Salofalk 1 g

Package Leaflet: Information for the User

Salofalk 1 g, 1 g, Suppositories

Mesalazine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What Salofalk 1 g suppositories are and what they are used for
• 2. Important information before taking Salofalk 1 g suppositories
• 3. How to take 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 mesalazine, which is an anti-inflammatory agent used to treat inflammatory bowel diseases. Salofalk 1 g suppositories are used for: the treatment of acute episodes of mild to moderate ulcerative colitis, limited to the rectum, also known as ulcerative proctitis.

2. Important information before taking Salofalk 1 g suppositories

When not to take Salofalk 1 g suppositories:

• If you are 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 you have severe liver or kidney disease.

Warnings and precautions

Before taking Salofalk 1 g suppositories, discuss with your doctor:

• If you have had problems with your lungs, especially if you have had bronchial asthma.
• If you have had an allergy to sulfasalazine, a substance related to mesalazine.
• If you have liver problems.
• If you have kidney problems.
• If you have ever experienced: severe skin rash or peeling, blisters, or ulcers in the mouth after taking mesalazine.

Mesalazine may cause a reddish-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a harmless chemical reaction between mesalazine and bleach.

Other precautions

During treatment, your doctor may decide to monitor you closely, including regular blood and urine tests. Taking mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. While taking mesalazine, you should drink plenty of fluids. Serious skin reactions (including severe cutaneous adverse reactions, SCAR, drug reaction with eosinophilia and systemic symptoms, DRESS, Stevens-Johnson syndrome, SJS, and toxic epidermal necrolysis, TEN) have been reported with mesalazine. If you experience any symptoms of these serious skin reactions, stop taking mesalazine and seek medical help immediately.

Salofalk 1 g suppositories and other medicines

Tell your doctor if you are taking or using any of the following medicines, as they may interact with Salofalk 1 g suppositories: azathioprine, 6-mercaptopurine, or thioguanine(used to treat immune system disorders), certain blood-thinning medicines(e.g., warfarin).

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any you plan to take. This does not necessarily mean you cannot take Salofalk 1 g suppositories, but it will allow your doctor to make an informed decision about your treatment.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Salofalk 1 g suppositories should only be taken during pregnancy if your doctor recommends it. While breastfeeding, Salofalk 1 g suppositories should only be taken if your doctor recommends it, as the medicine may pass into breast milk.

Driving and using machines

Salofalk 1 g suppositories have no or negligible influence on the ability to drive and use machines.

Important information about some ingredients of Salofalk 1 g suppositories

It is unlikely that the other ingredients of Salofalk 1 g suppositories will cause side effects (see section 6).

3. How to take Salofalk 1 g suppositories

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

The suppositories are for rectal use only. Do not take by mouth. Do not swallow.

Dosage

Adults and the elderly: the recommended dose is one 1 g suppository per day, taken at bedtime. Use in children: there is limited experience and documentation of 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 you need to take the medicine, depending on your condition. The desired therapeutic effect can only be achieved with regular and systematic use of the suppositories. If you feel that the effect of Salofalk 1 g suppositories is too strong or too weak, talk to your doctor.

If you take more Salofalk 1 g suppositories than you should

If you are unsure, consult your doctor. Your doctor will decide what to do next. If you have taken more Salofalk 1 g suppositories than you should, take the next dose at the normal time. Do not take a lower dose.

If you forget to take Salofalk 1 g suppositories

If you realize you have forgotten to take a dose, you can take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Salofalk 1 g suppositories

Do not stop taking Salofalk 1 g suppositories without consulting your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salofalk 1 g suppositories can cause side effects, although not everybody gets them.

If you experience any of the following symptoms after taking this medicine, contact your 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 colon (causing severe diarrhea and abdominal pain). These reactions are very rare.
• Severe worsening of general health, especially if accompanied by fever and (or) sore throat and mouth, which in very rare cases may be due to a reduced white blood cell count, making you more susceptible to serious infections (agranulocytosis). It may also lead to disorders affecting other blood cells (e.g., platelets or red blood cells, causing aplastic anemia or thrombocytopenia) and may cause symptoms such as unexplained bleeding, purple spots, or rashes under the skin, anemia (feeling tired, weak, and pale, especially of the lips and nails). Blood tests can confirm whether the symptoms are due to the effect of this medicine on the blood. These reactions are very rare.

Severe skin rasheswith red, flat, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and enlarged lymph nodes. It may be preceded by fever and flu-like symptoms. The frequency of these reactions is unknown.

• Dyspnea, chest pain, or irregular heartbeat, or swelling of limbs, which may indicate cardiac hypersensitivity reactions. These reactions are rare.
• Kidney problems(may occur very rarely), such as changes in urine color or amount, and swelling of limbs or sudden abdominal pain (due to kidney stones) (frequency unknown).

Patient reports of side effects while taking mesalazine include:

Common side effects(occurring in less than 1 in 10 patients)

• rash, itching.

Rare side effects(occurring in less than 1 in 1000 patients)

• abdominal pain, diarrhea, gas, nausea, and vomiting, constipation
• headache, dizziness
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity).

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

• severe abdominal pain due to acute pancreatitis
• shortness of breath, cough, wheezing, changes in chest X-ray due to allergic and (or) inflammatory lung conditions
• muscle and joint pain
• jaundice or abdominal pain due to poor liver function and bile flow disorders
• hair loss and baldness
• numbness and tingling of hands and feet (peripheral neuropathy)
• reversible reduction in sperm count in semen.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salofalk 1 g suppositories

Keep this 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 that month. Do not store above 30°C. Store in the original package to protect from light. Medicines should 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 pack and other information

What Salofalk 1 g suppositories contain

• The active substance is mesalazine; each 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 suppositories with a longitudinal, oval, and tapered shape. Salofalk 1 g suppositories are available in packs of 10, 30 suppositories. Not all pack sizes may be marketed.

Marketing authorization 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: zentrale@drfalkpharma.de

This medicinal product is authorized 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

Date of last revision of the leaflet: 08/2023