500 mg enteric-tablet is
mesalazine

What Mesalazine Orion is and what it is used for

Mesalazine Orion enteric-tablet contains 500 mg of the active substance mesalazine (also known as 5-aminosalicylic acid), which belongs to a group of medicines used to treat inflammatory bowel disease.

Mesalazine Orion is used to treat ulcerative colitis, an inflammatory bowel disease.

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

What you need to know before you use Mesalazine Orion

Do not take Mesalazine Orion:

  • if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to acetylsalicylic acid or other salicylates
  • if you have a disease that makes you bleed easily
  • if you have severe renal and / or hepatic impairment

Warnings and cautions

Talk to your doctor or pharmacist before taking Mesalazine Orion.

Tell your doctor before starting treatment with Mesalazin Orion:

  • if you are or want to become pregnant
  • if you are breast-feeding
  • if you have liver or kidney problems
  • if you have any lung disease, such as asthma
  • if you have previously had an allergic reaction to sulfasalazine
  • if you have stomach or intestinal ulcers
  • if you have a history of heart inflammation (which may be caused by a heart infection)
  • if you have ever developed severe skin rash or dandruff, blistering and / or sores in your mouth after using mesalazine.

If you get allergic symptoms (such as rash, itching ), cramps, abdominal pain, severe headache, and fever during treatment, do not take more tablets and contact a doctor immediately.

Before and regularly while taking Mesalazin Orion, your doctor may want to take urine and blood samples to check if your liver, kidneys, blood, and lungs are working properly.

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.

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with mesalazine treatment. Stop using mesalazine and seek medical attention immediately if you experience any of the symptoms of these severe skin reactions as described in section 4.

Children and young people

Safety information for the use of this medicine in children and adolescents is limited. Not given to children under 5 years.

Other medicines and Mesalazin Orion

You can usually continue treatment with other medicines while using Mesalazin Orion. However, tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Mesalazine Orion may affect or be affected by other medicines if taken at the same time.

This applies in particular to:

  • medicines used to lower blood sugar (antidiabetic drugs)
  • medicines used to lower blood pressure (antihypertensive medicines / diuretics)
  • drugs used to treat or prevent gout attacks
  • medicines that help the bowel movements ( laxatives that contain lactulose )
  • medicines that prevent blood clots ( anticoagulants )
  • drugs that reduce the activity of the immune system (eg azathioprine or 6-mercaptopurine or thioguanine)
  • medicines used to treat pain and inflammation (anti-inflammatory drugs).

Pregnancy and breastfeeding

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

There is limited experience with the use of mesalazine during pregnancy and lactation. The newborn can develop allergic reactions after breastfeeding, e.g. diarrhea. If the newborn develops diarrhea, breastfeeding should be discontinued.

Women who are pregnant or breastfeeding should not use Mesalazine Orion except on the advice of a doctor.

Driving and using machines

Mesalazine Orion has no or negligible effect on the operation of vehicles and machinery.

Mesalazine Orion contains sodium

This medicine contains 2.13 mmol (or 49 mg) sodium (the main ingredient in table salt/table salt) per enteric tablet. This corresponds to 2.5% of the maximum recommended daily sodium intake for adults.

Talk to your doctor or pharmacist if you need 8 tablets of entering daily for a long period, especially if you have been prescribed a low-salt (sodium-poor) diet.

How to take Mesalazine Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will tell you how long you should be treated with this medicine. Do not stop treatment earlier, even if you feel better, as the symptoms may return if you stop treatment too soon.

Always follow the doctor’s treatment instructions strictly, both in the acute inflammatory phase and in the maintenance treatment that has been agreed upon.

The recommended dose for adults is:

To treat an acute relapse of colitis, your doctor will usually prescribe between 1.5 grams (3 enteric tablets ) and 4 grams (8 enteric tablets ) of mesalazine per day, which can be given once a day or in divided doses.

To prevent multiple relapses, your doctor may prescribe a dose between 1.5 grams (3 enteric tablets ) and 3 grams (6 enteric tablets ) of mesalazine per day, which can be given once a day or in divided doses.

Mesalazine Orion enteric-tablet should be taken orally.

The enteric tablets should be swallowed whole with liquid and taken before meals.

Use for children and adolescents

Mesalazine Orion is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy. Not given to children under 5 years.

Possible side effects

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

All medicines can cause allergic reactions, but severe allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, stop taking the tablets and contact your doctor immediately:

  • allergic skin rash
  • fever
  • breathing difficulties.

If you get a fever or irritation in your throat or mouth, stop taking the tablets and contact a doctor immediately. These symptoms can, in very rare cases, be due to a decreased number of white blood cells in your blood (a condition called agranulocytosis ).

Stop using mesalazine and seek medical attention immediately if you get any of the following symptoms:

  • reddish, not raised, spots on the torso that resemble targets or are round, often with blisters in the middle, scaly skin, sores in the mouth, pharynx, nose, genitals and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms .

The following side effects have also been reported in patients taking mesalazine:

Rare (may affect up to 1 in 1,000 people):

  • abdominal pain, diarrhea, flatulence , nausea and vomiting
  • headache, dizziness
  • chest pain, shortness of breath or swollen arms and legs due to heart effects
  • increased sensitivity of the skin to sunlight and ultraviolet light ( photosensitivity ).

Very rare (may affect up to 1 in 10,000 people):

  • impaired renal function, sometimes with swollen arms and legs or radiating pain in the side of the lower back (flank pain)
  • severe abdominal pain due to acute pancreatitis
  • worsening of colitis symptoms
  • fever, sore throat or malaise due to decreased blood cell count
  • shortness of breath, cough, wheezing, abnormalities in the chest X-ray due to an allergic and / or inflammatory lung condition
  • diarrhea and severe abdominal pain due to allergic reaction to the drug in the intestine
  • skin rash or inflammation
  • muscle and joint pain
  • jaundice or abdominal pain due to liver disease or impaired bile flow
  • hair loss and development of baldness
  • erythema multiforme (serious side effect affecting the skin and mucous membranes)
  • numbness and tingling in fingers and toes ( peripheral neuropathy )
  • transient decrease in sperm production
  • disorders of blood values.

Has been reported (occurs in an unknown number of users):

  • kidney stones and kidney pain (see also section 2).

Increased skin sensitivity to sunlight and ultraviolet light ( photosensitivity ) More severe reactions have been reported in patients with pre-existing skin conditions such as atopic dermatitis/dermatitis and atopic eczema.

If these symptoms persist or become more severe, consult your doctor.

How to store Mesalazin Orion

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 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.

Contents of the pack and other information

Content declaration

  • The active substance is mesalazine.
  • Each enteric- containing tablet contains 500 mg of mesalazine.
  • The other ingredients are anhydrous sodium carbonate, glycine , povidone, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, calcium stearate, methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30 percent, methacrylic acid-methylmacacrylate copolymer (1: 1): methacrylate copolymer , dibutyl sebacate, talc, titanium dioxide (E171), macrogol, yellow iron oxide (E172) and red iron oxide (E172).

What the medicine looks like and contents of the pack

Mesalazine Orion enteric tablets are oblong with an orange coating.

The medicine is marketed in OPA / Alu / PVC / Alu-blister packed in cartons containing 100 enteric tablets.

Marketing Authorization Holder and Manufacturer

Faes Farma, SA

Máximo Aguirre, 14

48940 Leioa (Bizkaia)

Spain

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

This medicinal product is authorized under the European Economic Area under the names:

Finland: Mesalazine Orion 500 mg enterotabletite

Denmark: Mesalazine Orion 500 mg Enterotablett

Sweden: Mesalazine Orion 500 mg enteric-tablet is

Norway: Mesalazine Orion 500 mg Enterotablett

Malta: Mecolzine 500 mg gastro-resistant tablets

Cyprus: Mecolzine 500 mg gastro-resistant tablets

Bulgaria: Mecolzine 500 mg gastro-resistant tablets

Spain: Azzavix 500 mg compresses gastrointestinal disorder

Muhammad Nadeem

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