Ipocol 400mg Mr Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
_
Ipocol 400mg MR Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg mesalazine (5-aminosalicylic acid).
3 PHARMACEUTICAL FORM
Red-brown, round, enteric coated tablets.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
To treat mild to moderate ulcerative colitis and maintain ulcerative colitis in remission.
4.2 Posology and method of administration
Swallow whole with water. Do not break, crush or chew the tablets before swallowing.
Adults:
Acute disease: 6 tablets a day in divided doses, with concomitant corticosteroid therapy where clinically indicated.
Maintenance therapy: 3-6 tablets a day in divided doses.
Elderly:
Caution should be employed in the treatment of elderly patients. Mesalazine should not be used where there is evidence of renal impairment.
Children:
There is only limited documentation for an effect in children (age 6 - 18 years). Children 6 years of age and older
• Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
• Maintenance treatment: to be determined individually, starting at 1530 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
It is generally 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.
Route of administration:
Oral.
4.3 Contraindications
A history of sensitivity to salicylates or renal sensitivity to sulphasalazine.
Confirmed severe renal impairment (GFR less than 20 ml/min).
4.4 Special warnings and precautions for use
Use in the elderly should be cautious and subject to patients having normal renal function.
Renal disorder: Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N-acetyl-5-aminosalicylic acid. In rats, large doses of mesalazine injected intravenously produce tubular and glomerular toxicity. Mesalazine should be used with extreme caution in patients with confirmed mild to moderate renal impairment (see section 4.3). Patients on mesalazine should have renal function monitored, (with serum creatinine levels measured) prior to treatment start. Renal function should then be monitored periodically during treatment, for example every 3 months for the first year, then 6 monthly for the next 4 years and annually thereafter, based on individual patient history. Physicians should take into account risk factors such as prior and concomitant medications, duration and severity of disease and concurrent illnesses. Treatment with mesalazine should be discontinued if renal function deteriorates. If dehydration develops, normal electrolyte and fluid balance should be restored as soon as possible.
Serious blood dyscrasias have been reported very rarely with mesalazine.
Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasia.
If dehydration develops, normal electrolyte levels and fluid balance should be restored as soon as possible.
4.5
Interaction with other medicinal products and other forms of interaction
Concurrent use of lactulose and related agents should be avoided as this may lower luminal pH in the colon therefore inhibiting the disintegration of the coating and release of the mesalazine.
Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions (see Section 4.4 - Special Warnings and Precautions for Use).
Possible increased risk of leucopenia when aminosalicylates are given with azathioprine or mercaptopurine.
4.6 Pregnancy and lactation
No information is available with regard to teratogenicity; however, negligible quantities of mesalazine are transferred across the placenta and are excreted in breast milk following sulphasalazine therapy. Use during pregnancy should be with caution, and only if the potential benefits are greater than the possible hazards. Mesalazine should, unless essential, be avoided by nursing mothers.
4.7. Effects on ability to drive and use machines
Mesalazine can cause nausea. If this occurs patients should avoid driving, operating machinery, or other activities requiring full alertness.
4.8 Undesirable effects
The side effects are predominantly gastrointestinal, including nausea, diarrhoea, vomiting and abdominal pain. Headache has also been reported.
There have been rare reports of leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, alopecia, peripheral neuropathy, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, lupus erythematosus-like reactions and rash (including urticaria), drug fever, interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal. Renal failure, methaemoglobinaemia, eosinophilia, fibrosing alveolitis, myalgia and arthralgia have also been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
Mesalazine may very rarely be associated with an exacerbation of the symptoms of colitis, Stevens Johnson syndrome, erythema multiforme and bullous skin reactions including erythema.
Other side effects observed with sulphasalazine such as depression of sperm count and function have not been reported with mesalazine.
4.9 Overdose
Following overdose, gastric lavage, intravenous transfusion of electrolytes to promote diuresis and standard supportive measures are recommended. There is no specific antedote.
Pharmacodynamic properties
5.1
Mesalazine (5-aminosalicylic acid) is one of the two components of sulphasalazine, the other being sulphapyridine. It is the latter which is responsible for the majority of the side effects associated with sulphasalazine therapy whilst mesalazine is known to be the active moiety in the treatment of ulcerative colitis. It is understood that the activity of mesalazine in the treatment of ulcerative colitis may be due to its inhibitory effect on the lipoxygenase pathway. Leucotrienes formed by the lipoxygenase pathway are implicated in the pathogenesis of ulcerative colitis.
5.2. Pharmacokinetic properties
When given orally, mesalazine is readily absorbed from the small intestine with minimal amounts reaching the desired site of activity in the colon.
Therapeutic concentrations can only be produced by oral ingestion of a delayed or slow release preparation or by topical application (e.g. enema form). Mesalazine enteric-coated tablets are designed to disintegrate above pH 7.0 to release the active drug.
Clearance of mesalazine from circulation is predominantly due to acetylation, forming n-acetyl-5-aminosalicylic acid which is then excreted via glomerular filtration and active renal tubular secretion. The half-life of mesalazine is approximately one hour.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Microcrystalline cellulose, sodium carboxymethyl starch, corn starch, magnesium stearate, polyvinylpyrrolidone, mannitol, precipitated silica, dimethyl phthalate, methacrylic acid copolymer, dimethicone, talc, titanium dioxide, red ferric oxide.
6.2 Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 25°C in a dry place and protect from light.
6.5. Nature and content of container
Blister strips composed of: 245 pm PVC (PVDC coated), 20pm aluminium foil.
Pack sizes: 28, 30, 56, 60, 84, 90, 112, 120, 168 and 240.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Sandoz Limited Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
United Kingdom.
8. MARKETING AUTHORISATION NUMBER(S)
PL 04416/0244
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10 March 1997
10 DATE OF REVISION OF THE TEXT
25/06/2013