Package leaflet: Information for the user Mesalazine NORDIC 1/2/4 g granules for rectal suspension

Mesalazine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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 is in this leaflet

1.    What Mesalazine NORDIC granules for rectal suspension are and what they are used for

2.    What you need to know before you use Mesalazine NORDIC granules for rectal suspension

3.    How to use Mesalazine NORDIC granules for rectal suspension

4.    Possible side effects

5.    How to store Mesalazine NORDIC granules for rectal suspension

6.    Contents of the pack and other information

1. What Mesalazine NORDIC granules for rectal suspension are and what they are used for

Mesalazine NORDIC granules for rectal suspension contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease.

Mesalazine NORDIC granules for rectal suspension are used to treat:

-    mild to moderate left-sided ulcerative colitis.

2. What you need to know before you use Mesalazine NORDIC granules for rectal suspension Do not use Mesalazine NORDIC granules for rectal suspension:

-    if you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (listed in section 6).

-    If you have severe kidney disease (your doctor decides the severity of the disease)

-    If you have severe liver disease (your doctor decides the severity of your disease)

Warnings and precautions

Talk to your doctor before using Mesalazine NORDIC granules for rectal suspension:

-    If you have a history of allergy to sulfasalazine, a substance related to mesalazine.

-    If you have/had any liver or kidney disease

-    If you have problems with your lung function

-    If you are dehydrated or suffer from conditions leading to dehydration (vomiting, diarrhoea, stomatitis) Other medicines and Mesalazine NORDIC granules for rectal suspension

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Remember to tell your doctor about your treatment with Mesalazine NORDIC enema granules, if you are prescribed another medicine while the treatment is still ongoing.

It is especially important to tell your doctor if you are using:

-    Non-steroidal anti-inflammatory drugs as this may affect kidney function

-    azathioprine or 6-mercaptopurine

Pregnancy, breast-feeding and fertility

You should only use Mesalazine NORDIC granules for rectal suspension during pregnancy if your doctor tells you to.

If breast-feeding, you should only use Mesalazine NORDIC granules for rectal suspension if your doctor tells you to as this medicine may pass into breast milk.

Driving and using machines

Mesalazine NORDIC granules for rectal suspension does not affect the ability to drive or use machines.

3. How to use Mesalazine NORDIC granules for rectal suspension

Always use Mesalazine NORDIC granules for rectal suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Dosage

The usual dose is one enema a day, at bedtime.

Method of administration

Mesalazine NORDIC granules for rectal suspension may only be used via the anus. Do NOT take by the mouth. You should go to the toilet to empty your bladder and bowels, if necessary, before using the enema.

1.    Remove the nozzle and empty the contents of the sachet(s) into the concertina-shaped bottle.

2.    Add tap water or drinkable still water to the bottle up to the mark. Ensure the nozzle is firmly reattached, shake well for 30 seconds and then leave to rest for 5 minutes. Shake well for another 30 seconds.

3.    Remove the protective cap from the nozzle.

4.    To administer the enema, lie on your left side with the right leg bent in a position where it is easy to maintain balance.

Carefully insert the nozzle into the rectum and gently squeeze the enema out of the bottle till empty. Once the bottle is empty, withdraw the tip of the bottle from the rectum.

Remain relaxed in the administration position for 5-10 minutes or until the urge to pass the enema has disappeared.

Dispose of the empty bottle and wash your hands.

If you use more Mesalazine NORDIC granules for rectal suspension than you should

Follow the dose recommendations of your treating doctor. Do not change the dose of your own accord.

If you suspect that you have used too much Mesalazine NORDIC granules for rectal suspension, please tell your doctor so that he or she can decide what to do.

If you forget to use Mesalazine NORDIC granules for rectal suspension

Do not take a double dose to make up for forgotten individual doses, but take one the next morning if convenient. Otherwise, use one as usual the next night.

If you stop taking Mesalazine NORDIC granules for rectal suspension

You should not interrupt or discontinue Mesalazine NORDIC granules for rectal suspension treatment, unless you have discussed this with your doctor.

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

4. Possible side effects

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

Tell your doctor straight away if you get any sudden difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

The following side effects have also been reported:

Common (may affect upto 1 in 10 people):

-    Rash

Uncommon (may affect upto 1 in 100 people)

-    Joint pain and swelling

-    Fatigue

-    General discomfort

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

-    numbness and tingling in the feet and hands

-    Chest pain or breathlessness due to an effect on the heart

-    Headache

-    Dizziness

-    Nausea and vomiting

-    Abdominal pain

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

-    A decrease in the number of white blood cells and other blood disorders

-    Anaemia

-    Increased liver enzymes

-    Hair loss which is reversible

-    Skin lesions

-    Muscle pain

-    Discolouration of the urine

-    Severe abdominal pain due to inflammation of the pancreas

-    Liver disorders

-    Low concentration of sperm which is reversible

-    Shortness of breath, coughing and wheezing due to allergic lung conditions

If any of the side effects get serious, contact your doctor or pharmacist immediately.

Reporting of side effects

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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mesalazine NORDIC granules for rectal suspension

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

Store below 30°C in the original packaging in order to protect from light.

The product has to be used immediately after prepaaration.

This medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines or packaging you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mesalazine NORDIC granules for rectal suspension contains

The active substance is mesalazine.

The other ingredients are xanthum gum, crosscarmellose sodium and sodium chloride.

What Mesalazine NORDIC granules for rectal suspension looks like and contents of the pack

Mesalazine NORDIC granules for rectal suspension come in aluminium foil sachets with a concertina shaped bottle.

The following pack sizes are available: 7 and 14

Marketing Authorisation Holder

Nordic Group BV Siriusdreef 22 2132 WT Hoofddorp The Netherlands

Manufacturer

QPharma AB Agneslundsvagen 27 P.O. Box 590 SE-201 25 Malmo Sweden

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in 01/2015

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