400 mg and 800 mg enteric-coated tablets are 
mesalazine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Asacol is and what it is used for 
2. What you need to know before using Asacol 
3. How to use Asacol 
4. Possible side effects 
5. How to store Asacol 
6. Contents of the packaging and other information 

1. What Asacol is and what it is used for

Asacol contains the active substance mesalazine and is available in two strengths containing 400 mg or 800 mg mesalazine. It is an anti-inflammatory drug used to treat ulcerative colitis. Ulcerative colitis is a disease in which the lining of the colon ( colon ) or rectum ( rectum ) becomes inflamed (red and swollen), leading to frequent and bloody stools, often accompanied by stomach cramps.

Asacol dissolves in the colon and counteracts inflammation throughout the colon and rectum. Asacol is used to treat mild to moderate acute ulcerative colitis and to prevent recurrence of the disease.

Mesalazine contained in Asacol may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Asacol

Do not use Asacol

  • if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to salicylates (eg acetylsalicylic acid )
  • if you have severe hepatic impairment
  • if you have severe renal impairment

Warnings and cautions

Talk to your doctor before using Asacol if you have any other medical conditions or illnesses, especially if you have:

  • problems with your lungs, such as asthma.
  • previously allergic to sulfasalazine.
  • had an allergic reaction in the heart such as inflammation of the heart muscle or pericardium. If you have previously had allergic reactions in your heart that are suspected to be caused by mesalazine, you should not use Asacol. Asacol can be used with caution if you have previously had an allergic reaction in the heart that was not caused by mesalazine.

If you have stomach ulcers, you should use Asacol with caution.

Kidney stones can form when using mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Be sure to drink enough fluids during treatment with mesalazine.

Examination of liver, kidneys, and blood

Before and while taking Asacol, your doctor may want to check if your liver, kidneys, blood, and lungs are working properly.

Tablets in the stool

There have been occasional reports of whole tablets in the stool. What appears to be whole tablets can sometimes be the remnants of the tablet coating. If you frequently notice tablets or shells of tablets in your stool, you should consult your doctor.

Children and young people

Asacol is only recommended for use in children 6 years of age and older.

Other medicines and Asacol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as:

  • Drugs that counteract the development of blood clots ( anticoagulants, such as warfarin ).
  • Drugs that affect the immune system (eg azathioprine, 6-mercaptopurine, or thioguanine).

Asacol with food, drink, and alcohol

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Asacol has no or negligible effect on the ability to drive and use machines, but if you are still affected in any way, do not drive or use machines.

Asacol contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Asacol contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘sodium-free’.

3. How to use Asacol

Always use Asacol exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Asacol should be taken before a meal. The tablets must be swallowed whole, preferably with liquid. The tablets must not be chewed, crushed, or divided before swallowing.

Your doctor will decide what dose you should take.

The recommended dose is:

Adults  
Acute forest: 2400 mg once daily or 2400‑4800 mg daily divided into 2-3 dosing sessions.
Maintenance treatment: 1600‑2400 mg once daily or divided into 2-3 dosing sessions.
Use for children and adolescents:
There is only limited evidence of efficacy in children (6-18 years).
Children ≥ 6 years
Dose one depends on the weight of the child and is calculated by the doctor.

If you forget to take Asacol

If you forget to take a dose at the right time, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Asacol

Use Asacol for as long as your doctor prescribes it. Talk to your doctor before changing or stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Asacol immediately and contact a doctor immediately

you develop unexplained bruising (without injury), bleeding under the skin, purple spots or spots under the skin, anemia (feeling tired, weak, and pale especially on the lips, nails, and inside of the eyelids), high fever, acute stomach pain, sore throat or unusual bleeding (eg nosebleeds).

Asacol can in very rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you inform about your medication.

Other side effects ar

Common: affects up to 1 in 10 people

  • rash
  • indigestion

Uncommon: affects up to 1 in 100 people

  • the high number of white blood cells called eosinophilic granulocyte s
  • the feeling of tingling, numbness
  • itchy skin, hives
  • chest pain

Rare: affects up to 1 in 1,000 people

  • headache
  • dizziness
  • inflammation of the heart with symptoms such as chest pain or palpitations
  • diarrhea, abdominal pain, flatulence, the feeling of anxiety and discomfort in the stomach with vomiting reflexes and vomiting
  • increased skin sensitivity to sunlight and ultraviolet light ( photosensitivity )

Very rareaffects up to 1 in 10,000 people

  • a sharp decrease in the number of blood cells which may cause weakness, bruising or increase the risk of infection, low number of blood cells, decreased number of platelets, which increases the risk of bleeding
  • allergic reactions such as skin rash
  • fever that occurs when you take the medicine and that disappears when you stop taking the medicine (drug-triggered fever)
  • diseases of the immune system that may involve organs and joints
  • ulcerative colitis throughout the colon
  • affected or damaged nerves that can cause numbness or tingling
  • lung disease (scarring of lung tissue, allergic reactions) which may cause difficulty in breathing, coughing or wheezing and accumulation of fluid in the lungs, pneumonia
  • inflammation of the pancreas (associated with pain in the upper abdomen and back and nausea)
  • abnormal liver tests, hepatitis ( inflammation of the liver that causes flu-like symptoms and jaundice)
  • hair loss
  • muscle or joint pain
  • kidney problems (such as inflammation and scarring of the kidneys), renal failure, which may be transient if treatment is stopped early
  • transient reduction in sperm production

No known frequency: can not be calculated from the available data

  • a disease of the immune system (lupus-like syndrome) which may cause inflammation of the pericardium or alveoli, skin rash, and/or joint pain
  • inflammation of the membrane surrounding the lungs and thoracic cavity (pneumonia)
  • intolerance to mesalazine and/or worsening of the disease
  • kidney stones and pain from the kidneys (see also section 2)
  • weight loss
  • abnormal laboratory test results

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. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Asacol

Do not store above 25 ° C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is mesalazine. One tablet contains 400 mg or 800 mg of mesalazine.
  • The other ingredients are lactose monohydrate, sodium starch glycolate (type A), magnesium stearate (vegetable origin) E 572, talc E 553b, povidone, methacrylic acid-methyl methacrylate copolymer (1: 2), triethyl citrate, yellow iron oxide (E 172), 17 iron) macrogol 6000.

What the medicine looks like and the contents of the pack

Asacol 400 mg enteric-tablets: reddish-brown film-coated tablets, 100 tablets.

Asacol 800 mg enteric-tablets: reddish-brown film-coated tablets, 60, 3 x 60 and 180 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Tillotts Pharma AB, Gustavslundsvägen 135, 167 51 Bromma.

Manufacturer:

Haupt Pharma Wülfing GmbH, Bethelner Landstr 18, D-31028 Gronau, Germany

Rottendorf Pharma GmbH, Ostenfelder Strasse 51 – 61, 59320 Ennigerloh, Germany

Muhammad Nadeem

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