Package leaflet: Information for the user

Balzide 750 mg hard capsules

Balsalazide disodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Balzide is and what it is used for
What you need to know before taking Balzide
How to take Balzide
Possible side effects
How to store Balzide
Contents of the pack and other information

1. What Balzide is and what it is used for

Balzide is a medication that releases a substance called mesalazine, which acts as an intestinal anti-inflammatory agent with local action on the inner lining (mucosa) of the large intestine (colon).
Ulcerative colitis is a disease characterized by inflammation of the mucosa of the large intestine (colon) and rectum. Balzide acts locally to reduce inflammation (treatment during active phase).
After symptoms have disappeared, Balzide can be used to prevent further symptom relapses (maintenance treatment).
Balzide 750 mg capsules are used for the treatment of mild to moderate ulcerative colitis, both during the active phase and as maintenance therapy.
Balzide is indicated in adults.

2. What you need to know before taking Balzide

Do not take Balzide:

if you are allergic to balsalazide or mesalazine or to any of the excipients of this medicine (listed in section 6).
if you are allergic (hypersensitive) to acetylsalicylic acid and its derivatives.
if you are pregnant or breastfeeding.
if you have moderate or severe kidney disorders.
if you have severe liver disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Balzide if:

you have liver disease or mild kidney problems.
you suffer from asthma.
you have bleeding disorders.
you have an active peptic ulcer.

If any of these conditions apply to you, inform your doctor before taking Balzide.

Liver, kidney and blood tests
Before starting treatment with Balzide, urine and blood tests will be necessary to assess the function of your kidneys and to check for any signs of blood abnormalities. During treatment, your doctor will periodically analyze blood and urine samples to monitor the function of your liver, kidneys and blood.

Immediately stop treatment if you suspect a blood disorder, based on blood test results or the presence of symptoms which may include, for example, one or more of the following: unexplained bleeding, bruising, sore throat, fever, malaise, or red spots/pustules on the skin (purpura).

Children and adolescents (under 18 years of age)
The use of Balzide is not recommended in children.

Other medicines and Balzide
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

The effect of treatment may be influenced by other medicines taken concomitantly with Balzide. It may be necessary to reduce the dosage, take additional precautions, or in some cases, discontinue one of the medicines. This applies to all medicines, even those without a prescription, especially:

digitalis (digoxin), a heart medicine, whose blood levels may be reduced in patients receiving concomitant treatment with Balzide;
methotrexate, a medicine used to treat certain forms of arthritis, cancers, and psoriasis, whose renal elimination may be reduced in patients receiving concomitant treatment with Balzide.

Balzide with food and drink
Balzide should be taken with a full stomach.

Pregnancy and breastfeeding
Do not take Balzide during pregnancy or while breastfeeding.

Driving and using machines
No relevant effects of Balzide are known.

3. How to take Balzide

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Ulcerative colitis – Treatment during active phase: the dose is 3 capsules of Balzide (2.25 grams) 3 times daily (6.75 grams/day) until symptoms disappear or for a maximum of 12 weeks. Corticosteroids may be administered concomitantly if necessary.
Ulcerative colitis – Maintenance treatment: the recommended initial dose is 2 capsules of Balzide (1.5 grams) twice daily (3 grams/day). Additional benefit may be achieved with a dose of up to 8 capsules daily (6 grams).
Elderly
Balzide can also be used in individuals aged 65 years or older without any dose adjustment.
Your doctor may prescribe doses different from those stated in this leaflet. If so, please ask your doctor for further explanation.
Ensure adequate fluid intake while taking this medicine to maintain hydration, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever, or excessive sweating. This is to avoid kidney problems.
Balzide capsules must be swallowed whole with food.
If you take more Balzide than you should
If you have taken too many capsules, contact your doctor, pharmacist, or hospital immediately.
If you forget to take Balzide
Do not take a double dose to make up for the missed dose.
If you stop taking Balzide
Stopping treatment with Balzide may cause worsening of your condition. Do not discontinue use of this medicine unless advised by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment and contact your doctor immediately if:

you experience allergic reactions such as skin redness (rashes), breathing difficulties (bronchospasm), allergic pneumonia (with symptoms including shortness of breath, dyspnea, and dry cough accompanied by chills, sweating, and pain)
you have blood disorders with symptoms such as unexplained bleeding, bruising, spots/pustules on the skin (purpura), sore throat, fever, malaise, or if blood tests show abnormalities in blood cells (reduction in white blood cells, red blood cells, and platelets)
you develop skin signs such as facial redness with skin peeling, pain and redness of the inner mouth lining (lupus erythematosus-like syndrome)

The most common side effects are:

headache
gastrointestinal disorders (abdominal pain, diarrhea, nausea, and vomiting)

Less frequently reported side effects include:

gallstones
worsening of colitis symptoms (e.g. sudden change in bowel frequency, watery diarrhea with blood, mucus and/or pus)
inflammation of the kidney (nephritis), with possible symptoms including fever, increased urine output, cloudy urine or blood in the urine, abdominal pain, and fatigue
inflammation of the pancreas (acute pancreatitis), with possible symptoms including nausea, vomiting, fever, sweating, and yellowing of the skin
inflammation of the liver (hepatitis), with possible symptoms including fatigue, fever, loss of appetite, nausea or vomiting, muscle and joint pain, and yellowing of the skin and eyes
inflammation of the heart (myocarditis and pericarditis), with possible symptoms including chest pain, palpitations, fatigue, and breathing difficulties
joint pain
muscle pain
peripheral nerve disorders (neuropathy), for example with tingling or burning sensations, pain, and numbness
hair loss

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
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 stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Balzide contains

The active substance is balsalazide disodium 750 mg, equivalent to balsalazide 612.8 mg and mesalazine 262.5 mg.
The excipients are:
Capsule contents: magnesium stearate, anhydrous colloidal silica
Capsule shell: gelatin, shellac, black iron oxide (E172), titanium dioxide (E171), indigo carmine (E132)

Description of the appearance of Balzide and package contents
Balzide is white and blue gelatin capsules. The capsules are available in polyethylene bottles with a screw cap and child-resistant safety closure, containing 56, 112, 130, 224 (2x112), 260 (2x130), 672 (6x112) and 780 (6x130) capsules.
Please note that not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare, L-1611 Luxembourg.
Concessionaire for sale: Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7, Bagno a Ripoli - Florence.

Manufacturer
Doppel Farmaceutici s.r.l., Via Volturno, 48, Quinto De Stampi – Rozzano (Milan)
A. Menarini Manufacturing Logistics & Services s.r.l., Campo di Pile, L’Aquila.

This medicinal product is authorized in the European Economic Area countries under the following names:
United Kingdom: Balzide
Italy: Balzide

For further information about this medicine, please contact the Marketing Authorization Holder.