Mezavant XL 1200mg, gastro-resistant, prolonged release tablets

• 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 Mezavant XL is and what it is used for
2. What you need to know before you take Mezavant XL
3. How to take Mezavant XL
4. Possible side effects
5. How to store Mezavant XL
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to a family of drugs known as salicylates (which include acetylsalicylic acid [Aspirin])
• If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
• If you have severe kidney or severe liver problems

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.

Talk to your doctor before using Mezavant XL

• 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 ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using Mezavant
• 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

Before and periodically during treatment with Mezavant XL, your doctor may take samples of your urine and blood to check that your kidneys and liver are working well and that your blood is healthy.

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

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 Mezavant treatment. Stop using Mezavant and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Talk to your doctor

If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears contact your doctor immediately

Mezavant is not recommended to be given to children and adolescents weighing 50 kg or less and not in children below the age of 10 years due to lack of data on safety and efficacy (see section 3).

Studies have shown that Mezavant XL does not interfere with the following antibiotics, used to treat infections: amoxicillin, metronidazole or sulfamethoxazole.

However, Mezavant XL may interact with some other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Mesalazine or sulphasalazine (taken for treatment of ulcerative colitis)
• Non-steroidal anti-inflammatory drugs (for example medicines containing acetylsalicylic acid [Aspirin], ibuprofen or diclofenac)
• Azathioprine or 6-mercaptopurine or other medicines known to affect how your bone marrow works (known as ‘immunosuppressant’ medicines which reduce the activity of your body’s immune system). Bone marrow is the material inside your bones that produces blood cells.
• Coumarin-type anticoagulants (medicines which increase the time it takes for your blood to clot) e.g., warfarin

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

Since mesalazine crosses the placenta in pregnancy and is excreted in breast milk in small quantities, you should only use Mezavant XL during pregnancy or whilst breast-feeding if your doctor tells you to. Adverse outcomes [including low blood cell counts (white blood cells, red blood cells, and platelets)] were reported in infants born to mothers who took Mezavant XL during pregnancy. Diarrhoea has been reported in breastfed infants of mothers who took Mezavant XL.

If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice about taking Mezavant XL.

If you are undergoing urine tests, it is important to tell the doctor or nurse you are taking, or have recently taken this medicine as it can affect some results.

Mezavant XL is unlikely to have any effect on your ability to drive or use machines.

This medicine contains less than 1 mmol sodium (23 mg) per the maximum recommended dose (4 tablets), that is to say essentially ‘sodium-free’.

If you take too much Mezavant XL 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.

It is important to take your Mezavant XL 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 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 notice 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.
• If you develop allergic swelling of tongue, lips and around eyes.
• If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure within your skull (idiopathic intracranial hypertension).

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; inflammation which causes abdominal pain or diarrhoea; diarrhoea; indigestion; vomiting (being sick); abnormal liver function test; itching; rash, joint pain; back pain; weakness, fatigue (feeling extremely tired); 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; throat pain; an inflamed pancreas (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; muscle pain; hives; swollen face.

Rare side effects, seen in less than 1 in 1000 patients are: kidney failure; severe reduction in the number of white blood cells that makes infection more likely; increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).

Severe reduction in blood cells which can cause weakness or bruising; low blood cell counts; allergic reaction (hypersensitivity); serious allergic reaction which causes difficulty in breathing or dizziness; serious illness with blistering of the skin (possibly leading to peeling of the skin and resulting in painful, raw areas), mouth, eyes and genitals; allergic reaction which causes skin rash, fever and inflammation of internal organs; 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); hepatotoxicity (liver damage that may present as abnormal liver tests); allergic swelling of tongue, lips and around eyes; skin redness; skin rash typically on face, skin sensitivity to sunlight along with joint pain, arthritis, fatigue and overall feeling sickness; kidney problems (such as inflammation and scarring of the kidney); kidney stones and associated pain (see also section 2); reversible decrease in sperm production.

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 - 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.

The active substance is mesalazine 1200 mg.

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 Copolymer (1:1); Methacrylic Acid – Methyl Methacrylate Copolymer (1:2) Triethylcitrate; Titanium Dioxide (E171); Red Ferric Oxide (E172); Macrogol 6000.

Mezavant XL 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 (dimensions 20.5 × 9.5 × 7.5 mm) and stamped S476.

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