MEZAVANT XL 1200MG GASTRO-RESISTANT PROLONGED RELEASE TABLETS

Active substance: MESALAZINE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
− 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
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
1. What Mezavant XL is and what it is used for
Pharmacotherapeutic group: Aminosalicylic acid and similar agents.
Mezavant XL gastro-resistant, prolonged release tablets contain the active substance 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, Mezavant XL acts through the entire colon and rectum
to treat the inflammation and reduce symptoms. The tablets can also be taken to help prevent reccurrence of
ulcerative colitis.
2. What you need to know before you take Mezavant XL
Do not take Mezavant XL
−− 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 this medicine (listed in
section 6 of this leaflet)
−− If you have severe kidney or severe liver problems
Warnings and Precautions
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 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, 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.
Children and adolescents
Mezavant is not recommended to be given to children under 18 years of age due to lack of data on safety and
efficacy.
Other medicines and Mezavant XL
Studies have shown that Mezavant does not interfere with the following antibiotics, used to treat infections:
amoxicillin, metronidazole or sulfamethoxazole.
However, Mezavant may interact with some other medicines. Tell your doctor or pharmacist if you are taking
or 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 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
Mezavant XL with food and drink
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.

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 Mezavant XL in pregnancy or whilst breast-feeding.

United Kingdom
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard

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.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.hpra.ie
e-mail: medsafety@hpra.ie

Interference with laboratory tests
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.
Driving and using machines
Mezavant XL is unlikely to have any effect on your ability to drive or use machines.
3. How to take Mezavant XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are
not sure.
The recommended 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.
Whilst taking this medicine ensure you drink fluids to remain well hydrated especially after severe or prolonged
episodes of vomiting and/or diarrhoea, high fever or heavy sweating.
Mezavant XL 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 Mezavant XL than you should
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.
If you forget to take Mezavant XL
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
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
Like all medicines, this medicine 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, 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; changes in blood pressure; throat pain; 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; 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.
The following side effects have been reported but it is not known exactly how often they occur:
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, 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); allergic swelling of tongue, lips and around eyes; skin redness; muscular pain; kidney problems
(such as inflammation and scarring of the kidney).
If you get any side effects talk to your doctor. This includes any possible any side effects not listed in this
leaflet.
Reporting of side effects
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:

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Mezavant XL
• Keep this medicine out of the sight and reach of children
• Store below 25°C
• Store in the original package in order to protect from moisture
• Do not use this medicine after the expiry date which is stated on the box after “EXP”. The expiry date
refers to the last day of the month.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6. Content of the pack and other information
What Mezavant XL 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
Copolymer (1:1); Methacrylic Acid – Methyl Methacrylate Copolymer (1:2); Triethylcitrate; Titanium Dioxide
(E171); Red Ferric Oxide (E172); Macrogol 6000.
What Mezavant XL looks like and contents of the pack
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 and stamped S476.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park
Chineham, Basingstoke
Hampshire, RG24 8EP
United Kingdom

Manufacturer
Cosmo SpA
Via C. Colombo 1
20020 Lainate-Milan
Italy

+44 (0) 1256 894000
Tel:
Fax:
+44 (0) 1256 894711
Email: medinfo@uk.shire.com
By licence of Giuliani SpA, Milan, Italy
Representative for country: Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park,
Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom, Tel: +44 (0) 1256 894000, Fax: +44 (0)
1256 894711.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
Germany, Greece, Hungary, Iceland, Latvia, Luxembourg, Netherlands, Norway,
Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain and Sweden.
Ireland, Malta and United Kingdom
France

Mezavant
Mezavant XL
Mezavant L.P

This leaflet was last revised in August 2014
Detailed information on this medicine is available on the web site of: www.mhra.gov.uk (UK) or
www.hpra.ie (Ireland)

2000007/1
9493 V3

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)