Patient leaflet - SALOFALK 500 MG GASTRO-RESISTANT TABLETS
Salofalk® 500mg gastro-resistant tablets
(mesalazine)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– 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.
The name of your medicine is Salofalk 500mg gastro-resistant tablets but will be referred to as Salofalk tablets throughout the remainder of the leaflet.
What is in this leaflet:
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1. What Salofalk tablets are and what they are used for
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2. What you need to know before you take Salofalk tablets
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3. How to take Salofalk tablets
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4. Possible side effects
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5. How to store Salofalk tablets
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6. Contents of the pack and other information
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1. What Salofalk tablets are and what they are used for
Salofalk tablets contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease.
Salofalk tablets are used for:
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– 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.
2. what you need to know before you take salofalk tablets do not take salofalk tablets:
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– If you are allergic to salicylic acid, to salicylates such as Aspirin or to
any of the other ingredients of this medicine (listed in section 6).
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– If you have a serious liver or kidney disease.
Warnings and precautions
Talk to your doctor before taking Salofalk tablets:
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– If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma.
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– If you have a history of allergy to sulphasalazine, a substance related to mesalazine.
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– If you suffer with problems of your liver.
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– If you suffer with problems of your kidney.
Further precautions
During treatment your doctor may want to keep you under close medical supervision and you may need to have regular blood and urine tests.
In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileo-coecal area with removal of the ileocoecal valve, it has been observed that Salofalk tablets are excreted undissolved in the stool, due to an excessively rapid passage through the bowel. If you notice this occurrence in your own case, please inform your doctor.
Other medicines and Salofalk tablets
Tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):
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- Certain medicines that affect blood clotting (medicines for thrombosis or to thin your blood, e.g., warfarin)
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- Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk tablets and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
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 taking this medicine.
You should only use Salofalk tablets during pregnancy if your doctor tells you to.
You should also only use Salofalk tablets during breast-feeding if your doctor tells you to, as this the medicine may pass into breast milk.
Driving and using machines
Salofalk tablets have no or negligible influence on the ability to drive or use machines.
Salofalk tablets contain sodium
One Salofalk tablet contains 2.1 mmol (49 mg) sodium. If you need to be on a controlled sodium salt diet, you should take this into consideration.
3. how to take salofalk tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Method of administration
Salofalk tablets are for oral use only.
Take the tablets in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed, and taken with plenty of fluid.
Dosage
Adults and the elderly
| Ulcerative colitis | ||
| Acute episode | Prevention of recurrence/long-term treatment | |
| Mesalazine (active substance) |
3.0 g | |
| Salofalk 500mg gastro-resistant tablets | 3 × 1 to 3 × 2 | 3 × 1 |
Use in children
There is only limited documentation for an effect in children (age 6–18 years).
Children 6 years of age and older
Please ask your doctor about the precise dosage of Salofalk tablets 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 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 with15–30 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 tablets 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 tablets is too strong or too weak, talk to your doctor.
If you take more Salofalk tablets 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 tablets on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
If you forget to take Salofalk tablets
Do not take a larger than normal dose of Salofalk tablets next time but continue treatment at the prescribed dosage.
If you stop taking Salofalk tablets
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.
4. possible side effects
Like all medicines, Salofalk tablets 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:
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- Allergic skin rash
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- Fever
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- Breathing difficulties
If you experience a marked reduction of your general health, especially if accompanied by fever, and/or a sore throat and mouth, stop using these tablets and contact your doctor immediately. These symptoms can, very rarely, be due to a fall in the number of white cells in your blood (a condition called agranulocytosis) which may make you more prone to developing a serious infection. A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood.
The following side effects have also been reported by patients using mesalazine:
Rare: may affect up to 1 in 1,000 people
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– Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting
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– Headache, dizziness
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– Chest pain, breathlessness or swollen limbs because of an effect on your heart.
Very rare: may affect up to 1 in 10,000 people
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– Changes in kidney function, sometimes with swollen limbs or flank
pain
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– Severe abdominal pain because of acute inflammation of the
pancreas
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– Fever, sore throat or malaise because of blood count changes
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– Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions.
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– Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel
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– Skin rash or inflammation
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– Muscle and joint pain
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– Jaundice or abdominal pain because of liver and bile flow disorders – Hair loss and the development of baldness
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– Numbness and tingling in the hands and feet (peripheral neuropathy)
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– Reversible decrease in semen production
5. how to store salofalk tablets
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use the tablets after the expiry date that is printed on the label after “Exp.” The expiry date refers to the last day of that month.
If you notice any sign of deterioration or discolouration of the tablets, please consult your pharmacist immediately.
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.
6. contents of the pack and other information what salofalk tablets contain
The active substance is mesalazine. Each tablet contains 500mg mesalazine.
The other ingredients are:
Calcium stearate; cellulose, microcrystalline; croscarmellose sodium; basic butylated methylacrylate copolymer (=Eudragit E); methacrylic acid-methyl methacrylate copolymer (1:1) (=Eudragit L 100); glycine; silica, colloidal anhydrous; hypromellose; macrogol 6000; sodium carbonate, anhydrous; povidone K25; talc; colouring agents: titanium dioxide (E 171); iron oxide yellow (E 172)
What Salofalk tablets look like and contents of the pack
Salofalk tablets are oval, light yellow to ochre, gastro-resistant tablets, matt with smooth surface; they are not scored.
Salofalk tablets are available in blister packs of 100 tablets.
Manufactured by Dr.Falk Pharma GmbH. Leinenweberstrasse 5, 79108 Freiburg, Germany. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester M28 3PT.
PL 20774/1834 POM
This leaflet was last revised on 15th March 2021
Salofalk is a registered trademark of Dr Falk Pharma GmbH.
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Is this leaflet hard to see or read? Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471 269
L-01–1834–01