• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Octasa 1g Suppositories are and what they are used for
2. What you need to know before you use Octasa 1g Suppositories
3. How to use Octasa 1g Suppositories
4. Possible side effects
5. How to store Octasa 1g Suppositories
6. Contents of the pack and other information

• If you are allergic to salicylic acid, to salicylates such as acetylsalicylic acid (aspirin) or to the other ingredient of this medicine (listed in section 6).
• If you have a serious liver or kidney disease.

Talk to your doctor before using Octasa 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.

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.

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.

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 Octasa 1g Suppositories and your doctor will be able to decide, what is suitable for you.

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 Octasa 1g Suppositories during pregnancy, if your doctor tells you to.

You should also only use Octasa 1g Suppositories during breast-feeding, if your doctor tells you to, as this medicine may pass into breast milk.

Octasa 1g Suppositories are not expected to affect your ability to drive or operate machines.

The other ingredient in Octasa 1g Suppositories is not likely to cause side effects (see section 6. Contents of the pack and other information).

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

Adults and older people

To treat acute phase of ulcerative proctitis your recommended dose is one Octasa 1g Suppository once a day, at bedtime.

To prevent ulcerative proctitis your recommended dose is one Octasa 1g Suppository once a day, at bedtime.

The dose should be adjusted by your doctor as per your condition.

Use in children

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

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 Octasa 1g Suppositories regularly and consistently, as directed.

If you think your Octasa 1g Suppositories are too strong or too weak, talk to your doctor.

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

If you use too much Octasa 1g Suppositories on one occasion, just take your next dose as prescribed.

Do not use a smaller amount.

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.

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

• Allergic skin rash
• 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, of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These serious skin rashes can be preceded by fever and flu-like symptoms
• Fever
• Breathing difficulties

If you experience a marked reduction of your general health, especially if accompanied by fever, and/or a sore throat and mouth, stop using these suppositories and contact your doctor immediately.

These symptoms can, very rarely, be due to a fall in the number of white cells in your blood (a condition called agranulocytosis), which may make you more prone to developing a serious infection. A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood.

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

Rare side effects (may affect up to 1 in 1,000 patients):

• Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting, constipation
• Headache, dizziness
• Chest pain, breathlessness or swollen limbs because of an effect on your heart
• Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)

Very rare side effects (may affect up to 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
• Fever, sore throat or malaise, because of blood count changes
• Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions
• Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel
• Skin rash or inflammation
• 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

Not known (frequency cannot be estimated from the available data)

• Kidney stones and associated kidney pain (see also section 2)

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 online at yellowcard.mhra.gov.uk or via the free Yellow Card app.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance in Octasa 1g Suppositories is mesalazine, and one suppository of Octasa 1g Suppositories contains 1g mesalazine.

hard fat.

Octasa 1g Suppositories are light beige coloured, torpedo-shaped suppositories.

Octasa 1g Suppositories are available in packs of 10, 30 suppositories.

Not all pack sizes may be marketed.

The marketing authorisation holder is:

The manufacturer is:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Octasa 1g Suppositories

Reference number PL 36633/0011