Salofalk 1 g

Patient Information Leaflet

Salofalk 1 g, 1 g, suppositories
Mesalazinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Salofalk 1 g suppositories are and what they are used for
2. Important information before using Salofalk 1 g suppositories
3. How to use Salofalk 1 g suppositories
4. Possible side effects
5. How to store Salofalk 1 g suppositories
6. Contents of the pack and other information

1. What Salofalk 1 g suppositories are and what they are used for

Salofalk 1 g suppositories contain the active substance mesalazinum, which is an anti-inflammatory agent used in the treatment of inflammatory bowel diseases.
Salofalk 1 g suppositories are used for:
treatment of acute episodes of mild to moderate inflammatory disease limited to the rectum, known by physicians as ulcerative proctitis or ulcerative colitis.

2. Important information before using Salofalk 1 g suppositories

When not to use Salofalk 1 g suppositories:

• If the patient is allergic to salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin®), or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe liver or kidney disease.

Warnings and precautions
Before starting treatment with Salofalk 1 g suppositories, consult your doctor:

• If the patient has previously had lung problems, particularly bronchial asthma.
• If the patient has previously had an allergy to sulfasalazine, a substance related to mesalazine.
• If the patient has impaired liver function.
• If the patient has impaired kidney function.
• If the patient has ever experienced, after using mesalazine: severe skin rash, skin peeling, blisters, or oral ulcers.

Mesalazine may cause a red-brown discoloration of urine upon contact with the bleach
sodium hypochlorite present in toilet water. This is due to a chemical reaction between
mesalazine and the bleach and is harmless.
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Other precautions
During treatment, the doctor may decide on close medical monitoring, including
regular blood and urine tests.
Mesalazine use may lead to the formation of kidney stones. Symptoms may include
flank pain and haematuria. Adequate fluid intake should be maintained during treatment with mesalazine.
Severe cutaneous adverse reactions (SCAR), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with mesalazine therapy. Treatment with mesalazine must be discontinued and immediate medical help sought if any symptoms of these severe skin reactions occur (see section 4).
If the patient experiences severe or recurring headache, visual disturbances, or ringing or buzzing in the ears, they should contact their doctor immediately.

Salofalk 1 g suppositories and other medicines
Inform your doctor if you are taking or using any of the following medicines, due to possible interactions:

• Azathioprine, 6-mercaptopurine, or thioguanine (substances used in the treatment of immune system disorders).
• Certain anticoagulant medicines (medicines used for thrombosis or blood thinning, e.g. warfarin).

Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take. This does not necessarily exclude the possibility of using Salofalk 1 g suppositories, but will allow the doctor to make an appropriate decision regarding treatment.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Salofalk 1 g suppositories should be used during pregnancy only if prescribed by a doctor.
During breastfeeding, Salofalk 1 g suppositories should be used only if prescribed by a doctor, as the medicine may pass into breast milk.

Driving and operating machinery
Salofalk 1 g suppositories have no effect or have a negligible effect on the ability to drive and operate machinery.

Important information about certain ingredients of Salofalk 1 g suppositories
It is unlikely that the other ingredients of Salofalk 1 g suppositories will cause adverse effects (see section 6. Contents of the pack and other information).

3. How to use Salofalk 1 g suppositories

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
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Method of administration
This medicine is intended for rectal use only. Suppositories must be inserted through the anus. The medicine is NOT intended for oral use. Do not swallow.
Dosage
Adults and elderly patients:
The recommended dose is 1 suppository of Salofalk 1 g once daily at bedtime.
Use in children:
There is limited experience and insufficient documentation regarding the use of Salofalk 1 g suppositories in children.
Duration of treatment
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks.
Your doctor will decide how long treatment should continue. The duration of treatment depends on the patient's condition.
The desired therapeutic effect can only be achieved with regular and consistent use of Salofalk 1 g suppositories.
If you feel that the effect of Salofalk 1 g suppositories is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Salofalk 1 g suppositories
In case of doubt, consult your doctor. Your doctor will decide on further management.
If a higher than recommended dose of Salofalk 1 g suppositories has been used, the next dose should be taken at the usual time. Do not reduce the dose.
Missed dose of Salofalk 1 g suppositories
If the patient realizes shortly after the scheduled time that a dose has been missed, the missed dose may be administered immediately. If the patient remembers the missed dose shortly before the time for the next dose, the missed dose should not be taken; only the scheduled dose should be administered at its usual time.
Do not use a double dose to make up for a missed dose.
Discontinuation of Salofalk 1 g suppositories
Do not stop using this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur in a patient after taking this medicine, contact a doctor immediately and stop taking Salofalk:

• General allergic reactions, such as skin rash, fever, joint pain and (or) breathing difficulties, or general inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• Significant worsening of general health status, especially if accompanied by fever and (or) sore throat and oral cavity pain. In very rare cases, these symptoms may be caused by

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a reduced number of white blood cells, resulting in increased susceptibility to severe infections ( agranulocytosis ). There may also be disturbances affecting other blood cells (e.g. platelets or red blood cells, leading to aplastic anaemia or thrombocytopenia ) and may cause symptoms which may include unexplained bleeding, purpuric spots or skin eruptions, anaemia (feeling of fatigue, weakness and pallor, especially of lips and nails). Blood tests may confirm whether the symptoms in the patient are caused by this medicine's effect on blood. These reactions are very rare.

• Severe skin rashes with red, flat, disc-shaped or round patches on the trunk, often with blisters in their center, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes, extensive rash, fever and swollen lymph nodes. These may be preceded by fever and influenza-like symptoms. These reactions occur in an unknown number of patients (frequency unknown).
• Shortness of breath, chest pain or irregular heartbeat, or limb swelling, which may indicate hypersensitivity reactions affecting the heart. These reactions are rare.
• Problems with kidney function (may occur very rarely), e.g. change in colour or amount of urine produced, and limb swelling or sudden lower abdominal pain (caused by kidney stone) (occur in an unknown number of patients (frequency unknown)).
• Severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension) (frequency unknown [frequency cannot be estimated from available data]).

In addition, the following adverse reactions have been reported in patients taking mesalazine:
Common adverse reactions (occurring in less than 1 in 10 patients)

• rash, itching.

Uncommon adverse reactions (occurring in less than 1 in 1,000 patients)

• Abdominal pain, diarrhoea, flatulence, nausea and vomiting, constipation
• Headache, dizziness
• Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity).

Very rare adverse reactions (occurring in less than 1 in 10,000 patients)

• Severe abdominal pain due to acute pancreatitis
• Dyspnoea, cough, wheezing, lung opacities on X-ray due to allergic and (or) inflammatory conditions in the lungs
• Muscle and joint pain
• Jaundice or abdominal pain due to impaired liver function and abnormal bile flow
• Hair loss and alopecia
• Numbness and tingling of hands and feet (peripheral neuropathy)
• Reversible reduction in sperm count in semen.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
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5. How to store Salofalk 1 g suppositories

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Store in the original packaging to protect from light.
Medicines must 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 package and other information

What Salofalk 1 g suppositories contain

• The active substance in Salofalk 1 g is mesalazine; one suppository contains 1 g of mesalazine.
• The other ingredient is: hard fat.

What Salofalk 1 g suppositories look like and contents of the pack
Salofalk 1 g are light beige, elongated, rounded suppositories, tapered at the end.
Salofalk 1 g suppositories are available in packages containing 10 or 30 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder, Manufacturer and Importer
DR. FALK PHARMA GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761 / 1514-0
Fax: +49 (0) 761 / 1514-321
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Bulgaria, Czech Republic, Cyprus, Denmark, Finland, Germany, United Kingdom, Greece, Hungary, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia, Sweden, Spain: Salofalk.
Belgium, Luxembourg: Colitofalk.
France: Osperzo.
Italy: Cletrovaproct
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