Salofalk

Gastro-resistant prolonged-release granules: Salofalk 1000mg granules are stick-formed or round, grey-white granules. Each sachet contains 1.86 g granules.
One sachet of Salofalk 1000mg granules contains 1000 mg mesalazine.
Enema: Salofalk 4g/60ml rectal suspension is a very light tan to brown homogeneous suspension, free from foreign matter. It is contained in a white, opaque plastic bottle with a lubricated applicator.
One enema of Salofalk 4g/60ml enemas (= 60 g suspension) contains 4 g mesalazine.
Suppository: Salofalk 250mg Suppositories are white to cream-coloured, torpedo-shaped suppositories.
One suppository contains 250 mg mesalazine.
Excipients/Inactive Ingredients: Gastro-resistant prolonged-release granules: The other ingredients are aspartame (E 951), carmellose sodium, cellulose microcrystalline, citric acid, colloidal anhydrous silica, hypromellose, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methylcellulose, polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% nonoxynol), povidone, simethicone, sorbic acid, talc, titanium dioxide (E 171), triethyl citrate, vanilla custard flavour (containing sucrose).
Enema: The other excipients are: Carbomer 974P, potassium acetate, potassium metabisulphite (E 224), sodium benzoate (E 211), disodium edetate, purified water, xanthan gum.
Suppository: The other excipient is hard fat.

Salofalk contains the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Gastro-resistant prolonged-release granules: Salofalk 1000mg granules are used for the treatment of acute episodes and prevention of further episodes (recurrence) of mild to moderate ulcerative colitis.
Enema: Salofalk 4g/60ml enemas are used for the treatment of ulcerative colitis. It may be used alone or, particularly in the acute phase, with corticosteroids.
Suppository: Salofalk 250mg Suppositories are used for the treatment of acute episodes and prevention of further episodes (recurrence) of chronic ulcerative colitis.

Patients should always use Salofalk exactly as prescribed. Patients should check with their doctor or pharmacist if they are unsure.
Patients who think that the effect of Salofalk is too strong or too weak should talk to their doctor or pharmacist.
Patients who forget to use Salofalk should not use a double dose to make up for a forgotten dose.
Patients should not stop using this product until they have talked to their doctor.
Method of administration: Gastro-resistant prolonged-release granules: Salofalk granules are for oral use only.
Salofalk granules should not be chewed. Patients should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing.
Enema: This medicine may only be used rectally. It is not intended to be taken by mouth. Do not swallow. Salofalk 4g/60ml Enema should be administered preferably at bedtime.
Patients should empty their bowels if necessary and wash their hands.
The bottle should be shaken for at least 30 seconds, then the protective cap removed from the applicator, and the bottle held by its upper end.
Patients should lie down on their left side with their left leg outstretched and their right leg bent.
The applicator, which is coated with a lubricant for easy insertion, should be inserted into the rectum, the bottle being held pointed towards the navel.
Whilst holding the bottle tightly, it should be squeezed slowly.
The applicator should be removed from the rectum when the bottle is empty but this position should be maintained for at least 30 minutes to allow the enema to spread throughout the lower part of the large intestine.
Patients should wash their hands again and try not to empty their bowels again until the next morning.
Suppository: This medicine may only be used rectally. It is not intended to be taken by mouth. Do not swallow.
Dosage: Gastro-resistant prolonged-release granules: See table.

Click on icon to see table/diagram/image

Adults and the elderly: Unless otherwise prescribed by the doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is, depending on the clinical requirements in the individual case, 3 sachets of Salofalk 1000mg granules (equivalent to 3 g mesalazine per day) once daily preferably in the morning or 1 sachet of Salofalk 1000mg granules three times daily (in the morning, at midday, in the evening).
To prevent a relapse of ulcerative colitis, the normal dosage to prevent further episodes of ulcerative colitis is 1 sachet of Salofalk 500mg granules three times daily (equivalent to 1.5 g mesalazine per day). If upon the decision of the doctor the patient is at increased risk for recurrence, the dosage for prevention of further episodes of ulcerative colitis is 3 sachets of Salofalk 1000mg granules once daily preferably in the morning (equivalent to 3 g mesalazine per day).
Use in children: There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older: The doctor will advise the precise dosage of Salofalk granules for the 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: The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The doctor will decide how long patients need to continue the treatment with this medicine. This will depend on the patient's condition.
To obtain the maximum benefit from this medicine, patients should use Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, as directed.
Enema: Adults and the elderly: Unless otherwise prescribed by the doctor, the recommended dose for the treatment of acute episodes of ulcerative colitis is one enema a day to be used at bedtime.
Use in children and adolescents: There is little experience and information about the effect of this medicine when used in children.
Duration of treatment: The duration of use depends upon the condition. The doctor will decide how long patients are to continue the medication.
Patients should follow the treatment with Salofalk 4g/60ml enemas regularly and consistently, because this is the only way to achieve the desired therapeutic effect.
Suppository: Adults and the elderly: For the treatment of acute symptoms of inflammation, insert 2 Salofalk 250mg Suppositories into the rectum 3 times daily (in the morning, at midday and at bedtime) (equivalent to 1500 mg mesalazine daily).
In long-term treatment to prevent recurrences, insert 1 Salofalk 250mg suppository into the rectum 3 times daily (equivalent to 750 mg mesalazine daily).
Use in children: There is little experience and only limited documentation for an effect in children.
Duration of treatment: The doctor will decide how long patients need to continue the treatment with this medicine. The duration of use depends upon the nature, severity and progression of the condition.
Patients should follow the treatment with Salofalk 250mg Suppositories regularly and consistently, because this is the only way to achieve the desired therapeutic effect.

Patients who are in doubt should contact a doctor if they have used more Salofalk than they should.
Patients who use too much Salofalk on one occasion should just use the next dose as prescribed. A smaller amount should not be used.

Salofalk should not be used in: patients who are allergic to mesalazine, to salicylic acid, to salicylates such as acetylsalicylic acid (e.g., Aspirin) or to any of the other ingredients of this medicine (listed in Description); patients who have a serious liver or kidney disease.

Before using Salofalk: Caution should be exercised in patients who have a history of lung problems, particularly those suffering from bronchial asthma; who have a history of allergy to sulphasalazine; who suffer with liver problems; who suffer with kidney problems; who have ever developed a severe skin rash or skin peeling, blistering &/or mouth sores after using mesalazine.
Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.
Further precautions: During treatment, patients may be kept under close medical supervision, and regular blood and urine tests may need to be performed.
Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Patients should take care to drink sufficient amounts of liquid during treatment with mesalazine.
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Patients should stop using mesalazine and seek medical attention immediately if they notice any of the symptoms related to these serious skin reactions described in Side Effects.
Driving and using machines: Salofalk has no or negligible influence on the ability to drive and use machines.
Gastro-resistant prolonged-release granules: Aspartame, sucrose and sodium: This medicine contains 2 mg aspartame in each sachet of Salofalk 1000mg granules. Aspartame is a source of phenylalanine. It may be harmful in patients who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Salofalk 1000mg granules contain sucrose. Patients who have been told by their doctor that they have an intolerance to some sugars should contact their doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodium-free'.
Enema: Potassium metabisulphite and sodium benzoate: Salofalk 4g/60ml enemas contain potassium metabisulphite. Potassium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicinal product contains 60 mg sodium benzoate in each enema. Sodium benzoate may cause local irritation.

Patients who are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby should ask their doctor or pharmacist for advice before using this medicine.
Patients should only use Salofalk during pregnancy if their doctor tells them to.
Patients should only use Salofalk during breast-feeding if their doctor tells them to, as this medicine and its metabolites may pass into breast milk.

Like all medicines, Salofalk can cause side effects, although not everybody gets them.
Patients who get any side effects should talk to their doctor or pharmacist. This includes any possible side effects not listed as follows. By reporting side effects, patients can help provide more information on the safety of this medicine.
Healthcare professionals are asked to report any suspected adverse reactions according to the guidelines issued by the local health authority.
Patients who get any of the following symptoms after taking this medicine should contact their doctor and stop using Salofalk immediately.
General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties or a general inflammation of the large bowel (causing severe diarrhoea and abdominal pain). These reactions are very rare.
A marked reduction of general health, especially if accompanied by fever, and/or a sore throat and mouth. These symptoms can, very rarely, be due to a fall in the number of white cells in the blood, which may make patients more prone to developing a serious infection (agranulocytosis). Other cells of the blood may also be affected (e.g. platelets or red cells causing aplastic anaemia or thrombocytopenia) and cause symptoms which may include unexplained bleeding, purple spots or patches under the skin, anaemia (feeling tired, weak and looking pale, especially on lips and nails). A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
Serious skin rashes with reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
Shortness of breath, chest pain or irregular heartbeat, or swollen limbs which may be indicative of cardiac hypersensitivity reactions. These reactions are rare.
Problems with kidney function (can occur very rarely), e.g. a change in the colour or amount of urine produced and swollen limbs or a sudden flank pain (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).
The following side effects have also been reported by patients using mesalazine.
Gastro-resistant prolonged-release granules: Common side effects (may affect up to 1 in 10 people): Headache; Rash, itching.
Uncommon side effects (may affect up to 1 in 100 people): Abdominal pain, diarrhoea, dyspepsia, flatulence, nausea, vomiting; Severe abdominal pain because of acute inflammation of the pancreas; Changes in liver function parameters, changes in pancreatic enzymes.
Rare side effects (may affect up to 1 in 1,000 people): Dizziness; Jaundice or abdominal pain because of liver and bile flow disorders; Photosensitivity; Joint pain; Feeling weak or tired.
Very rare side effects (may affect up to 1 in 10,000 people): Peripheral neuropathy; Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions; Hair loss and the development of baldness; Muscle pain; Reversible decrease in semen production.
Enema/Suppository: Common side effects (may affect up to 1 in 10 people): Rash, itching.
Rare side effects (may affect up to 1 in 1,000 people): Abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation; Headache, dizziness; Photosensitivity.
Very rare side effects (may affect up to 1 in 10,000 people): Severe abdominal pain because of acute inflammation of the pancreas; Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions; Muscle and joint pain; Jaundice or abdominal pain because of liver and bile flow disorders; Hair loss and the development of baldness; Peripheral neuropathy; Reversible decrease in semen production.

Patients should tell their doctor if they take or use any of the following medicines as the effects of these medicines may change: Azathioprine, 6-mercaptopurine or thioguanine; Certain agents that inhibit blood clotting (e.g. warfarin).
Patients should tell their doctor or pharmacist if they are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription. Treatment with Salofalk may still be indicated. The doctor will decide what is suitable for the patient.
Gastro-resistant prolonged-release granules: Patients should tell their doctor or pharmacist if they are taking, have recently taken or might take any other medicines, in particular: Lactulose or other preparations that can change the acidity of stools.

Gastro-resistant prolonged-release granules: Any medicines should not be thrown away via wastewater or household waste. Patients should ask their pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Gastro-resistant prolonged-release granules: Store at or below 30°C.
Enema: Do not store above 30°C. Store in the original sealed blister packs in order to protect from light.
Suppository: Do not store above 25°C. Store in the original container in order to protect contents from light.

GIT Regulators, Antiflatulents & Anti-Inflammatories

A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.

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