Crohnax

Leaflet attached to the packaging: patient information

CROHNAX
250 mg
suppositories
Mesalazine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Crohnax and what is it used for
• 2. Important information before using Crohnax
• 3. How to use Crohnax
• 4. Possible side effects
• 5. How to store Crohnax
• 6. Package contents and other information

1. What is Crohnax and what is it used for

Crohnax is an anti-inflammatory medicine used to treat exacerbations and prevent relapses of ulcerative colitis with changes localized in the rectum.

2. Important information before using Crohnax

When not to use Crohnax

Do not use Crohnax if you have:

• hypersensitivity (allergy) to mesalazine;
• hypersensitivity (allergy) to any other component of this medicine (listed in section 6);
• hypersensitivity (allergy) to salicylic acid and its derivatives, which are contained in painkillers and used for colds;
• severe kidney or liver disorders;
• active gastric or duodenal ulcer disease;
• blood coagulation disorders. This medicine should not be used in children under 12 years of age, due to the lack of data on safety and efficacy in this age group.

Warnings and precautions

Before starting treatment with Crohnax, inform your doctor about any past or current kidney and/or liver disease, lung disease, especially asthma, and hypersensitivity (allergy) to sulfasalazine. Discuss this with your doctor before starting treatment. During treatment, your doctor may recommend blood and urine tests.

Crohnax and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor about taking:

• medicines used to reduce blood clotting, thin the blood (coumarin derivatives, acenocoumarol);
• medicines with strong anti-allergic, anti-inflammatory effects (glucocorticosteroids);
• medicines used to treat diabetes (sulfonylurea derivatives);
• a medicine used to treat cancer, psoriasis, and rheumatoid diseases (methotrexate);
• medicines used to treat gout (probenecid or sulfinpyrazone);
• medicines with diuretic effects, lowering blood pressure (furosemide, spironolactone);
• a medicine used to treat tuberculosis (rifampicin);
• medicines used after organ transplants, suppressing the immune system (azathioprine, 6-mercaptopurine).

Pregnancy and breastfeeding

The use of Crohnax in pregnant and breastfeeding women is decided by the doctor.

Driving and operating machinery

Crohnax does not affect the ability to drive and operate machinery.

3. How to use Crohnax

Use Crohnax as directed by your doctor. The medicine is intended for rectal administration. Unless your doctor advises otherwise, use 2 suppositories (500 mg) twice a day, in the morning and evening, for exacerbations. For relapse prevention, use 1 suppository (250 mg) twice a day. The duration of treatment is determined by your doctor, usually lasting 8-12 weeks. If you have any doubts about using the medicine, consult your doctor.

Using a higher dose of Crohnax than recommended

No cases of overdose have been reported. If you take more than the recommended dose, consult your doctor or pharmacist.

Missing a dose of Crohnax

Take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Crohnax can cause side effects, although not everybody gets them. Common side effects (occurring in 1 to 10 people out of 100):

• nervous system disorders: dizziness;
• general disorders and administration site conditions: feeling tired, weakness, malaise.

Uncommon side effects (occurring in 1 to 10 people out of 10,000):

• gastrointestinal disorders: abdominal pain, nausea, vomiting;
• Rare side effects (occurring in less than 1 person out of 10,000):
• renal and urinary disorders: acute and chronic interstitial nephritis, renal failure;
• general disorders and administration site conditions: drug fever, skin reactions;
• skin and subcutaneous tissue disorders: hair loss;
• hepatic and biliary disorders: toxic liver damage;
• gastrointestinal disorders: acute pancreatitis;
• respiratory, thoracic, and mediastinal disorders: interstitial lung disease, bronchospasm, respiratory reactions;
• blood and lymphatic system disorders: aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia;
• cardiac disorders: myocarditis, pericarditis.

If you experience any side effects, stop using the medicine. Side effects can be reported to a healthcare professional, the marketing authorization holder, or the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, [current address, phone number, and fax, email address].

5. How to store Crohnax

Keep the medicine out of sight and reach of children. Store in a temperature below 25°C. Do not use after the expiration date stated on the packaging.

6. Package contents and other information

What Crohnax contains

The active substance of the medicine is mesalazine. The excipient is solid fat.

What Crohnax looks like and what the package contains

The medicine is in the form of suppositories packaged in blisters and a cardboard box. The package contains 30 suppositories.

Marketing authorization holder and manufacturer

Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków

Date of the last update of the leaflet: