Octasa 400 mg modified-release tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 is and what it is used for
2. What you need to know before you take Octasa
3. How to take Octasa
4. Possible side-effects
5. How to store Octasa
6. Contents of the pack and other information

• If you are allergic to mesalazine or any of the other ingredients of this medication (listed in section 6)
• If you are allergic to salicylates (e. g. aspirin)
• If you have severe kidney problems
• If you have severe liver problems

Talk to your doctor before taking Octasa if you have any medical conditions or illnesses, particularly if you have:

• ever had any problems with your liver or kidneys. This is especially important if you are elderly.
  
• any lung problems, e. g. asthma
• suffered an allergy to sulfasalazine in the past
• ever had allergic reactions of your heart such as inflammation of the heart muscle or heart sac. If you have had previous mesalazine-induced allergic reactions of your heart, then do not take Octasa. Octasa can be taken with care if you have had a previous allergic reaction of the heart even if not caused by taking mesalazine.
• ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using 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 have an ulcer of the stomach or intestine, you may take Octasa with care.

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

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.

Before and while you are taking Octasa, your doctor may want to monitor you from time to time, to check that your liver, kidneys, blood and lungs are all right.

There have been a few reports of intact tablets in the stool. What appear to be intact tablets may sometimes be the remains of the tablet coating. If you often observe tablets or tablet shells in the stool, you should consult your doctor.

Octasa is only recommended for use in children 6 years and older.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines such as:

• drugs affecting the immune system e.g. azathioprine, or 6-mercaptopurine or thioguanine
• drugs that prevent the formation of blood clots (anticoagulants, e.g. warfarin).

You may eat and drink normally (including alcohol), when taking Octasa.

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 taking this medicine.

Octasa is not expected to affect your ability to drive or operate machinery. However, if you are affected in anyway, do not drive or operate machinery.

Patients who are intolerant to lactose should note that Octasa contains a small amount of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, i.e. is essentially “sodium- free”.

Adults (including the elderly):

To treat ulcerative colitis, your daily dose is 6 to 12 tablets. 6 tablets may be taken once daily or in divided doses (as advised by your doctor). Above 6 tablets a day should be taken in divided doses.

To prevent Crohn’s ileo-colitis or ulcerative colitis your daily dose is 3 to 6 tablets once daily or in divided doses. Follow your doctor’s instructions. Do not take more than 12 tablets a day and do not take more than 6 tablets at the same time.

Octasa is only recommended for use in children 6 years and older.

The daily dose depends on the child’s weight.

• To treat acute phases of ulcerative colitis:

20-30 kg weight: two to three tablets per day.

30-40 kg weight: two to four tablets per day in divided doses. 40 kg weight: three to five tablets per day in divided doses. The total dose should not exceed 4 g/day.

• To prevent ulcerative colitis or Crohn’s ileo-colitis:

20-30 kg weight: one tablet per day.

30-40 kg weight: one to 2 tablets per day

40 kg weight: one to three tablets per day in divided doses. The total dose should not exceed 2 g/day.

It is generally recommended that half the adult dose may be given to children up to 40 kg weight; and the normal adult dose to those above 40 kg.

You should not take a higher dose than your doctor has prescribed for you. Contact your nearest hospital casualty department or a doctor for advice if you or anyone else has swallowed too many tablets or if you think a child has swallowed any. Take this leaflet, and any tablets that you still have to show the doctor.

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Octasa without talking to your doctor first even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.

• 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 serious skin rashes can be preceded by fever and flu-like symptoms
• Unexplained bruising (without injury), bleeding under your skin, purple spots or patches under your skin, anaemia (feeling tired, weak and looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore throat or unusual bleeding (e.g. nose bleeds).
• Lung disease (scarring of lung tissue, allergic reaction) resulting in difficulty in breathing, cough, wheezing and collection of fluid in the lungs, pneumonia
• Abnormal liver function tests, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice)
• Inflammation of the heart with signs like chest pains or palpitations
• Disorder of the immune system (lupus-like syndrome) which can cause inflammation of the heart sac or membranes around the lungs and heart, rash and /or joint pain
• Kidney problems (associated with blood in urine and/or swelling in feet and ankles), kidney failure, which may be reversible if treatment is stopped early

The following side effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people)

• rash
• indigestion

Uncommon (may affect up to 1 in 100 people)

• fever
• high number of white blood cells called eosinophil granulocytes
• sensation of tingling, pricking and numbness
• hives, itching skin
• chest pain

Rare (may affect up to 1 in 1000 people)

• headache
• dizziness
• diarrhoea, stomach pain, wind (flatulence), feeling of unease and discomfort in the stomach with an urge to vomit and vomiting.
• increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).

Very rare (may affect up to 1 in 10000 people)

• severe reduction in blood cells which can cause weakness, bruising or make infections more likely, low blood cell counts; reduction in blood platelets which increases the risk of bleeding
• allergic reactions such as rash or skin eruption
• fever that occurs while taking the medicine and which disappears when the medicine is stopped (drug fever)
• immune system disease that can involve organs and joints
• ulcerative colitis involving the entire large intestine
• abnormal or damaged nerves giving a sensation of numbness or tingling
• inflamed pancreas (associated with pain in upper abdomen and back and feeling sick)
• abnormal liver function tests, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice)
• muscle or joint pain
• hair loss
• reversible decrease in sperm production

Not known (frequency cannot be estimated from available data)

• inflammation of the membranes of the pleural cavity surrounding the lungs (pleurisy)
• intolerance to mesalazine sometimes with worsening symptoms of underlying disease
• kidney stones and associated kidney pain (see also section 2)
• weight loss
• laboratory test results out of normal range

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report any 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 is mesalazine. Each tablet contains 400 mg mesalazine The other ingredients are: lactose monohydrate, sodium starch glycolate (Type A), triethyl citrate, E553b, methacrylic acide – methylmethacrylate copolymer (1:2), povidone E1201, magnesium stearate (vegetable origin), iron oxides E172, macrogol 6000

Octasa 400 mg Modified Release Tablets are red-brown, oblong, tablets.

They are available in pack sizes of 90 or 120 tablets.

Not all pack sizes may be marketed.

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Product name Octasa 400 mg Modified Release Tablets

Reference number PL 36633/0002