Salofalk 500

Patient Information Leaflet

SALOFALK 500, 500 mg, suppositories
Mesalazinum
Please read this leaflet carefully before using this 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 give it to others. The medicine may harm someone else, 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 500 is and what it is used for
2. Important information before using Salofalk 500
3. How to use Salofalk 500
4. Possible side effects
5. How to store Salofalk 500
6. Contents of the package and other information

1. What Salofalk 500 is and what it is used for

Salofalk 500 contains 500 mg of mesalazine as the active substance. It belongs to a group of medicines known as anti-inflammatory drugs.
After administration into the rectum, mesalazine acts locally on the mucosa and submucosa of the intestine.
Indications
Ulcerative proctitis – during exacerbation phase.

2. Important information before using Salofalk 500

When not to use Salofalk 500

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

Warnings and precautions
Before starting treatment, discuss the following with your doctor:

• If the patient has had lung problems, especially bronchial asthma.
• If the patient is hypersensitive to sulfasalazine, a substance similar to mesalazine, Salofalk 500 should be used only under medical supervision. If acute intolerance symptoms occur, such as cramps, severe abdominal pain, fever, severe headache or rash, the medicine must be discontinued immediately.
• If the patient has liver problems.
• If the patient has kidney problems.
• If the patient has ever experienced the following after taking mesalazine: severe skin rash, skin peeling, blisters or oral ulcers.

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If chest pain, shortness of breath or swelling of the limbs occurs, consult a doctor immediately,
as these reactions may be caused by the effect of Salofalk on the heart.
Mesalazine may cause a 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.
Other precautions
Before and during treatment, blood tests (complete blood count with differential, liver function parameters such as alanine or aspartate aminotransferase activity, serum creatinine concentration) and urine tests (dipstick testing and urine sediment) will be performed, depending on the treating physician's assessment. These tests are recommended 14 days after starting treatment, then 2–3 times at 4-week intervals. If results are normal, tests should be repeated every three months. If any additional symptoms of disease occur, contact your doctor promptly for appropriate evaluation.
Mesalazine use may lead to the formation of kidney stones. Symptoms may include flank pain and haematuria. Adequate fluid intake is recommended during mesalazine therapy.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with mesalazine treatment. Mesalazine should be discontinued and immediate medical attention sought if any of the symptoms of these serious skin reactions described in section 4 occur.
If the patient experiences severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears, they should contact their doctor immediately.
Use of Salofalk 500 in children
There is limited experience and insufficient documentation regarding the efficacy and safety of use in children.
Salofalk 500 with other medicines
Inform your doctor if the patient is taking or using any of the following medicines, as their effects may be altered (interactions):

• azathioprine, 6-mercaptopurine or thioguanine (medicines 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 other medicines the patient has recently taken, including those obtained without a prescription. This does not necessarily exclude the possibility of using Salofalk 500 suppositories, but will allow the doctor to make an appropriate treatment decision.
Pregnancy and breastfeeding
Consult a doctor or pharmacist before taking any medicine.
Salofalk 500 may be used during pregnancy only if authorized by a doctor.
Salofalk 500 may be used during breastfeeding only if authorized by a doctor, as the medicine passes into breast milk.
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Driving and operating machinery
The medicine has no influence on the ability to drive or operate machinery.
Salofalk 500 contains cetostearyl alcohol.
The medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Salofalk 500

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Unless otherwise directed by your doctor, the following dosage regimen should be followed.

Acute episodes of ulcerative proctitis:
Depending on clinical needs, one Salofalk 500 mg suppository (equivalent to 1500 mg of mesalazine per day) should be administered rectally three times daily.

How and when to use Salofalk 500
Salofalk 500 suppositories should be inserted rectally. When using the three-times-daily regimen, they should be administered in the morning, at midday, and in the evening.

For effective treatment, it is important to use Salofalk 500 suppositories regularly and consistently, as only this ensures effective therapy.

How long to use Salofalk 500
Your doctor will determine the duration of treatment based on the type, severity, and course of the disease.

Use in children
There is limited experience and insufficient documentation regarding the efficacy and safety of Salofalk 500 in children.

Use of a higher than recommended dose of Salofalk 500
If too many Salofalk 500 suppositories are used at once, the next dose should be taken at the usual time without reducing the dose.

If in doubt, inform your doctor about the overdose so that appropriate measures can be decided.

Missed dose of Salofalk 500
Do not use a double dose to make up for a missed dose. Continue treatment according to the prescribed schedule.

If the patient realizes shortly after the scheduled time that a dose was missed, the missed dose may be administered immediately. However, if the patient remembers the missed dose shortly before the next dose is due, the missed dose should not be taken; only the next scheduled dose should be administered.

Stopping Salofalk 500 treatment
Always inform your treating physician if you stop using Salofalk 500 suppositories on your own initiative or discontinue treatment prematurely (e.g. due to adverse reactions).

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse effects

Like all medicines, Salofalk 500 may cause adverse effects, although not everyone experiences them.
If the patient experiences any of the following symptoms after taking this medicine, contact a doctor immediately
and stop taking Salofalk:

• General allergic reactions, such as skin rash, fever, joint pain and (or) difficulty breathing, or general inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• Significant worsening of general health, especially if accompanied by fever and (or) sore throat and oral cavity pain. In very rare cases, these symptoms may be caused by a reduced number of white blood cells, resulting in increased susceptibility to severe infections (agranulocytosis). It may also lead to disorders affecting other blood cells (e.g. platelets or red blood cells, causing aplastic anaemia or thrombocytopenia) and may cause symptoms including unexplained bleeding, purpuric spots or skin eruptions, anaemia (feeling of fatigue, weakness and paleness, especially of lips and nails). Blood tests may confirm whether the symptoms experienced by the patient are due to the effect of this medicine 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 flu-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 stones) (occur in an unknown number of patients (frequency unknown)).
• Severe or recurring 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 determined from available data]).

The following adverse drug reactions have been observed in patients taking mesalazine:
Common (less than 1 in 10 patients)

• rash, itching.

Rare (less than 1 in 1,000 patients)

• abdominal pain, diarrhoea, flatulence (bloating), nausea and vomiting;
• headache, dizziness;
• increased skin sensitivity to solar and ultraviolet radiation (photosensitivity).

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

• severe abdominal pain due to acute pancreatitis;
• pallor and general weakness due to reduced number of red blood cells (anaemia);
• petechiae and bleeding due to reduced number of platelets;
• shortness of breath, cough, wheezing, lung shadowing on X-ray due to allergic or inflammatory lung reactions;

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• muscle and joint pain;
• jaundice or abdominal pain due to liver function disorders or impaired 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Salofalk 500

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of the stated month.
Store below 25°C. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Salofalk 500 contains

• The active substance is mesalazine.
• The other ingredients are: hard fat, cetyl alcohol, sodium docosanoyl.

What Salofalk 500 looks like and contents of the pack
Salofalk 500 is a suppository, packed in PVC/LDPE blisters in a cardboard box.
Each suppository contains 500 mg of mesalazine.
Pack sizes: 10, 30 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder, Manufacturer and Importer
DR. FALK PHARMA GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o.
ul. Leszno 14
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01-192 Warsaw
Tel. 22 620 11 71
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