Salofalk

Salofalk

mesalazine

Manufacturer:

Dr Falk

Distributor:

DCH Auriga
Full Prescribing Info
Contents
Mesalazine.
Description
Gastro-resistant tablet: 1 Salofalk 500 mg gastro-resistant tablet contains 500 mg mesalazine as the therapeutically active substance.
Suppository: Each suppository contains 500 mg mesalazine as the medically active ingredient. Excipient with known effect: cetyl alcohol.
Enema: Each Salofalk 2 g/30 ml enema (= 30 g suspension) contains 2 g mesalazine as the active substance.
Gastro-resistant prolonged release granules: Each sachet of 1.5 g/3 g contains 1.5 g/3 g mesalazine.
Excipients/Inactive Ingredients:
Gastro-resistant tablet: Basic butylated methylacrylate copolymer ((rel. molar mass: approx. 150000)) (=Eudragit E), Calcium stearate, Croscarmellose sodium (only present in Salofalk 500mg Tablets), Glycine, Hydrated iron(III) oxide (E 172), Hypromellose, Macrogol 6000, Methacrylic acid-methyl methacrylate copolymer (1:1) ((rel.molar mass: approx. 135000)) (=Eudragit L), Microcrystalline cellulose, Povidone K25, Silica colloidal anhydrous, Sodium carbonate anhydrous, Talc, Titanium dioxide (E 171).
Suppository: Hard fat; Docusate sodium; Hexadecane-1-ol.
Enema: Carbomer 35 000, potassium acetate, potassium metabisulphite (E 224, max. 0.14 g, equivalent to max. 0.08 g SO2, sodium benzoate (E 211), disodium edetate (Ph.Eur.), water, purified, xanthan gum.
Gastro-resistant prolonged release granules: Aspartame (E 951); Carmellose sodium (Ph.Eur.); Citric acid, anhydrous; Silica, colloidal anhydrous; Hypromellose; Magnesium stearate (Ph.Eur.); Methacrylic acid-methyl methacrylate copolymer (1:1) (Ph.Eur.); ((MW approx. 135000)) (Eudragit L 100); Methylcellulose; Cellulose, microcrystalline; Polyacrylate dispersion 40 % (Eudragit NE 40 D containing 2 % Nonoxynol 100); Povidone K 25; Simeticone; Sorbic acid (Ph.Eur.); Talc; Titanium dioxide (E 171); Triethyl citrate; Vanilla custard flavouring (containing propylene glycol).
Action
Pharmacotherapeutic group: Aminosalicylic acid and similar agents. ATC code: A07EC02.
Pharmacology: Pharmacodynamics: Mechanism of Action: The mechanism of the anti-inflammatory action is unknown. The results of In-vitro studies indicate that inhibition of lipoxygenase may play a role.
Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5-aminosalicylic acid/5-ASA) may also function as a radical scavenger of reactive oxygen compounds.
Mesalazine, orally administered, acts predominantly locally at the gut mucosa and in the submucous tissue from the luminal side of the intestine. It is important, therefore, that mesalazine is available at the regions of inflammation. Systemic bioavailability/plasma concentrations of mesalazine therefore are of no relevance for therapeutic efficacy, but rather a factor for safety. In order to fulfil these criteria, Salofalk tablets are coated with Eudragit L; they are thus gastro-resistant and the release of mesalazine is pH-dependent.
Clinical Studies: Gastro-resistant PR granules: The criteria used to evaluate the efficacy of the substance in the therapy of ulcerative colitis are frequency of bowel movements, rectal haemorrhage, abdominal pain, general well-being, temperature, extraintestinal manifestations, ESR, and haemoglobin. These criteria have been summarised in the clinical activity index (CAI) to evaluate the efficacy of treatment for ulcerative colitis.
The safety and efficacy of Salofalk granules (1.5 g to 3 g 5-ASA/day) was compared against mesalazine tablets (Salofalk 500 mg tablets, 1.5 g to 3.0 g 5-ASA/day) in a double-blind randomised multi-centre study in 233 patients with mild to moderately active ulcerative colitis over a period of 8 weeks. The primary efficacy criterion, complete response rate (per protocol analysis, PP) was very similar in the granules (68%) and the tablets (70%) groups. The efficacy analysis (PP) showed that more patients treated with mesalazine tablets (47%) had to increase the dose from 1.5 g mesalazine/day to 3.0 g mesalazine/day compared to patients treated with granules (38%). Similar results were obtained by the ITT (intention-to-treat) analysis: 39% of the granules group, 45% of the tablets group, i.e., more patients came into remission (49%) with the 1.5 g 5-ASA/day from granules than from tablets (43%). Granules, therefore, in total were at least as efficacious and as well tolerated as the tablets at the same dose. Subgroup analyses showed that the response rates to granules were higher in patients with high baseline disease activity (CAI>8) and with 1 or more extraintestinal manifestations than the tablets: (See Table 1.)

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In another study, the efficacy and safety of Salofalk granules of different dosages (1.5 g, 3.0 g, 4.5 g/day) were compared in 321 patients with mild to moderately active ulcerative colitis in a double-blind manner for a treatment period of 8 weeks. Complete response (CAI ≤ 4) was obtained by 50% in the 1.5 g dose group, by 66% in the 3.0 g group (in comparison to 1.5 g: p = 0.014) and by 55% in the 4.5 g group (in comparison to 1.5 g: not significant, p=0.318). The 3.0 g/day dose appears to be the optimal dose. In a double-blind, randomised comparative study, the efficacy and tolerability of once daily (o.d.) 3.0 g Salofalk granules was compared with three time daily (t.i.d.) 1.0 g Salofalk granules in 380 patients with active ulcerative colitis over a period of eight weeks. The data show that for Salofalk granules, a daily dose of 3 g mesalazine given o.d. is therapeutically equivalent to the conventional t.i.d. dosage regimen for the induction of remission (CAI ≤ 4) in patients with mild-to-moderate ulcerative colitis. The clinical remission rate in the PP analysis set (primary analysis) was 84.4% in the o.d. group and 81.3% in the t.i.d. group. The resulting p-value for the noninferiority test (pre-defined margin: -15%) was 0.0007 with a 95% CI of [-11.4%, 17.6%]. Remission rates in ITT analysis set were very similar, 80.8% in the o.d. group and 77.4% in the t.i.d. group. ITT test result (p = 0.0007) and 95% CI (-11.4%, 18.1%) agreed with the PP analysis. Once daily dosing of Salofalk granules was as safe and well tolerated as three times daily dosing of Salofalk granules.
Results of the various studies show that oral delayed release Salofalk granules are well tolerated in patients with ulcerative colitis.
Pharmacokinetics: General aspects of mesalazine: Absorption: Mesalazine absorption is highest in the proximal gut regions and lowest in distal gut areas.
Biotransformation: Mesalazine is metabolised both pre-systemically by the intestinal mucosa and the liver to the pharmacologically inactive N-acetyl-5- aminosalicylic acid (N-Ac-5-ASA). The acetylation seems to be independent of the acetylator phenotype of the patient. Some acetylation also occurs through the action of colonic bacteria. Protein binding of mesalazine and N-Ac-5-ASA is 43% and 78%, respectively.
Elimination: Mesalazine and its metabolite, N-Ac-5-ASA, are eliminated via the faeces (major part), renally (varies between 20% and 50%, dependent on kind of application, pharmaceutical preparation and route of mesalazine release, respectively) and biliary (minor part). Renal excretion predominantly occurs as N-Ac-5- ASA. About. 1% of total orally administered mesalazine dose is excreted into breast milk, mainly as N-Ac-5-ASA.
Salofalk 250 mg/500 mg tablets specific: Absorption: Salofalk 250 mg: Release of mesalazine from Salofalk 250 mg, gastro-resistant tablets, begins after a lag-phase of approximately 3-4 hours. Peak plasma concentrations are reached after approximately 5 hours (ileocoecal region) and, at 3 x 500 mg mesalazine/day (3 x 2 Salofalk 250 mg) under steady-state conditions, are 2.1 ± 1.7 μg/ml for mesalazine and 2.8 ± 1.7 μg/ml for the metabolite, N-Ac-5-ASA.
Salofalk 500 mg: Release of mesalazine from Salofalk 500 mg, gastro-resistant tablets, begins after a lag-phase of approximately 3-4 hours. Peak plasma concentrations are reached after approximately 5 hours (ileocoecal region) and, at 3 x 500 mg mesalazine/day under steady-state conditions, are 3.0 ± 1.6 μg/ml for mesalazine and 3.4 ± 1.6 μg/ml for the metabolite, N-Ac-5-ASA.
Distribution: Salofalk 250 mg: A combined pharmacoscintigraphic/pharmacokinetic study in patients showed that Salofalk 250 mg, gastro-resistant tablets, dissolve after approximately 3-4 hours in the ileum region when taken concurrently with food (test meal). The median gastric emptying time was approximately 3 hours. The tablets reached the colon after approximately 7 hours.
In a further study with probands, the duodeno-ileal transit time was approximately 3 hours, whereby maximum luminal 5-ASA concentrations were measured in the ileum 7-8 hours after concurrent administration of the tablets with the test meal. Approximately 75% of the mesalazine dose reached the colon in non-metabolised form.
Salofalk 500 mg: A combined pharmacoscintigraphic/pharmacokinetic study showed that Salofalk 500 mg, gastroresistant tablets, reach the ileocoecal region after approximately 3-4 hours in fasting subjects and reach the ascending colon within approximately 4-5 hours. The total transit time in the colon is approximately 17 hours.
Elimination: Salofalk 250 mg: Following long-term treatment with Salofalk 250 mg tablets at a daily dose of 500 mg mesalazine, 3 times daily (steady-state conditions), the total renal elimination rate for mesalazine and N-Ac-5-ASA was approximately 55% (24-hour value after last administration). The nonmetabolised mesalazine fraction was approximately 5%. The elimination half-life was 0.7-2.4 hours (mean 1.4 ± 0.6 hours) at a dose of 500 mg mesalazine, three times daily.
Salofalk 500 mg: The total renal elimination rate for mesalazine and N-Ac-5-ASA over 24 hours during multiple intake (3 x 1 Salofalk 500 mg, gastroresistant tablets, for 2 days; 1 gastro-resistant tablet on the third day = examination day) was approximately 60%. The non-metabolised mesalazine fraction after oral administration was approximately 10%.
Salofalk Suppositories specific: Absorption: After both a single administration and after several weeks of long-term treatment with 500 mg mesalazine three times daily as Salofalk suppositories, peak plasma concentrations of 5-ASA were in the range of 0.1 to 1.0 μg/ ml, those of the main metabolite N-Ac-5-ASA were in the range of 0.3 to1.6 μg/ml. Peak plasma concentrations of 5-ASA are partially reached the first hour of application.
Distribution: Scintigraphic studies with technetium-labelled Salofalk 500 mg suppositories showed peak spread of the suppository that had melted due to body temperature after 2 - 3 hours. The spread was limited primarily to the rectum and rectosigmoid junction. Salofalk suppositories are thus particularly suitable for treating proctitis (ulcerative colitis of the rectum).
Elimination: After a single rectal dose of 500 mg mesalazine as Salofalk suppositories approx. 11% (within 72 hours) was recovered in the urine, and after several weeks of long-term treatment with 500 mg mesalazine three times daily as Salofalk suppositories, approx. 13% of the 5-ASA dose administered was recovered in the urine. Approximately 10% of a single administered dose was eliminated via the bile.
Salofalk 2 g/30 ml / 4 g/60 ml enemas specific: Distribution: An imaging study in patients with mild-to-moderate acute ulcerative colitis showed that the rectal suspension at the start of treatment and at remission after 12 weeks is distributed mainly in the rectum and sigmoid colon and to a lesser extent in the colon.
Absorption and elimination: No specific pharmacological studies on Salofalk 2 g/30 ml enemas are available. In a study with Salofalk 4 g/60 ml enemas in ulcerative colitis patients in remission, peak plasma concentrations of 0.92 μg/ml 5-ASA and 1.62 μg/ml N-Ac-5-ASA were achieved after approximately 11-12 hours under steady-state conditions. The elimination rate was approximately 13% (45-hour value), with most (approximately 85%) being eliminated in the form of the metabolite, N-Ac- 5-ASA. The steady-state plasma concentrations of 5-ASA and N-Ac-5-ASA in children with chronic inflammatory bowel disease under treatment with Salofalk 2 g/30 ml enemas were 0.2-1.0 μg/ml and 0.4- 2.0 μg/ml respectively whereas with Salofalk 4 g/60 ml enemas were 0.5-2.8 μg/ml and 0.9-4.1 μg/ml respectively.
Salofalk Granules specific: Absorption: Mesalazine release from Salofalk granules starts after a lag phase of about 2-3 hours. Peak plasma concentrations are reached at about 4-5 hours. The systemic bioavailability of mesalazine after oral administration is estimated to be approximately 15-25 %. Food intake delays absorption by 1 to 2 hours but does not change the rate and extent of absorption.
Distribution: Owing to the granule size of approx. 1 mm, transit from the stomach to the small intestine is fast. A combined pharmacoscintigraphic/pharmacokinetic study showed that the compound reaches the ileocaecal region within approx. 3 hours and the ascending colon within approx. 4 hours. The total transit time in the colon amounts to about 20 hours. Approximately 80 % of an administered oral dose is estimated to be available in the colon, sigmoid colon and rectum.
Elimination: From a 3 x 500 mg daily mesalazine dose in long-term therapy, a total renal elimination of mesalazine and N-Ac-5-ASA under steady state conditions was calculated to be about 25 %. The unmetabolised excreted mesalazine part was less than 1 % of the oral dose. The elimination half-life in this study was 4.4 hours.
Toxicology: Preclinical safety data: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity (rat) or toxicity to reproduction.
Kidney toxicity (renal papillary necrosis and epithelial damage in the proximal convoluted tubule or the whole nephron) has been seen in repeatdose toxicity studies with high oral doses of mesalazine. The clinical relevance of this finding is unknown.
Indications/Uses
Gastro-resistant tablet: Ulcerative colitis: treatment of acute exacerbations and relapse prophylaxis. Crohn's disease: treatment of acute exacerbations.
Suppository: Treatment of acute episodes and maintenance of remission of ulcerative colitis that is limited to the rectum.
Enema: Acute attacks of ulcerative colitis (a chronic inflammatory disease of the large bowel).
Prolonged-Release Granules: For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.
Dosage/Direction for Use
Gastro-resistant tablet: Adults: For the therapy of chronic inflammatory bowel disorders (Crohn's disease, ulcerative colitis), both Salofalk 250 mg, gastro-resistant tablets, and Salofalk 500 mg, gastro-resistant tablets, are available. If the recommended dose exceeds 1.5 g mesalazine daily, Salofalk 500 mg should preferably be used. Depending upon the clinical requirements in individual cases, the following daily doses are recommended: (See Table 2.)

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Suppository: Adults and elderly: For the treatment of acute episodes of ulcerative colitis: Two Salofalk 250 mg suppositories or 1 Salofalk 500 mg suppository are inserted into the rectum three times daily (equivalent to 1500 mg mesalazine daily), according to the individual clinical requirement.
For the maintenance of remission of ulcerative colitis: One Salofalk 250 mg Suppository three times daily (equivalent to 750 mg mesalazine daily) inserted into the rectum.
Children under 6 years of age: There is little experience and only limited documentation for an effect in children.
Enema: Adults and elderly: The following dosage guidelines are generally applicable: In patients with symptoms of acute inflammation, the contents of one enema bottle (Salofalk 4 g/60 ml enemas) resp. two enema bottles (Salofalk 2 g/30 ml enemas) are administered into the intestine as an enema once daily at bedtime.
Children: Salofalk 4 g/60 ml enemas should not be used in children with a body weight below 40 kg because there is very limited experience with this patient group.
Gastro-resistant prolonged release granules: Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: Once daily, 1 sachet of Salofalk granules 3 g, 1-2 sachets of Salofalk granules 1.5 g, 3 sachets of Salofalk granules 1g or 3 sachets of Salofalk granules 500 mg (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.
It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk granules 500mg 3 times daily or 1 sachet of Salofalk granules 1g 3 times daily) if this is more convenient to the patient.
For the maintenance of remission of ulcerative colitis: The standard treatment is 0.5 g mesalazine 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.
Paediatric population: There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg bw/day once daily preferably in the morning or in divided doses. Maximum dose: 75 mg/kg bw/day. The total dose should not exceed the maximum adult dose.
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg bw/day in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that half the adult dose may 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 tablet: Salofalk 250 mg/500 mg should be taken 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.
Treatment with Salofalk 250 mg/500 mg should be administered regularly and consistently, both during the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect.
The duration of use is determined by the physician.
An acute exacerbation of ulcerative colitis or Crohn's disease generally subsides after 8-12 weeks.
For relapse prophylaxis of ulcerative colitis the dose can usually be reduced to 1.5 g mesalazine/day.
Note: In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileocoecal region with removal of the ileocoecal valve, it has been observed that Salofalk 250 mg/500 mg, gastro-resistant tablets, were excreted undissolved in the stool, due to an excessively rapid intestinal passage.
Suppository: When used three times a day, Salofalk 250 mg and 500 mg suppositories should be inserted into the rectum in the morning, at midday and at bedtime.
Treatment with Salofalk suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.
An acute episode of ulcerative colitis generally subsides within 8 - 12 weeks. The duration of use is determined by the physician.
Enema: Rectal use.
The best results are achieved if the bowel is emptied before administration of the Salofalk enema.
The desired therapeutic result can only be achieved if Salofalk enemas are used regularly and consistently. The duration of treatment is determined by the patient's doctor.
Acute attacks of ulcerative colitis usually regress after 8-12 weeks, after which Salofalk 2 g/30 ml/4 g/60 ml enemas should not generally be used.
Preparation: The bottle should be shaken for 30 seconds.
Then the protective cap of the applicator removed.
The bottle should be held around its side.
The correct position for administration is as follows: The patient should lie down on his/her left side with his/her left leg stretched out and right leg bent. This makes it easier for the enema to be administered and for the enema to be effective.
Administration of the rectal suspension: The tip of the applicator should be inserted deep into the rectum.
The bottle should be tipped downwards slightly and then squeezed slowly.
Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.
The patient should remain lying down in this position for at least 30 minutes to allow the contents of the enema to spread throughout the rectum.
If possible, the enema fluid should be allowed to exert its effects all night.
Gastro-resistant prolonged release granules: The contents of the sachets of Salofalk granules should not be chewed.
The granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid.
Both in the treatment of acute inflammatory episodes and during long term treatment, Salofalk granules should be used on a regular basis and consistently in order to achieve the desired therapeutic effects.
The duration of use is determined by the physician.
Overdosage
There are rare data on overdosage (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive.
Contraindications
Known hypersensitivity to salicylates or any of the excipients listed in Description.
Severe impairment of hepatic or renal function.
Special Precautions
Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urine status (test strips/sediment) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately.
Caution is recommended in patients with hepatic dysfunction.
Effects on ability to drive and use machines: No effects on the ability to drive and use machines have been observed.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk.
Patients with a history of adverse drug reactions to preparations containing sulphasalazine, should be kept under close medical surveillance on commencement of a course of treatment with Salofalk. Should Salofalk cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
Gastro-resistant tablet: Salofalk 250mg/500mg should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
Salofalk 250 mg/500 mg should not be used in children under 6 years of age.
1 Salofalk 250 mg tablet contains 2.1 mmol (48 mg) sodium. This must be taken into consideration in patients on a sodium-controlled (low-sodium/low-salt) diet.
Suppository: Salofalk suppositories should not be used in patients with impaired renal function. Mesalazine induced renal toxicity should be considered, if renal function deteriorates during treatment.
Cetyl alcohol, an excipient of Salofalk 500 mg suppositories can cause local skin irritation (e.g. contact dermatitis).
Enema: Salofalk enemas should not be used in patients with renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
Due to their potassium metabisulphite content, Salofalk enemas can provoke allergic reactions with anaphylactic symptoms and bronchial constriction (bronchospasm) in sensitive patients, particularly in those with asthma or a history of allergies.
Because the product contains sodium benzoate, it may provoke hypersensitivity reactions in suitably predisposed patients in the form of irritation of the skin, eyes and mucous membranes.
Gastro-resistant prolonged release granules: Salofalk granules should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.
In patients with phenylketonuria, it should be kept in mind that Salofalk Granules contain aspartame as a sweetening agent, equivalent to 0.56 mg (Salofalk granules 500 mg), 1.12 mg (Salofalk granules 1 g), 1.68 mg (Salofalk granules 1.5g) and 3.36 mg (Salofalk granules 3g) phenylalanine.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate data on the use of Salofalk in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the fetus/newborn child. To date, no other relevant epidemiological data are available. In one single case after long-term use of high dose mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported.
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development.
Salofalk should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breastfeeding: N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are secreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions such as diarrhoea in infant cannot be excluded. Therefore Salofalk should only be used during breast-feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, the breast-feeding should be discontinued.
Adverse Reactions
The following side effects have been reported with the use of mesalazine: (See Table 3.)

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Drug Interactions
Specific interaction studies have not been performed.
In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine should be taken into account.
There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.
Caution For Usage
Instructions for use and handling and disposal: No special requirements.
Incompatibilities: Not applicable.
Storage
Gastro-resistant tablet: Do not store above 25°C.
Suppository/Enema: Do not store above 25°C. Store in the original container in order to protect from light.
Gastro-resistant prolonged release granules: Store below 30°C.
Shelf life: Gastro-resistant tablet/Suppository: 3 years.
Enema: 2 years.
Gastro-resistant prolonged release granules: 3 years for Salofalk granules 3 g 4 years for Salofalk granules 500 mg, granules 1 g and 1.5 g.
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 500 mg (oval, light yellow to ochre, matt with smooth surface, not scored) x 100's. Supp 500 mg (white to cream coloured, torpedo-shaped) x 30's. Enema 2 g/30 mL (cream-colored to light, pale-brown homogenous suspension) x 7's. Gastro-resistant PR granules (sachet) (stick-formed or round, greyish white) 1.5 g x 35's. 3 g x 50's.
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