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Balzide 750mg Capsules

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Document: leaflet MAH BRAND_PL 16239-0001 change

Package leaflet: information for the user

Balzide 750 mg capsules, hard

Balsalazide disodium

Read all of this leaflet carefully before you start taking 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 Balzide is and what it is used for

2.    What you need to know before you take Balzide

3.    How to take Balzide

4.    Possible side effects

5.    How to store Balzide

6.    Contents of the pack and other information

1.    What Balzide is and what it is used for

Balzide is a medicine with the property to release a substance called mesalazine, which acts as an intestinal anti-inflammatory drug, with a localised action on the inner lining (mucosa) of the large bowel (colon).

Ulcerative colitis is a disease characterised by inflammation of the inner layer (mucosa) of the large bowel (colon) and rectum. Balzide acts locally, reducing the inflammation (treatment of the active phase).

Balzide can be used to prevent further aggravation of the symptoms, after their onset (maintenance phase treatment).

Balzide 750-mg capsules are used to treat slight to moderate ulcerative colitis either in the active phase or as maintenance therapy.

Balzide is indicated in adults.

2.    What you need to know before you take Balzide Do not take Balzide:

-    if you are allergic to balsalazide or mesalazine, or any of the other ingredients of this medicine (listed in section 6).

-    if you are allergic (hypersensitive) to acetylsalicylic acid and its derivatives.

-    if you are pregnant or breast-feeding.

-    if you suffer from moderate to severe kidney disorders.

-    if you suffer from severe liver disorders.

Warnings and precautions

Talk to your doctor or pharmacist before taking Balzide if you:

-    have liver disease or mild kidney problems

-    suffer from asthma

-    have a bleeding disorder

-    have an active peptic ulcer

Please inform your doctor before taking Balzide if you suffer from any of these conditions.

Tests on your liver, kidney and blood

Before you start treatment with Balzide you will have a blood and urine test to check how well your kidneys are working and what your blood is doing. During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine samples periodically during your treatment.

Stop treatment immediately if you suspect a blood complication either on the basis of the results from blood tests or from symptoms which may include, for example, one or more of the following; unexplained bleeding, bruising, sore throat, fever, malaise or purple spots/blotches on the skin (purpura).

Children and adolescents (under the age of 18)

Children should not use Balzide.

Other medicines and Balzide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

The effect of the treatment could be influenced by other medicinal products, if taken together with Balzide. It may be necessary to reduce the dose, or to take other precautions, or in some cases to stop taking one of the medicines. This applies to any medicines, even those not requiring a medical prescription, especially:

•    digitalis (digoxin), a medicine for the heart, whose blood levels may be reduced in patients that are also taking Balzide

•    methotrexate, a medicine used to treat some forms of arthritis, tumours and psoriasis, as its clearance by the kidneys may be reduced in patients that are also taking Balzide.

Balzide with food and drink Balzide must be taken on a full stomach.

Pregnancy and breast-feeding

Do not take Balzide during pregnancy or breast-feeding.

Driving and using machines

No relevant effects of Balzide are known.

3. How to take Balzide

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

Ulcerative colitis - treatment of the active phase: the dose is 3 capsules of Balzide (2.25 grams) 3 times a day (6.75 grams/day) until the symptoms wear off, or up to a maximum of 12 weeks. If necessary, steroids may be given in addition.

Ulcerative colitis - maintenance phase treatment: the initial dose recommended is 2 capsules of Balzide (1.5 grams) twice a day (3 grams/day). Further benefit may be obtained by taking a dose of up to 8 capsules a day (6 grams).

Elderly

Balzide can also be used in patients 65 or older without any dose adjustment.

Your doctor may prescribe doses for you that are different from those indicated in this information leaflet. If this happens, ask your doctor for further information.

Whilst taking this medicine ensure you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidneys.

Balzide capsules must be swallowed whole on a full stomach.

If you take more Balzide than you should

If you have taken too many capsules, contact your doctor, pharmacist, or a hospital immediately.

If you forget to take Balzide

Do not take a double dose to make up for a forgotten dose.

If you stop taking Balzide

Stopping treatment with Balzide could cause your disease to get worse. Do not stop taking the medicine unless advised to do so by your doctor.

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

4. Possible side effects

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

Stop taking the medicine and tell your doctor immediately if you:

•    have allergic reactions, such as reddening of the skin (rash), breathing disorders (bronchospasm), allergic pneumonia (symptoms include breathing difficulty, wheezing, and dry coughs, accompanied by chills, sweating and aching)

•    suffer from any blood disorders with symptoms such as unexplained bleeding, bruising, purple spots/blotches on the skin (purpura), sore throat, fever, malaise or have blood test changes that indicate blood disorders (decreased white blood cells, red blood cells, and platelets)

•    have skin signs, such as reddening of the face with skin peeling, pain and reddening of the inside of the mouth (a syndrome similar to lupus erythematosus)

The most common adverse side effects are:

•    headache

•    gastrointestinal disorders (stomach-ache, diarrhoea, nausea and vomiting)

Very rarely the following have been reported:

•    Gallstones

•    Worsening of the colitis symptoms (e.g. drastic change in stool frequency, watery diarrhoea that may contain blood, mucus, and/or pus)

•    Inflammation of the kidneys (nephritis), with fever, increased passing water, cloudy or bloody urine, abdominal pain and fatigue as possible symptoms

•    Inflammation of the pancreas (acute pancreatitis), with nausea, vomiting, fever, sweating, yellowing of the skin as possible symptoms

•    Inflammation of the liver (hepatitis), with tiredness, fever, loss of appetite, feeling sick or vomiting, muscle aches and joint pain, yellowish eyes and skin as possible symptoms

•    Inflammation of the heart (myocarditis and pericarditis), with chest pain, heart palpitations, fatigue, shortness of breath as possible symptoms

•    Joint pain

•    Muscular pain

• Disorders of the peripheral nerves (neuropathies), with e.g. a tingling or burning sensation, or pain and numbness

• Hair loss.

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. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Balzide

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

Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Store in the original bottle.

Do not use this medicine if you notice that the bottle is not intact or shows signs of having been tampered with.

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

6.    Contents of the pack and other information What Balzide contains

-    The active substance is 750 mg balsalazide disodium corresponding to 612.8 mg of balsalazide and 262.5 mg of mesalazine.

-    The other ingredients are:

Capsule contents: magnesium stearate, anhydrous colloidal silica

Capsule shell: gelatine, shellac, black iron oxide (E172), titanium dioxide (E171), indigotine (E132)

What Balzide looks like and contents of the pack

Balzide comes in white and blue gelatine capsules. The capsules are available in polyethylene bottles, with a childproof screw cap, containing 56, 112, 130, 224 (2x112), 260 (2x130), 672 (6x112) and 780 (6x130) capsules.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare, L-1611 Luxembourg.

Manufacturer

Doppel Farmaceutici s.r.l., Via Volturno, 48, Quinto De Stampi - Rozzano (Milan) or

A. Menarini Manufacturing Logistics & Services s.r.l., Campo di Pile, L’Aquila

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

United Kingdom:    Balzide

Italy:    Balzide

For further information about this drug, contact the holder of the marketing authorisation.

This leaflet was last revised in October 2015.

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