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The product code(s) for this leaflet is: PL 36633/0009 .
Octasa 1600mg modified release tablets
Octasa 1600 mg Modified Release Tablets
1. What Octasa is and what it is used for
2. What you need to know before you use Octasa
3. How to use Octasa
4. Possible side effects
5. How to store Octasa
6. Contents of the pack and other information
Octasa contains the active substance mesalazine. It is an anti-inflammatory medicine used for the treatment of ulcerative colitis. Ulcerative colitis is a disease in which the lining of the large intestine (colon) or the back passage (rectum) becomes inflamed (red and swollen). This may lead to frequent and bloody stools, often with abdominal cramps.
Octasa treats and prevents inflammation throughout the entire colon and rectum (mild to moderate acute ulcerative colitis and for the prevention of relapse).
Talk to your doctor or pharmacist before using Octasa if you have any medical conditions or illnesses, particularly if you have:
If you have a stomach ulcer, you should use 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.
Before and while you are taking Octasa, your doctor may want to check that your liver, kidneys, blood and lungs are working properly.
Do not give this medicine to children or adolescents under the age of 18 years of age, because Octasa has not been tested in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines such as:
Please refer to Section 3.
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. Since mesalazine is excreted in breast milk in small quantities, due care should be taken if using Octasa whilst breast-feeding. If the infant develops diarrhoea, breast-feeding should be discontinued.
Octasa has no or negligible influence on the ability to drive and use machines. However, if you are affected in any way you should not drive or operate machinery.
Always use Octasa exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The tablets must be swallowed whole preferably with a glass of water. Do not chew, crush or break the tablets before swallowing. This is important for these tablets with modified release, if the tablets are not swallowed whole, they may not work as intended.
Octasa can be taken with or without food.
Your doctor will decide which dose you should take.
Adults
Active phase of disease: When the disease is getting worse, the dose can be increased up to 4800 mg (three tablets) daily taken once daily or as one tablet 2 to 3 times a day.
Maintenance treatment: 1600 mg taken daily.
If you take more Octasa than you should, or if children have been taking medicine by accident, please contact your doctor, the nearest hospital or pharmacy to get an opinion of the risk and advice on action to be taken. Take the box with you, if possible
If you forget to take a dose at the right time, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
Use Octasa for as long as your doctor prescribed it to you. Talk to your doctor before changing or stopping the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
you develop one or more of these 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 and nails), fever (high temperature), acute stomach pain, sore throat or unusual bleeding (e.g. nose bleeds).
Octasa can in very rare cases affect the white blood cells so, in those cases, your immune system could get worse. If you get an infection with symptoms such as fever with serious worsening of your general condition, or fever with local symptoms of infection such as sore throat/pharynx/mouth or urinary problems you should immediately see your doctor. Blood tests can then be taken to check for lack of white blood cells (agranulocytosis). It is important that you inform your doctor about all of your medications.
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
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 side effects directly via the 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.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton and the blister strips.The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
No special requirements for disposal.
Octasa 1600 mg modified-release tablets are reddish brown in colour. The tablets are oblong shaped and approximately 2.3 cm in length, 1.1 cm in width and 0.9 cm in thickness.
Tablets are available in packs in blister strips. The blister strips are packed in a carton containing either 30 tablets, 60 tablets or 90 tablets.
Not all pack sizes may be marketed.
MA Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Yaldigo 1600 mg Tablette mit veränderter Wirkstofffreisetzung
Belgium Mesalazine Tillotts 1600 mg comprimés à libération modifiée
Czech Republic Asacol
Denmark Asacol
Estonia Yaldigo
Finland Asacol 1600 mg säädellysti vapauttavat tablettit
Germany Asacol 1600 mg Tablette mit veränderter Wirkstofffreisetzung
Greece Mesalazine ESPL 1600 mg δισκία ελεγχόμενης αποδέσμευσης
Iceland Asacol 1600 mg töflur með breyttan losunarhraða
Ireland Asacolon 1600 mg Modified-release tablet
Italy Mesalazina ESPL
Latvia Yaldigo 1600 mg modificētās darbības tabletes
Lithuania Yaldigo 1600 mg modifikuoto atpalaidavimo tabletės
Luxembourg Mesalazine Tillotts 1600 mg comprimés à libération modifiée
Malta Mesalazine ESPL 1600 mg modified- release tablets
Netherlands Yaldigo 1600 mg, tabletten met gereguleerde afgifte
Norway Asacol 1600 mg tabletter med modifisert frisetting
Sweden Asacol tabletter med modifierad frisättning
This leaflet was last approved in November 2019