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SALOFALK 1000 mg. 100 sachets

Product Code: SALOFALK 1000 mg. 100 sachets
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SALOFALK 1000 mg. 100 sachets

What are Salofalk 1000 mg granules and what it is used
Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk 1000 mg granules are used for:
treatment of acute conditions and preventing future episodes (recurrence) of an inflammatory disease limited to the colon (colon), known to physicians as ulcerative colitis.

2. What you need to know before taking Salofalk 1000 mg granules
Do not take Salofalk granules:
if you are allergic to mesalazine, salicylic acid, to salicylates such as aspirin or any of the other ingredients of this medicine (listed in section 6);
if you have a serious disease of the liver or kidneys.
Warnings and Precautions
Talk to your doctor before taking Salofalk 1000 mg granules:
if you have a history of lung problems, particularly if you suffer from asthma;
if you have a history of allergy to sulfasalazine, a substance similar to mesalazine;
if you have liver problems;
if you have kidney problems.
Additional Warnings
During treatment, your doctor may require close medical monitoring of your condition and may you need to conduct regular blood tests and urine.

Other medicines and Salofalk granules
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. In particular:
azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat disorders of the immune system);
some agents that inhibit blood clotting (medicines for thrombosis / thrombus or blood thinners, eg. warfarin);
lactulose (a drug used to treat constipation) or other drugs that can change the acidity of the faeces.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is possible in this case you can use Salofalk granules, if your doctor considers.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
During pregnancy you should use Salofalk granules only if your doctor has advised you to do so.
During the period of lactation you should use Salofalk granules only if your doctor has advised you to do it, because this medicine can pass into breast milk.

Driving and using machines
Salofalk granules do not affect or negligible influence on the ability to drive or operate machinery.

Salofalk 1000 mg granules contain aspartame and sucrose
This medicine contains aspartame as a sweetener. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet Salofalk 1000 mg granules contains the equivalent of 1,12 mg phenylalanine.
One sachet contains 0,04 mg sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Salofalk 1000 mg granules
Always take Salofalk granules exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.

Method of administration
Salofalk granules are for oral administration (oral administration). Salofalk granules should not be chewed. You should take Salofalk granules by placing them directly on the tongue and then swallow them whole with very liquid, without chewing.

Age and body weight Single dose Total daily dose
Adults, old people and children weighing more than 40 kg

Treatment of acute conditions
3 sachets Salofalk 1000 mg granules 1 x 3 or 3 sachets x 1 sachet
Prevention of future episodes (for patients at increased risk for relapse) 3 sachets Salofalk 1000 mg granules 1 x 3 sachets
Children aged 6 years and older
Treatment of acute conditions 30-50 mg mesalazine / kg of body weight per day, 1 time per day or in divided doses
Prevention of future episodes 15-30 mg mesalazine / kg of body weight per day, in divided doses
Adults and the elderly
Unless otherwise prescribed by your doctor, the usual dosage for the treatment of acute ulcerative colitis is:
Depending on the clinical requirements in individual cases, once a day, preferably in the morning, be taken 3 sachets Salofalk 1000 mg pellets (equivalent to 3 g mesalazine per day) or 1 sachet Salofalk 1000 mg pellets, three times daily (morning, noon and evening).
For prevention of recurrence of ulcerative colitis:
The usual dose for preventing future episodes of ulcerative colitis is:
1 sachet Salofalk 500 mg pellets, three times daily (equivalent to 1,5 g mesalazine per day).
If in the opinion of your doctor you are at increased risk for relapse, the dosage for the prevention of future episodes of ulcerative colitis is:
3 sachets Salofalk 1000 mg granules once a day, preferably in the morning (equivalent to 3 g mesalazine per day).
Use in children
There is only limited data on the effects in children (aged 6-18 years).

Children aged 6 years and older
Please ask your doctor for the correct dosage of Salofalk granules for your child.
In acute conditions, to determine the individual dosage, starting with 30-50 mg mesalazine per kilogram of body weight per day, which should be given once a day, preferably in the morning or in divided doses. The maximum dose is 75 mg mesalazine per kilogram of body weight per day. The total dose should not exceed the maximum adult dose.
To prevent relapse, to define individual dosage, starting with 15-30 mg mesalazine per kilogram of body weight per day, which should be given in divided doses.
The total dose should not exceed the recommended adult dose.
It is generally recommended in body weight up to 40 kg is applied to one half of the adult dose, and a body weight exceeding 40 kg, - the normal adult dose.

Duration of treatment
Your doctor will determine how long you should continue treatment with this medicine. This will depend on your condition.
To get maximum benefit from treatment with this medicine, you should take Salofalk granules regularly and consistently both during the acute inflammatory conditions, and in long term treatment as prescribed.
If you think Salofalk granules are too strong or too weak, talk to your doctor.

If you take more dose Salofalk granules
If in doubt, contact your doctor so that he / she can decide what should be done.
If you used it once more than the amount Salofalk granules just take your next dose as prescribed.
Do not use less quantity.

If you forget to take Salofalk granules
Do not take a double dose to make up the missed dose.

If you stop taking Salofalk granules
Do not stop taking this product until you consult 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 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 experience any of these symptoms after taking this medicine, you should immediately contact your doctor:
allergic skin rash;
difficulty breathing.
If you feel a marked decline in general health, especially if accompanied by fever and / or sore throat and mouth, stop using these granules and contact your doctor immediately.
These symptoms can, very rarely, be due to a strong reduction in the number of white blood cells (a condition called agranulocytosis), which make you more susceptible to developing serious infection.
A blood test can confirm whether these symptoms are due to the effects of this medicine on your blood.

The following adverse reactions have also been reported by patients using mesalazine:
Rare side effects (may affect up to 1 in 1000 patients):
abdominal pain, diarrhea, flatulence (bloating), nausea and vomiting;
headache, dizziness;
chest pain, shortness of breath or seepage of limbs due to cardiac disorders.
Very rare side effects (may affect up to 1 in 10,000 patients):
changes in kidney function, sometimes with swollen limbs and pain in the groin;
severe abdominal pain due to inflammation of the pancreas;
fever, sore throat, or malaise because of blood dyscrasias;
dyspnea, cough, wheezing, pulmonary shading in radiography due to allergic and / or inflammatory disease of the lungs;
severe diarrhea and abdominal pain because of allergic reaction to this medicine inside the colon;
rash or skin irritation;
muscle and joint pain;
jaundice or abdominal pain because of liver or biliary disorders;
hair loss and baldness;
numbness and tingling in the hands and feet (peripheral neuropathy);
reversible decrease in sperm produced.
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You can also report adverse events directly via:
Drug Agency
str. "Damyan Gruev" № 8
1303 Sofia
website: www.bda.bg
As reported side effects, you can do your bit to obtain more information on the safety of this medicine.

5. How to store Salofalk 1000 mg granules
Keep out of reach of children.
Do not use Salofalk granules after the expiry date stated on the carton and sachet after 'EXP'. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What Salofalk contain 1000 mg granules
The active substance is mesalazine and one sachet of Salofalk 1000 mg 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 (1: 1) (Eudragit L 100); methyl cellulose; polyacrylate dispersion 40% (Eudragit NE 40 D, containing 2% nonoxynol 100); povidone K 25; simethicone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; flavor "with vanilla custard" (containing sucrose).

Look how Salofalk 1000 mg granules and contents of the pack
Salofalk 1000 mg gastro-resistant prolonged-release granules are rod-shaped or round, gray-white granules.
Each sachet contains 1,86 g granules.
Salofalk 1000 mg granules are provided in packs of 20, 50, 60, 100 and 150 sachets.
Not all pack sizes may be marketed.



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