio methacrylate copolymer (type A) (Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit RS), lactose monohydrate, maize starch, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acid-methyl methacrylate copolymer (1:2) (Eudragit S 100), povidone K25, purified water, sucrose, talc, triethyl citrate, gelatin, erythrosine (E127), titanium dioxide (E171), red and black iron oxide (E172), sodium laurilsulphate (see also end of Section 2 for further, important information on lactose and sucrose).

What Budenofalk 3mg capsules look like and contents of the pack

Budenofalk 3mg capsules are pink coloured gastro-resistant hard capsules contained in blister strips.

Budenofalk 3mg capsules are available in pack sizes of 10, 50, 90,

100 or 120 - not all may be marketed.

07.04.16 11:13