Salofalk

Salofalk

mesalazine

Manufacturer:

Dr Falk

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

A. Menarini
Full Prescribing Info
Contents
Mesalazine.
Description
Gastro-resistant tab: One tablet of Salofalk tablets contains 250 mg or 500 mg mesalazine.
PR granules: 1000 mg: One sachet of Salofalk 1000mg granules contains 1000 mg mesalazine.
One sachet contains 1.86 g granules.
3 g: One sachet of Salofalk 3g granules contains 3 g mesalazine.
Each sachet contains 5.58 g granules.
Enema: One enema of Salofalk 4g/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 anhydrous, talcum, titanium dioxide (E171).
PR granules: Aspartame (E 951), carmellose sodium, microcrystalline cellulose, anhydrous citric acid, colloidal anhydrous silica, hypromellose, magnesium stearate, methacyrlic acid-methyl methacrylate copolymer (1:1) (MW: approx. 135,000) (Eudragit L 100), methylcellulose, polyacrylate dispersion 40 % (Eudagrit NE 40 D containing 2 % nonoxynol 100), povidone K 25, 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.
500 mg: Hard fat, docusate sodium and cetyl alcohol.
Action
Salofalk contains the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.
Indications/Uses
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 by doctors 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 by doctors 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 by doctors as ulcerative colitis.
500 mg: The treatment of acute episodes of a chronic inflammatory disease limited to the rectum (back passage) known by doctors as ulcerative colitis.
Dosage/Direction for Use
Always take/use this medicine exactly as advised by the doctor or pharmacist. Check with the doctor or pharmacist if not sure.
Use in children: There is little experience and only limited documentation for an effect in children (age 6-18 years).
Duration of treatment: The doctor will decide how long the patient should continue taking/using the medication. The duration depends on the patient's condition.
The patient should follow the treatment 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.
If the patient thinks that the effect of Salofalk is too strong or too weak, he/she should talk to the doctor.
If the patient forgets to take/use Salofalk: Do not take/use a larger than normal dose of Salofalk next time, but continue treatment at the prescribed dosage.
If the patient stops taking/using Salofalk: Do not stop taking/using this product until instructed by the doctor.
If the patient has any further questions on the use of this medicine, he/she should ask the doctor or pharmacist.
Adults and elderly: Gastro-resistant tab: Unless otherwise prescribed by the doctor, the normal daily doses of Salofalk tablets are: See Table 1.

Click on icon to see table/diagram/image

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 1000mg granules (equivalent to 3 g mesalazine per day) or 1 sachet of Salofalk 3g 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) or 1 sachet of Salofalk 3g 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 4g/60ml 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 250mg or 1 Salofalk 500mg 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 250mg suppository into the rectum 3 times daily (equivalent to 750 mg mesalazine daily).
Children 6 years of age and older: Please ask the doctor about the precise dosage of Salofalk for the child.
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 500mg tablets and the dosage recommendations, Salofalk 250mg gastro-resistant tablets should preferably be used in children.
Gastro-resistant PR granules: 3 g: Due to their high content in active substance, Salofalk 3g granules are not suitable for children weighing less than 40kg. Please use Salofalk 500mg granules or 1000mg instead.
1000 mg: 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.
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.
Gastro-resistant PR granules: Salofalk granules are for oral use only.
Salofalk granules should not be chewed. The patient 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, 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.
Gastro-resistant PR granules: See Table 2.

Click on icon to see table/diagram/image
Overdosage
If the patient takes/uses more Salofalk than he/she should, the patient should contact a doctor if in doubt, so that the doctor can decide what to do.
If the patient uses too much Salofalk on one occasion, he/she should just take the next dose as prescribed. Do not use a smaller amount.
Contraindications
Do not take/use Salofalk: If the patient is or has been told to be hypersensitive (allergic) to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of this medicine listed in Description.
If the patient has a serious liver or kidney disease.
Special Precautions
Take special care with Salofalk.
Before the patient starts taking/using this medicine, the doctor should know: If the patient has a history of problems with the lungs, particularly if suffering from bronchial asthma; If the patient has a history of allergy to sulphasalazine, a substance related to mesalazine; If the patient suffers with problems of the liver; If the patient suffers with problems of the kidney.
Further precautions: During treatment, the doctor may want to keep the patient under close medical supervision, and the patient 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. If the patient notices this occurrence in their own case, please inform the doctor.
Driving and using machines: There are no effects on the ability to drive and use machines.
Gastro-resistant tab: Salofalk tablets contain sodium: One Salofalk 250 mg tablet contains 2.1 mmol (48 mg) sodium.
One Salofalk 500 mg tablet contains 2.1 mmol (49 mg) sodium.
If the patient needs to be on a controlled sodium salt diet, the patient should take this into consideration.
Gastro-resistant PR granules: This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if the patient suffers from phenylketonuria.
1000 mg: One sachet of Salofalk 1000mg granules contains the equivalent of 1.12 mg phenylalanine.
This medicine contains the sucrose. One sachet contains 0.04 mg sucrose.
3 g: One sachet of Salofalk 3g granules contains the equivalent of 3.36 mg phenylalanine.
One sachet contains 0.12 mg sucrose.
If the patient has an intolerance to some sugars, the patient should contact the doctor before taking this medicinal product.
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 contains cetyl alcohol: Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis).
Use In Pregnancy & Lactation
Ask the doctor or pharmacist for advice before taking any medicine.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she should ask the doctor or pharmacist for advice before using this medicine.
The patient should only use Salofalk during pregnancy if advised by the doctor.
The patient should only use Salofalk during breast-feeding if advised by the doctor, as this medicine and its metabolites may pass into breast milk.
Side Effects
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. If the patient gets any of the following symptoms after taking this medicine, the patient should contact the doctor immediately: Allergic skin rash; Fever; Breathing difficulties.
If the patient experiences a marked reduction of general state of health, especially if accompanied by fever and/or a sore throat and mouth, the patient should stop using Salofalk and contact the doctor immediately.
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.
The following side effects have also been reported by patients using mesalazine: Rare side effects (that affect less than 1 in 1,000 patients): Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting; Headache, dizziness; Chest pain, breathlessness or swollen limbs because of an effect on the heart.
Gastro-resistant tab/PR granules/Supp: Increased sensitivity of the skin to sun and ultraviolet light (photosensitivity).
Very rare side effects (that affect less than 1 in 10,000 patients): Changes in kidney function, sometimes with swollen limbs or flank pain; Severe abdominal pain because of acute inflammation of the pancreas; 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; Skin rash or inflammation; Muscle and joint pain; 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 side effects occur, the patient should talk to the doctor or pharmacist. This includes any possible side effects not previously listed.
Drug Interactions
Please tell the doctor if the patient is taking or using any of the medicines mentioned as follows, as the effects of these medicines may change (interactions): 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).
Please tell the doctor or pharmacist if the patient is taking/using, has recently taken/used or might take/use any other medicines. It may still be all right for the patient to use Salofalk and the doctor will be able to decide what is suitable for the patient.
Gastro-resistant PR granules: Lactulose (medicine used to treat constipation) or other preparations that can change the acidity of the stools.
Caution For Usage
Gastro-resistant PR granules/Supp: Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist 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, please 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.
Storage
Gastro-resistant tab: Do not store above 25°C.
Gastro-resistant PR granules: 3 g: 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.
ATC Classification
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Presentation/Packing
Gastro-resistant tab 250 mg x 100's. 500 mg x 100's. Gastro-resistant PR granules (rod-shaped or round, grey-white) 1,000 mg x 50's. 3 g x 30's. Enema 4 g/60 mL (cream-coloured to light, pale-brown homogeneous suspension) x 7's. Supp (white to cream-coloured, torpedo-shaped) 250 mg x 30's. 500 mg x 30's.
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