Salofalk 4 g/60 ml rectal suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Salofalk 4g/60ml rectal suspension

mesalazine

Read all of this leaflet carefully before you start using this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Salofalk 4g/60ml rectal suspension is and what it is used for
2. What you need to know before using Salofalk 4g/60ml rectal suspension
3. How to use Salofalk 4g/60ml rectal suspension
4. Possible adverse effects
5. How to store Salofalk 4g/60ml rectal suspension
6. Contents of the pack and other information

1. What Salofalk 4g/60ml rectal suspension is and what it is used for

Mesalazine, the active substance of Salofalk 4g/60ml rectal suspension, is an anti-inflammatory agent used in inflammatory bowel diseases.

Salofalk 4g/60ml rectal suspension is used for:

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

Ulcerative colitis is an inflammatory disease of the large intestine.

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

Do not use Salofalk 4g/60ml rectal suspension:

• if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g., Aspirin®), or to any of the other ingredients 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 4g/60ml rectal suspension:

• 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 a severe skin rash, skin peeling, blisters, or mouth sores after taking mesalazine

Mesalazine may cause a harmless discoloration of urine to a red-brown color, especially when it comes into contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is not harmful.

Additional precautions

During treatment, your doctor may wish to monitor you medically 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 to drink sufficient fluids 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, changes in vision, or ringing or buzzing in the ears, contact your doctor immediately.

Use of Salofalk 4g/60ml rectal suspension 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, including those obtained without a prescription. It may still be appropriate for you to use Salofalk 4g/60ml rectal suspension, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should use Salofalk 4g/60ml rectal suspension during pregnancy only if your doctor has instructed you to do so.

Similarly, you should use Salofalk 4g/60ml rectal suspension during breastfeeding only if your doctor has instructed you to do so, as this medicine may pass into breast milk.

Driving and using machines

The effect of Salofalk 4g/60ml rectal suspension on the ability to drive and operate machinery is negligible or none.

Salofalk 4g/60ml rectal suspension contains potassium metabisulfite and sodium benzoate

Potassium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.

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

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

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. Do not ingest.

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

Best results are achieved if the bowel is empty before administration of Salofalk 4g/60ml rectal suspension.

• Shake well for at least 30 seconds before use and ensure that the suspension is thoroughly mixed.
• Remove the protective cap. Hold the container vertically to prevent the contents from spilling out.
• Lie on your left side with your left leg straight and your right knee bent to maintain balance.
• Insert the applicator tip, which is covered with a lubricating film, deeply into your rectum. Point the bottle towards your navel.
• Tilt the bottle slightly downwards and then slowly and evenly squeeze the bottle. Once the bottle is empty, slowly withdraw the applicator.
• After using Salofalk 4g/60ml rectal suspension, please remain in the same position for at least 30 minutes. This allows the medicine to distribute evenly throughout the intestine.

For best results, allow Salofalk 4g/60ml rectal suspension to work throughout the night.

Dosage

Adults and elderly patients

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

Use in children

There is limited experience and scarce documentation on the use of this medicine in children.

Duration of treatment

The duration of treatment depends on your individual condition.

Your doctor will decide how long you should continue taking the medicine.

To achieve the desired therapeutic effects, Salofalk 4g/60ml rectal suspension must be used regularly and consistently, as this is the only way to achieve the desired therapeutic effect.

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

If you use more Salofalk 4g/60ml rectal suspension than you should

Contact your doctor if you have any doubts so that he/she can decide what action to take.

If you accidentally use too much Salofalk 4g/60ml rectal suspension at one time, simply continue with the next dose as prescribed. Do not reduce the dose.

If you forget to use Salofalk 4g/60ml rectal suspension

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

If you stop using Salofalk 4g/60ml rectal suspension

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

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

4. Possible adverse effects

If you experience any of the following symptoms after using this medicine, 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 generalized inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A significant worsening of your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms, although very rare, may be caused by a decrease in the number of white blood cells in the blood (agranulocytosis), which can increase your susceptibility to serious infections. Other blood cells may also be affected (such as platelets and red blood cells), leading to aplastic anaemia or thrombocytopenia, which may cause symptoms such as unexplained bleeding, small or large purple spots under the skin, and anaemia (feeling tired and weak, paleness, especially in the lips and nails). A blood test can confirm whether these symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with flat, red, circular lesions or target-shaped rashes on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, generalized rash, fever and swollen lymph nodes. These may 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 may indicate cardiac hypersensitivity reactions. These reactions are rare.
• Kidney function problems (may occur very rarely), for example, changes in the colour or amount of urine produced, 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).
• Severe or recurrent headache, vision disturbances, or ringing or buzzing 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:

Frequent: may affect up to 1 in 10 people

• Skin rash, pruritus

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

• Abdominal pain, diarrhoea, 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 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

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

Do not use this medicine after the expiry date stated on the label at the bottom of the bottle and on the cardboard box. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Salofalk 4g/60ml rectal suspension

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

The other components are:

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

Appearance of the product and contents of the pack

Salofalk 4g/60ml rectal suspension is cream to light in colour, a homogeneous pale brown suspension free from foreign particles.

Salofalk 4g/60ml rectal suspension is available in cartons containing 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 further information about this medicinal product from 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 medicinal product is authorized in EEA member states under the following names:

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

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

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