Salofalk

Package leaflet: Information for the user

SALOFALK, 4 g/60 ml, rectal suspension
Mesalazinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Salofalk is and what it is used for

Salofalk contains mesalazinum as the active substance. Salofalk is a locally-acting anti-inflammatory medicinal product used in inflammatory diseases of the large intestine.
The Salofalk rectal suspension exerts a direct anti-inflammatory effect on the diseased connective tissue and mucous membrane of the large intestine.
The indication for Salofalk rectal suspension is the treatment of acute episodes of ulcerative colitis.

2. Important information before using Salofalk

When not to use Salofalk

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

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

Warnings and precautions
Before starting treatment with Salofalk, 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 should be used only under medical supervision. If acute intolerance symptoms occur, such as seizures, abdominal cramps, acute abdominal pain, fever, severe headache, or rash, the medicine must be discontinued immediately and the doctor contacted.

• If the patient has liver problems.

• If the patient has kidney problems.

• If the patient has previously experienced severe skin rash, skin peeling, blisters, or oral ulcers after taking mesalazine.

If chest pain, shortness of breath, or limb swelling occur, the patient should consult a doctor immediately, as these reactions may be caused by Salofalk affecting the heart.
Mesalazine may cause a brownish discoloration of urine when it comes into contact with sodium hypochlorite bleach present in toilet water. This is due to a chemical reaction between mesalazine and the bleach and is harmless.

Other precautions
Before and during treatment, depending on the treating physician's assessment, blood tests (complete blood count with differential, liver function parameters such as alanine aminotransferase or aspartate aminotransferase activity, serum creatinine concentration) and urine tests (dipstick testing and urine sediment) will be performed. These tests are recommended 14 days after starting treatment, then every 4 weeks for 2–3 times. If results are normal, testing should continue every three months. If any additional symptoms of disease occur, contact the doctor immediately for appropriate evaluation.

Mesalazine use may lead to the formation of kidney stones. Symptoms may include flank pain and hematuria. 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 must be discontinued immediately and medical help sought if any of the severe skin reactions listed 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.

Salofalk and 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 anticoagulants (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 available without a prescription. This does not necessarily exclude the possibility of using Salofalk enema; however, it allows the doctor to make an appropriate treatment decision.

Pregnancy and breastfeeding
Consult a doctor or pharmacist before using any medicine.
Salofalk may be used during pregnancy only if prescribed by a doctor.
Salofalk may be used during breastfeeding only if prescribed by a doctor, as the drug passes into breast milk.

Driving and operating machinery
Salofalk has no influence on the ability to drive or operate machinery.

Salofalk enema contains potassium metabisulfite and sodium benzoate.
Potassium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains 60 mg of sodium benzoate per enema dose of Salofalk. Sodium benzoate may cause local irritation.

3. How to use Salofalk

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. The rectal suspension of Salofalk should usually be used according to the instructions below.
The contents of one bottle (60 ml of suspension, corresponding to 4 g of mesalazine) should be administered into the rectum as an enema once daily, in the evening before going to bed.

How and when to use the Salofalk rectal suspension
The best treatment results are achieved when the Salofalk rectal suspension is used immediately after prior bowel evacuation.
The desired therapeutic effect can only be obtained if Salofalk rectal suspension is administered regularly and consistently.
Before use, shake the bottle vigorously for at least 30 seconds to ensure a homogeneous mixture. Then remove the protective cap. Hold the container in an upright position to avoid spilling. Lie on your left side with the left leg straight and the right leg bent to maintain balance. Carefully insert the applicator tip (coated with a thin layer of lubricant) into the rectum, directing the bottle toward the navel. Then, while firmly holding the bottle, rotate it to direct toward the back. Now gently and slowly squeeze the bottle to prevent defecation reflex. After administering the full contents, remove the empty bottle.

After administration of the Salofalk rectal suspension, remain lying on your left side for at least 30 minutes to allow the medicine to spread evenly throughout the entire colon.
The best treatment outcome is achieved when the Salofalk suspension can act throughout the night.

How long to use Salofalk rectal suspension
The duration of treatment depends on the type, severity, and course of the disease.
After this period, Salofalk rectal suspension should generally not be used anymore.
The duration of treatment is determined by the doctor.

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

Use of a higher than recommended dose of Salofalk
If a higher than recommended dose of Salofalk has been used, consult your doctor immediately so that appropriate measures can be taken.

Missed dose of Salofalk
Do not use a double dose to make up for a missed dose; continue treatment according to previous instructions.
If the patient realizes shortly after the scheduled time that a dose was missed, it may be administered immediately. However, if the patient remembers the missed dose just before the next scheduled dose, the missed dose should not be taken; only the next scheduled dose should be administered.

Stopping treatment with Salofalk
In any case of deciding to discontinue treatment with Salofalk suspension on your own or to stop treatment prematurely (e.g. due to occurrence of adverse reactions), always inform your treating physician.

4. Possible adverse effects

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

• General allergic reactions, such as skin rash, fever, joint pain and (or) difficulty breathing, or generalised inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• Significant worsening of general health condition, 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, leading to increased susceptibility to severe infections (agranulocytosis). It may also cause disturbances in other blood cells (e.g. platelets or red blood cells, resulting in aplastic anaemia or thrombocytopenia) and may lead to 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 in the patient are caused by 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 the centre, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes, widespread 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.
• Kidney function problems (may occur very rarely), e.g. change in colour or amount of urine produced, or limb swelling or sudden lower abdominal pain (caused by kidney stones) (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 determined from available data]).

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

• rash, itching.

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Rare (less than 1 in 1,000 patients)

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

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

• severe abdominal pain due to acute pancreatitis;
• pallor and general weakness caused by reduced number of red blood cells (anaemia);
• petechiae and bleeding caused by reduced number of platelets;
• shortness of breath, cough, wheezing, lung opacities on X-ray due to allergic or inflammatory lung reactions;
• 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.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Salofalk

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Store in the original packaging to protect from light.
Remove the medicine from the blister pack immediately before use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Salofalk contains

• The active substance is mesalazine.
• The other ingredients are: sodium benzoate (E 211), potassium metabisulphite (E 224, max. 0.28 g, which
  corresponds to max. 0.16 g sulfur dioxide), disodium edetate, carbomer, potassium acetate, xanthan gum,
  purified water.

What Salofalk looks like and contents of the pack

One rectal enema of Salofalk contains the active substance mesalazine (i.e. 5-aminosalicylic acid) at a dose of 4 g in 60 ml of suspension in a bottle.

Round, white low-density polyethylene (LDPE) bottles with cannulas, closed with protective green caps made of low-density polyethylene, packed into two PVC/paper blisters in a cardboard box.

Pack size: 7 bottles containing 60 ml of rectal suspension each.

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.
Leszno Street 14
01-192 Warsaw
Phone: 22 620 11 71