Mesalamine Delayed-Released Tablets USP 400mg Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Mesalamine Delayed-Released Tablets USP 400mg Taj Pharma
Mesalamine Delayed-Released Tablets USP 800mg Taj Pharma
Mesalamine Delayed-Released Tablets USP 1.2g Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

    a) Each Delayed Released Tablet contains:
    Mesalamine USP…………………….400mg|

    b) Each Delayed Released Tablet contains:
    Mesalamine USP…………………….800mg

    b) Each Delayed Released Tablet contains:
    Mesalamine USP…………………….1.2g

  2. PHARMACEUTICAL FORM

Red-brown, oblong, modified release tablets.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Ulcerative Colitis:

For the treatment of mild to moderate acute exacerbations. For the maintenance of remission.

Crohn’s ileo-colitis

For the maintenance of remission.

4.2 Posology and method of administration

Swallow whole with water. Do not break, crush or chew the tablets before swallowing.

ADULTS:

Oral:

Acute disease: Six tablets a day in divided doses, with concomitant corticosteroid therapy where clinically indicated.

Maintenance therapy: Three to six tablets once daily or in divided doses.

ELDERLY: The normal adult dosage may be used unless renal function is impaired (see section 4.4).

CHILDREN: There is no dosage recommendation.

4.3 Contraindications

A history of sensitivity to salicylates or renal sensitivity to sulphasalazine. Confirmed severe renal impairment (GFR less than 20 ml/min). Children under 2 years of age.

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. Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma  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.

4.5 Interaction with other medicinal products and other forms of interaction

‘Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma ‘ Tablets should not be given with lactulose or similar preparations, which lower stool pH and may prevent release of mesalazine.

Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions (see section 4.4)

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 of ‘Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma ‘ during pregnancy should be with caution, and only if the potential benefits are greater than the possible hazards. ‘Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma ‘ should, unless essential, be avoided by nursing mothers.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

The side effects are predominantly gastrointestinal, including nausea, diarrhoea 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 has 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 and erythema multiforme.

Other side effects observed with sulphasalazine such as depression of sperm count and function, have not been reported with ‘Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma ‘.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Following tablet ingestion, gastric lavage and intravenous transfusion of electrolytes to promote diuresis. There is no specific antidote.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Mesalazine 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.

5.2 Pharmacokinetic properties

‘Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma ‘ Tablets contain 400 mg of available mesalazine. This is released in the terminal ileum and large bowel by the effect of pH. Above pH 7 the Eudragit S coat disintegrates and releases the active constituent. ‘Mesalamine Delayed-Released Tablets USP 400mg / 800mg / 1.2g Taj Pharma ‘ Tablets contain, in a single tablet, an equivalent quantity of mesalazine to that theoretically available from the complete azo-reduction of 1g of sulphasalazine.

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 SPC.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Core: Lactose, Sodium starch glycollate, Magnesium stearate, Talc, Povidone

Coating:Methacrylic acid-methyl, methacrylate copolymer Dibutyl sebacate, Iron oxides, Macrogol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store tablets in a dry place at a temperature not exceeding 25°C and protect from direct sunlight. Keep the bottle tightly closed

6.5 Nature and contents of container

HDPE oblong bottle with a child-resistant closure, cotton, and silica gel desiccant pouches.

Pack-sizes of 90 or 120 tablets.

HDPE round bottle with a child-resistant closure, cotton, and silica gel desiccant pouches.

Pack-sizes of 84 or 168 tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD;

Plot No. 220, Mahagujarat Industrial Estate,

Moraiyya, Tal-Sanand, Dist-Ahmedabad, Gujarat.

PACKAGE LEAFLET: INFORMATION FOR THE USER

MESALAMINE
DELAYED-RELEASED TABLETS USP
400MG / 800MG / 1.2G
TAJ PHARMA

(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 Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma are and what they are used for
  2. Before you take Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma
  3. How to take Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma
  4. Possible side effects
  5. How to store Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma
  6. Further information

    1. WHAT MESALAMINE DELAYED-RELEASED TABLETS USP 400MG / 800MG / 1.2G TAJ PHARMA ARE AND WHAT THEY ARE USED FOR

Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma  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. Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis.
  • Crohn’s ileo-colitis– a disease affecting the small bowel (terminal ileum) and colon in which the lining of the bowel becomes swollen and sore. This may lead to the development of ulcers, abscesses and narrowing (strictures) in the bowel. Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma  act locally in the terminal ileum and colon to control the disease and prevent further flares of Crohn’s ileocolitis.
  1. BEFORE YOU TAKE MESALAMINE DELAYED-RELEASED TABLETS USP 400MG / 800MG / 1.2G TAJ PHARMA

Do not take Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma if you:

  • are allergic (hypersensitive) to any of the ingredients in the product (see Section 6 on ‘What Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma 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.

DO NOT give the tablets to children under 2 years of age.

Take special care with Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma

  • Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma should be used with extreme caution in patients with confirmed mild to moderate kidney impairment.
  • Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma should be used with caution in the elderly.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma should NOT be taken with Lactulose (a medicine for constipation).

Use of non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, aspirin, Cox-II inhibitors) and azathioprine in particular may increase the risk of kidney reactions.

Pregnancy and breast-feeding

Women who are pregnant or breast-feeding should not take Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma unless advised otherwise by their doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Tests on your liver, kidney and blood

Before you start treatment with Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma you will have a blood and urine test to check how well your kidneys are working and what your blood is doing. During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine sample periodically during your treatment.

Driving and using machines

Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma are not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma

Lactose – if you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

  1. HOW TO TAKE MESALAMINE DELAYED-RELEASED TABLETS USP 400MG / 800MG / 1.2G TAJ PHARMA

Always take Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma exactly as your doctor has told you. You should check with your doctor if you are not sure.

The tablets should be swallowed whole with water; do not break, crush or chew them.

Whilst taking this medicine ensure you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and /or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidneys.

The usual dose is:

  • Treating ulcerative colitis– 6 tablets each day divided throughout the day. For example:
    • 2 tablets 3 times a day OR
    • 3 tablets twice a day.
  • Preventingfurther episodes of ulcerative colitis
    • between 3 and 6 tablets once daily or divided throughout the day. For example:
    • a daily dosage of 3 tablets may be taken as 3 tablets once a day or 1 tablet 3 times a day
    • a daily dosage of 6 tablets may be taken as 6 tablets once a day or 3 tablets twice a day.
  • Preventingfurther episodes of Crohn’s ileo-colitis – between 3 and 6 tablets divided throughout the day. For example:
    • 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.

Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma are not recommended for use in children.

If you stop taking Ascol 400mg MR tablets

Keep taking the tablets for as long as your doctor tells you. Your symptoms may come back if you stop treatment too early. Remember to get a repeat prescription at the right time so that you do not miss a day of treatment.

If you take more Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma 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 much medicine, 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 Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma

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

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma can cause side effects, although not everybody gets them.

Allergic reactions can occur. Tell your doctor if you get:

  • a rash with or without itching, any shortness of breath, palpitations (rapid heartbeat) or chest pain. These effects will usually disappear when you stop taking the medicine.

Tell your doctor immediately

if you experience any of the following symptoms:

  • fever, sore throat, mouth or lip ulcers, spots underneath your skin anywhere on your body, including the genital and anal regions, become very pale, swollen ankles or have unusual bleeding (e.g. unexpected nosebleeds or bleeding gums)
  • skin rash with flaking, boils or sore lips or mouth
  • bruising more easily or suspect blood abnormalities
  • problems with kidney function

Common side effects (in more than 1 in 100 people but less than 1 in 10 people):

  • diarrhoea
  • abdominal pain
  • nausea (feeling sick)

Rare side effects (in less than 1 in 1000 people):

  • problems with heart, lung, liver or kidney function
  • inflammation of the pancreas
  • blood abnormalities
  • numbness and tingling of the fingers and toes due to damaged nerves
  • hair loss
  • fever
  • skin rash.

Very rare side effects (in less than 1 in 10,000 people):

  • worsening of symptoms of colitis
  • Erythema multiforme and Stevens-Johnson syndrome (skin and mucous membrane disease).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. HOW TO STORE MESALAMINE DELAYED-RELEASED TABLETS USP 400MG / 800MG / 1.2G TAJ PHARMA 400MG MR TABLETS

Keep out of the sight and reach of children.

Store Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma in their original pack below 25°C (77°F) in a dry place, protected from direct sunlight.

Do not remove the moisture absorbing pouch from the bottle. The pouch is not part of your medicine and is marked DO NOT EAT. Keep the bottle tightly closed.

Do not use Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  1. FURTHER INFORMATION

What Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma contain

The active substance is mesalazine (also known as 5-aminosalicylic acid). Each tablet contains 400mg mesalazine.

The other ingredients are

Core: lactose monohydrate, sodium starch glycollate, magnesium stearate, talc, povidone.

Coating: methacrylic acid-methyl methacrylate copolymer (1:2), dibutyl sebacate, ferric oxide yellow (E172), ferric oxide red (E172) and macrogol 6000.

See also Section 2 on ‘Important information about some of the ingredients of Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma

What Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma look like and contents of the pack

Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma are red-brown, coated and oblong shaped. They are packed in a plastic bottle with a child-resistant closure that contains a cotton/silica gel moisture absorbing pouch. Mesalamine Delayed-Released Tablets USP 400MG / 800MG / 1.2G Taj Pharma are available in packs of 84, 90, 120 or 168 tablets (not all pack sizes may be marketed).

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD;

Plot No. 220, Mahagujarat Industrial Estate,

Moraiyya, Tal-Sanand, Dist-Ahmedabad, Gujarat.

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