Mezavant 1200 mg Tablets

MEZAVANT is a gastro - resistant, prolonged release tablet which contains mesalazine. MEZAVANT is used for the treatment and maintenance for the remission of ulcerative colitis.

Do not take MEZAVANT

• if you are allergic (hypersensitive) to a family of medicines named salicylates (which include aspirin) and non - steroidal anti - inflammatory medicines (e.g., ibuprofen).
• if you are allergic (hypersensitive) to mesalazine or any of the other ingredients of MEZAVANT (see ‘What MEZAVANT contains’).
• if you have severe kidney or severe liver problems.

Warnings and precautions

Take special care with MEZAVANT:

• 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.
• As it may produce red - brown urine discolouration after contact with sodium hypochlorite, bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.
• 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 (especially asthma).
• If you experience symptoms such as stomach cramps, abdominal pain, bloody and excessive stools (diarrhoea), fever, headache or rash, contact your doctor. These symptoms could be a sign of acute intolerance syndrome, a condition with symptoms similar to those of ulcerative colitis.
• if you develop unexplained bleeding, bruising, skin discolouration, fever or a sore throat contact your doctor. MEZAVANT treatment may cause abnormality in the blood's cellular components.
• MEZAVANT may cause kidney stones. You should drink a fair amount of fluid (such as water) during treatment with MEZAVANT.
• Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS), Steven - 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.

Children

Do not give MEZAVANT to children below the age of 18 years.

Do not share medicines prescribed for you with any other person. Always take MEZAVANT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take your tablets at the same time each day with or without food. The tablets should be swallowed whole and must not be crushed or chewed. The usual daily dose for adults for initiation of remission is 2,4 g to 4,8 g (two to four tablets) taken once a day. The highest daily dose of 4,8 g (four tablets) daily is recommended for adults, if they do not respond to the lower doses of MEZAVANT. If you are taking four tablets a day, your doctor should check how you are responding to your treatment, 8 weeks after starting treatment. The usual adult dose for maintenance of remission is 2,4 g (two tablets) once daily.

Once your symptoms have cleared and to help prevent reoccurrence of another episode, your doctor will inform you if you need to adjust the number of tablets you are taking. MEZAVANT should not be given to children under 18 years of age. Safety of using MEZAVANT if you have kidney or liver problems has not been established. (see 'Do not take MEZAVANT' and 'Take special care with MEZAVANT')

If you take more MEZAVANT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you take too much MEZAVANT 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 MEZAVANT

It is important to take your MEZAVANT 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 MEZAVANT, ask your doctor or pharmacist.

MEZAVANT can have side effects. Not all side effects reported for MEZAVANT are included in this leaflet. If your general health worsens or if you experience any untoward effects while taking MEZAVANT, please consult your doctor or pharmacist or healthcare provider for advice. If any of the following happens, stop taking MEZAVANT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• skin rash or itching,
• fainting,
• fever (high body temperature),
• enlarged lymph node,
• skin pain,
• shedding of your skin.

These are all very serious side effects. If you have them, you may have had a serious reaction to MEZAVANT. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• acute intolerance syndrome. This is a serious condition which occurs less frequently, but, means your treatment would have to be stopped immediately,
• unexplained bruising (without injury),
• anaemia (feeling tired, weak and looking pale, especially on lips, nails and inside of eyelids), and
• unusual bleeding (e.g., nose bleeds).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• hypersensitivity (allergic reactions including itching, rash, hives and swelling of the face).
• chronic digestive disease characterized by inflammation of the inner lining of the colon (known as colitis),
• headache,
• flatulence,
• nausea (feeling sick),
• vomiting,
• abdominal pain,
• diarrhoea,
• indigestion,
• abdominal swelling,
• back pain,
• joint pain,
• weakness,
• tiredness,
• and abnormal liver functions tests (ALT, AST, bilirubin).

Less frequent side effects:

• sore throat,
• drowsiness,
• dizziness,
• fast or irregular heart rate,
• nervousness,
• excessive sweating,
• facial flushing,
• light - headedness,
• unsteadiness, or feeling loss of balance,
• growths on the inside of the colon or rectum,
• acne,
• hair loss,
• loss of appetite,
• less urine than what is normal for you,
• confusion,
• shortness of breath,
• low blood platelet count,
• and kidney stones.

The following side effects have been reported but it is not known exactly how often they occur:

• numbness and pain in your hands and feet,
• yellowing of the skin and eyes, also called jaundice,
• muscle pain,
• blood in the urine,
• liver damage that may present as abnormal liver tests,
• inflammation of the heart and lining around the heart,
• inflammation of the lung; difficulty in breathing or wheezing,
• skin sensitivity to sunlight along with joint pain, serious illness with blistering of the skin (possibly leading to peeling of the skin and resulting in painful, raw areas), mouth, eyes and genitals,
• any abnormal colouration of the urine,
• anaphylactic reaction, Steven - Johnson syndrome and DRESS syndrome (Drug Rash with Eosinophilia and Systemic Symptoms) (a severe allergic reaction),
• increased pressure inside your skull,
• lung disease and - infection,
• photosensitivity (an extreme sensitivity to ultraviolet (UV) rays from the sun and other light sources),
• kidney failure and nephrogenic diabetes insipidus (the inability to concentrate urine, which leads to the urination of large amounts of dilute urine,
• and reversible low sperm count.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. Additionally, suspected adverse reactions can be reported to [email protected] or on the 24 hours contact number: 082 525 3040. By reporting side effects, you can help provide more information on the safety of MEZAVANT.

Store all medicines out of reach of children.

• Store at or below 25 °C
• Store in outer container until before use.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).