Pentasa Enema (Mesalazine)

• Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

• What Pentasa Enema is and what it is used for
• What you need to know before you use Pentasa Enema
• How to use Pentasa Enema
• Possible side effects
• How to store Pentasa Enema
• Contents of the pack and other information

• are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (see section 6)
• are allergic to other salicylates e.g. acetylsalicylic acid
• have severe liver and/or kidney problems

Talk to your doctor or pharmacist before using these enemas if you:

• are allergic to sulphasalazine (risk of allergy to salicylates)
• currently have or have previously had liver or kidney disease
• have a medical condition that can make you prone to bleeding
• are on medication that may affect kidney function e.g. Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• have lung problems, in particular asthma
• suddenly develop abdominal cramps, abdominal pain, fever, severe headache and rash. In such circumstances you should stop taking Pentasa immediately.
• Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine.
• have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.

Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.

Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Stop using Pentasa Enema and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4

If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears contact your doctor immediately.

While you are on treatment with this medicine, your doctor will normally arrange blood and urine tests to check your kidney function especially at the beginning of treatment.

You should make sure that you don’t become dehydrated, while you are using this medicine. This can occur after severe or prolonged attacks of vomiting and/or diarrhoea, high fever or heavy sweating. If this occurs, you should talk to your doctor or a pharmacist for advice as soon as possible.

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 transplantations or to treat auto-immune diseases)
• 6-mercaptopurine or thioguanine (chemotherapy, used to treat leukaemia)
• certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood, e.g. warfarin)

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 using this medicine.

There is limited experience with the use of mesalazine during pregnancy and breast-feeding. Blood disorders have been reported in newborns of mothers being treated with this medicine. The newborn may develop allergic reactions after breast-feeding, e.g. diarrhoea. If the newborn develops diarrhoea, breast-feeding should be discontinued.

This medicine is not known to affect the ability to drive and/or use machines.

If you accidentally use too much enema, you should go to your nearest emergency department or contact your doctor immediately. Take the carton with you.

If you forget to use a dose, use the next dose in the morning if it is convenient. Otherwise, use one as usual the next night. Do not use a double dose to make up for the forgotten one.

• 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.
• itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing or wheeziness (signs of an allergic reaction).
• unexplained bleeding, bruising, skin rashes, fever or sore throat (signs of blood disorder).
• a change in the colour or amount of urine produced (signs of kidney problems).

If you experience any of the above side effects, you should contact your doctor or go to the nearest hospital emergency department immediately.

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

• diarrhoea
• abdominal pain
• nausea
• vomiting
• headache
• rash
• flatulence (passing wind)
• rectal discomfort,
• irritation at the site of application

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))
• 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)
• change in urine colour.
• If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure within your skull (idiopathic intracranial hypertension).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Each bottle contains 1g of the active ingredient, mesalazine in 100ml of liquid. The mesalazine settles out as a separate layer. It also contains the following inactive ingredients: disodium edetate, sodium metabisulphite, sodium acetate, hydrochloric acid, purified water.

The enema is a white to a slightly yellow suspension presented in a polythene bottle. Each pack contains 7 individually foil-wrapped enema bottles and 7 polythene bags for disposal of the empty enema bottle after use.