1 g, 2 g, and 4 g depot granules
mesalazine
What Pentasa Sachet is and what it is used for
Pentasa Sachet is used to treat mild to moderate ulcers of ulcerative colitis and to prevent future relapses.
Ulcerative colitis is an inflammatory bowel disease in which the inside of the intestine becomes inflamed and develops small wounds that can bleed.
Pentasa Sachet contains granules that slowly release the active ingredient (mesalazine). It reduces inflammation and painful symptoms.
What you need to know before using Pentasa Sachet
Do not use Pentasa Sachet
- if you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (see section 6).
- if you are allergic to other salicylates, such as acetylsalicylic acid.
- if you suffer from severe liver and/or kidney disease.
Warnings and cautions
Talk to your doctor or pharmacist before using Pentasa Sachet:
- if you are allergic to sulfasalazine (risk of allergy to salicylates)
- if you have or have previously had liver or kidney disease
- if you tend to bleed
- if you have stomach ulcers (in the stomach or duodenum one)
- during concomitant treatment with certain drugs that may affect kidney function, such as NSAIDs (certain painkillers and anti-inflammatory drugs) and acetylsalicylic acid
- if you have a lung disease (especially asthma )
- if you experience stomach cramps, abdominal pain, fever, severe headache, and rash. In that case, stop using Pentasa Sachet immediately.
- if you have ever developed severe rash or dandruff, blistering, and / or sores in your mouth after using 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.
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.
When you are treated with this medicine, your doctor will usually ask you to provide blood and urine tests to check your kidney function, especially at the beginning of treatment.
Other medicines and Pentasa Sachet
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following:
- azathioprine (used after transplants or to treat autoimmune diseases)
- 6-mercaptopurine or thioguanine ( cytotoxic drug, used to treat leukemia )
- certain anticoagulants (antithrombotic drugs or blood thinners)
Pregnancy, breastfeeding, and fertility
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.
Limited experience of use in pregnant women and breast-feeding mothers. Blood disorders have been reported in newborns whose mothers were treated with this drug. Newborns can experience hypersensitivity reactions such as diarrhea. If the breastfed baby develops diarrhea, breastfeeding should be stopped.
Driving and using machines
Pentasa Sachet has no known effect on the ability to drive and use machines.
How to use Pentasa Sachet
Always use Pentasa Sachet exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
To treat relapses of the disease, your doctor will usually prescribe a dose of up to 4 g of mesalazine per day, to be taken once daily or divided into several doses. This can be taken as two Pentasa Sachet 2 g once daily. Pentasa Sachet 1 g can also be used to get the dose that is best for you.
To prevent new outbreaks of the disease, your doctor will usually prescribe 2 g of mesalazine per day, as one Pentasa Sachet 2 g or two Pentasa Sachet 1 g once daily.
Children ≥ 6 years
Dose one depends on the weight of the child and is calculated by the doctor. A general recommendation is half the adult dose for children weighing up to 40 kg and the normal adult dose for those weighing over 40 kg.
You should take granules orally (by mouth), immediately after opening the foil pouch, as described below. Depot granules must not be chewed.
- Open the foil bag
- Pour the contents directly on the tongue and rinse the granules immediately with a little water or orange juice, making sure that nothing is left in the mouth
OR - Mix the contents of the sachet with yogurt. Take the mixture immediately without chewing on the granules
If you use more Pentasa Sachet than you should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital immediately for an assessment of the risk and advice.
If you forget to use Pentasa Sachet
If you forget to take a dose, take it as soon as you remember and then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Pentasa Sachet can cause side effects, although not everybody gets them.
Isolated cases of severe allergic reactions (including severe superficial wounds that may affect the skin as a protective barrier of the body) have been reported. The allergic reaction may lead to swelling of the face and throat and/or difficulty breathing or swallowing ( Quincke’s edema ). Should this occur, contact a doctor immediately or see an emergency department.
Stop taking Pentasa and contact a doctor 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.
Common (may affect up to 1 in 10 people)
- diarrhea
- magnet
- nausea
- vomiting
- headache
- rash
- gas problems
Rare (may affect up to 1 in 1,000 people)
- myocarditis and pericarditis ( myocarditis and pericarditis) which can cause shortness of breath and chest pain or palpitations
- inflammation of the pancreas (symptoms include back and/or abdominal pain)
- elevated levels of amylase (the enzyme that helps break down carbohydrates)
- dizziness
- increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).
Very rare (may affect up to 1 in 10,000 people)
- anemia and other blood changes (decreased number of certain blood cells, which can cause bleeding, bruising, fever, and sore throat).
- liver disease (with symptoms such as jaundice (yellowing of the skin and/or eyes) and/or slow bowel movements)
- kidney disease (with symptoms such as blood in the urine, and/or edema (swelling caused by water accumulating in the body)
- peripheral neuropathy (a condition that affects nerves in the hands and feet with symptoms such as tingling and numbness).
- allergic and fibrotic lung reactions, inflammation of the alveoli or scar tissue of the lungs (with symptoms such as cough, bronchospasm, discomfort or pain when breathing, difficulty breathing, and bloody and/or extensive vomiting)
- pancreatitis (a type of inflammatory bowel disease (IBD) that affects the entire inside of the colon)
- hair loss (ceases after treatment)
- muscle and joint pain
- inflammation that can affect various parts of the body such as joints, skin, kidneys, heart, etc. (symptoms such as joint pain, fatigue, fever, abnormal or unexplained bleeding (especially nosebleeds), bruising, purple discoloration of the skin (including severe superficial sores and blisters such as can affect the skin as a protective barrier of the body)
- accumulation of fluid around the heart (shedding in the pericardium) that can cause pain or pressure over the chest
- discolored urine
- transient decrease in sperm count (ceases after treatment)
- severe diarrhea and abdominal pain due to an allergic reaction in the gastrointestinal tract
- allergic reactions and fever may occur in isolated cases
Has been reported (occurs in an unknown number of users)
- kidney stones and kidney pain (see also section 2)
Isolated cases of benign intracranial hypertension (benign pressure increase in the skull due to fluid accumulating around the brain) have been reported in adolescents. Symptoms include headache, nausea, vomiting, and/or visual or hearing impairment.
How to store Pentasa Sachet
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 and foil bag. The expiration date is the last day of the specified month.
No special storage instructions.
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
- Each sachet contains 1 g, 2 g, or 4 g of mesalazine.
- The other ingredients are ethylcellulose and povidone.
What the medicine looks like and the contents of the pack
This drug is granules with a prolonged release . The microgranules are white-gray to light white-brown.
This medicine is supplied in foil bags in the following pack sizes:
1 g sachet: 50, 100, or 150 sachets
Dose bag 2 g: 10 (sample pack), 60 or 120 sachets
4 g sachet: 20, 30, 50, or 100 sachets
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer
Ferring GmbH
Wittland 11
DE-24109 Kiel
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Quintasa Sachet | Denmark |
| Pentasa Sachet | Ireland, Spain, Sweden, Great Britain (Northern Ireland), Germany (1 g) |
| Pentasa Xtend | Germany (2 g) |
| Pentasa | Cyprus, Greece, Slovenia |