Mesavancol 1200 mg maagsapresistent, tabletten met verlengde afgifte

Pharmacotherapeutic group: Aminosalicylic acid and similar agents.

Mesavancol® gastro-resistant, prolonged release tablets contain mesalazine, which is an anti-inflammatory drug for the treatment of ulcerative colitis.

Ulcerative colitis is a disease of the colon (large bowel) and rectum (back passage), where the lining of the gut becomes red and swollen (inflamed) resulting in symptoms of frequent and bloody stools together with stomach cramps.

When given for an acute episode of ulcerative colitis, Mesavancol® acts through the entire colon and rectum to treat the inflammation and reduce symptoms. The tablets can also be taken to help prevent reoccurrence of ulcerative colitis.

Do not take Mesavancol®

• If you are allergic (hypersensitive) to a family of drugs known as salicylates (which include aspirin)
• If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of Mesavancol® listed in section 6 of this leaflet
• If you have severe kidney or severe liver problems

Take special care with Mesavancol®: Before treatment with Mesavancol, tell your doctor

• If you have any kidney or liver problems
• If you have previously had inflammation of the heart (which may be the result of an infection in the heart)
• If you have had a previous allergic reaction to sulphasalazine (another medicine used to treat ulcerative colitis)
• If you have narrowing or blockage of the stomach or the gut
• If you have lung problems

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, that contain:

• Mesalazine or sulphasalazine (taken for treatment of ulcerative colitis)
• Non-steroidal anti-inflammatory drugs (for example medicines containing aspirin, ibuprofen or diclofenac)
• Azathioprine or 6-mercaptopurine (known as ‘immunosuppressant’ medicines which reduce the activity of

your body’s immune system).

• Coumarin-type anticoagulants (medicines which increase the time it takes for your blood to clot) e.g. warfarin

Taking Mesavancol® with food and drink

Mesavancol® should be taken with food at the same time each day. The tablets should be swallowed whole and must not be crushed or chewed.

Pregnancy and breast-feeding

Since mesalazine crosses the placenta in pregnancy and is excreted in breast milk in small quantities, due care should be taken if using Mesavancol® in pregnancy or whilst breast-feeding.

If you are pregnant, think you might be pregnant or are breast-feeding you should ask your doctor for advice about taking Mesavancol.

Driving and using machines

Mesavancol® is unlikely to have any effect on your ability to drive or use machines.

Always take Mesavancol® as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual daily dose for adults is 2.4g to 4.8g (two to four tablets) taken once a day for an acute episode of ulcerative colitis. If you are taking the highest daily dose of 4.8g/day, you should be evaluated after 8 weeks treatment. Once your symptoms have cleared and to help prevent reoccurrence of another episode, your doctor should direct you to take 2.4g (two tablets) once a day.

Remember to take your tablets at the same time each day with food. The tablets should be swallowed whole and must not be crushed or chewed.

Mesavancol® is not recommended to be given to children under 18 years of age due to lack of data on safety and efficacy.

If you take more Mesavancol® than you should

If you take too much Mesavancol® you may have one or more of the following symptoms: tinnitus (ringing in ears), dizziness, headache, confusion, drowsiness, shortness of breath, excess loss of water (associated with sweating, diarrhoea and vomiting), low blood sugar (which can cause light-headedness), rapid breathing, changes in the blood chemistry and increased body temperature.

If you do take too many tablets, contact your doctor, pharmacist or hospital casualty department straight away. Take your tablet pack with you.

If you forget to take Mesavancol®

It is important to take your Mesavancol® tablets every day, even when you don’t have any symptoms of ulcerative colitis. Always finish the prescribed course.

If you forget to take your tablets then take them as usual the next day. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Mesavancol® can cause side effects, although not everybody gets them.

Common side effects, occurring in less than 1 in 10 patients are headache, changes in blood pressure, flatulence (passing wind), nausea (feeling sick), bloated or painful stomach, diarrhoea, indigestion, vomiting (being sick), abnormal liver function test, itching, rash, muscle and joint pain, back pain, weakness and fever (high temperature).

Uncommon side effects, seen in less than 1 in 100 patients are: a reduction in blood platelets which increases the risk of bleeding and bruising; dizziness; feeling sleepy or tired; trembling or shaking; ear pain; racing heartbeat; changes in blood pressure; an inflamed pancreas or colon (associated with pain in upper abdomen and back and feeling sick); rectal polyp (a non-cancerous growth in the back passage causing symptoms such as constipation and bleeding); acne; hair loss; itchy skin with or without a rash; hives; swollen face; fatigue (feeling extremely tired).

The following side effects are associated with other medicines containing mesalazine. These are: severe reduction in blood cells which can cause weakness, bruising or make infections more likely, low blood cell counts; neuropathy (abnormal or damaged nerves giving a sensation of numbness and tingling); inflammation of the heart and lining around the heart; inflammation of the lung; difficulty in breathing or wheezing; gall stones; hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice); allergic swelling of tongue, lips and around eyes; skin redness; muscular pain; kidney problems (such as inflammation and scarring of the kidney).

If any of the side effects become serious or persist, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Tell your doctor immediately

• If you experience symptoms such as cramping, severe stomach pain, bloody and excessive stools (diarrhoea), fever, headache or rash. These symptoms could be a sign of Acute Intolerance Syndrome which can happen during an acute episode of ulcerative colitis. This is a serious condition which occurs rarely, but means your treatment would have to be stopped immediately
• If you develop unexplained bruising (without injury), rash, 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)
• If you develop allergic swelling of tongue, lips and around eyes

• Keep out of the reach and sight of children
• Store below 25°C
• Store in the original package in order to protect from moisture
• Do not use Mesavancol® after the expiry date which is stated on the box
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer require or medicines that have expired. These measures will help to protect the environment.

What Mesavancol® contains

The active substance is mesalazine 1200mg.

The other ingredients are: Carmellose sodium; Carnauba Wax; Stearic Acid; Silica, Colloidal Hydrated; Sodium Starch Glycolate (Type A); Talc; Magnesium Stearate; Methacrylic Acid-Methyl Methacrylate Copolimer (1:1); Methacrylic Acid Methyl Methacrylate Copolymer (1:2); Triethylcitrate;

Titanium Dioxide (E171); Red Ferric Oxide (E172); Macrogol 6000.

What Mesavancol® looks like and contents of the pack

Mesavancol® is supplied in foil blister strips which are contained in a cardboard box. The pack contains 60 or 120 tablets. Not all pack sizes may be marketed.

The red-brown tablets are oval shaped and stamped S476.

Marketing Authorisation Holder and Manufacturer

Giuliani S.p.A.

Via P. Palagi 2, 20129 Milaan Italië

Tel: +39 0220541 Fax: +39 022054222

e-mail: infomed@giulianipharma.com

Manufacturer

Cosmo S.p.A.

Via Lainate, 1 20020 Milaan

Italië

In het register ingeschreven onder

RVG 33597

Deze bijsluiter is voor het laatst goedgekeurd in mei 2013