Mesalazine Mylan Generics

Package leaflet: Information for the patient

Mesalazina Mylan Generics 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets

mesalazine
Generic Medicine
Read this leaflet carefully before you start using 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Mesalazina Mylan Generics is and what it is used for

Mesalazina Mylan Generics contains the active substance mesalazine, used to treat inflammatory bowel diseases.
Mesalazina Mylan Generics is used for the treatment of ulcerative colitis and Crohn's disease.
This medicine is used both for treating active disease and for preventing relapses.

2. What you should know before using Mesalazina Mylan Generics

Do not use Mesalazina Mylan Generics

• if you are allergic to mesalazine, salicylates, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney or liver problems;
• if you have stomach or intestinal ulcers (lesions);
• if you have a tendency to bleed easily (hemorrhagic diathesis);
• if you are in the last weeks of pregnancy;
• if you are breastfeeding;
• in children under 2 years of age. In children under 6 years of age, your doctor will evaluate whether treatment is necessary (see section “Children”).

Contact your doctor before using mesalazine if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Warnings and precautions

Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite, a component of bleach present in toilet water. This is due to a harmless chemical reaction between mesalazine and bleach.

Serious skin adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported during treatment with mesalazine. Stop taking mesalazine and contact your doctor immediately if you experience any of the symptoms related to these serious skin reactions described in section 4.

Mesalazine use may lead to kidney stone formation. 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.

After stopping treatment or during inadequate maintenance therapy, symptoms of the disease may reappear.

Talk to your doctor or pharmacist before using Mesalazina Mylan Generics.

Be especially careful and inform your doctor:

• if you have liver problems, as increased liver enzyme levels have been reported in patients treated with mesalazine-containing formulations;
• if you are taking oral hypoglycemic agents, diuretics, coumarins, or corticosteroids;
• if you have unusually slow gastric digestion or a narrowing of the opening between the stomach and intestine (pyloric stenosis), as the medicine may cause gastric irritation and may lose its effectiveness. Symptoms of the disease may recur after stopping treatment with Mesalazina Mylan Generics or during inadequate maintenance therapy;
• if you develop unexplained bleeding, blood collections in tissues (hematomas), reddish spots on the skin (purpura), reduced hemoglobin levels in the blood (anemia), fever, or sore throat, as rare cases of serious blood disorders have been reported following mesalazine treatment. If such a disorder is suspected, treatment must be stopped and comprehensive blood tests should be performed;
• if you have kidney problems;
• if you suffer from asthma or have lung problems;
• if you have previously had an allergic reaction to medicines containing sulfasalazine, a substance similar to mesalazine;
• if you have inflammation of the heart or the membrane surrounding the heart (myocarditis or pericarditis).

Before starting and during treatment, your doctor may decide to monitor you closely and may regularly perform blood and urine tests.

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

Stop taking Mesalazina Mylan Generics immediately if you experience cramps and abdominal pain, bloody diarrhea, fever, severe headache, or skin rash.

If you use this medicine for a long time, sensitization reactions may occur.

Children

Mesalazina Mylan Generics is contraindicated in children under 2 years of age (see section “Do not use Mesalazina Mylan Generics”).

Mesalazina Mylan Generics is not recommended for use in children under 6 years of age unless carefully evaluated by a doctor.

Other medicines and Mesalazina Mylan Generics

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take this medicine together with medicines containing lactulose, as they may cancel the effect of Mesalazina Mylan Generics.

Be especially careful and inform your doctor if you are taking:

• medicines that lower blood sugar levels, such as oral hypoglycemics (sulfonylureas);
• medicines for blood clotting disorders (anticoagulants) such as coumarins, especially warfarin;
• methotrexate, a medicine used to treat certain cancers and autoimmune diseases;
• probenecid or sulfinpyrazone, medicines used to lower blood uric acid levels;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• medicines used to treat inflammation and pain known as non-steroidal anti-inflammatory drugs (e.g., salicylates);
• azathioprine, 6-mercaptopurine, or thioguanine, used to treat certain autoimmune diseases;
• corticosteroids, used for inflammation.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Mesalazina Mylan Generics during the last weeks of pregnancy.

During the first part of pregnancy, take Mesalazina Mylan Generics only if clearly needed and under direct medical supervision.

Breastfeeding

Do not take Mesalazina Mylan Generics if you are breastfeeding, as this medicine passes into breast milk.

Driving and using machines

Mesalazina Mylan Generics does not affect the ability to drive or use machinery.

Mesalazina Mylan Generics contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Mesalazina Mylan Generics contains sodium

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

3. How to use Mesalazina Mylan Generics

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you the dose recommended for you.
Adults
The recommended dose is 1–2 tablets of 400 mg or 1 tablet of 800 mg, three times
daily. Your doctor may increase the dose according to need.
Swallow the tablets whole, without dividing or chewing them, preferably with a glass
of water and taken away from meals.
Do not exceed the recommended dose without consulting your doctor. It is advisable to start with the lowest dose.
If the disease is active, the duration of treatment is usually 6–12 weeks. Your doctor
may adjust the duration of treatment if necessary.
Use in children and adolescents
Mesalazina Mylan Generics is contraindicated in children under 2 years of age. Mesalazina
Mylan Generics is not recommended for use in children under 6 years of age. After careful evaluation, your doctor may decide to administer reduced doses.
Children and adolescents aged between 6 and 18 years
Your doctor will advise you on the recommended dose to administer to your child.
If you take more Mesalazina Mylan Generics than you should
If you (or someone else) have ingested an excessive amount of tablets, or if you think a child
has ingested any tablets, consult a doctor immediately or go to the nearest
hospital emergency department.
Take this leaflet, the blister pack, and the container with you to the hospital or doctor so that
they know which medicine has been taken.
If you forget to take Mesalazina Mylan Generics
Do not take a double dose to make up for a forgotten dose, but resume your normal
dosing schedule as indicated.
If you stop treatment with Mesalazina Mylan Generics
After stopping treatment, symptoms may recur (see section “Warnings and precautions”).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop treatment with mesalazine and contact your doctor immediately if you notice any of the following symptoms:

• flat, red 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 serious skin reactions may be preceded by fever and flu-like symptoms. Immediately discontinue taking Mesalazina Mylan Generics if you develop a skin rash, itching, abdominal cramps and pain, bloody diarrhoea, fever, or severe headache. Inform your doctor immediately if you experience severe or recurrent headache, visual disturbances, ringing or buzzing in the ears. These may be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension) [Frequency not known (frequency cannot be estimated from the available data)].

The following side effects may occur during treatment with Mesalazina Mylan Generics:
Common (may affect up to 1 in 10 people):

• weakness, fever;
• headache;
• increased blood pressure (hypertension);
• nausea, diarrhoea, abdominal distension;
• skin rash.

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

• fatigue, facial swelling;
• drowsiness, tremor;
• increased heart rate (tachycardia);
• decreased blood pressure (hypotension);
• abdominal pain;
• itching.

Rare (may affect up to 1 in 1,000 people):

• dizziness;
• inflammation of the heart or of the membrane surrounding the heart (pericarditis or myocarditis);
• presence of gas in the intestine (flatulence);
• vomiting;
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).

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

• high fever;
• a rare type of anaemia in which the number of red blood cells, white blood cells, and platelets is reduced (aplastic anaemia);
• reduced number of white blood cells in the blood (agranulocytosis, neutropenia, leucopenia);
• reduced number of platelets in the blood (thrombocytopenia);
• reduced number of all blood cells (pancytopenia);
• numbness or weakness of arms and legs (peripheral neuropathy);
• difficulty breathing, cough, bronchial narrowing, inflammation of the alveoli and lungs (bronchospasm, alveolitis, pulmonary eosinophilia, pulmonary infiltration, and pneumonia);
• inflammation of the pancreas (acute pancreatitis);
• gallstones (cholelithiasis);
• kidney problems including kidney inflammation (interstitial nephritis), kidney and urinary disorders (nephrotic syndrome), and reduced kidney function (acute and chronic renal failure);
• hair loss (alopecia);
• muscle and joint pain (myalgia and arthralgia);
• skin allergic reactions (rash), drug fever, a type of autoimmune disease (lupus erythematosus syndrome), inflammation of the colon (pancolitis);
• liver disease (hepatitis), changes in certain liver parameters (transaminases and cholestasis);
• reduced number of sperm in the ejaculate (oligospermia).

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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 . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Mesalazina Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C and protect from direct sunlight.
Do not dispose of any medicine 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 Mesalazina Mylan Generics contains
400 mg gastro-resistant tablets

• The active substance is mesalazine. Each gastro-resistant tablet contains 400 mg of mesalazine.
• The other components are: lactose, povidone, sodium croscarmellose, magnesium stearate, methacrylic acid copolymers (Eudragit FS 30D), triethyl citrate, talc, red iron oxide, macrogol 6000, sodium hydroxide.

800 mg gastro-resistant tablets

• The active substance is mesalazine. Each gastro-resistant tablet contains 800 mg of mesalazine.
• The other components are: lactose, povidone, sodium croscarmellose, magnesium stearate, methacrylic acid copolymers (Eudragit FS 30D), triethyl citrate, talc, red iron oxide, macrogol 6000, sodium hydroxide.

Description of the appearance of Mesalazina Mylan Generics and package contents
Pack size: 60 tablets of 400 mg.
Pack size: 60 tablets of 800 mg.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)