Salofalk (mesalazine) rectal suppositories 1000 mg. №10

Description

Salofalk (mesalazine) rectal suppositories 1000 mg. №10

Composition

active ingredient: mesalazine;

1 suppository contains 1000 mg of mesalazine (5-aminosalicylic acid);

excipient: solid fat.

Dosage form

Suppositories are rectal.

Basic physical and chemical properties: light beige suppositories, torpedo-shaped with a smooth and undamaged surface. During storage, a white coating may form on the surface as a result of recrystallization of solid fats.

Pharmacological group

The gastrointestinal tract and metabolism. Antidiarrheals, intestinal anti-inflammatory/antimicrobials. Intestinal anti-inflammatory drugs. Aminosalicylic acid and the like. Mesalazine.
ATX code A07EC02.

Pharmacological properties

It belongs to the category of agents acting on the foci of inflammation. Shows itself as an antioxidant.
Available in various application forms.
The drug Salofalk rectal suppositories begins to act from an hour and a half after administration or administration (depending on the form of application).
The forms of oral administration of the medication are protected by the membrane from the destructive effect, and therefore they fall as intended in the place of action – the small and large intestines.
Salofalk rectal suppositories is not affected by factors such as pH, other medications and food intake.
The withdrawal of the drug is carried out by the kidneys.

Indications

Treatment of exacerbations of ulcerative colitis limited to the rectum (ulcerative proctitis).

Contraindications

Hypersensitivity to mesalazine, to any of the components of the drug or to salicylates, peptic ulcer of the stomach and duodenum in the acute stage, severe liver and / or kidney failure, hemorrhagic diathesis.

Use during pregnancy or lactation

Pregnancy
There are no adequate data on the use of Salofalk 1000 mg suppositories in pregnant women. However, data from the use of a limited number of pregnant women indicate that there are no undesirable effects of mesalazine on the course of pregnancy or on the health of the fetus and newborn. To date, there are no other epidemiological data regarding this drug. Only in one case, after prolonged use of mesalazine at a high dose (2-4 g orally) during pregnancy, renal failure was reported in the newborn.

An animal study with oral mesalazine did not confirm direct or indirect adverse effects on pregnancy, embryonic/fetal development, childbirth or postnatal development.

Salofalk 1000 mg suppositories should be used during pregnancy only when the expected benefit outweighs the possible risk.

Lactation
N-acetyl-5-aminosalicylic acid and, to a lesser extent, mesalazine are excreted in breast milk. To date, there is only limited experience in the use of women during breastfeeding. Hypersensitivity reactions in the infant, such as diarrhea, cannot be ruled out. Therefore, Salofalk 1000 mg suppositories should be used during lactation only when the expected benefit to the mother outweighs the possible risk to the baby. If an infant develops diarrhea, breastfeeding should be discontinued.

Method of administration and dosage

This medicine is for rectal use only.

Apply Salofalk 1000 mg suppositories preferably in the evening before going to bed.

The desired therapeutic result can be achieved only with regular and constant use of Salofalk, rectal suppositories 1000 mg each.

The duration of use is determined by the doctor.

Adults and elderly patients

One suppository of Salofalk 1000 mg is injected into the rectum 1 time per day (equivalent to 1000 mg of mesalazine per day).

Children

There are no sufficient data on the use of this drug in children.

Overdose

Usually, there is no overdose at a controlled dose. Overdose symptoms appear the same as the side effects.

Side effects

Salofalk is well tolerated, but sometimes (extremely rarely) patients notice pain in the joints and muscles.
Individual reactions of some people can manifest themselves in the form of allergic reactions: urticaria, spasms in the bronchi, itching, myo- and pericarditis, and fever.
In some cases, problems arise with the circulatory system, the organs of the digestive tract – abdominal pain, nausea, vomiting, inflammation in the pancreas, hepatitis and others.
Dizziness and headaches are extremely rare.
Mesalazine and drugs similar in structure to it can cause systemic lupus erythematosus syndrome.