Salofalk 1 g suppositories

Patient Information Leaflet

Introduction

Patient Information Leaflet

Salofalk 1 g Suppositories

Mesalazine

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, inform your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Salofalk 1 g suppositories are and what they are used for
2. What you need to know 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

Pack contents and additional information

1. What Salofalk 1 g Suppositories is and what it is used for

Salofalk 1 g suppositories contain the active substance mesalazine, an anti-inflammatory agent used in the treatment of inflammatory bowel diseases.

Salofalk 1 g suppositories are used for:

the treatment of mild to moderate acute episodes of an inflammatory disease limited to the rectum, known by physicians as ulcerative colitis or ulcerative proctitis.

2. What you need to know before using Salofalk 1g suppositories

Do not use Salofalk 1g suppositories

• if you are allergic to salicylic acid, salicylates such as acetylsalicylic acid (e.g., Aspirin), or to any of the other components of this medicine (listed in section 6).
• if you have severe impairment of liver or kidney function.

Warnings and precautions

Consult your doctor before starting to use Salofalk 1 g suppositories

• if you have a history of lung disease, particularly if you suffer from bronchial asthma
• if you are allergic to medicines containing sulfasalazine, a substance related to mesalazine
• if you have liver problems
• if you have kidney problems
• if you have ever experienced severe skin rash, peeling skin, blisters, or mouth sores after taking mesalazine.

Mesalazine may cause discoloration of urine to a red-brown color upon contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Additional precautions

During treatment, your doctor may wish to keep you under medical supervision and may require regular blood and urine tests.

Kidney stones may occur during treatment with mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure you drink an adequate amount of fluid during treatment with mesalazine.

Severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been observed with mesalazine treatment. Stop taking mesalazine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

If you experience severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears, contact your doctor immediately.

Use of Salofalk 1 g suppositories with other medicines

Inform your doctor if you are taking or have recently taken any of the following medicines, as their effects may be altered (interactions):

• Azathioprine, 6-mercaptopurine, or thioguanine (medicines used to treat immunological disorders)
• Certain agents that inhibit blood coagulation (medicines for thrombosis or blood thinning, such as warfarin)

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It may still be appropriate for you to use Salofalk 1 g suppositories, and your doctor will decide what is suitable for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should use Salofalk 1 g suppositories during pregnancy only if your doctor has instructed you to do so.

Similarly, you should use Salofalk 1 g suppositories during breastfeeding only if directed by your doctor, as this medicine may pass into breast milk.

Driving and use of machines

The influence of Salofalk 1g suppositories on the ability to drive or operate machinery is none or negligible.

Important information about some components of Salofalk 1g suppositories

It is unlikely that the other component of Salofalk 1g suppositories will cause adverse effects (see section 6. Additional information).

3. How to use Salofalk 1 g suppositories

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

This medicine is for rectal use only and must be inserted through the anus. It must not be swallowed.

Dosage

Adults and elderly patients

The recommended dosage is 1 suppository once daily at bedtime.

Use in children

There is limited experience and insufficient documentation regarding the effect of this medicine in children.

Duration of treatment

Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you should continue treatment with this medicine, depending on the course of your disease.

To achieve the desired therapeutic effects, you must use Salofalk 1 g suppositories regularly and consistently as directed.

If you feel that your Salofalk 1 g suppositories are too strong or too weak, consult your doctor.

If you use more Salofalk 1 g suppositories than you should

Contact your doctor if you have any doubts, so that he or she can decide what you should do.

If you have used too much Salofalk 1 g suppositories at one time, continue with the next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk 1 g suppositories

If you forget to use this medicine, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Take the next dose at the usual time. Do not use a double dose to make up for a forgotten dose.

If you stop using Salofalk 1 g suppositories

Do not stop using this medicine until you have spoken with your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following symptoms after using this medicine, you should contact your doctor and stop using Salofalk 1 g suppositories immediately:

• General allergic reactions such as skin rashes, 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.
• A marked decline in your general health status, especially if accompanied by fever and/or sore throat and mouth. These symptoms may, very rarely, be due to a decrease in the number of white blood cells in the blood, which may make you more susceptible to developing a serious infection (agranulocytosis). Other blood cells may also be affected (e.g. platelets or red blood cells, leading to aplastic anaemia or thrombocytopenia) and cause symptoms that may include unexplained bleeding, skin spots, or purple patches under the skin, anaemia (feeling tired, weak, and pale appearance, especially in lips and nails). A blood sample may confirm whether your symptoms are due to an effect of this medicine on your blood. These reactions are very rare.
  • Severe skin rashes with non-elevated reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers, generalized rash, fever, and swollen lymph nodes. These may be preceded by fever or flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
  • Breathing difficulty, chest pain, or irregular heartbeat, or swollen extremities, which may indicate cardiac hypersensitivity reactions. These reactions are rare.
  • Problems with your kidney function (may occur very rarely), for example, a change in the colour or amount of urine produced, swollen extremities, or sudden flank pain (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).
• Severe or recurrent headache, visual disturbances, seizures, or ringing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from available data]).

The following adverse effects have also been reported in patients using mesalazine:

Common adverse effects (may affect up to 1 in 10 patients)

• Rash, pruritus

Rare adverse effects (may affect up to 1 in 1,000 patients)

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

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Severe abdominal pain due to acute inflammation of the pancreas
• Feeling of suffocation, cough, wheezing, lung shadow on X-ray due to allergy and/or inflammatory condition of the lungs
• Muscle and joint pain
• Jaundice or abdominal pain due to disorders of the liver and gallbladder
• Hair loss and development of baldness
• Numbness and tingling in hands and feet (peripheral neuropathy)
• Reversible decrease in semen production

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Salofalk 1g Suppositories

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the suppository blister and on the cardboard box. The expiry date refers to the last day of the month indicated.

Store below 30°C. Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Salofalk 1 g suppositories

The active substance in Salofalk 1 g suppositories is mesalazine. Each suppository contains 1 g of mesalazine.

The other component is:

hard fat.

Appearance of the product and contents of the pack

Salofalk 1 g suppositories are ivory-coloured, torpedo-shaped suppositories.

Salofalk 1 g suppositories are available in packs of 10, 12, 15, 20, 30, 60 and 90 suppositories.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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]

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Dr. Falk Pharma España
Camino de la Zarzuela, 19
28023 Madrid
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:

Germany, Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, United Kingdom, Greece, Hungary, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and Spain: Salofalk

Belgium and Luxembourg: Colitofalk

France: Osperzo

Italy: Cletrovaproct

Date of the most recent review of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http*://www.aemps.es/*