Mesavancol

Package leaflet: Information for the user

MESAVANCOL 1200 mg prolonged-release gastro-resistant tablets

(mesalazine)
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. Never give it to other people, even if their symptoms are the same as yours.
• If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What MESAVANCOL is and what it is used for

Pharmacotherapeutic category: Aminosalicylic acid and analogues
MESAVANCOL, in prolonged-release gastro-resistant tablets, contains the active substance mesalazine,
an anti-inflammatory drug used to treat ulcerative colitis.
Ulcerative colitis is a disease affecting the colon (large intestine) and rectum, in which the inner lining
of the intestine becomes red and swollen (inflamed), causing symptoms such as frequent bowel movements and bloody stools,
often accompanied by stomach cramps.
When administered during an acute episode of ulcerative colitis, MESAVANCOL acts throughout the entire colon and rectum to treat inflammation and reduce symptoms. The tablets can also be taken to help prevent recurrence of ulcerative colitis.

2. What you should know before taking MESAVANCOL

Do not take MESAVANCOL

• If you are allergic (hypersensitive) to a class of medicines known as salicylates (which includes aspirin).
• If you are allergic (hypersensitive) to mesalazine or to any of the excipients of this medicine (listed in section 6 of this leaflet).
• If you have severe kidney or liver problems.

Warnings and precautions
Talk to your doctor before using MESAVANCOL:

• If you have any kidney or liver problems.
• If you have previously had inflammation of the heart (which could be the result of a cardiac infection).
• If you have previously had allergies to sulfasalazine (another medicine used to treat ulcerative colitis).
• If you have a narrowing or blockage of the stomach or intestine.
• If you have lung problems.
• If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Exercise particular caution with mesalazine:

• If you experience severe or recurrent headache, vision disturbances, ringing or buzzing in the ears, contact your doctor immediately;
• Serious skin adverse reactions have been reported with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Discontinue use of mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Before and periodically during treatment with MESAVANCOL, your doctor may request urine and blood tests to ensure that your kidneys and liver are functioning properly and that blood parameters are normal.
Treatment with mesalazine should be discontinued if kidney function worsens.
Use of mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink an adequate amount of fluids during treatment with mesalazine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum recommended dose (4 tablets), i.e. essentially "sodium-free".
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction occurring between mesalazine and bleach.

Children and adolescents
MESAVANCOL is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

Other medicines and MESAVANCOL
Studies have shown that MESAVANCOL does not interfere with the following antibiotics used to treat infections: amoxicillin, metronidazole, or sulfamethoxazole.
However, MESAVANCOL may interact with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Mesalazine or sulfasalazine (for the treatment of ulcerative colitis).
• Non-steroidal anti-inflammatory drugs (e.g. medicines containing aspirin, ibuprofen, or diclofenac).
• Azathioprine or 6-mercaptopurine, or any other medicine known to affect bone marrow function (known as "immunosuppressants", medicines that reduce the activity of your immune system). Bone marrow is the tissue inside your bones that produces blood cells.
• Coumarin anticoagulants (medicines that prolong blood clotting time), for example warfarin.

MESAVANCOL with food and drink
MESAVANCOL should be taken at the same time every day with meals. The tablets must be swallowed whole; do not chew or crush the tablets.

Pregnancy and breastfeeding
Since mesalazine crosses the placenta during pregnancy and is excreted in small amounts in breast milk, use MESAVANCOL during pregnancy or breastfeeding only on medical advice.
Adverse outcomes [including low blood cell counts (white blood cells, red blood cells, and platelets)] have been reported in newborns born to mothers who took MESAVANCOL during pregnancy.
Diarrhea has been reported in breastfed infants of mothers taking MESAVANCOL.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking MESAVANCOL.

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 the results of certain tests.

Driving and using machines
It is unlikely that MESAVANCOL will affect your ability to drive or operate machinery.

3. How to take MESAVANCOL

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
The recommended dose for adults is 2.4 g - 4.8 g (two to four tablets) to be taken once daily for an acute episode of ulcerative colitis. If you are taking the higher dose of 4.8 g/day, your doctor should examine you after 8 weeks of treatment.
Once your symptoms have resolved and to help prevent recurrence of another episode, your doctor may prescribe 2.4 g (two tablets) to be taken once daily.
Remember to take your tablets at the same time every day with meals. The tablets must be swallowed whole and must not be chewed or crushed.
During treatment with this medicine, ensure you drink sufficient fluids to stay well hydrated, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever, or excessive sweating.
MESAVANCOL is not recommended for children and adolescents under 18 years of age due to lack of data on safety and efficacy.

If you take more MESAVANCOL than you should
If you take too much MESAVANCOL, you may experience one or more of the following symptoms: tinnitus (ringing or buzzing in the ears), dizziness, headache, confusion, drowsiness, shortness of breath, excessive fluid loss (associated with sweating, diarrhoea, and vomiting), decreased blood sugar levels (which may cause feeling unwell), rapid breathing, changes in blood chemistry, and increased body temperature.
If you take too many tablets, contact a doctor, pharmacist, or emergency services immediately. Bring the tablet packaging with you.

If you forget to take MESAVANCOL
It is important that you take your MESAVANCOL tablets every day, even when you do not have symptoms of ulcerative colitis. You should always complete the prescribed course of treatment.
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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Serious side effects
Stop treatment with mesalazine and contact your doctor immediately if you experience any of the following symptoms:
reddish, flat patches on the trunk, target-shaped or circular, often with central blisters,
skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever, and swollen lymph nodes.
These severe skin rashes may be preceded by fever and flu-like symptoms.
Contact your doctor immediately

• If you experience severe or recurrent headache, vision disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).
• If you develop symptoms such as cramps, severe stomach pain, excessive bowel movements (diarrhea) with blood, fever, headache, or rash. These symptoms could indicate Acute Intolerance Syndrome, which may occur during an acute episode of ulcerative colitis. This is a rare but serious condition indicating that treatment must be stopped immediately.
• If you develop unexplained bruising (without trauma), rash, anaemia (feeling tired, weak, and pale appearance, especially in the lips, nails, and inside the eyelids), fever (elevated temperature), sore throat, or unusual bleeding (e.g. nosebleeds).
• If you develop allergic swelling of the tongue, lips, or around the eyes.
• If you develop increased intracranial pressure causing headache, which may originate behind the eyes and worsen with eye movement, along with blurred or hazy vision, double vision, perception of flashing lights, problems with peripheral vision, and temporary or permanent vision loss. These side effects may be accompanied by dizziness, nausea, vomiting, and perception of ringing in the ears.

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects, occurring in less than 1 in 10 patients: headache; changes in blood pressure values, flatulence (excessive passage of gas through the rectum), nausea (feeling unwell), bloating or stomach pain, inflammation causing abdominal pain or diarrhoea; diarrhoea, indigestion, vomiting, abnormal liver function tests, skin itching, rash, joint pain, back pain, weakness, fatigue (excessive tiredness); fever (elevated temperature).
Uncommon side effects, observed in less than 1 in 100 patients: reduced platelet count increasing the risk of bleeding and bruising; dizziness; drowsiness or fatigue; tremors or shaking; ear pain; increased heart rate; sore throat; inflammation of the pancreas (associated with pain in the upper abdomen and back and feeling unwell); rectal polyp (a benign tumour in the rectum which may cause symptoms such as constipation and/or bleeding); acne; hair loss; muscle pain; urticaria; facial swelling.
Rare side effects, observed in less than 1 in 1,000 patients: kidney failure, severe reduction in white blood cells increasing the likelihood of infections, increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).
The following side effects have been reported, but their frequency is unknown:
severe decrease in blood cells causing weakness or bruising; reduction in blood cells; allergic reaction (hypersensitivity); severe allergic reaction causing difficulty breathing or dizziness; serious illness with blistering of the skin, mouth, eyes, and genitals; allergic reaction causing rash, fever, and inflammation of internal organs; neuropathy (nerve disorder or damage causing numbness and tingling); inflammation of the heart and the outer lining of the heart; lung inflammation; difficulty breathing or wheezing; gallstones; hepatitis (liver inflammation causing flu-like symptoms and jaundice); hepatotoxicity (liver damage which may present with abnormal liver tests); allergic swelling of the tongue, lips, and area around the eyes; skin redness; rash usually on the face, skin sensitivity to sunlight with joint pain, arthritis, fatigue and general malaise, kidney problems (such as kidney inflammation and kidney damage); kidney stones and associated kidney pain (see also section 2), reversible reduction in sperm production.
If you experience any side effect, contact your doctor. This includes any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MESAVANCOL

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Medicines should not be disposed of 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 MESAVANCOL contains
The active substance is Mesalazine 1200 mg.
The excipients are: Sodium carboxymethylcellulose; Carnauba wax; Stearic acid; Hydrated colloidal silica; Sodium starch glycolate (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.

Description of the appearance of MESAVANCOL and package contents
MESAVANCOL is available in aluminum-coated blisters, contained in a cardboard box. The package may contain either 60 or 120 tablets.
It is possible that not all pack sizes are marketed.
The red-brown tablets are oval-shaped and marked with the code S476.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Giuliani S.p.A.
Via P. Palagi 2, 20129 Milan
Italy
Tel: +39 0220541
Fax: +39 0236167235

Manufacturer
Cosmo S.p.A.
Via C. Colombo 1, 20045 Lainate (MI)
Italy

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