Patient leaflet - Salofalk 500 mg suppositories

1. What Mesalazine Dr Falk Pharma 500 mg suppositories are and what they are used for

Mesalazine Dr Falk Pharma suppositories contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Mesalazine Dr Falk Pharma suppositories are used for:

the treatment of mild and moderate episodes of an inflammatory disease in the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis.

2. What you need to know before you use Mesalazine Dr Falk Pharma 500 mg suppositories

Do not use Mesalazine Dr Falk Pharma suppositories

If you are allergic to salicylic acid, to 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 a serious liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine:

If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma.
If you have a history of allergy to sulphasalazine, a substance related to mesalazine.
If you suffer with problems of your liver.
If you suffer with problems of your kidney.
If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.

Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.

During treatment your doctor may want to keep you under close medical supervision and you may need to have regular blood and urine tests.

Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Stop using mesalazine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears contact your doctor immediately.

Other medicines and Mesalazine Dr Falk Pharma suppositories

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the medicines mentioned below as the effects of these medicines may change (interactions):

Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood, e.g., warfarin)
Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should only use this medicine during pregnancy if your doctor tells you to.

You should also only use this medicine during breast-feeding if your doctor tells you to, as this medicine and its metabolites may pass into breast milk.

Driving and using machines

There are no effects on the ability to drive and use machines.

Mesalazine Dr Falk Pharma suppositories contain cetyl alcohol

Cetyl alcohol may cause local skin reactions (e.g., contact dermatitis).

3. How to use Mesalazine Dr Falk Pharma 500 mg suppositories

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take by mouth.

Dosage

Adults and elderly:

The recommended dose is one or two suppositories two to three times daily.

Use in children

There is little experience and only limited documentation for an effect in children.

Duration of treatment

The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you need to continue the treatment with this medicine. This will depend on your condition.

To obtain the maximum benefit from this medicine, you should use Mesalazine Dr Falk Pharma suppositories regularly and consistently, as directed.

If you think your Mesalazine Dr Falk Pharma suppositories are too strong or too weak, talk to your doctor.

PL 10341/0009; Salofalk 500 mg suppositories

Dr. Falk Pharma UK Ltd mock-up-leaflet eCTD 0035, Debranding, initial, 16.04.2025 1 of 2

If you use more Mesalazine Dr Falk Pharma suppositories than you should

Contact a doctor if you are in doubt, so he or she can decide what to do.

If you use too many suppositories on one occasion, just use your next dose as prescribed. Do not use a smaller amount.

If you forget to use Mesalazine Dr Falk Pharma suppositories

Do not use a larger than normal dose of Mesalazine Dr Falk Pharma suppositories next time, but continue treatment at the prescribed dosage.

If you stop using Mesalazine Dr Falk Pharma suppositories

Do not stop using this product until you have talked to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms after taking this medicine, you should contact your doctor and stop using Mesalazine Dr Falk Pharma suppositories immediately:

General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties or a general inflammation of your large bowel (causing severe diarrhoea and abdominal pain). These reactions are very rare.
A marked reduction of your general health, especially if accompanied by fever, and/or a sore throat and mouth. These symptoms can, very rarely, be due to a fall in the number of white cells in your blood, which may make you more prone to developing a serious infection (agranulocytosis). Other cells of the blood may also be affected (e.g., platelets or red cells causing aplastic anaemia or thrombocytopenia) and cause symptoms which may include unexplained bleeding, purple spots or patches under your skin, anaemia (feeling tired, weak and looking pale, especially on lips and nails). A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood. These reactions are very rare.
Serious skin rashes with reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
- Shortness of breath, chest pain or irregular heartbeat, or swollen limbs which may be indicative of cardiac hypersensitivity reactions. These reactions are rare.
- Problems with your kidney function (can occur very rarely), e.g., a change in the colour or amount of urine produced and swollen limbs or a sudden flank pain (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).
- Strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure within your skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from the available data]).

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

Common: may affect up to 1 in 10 patients

Rash, itching

Rare side effects (that affect less than 1 in 1,000 patients)

Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting, constipation
Headache, dizziness
Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)

Very rare side effects (that affect less than 1 in 10,000 patients)

Changes in kidney function, sometimes with swollen limbs or flank pain
Severe abdominal pain because of acute inflammation of the pancreas
Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions
Muscle and joint pain
Jaundice or abdominal pain because of liver or bile flow disorders
Hair loss and the development of baldness
Numbness and tingling in the hands and feet (peripheral neuropathy)
Reversible decrease in semen production

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mesalazine Dr Falk Pharma 500 mg suppositories

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

Do not use this medicine after the expiry date which is stated on the blister strip and on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original container in order to protect contents from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mesalazine Dr Falk Pharma suppositories contain

The active substance is mesalazine and one suppository contains 500mg mesalazine.

The other ingredients are

Hard fat, docusate sodium, cetyl alcohol.

What Mesalazine Dr Falk Pharma suppositories look like and contents of the pack

Mesalazine Dr Falk Pharma suppositories are in white opaque PVC/PE strips of 5.

Available in packs of 10 or 30 suppositories.

Not all packs may be marketed.

Marketing Authorisation Holder

Dr Falk Pharma UK Ltd

Unit K, Bourne End Business Park, Cores End Road Bourne End, SL8 5AS

Tel: 01628 536600

e-mail: office@drfalkpharma.co.uk

Manufacturer

DR. FALK PHARMA GmbH

Leinenweberstr. 5 79108 Freiburg Germany

This leaflet was last revised in 04/2025.

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