Salofalk Mesalazine rectal suspension 4g/60ml enemas 60ml №7

Salofalk Mesalazine rectal suspension 4g/60ml enemas 60ml №7

Product Code: 8091
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active substance:mesalazine;

1 enema (60 g suspension) contains 4.0 g mesalazine (5-aminosalicylic acid)

excipients:sodium benzoate (e 211), potassium metabisulfite (E 224), sodium edetate, carbomer 934 P, potassium acetate, xanthan gum, purified water.


Dosage form

the Suspension is rectal.

Basic physico-chemical properties:homogeneous suspension that the color from very light brown to brown, devoid of foreign particles.


drug description

anti-Inflammatory drugs used to treat bowel disease.

code ATX a07e C02.


Pharmacological properties


the Mechanism of anti-inflammatory action is unknown. The results of in vitro studies indicate that lipooxygenase inhibition can play a role.

the effect on the concentration of prostaglandins in the intestinal mucosa was also demonstrated. Mesalazine (5-aminosalicylic acid/5-ask) can also act as an absorber of the radicals of reactive oxygen compounds.

Mesalazine with rectal administration acts mainly locally on the intestinal mucosa and on submucosal tissue from the intestinal lumen.

Preclinical data, based on the traditional studies of safety pharmacology, genotoxicity, Carcinogenicity (rat) or toxicity to the reproductive system, do not indicate a special risk to humans.

nephrotoxicity (renal papillary necrosis and epithelial damage in proximal tubules (Pars convoluta) or the whole nephron) was observed in toxicity studies in repeated high oral doses of mesalazine. The clinical significance of this data is unknown.


General properties of mesalazine


the uptake of mesalazine is highest in the proximal part of the intestine and lower in the distal part.


Mesalazine as posisteme metabolized in the intestinal mucosa and in the liver to pharmacologically inactive N-acetyl-5-PASK (N-AC-5-ASA). Obviously, acetylation does not depend on the phenotype of the patient's acetylation apparatus. Some acetylation also occurs due to the action of bacteria in the large intestine. Binding of mesalazine and N-AC-5-ask with proteins is respectively 43% and 78%.


Mesalazine and its metabolite N-AC-5-ASA excreted in the faeces (major part), the kidneys (varies between 20 and 50% depending on the type of application, pharmaceutical form and route of mesalazine release, respectively) and bile (a small part). Renal excretion occurs mainly in the form of N-AC-5-ask. About 1% of total administered by oral dose of mesalazine is excreted in breast milk mainly as N-AC-5-ASA.

Features of Salofalk enema 4 g/60 ml


Scintigraphic studies in patients with minor or moderate acute ulcerative colitis showed that enema fluid at the beginning of treatment and after 12 weeks of use is distributed mainly in the rectum and sigmoid and to a lesser extent - in the colon.

Absorption and removal

in a study In patients with ulcerative colitis in remission peak concentrations in plasma were 5-ASA 0,92 µg/ml and for N-AC-5-ASA was 1.62 mcg/ml in about 11-12 hours at constant conditions. The rate of elimination was 13% (the value after 45 hours), with a larger number (about 85%) were derived in the form of the metabolite N-AC-5-ASA.

the Concentration of plasma 5-ASA and N-AC-5-ASA in children with chronic inflammation of the large intestine in the treatment of Salofalk 4 g/60 ml was 0.5 to 2.8 µg/ml and 0.9-to 4.1 µg/ml, respectively.


Treatment of acute exacerbations of ulcerative colitis (chronic inflammatory disease of the large intestine).


Hypersensitivity to mesalazine, to any of the components of the drug or to salicylates, gastric ulcer and duodenal ulcer in the acute stage, severe hepatic and/or renal failure, hemorrhagic diathesis.


Interaction with other medicinal products and other forms of interaction

there were no Special studies of drug interaction.

during the complex treatment of Salofalk and azathioprine, 6-mercaptopurine or thioguanine in some studies, a higher frequency of myelosuppressive effects was found, supposedly indicating the presence of interaction, but the mechanism of interaction is not fully established. It is recommended to regularly monitor the level of leukocytes, and the dosage regimen of thiopurin should be corrected.

There is evidence that mesalazine might decrease the anticoagulant effect of warfarin.

may increase the hypoglycemic action of sulfonylurea derivatives, toxic effects of methotrexate. The activity of furosemide, spironolactone, sulfonamides, rifampicin, uricosuric drugs (probenecide and sulfinpirazon) may weaken. Mesalazine vozm to strengthen the undesirable effect of glucocorticoids on the gastric mucosa, reduce the absorption of digoxin.

application Features

At the discretion of the physician need during and after treatment to do blood tests (full blood count liver function such as ALT or AST; serum creatinine) and urine (test strips, sediment). Roughly tests are recommended 14 days from the start of treatment and then another 2-3 times with an interval of 4 weeks.

if the test results are normal, routine checks can be performed every 3 months, but if other additional symptoms occur, the tests should be done urgently.

caution should be used in patients with impaired liver function.

Should be used with caution enemas of Salofalk when impaired renal function mild to moderate severity. It is necessary to regularly monitor kidney function, namely to measure blood urea nitrogen levels, creatinine in patients with proteinuria. With the deterioration of renal function during treatment should be borne in mind induced by mesalazine toxicity relative to the kidneys.

Patients with pulmonary diseases, in particular asthma, should be under medical supervision during the course of treatment with enemas of Salofalk.

Patients who have hypersensitivity reactions including cramping, acute abdominal pain, fever, severe headache and rash preparations containing sulfasalazine should be under medical supervision from the beginning of the treatment course with the use of enemas of Salofalk. In case of acute symptoms of intolerance therapy should be stopped immediately.

due to the fact that 4 g/60 ml Salofalka enemas contain potassium metabisulfite, they can provoke allergic reactions with anaphylactic symptoms and bronchial contraction (bronchospasm) in sensitive patients, especially in patients with bronchial asthma or in patients with a history of allergies.

Since the drug contains sodium benzoate, it can provoke the development of hypersensitivity reactions in patients in the form of irritation of the skin, eyes or mucous membranes.

there is no need to reduce doses to elderly patients.

use during pregnancy or lactation.

Adequate data on the use of enemas of Salofalk in pregnant women no. However, data on use in a limited number of pregnant women indicate the absence of undesirable effects of mesalazine on pregnancy or on the health of the fetus and (or) newborn. To date, no other epidemiological data relevant to the drug are available. Only in one case, after prolonged use during pregnancy mesalazine in a high dose (2-4 g orally) reported renal failure in the newborn. There were reports of violations of the blood system (leukopenia, thrombocytopenia, anemia) in newborns whose mothers used mesalazine.

studies on animals taking mesalazine orally did not show a direct or indirect adverse effect on pregnancy, embryo/fetus development, childbirth or postnatal development.

Enema of Salofalk must be taken during pregnancy only when the expected benefits of the use prevail the potential risks.

N-acetyl-5-aminosalicylic acid and to a lesser extent mesalazine are excreted in breast milk. Today, there is only limited experience in women during breastfeeding. Hypersensitivity reactions in infants, such as diarrhea, cannot be excluded. So enema of Salofalk can be used during breastfeeding only if the expected benefit from the application to prevail the risk. If the infant develops diarrhoea, breast-feeding should be discontinued.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

Any impact on the ability to drive and use machinery has not been observed. In cases, if during treatment there is dizziness, you should refrain from driving and working with mechanisms.

Method of application and doses


patients with symptoms of acute inflammation are recommended to use the content of one enema (60 g of suspension) rectally once a day in the evening, before bedtime.

the Best result is achieved if prior to use enema of Salofalk cleaned intestines.

The Desired the therapeutic result can be achieved only with regular and constant use of enemas of Salofalk.

The duration of use is determined by the physician.

Usually, exacerbation of ulcerative colitis subside within 8-12 weeks after that enema of Salofalk, as a rule, do not apply.

For more easy insertion of the enema applicator lubricated with paraffin and white vaseline.

instructions for introducing the suspension


  • Shake the enema for 30 seconds.
  • Remove the protective cap from the applicator.
  • The
  • to Hold the enema in the lateral surface.

the Correct position when inserting an enema is as follows:

  • the Patient has to lie on the left side and pull your left foot, bending right. This facilitates the introduction of enema and increases its effectiveness.

the Introduction of an enema:

  • Insert the tip of the applicator away from the rectum.
  • The
  • to Raise an enema upside down and slowly squeeze.
  • as soon as the enema is empty, slowly remove the tip of the applicator from the rectum.
  • the Patient should continue to lie for at least 30 minutes, so that the enema content spread through the rectum.
  • if possible, let the enema fluid cause its effect throughout the night.

Children.there is not enough experience in the use of this drug for children.


to date, no cases of intoxication or specific antidotes have been reported. There are cases of overdose (such as intentional suicide with a high oral dose of mesalazine) that do not indicate renal or hepatic toxicity. There is no specific antidote, treatment should be symptomatic and supportive.

if necessary, apply the infusion of electrolytes (forced diuresis).

Side effects

The The The The The The The The The The The The The The
organ system
frequency according to MedDRA
(3 1/10000;<1/1000)
very rare
blood System and the lymphatic system
Changes in the composition of the blood (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia)
nervous system
Headache, dizziness
peripheral neuropathy
cardiovascular system
Myocarditis, pericarditis
& nbsp;
the respiratory system, thorax and mediastinum
Allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, pulmonary infiltration, pneumonitis, pleuritis)
Gastrointestinal tract
the abdominal Pain, diarrhoea, flatulence, nausea and vomiting
acute pancreatitis
impairment of renal function, including acute and chronic intestinal nephritis, nephrotic syndrome and renal failure
the Skin and its derivatives
the musculoskeletal system and connective tissue
Myalgia, arthralgia, convulsions
hypersensitivity Reactions, including allergic rash, drug fever, lupus erythematosus syndrome, pancolitis, Quincke edema
Liver and gall bladder
changes in liver function parameters (increased transaminase activity and bile stagnation parameters), hepatitis, cholestatic hepatitis, hepatic insufficiency
reproductive system
Oligospermia (reverse)
the introduction
Anal discomfort, rectal pain, tenesmus, irritation

fatigue, paresthesia, methemoglobinemia, prolonged diarrhea, increased colitis symptoms are also possible.

the Mechanism of development of myocarditis, pericarditis, pancreatitis, nephritis and hepatitis due to the use of mesalazine is unknown; it may have allergic etiology.

it should be noted that some of these disorders can be explained by inflammation of the intestine.


shelf Life

2 years.

Do not use after the expiry date indicated on the package.

storage Conditions

Keep out of reach of children at temperature not exceeding 30 ° C in original package to protect from light. Open the blister just before use.



60 g of the slurry enema; enemas for 7 in blisters in a carton made of cardboard.


Category vacation

According to the recipe.



Etc. Falk Pharma GmbH/Dr. Falk Pharma GmbH.

location of the manufacturer and address of the place of business

Leinenweberstr 5, D-79108 Freiburg, Germany/Leinenweberstrasse 5, D-79108 Freiburg, Germany.

salofalk worth us SUSPENSION 60ML No. 7

the Drug salofalk worth us belongs to the category of anti-inflammatory medicinal drugs used in diseases of the intestine. It is used in the treatment of exacerbation of ulcerative colitis, as well as for the prevention of recurrence of this disease. In addition to the suspension, Salofalk is available in the form of tablets, granules and candles. However, these forms of release can not be called interchangeable, each of them has its own restrictions on the use. Before switching to another format of the drug, this decision should be agreed with the attending physician. 

suspension salofalk worth us

  • the Tool is designed solely for rectal use. 
  • In cases of gastric ulcer, hemorrhagic diathesis, renal or liver failure to use this tool you should not. 
  • Suspension of Salofalk not used in Pediatrics due to lack of clinical data on its impact on pediatric patients. 


the Suspension is injected into the rectum once a day, better in the evening. The introduction is made with an enema, is sold complete with the drug. The maximum duration of therapy with this form of Salofalk should not exceed 12 weeks.

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