Patient leaflet - Salofalk 1 g suppositories
1. What Salofalk 1g Suppositories are and what they are used for
Salofalk 1g Suppositories contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.
Salofalk 1g Suppositories are used for
- the treatment of mild to moderate acute episodes of an inflammatory disease limited to the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis.
2. What you need to know before you use Salofalk 1g Suppositories
Do not use Salofalk 1g Suppositories
- If you are allergic to salicylic acid, to salicylates such as acetylsalicylic acid (e.g., Aspirin®) or the other ingredient of this medicine (listed in section 6).
- If you have a serious liver or kidney disease.
Warnings and precautions
Talk to your doctor before using Salofalk 1g Suppositories
- 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.
Further precautions
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 Salofalk 1g Suppositories
Tell your doctor, if you take or use any of the medicines mentioned below, as the effects of these medicines may change (interactions)
- Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders).
- Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood, e.g., warfarin).
Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines. It may still be all right for you to use Salofalk 1g Suppositories and your doctor will be able to decide, what is suitable for you.
Pregnancy and breast-feeding
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 Salofalk 1g Suppositories during pregnancy, if your doctor tells you to.
You should also only use Salofalk 1g Suppositories during breast-feeding, if your doctor tells you to, as this medicine may pass into breast milk.
Driving and using machines
Salofalk 1g Suppositories are not expected to affect your ability to drive or operate machines.
Important information about some of the ingredients of Salofalk 1g Suppositories
The other ingredient in Salofalk 1g Suppositories is not likely to cause side effects (see section 6. Contents of the pack and other information).
3. How to use Salofalk 1g Suppositories
Always use this medicine exactly as your doctor 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 older people
The recommended dose is one Salofalk 1g Suppository once a day, at bedtime.
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 Salofalk 1g Suppositories regularly and consistently, as directed.
If you think your Salofalk 1g Suppositories are too strong or too weak, talk to your doctor.
If you use more Salofalk 1g 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 much Salofalk 1g Suppositories on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
If you forget to use Salofalk 1g Suppositories
If you forget to use this medicine, use it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed. Then use the next dose at
its usual time. Do not use a double dose to make up for a forgotten dose.
If you stop using Salofalk 1g 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 medicine, 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 using this medicine, you should contact your doctor and stop using Salofalk 1g 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). Salofalk 1g Suppositorien Gebrauchsinformation (GI) für Großbritannien
- 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 side effects (may affect up to 1 in 10 people)
- Rash, itching
Rare side effects (may affect up to 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 (may affect up to 1 in 10,000 patients)
- 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 national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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 Salofalk 1g 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 to protect the environment.
6. Contents of the pack and other information
What Salofalk 1g Suppositories contain
The active substance in Salofalk 1g Suppositories
is mesalazine, and one suppository of Salofalk 1g Suppositories contains 1 g mesalazine.
The other ingredient is
hard fat.
What Salofalk 1g Suppositories look like and contents of the pack
Salofalk 1g Suppositories are light beige coloured, torpedo-shaped suppositories.
Salofalk 1g Suppositories are available in packs of 10, 12, 15, 20, 30, 60, 90 suppositories.
Not all package 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: zentrale@drfalkpharma.de
This medicinal product is authorised in the Member States of the EEA under the following names
Austria, Bulgaria, Czech Republic, Cyprus, Denmark, Finland, Germany, Great Britain, Greece, Hungary, Ireland, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Sweden and Spain: Salofalk®.
Belgium and Luxembourg: Colitofalk®.
France: Osperzo®.
Italy: Cletrovaproct®.
This leaflet was last revised in 01/2025
3101531.1 GB/12.24