Ipocol 400mg Mr Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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IPOCOL 400 mg 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.
1. What Ipocol MR Tablets are and what they
are used for
2. Before you take Ipocol MR Tablets
3. How to take Ipocol MR Tablets
4. Possible side effects
5. Howto store Ipocol MR Tablets
6. Further information
IWhat Ipocol MR Tablets are and what they are used for
Ipocol MR Tablets contain the active substance mesalazine (also known as 5-aminosalicylic 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. Ipocol MR Tablets act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis.
Ipocol 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 moieinfoBieftorelyoctakeyipocol MR 2 Tablets
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 Ipocol 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 Ipocol MR Tablets
DO NOT take Ipocol MR Tablets if you:
• are allergic (hypersensitive) to mesalazine or any of the other ingredients of Ipocol MR Tablets (see section 6 - What Ipocol MR Tablets contain).
• are allergic to aspirin or any other salicylate.
• have had kidney problems or blood abnormalities while taking other medicines such as sulphasalazine.
• Have severe kidney impairment.
Take special care with Ipocol MR Tablets
• Ipocol MR Tablets should be used with extreme caution in patients with confirmed mild to moderate kidney impairment
• Ipocol 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.
Ipocol MR Tablets should NOT be taken with lactulose or similar medicines to treat constipation.
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.
- 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 Ipocol 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.
Sandoz Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com
Ref: Brand alignment
Proof no.
004.0
RA Approved?
Yes
Colours:
Black
Black 20%
Date prepared: 31/07/2012 Date approved: 31/07/2012
Dimensions: 130 x 295 mm Artwork/RA Checklist: Pack size
^ Kl Product name ^ ^ PL number Strength/dosage Storage
Prepared by: TB
Approved by: RC
Fonts:
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Font size: 7pt ^ Warnings ^ Excipients Braille
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 Ipocol 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 Ipocol 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 Ipocol 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
• 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.
How to store Ipocol MR Tablets
Keep out of the reach and sight of children.
Store Ipocol MR Tablets at or below 25°C in a dry place and protect from light.
Do not take Ipocol MR Tablets after the expiry date shown on the label.
Do not take Ipocol 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
4 Possible side effects
Like all medicines Ipocol 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
• inflammation 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
What Ipocol MR Tablets contain
Each tablet contains 400 mg of the active ingredient mesalazine.
The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch, corn starch, magnesium stearate, polyvinyl pyrrolidone, mannitol, precipitated silica, dimethylphthalate, methacrylic acid copolymer, dimethicone, talc, titanium dioxide and red ferric oxide.
What Ipocol MR Tablets look like and contents of the pack
Ipocol 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
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR, UK.
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 last revised in 07/2012.
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Sandoz Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com
Ref: Brand alignment
Proof no.
004.0
RA Approved?
Yes
Colours:
Black
Black 20%
Date prepared: 31/07/2012 Date approved: 31/07/2012
Dimensions: 130 x 295 mm Artwork/RA Checklist: Pack size
^ Kl Product name ^ ^ PL number Strength/dosage Storage
Prepared by: TB
Approved by: RC
Fonts:
Helvetica
Font size: 7pt ^ Warnings ^ Excipients Braille