Skip to Content

LEXTRASA 400MG MR TABLETS

Active substance(s): MESALAZINE / MESALAZINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SOFAR SPA
Lextrasa 400 mg MR Tablets

PL
PL 14036/0001

Patient Information Leaflet
- 05/2017

PACKAGE LEAFLET: INFORMATION FOR THE USER

LEXTRASA 400mg MR Tablets
Mesalazine
Read all of this leaflet carefully before you start taking this medicine
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lextrasa MR Tablets are and what they are used for
2. Before you take Lextrasa MR Tablets
3. How to take Lextrasa MR Tablets
4. Possible side effects
5. How to store Lextrasa MR Tablets
6. Further information
1. What Lextrasa MR Tablets are and what they are used for
Lextrasa MR Tablets contain the active substance mesalazine (also known as 5aminosalicylic acid) which is an anti-inflammatory drug used in the treatment of:
Ulcerative colitis: a disease of the large bowel (colon) and back passage (rectum) in
which the lining of the bowel becomes inflamed (red and swollen). Symptoms can
include rectal bleeding, frequent diarrhoea and abdominal pain. Lextrasa MR Tablets act
locally in the colon to reduce inflammation and can also prevent further episodes (flares)
of ulcerative colitis.
Lextrasa MR Tablets can also be used to prevent further attacks of ulcerative colitis.
This medicine is sometimes prescribed for other purposes and you should consult your
doctor for more information if necessary.

2. Before you take Lextrasa MR Tablets
DO NOT take Lextrasa MR Tablets if you:
• are allergic (hypersensitive) to mesalazine or any of the other ingredients of
Lextrasa MR Tablets (see section 6 – What Lextrasa MR Tablets contain).
• are allergic to aspirin or any other salicylate.
Product name change

SOFAR SPA
Lextrasa 400 mg MR Tablets




PL
PL 14036/0001

Patient Information Leaflet
- 05/2017

have had kidney problems or blood abnormalities while taking other medicines
such as sulphasalazine.
Have severe kidney impairment.

Take special care with Lextrasa MR Tablets
• Lextrasa MR Tablets should be used with extreme caution in patients with
confirmed mild to moderate kidney impairment.
• Lextrasa MR Tablets should be used with extreme caution in the elderly.
• If you become dehydrated (lose too much water), it is important to replace your
fluid as soon as possible, contact your doctor or pharmacist for advice.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines,
including those obtained without a prescription.
Lextrasa MR Tablets should NOT be taken with lactulose or similar medicines to treat
constipation.
Use of non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, aspirin,
Cox-II inhibitors) and azathioprine (used for organ transplant therapy) in particular may
increase the risk of kidney reactions.
Pregnancy and breast-feeding
Women who are pregnant or breast-feeding should not take Lextrasa MR Tablets unless
advised otherwise by their doctor.
Ask you doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine can cause you to feel sick (nausea). If this happens, do not drive, operate
machinery or do anything that requires full alertness.

3. How to take Lextrasa MR Tablets
Always take Lextrasa MR Tablets exactly as the doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with water; do not break, crush or chew them.
The usual dose is:
Adults and the elderly:
• Treating ulcerative colitis - 6 tablets each day divided throughout the day, e.g.
Product name change

SOFAR SPA
Lextrasa 400 mg MR Tablets

PL
PL 14036/0001

Patient Information Leaflet
- 05/2017

- 2 tablets 3 times a day, or
- 3 tablets twice a day.


Preventing further episodes of ulcerative colitis – between 3 and 6 tablets each
day divided throughout the day, e.g.
- a daily dosage of 3 tablets may be taken as 1 tablet 3 times a day
- a daily dosage of 6 tablets may be taken as 3 tablets twice a day.

DO NOT take more than 6 tablets a day.
Your doctor will need to monitor your kidney function prior to starting Lextrasa MR
Tablets, every three months for the first year, then 6 monthly for the next four years and
annually after that.
Children 6 – 18 years of age:
• To treat anaemia: Starting with 30-50 mg/kg/day in divided doses. Maximum dose
75 mg/kg/day the total dose should not exceed 4 g/day.
• Maintenance dose: Starting at 15-30 mg/kg/day in divided doses. The total dose
should not exceed 2 g/day.
It is recommended that half the adult dose may be given to children up to a body weight of
40 kg; and the normal adult dose to those above 40 kg.
Your doctor may decide to change your dose, it is always important to follow your
doctor’s directions about when and how to take your medicine. Remember to get a repeat
prescription at the right time so that you do not miss a day of treatment.
If you take more Lextrasa MR Tablets than you should
Do not exceed the recommended dose. You should only take as many tablets as your
doctor has instructed on the pharmacist’s label. If you take too many tablets, or someone
accidentally swallows some, tell your doctor immediately or go to your nearest Accident
& Emergency Department (take the tablet pack with you if possible).
If you forget to take Lextrasa MR Tablets
If you forget to take a dose at the required time, take it as soon as you remember and
continue taking your tablets as before. DO NOT take more than two doses in one hour. If
it is almost time for your next dose, wait until then and carry on as before. If you are at all
concerned about this, consult your doctor or pharmacist.
If you stop taking Lextrasa MR Tablets
If you suddenly stop taking this medicine your symptoms may come back. You
should not stop taking your medicine unless you have been advised to do so by your
doctor.

Product name change

SOFAR SPA
Lextrasa 400 mg MR Tablets

PL
PL 14036/0001

Patient Information Leaflet
- 05/2017

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

4. Possible side effects
Like all medicines Lextrasa MR Tablets can cause side effects, although not everybody
gets them,
If you experience any of the following serious side effects stop taking this medicine and
contact your doctor or go to your nearest hospitals casualty department immediately:





allergic reaction. Symptoms include skin rash, lumps or hives, swelling of the
face, lips, hands or feet, sudden wheeziness, tightness of the chest or breathing
problems.
liver problems. Symptoms include feeling tired, feeling sick, pain below the right
ribs, your skin or the whites of your eyes turn yellow.
changes in your blood. Symptoms include unusual bleeding, bruising, rash, fever,
sore throat or excessive tiredness, or you become susceptible to infection.

Other side effects:
Common side effects you may experience include:

headaches.

feeling sick, being sick, diarrhoea, stomach pains caused by inflammation
(swelling, redness and pain) in the intestines.
More rarely you may suffer from:

kidney problems.

inflammation in the lungs, which causes severe cough or difficulty breathing.

inflamation of the pericardium (the sac that surrounds the lungs) which can cause
chest pains

inflammation of the pancreas, which causes severe pain in the abdomen.

inflammation of the heart muscle, which can cause chest pains, breathlessness
or irregular heartbeat.

lupus (a disease where the body attacks internal organs such as lungs, heart,
stomach and joints). Symptoms include tiredness, fever, joint pain.

a disorder of the nerves which can cause weakness, tingling or numbness
(peripheral neuropathy).

hair loss.

fever.

muscle pain.

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

Product name change

SOFAR SPA
Lextrasa 400 mg MR Tablets

PL
PL 14036/0001

Patient Information Leaflet
- 05/2017

5. How to store your Lextrasa MR Tablets
Keep out of the reach and sight of children.
Store Lextrasa MR Tablets at or below 25°C in a dry place and protect from light.
Do not take Lextrasa MR Tablets after the expiry date shown on the label.
Do not take Lextrasa MR Tablets if you notice any visible signs of deterioration of these
tablets such as cracks in the coat, take them to your pharmacist for advice.
Medicines should not be disposed of via household waste. Ask your pharmacist how to
dispose of medicines you no longer require. These measures will help to protect the
environment.

6. Further information
What Lextrasa MR Tablets contain
Each tablet contains 400mg of the active ingredient mesalazine.
The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch, corn
starch, magnesium stearate, polyvinyl pyrrolidone, mannitol, precipitated silica, dimethyl
phthalate, methacrylic acid copolymer, dimethicone, talc, titanium dioxide and red ferric
oxide.
What Lextrasa MR Tablets look like and contents of the pack
Lextrasa MR Tablets are red-brown, coated and round shaped.
The tablets are available in blister packs of 28, 30, 56, 60, 84, 90, 112, 120, 168 or 240
tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder
SOFAR SPA, Via Firenze 40, 20060 Trezzano Rosa (MI, Italy).

Manufacturer
Sofar Pharmaceuticals, Via Firenze 40, 20069 Trezzano Rosa, Milan, Italy.
Distributed by: IXL Pharma Ltd, Northampton Road, Brixworth, Northamptonshire, NN6
9DQ
This leaflet was revised in 06/2013

Product name change

Expand Transcript

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