Asamax 500

Leaflet accompanying the packaging: patient information

Asamax 250, 250 mg, enteric-coated tablets
Asamax 500, 500 mg, enteric-coated tablets
Mesalazine

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

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Keep this leaflet, so you can read it again if you need to.
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If you have any doubts, consult your doctor or pharmacist.
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This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Asamax 250 and Asamax 500 and what are they used for
• 2. Important information before taking Asamax 250 and Asamax 500
• 3. How to take Asamax 250 and Asamax 500
• 4. Possible side effects
• 5. How to store Asamax 250 and Asamax 500
• 6. Contents of the packaging and other information

1. What is Asamax 250 and Asamax 500 and what are they used for

Asamax 250 and Asamax 500 enteric-coated tablets contain the active substance mesalazine.
Mesalazine has a direct anti-inflammatory effect. Asamax 250 and Asamax 500 enteric-coated tablets inhibit the development of the disease process in the intestines.

Indications for use of Asamax 250 and Asamax 500

Mild to moderate ulcerative colitis, both in the acute and remission phases of the disease.
Crohn's disease in the colon, both in the acute and remission phases of the disease.

2. Important information before taking Asamax 250 and Asamax 500

When not to take Asamax 250 and Asamax 500

Warnings and precautions

Before starting mesalazine treatment, the patient should inform their doctor:

• if they have a history of myocarditis or pericarditis.
• if they have a history of liver or kidney disease.
• if they have a history of sulfa allergy.
• if they are taking any other medicines, including those not prescribed by a doctor.

if the patient experiences any of the following symptoms, they should stop taking mesalazine and seek medical attention immediately:
severe skin rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Before starting treatment with Asamax 250 and Asamax 500, the patient should discuss this with their doctor or pharmacist.

• Before starting treatment and during treatment, the doctor will recommend regular blood tests (blood count, liver and kidney function parameters). If serious blood count disorders occur, the doctor will stop the treatment.
• The doctor will exercise caution in patients with liver dysfunction.
• The medicine should not be taken by patients with kidney dysfunction. In patients who develop kidney failure during treatment, the possibility of mesalazine toxicity should be considered.
• The doctor will closely monitor patients with lung diseases, especially asthma.
• The doctor will closely monitor patients who have experienced side effects after taking sulfasalazine-containing medicines and will stop the treatment if they occur.
• taking mesalazine may lead to the development of kidney stones. Symptoms may include abdominal pain and hematuria. During mesalazine treatment, the patient should drink sufficient fluids.
• mesalazine may cause 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.

Children and adolescents

There are limited data on the use of mesalazine in children and adolescents (aged 6-18 years).

Asamax 250 and Asamax 500 and other medicines:

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In patients taking azathioprine, 6-mercaptopurine, or thioguanine, there is a possibility of increased bone marrow suppression. There is limited evidence that mesalazine may reduce the anticoagulant effect of warfarin.

Asamax 250 and Asamax 500 with food and drink:

Asamax 250 and Asamax 500 enteric-coated tablets should be taken after a meal, with a drink. Do not chew.

Pregnancy, breastfeeding, and fertility:

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Asamax 250 and Asamax 500 should be used during pregnancy only if the potential benefits outweigh the expected risks.
There are insufficient data on the use of mesalazine in pregnant women. Data from a limited number of pregnant women exposed to mesalazine did not show a negative effect on pregnancy, fetal health, or the newborn. Other epidemiological data are not available at present.
In a single case, after taking high doses of mesalazine (2-4 g orally) during pregnancy, renal failure was reported in the newborn.
Animal studies with oral mesalazine did not show a direct or indirect harmful effect on pregnancy, embryonic or fetal development, or newborn development.
Asamax 250 and Asamax 500 should be used during breastfeeding only if the potential benefits outweigh the expected risks.
N-acetyl-5-aminosalicylic acid and, to a lesser extent, mesalazine pass into breast milk in small amounts. To date, there are only limited data from breastfeeding women. In breastfed infants, it is not possible to exclude hypersensitivity reactions such as diarrhea. If diarrhea occurs in a breastfed infant, breastfeeding should be discontinued.
The use of mesalazine during pregnancy and breastfeeding is always decided by the doctor.
Very rarely, reversible decreased sperm count in semen has been reported in association with mesalazine. There are no data on the effect of mesalazine on female fertility.

Driving and using machines:

No effect of mesalazine on the ability to drive and use machines has been observed.

3. How to take Asamax 250 and Asamax 500

Asamax 250 and Asamax 500 should always be taken as directed by the doctor. If in doubt, consult the doctor.
Dosage and treatment duration are always determined by the doctor, depending on the severity of symptoms. The desired therapeutic effect of mesalazine treatment can only be achieved if the dosage recommendations are consistently and accurately followed.
Recommended dose:

Adults

Ulcerative colitis:
In the acute phase: 2 to 4.5 g per day in three or four divided doses. In the remission phase, to prevent disease relapse: at least 2 g per day, in divided doses.
Crohn's disease:
In the acute phase: up to 4.5 g per day in three or four divided doses. In the remission phase, to prevent disease relapse: up to 3 g per day in three or four divided doses.

Use in children and adolescents:

There are limited data on the use of mesalazine in children (aged 6-18 years)
Children aged 6 and older:
In the acute phase: The dosage should be determined individually, starting with doses of 30-50 mg/kg body weight per day in divided doses. The maximum dose: 75 mg/kg body weight per day in divided doses. The total dose should not exceed 4 g per day.
In the remission phase: The dosage should be determined individually, starting with doses of 15-30 mg/kg body weight per day in divided doses. The maximum dose: 75 mg/kg body weight per day in divided doses. The total dose should not exceed 2 g per day.
For children with a body weight of up to 40 kg, half of the adult dose is recommended, and for children with a body weight over 40 kg, the adult dose is recommended.

Duration of treatment:

The treatment duration is always determined by the doctor, depending on the severity of symptoms.

Method of administration:

The tablets should be swallowed whole, without chewing, with a drink. Take after a meal.

Taking a higher dose of Asamax 250 or Asamax 500 than recommended:

There are limited data on overdose (e.g., attempted suicide after oral ingestion of large doses of the medicine), which do not indicate toxic effects of mesalazine on the liver and kidneys. There is no specific antidote, and treatment of overdose is symptomatic and supportive.
In case of overdose, the patient should contact their doctor immediately.

Missing a dose of Asamax 250 or Asamax 500:

If the patient forgets to take a dose, they should take it as soon as possible, unless the time to the next dose is less than 2-3 hours. In this case, they should only take the next dose.
Do not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Asamax 250 and Asamax 500 can cause side effects, although not everybody gets them.
The patient should stop taking mesalazine and seek medical attention immediately if they experience any of the following symptoms:

• red, flat, plate-like, or round patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and swollen lymph nodes. The occurrence of such severe skin rashes may be preceded by local inflammation, skin lesions, fever, and flu-like symptoms (see also section 2).
• such severe skin rashes may also be associated with elevated liver enzyme activity and increased white blood cell count (eosinophilia) shown in blood tests ordered, if necessary, by the doctor.

Other possible side effects:
Rare side effects (may affect up to 1 in 100 people) include:

• headache
• dizziness
• myocarditis, pericarditis
• abdominal pain, diarrhea, bloating, nausea, vomiting
• increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity)

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

• changed blood cell count (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia); eosinophilia in the course of hypersensitivity reactions.
• hypersensitivity reactions, such as allergic rash, drug fever, lupus erythematosus, ulcerative colitis
• peripheral neuropathy (a disease of the peripheral nerves characterized by numbness, tingling, or weakness of the limbs)
• allergic and fibrotic lung reactions (including, among others: shortness of breath, cough, bronchospasm, pneumonitis, pulmonary eosinophilia - accumulation of a certain type of white blood cell in the lungs, pulmonary infiltrates, pneumonia)
• acute pancreatitis
• changes in liver function parameters (increased transaminase activity, cholestasis), hepatitis, cholestatic hepatitis
• muscle pain, joint pain
• hair loss
• kidney dysfunction, including acute and chronic interstitial nephritis and kidney failure
• reversible decreased sperm count in semen

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Asamax 250 and Asamax 500

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C. Store in the original packaging.
Do not use Asamax 250 and Asamax 500 after the expiration date stated on the carton and blister after: "Expiration date (EXP):" / "EXP:".
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Asamax 250 and Asamax 500 contain.
The active substance of Asamax 250 and Asamax 500 is mesalazine.
One enteric-coated tablet of Asamax 250 contains 250 mg of mesalazine.
One enteric-coated tablet of Asamax 500 contains 500 mg of mesalazine.
The other ingredients are: microcrystalline cellulose, povidone K25 and K90, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, macrogol 6000, methacrylic acid copolymer - Type A, methacrylic acid copolymer - Type B, triethyl citrate, talc, titanium dioxide (E171), yellow iron oxide (E172).

What Asamax 250 and Asamax 500 look like and contents of the pack

Asamax 250 and Asamax 500 enteric-coated tablets are packaged in blisters (Al/PVC/PVDC) in a cardboard box. One pack contains 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw
phone: (22) 545 11 11

Manufacturer:

Sever Pharma Solutions AB
Agneslundsvägen 27
212 15 Malmö
Sweden
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.
Date of last revision of the leaflet:09/2023