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MESALAZINE NORDIC 4 G GRANULES FOR RECTAL SUSPENSION

Active substance(s): MESALAZINE

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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
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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.

5. Carefully insert the nozzle into the rectum and gently squeeze the enema out of the bottle till empty.
6. Once the bottle is empty, withdraw the tip of the bottle from the rectum.
7. Remain relaxed in the administration position for 5-10 minutes or until the urge to pass the enema
has disappeared.
8. 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.

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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.

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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 30ÂșC 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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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