Salofalk

Mesalazine.

Gastro-resistant tab: One tablet of Salofalk tablets contains 250 mg or 500 mg mesalazine.
PR granules: Salofalk 1000 mg granules are stick-formed or round, grey-white granules.
Each sachet contains 1.86 g granules.
Enema: One enema of Salofalk 4 g/60 ml enemas (=60 g suspension) contains 4 g mesalazine.
Supp: One suppository contains 250 mg or 500 mg mesalazine.
Excipients/Inactive Ingredients: Gastro-resistant tab: 250 mg: Eudragit E, calcium stearate, glycine, iron oxide yellow (E172), hydroxypropyl methylcellulose, macrogol 6000, Eudragit L 100, cellulose microcrystalline, poly (vinyl-2-pyrollidone) K25, silica colloidal anhydrous, sodium carbonate anhydrous, talcum, titanium dioxide (E171).
500 mg: Butylmethacrylate-co-(2-dimethyl-aminoethyl)-methacrylate-methylmethacrylate copolymer (1:2:1), calcium stearate, croscarmellose sodium, glycine, Iron oxide yellow (E 172), hypromellose, macrogol 6000, methacrylic acid-methyl methacrylate copolymer (1:1), cellulose microcrystalline, povidone K25, silica colloidal anhydrous, sodium carbonate, talcum, titanium dioxide (E171).
PR granules: Aspartame (E 951), carmellose sodium, cellulose microcrystalline, citric acid, silica, colloidal anhydrous, 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: Carbomer 974P, potassium acetate, potassium metabisulphite (E 224), sodium benzoate (E 211), disodium edetate, water, purified, xanthan gum.
Supp: 250 mg: Hard fat.

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

Salofalk is used for: Gastro-resistant tab/PR granules: The treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known as ulcerative colitis.
Gastro-resistant tab: The treatment of acute episodes of Crohn's disease (a chronic inflammatory bowel disease).
Enema: The treatment of acute episodes of an inflammatory disease known as ulcerative colitis. Ulcerative colitis is an inflammatory disease of the large bowel.
Supp: 250 mg: The treatment of acute episodes and prevention of further episodes (recurrence) of a chronic inflammatory disease limited to the rectum (back passage) known as ulcerative colitis.

Always take/use this medicine exactly as advised.
Use in children: There is little experience and only limited documentation for an effect in children (age 6-18 years).
Duration of treatment: This medication should be taken exactly as prescribed. The duration depends on the patient's condition.
Treatment should be followed with Salofalk regularly and consistently, both during the acute episode of inflammation and also as long-term treatment, because this is the only way the desired therapeutic effect can be achieved.
Patients should seek medical advice if the effect of Salofalk is too strong or too weak.
Gastro-resistant PR granules: The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The doctor will decide how long patient needs to continue the treatment with this medicine. This will depend on the patient's condition.
To obtain the maximum benefit from this medicine, patient should use Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, as directed.
If the patient thinks that the Salofalk granules are too strong or too weak, consult a doctor.
Forgotten intake of Salofalk: Do not take/use a larger than normal dose of Salofalk next time, but continue treatment at the prescribed dosage.
Stopping intake of Salofalk: Do not stop taking/using this product until instructed by the doctor.
The recommended dose is: Adults and elderly: Gastro-resistant tab: Unless otherwise prescribed by the doctor, the normal daily doses of mesalazine (the active substance of Salofalk) or Salofalk tablets are: See Table 1.

Click on icon to see table/diagram/image

Gastro-resistant tab 250 mg: For dosage recommendations above 1.5 g mesalazine per day, Salofalk 500 mg tablets should preferably be used.
Gastro-resistant PR granules: 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 1000 mg granules (equivalent to 3 g mesalazine per day) once daily preferably in the morning, or 1 sachet of Salofalk 1000 mg 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 500 mg 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 1000 mg granules once daily preferably in the morning (equivalent to 3 g mesalazine per day).
Enema: If the patient has acute signs of inflammation use 1 Salofalk 4 g/60 ml enema (=60 g suspension, equivalent of 4 g mesalazine per day) once daily.
Supp: For the treatment of acute symptoms of inflammation, insert 2 Salofalk 250 mg or 1 Salofalk 500 mg suppository 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 250 mg suppository into the rectum 3 times daily (equivalent to 750 mg mesalazine daily).
Children 6 years of age and older: 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.
Gastro-resistant tab: The dosage depends on how severe the condition is and on the child's body weight.
In acute episodes: To be determined individually, starting with 30-50 mg 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 (ulcerative colitis): To be determined individually, starting with 15-30 mg per kg body weight per day that should be given in divided doses. The total dose should not exceed the recommended adult dose.
Due to the size of Salofalk 500 mg tablets and the dosage recommendations, Salofalk 250 mg gastro-resistant tablets should preferably be used in children.
Gastro-resistant PR granules: 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.
Method of administration: Gastro-resistant tab: 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.
Enema: This medicine may only be used rectally, so it has to be inserted through the anus. It is not intended to be taken by mouth. Do not swallow.
Administer the contents of one enema bottle into the bowel as an enema in the evening before bedtime.
Supp: This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take by mouth. Do not swallow.
Gastro-resistant PR granules: Salofalk granules are for oral use only.
Salofalk granules should not be chewed. The Salofalk granules should be taken by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing. (See Table 2.)

Click on icon to see table/diagram/image

Patients should seek medical attention immediately if too many Salofalk may have been taken.
Take the next dose as prescribed if too much Salofalk was taken on one occasion. Do not use a smaller amount.

Salofalk should not be taken by: Patients who are: hypersensitive/allergic to mesalazine, to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of this medicine (listed in Description).
Patients who have serious liver or kidney disease.

Take special care with Salofalk.
Before taking Salofalk, caution should be exercised in case of: History of problems with the lungs, particularly if suffering from bronchial asthma; History of allergy to sulphasalazine, a substance related to mesalazine; Any liver problems; Any kidney problems.
Gastro-resistant tab 500 mg/PR granules/Supp: Severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.
Gastro-resistant tab 500 mg/PR granules: 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, the patient may be kept under close medical supervision, and may need to have regular blood and urine tests.
Gastro-resistant tab: In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileocoecal 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. Patients should seek medical attention if one notice this occurrence.
Gastro-resistant tab 500 mg/PR granules/Supp: Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. It is advised to drink sufficient amount of liquid during treatment with mesalazine.
Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS) (Gastro-resistant tab 500 mg), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Mesalazine should be stopped, and patients should seek medical attention if one notice any of the symptoms related to these serious skin reactions described in Side Effects.
Driving and using machines: There are no effects or negligible influence on the ability to drive and use machines.
Gastro-resistant tab: Salofalk tablets contain sodium: 250 mg: One Salofalk 250 mg tablet contains 2.1 mmol (48 mg) sodium. Take this into consideration if patient needs to be on a controlled sodium salt diet.
500 mg: The maximum recommended daily dose of this medicinal product contains 441 mg sodium (found in table salt). This is equivalent to 22% of the adult recommended maximum daily dietary intake for sodium. Caution should be exercised if there is a need for 7 or more Salofalk 500mg tablets daily for a prolonged period, especially if it is advised to follow a low salt (sodium) diet.
Gastro-resistant PR granules: Salofalk 1000 mg granules contain aspartame, sucrose and sodium.
This medicine contains 2 mg aspartame in each sachet of Salofalk 1000 mg granules. Aspartame is a source of phenylalanine. It may be harmful if patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
If the patient has an intolerance to some sugars, contact a 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: Salofalk 4g/60ml enemas contain potassium metabisulphite and sodium benzoate: This medicine contains potassium metabisulphite. It may therefore cause allergic reactions like allergic shock and bronchial constriction (bronchospasm) particularly if the patient suffers from asthma or have a history of allergies.
Salofalk 4g/60ml enemas also contain sodium benzoate which may provoke hypersensitivity reactions like irritation of the skin, eyes and mucous membranes.
Supp: 500 mg: Salofalk 500mg Suppositories contain cetyl alcohol: Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis).

Medical advice may be needed in case of pregnancy or breast-feeding, possible pregnancy or planning to have a baby.
Salofalk should only be taken during pregnancy as prescribed.
Salofalk should only be taken during breast-feeding as prescribed, as this medicine and its metabolites may pass into breast milk.

Like all medicines, Salofalk can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Patients should seek medical attention immediately in any case of: Allergic skin rash; Fever; Breathing difficulties.
Salofalk should be stopped in any case of a marked reduction of general state of health, especially if accompanied by fever and/or a sore throat and mouth. Urgent medical advice or treatment may be needed.
These symptoms can, very rarely, be due to a fall in the number of white cells in the blood (a condition called agranulocytosis), which may make the patient more prone to developing a serious infection. A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood.
Gastro-resistant tab 500 mg/Supp: Stop using mesalazine and seek medical attention immediately if the patient notices any of the following symptoms: 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 (Gastro-resistant tab 500 mg), fever (Gastro-resistant tab 500 mg) and enlarged lymph nodes (Gastro-resistant tab 500 mg). These serious skin rashes can be preceded by fever and flu-like symptoms.
Gastro-resistant PR granules: If a patient gets any of the following symptoms after taking this medicine, the patient should contact a doctor and stop the intake of Salofalk granules 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 the patient 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 the 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 in patients using medicines containing mesalazine: Common (may affect up to 1 in 10 patients): Gastro-resistant tab 500 mg/PR granules: Headache.
Gastro-resistant PR granules: Rash, itching.
Uncommon (may affect up to 1 in 100 patients): Gastro-resistant tab 500 mg/PR granules: Abdominal pain, diarrhoea, dyspepsia, wind (flatulence), nausea and vomiting; Severe abdominal pain because of acute inflammation of the pancreas; Changes in liver function parameters, changes in pancreatic enzymes.
Gastro-resistant tab 500 mg: Changes in the number of white blood cells.
Rare side effects (may affect up to 1 in 1,000 patients): Dizziness; Chest pain, breathlessness or swollen limbs because of an effect on the heart.
Gastro-resistant tab 250 mg/PR granules/Enema/Supp: Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting; Headache.
Gastro-resistant tab/PR granules/Supp: Increased sensitivity of the skin to sun and ultraviolet light (photosensitivity).
Gastro-resistant tab 500 mg/PR granules: Jaundice or abdominal pain because of liver and bile flow disorders; Joint pain; Feeling weak or tired.
Very rare side effects (may affect up to 1 in 10,000 patients): Changes in kidney function, sometimes with swollen limbs or flank pain; Fever, sore throat or malaise, because of blood count changes; Shortness of breath, cough, wheezing, lung shadow on X-ray due to allergic and/or inflammatory lung conditions; Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel; Hair loss and the development of baldness; Numbness and tingling in the hands and feet (peripheral neuropathy); Reversible decrease in semen production.
Gastro-resistant tab 250 mg/PR granules/Enema/Supp: Severe abdominal pain because of acute inflammation of the pancreas; Skin rash or inflammation; Muscle and joint pain; Jaundice or abdominal pain because of liver and bile flow disorders.
Gastro-resistant tab 500 mg: Skin rash or inflammation, allergic condition which causes joint pain, skin rashes and fever; Muscle pain.
Not known (frequency cannot be estimated from the available data): Gastro-resistant tab 500 mg/Supp: Kidney stones and associated kidney pain (see Precautions).
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed.

Caution should be exercised if any of the following medicines are being taken: Effects of these medicines may change (interactions) with Salofalk: Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders); Certain agents that inhibit blood clotting (medicines for thrombosis or to thin the blood, e.g. warfarin).
Caution should be exercised in patients who are taking/using any other medicines.
Gastro-resistant PR granules: Lactulose (medicine used to treat constipation) or other preparations that can change the acidity of the stools.
Tell a doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right to use Salofalk granules and the doctor will be able to decide what is suitable.

Gastro-resistant PR granules/Supp: Medicines should not be disposed of via wastewater or household waste. Patients should be advised how to dispose of medicines no longer required. These measures will help to protect the environment.
Enema: The best results are achieved if the bowel is emptied before administration of Salofalk 4g/60ml enemas.
Shake well for at least 30 seconds before use to ensure that the suspension is well mixed.
Remove the protective cap. Hold the container upright so that the contents do not spill out.
Lie on the left side with the left leg stretched out and the right knee bent for balance.
Insert the applicator tip, which is covered with a lubricant film, deep into the rectum. Keep the bottle pointed towards the navel.
Tip the bottle slightly downwards and then squeeze it slowly and evenly.
Once the bottle is empty, remove the applicator slowly.
After using Salofalk 4g/60ml enemas, remain in the same position for at least 30 minutes. This enables the medicine to spread evenly through the bowel. For the best results, Salofalk 4g/60ml enemas should be allowed to exert their effects all night.

Gastro-resistant tab: Do not store above 25°C.
Gastro-resistant PR granules: Store at or below 30°C.
Enema: Do not store above 25 °C. Store in the original sealed blister packs in order to protect from light.
Supp: 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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