Package Leaflet: Information for the User

Mezavant 1.200 mg, prolonged-release, gastrorresistant tablets

(mesalazine)

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• Keep this leaflet, as 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 pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of thepackage leaflet:

1.What Mezavant is and what it is used for

2.What you need to know before you start taking Mezavant

3.How to take Mezavant

4.Possible side effects

5.Storage of Mezavant

6.Contents of the pack and additional information

Therapeutic group:acidsaminosalicílicoysilicates.

Mezavant,withprolongedgastrorresistentesrelease,containstheactiveingredientmesalazina, whichisapharmacologicalantiinflamatoryforthetreatmentofulcerativecolitis.

Ulcerativecolitisisadiseaseofthecolon(largeintestine)andrectum(finalportionofthelargeintestine),inwhichtheintestinereversesandswells(inflama),causingsymptomssuchasbloodydiarrheaandabdominalpain.

Whenadministeredforanacuteepisodeofulcerativecolitis,Mezavantactsontheentirecolonandrectumtreatinginflammationandreducingsymptoms.Thepreparedformulationscanbetakentopreventrecurrenceofulcerativecolitis.

Do not take Mezavant

• If you are allergic (hypersensitive) to a class of medicines known as salicylates (which includes acetylsalicylic acid [Aspirin]).

• If you are allergic (hypersensitive) to mesalazine or to any of the other components of this medicine (including those listed in section 6).
• If you have any severe kidney or liver problems.

Warnings and precautions

Mesalazine may cause a brownish-red discoloration of the urine after contact with sodium hypochlorite bleach in toilet water. This is a harmless chemical reaction between mesalazine and the bleach.

Consult your doctor before starting to take Mezavant

• If you have any kidney or liver problems.
• If you have had heart inflammation previously (which could be a consequence of a heart infection).
• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after using Mezavant.
• If you have had a previous allergy to sulfasalazine (another medicine used to treat ulcerative colitis).
• If you have a narrowing or obstruction of the stomach or intestine.
• If you have lung problems.

Before and periodically during treatment with Mezavant, your doctor may take urine and blood samples to check that your kidneys and liver are functioning properly and that your blood is healthy.

Calculi (kidney stones) may form with the use of Mezavant. Symptoms may include abdominal side pain and blood in the urine. Be careful to drink enough liquid during treatment with Mezavant.

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN), have been reported associated with Mezavant treatment. If you observe any symptoms related to these severe skin reactions described in section 4, discontinue Mezavant administration and seek immediate medical attention.

Children and adolescents

Mezavant is not recommended for children and adolescents weighing 50 kg or less, nor for children under 10 years of age due to a lack of data on safety and efficacy (see section 3).

Other medicines and Mezavant

Studies have shown that Mezavant does not interfere with the following antibiotics used to treat infections:amoxicillin, metronidazole, or sulfamethoxazole.

However, Mezavant may interact with other medicines.Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine that contains:

• Mesalazine or sulfasalazine (taken to treat ulcerative colitis).
• Non-steroidal anti-inflammatory drugs (e.g. medicines containing acetylsalicylic acid [Aspirin], ibuprofen, or diclofenac).
• Azathioprine, 6-mercaptopurine, or other medicines known to affect the functioning of the bone marrow (known as immunosuppressive medicines that reduce the activity of the immune system). The bone marrow is the tissue within the bones that produces blood cells.
• Coumarin anticoagulants (medicines that prolong the time it takes for blood to clot), for example, warfarin.

Mezavant with food and drinks

Mezavant should be taken with food at the same time every day. The tablets should be swallowed whole and not crushed or chewed.

Pregnancy and breastfeeding

Since mesalazine crosses the placenta during pregnancy and is excreted in breast milk in small amounts, Mezavant should only be taken during pregnancy or breastfeeding if your doctor advises it. Adverse effects (including low blood counts (in white blood cells, red blood cells, and platelets) in infants born to mothers taking Mezavant during pregnancy have been reported. Diarrhea in infants of mothers taking Mezavant has also been reported.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before taking Mezavant.

Interference with analytical tests

If you are having urine tests, it is essential to inform your doctor or nurse that you are taking or have recently taken this medicine, as it may affect some test results.

Driving and operating machinery

It is unlikely that Mezavant will have any effect on your ability to drive or use machines.

Mezavant contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per maximum recommended dose (4 tablets); it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 2.4 g to 4.8 g (two to four tablets) administered once a day for an acute episode of ulcerative colitis.If you are taking the highest daily dose of 4.8 g/day, you should be evaluated after an 8-week treatment.Once your symptoms have subsided and to prevent the recurrence of episodes, your doctor should instruct you to take 2.4 g (two tablets) once a day.

For an acute episode of ulcerative colitis (in the first 8 weeks of treatment) in children and adolescents weighing more than 50 kg and aged 10 years or older, the recommended dose is 2.4 g to 4.8 g (two to four tablets) administered once a day.

To prevent the recurrence of another episode of ulcerative colitis in children and adolescents weighing more than 50 kg and aged 10 years or older, the recommended dose is 2.4 g (two tablets) administered once a day.

Do not forget to take the tablets at the same time every day, with food.The tablets should be swallowed whole and not crushed or chewed.

While taking this medication, make sure to drink liquids to stay well hydrated, especially after severe or prolonged episodes of vomiting or diarrhea, high fever or excessive sweating.

This medication is not recommended for children and adolescents weighing 50 kg or less, nor for children under 10 years of age, due to the lack of data on safety and efficacy.

If you take more Mezavant than you should

If you take too much Mezavant, you may experience one or more of the following symptoms: tinnitus (ringing in the ears), dizziness, headache, confusion, drowsiness, shortness of breath, excessive water loss (associated with sweating, diarrhea, and vomiting), low blood sugar (which may cause dizziness), rapid breathing, changes in blood chemistry, and increased body temperature.

If you take too many tablets, contact your doctor, pharmacist, or hospital emergency unit immediately. Bring the packaging of the tablets.

If you forgot to take Mezavant

It is essential to take the Mezavant tablets every day, even when you do not have any symptoms of ulcerative colitis.Always complete the prescribed cycle.

If you forget to take the tablets, take them in the usual manner the next day.Do not take a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Inform your doctor immediately

• if you experience symptoms such ascramping, intense stomach pain, bloody stools and diarrhea, fever, headache, or skin rash.These symptoms may be indicative of acute intolerance syndrome, which can appear during an acute episode of ulcerative colitis.This is a serious disease that occurs infrequently, but it requires immediate discontinuation of treatment.
• if you experience unexplained bruising (without injury), skin rash, anemia (feeling tired and weak, and having a pale appearance, especially on the lips, nails, and inner eyelids), fever (high temperature), sore throat, or unusual bleeding (e.g., nasal bleeding).
• if you notice flat, reddish spots, resembling a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, generalized rash, fever, and lymph node enlargement. These severe skin eruptions may be preceded by fever and flu-like symptoms.
• if you experience allergic swelling of the tongue, lips, and around the eyes.
• if you experience increased intracranial pressure causing headache, which may be located at the back of the eyes and worsen with eye movement, blurred or dim vision, double vision, flashes of light, difficulty looking to the sides, and brief or permanent vision loss. These effects may be associated with dizziness, nausea, vomiting, and ringing in the ears.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Thefrequent side effects, which occur in less than 1 in 10 patients, are headache, changes in blood pressure, flatulence (gas), nausea (urge to vomit), dullness or stomach pain, abdominal inflammation or diarrhea, diarrhea, indigestion, vomiting, abnormal liver function tests, itching, rash, joint pain, back pain, weakness, fatigue (extreme tiredness),fever (high temperature).

Theinfrequent side effects, observed in less than 1 in 100 patients, are: decreased platelet count in the blood, which increases the risk of bleeding and bruising; dizziness; feeling sleepy or tired; tremors or abnormal involuntary movements; ear pain; elevated heart rate; sore throat; pancreatitis (associated with abdominal and back pain, and nausea); rectal polyp (non-cancerous growth in the lower part of the large intestine that causes symptoms such as constipation and bleeding); acne; hair loss;muscle pain; urticaria; facial swelling.

Therare side effects,observed in less than 1 in 1000 patients, are: renal insufficiency; severe reduction in white blood cell count, which increases the risk of infection; increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).

The following side effects have been reported, but it is not known exactly how often they occur:

Severe reduction in blood cells that can cause weakness or bruising; low blood cell counts; allergic reaction (hypersensitivity); severe allergic reaction that causes difficulty breathing or dizziness; severe disease with blistering of the skin(which can cause skin peeling and painful open sores), mouth, eyes, and genitals; allergic reaction that causes skin rash, fever, and inflammation of internal organs;neuropathy (abnormalities or damage to the nerves that cause numbness and tingling); inflammation of the heart and heart lining; inflammation of the lungs; difficulty breathing or wheezing; gallstones; hepatitis (inflammation of the liver that causes flu-like symptoms and jaundice); hepatotoxicity (liver damage that may present as abnormal liver function tests); allergic swelling of the tongue, lips, and around the eyes; skin redness;eruption of the skin, usually on the face, sensitivity of the skin to sunlight, along with joint pain, arthritis, fatigue, and general feeling of discomfort;renal problems (such as inflammation and scarring of the kidneys); kidney stones and associated pain (see also section2); reversible decrease in sperm production.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children
• Store below25°C
• Store in the original packagingto protect it from humidity
• Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Mezavant

The active ingredient is 1.200 mg of mesalazine.

The other components are sodium carboxymethylcellulose; carnauba wax; stearic acid; hydrated colloidal silica; sodium starch glycolate (type A) (derived from potato); talc; magnesium stearate; copolymer of methacrylic acid – methyl methacrylate (1:1); copolymer of methacrylic acid – methyl methacrylate (1:2); triethyl citrate; titanium dioxide (E171); iron oxide red (E172); and macrogol 6000.

Appearance of Mezavant and packaging size

Mezavant is supplied in blister packs with leaflets inside a cardboard box. The packaging contains 60 or 120 tablets.Only some packaging sizes may be marketed.The brown-red tablets are oval in shape (the dimensions are 20.5×9.5×7.5mm) and have S476 printed on them.

Holder of the marketing authorization andresponsible for manufacturing

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, 9th floor,

Edificio Los Cubos

28027 Madrid

Spain

Phone: +34 91 790 42 22

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: March 2023

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/