Informations for option: Octasa 800mg Mr Tablets, show other option

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1. Octasa 800mg Mr Tablets
2. Octasa 800mg Mr Tablets

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.

If you take more Octasa than you should

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 t ablets 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 Octasa

If you forget to take a dose at the right time, 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.

If you stop taking Octasa

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.

4. Possible side-effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Organ specific side effects affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported.

Stop taking the medicine and seek urgent medical advice immediately

If you develop 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).

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

Common:

•    rash

•    indigestion Uncommon

•    fever

•    high number of white blood cells called eosinophil granulocytes

•    sensation of tingling, pricking and numbness

•    hives, itching skin

•    chest pain Rare

•    headache

•    dizziness

•    inflammation of the heart with signs like chest pains or palpitations

•    diarrhoea, stomach pain, wind (flatulence), feeling of unease and discomfort in the stomach with an urge to vomit and vomiting

Very rare

•    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

•    lung disease (scarring of lung tissue, allergic reaction) resulting in difficulty in breathing or wheezing and collection of fluid in the lungs, pneumonia

•    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)

•    hair loss

•    muscle and joint pain

•    kidney problems (such as inflammation and scarring of the kidney), kidney failure, which may be reversible if treatment is stopped early

•    reversible decrease in sperm production Not known

•    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

•    weight loss

•    laboratory test results out of normal range

Evaluation of the side effects is based on the following frequencies: 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

Reporting of side effects

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 at Yellowcard.mhra.gov.uk. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Octasa

-    Keep out of the reach and sight of children.

-    Do not store above 25 °C.

-    Keep the tablets in the original package to protect them from moisture.

Do not use this medicine after the expiry date which is stated on the outer packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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Telephone 0800 1985000 for help.

What Octasa contains

The active substance is mesalazine. Each tablet contains 800 mg mesalazine The other ingredients are lactose monohydrate, sodium starch glycolate (Type A), triethyl citrate, talc E553b, methacrylic acide - methylmethacrylate copolymer (1:2), povidone E1201, magnesium stearate (vegetable origin), iron oxides E172, macrogol 6000

What Octasa looks like and contents of the pack

Octasa 800 mg Modified Release Tablets are red-brown, oblong, tablets.

They are available in pack sizes of 90 or 180 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is:

Tillotts Pharma UK Ltd,

Wellingore Hall, Wellingore Lincolnhire, LN5 0HX

United Kingdom Tel: + 44 (0) 1522 813500 The manufacturer is:

Haupt Pharma Wulfing GmbH,

D - 31028 Gronau Germany Rottendorf Pharm GmbH,

Ostenfelder Strasse 51 - 61,

59320 Enningerloh, Germany

This information applies only to Tillotts Pharma UK Ltd. Octasa 800 mg Modified Release Tablets. PL 36633/0001

This leaflet was last revised in

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