Salofalk

Package leaflet: Information for the user

Salofalk, 1.5 g, prolonged-release granules
Mesalazinum
Please read this leaflet carefully before taking 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Salofalk is and what it is used for
2. What you need to know before taking Salofalk
3. How to take Salofalk
4. Possible side effects
5. How to store Salofalk
6. Contents of the pack and other information

1. What Salofalk is and what it is used for

Salofalk 1.5 g granules contain the active substance mesalazinum, which has anti-inflammatory action and is used in the treatment of inflammatory bowel disease.
Salofalk 1.5 g granules are used for:

• Treatment of acute episodes and prevention of further episodes (relapses) of mild to moderate ulcerative colitis, an inflammatory disease of the large intestine (colon).

2. Important information before taking Salofalk

When not to take Salofalk

• if the patient is allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin) or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney disease.

Warnings and precautions
Before starting treatment with Salofalk, discuss with your doctor:

• if the patient has previously had lung problems, particularly if bronchial asthma occurred,
• if the patient has previously experienced allergy to sulfasalazine, a substance related to mesalazine,
• if the patient has impaired liver function,
• if the patient has impaired kidney function,
• if the patient has ever experienced severe skin rash, skin peeling, blisters or oral ulcers after taking mesalazine.

palpl-sag1500-pl11-1-nov25-clean.docx 1
Mesalazine may cause reddish-brown discoloration of urine upon contact with sodium hypochlorite bleach present in toilet water. This is due to a chemical reaction between mesalazine and bleach and is harmless.
Other precautions
During treatment, the doctor may decide on close medical monitoring, including regular blood and urine tests.
Mesalazine use may lead to the formation of kidney stones. Symptoms may include abdominal side pain and blood in the urine. Adequate fluid intake should be maintained during mesalazine treatment.
Severe skin reactions have occurred with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Treatment with mesalazine should be discontinued and immediate medical help sought if any symptoms of these severe skin reactions occur, as described in section 4.
If the patient experiences severe or recurring headache, visual disturbances, or ringing or buzzing in the ears, medical advice should be sought immediately.
Salofalk and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines planned for future use. This particularly applies to the following medicines:

• azathioprine, 6-mercaptopurine or thioguanine (medicines used in the treatment of immune system disorders),
• some anticoagulant medicines (medicines used for thrombosis or blood thinning, e.g. warfarin),
• lactulose (a medicine used for constipation) or other medicines that may alter stool acidity.

Inform your doctor or pharmacist about all other medicines currently or recently taken, including those available without prescription. This does not necessarily exclude the possibility of using Salofalk granules, but will allow the doctor to make an appropriate treatment decision.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Salofalk granules may be taken during pregnancy only if prescribed by a doctor.
Salofalk granules may also be taken during breastfeeding only if recommended by a doctor, as the medicine may pass into human milk.
Driving and operating machinery
Salofalk has no effect or negligible effect on the ability to drive and operate machinery.
Salofalk contains aspartame, sucrose and sodium.
The medicine contains 3 mg of aspartame per sachet of Salofalk. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
palpl-sag1500-pl11-1-nov25-clean.docx 2
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to take Salofalk

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Method of administration
Salofalk granules must only be taken orally.
Do not chew the granules. Place the granules directly on the tongue and swallow them whole, taking a large amount of liquid to help swallow, without chewing.

Dosage

| Age and body weight | Single dose | Total daily dose | |---------------------|-------------|------------------| | Adults, elderly patients, and children with body weight above 40 kg | Up to 2 sachets of Salofalk 1.5 g | 1–2 sachets | | Treatment of acute episodes | | | | Prevention of further episodes | 2 sachets of Salofalk 1.5 g | 1 x 2 sachets | | (in patients at increased risk of relapse) | | | | Adults and elderly patients | | | | If your doctor does not advise otherwise, the usual dose for the treatment of acute episodes of ulcerative colitis is: | | | | 1–2 sachets of Salofalk 1.5 g granules once daily, preferably in the morning (equivalent to 1.5–3 g mesalazine per day), depending on the individual clinical needs of the patient. | | | | Prevention of relapses of ulcerative colitis | | | | The usual dose for preventing relapses of ulcerative colitis is: | | | | 500 mg mesalazine three times daily (equivalent to 1.5 g mesalazine per day). | | | | If your doctor considers the risk of relapse to be higher, the dose used to prevent further episodes of ulcerative colitis is: | | | | 2 sachets of Salofalk 1.5 g granules once daily, preferably in the morning (equivalent to 3 g mesalazine per day). | | |

Use in children
Data on use in children (aged 6–18 years) are limited.

Children aged 6 years and older
The exact dose of Salofalk 1.5 g granules in a child should be determined by the doctor.

Acute episode
The dose should be individually adjusted; usually starting at 30 to 50 mg mesalazine per kg body weight once daily, preferably in the morning, or in divided doses. The maximum dose is 75 mg mesalazine/kg body weight/day. The total dose should not exceed the maximum dose used in adults.

In children weighing up to 40 kg, a dose equal to half the adult dose is usually recommended. In children weighing more than 40 kg, the usual adult dose is applied.

Due to the high content of active substance, Salofalk 1.5 g granules are not suitable for children weighing less than 40 kg. Salofalk 1000 mg granules should be used instead.

Duration of treatment
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The duration of treatment will be determined by your doctor and depends on the patient's condition.

To achieve the maximum benefit from Salofalk granules, it is essential to take the medicine regularly and consistently, both during acute inflammatory episodes and during long-term maintenance therapy, as directed.

If you feel the effect of Salofalk granules is too strong or too weak, consult your doctor.

Taking more than the recommended dose of Salofalk
In case of doubt, consult your doctor. Your doctor will decide on further management.

If a single dose of Salofalk granules greater than recommended has been taken, take the next dose at the usual time. Do not reduce the dose.

Missed dose of Salofalk
Do not take a double dose to make up for a missed dose.

Stopping Salofalk
Do not stop taking Salofalk without first consulting your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following symptoms after taking this medicine, contact a doctor immediately
and stop taking Salofalk:

• 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.
• Significant worsening of general health condition, especially if accompanied by fever and (or) sore throat and oral cavity pain. In very rare cases, these symptoms may be caused by a reduced number of white blood cells, leading to increased susceptibility to severe infections (agranulocytosis). There may also be disturbances in other blood cells (e.g. platelets or red blood cells, causing aplastic anaemia or thrombocytopenia) and may lead to symptoms including unexplained bleeding, purplish spots or skin rashes, anaemia (feeling of fatigue, weakness and paleness, especially of lips and nails). Blood tests may confirm whether the symptoms experienced by the patient are caused by this medicine's effect on blood. These reactions are very rare.
• Severe skin rashes with red, flat, disc-shaped or circular patches on the trunk, often with blisters in their center, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes, extensive rash, fever and swollen lymph nodes. These may be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency unknown).
• Shortness of breath, chest pain or irregular heartbeat, or limb swelling, which may indicate hypersensitivity reactions affecting the heart. These reactions are rare.
• Kidney function problems (may occur very rarely), e.g. change in colour or amount of urine produced, or limb swelling or sudden lower abdominal pain (caused by kidney stones) (occur in an unknown number of patients (frequency unknown)).
• Severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension) (frequency unknown [frequency cannot be determined from available data]).

Patients taking mesalazine have also reported the following adverse reactions.
Common adverse reactions (occurring in less than 1 in 10 patients)

• headache,
• rash, itching.

Uncommon adverse reactions (occurring in less than 1 in 100 patients)

• abdominal pain, diarrhoea, digestive disturbances, flatulence (bloating), nausea and vomiting,
• severe abdominal pain due to acute pancreatitis,
• changes in liver function parameters, changes in pancreatic enzyme activity.

Rare adverse reactions (occurring in less than 1 in 1000 patients)

• dizziness,
• jaundice or abdominal pain due to liver function disorders and impaired bile flow,
• increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity),
• joint pain,
• feeling of weakness or fatigue.

Very rare adverse reactions (occurring in less than 1 in 10,000 patients)

• numbness and tingling of hands and feet (peripheral neuropathy),
• shortness of breath, cough, wheezing, lung X-ray shadow due to allergic and (or) inflammatory lung reactions,
• hair loss and alopecia,
• muscle pain,
• reversible reduction in sperm count in semen.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Salofalk

palpl-sag1500-pl11-1-nov25-clean.docx 5
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box and sachet after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must 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 other information

What Salofalk contains

• The active substance in Salofalk is mesalazine: one sachet contains 1.5 g of mesalazine.
• The other components of the medicine are: microcrystalline cellulose, hypromellose (50 mPas), colloidal anhydrous silica, polyacrylate dispersion 40%, magnesium stearate, simethicone, 33% emulsion. Coating: copolymer of methacrylic acid and methyl methacrylate (1:1), triethyl citrate, talc, magnesium stearate, hypromellose (50 mPas), sodium carboxymethylcellulose, aspartame (E 951), citric acid, povidone (K 25). Vanilla Custard flavour (GIV:75016-32/PHP-132872): flavours identical to natural ones, maltodextrin, sucrose, propylene glycol.

What Salofalk looks like and contents of the pack
Salofalk 1.5 g prolonged-release granules are beige or brownish granules of elongated or round shape, possibly with yellowish spots on the surface.
Each sachet contains 2.74 g of granules.
Salofalk 1.5 g granules are available in packs containing 20, 30, 35, 45, 50, 60, 70, 90, 100 and 150 sachets.
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: [email protected]
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Denmark, Finland, Greece, Spain, the Netherlands, Ireland, Latvia, Germany, Norway, Poland, Portugal, the Czech Republic, Slovakia, Slovenia, Sweden, Hungary, the United Kingdom, Italy: Salofalk.
Belgium, Luxembourg: Colitofalk.
Austria: Mesagran.
France: Osperzo.
palpl-sag1500-pl11-1-nov25-clean.docx 6