SALOFALK 4 g/60 ml RECTAL SUSPENSION

2. What you need to know before starting to use Salofalk 4g/60ml rectal suspension

Do not useSalofalk4g/60mlrectal suspension:

• if you are allergic to mesalazine, 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 4g/60ml rectal suspension:

• if you have a history of lung disease, particularly if you suffer from bronchial asthma
• if you are allergic to medications containing sulfasalazine, a substance related to mesalazine
• if you have liver problems
• if you have kidney problems
• If you have ever suffered from a severe skin rash, peeling, or blisters 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 may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough liquid during treatment with mesalazine.

Severe skin rashes, 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 immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Salofalk 4g/60ml rectal suspension with other medications

Tell your doctor if you use or take any of the following medications, as their effects may be altered (interactions):

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

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication, even those purchased without a prescription. It may be correct to use Salofalk 4g/60ml rectal suspension, and your doctor will decide what is appropriate for you.

Pregnancy and lactation

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

You should use Salofalk 4g/60ml rectal suspension during pregnancy only if your doctor has indicated it.

Similarly, you should only use Salofalk 4g/60ml rectal suspension during breastfeeding if your doctor indicates it, as this medication may pass into breast milk.

Driving and using machines

The influence of Salofalk 4g/60ml rectal suspension on the ability to drive and use machines is nil or insignificant.

Salofalk4g/60ml rectal suspension contains potassium metabisulfite and sodium benzoate

Potassium metabisulfite can rarely cause severe hypersensitivity reactions and bronchospasm.

This medication contains 60 mg of sodium benzoate in each Salofalk 4g/60ml rectal suspension enema. Sodium benzoate may cause local irritation.

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3. How to use Salofalk 4g/60ml rectal suspension

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Method of administration

This medication can only be used rectally, so it must be inserted through the anus. It should not be ingested. Do not swallow.

Administer the contents of one enema bottle into the intestine as an enema, at night before bedtime.

The best results are achieved if the intestine is empty before administering Salofalk 4g/60ml rectal suspension.

• Shake well for at least 30 seconds before use and ensure the suspension is well mixed.
• Remove the protective cap. Hold the container vertically so the contents do not spill out.
• Lie on your left side with your left leg straight and your right knee bent to maintain balance.
• Insert the tip of the applicator, which is covered with a lubricating film, deeply into your rectum. Keep the bottle pointing towards your navel.
• Tilt the bottle slightly downwards and then press the bottle slowly and evenly. Once the bottle is empty, remove the applicator slowly.
• After using Salofalk 4g/60ml rectal suspension, please remain in the same position for at least 30 minutes. This allows the medication to distribute evenly throughout the intestine.

To achieve the best results, you should allow Salofalk 4g/60ml rectal suspension to take effect throughout the night.

Posology

Adults and elderly patients

If you have acute symptoms of inflammation, use 1 enema of Salofalk 4g/60ml rectal suspension (=60g suspension, equivalent to 4g of mesalazine per day) once a day, at bedtime.

Use in children

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

Duration of treatment

The duration of treatment depends on your particular conditions.

Your doctor will decide how long you need to continue using the medication.

In order to achieve the desired therapeutic effects, you should use Salofalk 4g/60ml rectal suspension regularly and uniformly, as this is the only way to achieve the desired therapeutic effect.

If you feel that the effect of Salofalk 4g/60ml rectal suspension is too strong or too weak, consult your doctor or pharmacist.

If you use moreSalofalk4g/60ml rectal suspensionthan you should

Contact your doctor if you have doubts, and they will decide what to do.

If you use too much Salofalk 4g/60ml rectal suspension on one occasion, limit yourself to applying the next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk4g/60ml rectal suspension

Do not use a larger amount of Salofalk 4g/60ml rectal suspension than normal; continue with the treatment at the prescribed dose.

If you interrupt treatment withSalofalk4g/60ml rectal suspension

Do not stop using this medication until you talk to your doctor.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible adverse effects

If you experience any of the following symptoms after using this medication, you should contact your doctor and stop using Salofalk rectal suspension immediately:

• General allergic reactions such as skin rash, fever, joint pain, and/or difficulty breathing or a general inflammation of the large intestine (causing severe diarrhea and abdominal pain). These reactions are very rare.
• A significant worsening of your general health, especially if accompanied by fever and/or throat and mouth pain. These symptoms, very rarely, can be caused by a decrease in the number of white blood cells in the blood (agranulocytosis), which can increase your propensity to contract a serious infection. Other blood cells (such as platelets and red blood cells) can also be affected, causing aplastic anemia or thrombocytopenia, which can cause symptoms such as unexplained bleeding, small or large purple spots under the skin, and anemia (feeling of fatigue and weakness and paleness, especially in the lips and nails). A blood test can confirm if the symptoms are due to an effect of this medication on the blood. These reactions are very rare.
• Severe skin rashes with reddish, non-elevated, circular or target-shaped spots on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and enlarged lymph nodes. They can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of people (frequency not known).
• Difficulty breathing, chest pain, or irregular heartbeat, or swelling of the limbs, which can indicate cardiac hypersensitivity reactions. These reactions are rare.
• Kidney function problems (can occur very rarely), such as a change in the color or amount of urine produced and swelling of the limbs or sudden pain in the side (caused by a kidney stone) (occur in an unknown number of people (frequency not known).

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

Frequent: may affect up to 1 in 10 people

• Skin rash, itching

Rare: may affect up to 1 in 1,000 people

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

Very rare: may affect up to 1 in 10,000 people

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

Reporting 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Salofalk 4g/60ml rectal suspension

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions. Keep the container in the original sealed blister to protect it from light.

Do not use this medication after the expiration date shown on the label on the bottom of the bottle and on the carton. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofSalofalk4g/60ml rectal suspension

The active ingredient is mesalazine. One enema of Salofalk 4g/60ml rectal suspension (60g suspension) contains 4g of mesalazine.

The other components are:

Carbomer 35,000, potassium acetate, potassium metabisulfite (E224), sodium benzoate (E211), sodium edetate, purified water, xanthan gum.

Appearance of the product and package contents

Salofalk 4g/60ml rectal suspension is a cream to light brown, homogeneous pale brown suspension without foreign particles.

Salofalk 4g/60ml rectal suspension is available in boxes with 7 enemas.

Marketing authorization 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]

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

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Tel: + 34 91 372 95 08

This medication is authorized in EEA member states with the following names:

Germany: Salo

Denmark, Spain, Finland, Norway, and Sweden: Salofalk

Date of the last revision of this prospectus:December 2023

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