Package Insert: Information for the User

Salofalk1g Suppositories

Mesalazine

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, report them to your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and Additional Information

Salofalk1 g suppositories, contains the active ingredient mesalazine, an anti-inflammatory that is used in the treatment of inflammatory diseases of the intestine.

Salofalk1 g suppositoriesis used for:

the treatment of acute episodes of mild to moderate limited inflammation of the rectum known as ulcerative colitis or proctitis ulcerosa by doctors.

No 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 medication (listed in section 6).
• If you have severe liver or kidney function disorders.

Warnings and precautions

Consult your doctor before starting to use Salofalk 1 g suppositories.1 g suppositories

• If you have a history of lung disease, particularly if you suffer frombronchial asthma
• If you are allergic to medications containing sulfasalazine, a related substance to mesalazine
• If you have liver problems
• If you have kidney problems
• If you have ever experienced intense skin rash or peeling, blisters, or mouth sores after using mesalazine.

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

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.

Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain on the sides and blood in the urine. Make sure to drink enough liquid during mesalazine treatment.

Severe skin eruptions, 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 observe any symptoms related to these severe skin reactions described in section 4.

Use of Salofalk 1 g suppositories with other medications

Inform your doctor if you use or take any of the medications listed below, as the effects of these medications may be altered (interactions):

• Azathioprine, 6-mercaptopurine, or thioguanine(medications for treating immunological disorders)
• Certain anticoagulant agents(medications for thrombosis or to thin the blood, such as warfarin)

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. It may be correct to useSalofalk1 g suppositoriesand your doctor will decide what is appropriate for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You must use Salofalk 1 g suppositories during pregnancy only if your doctor has indicated this.

Similarly, you should only useSalofalk 1gSuppositoriesduring breastfeeding if your doctor advises this, as this medication may pass into breast milk.

Driving and operating machinery

The influence of Salofalk 1g suppositories on the ability to drive or operate machinery is negligible or insignificant.

Important information about some components of Salofalk 1 g suppositories

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Administration mode

This medication can only be used rectally, by inserting it through the anus. It must not be ingested.

Dosage

Adults and elderly people

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

Use in children

There is limited experience and documentation on the effect in children.

Treatment duration

The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. . Your doctor will decide for how long you should continue treatment with this medication. This will depend on the progression of your disease.

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

If you think 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

Consult your doctor if you are unsure, and they will decide what to do.

If you use too many Salofalk 1 g suppositories at one time, apply the next dose as prescribed. Do not use a lower dose.

If you forgot to use Salofalk 1 g suppositories

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

If you interrupt treatment with Salofalk 1 g suppositories

Do not stop using this medication until you speak with your doctor.

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

If you experience any of the following symptoms after using this medication, you must 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 notable decrease in your overall state of health, especially if accompanied by fever and/or sore throat and mouth. These symptoms may be due to a rare decrease in the number of white blood cells in your blood, which may make you more prone to developing a severe infection (agranulocytosis). Other blood cells (such as platelets or red blood cells, which causeaplastic anemia or thrombocytopenia) may also be affected and cause symptoms that may include unexplained bleeding, purple patches or spots under the skin, anemia (feeling tired, weakness, and pale appearance, especially on lips and nails). A blood sample may confirm if your symptoms are due to an effect of this medication on your blood. These reactions are very rare.
• • Severe skin rashes withflat, red patches, or circular patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, generalized rash, fever, and enlarged lymph nodes. These may be preceded by fever or flu-like symptoms. These reactions occur in an unknown number of patients (unknown frequency).
  • Difficulty breathing, chest pain, or irregular heartbeats, or swollen limbs that may indicatecardiac hypersensitivity reactions. These reactions are rare.
  • Problems with your kidney function(may occur very rarely), for example, a change in the color or amount of urine produced and swollen limbs or sudden side pain (caused by a kidney stone) (occur in an unknown number of patients (unknown frequency)).

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

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

• Rash, itching

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

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

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

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the suppository blister pack and on the cardboard box. The expiration date is the last day of the month indicated.

Store at a temperature not exceeding 30°C. Keep in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofSalofalk1 g suppositories

The active ingredient ofSalofalk1 g suppositoriesis mesalazine, and aSalofalk1 g suppositoriessuppository contains 1g of mesalazine.

The other component is:

hard fat.

Appearance of the product and contents of the packaging

Salofalk1 g suppositoriesare torpedo-shaped suppositories of a cream color.

Salofalk1g suppositoriesare available in boxes of 10, 12, 15, 20, 30, 60, and 90 suppositories.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr.5

79108 Freiburg

Germany

Phone +49 (0) 761 / 1514-0

Fax +49(0) 761 / 1514-321

Email:[email protected]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Dr. Falk Pharma Spain

Camino de la Zarzuela, 19

28023 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet:August 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/