SALOFALK 1 g SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

Salofalk1g Suppositories

Mesalazine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Salofalk 1g Suppositories and what is it used for
2. What you need to know before you use Salofalk 1g Suppositories
3. How to use Salofalk 1g Suppositories
4. Possible side effects
5. Storage of Salofalk 1g Suppositories

Contents of the pack and further information

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

Salofalk 1g Suppositories contains the active substance mesalazine, an anti-inflammatory that is used to treat inflammatory bowel diseases.

Salofalk 1g Suppositories is used for:

treatment of acute episodes of mild to moderate ulcerative colitis or proctitis, limited to the rectum.

2. What you need to know before you use Salofalk 1g Suppositories

Do not useSalofalk1g Suppositories

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

Warnings and precautions

Consult your doctor before starting to use Salofalk 1g 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 liverproblems
• if you have kidneyproblems
• If you have ever suffered from a severe skin rash, skin peeling, blisters, or ulcers in the mouth after using mesalazine.

Mesalazine may cause a discoloration of the urine to a reddish-brown color after 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 want to keep you under medical supervision, and you may need to have regular blood and urine tests.

Kidney stones can occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.

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

Using Salofalk 1g Suppositories with other medicines

Tell your doctor if you are using or taking any of the following medicines, as the effects of these medicines may be altered (interactions):

• Azathioprine, 6-mercaptopurine or thioguanine(medicines for treating immune system disorders)
• Certain agents that inhibit blood coagulation(medicines for thrombosis or to thin the blood, such as warfarin)

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should use Salofalk 1g Suppositories during pregnancy only if your doctor has told you to.

Similarly, you should only use Salofalk 1g Suppositories during breastfeeding if your doctor has told you to. This medicine may pass into breast milk.

Driving and using machines

The influence of Salofalk 1g Suppositories on the ability to drive or use machines is negligible.

Important information about some of the ingredients of Salofalk 1g Suppositories

It is unlikely that the other component of Salofalk 1g Suppositories will cause side effects (see section 6. Further information).

3. How to use Salofalk 1g Suppositories

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

Method of administration

This medicine can only be used rectally, so it must be inserted through the anus. It must not be swallowed.

Posology

Adults and the elderly

The recommended dose is 1 suppository once a day, at bedtime.

Use in children

There is limited experience and documentation of the effect 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 continue treatment with this medicine, depending on the progression of your disease.

In order to achieve the desired therapeutic effects, you should use Salofalk 1g Suppositories regularly and uniformly, as indicated.

If you think that Salofalk 1g Suppositories is too strong or too weak, talk to your doctor.

If you use more Salofalk 1g Suppositories than you should

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

If you use too much Salofalk 1g Suppositories at one time, just apply the next dose as prescribed. Do not use a smaller dose.

If you forget to use Salofalk 1g 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. Use the next dose at the usual time. Do not use a double dose to make up for forgotten doses.

If you stop using Salofalk 1g Suppositories

Do not stop using this medicine until you have talked to 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, this medicine can cause side effects, although not everybody gets them.

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

• General allergic reactionssuch as skin rashes, fever, joint pain, and/or breathing difficulties or a general inflammation of your large intestine (which causes severe diarrhea and abdominal pain). These reactions are very rare.
• A marked decrease in your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms can be due, very rarely, to a decrease in the number of white blood cells in the blood, which can make you more prone to developing a serious infection (agranulocytosis). Other blood cells (such as platelets or red blood cells, which cause aplastic anemia or thrombocytopenia) may also be affected and cause symptoms that can include unexplained bleeding, bruising, or purple spots under the skin, anemia (feeling tired, weak, and pale, especially in the lips and nails). A blood test can confirm if your symptoms are due to an effect of this medicine on your blood. These reactions are very rare.
• • Severe skin rashes with reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and enlargement of the lymph nodes. These can be preceded by fever or flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
  • Breathing difficulties, chest pain, or irregular heartbeats, or swollen limbs that may indicate cardiac hypersensitivity reactions. These reactions are rare.
  • Kidney problems(can occur very rarely), such as a change in the color or amount of urine produced and swollen limbs or sudden pain in the side (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).

The following side effects have also been reported by patients using mesalazine:

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

• Rash, itching

Uncommon side effects(may affect up to 1 in 100 patients)

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

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

• Severe abdominal pain due to acute inflammation of the pancreas
• Shortness of breath, 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 liver and bile duct disorders
• Hair loss and development of baldness
• Numbness and tingling in hands and feet (peripheral neuropathy)
• Reversible decrease in semen production

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Salofalk 1g Suppositories

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister pack of the suppositories and on the carton. The expiry date is the last day of the month stated.

Store at a temperature not above 30°C. Keep 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. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Salofalk 1g Suppositories

The active substance of Salofalk 1g Suppositories is mesalazine, and one suppository of Salofalk 1g Suppositories contains 1g of mesalazine.

The other component is:

hard fat.

Appearance of the product and pack contents

Salofalk 1g Suppositories are torpedo-shaped suppositories of ivory color.

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

Not all 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: zentrale@drfalkpharma.de

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area 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 last revision of this leaflet:August 2023

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