Product Description:
- Pentasa prolonged-release tablets contain mesalazine, which has an anti-inflammatory effect, and is used for chronic inflammation of the intestine ( ulcerative colitis and crohn's disease ).
- Compared to regular tablets, prolonged-release tablets allow a gradual release of the active substance in the intestine, so that the medicine has more time to work at the desired site (the intestinal wall).
How To Use:
- Always use this medicine exactly as your doctor or pharmacist has told you.
- Contact a doctor or pharmacist if you are unsure.
- The dose and the duration of the treatment are determined by the doctor who adapts it especially for you.
Adults:
The dosage is individual:
- The usual dose for the treatment of active ulcerative colitis is up to 4 g once a day or divided into several doses.
- The usual dose for the treatment of active Crohn's disease is up to 4 g daily divided into several doses.
- The usual dose for maintenance treatment - both for ulcerative colitis and Crohn's disease - is up to 4 g daily, divided into several doses.
- In mild to moderate ulcerative colitis , however, the recommended dose for maintenance treatment is 2 g once a day.
Children (≥6 years):
- There is limited documentation with regard to efficacy in children.
- The dosage is individual and determined by the doctor.
- The dose is calculated based on the child's weight.
- In general, half an adult dose is recommended for children with a body weight of up to 40 kg and a normal adult dose for children with a body weight of over 40 kg.
- Pentasa 1 g prolonged-release tablets should be swallowed whole.
- Pentasa 500 mg prolonged-release tablets, on the other hand, have a score line and can be divided, but must not be chewed or crushed.
- To make it easier to take the medicine, the prolonged-release tablets (both strengths) can be dissolved in a little water or juice immediately before taking.
- The preparation can be taken regardless of a meal.
- If you think that the effect of Pentasa prolonged-release tablets is too strong or too weak, you should consult your doctor or pharmacist about this.
If you take too much Pentasa:
- Contact a doctor, hospital or Poison Information if you have taken too much medicine or if a child has taken medicine by accident.
- For other questions about the medicine, contact your doctor or pharmacist.
If you have forgotten to take Pentasa:
- You should not take a double dose to make up for a missed dose.
If you stop treatment with Pentasa:
- Ask your doctor or pharmacist if you have any questions about the use of this medicine.
Warnings And Precautions:
Do not use Pentasa:
- If you are allergic to mesalazine or any of the other ingredients of this medicine.
- If you are allergic to salicylates,
- If you have severe liver or kidney disorders.
Talk to your doctor or pharmacist before using Pentasa:
- If you are allergic to sulfasalazine, as in such cases there may also be a certain risk of allergic reactions to Pentasa prolonged-release tablets (risk of allergy to salicylates).
- If you have impaired liver or kidney function; further precautions are agreed with a doctor.
- If you are using certain other medicines at the same time.
- If you have lung diseases, especially asthma.
- If serious changes occur in the blood picture or inflammation of the heart muscle and pericardium (myocarditis and pericarditis).
- A doctor should be contacted and the treatment discontinued.
- Such conditions are seen in rare cases. Signs of serious changes in the blood picture can be bleeding, bruising, sore throat and fever . Signs of inflammation of the heart muscle and pericardium are fever and chest pain followed by shortness of breath.
- If you have ever had a severe rash or peeling of the skin, blisters and/or mouth sores after using mesalazine.
- In connection with treatment with mesalazine, serious skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
- Stop taking mesalazine and consult a doctor immediately if you develop any of the symptoms associated with severe skin reactions.
- While you are being treated with this medicine, your doctor will usually carry out blood and urine tests to check your kidney function, especially at the start of treatment.
- Kidney stones can form when using mesalazine. Symptoms can be pain in the sides of the stomach and blood in the urine . Be sure to drink enough fluids during treatment with mesalazine.
Taking Pentasa together with food and drink:
- The preparation can be taken regardless of a meal.
Pregnancy and breastfeeding:
- Talk to your doctor or pharmacist before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.
- There is little experience with the use of Pentasa during pregnancy.
- The active ingredient in Pentasa crosses the placenta, and it is possible that the fetus could be affected. Therefore, consult a doctor before using Pentasa if you are pregnant.
- The active substance in Pentasa passes into breast milk, and it is possible that children who are breastfed may be affected. If the child develops diarrhoea , breastfeeding should be stopped.
Driving and using machines:
- Pentasa prolonged-release tablets have no or negligible influence on the ability to drive and use machines.
Ingredients:
- The active substance is respectively 500 mg or 1 g (=1000 mg) of mesalazine.
What Pentasa looks like and contents of the pack:
- Pentasa 500 mg prolonged-release tablets are grey-white to slightly brown, mottled, round tablets with a score line.
- They are marked with 500 mg on one side and PENTASA on the other.
- Pentasa 1 g prolonged-release tablets are grey-white to slightly brown, mottled, oval tablets.
- They are marked with PENTASA on both sides.
- The prolonged-release tablets are packed in blister packs of aluminum foil which are in turn packed in cardboard boxes.
- Pentasa 500 mg prolonged-release tablets are available in packs of 100 and 3×100, while
- Pentasa 1 g prolonged-release tablets are available in packs of 60.