Salofalk - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Mesalazine has anti-inflammatory effect. Inhibits the synthesis of metabolites of arachidonic acid (prostaglandins), the activity of neutrophilic lipoxygenase, inhibits the migration, degranulation and phagocytosis of neutrophils, the secretion of immunoglobulins by lymphocytes; binds and destroys the free radicals of oxygen.

Pharmacokinetics:The release of mesalazine occurs in the rectum and colon. Metabolized already in the intestinal mucosa and in the liver in N-acetyl-5-ASA, so the concentration in the plasma is relatively low. It binds to plasma proteins by 43% (metabolite - by 75 - 83%). Mesalazine and its metabolites do not penetrate the blood-brain barrier, but penetrate into the breast milk (in the form of metabolite) 0.1% of the dose.
Excretion: Mesalazine and its metabolites are excreted from the body with urine and feces.

Indications:Treatment of ulcerative colitis (distal parts of the rectum) during an exacerbation, and also as maintenance therapy during remission.

Contraindications:Hypersensitivity to the drug and other derivatives of salicylic acid, gastric ulcer and duodenal ulcer in acute hemorrhagic diathesis (with a tendency to bleeding), severe renal / hepatic failure, children up to 18 years.

Carefully:Salofalk used with caution in patients with impaired respiratory function (especially asthma), increased sensitivity to sulfasalazine, with impaired liver function and kidney deficient glucose -6 - phosphate dehydrogenase.

Pregnancy and lactation:Sufficient data on the use of salofalk suppositories rectal 250 mg in pregnant women do not. However, data on the use of mesalazine in a few pregnant women have demonstrated the absence of undesirable effect of mesalazine on pregnancy or the fetus / newborn health. Studies on animals, which mesalazine Administered orally, do not indicate direct or indirect negative effect on pregnancy, embryo / fetus, childbirth and post-natal development. Salofalk suppositories rectal 250 mg should be used during pregnancy only in thosecases where the potential benefit of its use for the mother exceeds the possible risk to the fetus.
If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:Adults:
For the treatment of exacerbations of ulcerative colitis:
2 suppositories 3 times a day (corresponding to 1500 mg of mesalazine per day), rectally.
As maintenance therapy during remission
1 suppository 3 times a day (corresponding to 750 mg of mesalazine per day), rectally.
The duration of treatment is determined by the doctor.

Side effects:Against the background of the use of mesalazine, the following side effects were observed, systematized according to the organ system and frequency of occurrence.

Organs and Systems	Frequency, according to classification MedDRA
	Rarely (≥1/10,000; < 1/1,000)	Very rarely (<1 / 10,000)
Violations of the blood and lymphatic system		Pathological indicators uniform elements of blood (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia)
Disturbances from the nervous system	Headache, dizziness	Peripheral neuropathy
Heart Disease	Myocarditis, pericarditis
Disturbances from the respiratory, thoracic and mediastinal organs		Allergic and fibrotic reactions from the lungs (including dyspnea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, pulmonary infiltrates, pneumonitis)
Infringements from gastrointestinal tract	Abdominal pain, diarrhea, bloating, nausea, vomiting	Acute pancreatitis
Disorders from the kidneys and urinary tract		Impaired renal function, including acute and chronic interstitial nephritis, renal failure

Disturbances from the skin and subcutaneous tissues		Alopecia
Disturbances from musculoskeletal system and connective tissue		Myalgia, arthralgia
Immune system disorders		Reactions hypersensitivity, for example - allergic exanthema, drug fever, lupus erythematosus (SLE), pancolitis
Disturbances from the liver and bile ducts		Changes in liver function (increased activity of transaminases and cholestasis parameters), cholestatic hepatitis
Disorders from the reproductive system		Oligospermia (reversible)

Overdose:Cases of an overdose have not been revealed.In case of an overdose, symptomatic treatment is performed.

Interaction:Studies of the interaction of the drug Salofalk with other drugs have not been conducted.
In patients who are simultaneously receiving treatment with azathioprine, 6-mercaptopurine, or thioguanine, one should remember the possible increase in the myelosuppressive effect of azathioprine and 6-mercaptopurine or thioguanine. The use of mesalazine together with anticoagulants, for example, warfarin, can reduce the anticoagulant effect of mesalazine.

Special instructions:Before the beginning of treatment and in the process of it, at the discretion of the attending physician, the following tests should be performed: blood test (general blood test, liver function parameters (such as ALT and ACT activity), plasma creatinine content) and urinalysis.
Conducting a follow-up examination is usually recommended 14 days after the start of treatment and then 2-3 times with an interval of 4 weeks. If the results obtained correspond to the norms of values, then it is sufficient to carry out these analyzes every 3 months. If additional symptoms appear, follow-up examinations should be performed immediately.Caution should be exercised in patients with impaired hepatic function. The use of salofalk suppository rectal is not recommended for patients with impaired renal function.
If, during treatment, there is a decrease in kidney function, one should assume the effect of nephrotoxicity associated with mesalazine.
When applying Salofalk suppositories rectal to patients with lung diseases, in particular, bronchial asthma, it is necessary to carry out careful monitoring during treatment.
Treatment of patients with known hypersensitivity to drugs containing sulfasalazine, you can start only under close medical supervision. When symptoms of acute intolerance, such as spasms, acute abdominal pain, fever, severe headaches and skin rash should be discontinued immediately.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the management of vehicles and the maintenance of moving mechanisms. When these undesirable phenomena (such as dizziness, etc.) appear, one should refrain from performing these activities.

Form release / dosage:Suppositories rectal 250 mg.

Packaging:5 suppositories per blister laminated PVC / low density polyethylene; 2 or 6 blisters together with instructions for use in a pack of cardboard.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013074 / 02

Date of registration:07.12.2007 / 25.02.2013

Expiration Date:Unlimited

The owner of the registration certificate: Dr. Falk Farma GmbH Dr. Falk Farma GmbH Germany

Manufacturer: & nbsp

Dr. FALK PHARMA, GmbH Germany

Representation: & nbspDOCTOR FALK PHARMA GmbH DOCTOR FALK PHARMA GmbH Germany

Information update date: & nbsp2016-09-22

Illustrated instructions

Instructions

Salofalk (Salofalk)