Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Salofalk 1g Suppositories
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Mesalazine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
What you need to know before you take it
e 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.
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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).
How to take it
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 paluk-sas1g-en9-jan25.docx
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.
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
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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 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.
How to store it
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.
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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: [email protected] 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
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Frequently asked questions about Salofalk 1g Suppositories
How do I take Salofalk 1g Suppositories?
Salofalk 1g Suppositories comes as suppository containing 1g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Salofalk 1g Suppositories?
The active substance in Salofalk 1g Suppositories is mesalazine.
Are there equivalent medicines to Salofalk 1g Suppositories?
Medicines with the same active substance, strength and form include: Octasa 1g Suppositories, Pentasa Suppositories 1g, Mesalazine Ferring 1g Suppositories. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Salofalk 1g Suppositories, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Salofalk 1g Suppositories without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: mesalazine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of acute mild to moderate ulcerative colitis that is limited to the rectum (ulcerative proctitis).
4.2. Posology and method of administration
Posology
Adults and older people:
One Salofalk 1g Suppository once daily (equivalent to 1g mesalazine daily) inserted into the rectum.
Paediatric population
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. The duration of use is determined by the physician.
Method of administration:
For rectal administration only.
Salofalk 1g Suppositories should be administered preferably at bedtime.
Treatment with Salofalk 1g Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.
4.3. Contraindications
Salofalk 1g Suppositories are contraindicated in patients with:
- known hypersensitivity to salicylates or to the excipient listed in section 6.1
- severe impairment of hepatic or renal function
4.4. Special warnings and precautions for use
Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip-sticks) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately.
Caution is recommended in patients with impaired hepatic function.
Mesalazine should not be used in patients with impaired renal function.
Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment. If this is the case, Salofalk 1g Suppositories should be discontinued immediately.
Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. It is recommended to ensure adequate fluid intake during treatment
Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g., in toilets cleaned with sodium hypochlorite contained in certain bleaches).
Serious blood dyscrasias have been reported very rarely with mesalazine. Hematological investigations should be performed if patients suffer from unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain. Salofalk 1g Suppositories should be discontinued in case of suspected or confirmed blood dyscrasia.
Cardiac hypersensitivity reactions (myocarditis and pericarditis) induced by mesalazine have been rarely reported. Salofalk 1g Suppositories should then be discontinued immediately.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with mesalazine.
Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARs), 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.
Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
Idiopathic intracranial hypertension
Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine should be considered.
Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with mesalazine. Should Salofalk 1g Suppositories cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
4.5. Interaction with other medicinal products and other forms of interaction
Specific interaction studies have not been performed. In patients, who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, 6- mercaptopurine or thioguanine should be taken into account. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data on the use of mesalazine in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the foetus/newborn child. To date no other relevant epidemiologic data are available.
In one single case after long-term use of a high dose of mesalazine (2-4 g, orally) during pregnancy, renal failure in a neonate was reported.
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Salofalk 1g Suppositories should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breastfeeding
N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. Only limited experience during lactation in women is available to date.
Hypersensitivity reactions such as diarrhoea in the infant cannot be excluded. Therefore, Salofalk 1g Suppositories should only be used during breastfeeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, breastfeeding should be discontinued.
4.7. Effects on ability to drive and use machines
Mesalazine has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
In clinical studies involving 248 participants, approximately 3% experienced adverse reactions while receiving Salofalk 1g Suppositories. The most commonly reported ADRs were headache, in approximately 0.8% and gastrointestinal side effects (constipation in approximately 0.8%; nausea, vomiting and abdominal pain in 0.4% each).
The following side effects have been reported with the use of mesalazine:
Organ Class System
Frequency According to MedDRA Convention
common
(≥ 1/100 to <1/10)
rare
(≥ 1/10,000; <1/1,000)
very rare
(< 1/ 10,000)
not known
(cannot be estimated from the available data)
Blood and lymphatic system disorders
Altered blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia)
Nervous system disorders
Headache, dizziness
Peripheral neuropathy
Idiopathic intracranial hypertension (see section 4.4)
Cardiac disorders
Myocarditis, pericarditis
Respiratory, thoracic and mediastinal disorders
Allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis)
Gastrointestinal disorders
Abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation
Acute pancreatitis
Renal and urinary disorders
Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency
Nephrolithiasis*
Skin and subcutaneous tissue disorders
Rash, pruritus
Photosensitivity
Alopecia
Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)
Musculoskeletal and connective tissue disorders
Myalgia, arthralgia
Immune system disorders
Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis
Hepatobiliary disorders
Changes in liver function parameters (increase in transaminases and parameters of cholestasis), hepatitis, cholestatic hepatitis
Reproductive system disorders
Oligospermia (reversible)
* see section 4.4 for further information
Severe cutaneous adverse reactions (SCARs), 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 (see section 4.4).
Photosensitivity
More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
There are rare data on overdosage (e.g., intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive.
💬 Ask about this leaflet
Ask anything about Salofalk 1g Suppositories. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Mesalazine
- Asacol 800mg MR Tablets
- Mesalazine Dr Falk Pharma 2g Enema (previously known as Salofalk)
- Mesalazine Dr Falk Pharma 500mg suppositories (previously known as Salofalk)
- Mesalazine Ferring 1 g Rectal Suspension
- Mesalazine Ferring 1g Suppositories
- Mesalazine Tillotts 1g Suppositories
- Mesalazine Tillotts 400 mg Modified-release tablets
- Mezavant XL 1200mg, gastro-resistant, prolonged release tablets
- Octasa 1600 mg modified-release tablets
- Octasa 1g Suppositories
- Octasa 400 mg modified-release tablets
- Octasa 800 mg modified-release tablets
- Pentasa Enema (Mesalazine)
- Pentasa Sachet 1g prolonged release granules