Salofalk 1000mg
gastro-resistant prolonged release granules
mesalazine
Read all of this leaflet carefully before you start taking this medicine.
- 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Salofalk 1000mg granules are and what they are used for
2. Before you use Salofalk 1000mg granules
3. How to use Salofalk 1000mg granules
4. Possible side effects
5. How to store Salofalk 1000mg granules
6. Further information
WHAT SALOFALK 1000mg GRANULES ARE AND WHAT THEY ARE USED FOR
Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.
Salofalk 1000mg granules are used for:
- the treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis.
BEFORE YOU TAKE SALOFALK 1000mg GRANULES
Do not take Salofalk granules
- If you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of Salofalk 1000mg granules (these are listed in section 6, Further information)
- If you have a serious liver and/or kidney disease
- If you have a stomach or duodenal ulcer
- If you have a tendency to bleed easily or you have ever been told that there is a problem with the clotting of your blood
Take special care with Salofalk granules.
Before you start taking this medicine you should tell your doctor
- If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma
- If you have a history of allergy to sulphasalazine, a substance related to mesalazine
- If you suffer with problems of your liver
- If you suffer with problems of your kidney
Further precautions
During treatment your doctor may want to keep you under close medical supervision, where you will have regular blood and urine tests.
Using other medicines
Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):
Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood)
Glucocorticoids (certain steroid-like anti-inflammatory agents, such as prednisolone)
Sulphonyl ureas (substances used to control your blood sugar, such as glibenclamide)
Methotrexate (an agent used to treat leukaemia or immune disorders)
Probenecid/sulphinpyrazone (agents used to treat gout)
Spironolactone/frusemide (agents used to treat heart problems)
Rifampicin (substance used against tuberculosis)
Medicines containing azathioprine or 6-mercaptopurine (used to treat immune disorders)
Lactulose (substance used for treating constipation) or other preparations that can change the acidity of your stools
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk granules and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should only use Salofalk granules during pregnancy if your doctor tells you to.
Salofalk granules should not be used during breast-feeding as the drug and its metabolite may pass into breast milk.
Driving and using machines
There are no effects on the ability to drive and use machines.
Important information about some of the ingredients of Salofalk 1000mg granules
This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet of Salofalk 1000mg granules contains the equivalent to 1.12 mg phenylalanine.
HOW TO TAKE SALOFALK 1000mg GRANULES
Always take Salofalk granules exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Method of administration
Salofalk granules are for oral use only.
Salofalk granules should not be chewed. You should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing.
Dosage
Adults and the elderly
Unless otherwise prescribed by your doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is:
3 sachets of Salofalk 1000mg granules once daily preferably in the morning or 1 sachet of Salofalk 1000mg granules three times daily (equivalent to 3 g mesalazine per day), depending on the clinical requirements in the individual case.
If 500 mg dosages are required, Salofalk 500mg granules should be used.
To prevent a relapse of ulcerative colitis
Use 1 sachet of Salofalk 500mg granules three times daily (equivalent to 1.5 g mesalazine per day).
Children
There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years and older
Please ask your doctor about the precise dosage of Salofalk granules for your child.
In acute episodes: to be determined individually, starting with 30-50 mg mesalazine per kg body weight per day that should be given once daily preferably in the morning or in divided doses. The maximum dose is 75 mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose.
To prevent a relapse: to be determined individually, starting with 15-30 mg mesalazine per kg body weight per day that should be given in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that half the adult dose should be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Duration of treatment
How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication.
You should follow the treatment with Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, because this is the only way to achieve the desired therapeutic effect.
If you think that the effect of Salofalk granules is too strong or too weak, talk to your doctor.
If you take more Salofalk granules than you should
Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too much Salofalk granules on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
If you forget to take Salofalk granules
Do not take a larger than normal dose of Salofalk granules next time, but continue treatment at the prescribed dosage.
If you stop taking Salofalk granules
Do not stop taking this product until you have talked to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Salofalk granules can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately:
Allergic skin rash
Fever
Breathing difficulties
If you experience the following serious side effects, stop taking the medicine and contact your doctor immediately:
If you experience a serious reduction of your general health condition with fever, and/or sore throat and mouth, please report to your doctor immediately. The symptoms might derive from a reduction in the number of white blood cells in your blood (agranulocytosis). This may increase your chances of suffering from a serious infection.
A blood test will be taken to check possible reduction of white blood cells.
It is important to inform your doctor about your medicine.
The following side effects have also been reported:
Rare side effects (that affect less than 1 in 1,000 patients):
- Abdominal pain, diarrhoea, wind, nausea and vomiting
- Headache, dizziness
Very rare side effects (that affect less than 1 in 10,000 patients):
- Changes in kidney function, sometimes with swollen limbs or flank pain because of renal disorders
- Chest pain, breathlessness or swollen limbs because of heart disorders
- Severe abdominal pain because of acute inflammation of the pancreas
- Severe breathlessness because of allergic inflammation of the lung
- Severe diarrhoea and abdominal pain because of allergic inflammation of the intestine
- Skin rash or inflammation
- Muscle and joint pain
- Fever, sore throat, or malaise because of blood count changes
- Jaundice or abdominal pain because of liver and bile flow disorders
- Hair loss and the development of baldness
- Numbness and tingling in the hands and feet (peripheral neuropathy)
- Reversible decrease in semen production
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE SALOFALK 1000mg GRANULES
Keep out of the reach and sight of children.
Do not use Salofalk granules after the expiry date which is stated on the carton and the sachet. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
Further Information
What Salofalk 1000mg granules contain
The active substance in Salofalk 1000mg granules is mesalazine and one sachet of Salofalk 1000mg granules contains 1000 mg mesalazine.
The other ingredients are aspartame (E 951); carmellose sodium; cellulose, microcrystalline; citric acid, anhydrous; silica, colloidal anhydrous; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate dispersion 40 per cent (Eudragit NE 40 D containing 2 per cent nonoxynol 100); povidone K 25; simeticone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavour (containing propylene glycol).
What Salofalk 1000mg granules look like and contents of the pack
Salofalk 1000mg granules are rod-shaped or round, grey-white granules.
Salofalk 1000mg granules are available in packs of 20,50,60, 100 and 150 sachets.
Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
www.drfalkpharma.de
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark, Finland, Germany, Great Britain, Greece, Ireland, The Netherlands, Norway, Portugal, Slovenia, Sweden and Spain: Salofalk
Belgium, Luxembourg: Colitofalk
Austria: Mesagran.
This leaflet was last approved in May 2010
1042800
GB-IE/06.10
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