Mezavant 1.200 mg prolonged-release gastro-resistant tablets

Package leaflet: Information for the user

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 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Mezavant is and what it is used for

Pharmacotherapeutic group: aminosalicylic acid and related agents.

Mezavant, gastro-resistant prolonged-release tablets, contains the active substance mesalazine, which is an anti-inflammatory drug used to treat ulcerative colitis.

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

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

2. What you need to know before taking 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 to 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 cause a red-brown discoloration of urine after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Consult your doctor before starting Mezavant

• If you have any kidney or liver problems.
• If you have previously had inflammation of the heart (which could be due to an infection in the heart).
• If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after using Mezavant.
• If you have previously had an allergic reaction 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 functioning properly and that your blood is healthy.

Kidney stones may form with the use of Mezavant. Symptoms may include pain in the sides of the abdomen and blood in the urine. Take care to drink an adequate amount of fluid during treatment with Mezavant.

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with Mezavant treatment. If you experience any of the symptoms related to these severe skin reactions described in section 4, stop taking Mezavant immediately and seek urgent medical attention.

Consult your doctor:

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

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 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 need to take any other medicine containing:

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

Taking Mezavant with food and drink

Mezavant should be taken with food at the same time each day. The tablets should be swallowed whole and must not be 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 advised by your doctor. Undesirable effects (including low blood counts (white blood cells, red blood cells, and platelets)) have been reported in infants born to mothers who took Mezavant during pregnancy. Diarrhea has been reported in infants of mothers taking Mezavant.

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

Interference with laboratory tests

If you are undergoing urine tests, it is important 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 using machines

It is unlikely that Mezavant will have any effect on the ability to drive or operate machinery.

Mezavant contains sodium

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

3. How to take Mezavant

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 2.4 g to 4.8 g (two to four tablets) taken 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 resolved and to prevent recurrence of episodes, your doctor should instruct you to take 2.4 g (two tablets) once daily.

For an acute episode of ulcerative colitis (during 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) taken once daily.

To prevent 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) taken once daily.

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

While taking this medicine, make sure you drink fluids to stay well hydrated, especially after severe or prolonged episodes of vomiting or diarrhoea, high fever, or excessive sweating.

Mezavant is not recommended for children and adolescents weighing 50 kg or less, or for children under 10 years of age, due to 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, dyspnoea, excessive fluid loss (associated with sweating, diarrhoea 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 department immediately. Bring the tablet packaging with you.

If you forget to take Mezavant

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately

• If you experience symptoms such as cramps, severe stomach pain, bloody and excessive bowel movements (diarrhea), fever, headache, or skin rash. These symptoms could indicate acute intolerance syndrome, which may occur during an acute episode of ulcerative colitis. This is a serious condition that occurs infrequently but requires immediate discontinuation of treatment.
• If you develop unexplained bruising (without injury), skin rash, anemia (feeling tired and weak, and looking pale, especially in the lips, nails, and inner lining of the eyelids), fever (high temperature), sore throat, or unusual bleeding (e.g., nosebleeds).
• If you notice non-elevated red spots resembling targets or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers, widespread rash, fever, and swollen lymph nodes. These serious skin rashes may be preceded by fever and flu-like symptoms.
• If you experience allergic swelling of the tongue, lips, and around the eyes.
• If you have severe or recurrent headaches, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).

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

Uncommon side effects, observed in less than 1 in 100 patients, are: decreased number of blood platelets, increasing the risk of bleeding and bruising; dizziness; feeling sleepy or tired; tremors or abnormal involuntary movements; ear pain; increased heart rate; sore throat; inflammation of the pancreas (associated with pain in the upper abdomen and back, and nausea); rectal polyp (a non-cancerous growth in the final part of the large intestine causing symptoms such as constipation and bleeding); acne; hair loss; muscle pain; hives; facial swelling.

Rare side effects, observed in less than 1 in 1000 patients, are: kidney failure; severe reduction in white blood cells increasing the likelihood of infection; increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

The following side effects have been reported but their frequency is unknown:

Severe decrease in blood cells that may cause weakness or bruising; low counts of blood cells; allergic reaction (hypersensitivity); severe allergic reaction causing difficulty breathing or dizziness; serious illness with blistering of the skin (which may lead to skin peeling and painful raw areas), mouth, eyes, and genitals; allergic reaction causing skin rash, fever, and inflammation of internal organs; neuropathy (abnormalities or damage to nerves causing numbness and tingling sensations); inflammation of the heart and heart lining; lung inflammation; breathing difficulty or wheezing; gallstones; hepatitis (liver inflammation causing flu-like symptoms and jaundice); hepatotoxicity (liver damage which may present as abnormal liver tests); allergic swelling of the tongue, lips, and area around the eyes; redness of the skin; skin rash usually on the face, skin sensitivity to sunlight together with joint pain, arthritis, fatigue, and general malaise; kidney problems (such as inflammation and scarring of the kidneys); kidney stones and associated pain (see also section 2); reversible decrease in sperm production.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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
• Keep in the original packaging to protect from moisture
• Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date is the last day of the month indicated

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Mezavant

The active substance is 1,200 mg of mesalazine.

The other components are sodium carboxymethylcellulose; carnauba wax; stearic acid; colloidal anhydrous silica; sodium starch glycolate (type A) (derived 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 sizes

Mezavant is supplied in blister strips with foils inside a cardboard box. The pack contains 60 or 120 tablets. Only certain pack sizes may be marketed. The reddish-brown tablets are oval-shaped (dimensions are 20.5 × 9.5 × 7.5 mm) and are imprinted with S476.

Marketing Authorisation Holder and Manufacturer

Further information about this medicinal product can be requested from the local representative of the marketing authorization holder:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, 9th floor,

Edificio Los Cubos

28027 Madrid

Spain

Tel: +34 91 790 42 22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 01/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/