MESALAZINA 400 mg Enteric-Coated Tablet

Зміст інструкції

1. Mesalazina Dorom 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets
   1. What is Mesalazina Dorom and what is it used for
   2. What you need to know before taking Mesalazina Dorom
   3. How to take Mesalazina Dorom
   4. Possible side effects
   5. How to store Mesalazina Dorom
   6. Contents of the pack and other information

Mesalazina Dorom 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets

mesalazine

Generic medicine

Read this leaflet carefully before you start 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, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Mesalazina Dorom and what is it used for

Mesalazina Dorom is a medication that contains mesalazine, a substance with anti-inflammatory activity that acts on the terminal part of the intestine. This medicine is, in fact, used to reduce symptoms and to prevent complications and relapses in diseases, such as

Ulcerative Colitisand Crohn's Disease, in which the intestine is particularly inflamed and may present even severe lesions.
In the treatment of acute phases of these diseases, the doctor may advise you to combine the use of Mesalazina Dorom with the use of other anti-inflammatory drugs called corticosteroids.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Mesalazina Dorom

Do not take Mesalazina Dorom

• if you are allergic to the active ingredient, to similar substances (salicylates) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from diseases of the stomach or the first part of the intestine characterized by open bleeding wounds (gastric, duodenal ulcers or peptic ulcer);
• if you suffer from severe kidney or liver diseases;
• if you have a personal predisposition to bleeding (haemorrhagic diathesis);
• to administer it to children under the age of 6 years;
• in the last weeks of pregnancy and during breastfeeding.

Tell your doctor before using mesalazine

• if you have ever developed a severe skin rash or exfoliation of the skin, blisters and/or ulcers in the mouth after using mesalazine.

Warnings and precautions
Consult your doctor or pharmacist before taking Mesalazina Dorom.
In the active phases of severe illnesses, your doctor may decide to combine the use of
mesalazine with other potent anti-inflammatory drugs called corticosteroids,administered systemically
(i.e. in a way that the drug can generally reach all districts of the body).
It is possible that the symptoms of the disease may reappear after stopping treatment or
during maintenance treatment, if it is inadequate.
In patients who have particularly slow digestion and in those with a narrowing
of the valve between the stomach and the intestine (pyloric stenosis), it is possible that the release of
mesalazine, from the tablet, occurs partially in the stomach instead of directly
in the intestine. This phenomenon can cause irritation of the stomach wall and a decrease
in the effectiveness of the drug.
Mesalazine may cause a reddish-brown discoloration of the urine after contact with sodium hypochlorite
contained in the bleach present in the toilet water. This is caused by a harmless chemical
reaction that occurs between mesalazine and bleach.
Discontinue treatment promptly (see also section “Possible side effects”):

• if allergic-type reactions occur;
• in the case of suspected acute intolerance syndrome which can manifest with symptoms such as, cramps, acute abdominal pain and diarrhea with blood, sometimes fever, headache and erythema.

In case of severe or recurrent headache, visual disturbances, ringing or whistling in the ears, contact
your doctor immediately.
Take special care with mesalazine
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Stop using mesalazine and
consult your doctor immediately if you observe any of the symptoms related to these serious
skin reactions described in section 4.
Before starting therapy with mesalazine, your doctor will subject you to all the necessary tests for
a correct diagnosis of the disease (e.g. blood and urine tests).
It is possible that your doctor will decide to subject you to regular checks, even during therapy, to
check your state of health, for example if you suffer from lung diseases such as
asthma, if you have previously experienced side effects after taking sulfasalazine.
The use of mesalazine can cause the formation of kidney stones. Symptoms may include pain
on the sides of the abdomen and blood in the urine. It is recommended to drink a sufficient amount of fluids
during treatment with mesalazine.
The doctor will carefully assess your state of health and will prescribe mesalazine only if
actually necessary, especially if you suffer from kidney or liver problems, if you suffer from diseases
of the heart affecting the myocardium and pericardium (myocarditis or pericarditis), if you are already taking
drugs for diabetes (oral hypoglycemic agents), drugs that help eliminate excess fluids with
urine (diuretics), anticoagulant drugs that help fluidify the blood (coumarins) and
anti-inflammatory drugs (corticosteroids). See also the following section “Other medicines and
Mesalazina Dorom”.
Prolonged use may give rise to sensitization phenomena (allergies). If you have any
doubts about the use of this medicine, consult your doctor or pharmacist.

Children and adolescents
Avoid using the medicine in children under the age of 6 years.

Other medicines and Mesalazina Dorom
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Taking mesalazine may enhance the effect of the following medicines:

• drugs used to treat diabetes (such as sulfonylureas).

Taking mesalazine may interfere with the correct functioning of the following medicines:

• anticoagulant drugs that help fluidify the blood (coumarins);
• anticancer drugs (methotrexate);
• drugs used to treat or prevent gout (probenecid and sulfinpyrazone);
• diuretic drugs that help eliminate excess fluids with urine (spironolactone and furosemide);
• some antibiotics (rifampicin);
• non-steroidal anti-inflammatory drugs (NSAIDs);
• azathioprine (a drug with anti-inflammatory and immunosuppressive action).

Mesalazina Dorom should not be taken together with lactulose (a sugar often used to
solve constipation problems) or other substances capable of lowering the pH of the intestine, as
this phenomenon may hinder the release of mesalazine from the tablet.
In cases of severe colitis, when treatment with mesalazine is associated with the use of corticosteroids, it is
possible that the same increases the side effects caused by corticosteroids on the stomach. In
particular, the doctor may decide to combine the use of corticosteroids with that of mesalazine
topically.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Mesalazine should not be taken in the last weeks of pregnancy. In the other weeks it will be
prescribed by your doctor only if actually necessary and under his strict control.

Breastfeeding
Mesalazine should not be taken during breastfeeding.

Driving and operating machinery
This medicine does not alter the ability to drive vehicles and operate machinery.

Mesalazina Dorom contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (per 400 mg or
800 mg tablet), i.e. essentially “sodium-free”.

3. How to take Mesalazina Dorom

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor will adjust the dosage based on the extent and severity of your condition.
If you are starting treatment with mesalazine for the first time, you will need to reach the complete
dose after a few days of therapy, gradually increasing the dosage.

Use in adults
The recommended dose is 1 - 2 tablets of 400 mg or one 800 mg tablet 3 times a
day.
In more severe forms, the dose may be increased to 10 tablets of 400 mg or 5
tablets of 800 mg per day.
The dose may change according to your doctor's prescription.

Active phase of the disease
The maximum total dose should not exceed 4 g per day.

Maintenance treatment of the disease
A total dose of 2 g per day is recommended.

Use in children and adolescents (aged 6 years and over, up to 18 years)
It is generally recommended that half the adult dose can be given to children weighing
up to 40 kg and the normal adult dose to those weighing over 40 kg .

Acute phase of the disease
The recommended dose will be established by the doctor. As a rule, treatment is started with 30 - 50 mg/kg per day in divided doses. The usual maximum dose is 75 mg/kg per day in divided doses.
The total dose should not exceed 4 g per day.

Maintenance phase of the disease
The recommended dose will be established by the doctor. As a rule, treatment is started with 15 - 30 mg/kg per day in divided doses. The total dose should not exceed 2 g/kg per day.
Take the tablets whole, without breaking or chewing them, preferably with a glass of water and
away from meals.

Duration of treatment
The duration of treatment for acute phases is on average 4-6 weeks, but may vary depending on
your doctor's judgement, based on your state of health. In case of long-term treatment to
prevent relapses, the daily dose will be established by the doctor based on the course of the disease.

If you take more Mesalazina Dorom than you should
Inform your doctor, pharmacist or go to the nearest hospital if you (or someone else) should
take an excessive amount of the medicine; bring this leaflet with you.

If you forget to take Mesalazina Dorom
Do not take a double dose to make up for a missed tablet.

If you stop taking Mesalazina Dorom
Ask your doctor for advice before stopping treatment with mesalazine.
If you have any doubts about 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.

Stop treatment with mesalazine and contact your doctor immediatelyif you notice any of the
following symptoms:

• reddish-purple skin rash that is not raised, often with a target or circular shape, often with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes,

widespread rash, fever and swollen lymph nodes. These severe skin rashes can be preceded by fever and flu-like symptoms;

• symptoms of a severe allergic reaction such as: difficulty breathing, swelling of the face, eyes, mouth or throat;
• episodes of severe intestinal intolerance with abdominal pain, bloody diarrhoea, cramps, fever, headache and rash.

Tell your doctor immediately if you experience severe or recurrent headache, vision disturbances, ringing or
whistling in the ears. These may be symptoms of increased pressure inside the skull (idiopathic intracranial
hypertension) (the frequency cannot be defined on the basis of available data).

During the use of mesalazine, the following side effects may occur:
Common(may affect up to 1 in 10 people):

• headache*;
• skin reactions;
• nausea*;
• diarrhoea*;
• abdominal tension;
• feeling of strong fatigue (asthenia);
• fever;
• hypertension.

Uncommon(may affect up to 1 in 100 people):

• tachycardia;
• drowsiness;
• tremor;
• pruritus;
• pain in the upper abdomen (epigastralgia);
• bloody diarrhoea;
• abdominal pain*;
• fatigue;
• fluid retention in the face (facial edema);
• hypotension.

Rare(may affect up to 1 in 1000 people):

• heart inflammation (myocarditis, pericarditis);
• dizziness;
• flatulence;
• vomiting;
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).

Very rare(may affect up to 1 in 10,000 people):

• allergic reaction (e.g. allergic dermatitis);
• drug fever (increase in body temperature that occurs at the same time as taking a medicine, and which disappears as soon as the medicine is stopped);
• development of a chronic autoimmune disease called Systemic Lupus Erythematosus or similar conditions (lupoid syndrome);
• inflammation of the colon (colitis);
• changes in the number of blood cells (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia);
• nerve disorders (peripheral neuropathy);
• hair loss (alopecia);
• changes in liver function tests (elevated transaminases and cholestasis);
• hepatitis (including cholestatic hepatitis);
• inflammation of the pancreas (pancreatitis and acute pancreatitis);
• kidney problems (tubulo-interstitial nephritis, nephrotic syndrome, renal failure);
• respiratory disease characterized by hardening of the tissue (pulmonary fibrosis and other symptoms including dyspnoea, cough, bronchospasm, alveolitis, eosinophilic pneumonia, pulmonary infiltration, pneumonia and interstitial lung disease);
• painful muscle syndrome (myalgia);
• joint pain (arthralgia);
• decreased number of spermatozoa in semen (oligospermia);
• very high fever (hyperpyrexia);
• gallstones (cholelithiasis).

*especially in patients who do not tolerate similar substances such as salicylazosulfapyridine.

Not known(the frequency cannot be estimated from the available data):

• excessive fluid accumulation (angioedema);
• kidney stones and associated kidney pain (see also section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. 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 Mesalazina Dorom

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Mesalazina Dorom contains

• The active ingredient is mesalazine. One gastro-resistant tablet contains 400 mg or 800 mg of mesalazine.
• The other ingredients are: inside the tablet: maltodextrin, povidone, sodium lauryl sulfate, sodium carboxymethylcellulose (Type A), talc, magnesium stearate; in the tablet coating: polyacrylate dispersion 30 percent, sodium hydroxide, triethyl citrate, iron oxide red, iron oxide yellow, titanium dioxide, talc, macrogols.

Description of the appearance of Mesalazina Dorom and contents of the pack
Mesalazina Dorom 400 mg gastro-resistant tablets are presented in a box containing a blister
of 50 and 60 tablets.
Mesalazina Dorom 800 mg gastro-resistant tablets are presented in a box containing a blister
of 24 and 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – Via Grignano, 43 – 24041 Brembate (Bergamo)