Mezavant

Leaflet accompanying the packaging: information for the user

Mezavant, 1200 mg, prolonged-release gastro-resistant tablets

(Mesalazine)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Mezavant and what is it used for
• 2. Important information 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 is Mezavant and what is it used for

Pharmaco-therapeutic group: aminosalicylic acid and similar drugs.
Mezavant, prolonged-release gastro-resistant tablets, contain the active substance mesalazine, which is an anti-inflammatory drug used to treat ulcerative colitis.
Ulcerative colitis is a disease of the colon (large intestine) and rectum (back passage), in which the mucous membrane of the intestine becomes red and swollen (inflamed), resulting in frequent bloody stools, accompanied by stomach cramps.
When administered during an exacerbation of ulcerative colitis, Mezavant acts throughout the intestine and rectum, treating the inflammation and reducing symptoms. The tablets can also be taken to prevent the recurrence of ulcerative colitis.

2. Important information before taking Mezavant

When not to take Mezavant:

Warnings and precautions

Mesalazine may cause a reddish-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.
Before starting treatment with Mezavant, you should discuss this with your doctor

Before starting treatment with Mezavant and periodically during treatment, your doctor may take urine and blood samples to check if your kidneys and liver are working properly and if your blood count is normal.
Taking Mezavant may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. During treatment with Mezavant, you should drink plenty of fluids.
Severe skin reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with Mezavant treatment. If you notice any of the symptoms associated with these severe skin reactions, as described in section 4, you should stop taking Mezavant and consult your doctor immediately.

Children and adolescents

Mezavant is not recommended for use in children and adolescents with a body weight of 50 kg or less or in children under 10 years of age due to a lack of data on safety and efficacy (see section 3).

Mezavant and other medicines

Studies have shown that Mezavant does not affect the action of the following antibiotics used to treat infections: amoxicillin, metronidazole, and sulfamethoxazole.
However, Mezavant may interact with some other medicines.
Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

• Mesalazine or sulfasalazine (used to treat ulcerative colitis);
• Non-steroidal anti-inflammatory drugs (e.g., drugs containing acetylsalicylic acid (Aspirin), ibuprofen, or diclofenac);
• Azathioprine or 6-mercaptopurine or other drugs with a known effect on bone marrow function (known as immunosuppressive drugs, which reduce the activity of the body's immune system); bone marrow is the tissue inside the bones that produces blood cells.
• Anticoagulant drugs derived from coumarin (drugs that prolong the blood clotting time of the patient), e.g., warfarin.

Mezavant with food and drink

Mezavant should be taken with food, at the same time every day. The tablets should be swallowed whole. Do not crush or chew them.

Pregnancy and breastfeeding

Since mesalazine passes through the placenta during pregnancy and passes into human milk in small amounts, Mezavant should be used during pregnancy or breastfeeding only on the advice of a doctor. Cases of complications [including a decrease in the number of blood cells (white blood cells, red blood cells, and platelets)] have been reported in infants whose mothers took Mezavant during pregnancy. Cases of diarrhea have been reported in breastfed infants whose mothers took Mezavant.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking Mezavant.

Effect on laboratory test results

If you are going to have a urine test, remember to inform your doctor or nurse that you are taking this medicine, as it may affect the test results.

Driving and using machines

It is unlikely that Mezavant will affect your ability to drive or use machines.

Mezavant contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per maximum recommended dose (4 tablets), i.e., the medicine is considered "sodium-free".

3. How to take Mezavant

This medicine should always be taken exactly as advised by your doctor. If you are unsure, ask your doctor or pharmacist.
The recommended dose for adults is 2.4 g to 4.8 g (two to four tablets) taken once daily in the treatment of an acute episode of ulcerative colitis. If the highest daily dose of 4.8 g per day is taken, you should have a follow-up examination after 8 weeks of treatment. After symptoms have subsided, to prevent the recurrence of another episode, your doctor may recommend taking a dose of 2.4 g (two tablets) once daily.
In the treatment of an acute episode of ulcerative colitis (the first 8 weeks of treatment) in children and adolescents with a body weight over 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 the recurrence of another episode of ulcerative colitis in children and adolescents with a body weight over 50 kg and aged 10 years or older, the recommended dose is 2.4 g (two tablets) taken once daily.
Remember to take the tablets with food, at the same time every day. The tablets should be swallowed whole. Do not crush or chew them.
While taking this medicine, remember to drink plenty of fluids to keep your body hydrated, especially after severe or prolonged episodes of vomiting and (or) diarrhea, high fever, or excessive sweating.
Mezavant is not recommended for use in children and adolescents with a body weight of 50 kg or less or in children under 10 years of age due to a lack of data on safety and efficacy.

Taking a higher dose of Mezavant than recommended

After taking too much Mezavant, one or more of the following symptoms may occur: ringing in the ears (tinnitus), dizziness, headaches, disorientation, drowsiness, shortness of breath, excessive water loss (due to sweating, diarrhea, and vomiting), decreased blood sugar levels (which may cause dizziness), rapid breathing, changes in blood count, and elevated body temperature.
If you have taken too many tablets, contact your doctor, pharmacist, or hospital emergency department immediately. Take the packaging with you.

Missing a dose of Mezavant

It is important to take Mezavant tablets every day, even if you do not have symptoms of ulcerative colitis. Always finish the prescribed treatment course.
If you forget to take a tablet, take it as usual the next day. Do not take a double dose to make up for a missed tablet.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Tell your doctor immediately

• If you experience symptoms such as cramps, severe stomach pain, bloody or very frequent stools (diarrhea), fever, headache, or rash. These symptoms may indicate an acute intolerance syndrome, which may occur during an acute episode of ulcerative colitis. This is a serious condition that requires immediate discontinuation of the medicine.
• If you develop unexplained bruising (without injury), rash, anemia (feeling tired, weak, and pale, especially of the lips, nails, and inside of the eyelids), fever (high temperature), sore throat, or unusual bleeding (e.g., nosebleeds).
• If you develop red, flat, target-shaped or circular patches on the torso, often with blisters in the center, skin peeling, mouth sores, throat, nose, genital, and 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 swelling of the tongue, lips, and eyes on an allergic basis.
• If you experience increased intracranial pressure causing headache, which may start as pain behind the eyes and worsen with eye movement, as well as blurred or double vision, flashes of light in the field of vision, loss of peripheral vision, and transient or permanent loss of vision. These symptoms may be accompanied by dizziness, nausea, vomiting, and tinnitus.

Like all medicines, Mezavant can cause side effects, although not everybody gets them.
Common side effects, occurring in less than 1 in 10 patients: headache, changes in blood pressure, bloating (gas), nausea (nausea), bloated or painful stomach, inflammation causing abdominal pain or diarrhea, diarrhea, indigestion, vomiting, abnormal liver function test results, itching, rash, joint pain, back pain, weakness, fatigue (feeling of extreme tiredness), fever (high temperature).
Uncommon side effects, occurring in less than 1 in 100 patients: decreased platelet count, which increases the risk of bleeding and bruising; dizziness; feeling of drowsiness or fatigue; tremors or shaking; ear pain; rapid heartbeat; sore throat; pancreatitis (associated with abdominal and back pain and nausea); rectal polyp (a non-cancerous growth in the rectum, causing symptoms such as constipation and bleeding); acne; hair loss; muscle pain; hives; facial swelling.
Rare side effects, occurring in less than 1 in 1000 patients, include: kidney failure, significant decrease in white blood cell count, which increases the risk of infection, increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity).

Side effects with unknown frequency:

Significant decrease in blood cell count, which may cause weakness or bruising, low blood cell count; allergic reaction (hypersensitivity); severe allergic reaction causing difficulty breathing or dizziness; severe skin disease with blistering (which may cause skin peeling and formation of painful areas without skin), in the mouth, eyes, and genitals; allergic reaction causing skin rash, fever, and inflammation of internal organs; neuropathy (nerve damage or disorder causing numbness and tingling); myocarditis and pericarditis; pneumonia; breathing difficulties or wheezing; gallstones; hepatitis (associated with flu-like symptoms and jaundice); hepatotoxicity (liver damage, which may be indicated by abnormal liver test results); allergic swelling of the tongue, lips, and eyes; skin redness, rash, usually on the face, sensitivity to sunlight, and joint pain, arthritis, fatigue, and general malaise; kidney problems (such as inflammation and scarring of the kidneys); kidney stones and associated kidney pain (see also section 2); reversible reduction in sperm production.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of Adverse Reactions of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mezavant

• Keep the medicine out of the sight and reach of children.
• Store in a temperature below 25°C.
• Store 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 refers to the last day of the month.
• 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 other information

What Mezavant contains

The active substance is mesalazine 1200 mg.
The other ingredients are: sodium carmellose, carnauba wax, stearic acid, silica, colloidal, hydrated, sodium carboxymethylcellulose (Type A), talc, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), triethyl citrate, titanium dioxide (E171), iron oxide, red (E172), Macrogol 6000.

What Mezavant looks like and contents of the pack

Mezavant is available in blisters of Polyamide/Aluminum/PVC/Aluminum in a cardboard box. The pack contains 60 or 120 tablets. Not all pack sizes may be marketed.
The red-brown tablets are oval in shape (dimensions 20.5 × 9.5 × 7.5 mm) and have the marking S476.

Marketing authorization holder and manufacturer

Marketing authorization holder Manufacturer

Takeda Pharmaceuticals International AG
Ireland Branch
Block 2 Miesian Plaza

• 50 – 58 Baggot Street Lower Dublin 2, D02 HW68 Ireland Tel: +800 6683 8470 e-mail: [email protected] Cosmo SpA Via C. Colombo 1 20045 Lainate-Milan Italy

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

Date of last revision of the leaflet: 03/2023