Pentasa Sachet 1g prolonged release granules

PENTASA^®

Sachet 1g prolonged release granules

Sachet 2g prolonged release granules

Sachet 4g prolonged release granules

Mesalazine

Pentasa Sachet is used for the treatment of mild to moderate attacks of ulcerative colitis and to help maintain freedom from further attacks.

Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine becomes inflamed and develops many tiny breaks in its surface (ulcers) which may bleed.

Pentasa Sachet contains granules that slowly release the active ingredient (mesalazine). This helps reduce the inflammation and the painful symptoms.

Always take Pentasa Sachet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults:

To treat an attack of colitis, your doctor will usually prescribe a dose of up to 4 g mesalazine a day to be taken either once a day or in divided doses. This may be taken as one Pentasa Sachet 4 g or two Pentasa Sachet 2g once daily. Pentasa Sachet 1g might also be used to provide the dose that is most suited to you.

To help maintain freedom from further attacks, your doctor will usually prescribe 2 g mesalazine a day administered as one Pentasa Sachet 2g or two Pentasa Sachet 1g once daily

Use in children and adolescents

Children 6 years of age and older:

The dose for children will be calculated by your doctor and depends on the child’s weight. It is generally recommended that half the adult dose is given to children up to 40 kg of body weight and the normal adult dose to children above 40 kg of body weight.

You should take the granules orally (by mouth), immediately after opening the sachet, as described below. Do not chew the granules.

1. Open the foil sachet

2. Empty the contents of the sachet onto the tongue and wash the granules down immediately with some water or orange juice ensuring that none remain in the mouth

OR

3. Mix the entire content of the sachet with yogurt. Intake immediately without chewing on the granules.

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

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

There have been very few reports of a severe allergic reaction (including severe skin erosions that may affect the skin as the protective barrier of the body). The allergic reaction might lead to swelling of the face and neck and/or difficulty in breathing or swallowing (Quincke´s oedema). If this happens contact your doctor or nearest casualty department immediately.

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

reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These serious skin rashes can be preceded by fever and flu-like symptoms.

The following common side effects may affect up to 1 in 10 people:

• diarrhoea
• abdominal pain
• nausea
• vomiting
• headache
• rash
• flatulence (passing wind)

The following rare side effects may affect up to 1 in 1,000 people:

• inflammation of some areas of the heart (myocarditis and pericarditis) which can cause shortness of breath and chest pain or palpitations (rapid or irregular heart beats)
• inflammation of the pancreas (symptoms include back and/or stomach pain).
• Increased amylase (enzyme that helps digest carbohydrates)
• dizziness
• Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).

The following very rare side effects may affect up to 1 in 10,000 people:

• anaemia and other blood disorders (decrease in the numbers of certain blood cells, which can cause unexplained bleeding, bruising, fever or sore throat)
• liver disorders (symptoms include jaundice (yellowing of the skin and/or eyes) and/or pale bowel motions)
• kidney disorders (symptoms include blood in the urine, and/or oedema (swelling due to build up of fluid))
• peripheral neuropathy (a condition affecting the nerves of the hands and feet symptoms include tingling and numbness)
• allergic and fibrotic lung reactions, inflammation of the lining of the lungs or lung scarring (symptoms include coughing, bronchospasm, chest discomfort or pain on breathing, breathing difficulties, bloody and/or excessive phlegm)
• Pancolitis (a kind of inflammatory bowel disorder (IBD) that affects the entire internal lining of the large bowel)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation which can affect different parts of the body such as joints, skin, kidneys, heart etc. (symptoms include painful joints, fatigue, fever, abnormal or unexplained bleeding (e.g. nose bleeds), bruising, purple discoloration of the skin (including severe skin erosions and severe blistering that may affect the skin as the protective barrier of the body))
• accumulation of fluid around the heart (pericardial effusion) which can cause chest pain or pressure
• change in urine colour.
• semen with a low concentration of sperm (oligospermia) (this is reversible)
• severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel
• allergic reactions and fever may occasionally occur.

Not known (frequency cannot be estimated from the available data)

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

There have been very few reports of benign intracranial hypertension (build up of fluid around the brain) in adolescents. Symptoms include headache, nausea, vomiting, and/or visual or hearing disturbances.

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 sachet. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicnes you no longer use. These measures will help protect the environment.