Patient Information

Salofalk4g/60ml Rectal Suspension

Mesalazine

Read this entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Mesalazine, active ingredient of Salofalk4g/60ml rectal suspension, is an anti-inflammatory used in inflammatory intestinal diseases.

Salofalk4g/60ml rectal suspensionis used for:

treatment of acute episodes of an inflammatory disease called ulcerative colitis.

Ulcerative colitis is an inflammatory disease of the large intestine.

No useSalofalk4g/60mlsuspensión rectal:

• If you are allergic to mesalazine, acetylsalicylic acid (for example, 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 Salofalk4g/60ml suspensión rectal:

• 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 experienced intense skin rash, skin 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 chemical reaction between mesalazine and bleach and is harmless.

Additional precautions

Your doctor may want to keep you under medical supervision during treatment, and regular blood and urine tests may be required.

Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain and blood in the urine. Ensure you drink enough liquid during mesalazine treatment.

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 symptoms related to these severe skin reactions described in section 4.

Use of Salofalk 4g/60 ml suspension rectal with other medications

Inform 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 immunological disorders)
• Certain blood-thinning agents(medications for thrombosis or to thin the blood, such as warfarin)

Inform 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 useSalofalk4g/60mlsuspension rectaland 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 should use Salofalk4g/60ml suspension rectalduring pregnancy only if your doctor has indicated it.

Similarly, you should only use Salofalk4g/60ml suspension rectalduring breastfeeding if your doctor has indicated it, as this medication may pass into breast milk.

Driving and operating machinery

The influence of Salofalk 4g/60 ml suspension rectal on the ability to drive and operate machinery is negligible or insignificant.

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

Potassium metabisulfite rarely may cause severe hypersensitivity reactions and bronchospasm.

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

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Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration Mode

This medication can only be used rectally by inserting it through the anus. Do not ingest. Do not swallow.

Administer the contents of a bottle enema inside the intestine as a lavage, at night before going to bed.

The best results are achieved if the intestine is empty before the administration ofSalofalk4g/60ml rectal suspension.

• Shake well, at least for 30 seconds before use and make sure the suspension is well mixed.
• Remove the protective cap. Hold the container vertically so that 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.
• Incline the bottle slightly downwards and then press the bottle slowly and uniformly. Once the bottle is empty, remove the applicator slowly.
• After usingSalofalk4g/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, allowSalofalk4g/60ml rectal suspension to exert its effects throughout the night.

Dosage

Adults and elderly patients

If you have acute symptoms of inflammation, use 1 enema ofSalofalk4g/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.

Treatment duration

The duration of treatment depends on your individual circumstances.

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

In order to achieve the desired therapeutic effects, you should use Salofalk 4 g/60 ml 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 4 g/60 ml 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 are unsure, so that they can decide what to do.

If you use too much Salofalk4g/60ml rectal suspensionon one occasion, limit yourself to applying the next dose as prescribed. Do not use a lower dose.

If you forgot to use Salofalk4g/60ml rectal suspension

Do not use a higher dose than normal of Salofalk4g/60ml rectal suspension, continue with the treatment at the prescribed dose.

If you interrupt the treatment withSalofalk4g/60ml rectal suspension

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

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

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

• General allergic reactions such as skin rash, fever, joint pain, and/or difficulty breathing or a general inflammation of the large intestine (which causes intense diarrhea and abdominal pain). These reactions are very rare.
• A significant worsening of your overall health, especially if accompanied by fever and/or throat and mouth pain. These symptoms, very rarely, may be caused by a decrease in the number of white blood cells in the blood (agranulocytosis), which may increase your susceptibility to a severe infection. Other blood cells (such as platelets and red blood cells) may also be affected, causing aplastic anemia or thrombocytopenia, which may cause symptoms such as unexplained bleeding, small or large purple spots under the skin, and anemia (feeling tired and weak and paleness, especially in the lips and nails). A blood test can confirm if the symptoms are due to the effect of this medication on the blood. These reactions are very rare.
• Severe skin eruptions with flat, red, non-elevated circular spots or target-shaped spots on the trunk, often with central vesicles, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, generalized rash, fever, and lymph node enlargement. They may be preceded by fever and symptoms similar to the flu. These reactions occur in an unknown number of people (unknown frequency).
• Difficulty breathing, chest pain, or irregular heartbeat, or swelling of the extremities, which may indicate cardiac hypersensitivity reactions. These reactions are rare.
• Renal function problems (which may occur very rarely), for example, a change in the color or amount of urine produced and swelling of the extremities or sudden pain in the side (caused by a kidney stone) (occur in an unknown number of people (unknown frequency).

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

Frequent: may affect up to 1 in 10 people

• Skin rash, pruritus

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

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

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

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

Reporting of adverse effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse 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 adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not usethis medicationafter the expiration date that appears on the label at the bottom of the bottle and on the cardboard box. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSalofalk4g/60ml rectal suspension

The active ingredient is mesalazine. A 4g/60ml rectal suspension ofSalofalk(60g of suspension)contains 4g of mesalazine.

The other components are:

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

Appearance of the product and contents of the packaging

Salofalk4g/60ml rectal suspension is cream to light in color, a pale brown homogeneous suspension without foreign bodies.

Salofalk4g/60ml rectal suspension is available in boxes of 7 enemas.

Holder of the marketing authorization and responsible manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr.5

79108 Freiburg

Germany

Phone +49 (0) 761 / 1514-0

Fax: +49(0) 761 / 1514-321Email:[email protected]

For more information about this medication, please contact the local representative of the marketing authorization holder:

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Phone: + 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

Last review date of this leaflet:December 2023

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