Package leaflet: Information for the patient

Asamax 250, 250 mg, enteric-coated tablets
Asamax 500, 500 mg, enteric-coated tablets
Mesalazinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:

What Asamax 250 and Asamax 500 are and what they are used for
Important information before taking Asamax 250 and Asamax 500
How to take Asamax 250 and Asamax 500
Possible side effects
How to store Asamax 250 and Asamax 500
Contents of the pack and other information

1. What Asamax 250 and Asamax 500 are and what they are used for
Asamax 250 and Asamax 500 enteric-coated tablets contain the active substance mesalazine.
Mesalazine exerts a direct anti-inflammatory effect. Asamax 250 and Asamax 500 enteric-coated tablets suppress the disease process in the intestines.
Indications for Asamax 250 and Asamax 500
Mild to moderate ulcerative colitis, both in the acute phase and in remission.
Crohn's disease affecting the colon, both in the acute phase and in remission.

2. Important information before taking Asamax 250 and Asamax 500

When not to use 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 impairment of kidney or liver function.

Warnings and precautions
Before starting mesalazine treatment, inform your doctor:

if you have ever experienced severe skin rash or skin peeling, blisters or oral ulcers after taking mesalazine.

Special caution is required when using mesalazine:
Serious skin reactions have been reported with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious symptoms. You must stop taking mesalazine and seek immediate medical help if you develop any of these severe skin reactions listed in section 4.
Please discuss this with your doctor or pharmacist before starting treatment with Asamax 250 or Asamax 500.

Before starting and during treatment, your doctor may recommend regular blood tests (complete blood count, liver and kidney function tests). If serious blood abnormalities occur, your doctor will discontinue treatment.
Your doctor will exercise caution in patients with liver function disorders.
This medicine should not be used in patients with impaired kidney function. In patients who develop kidney failure during treatment, mesalazine toxicity should be considered.
Your doctor will closely monitor patients with lung diseases, especially bronchial asthma.
Your doctor will closely monitor patients who have previously experienced adverse reactions to sulfasalazine-containing medicines and will discontinue treatment immediately if such reactions occur.
If signs of heart hypersensitivity reactions (myocarditis or pericarditis) occur, your doctor will stop treatment.
Mesalazine use may lead to kidney stone formation. Symptoms may include flank pain and haematuria. Adequate fluid intake is recommended during mesalazine treatment.
Mesalazine may cause reddish-brown discoloration of urine upon contact with sodium hypochlorite bleach present in toilet water. This is due to a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents
Limited data are available on the use of mesalazine in children and adolescents (aged 6–18 years).
Asamax 250 and Asamax 500 with other medicines:
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
In patients taking azathioprine, 6-mercaptopurine or thioguanine concomitantly, there may be an increased risk of myelosuppression (reduced bone marrow activity, leading to decreased blood cell counts).
Limited evidence suggests that mesalazine may reduce the anticoagulant effect of warfarin (a blood-thinning medicine).
Asamax 250 and Asamax 500 with food and drink:
Asamax 250 and Asamax 500 enteric-coated tablets should be taken after meals, with liquid. Do not chew.
Pregnancy, breastfeeding and fertility:
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Asamax 250 and Asamax 500 should be used during pregnancy only if the potential benefit outweighs the potential risk.
There are insufficient data on the use of mesalazine in pregnant women. Data from a limited number of pregnant women exposed to mesalazine do not indicate harmful effects on pregnancy or the health of the fetus or newborn. Other epidemiological data are currently not available.
In a single case, neonatal renal failure has been reported after high-dose mesalazine use (2–4 g orally) during pregnancy.
Animal studies with orally administered mesalazine have not shown direct or indirect harmful effects on pregnancy, embryonic or fetal development, or neonatal development.
Asamax 250 and Asamax 500 should be used during breastfeeding only if the potential benefit outweighs the potential risk.
N-acetyl-5-salicylic acid and, to a lesser extent, mesalazine pass into breast milk in small amounts. Data from breastfeeding women are currently limited. Hypersensitivity reactions in the breastfed infant, such as diarrhoea, cannot be excluded. If diarrhoea occurs in a breastfed infant, breastfeeding should be discontinued.
The decision to use mesalazine during pregnancy and breastfeeding is always made by the doctor.
Reversible reduction in sperm count has very rarely been reported with mesalazine use. There are no data on the effect of mesalazine on female fertility.
Driving and operating machinery:
No effects of mesalazine on the ability to drive or operate machinery have been observed.

3. How to use Asamax 250 and Asamax 500

Asamax 250 and Asamax 500 should always be used as directed by the physician. In case of
doubt, consult your doctor.
The dosage and duration of treatment are always determined by the physician depending on the severity of symptoms. The desired therapeutic effect of mesalazine treatment can only be achieved if dosage instructions are consistently and strictly followed.
Recommended dosage:
Adults
Ulcerative colitis:
During acute phase: 2 to 4.5 g daily, divided into three or four doses. During remission phase, to prevent disease relapse: at least 2 g daily, in divided doses.
Crohn's disease:
During acute phase: up to 4.5 g daily, divided into three or four doses.
During remission phase, to prevent disease relapse: up to 3 g daily, divided into three or four doses.
Use in children and adolescents:
There is limited data on the use of mesalazine in children (aged 6–18 years).
Children aged 6 years and older:
During acute phase: dosage should be individually adjusted, starting at 30–50 mg/kg body weight daily, in divided doses. Maximum dosage: 75 mg/kg body weight daily, in divided doses. Total daily dose should not exceed 4 g.
During remission phase: dosage should be individually adjusted, starting at 15–30 mg/kg body weight daily, in divided doses. Maximum dosage: 75 mg/kg body weight daily, in divided doses. Total daily dose should not exceed 2 g.
Children with body weight up to 40 kg should receive half the adult dose; children with body weight above 40 kg should receive the adult dose.
Duration of treatment:
The duration of treatment is always determined by the physician depending on the severity of symptoms.
Method of administration:
Tablets should be swallowed whole, without chewing, with liquid. Take after meals.
Overdose of Asamax 250 or Asamax 500:
There are few reports of overdose (e.g. suicide attempts following ingestion of large oral doses), which do not indicate toxic effects of mesalazine on the liver or kidneys. There is no specific antidote; treatment of overdose is symptomatic and supportive.
In case of overdose, contact your doctor immediately.
Missed dose of Asamax 250 or Asamax 500:
If a patient forgets to take a dose, it should be taken as soon as possible, provided that the time until the next scheduled dose is longer than 2–3 hours. Otherwise, only the next dose should be taken. Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Asamax 250 and Asamax 500 may cause adverse reactions, although not everyone will experience them.
Treatment with mesalazine should be discontinued and immediate medical advice sought if the patient develops any of the following symptoms:

red, flat, disc-shaped or circular lesions on the trunk, often with blisters in their center, skin peeling, oral, throat, nasal, genital or ocular mucosal ulcers, extensive rash, fever and enlarged lymph nodes. Such severe skin reactions may be preceded by local inflammatory conditions, skin eruptions, fever and influenza-like symptoms (see also section 2).
such severe skin reactions may also be associated with increased liver enzyme activity and elevated white blood cell count (eosinophilia) shown in blood tests ordered, if necessary, by a physician.

Other possible adverse reactions:
Adverse reactions occurring rarely (may occur in fewer than 1 in 1,000 people) include:

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

Adverse reactions occurring very rarely (may occur in fewer than 1 in 10,000 people) include:

changes in blood cell counts (aplastic anaemia – resulting from impaired bone marrow function, agranulocytosis – absence of white blood cells in blood, pancytopenia – decreased number of white and red blood cells and platelets, neutropenia – decreased number of one type of white blood cells (neutrophils), leukopenia – decreased number of white blood cells, thrombocytopenia – decreased number of platelets); eosinophilia (increased number of a type of white blood cells – eosinophils) occurring in hypersensitivity reactions.
hypersensitivity reactions such as allergic rash, drug fever, systemic lupus erythematosus, colitis
peripheral neuropathy (a disease of peripheral nerves characterized by numbness, tingling or weakness of limbs)
allergic and fibrosing lung reactions (including: dyspnoea, cough, bronchospasm, pulmonary alveolitis, pulmonary eosinophilia – accumulation in the lungs of a certain type of white blood cells (acidophilic granulocytes), pulmonary infiltrates, pneumonia)
acute pancreatitis
changes in liver function parameters (increased transaminase activity, cholestatic parameters), hepatitis, cholestatic hepatitis
muscle pain, joint pain
alopecia
kidney function disorders, including: acute and chronic interstitial nephritis and renal failure
transient decrease in sperm count in semen

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Asamax 250 and Asamax 500

Keep this medicine out of sight and reach of children.
Store below 30°C. Keep in the original packaging.
Do not use Asamax 250 and Asamax 500 after the expiry date stated on the carton and blister pack following: "Expiry date (EXP):” / “EXP:”.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Asamax 250 and Asamax 500 contain
The active substance in Asamax 250 and Asamax 500 is mesalazine.
One prolonged-release rectal tablet of Asamax 250 contains 250 mg of mesalazine.
One prolonged-release rectal 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, polyethylene glycol 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
Prolonged-release rectal tablets of Asamax 250 and Asamax 500 are packed in blisters (Al/PVC/PVDC)
in a cardboard box. One pack contains 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Astellas Pharma Sp. z o.o.
Żwirki i Wigury 16C
02-092 Warsaw
tel. (22) 545 11 11

Manufacturer:
Sever Pharma Solutions AB
Agneslundsvägen 27
212 15 Malmö
Sweden

For further information, please contact the Marketing Authorisation Holder.