MESAVANCOL 1200 mg Extended-Release Tablet

Зміст інструкції

1. MESAVANCOL 1200 mg prolonged-release gastro-resistant tablets
   1. What is MESAVANCOL and what is it 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

MESAVANCOL 1200 mg prolonged-release gastro-resistant tablets

(mesalazine)

Read this leaflet carefully before taking this medicine, as 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, even if their symptoms 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 this leaflet:

• 1. What MESAVANCOL is and what it is used for
• 2. What you need to know before you take 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 is MESAVANCOL and what is it used for

Pharmacotherapeutic category: Aminosalicylic acid and analogues
MESAVANCOL, in prolonged-release gastro-resistant tablets, contains the active ingredient 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, in which the inner lining
of the intestine becomes red and swollen (inflamed), with symptoms such as frequent bowel movements and stools mixed with
blood, accompanied by stomach cramps.
When administered for 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 the recurrence of ulcerative colitis.

2. What you need to know before taking MESAVANCOL

Do not take MESAVANCOL

• If you are allergic (hypersensitive) to a class of drugs known as salicylates (which includes aspirin).
• If you are allergic (hypersensitive) to mesalazine or 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 problems with your kidneys or liver.
• If you have previously had inflammation of the heart (which may be the result of a heart infection).
• If you have previously had allergies to sulfasalazine (another medicine used to treat ulcerative colitis).
• If you have a narrowing or closure of the stomach or intestine.
• If you have lung problems.
• If you have ever developed a severe skin rash or skin exfoliation, blisters and/or ulcers in the mouth after using mesalazine. Pay particular attention with mesalazine: serious skin adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with mesalazine treatment. Stop using mesalazine and contact your doctor immediately if you observe any of the symptoms related to these serious skin reactions described in paragraph 4.

Before and periodically during treatment with MESAVANCOL, your doctor may request urine and blood tests to verify that your kidneys and liver are working properly and that your blood tests are
normal.
The use of mesalazine may cause 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 a sufficient 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”.

Children and adolescents
MESAVANCOL is not recommended in children and adolescents under 18 years of age due to the
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.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicine.

• Mesalazine or sulfasalazine (for the treatment of ulcerative colitis).
• Non-steroidal anti-inflammatory drugs (for example, drugs containing aspirin, ibuprofen or diclofenac)
• Azathioprine or 6-mercaptopurine or any other medicine known to affect the work of the bone marrow (known as “immunosuppressants”, drugs that reduce the activity of your immune system). The bone marrow is the material inside your bones that produces blood cells.
• Cumarinic anticoagulants (medicines that increase the time it takes for blood to clot) for example warfarin.

MESAVANCOL with food and drink
MESAVANCOL should be taken at the same time each 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 as directed by your doctor.
Adverse outcomes [including a low number of blood cells (white blood cells, red blood cells and platelets)]
have been reported in newborns born to mothers who have taken MESAVANCOL during pregnancy.
Diarrhea has been reported in breastfed infants of mothers who have taken MESAVANCOL.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
ask your doctor if you can take MESAVANCOL.

Interference with laboratory tests
If you have undergone urine tests, it is important to inform your doctor or nurse that you are taking, or
have recently taken the medicine as it may affect the results of some tests.

Driving and operating machinery
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 your doctor has instructed. If you have any doubts, 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 a
day for an acute episode of ulcerative colitis. If you are taking the higher dose of 4.8 g/day, your doctor should
visit you after 8 weeks of treatment.
Once your symptoms have resolved and to help prevent the recurrence of another episode, your
doctor may prescribe 2.4 g (two tablets) to be taken once a day.
Remember to take your tablets at the same time each day with meals. The tablets must be
swallowed whole and should not be chewed or crushed.
During treatment with this medicine, make sure to drink fluids to stay well hydrated, especially
after severe or prolonged episodes of vomiting and/or diarrhea, high fever or heavy sweating.
It is not recommended to give MESAVANCOL to children and adolescents under 18 years of age due to
a lack of safety and efficacy data.

If you take more MESAVANCOL than you should
If you should 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 water
loss (associated with sweating, diarrhea and vomiting), decreased blood sugar levels (which can
cause feeling unwell), rapid breathing, changes in blood chemistry and increased
body temperature.
If you should take too many tablets, contact a doctor, pharmacist or
emergency room immediately. Bring the package of tablets with you.

If you forget to take MESAVANCOL
It is important that you take your MESAVANCOL tablets every day, even when you do not experience
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 a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Stop treatment with mesalazine and contact your doctor immediately if you notice any of the following symptoms:
reddish, non-raised patches on the trunk, target-shaped or circular, often with central blisters,
skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms.

Inform your doctor immediately

• If you experience symptoms such as cramps, severe stomach pain, excessive stools (diarrhea) and with blood, fever, headache or skin rashes. These symptoms may be a sign of Acute Intolerance Syndrome

which can occur during an acute episode of ulcerative colitis. This is a serious condition that occurs rarely, but indicates that treatment should be stopped immediately.

• If you develop unexplained bruising (without trauma), skin rashes, anemia (feeling tired, weak and pale, especially on the lips, nails and inside the eyelids), fever (temperature increase), sore throat or unusual bleeding (e.g. nosebleeds).
• If you develop allergic swelling of the tongue, lips and around the eyes.
• If you develop increased brain pressure resulting in headache, which can originate behind the eyes and worsen with eye movement, along with blurred and cloudy vision, double vision, perception of flashing lights, problems with side vision and temporary or permanent vision loss. These side effects may be accompanied by dizziness, nausea, vomiting and a ringing sensation in the ears.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects, which occur in less than 1 in 10 patients: headache; changes in blood pressure values, flatulence (excessive passage of gas through the rectum), nausea (feeling unwell), swelling or stomach pain, inflammation causing abdominal pain or diarrhea; diarrhea, indigestion, vomiting, abnormal liver function tests, skin itching, rash, joint pain, back pain, weakness, fatigue (excessive tiredness); fever (temperature increase).

Uncommon side effects, which have been observed in less than 1 in 100 patients: reduction of platelets which increases the risk of bleeding and bruising; dizziness; feelings of drowsiness or tiredness; 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 tumor in the rectum that can cause symptoms such as constipation and/or 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 the number of white blood cells which increases the likelihood of infections, increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

The following side effects have been reported, but it is not known exactly how often they occur:
severe decrease in the number of blood cells that can cause weakness or bruising; reduction of 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 skin rashes, fever and inflammation of internal organs; neuropathy (abnormality or damage to nerves causing a sensation of numbness and tingling); inflammation of the heart and the outer lining of the heart; lung inflammation; difficulty breathing or wheezing; gallstones; hepatitis (inflammation of the liver that produces flu-like symptoms and jaundice); hepatotoxicity (liver damage that can present with abnormal liver tests); swelling of an allergic nature of the tongue, lips and the area around the eyes; skin redness; rash generally on the face, skin sensitivity to sunlight with joint pain, arthritis, fatigue and general malaise, kidney problems (such as inflammation and kidney damage); kidney stones and associated kidney pain (see also paragraph 2), reversible reduction in sperm production.
If you get any side effect, talk to your doctor. This includes any possible side

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Store at a temperature below 25°C.
Store in the original packaging, to protect the medicine from moisture.
Do not use this medicine after the expiry date which is indicated on the packaging after "Expiry". The
expiry date refers to the last day of that month.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MESAVANCOL contains
The active ingredient is Mesalazine 1200 mg
The excipients are: Sodium carmellose; Carnauba wax; Stearic acid; Hydrated colloidal silica; Sodium starch-
glycolate (Type A); Talc; Magnesium Stearate; Acrylic acid-methyl methacrylate copolymer (1:1);
Acrylic acid-methyl methacrylate copolymer (1:2); Triethyl citrate; Titanium Dioxide (E171); Iron Oxide
Red (E172); Macrogol 6000.

Description of the appearance of MESAVANCOL and contents of the pack
MESAVANCOL is available in blister packs coated with aluminium, contained in a cardboard box. The
pack may contain 60 or 120 tablets.
Not all pack sizes may be marketed.
The reddish-brown tablets are oval in shape and bear the inscription S476.

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

Exclusive distributor for sales in Italy
Takeda Italia S.p.A.
Via Elio Vittorini 129, 00144 Rome
Italy

Manufacturer
Cosmo S.p.A.
Via C. Colombo 1, 20045 Lainate (MI)
Italy
This medicinal product is authorised in the Member States of the European Economic Area under the following
names: