Package leaflet: Information for the patient

CROHNAX
Mesalazinum
500 mg
suppositories
CROHNAX
Mesalazinum
1000 mg
suppositories
Please read the entire leaflet carefully before using the medicine, because it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Crohnax is and what it is used for
Important information before using Crohnax
How to use Crohnax
Possible side effects
How to store Crohnax
Contents of the pack and other information

1. What Crohnax is and what it is used for

Crohnax is a medication with anti-inflammatory action on the diseased wall of the rectum.
Crohnax is used in the treatment of ulcerative proctitis, i.e. ulcerative colitis with lesions localized in the rectum.

2. Important information before using Crohnax

When not to use Crohnax
Crohnax must not be used if the patient has:
hypersensitivity (allergy) to any of the components of the medicine;
hypersensitivity (allergy) to salicylic acid and its derivatives (e.g. aspirin);
severe impairment of kidney or liver function;
peptic ulcer of the stomach or duodenum;
blood coagulation disorders.
The medicine should not be used in children under 12 years of age.

Warnings and precautions
Caution is advised when using Crohnax in patients with current or past history of kidney and/or liver disease, lung disease, especially asthma or chronic non-specific lung disease (CNSLD), or hypersensitivity to sulfasalazine.
Control blood tests (complete blood count, liver function tests – alanine or aspartate aminotransferase activity, creatinine concentration) and urine tests (dipstick test and urine sediment) should be performed 14 days after starting treatment, then 2–3 times at 4-week intervals. If results are normal, subsequent tests should be performed every 3 months. However, if additional symptoms occur, tests should be performed immediately.
Do not use the medicine for 6 weeks after varicella vaccination.

Children and adolescents
Use as directed by the physician.

Crohnax and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take. In particular, inform the doctor about the use of:

medicines used to reduce blood clotting, anticoagulants (coumarin derivatives, acenocoumarol);
medicines with strong anti-allergic, anti-inflammatory action (glucocorticosteroids);
painkillers, anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, e.g. indomethacin);
medicines used in diabetes (sulfonylurea derivatives);
a medicine used, among others, in the treatment of cancer, psoriasis, and rheumatoid diseases (methotrexate);
medicines used in the treatment of gout (probenecid or sulfinpyrazone);
diuretic medicines, lowering blood pressure (furosemide, spironolactone);
a medicine used in the treatment of tuberculosis (rifampicin);
medicines used after organ transplantation, which suppress the immune system (azathioprine, 6-mercaptopurine).

Pregnancy and breastfeeding
Before taking any medicine, consult a doctor or pharmacist.
The decision to use mesalazine during pregnancy and breastfeeding is always made by the physician, as mesalazine may pass into breast milk in small amounts.
If diarrhea occurs in an infant breastfed by a woman using Crohnax, breastfeeding should be discontinued.

Driving and operating machinery
Crohnax does not affect the ability to drive vehicles or operate machinery.

3. How to use Crohnax

Crohnax is intended for rectal administration. It is recommended to empty the bowels before administration.
For a dosing regimen of twice daily, suppositories should be administered in the morning and evening.
For a once-daily regimen, the suppository should be administered in the evening, before bedtime.

Adults and elderly patients:
During the acute phase of the disease, the usual daily dose is 1000–2000 mg given in 1 to 3 doses.
During remission, to prevent relapse, the usual daily dose is 250–500 mg given in 1 or 2 doses.

Children and adolescents:
There is limited experience and insufficient documentation regarding the efficacy and safety of Crohnax in children.
The typically used dose in this group is 500 mg in the evening or 1000 mg in two divided doses.

It is recommended that the suppository remains in the rectum as long as possible. If it is expelled within less than 10 minutes after administration, a new suppository should be inserted.

For effective treatment, it is important that Crohnax is used regularly and consistently, according to the physician's instructions.

Use of more than the recommended dose of Crohnax
If more than the recommended dose has been used, contact your doctor or pharmacist immediately.

Missed dose of Crohnax
Take the missed dose as soon as possible. Then take the next dose at the usual scheduled time. However, if this would mean taking two doses in a short interval, it is recommended not to take the missed dose. Do not use a double dose to make up for a missed dose.

Stopping treatment with Crohnax
Always inform your physician if you decide to discontinue treatment with Crohnax on your own or if you plan to stop treatment prematurely (e.g. due to occurrence of adverse reactions).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. The following may occur during treatment:

Common (≥1/100 to <1/10):

Gastrointestinal disorders such as abdominal pain, nausea, vomiting, diarrhoea;
Nervous system disorders such as headache and dizziness;
Skin and subcutaneous tissue disorders such as urticaria, erythematous rash.

Uncommon (≥1/1,000 to <1/100):

Cardiac disorders such as myocarditis and pericarditis;
Gastrointestinal disorders such as increased amylase activity and pancreatitis.

Rare (≥1/10,000 to <1/1,000):

Blood and lymphatic system disorders such as leukopenia (reduced white blood cell count), granulocytopenia (reduced number of a type of white blood cells – granulocytes), neutropenia (reduced number of a type of white blood cells – neutrophils), agranulocytosis (reduced number of a type of white blood cells – neutrophils), aplastic anaemia (bone marrow failure leading to anaemia), thrombocytopenia (reduced platelet count), eosinophilia (increased number of a type of white blood cells – eosinophils), pancytopenia (reduction in all blood cell counts);
Nervous system disorders such as peripheral neuropathy (inflammation of peripheral nerves);
Respiratory, thoracic and mediastinal disorders such as allergic reactions (dyspnoea, cough, allergic alveolitis, eosinophilic pneumonia, pulmonary infiltrates, pneumonia);
Hepatobiliary disorders such as increased liver enzyme and bilirubin activity, hepatotoxicity (hepatitis, liver cirrhosis, liver failure);
Skin and subcutaneous tissue disorders such as reversible alopecia, erythema multiforme, Stevens-Johnson syndrome (formation of blisters on mucous membranes which resolve quickly. The predominant skin lesions, however, are coalescing erosions which transform into layered and haemorrhagic crusts. The most common sites of involvement are the oral cavity and genital organs, sometimes also the ocular and nasal mucosa);
Musculoskeletal and connective tissue disorders such as muscle and joint pain, lupus-like symptoms (vasculitis and arthritis, muscle and joint pain);
Renal and urinary disorders such as acute and chronic interstitial nephritis, renal failure and nephrotic syndrome.

If any adverse reactions occur, treatment should be discontinued. Adverse reactions can be reported to a healthcare professional, the marketing authorisation holder, or to the President of 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, e-mail: [email protected].

5. How to store Crohnax

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

6. Contents of the pack and other information

What Crohnax contains
The active substance is mesalazine.
The excipients are cetyl stearyl alcohol, sodium docosanoate and solid fat.

What Crohnax looks like and contents of the pack
The packaging consists of PVC/PE foil blisters and a leaflet in a cardboard box.
Crohnax, 500 mg: 30 suppositories.
Crohnax, 1000 mg: 14, 15, 28 or 30 suppositories.

Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
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