ASAMAX 500 mg Suppositories

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Asamax 250 and Asamax 500 and what is it used for
   1. Indications for use of Asamax 250 and Asamax 500
3. Important information before using Asamax 250 and Asamax 500
   1. When not to use Asamax 250 and Asamax 500
   2. Warnings and precautions
   3. Children and adolescents
   4. Asamax 250 and Asamax 500 and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
4. How to use Asamax 250 and Asamax 500
   1. Using a higher dose of Asamax 250 or Asamax 500 than recommended
   2. Missing a dose of Asamax 250 or Asamax 500
5. Possible side effects
   1. Reporting side effects
6. How to store Asamax 250 and Asamax 500
7. Contents of the packaging and other information
   1. What Asamax 250 and Asamax 500 contain
   2. What Asamax 250 and Asamax 500 look like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Asamax 250 250 mg suppositories
Asamax 500 500 mg suppositories
Mesalazine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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.
• 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 is it used for
• 2. Important information before using Asamax 250 and Asamax 500
• 3. How to use 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 is it used for

Asamax 250 and Asamax 500 suppositories contain the active substance - mesalazine. Mesalazine has a direct anti-inflammatory effect on the diseased tissue of the intestine. Regular intake of the medicine according to the doctor's recommendations can stop the development of the disease process in the rectum.

Indications for use of Asamax 250 and Asamax 500

Ulcerative rectitis.

2. Important information before using Asamax 250 and Asamax 500

When not to use Asamax 250 and Asamax 500

Warnings and precautions

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

When to exercise special caution when using mesalazine:
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious symptoms, have been reported with mesalazine treatment. The patient should stop using mesalazine and seek medical attention immediately if they experience any of these severe skin reactions, listed in section 4.
Before starting Asamax 250 and Asamax 500 treatment, the patient should discuss this with their doctor or pharmacist.

• Before starting treatment and during treatment, the doctor will recommend regular blood tests (morphology, liver and kidney function parameters). If serious blood count disorders occur, the doctor will discontinue treatment.
• The doctor will exercise caution in patients with liver function disorders.
• The medicine should not be used in patients with kidney function disorders. 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 using sulfasalazine-containing medicines and will discontinue treatment if they occur.
• If the patient experiences heart hypersensitivity reactions (myocarditis and pericarditis), the doctor will discontinue treatment.
• Mesalazine may cause kidney stones. Symptoms may include abdominal pain and hematuria. During mesalazine treatment, the patient should drink plenty of fluids.
• Mesalazine may cause a reddish-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a harmless chemical reaction between mesalazine and bleach.

Children and adolescents

Data on the use of mesalazine in children and adolescents are limited.

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 who are also taking azathioprine, 6-mercaptopurine, or thioguanine, there is a possibility of increased bone marrow suppressive effects of these medicines.
There is limited evidence that mesalazine may reduce the anticoagulant effect of warfarin (a medicine that reduces blood clotting).

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 using this medicine.
Asamax 250 and Asamax 500 should only be used during pregnancy 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 women exposed to mesalazine during pregnancy did not show a negative effect on pregnancy or the health of the fetus or newborn. Other epidemiological data are not available at present.
In a single case, after using high doses of mesalazine (2-4 g orally) during pregnancy, kidney failure was reported in a 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 only be used during breastfeeding 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, hypersensitivity reactions such as diarrhea cannot be excluded. 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.
Reversible decreased sperm count in semen has been rarely reported with mesalazine use. There are no data on the effect of mesalazine on fertility in women.

Driving and using machines

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

3. How to use Asamax 250 and Asamax 500

These medicines should always be used according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The dosage and duration of treatment are always determined by the doctor, depending on the severity of symptoms.
The desired therapeutic effect of mesalazine can only be achieved if the dosage recommendations are consistently and accurately followed.
Dosage
The recommended dose is 500 mg of mesalazine three times a day, rectally. In the remission phase, to prevent relapse, the dose can be reduced to 250 mg of mesalazine three times a day, rectally.
Use in children
The safety and efficacy of the medicine in children have not been established due to limited experience and data.
Duration of treatment
The duration of treatment is always determined by the doctor, depending on the severity of symptoms.
Method of administration
The suppository should be inserted into the rectum through the anus. It is easiest to insert the suppository into the rectum while lying on your side, with your legs slightly bent.

Using a higher dose of Asamax 250 or Asamax 500 than recommended

There are limited data on overdose (e.g., attempted suicide after taking 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 using a higher dose of the medicine than recommended, the patient should contact their doctor immediately.

Missing a dose of Asamax 250 or Asamax 500

If the patient forgets to take the next 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. They should not take a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, these medicines can cause side effects, although not everybody gets them.
The patient should stop using 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, or eyes, widespread rash, fever, and swollen lymph nodes. The occurrence of such serious skin rashes may be preceded by local inflammatory conditions, skin eruptions, fever, and flu-like symptoms (see also section 2).
• such serious skin rashes may also be associated with increased liver enzyme activity and increased white blood cell count (eosinophilia) shown in blood tests ordered, if necessary, by the doctor.

Other possible side effects:
Uncommon side effects (may occur in less than 1 in 100 people):

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

Rare side effects (may occur in less than 1 in 1,000 people):

• changed blood count (aplastic anemia - a result of disrupted bone marrow function, agranulocytosis - lack of white blood cells in the blood, pancytopenia - decreased number of white, red, and platelet blood cells, neutropenia - decreased number of one type of white blood cell (neutrophils), leukopenia - decreased number of white blood cells, thrombocytopenia - decreased number of platelets); eosinophilia (increased number of one type of white blood cell) in the course of hypersensitivity reactions.
• hypersensitivity reactions, such as allergic rash, drug fever, lupus erythematosus, 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, pulmonary infiltrates, eosinophilic pneumonia - accumulation of a certain type of white blood cell (eosinophils) in the lungs, lung inflammation)
• acute pancreatitis
• changes in liver function parameters (increased aminotransferase activity, occurrence of cholestasis parameters), hepatitis, cholestatic hepatitis
• muscle pain, joint pain
• hair loss
• kidney function disorders, 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. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-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 to 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 to protect from moisture. Do not use Asamax 250 and Asamax 500 after the expiry date stated on the carton and blister after "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 suppository of Asamax 250 contains 250 mg of mesalazine.
One suppository of Asamax 500 contains 500 mg of mesalazine.
The other ingredients are: solid fat, cetyl alcohol, sodium docuzate.

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

Asamax 250 and Asamax 500 suppositories are packaged in PVC/LDPE foil packs of 6 pieces each.
A cardboard box contains 30 suppositories.

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:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI), Italy
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: