MEZAVANT 1200 mg PROLONGED-RELEASE GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Mezavant 1.200 mg, gastro-resistant prolonged-release tablets

(mesalazine)

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.

Contents of the pack and other information:

1. What is Mezavant and what is it used for
2. What you need to know before you take Mezavant
3. How to take Mezavant
4. Possible side effects
5. Storage of Mezavant
6. Contents of the pack and further information

1. What is Mezavant and what is it used for

Pharmacotherapeutic group: aminosalicylic acid and similar agents.

Mezavant, gastro-resistant prolonged-release tablets, contains the active substance mesalazine, which is an anti-inflammatory drug for the treatment of ulcerative colitis.

Ulcerative colitis is a disease of the colon (large intestine) and rectum (the last part of the large intestine), in which the lining of the intestine becomes red and swollen (inflamed), causing symptoms such as frequent bowel movements with blood along with stomach discomfort.

When administered for an acute episode of ulcerative colitis, Mezavant acts throughout the colon and rectum, treating inflammation and reducing symptoms. The tablets can also be taken to prevent the recurrence of ulcerative colitis.

2. What you need to know before you take Mezavant

Do not take Mezavant

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

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

Warnings and precautions

Mesalazine may produce a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and the bleach and is harmless.

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 sores in the mouth after using Mezavant.
• If you have had a previous allergy to sulfasalazine (another medicine used to treat ulcerative colitis).
• If you have 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 working properly and that your blood is healthy.

Kidney stones can form with the use of Mezavant. The symptoms may include pain in the sides of the abdomen and blood in the urine. Be careful to drink a sufficient amount of 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 (NET), have been reported in association with Mezavant treatment. If you observe any of the symptoms related to these severe skin reactions described in section 4, discontinue Mezavant administration and seek immediate medical attention.

Consult your doctor:

If you experience severe or recurrent headache, vision changes, or ringing or buzzing in the ears, contact your doctor immediately

Children and adolescents

Mezavant is not recommended for children and adolescents who weigh 50 kg or less or for children under 10 years of age due to the 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 recently taken, or might take any other medicine that contains:

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

Taking 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, you should only take Mezavant during pregnancy or breastfeeding if your doctor advises you to. Adverse outcomes (including low blood cell counts in newborns) have been reported in infants born to mothers who took Mezavant during pregnancy. Diarrhea has been reported in infants of mothers who took Mezavant.

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

Interference with laboratory tests

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

Driving and using machines

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); this is essentially "sodium-free".

3. How to take Mezavant

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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 daily 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 8 weeks of treatment. Once symptoms have subsided and to prevent recurrence of episodes, your doctor should advise you to take 2.4 g (two tablets) once daily.

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

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

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 medicine, make sure to drink liquids to stay well-hydrated, especially after severe or prolonged episodes of vomiting or diarrhea, high fever, or excessive sweating.

Mezavant is not recommended for children and adolescents who weigh 50 kg or less or 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: ringing in the ears (tinnitus), dizziness, headache, confusion, drowsiness, shortness of breath, excessive water loss (associated with sweating, diarrhea, and vomiting), low blood sugar (which can 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 department immediately. Bring the tablet packaging with you.

If you forget to take Mezavant

It is important that you take the Mezavant tablets every day, even when you have no symptoms of ulcerative colitis. Always finish the prescribed treatment cycle.

If you forget to take the tablets, take them as usual the next day. Do not take a double dose to make up for the forgotten dose.

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.

Tell your doctor immediately

• If you experience symptoms such as cramps, severe stomach pain, bloody diarrhea, fever, headache, or skin rash. These symptoms could be indicative of acute intolerance syndrome, which can occur during an acute episode of ulcerative colitis. This is a rare but serious disease that requires immediate discontinuation of treatment.
• If you suffer from unexplained bruising (without injury), skin rash, anemia (feeling tired and weak, and having a pale appearance, especially in the lips, nails, and inner eyelids), fever (high temperature), sore throat, or unusual bleeding (e.g., nosebleeds).
• If you observe reddish, non-elevated spots, with a target-like or circular appearance on the trunk, often with central blisters, skin peeling, mouth ulcers, genital ulcers, and eye ulcers, generalized rash, fever, and swollen lymph nodes. These severe skin rashes can be preceded by fever and flu-like symptoms.
• If you suffer from allergic swelling of the tongue, lips, and around the eyes.
• If you experience severe or recurrent headache, vision changes, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

The common side effects, which occur in less than 1 in 10 patients, are headache, changes in blood pressure, flatulence (gas), nausea (feeling sick), bloating or stomach pain, abdominal pain or diarrhea, diarrhea, indigestion, vomiting, abnormal liver function tests, itching, rash, joint pain, back pain, weakness, fatigue (feeling extremely tired), fever (high temperature).

The uncommon side effects, which occur in less than 1 in 100 patients, are: decrease in the number of blood platelets, which increases the risk of bleeding and bruising; dizziness; feeling sleepy or tired; tremors or abnormal involuntary movements; ear pain; rapid heartbeat; sore throat; pancreatitis (inflammation of the pancreas, associated with pain in the upper abdomen and back, and nausea); rectal polyp (a non-cancerous lump in the last part of the large intestine that can cause symptoms such as constipation and bleeding); acne; hair loss; muscle pain; hives; facial swelling.

The rare side effects, which occur in less than 1 in 1000 patients, are: kidney failure; drastic reduction in the number of white blood cells, which increases the likelihood of infection; increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

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

Severe decrease in blood cells, which can cause weakness or bruising; low blood cell counts; allergic reaction (hypersensitivity); severe allergic reaction that causes difficulty breathing or dizziness; severe skin disease with blistering of the skin (which can cause skin peeling and painful raw areas), 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); heart inflammation and inflammation of the heart lining; lung inflammation; breathing difficulties or wheezing; gallstones; hepatitis (inflammation of the liver that causes flu-like symptoms and jaundice); liver damage (which can present as abnormal liver tests); allergic swelling of the tongue, lips, and around the eyes; skin redness; skin rash, usually on the face, sensitivity of the skin to sunlight, along with joint pain, arthritis, fatigue, and general feeling of being unwell; kidney problems (such as inflammation and scarring of the kidneys); kidney stones and the associated pain (see also section 2); reversible decrease in sperm production.

Reporting of side effects

If you experience 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 to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mezavant

• Keep this medicine out of the sight and reach of children
• Store below 25°C
• Store in the original packaging to protect from moisture
• Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month shown

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Mezavant

The active substance is 1.200 mg of mesalazine.

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

Appearance of Mezavant and pack size

Mezavant is supplied in blister packs with foil inside a cardboard box. The pack contains 60 or 120 tablets. Not all pack sizes may be marketed.

The brown-red tablets are oval in shape (dimensions 20.5 × 9.5 × 7.5 mm) and have S476 printed on them.

Marketing authorisation holder and manufacturer

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, 9th floor,

Edificio Los Cubos

28027 Madrid

Spain

Tel: +34 91 790 42 22

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: 01/2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/