Asamax 250

Leaflet attached to the packaging: patient information

Asamax 250 250 mg suppositories
Asamax 500 500 mg suppositories
Mesalazine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 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 pack 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 as recommended by the doctor may 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 taking Asamax 250 and Asamax 500

When not to take Asamax 250 and Asamax 500

• 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 dysfunction.

Warnings and precautions

Before starting mesalazine treatment, inform your doctor:

• if you have ever experienced severe skin rash or skin peeling after taking mesalazine.

When to exercise special caution when taking 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. Stop taking mesalazine and seek medical attention immediately if you experience any of these severe skin reactions, listed in section 4.
Before starting Asamax 250 and Asamax 500, discuss this with your doctor or pharmacist.

• Before starting treatment and during treatment, your doctor will recommend regular blood tests (morphology, liver and kidney function parameters). If serious blood disorders occur, your doctor will stop the treatment.
• Your 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, mesalazine toxicity should be considered.
• Your doctor will closely monitor patients with lung diseases, especially asthma.
• Your doctor will closely monitor patients who have experienced side effects after taking sulfasalazine-containing medicines and will stop the treatment if they occur.
• If you experience heart hypersensitivity reactions (myocarditis and pericarditis), your doctor will stop the treatment.
• Mesalazine may cause kidney stones. Symptoms may include pain in the sides of the abdomen and hematuria. During mesalazine treatment, you should drink sufficient fluids.
• Mesalazine may cause 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

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In patients taking azathioprine, 6-mercaptopurine, or thioguanine, there is a possibility of increased bone marrow suppression. Limited evidence suggests that mesalazine may decrease the anticoagulant effect of warfarin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking 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.
In a single case, after taking high doses of mesalazine (2-4 g orally) during pregnancy, kidney 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 postnatal 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, only limited data are available from breastfeeding women. In breastfed infants, it is not possible to exclude hypersensitivity reactions such as diarrhea. If diarrhea occurs in the breastfed infant, breastfeeding should be discontinued.
The use of mesalazine during pregnancy and breastfeeding is always decided by the doctor.
Reversible reduction in sperm count in semen has been rarely reported with mesalazine use. 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

These medicines should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Dosage and treatment duration are always determined by your 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.
Treatment duration
Treatment duration is always determined by your 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.

Overdose of Asamax 250 or Asamax 500

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.
If you have taken more than the recommended dose of the medicine, contact your doctor immediately.

Missed dose of Asamax 250 or Asamax 500

If you forget to take the next dose, take it as soon as possible, unless the time to the next dose is less than 2-3 hours. In this case, take only the next dose. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, these medicines can cause side effects, although not everybody gets them.
Stop taking mesalazine and seek medical attention immediately if you 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 eruptions, fever, and flu-like symptoms (see also section 2).
• such severe skin rashes may also be associated with elevated liver enzymes and increased white blood cell count (eosinophilia) shown in blood tests, if necessary, prescribed by your doctor.

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

• 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):

• 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, colitis.
• peripheral neuropathy (a disease of the peripheral nerves characterized by numbness, tingling, or weakness of the limbs).
• allergic and fibrotic lung reactions (including dyspnea, cough, bronchospasm, pulmonary alveolitis, eosinophilic pneumonia, pulmonary infiltrates, pneumonia).
• acute pancreatitis.
• changes in liver function parameters (increased aminotransferase activity, cholestasis parameters), hepatitis, cholestatic hepatitis.
• muscle pain, joint pain.
• hair loss.
• kidney dysfunction, including acute and chronic interstitial nephritis and kidney failure.
• reversible reduction in 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 you experience any side effects, including those not listed in this leaflet, inform your doctor. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Asamax 250 and Asamax 500

Keep the medicine out of the sight and reach of children.
Store 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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
tel. (22) 545 11 11
Manufacturer:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI), Italy

Date of last revision of the leaflet: