rectal suppositories 10 mg + 11 mg, № 12
Other ingredients: methyl parahydroxybenzoate (e 218), propyl parahydroxybenzoate (e 216), anhydrous calcium hydrophosphate, cocoa butter, magnesium stearate.
1 suppository contains hydrocortisone acetate 10 mg, zinc sulfate monohydrate 11 mg. Supplementary substances: shark liver oil, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), calcium hydrophosphate anhydrous, cocoa butter, magnesium stearate.
No. UA / 1954/01/01 from
pharmacodynamics. Hydrocortisone acetate – corticosteroids, when applied topically, has anti-inflammatory, antiallergic, vasoconstrictor and antipruritic action. Inhibits the release of inflammatory mediators, blocks the metabolism of arachidonic acid.
Zinc sulfate monohydrate promotes healing of wounds and erosion, normalizes the water balance of the skin.
Pharmacokinetics. When applied topically, the ingredients of the drug are excreted in the composition of mucus or in very small quantities are excreted in urine and bile. Any manifestations of resorptive action when using the drug in the recommended doses are not observed. The components of the drug do not penetrate into breast milk.
external and internal hemorrhoids, fissures, fistulas, ulcers, erosion of the perianal region and rectum, accompanied by severe inflammatory phenomena; proctitis, anal itching, eczema, perianal dermatitis.
prewash the skin around the anus with warm water; clean the affected area with a moist soft wipe; dry it gently with toilet paper or a soft cloth. Before inserting the suppository, it is necessary to remove the protective plastic sheath from it. Insert the suppository into the anus as deep as possible. Introduce one suppository up to 4 times per day (at night, in the morning and after each bowel movement). Duration of treatment is no more than 7 days.
Children. The safety and effectiveness of Relief ® Ultra in children under the age of 12 years has not been established. No data. The drug can be used in children from the age of 12 years.
increased individual sensitivity to any component of the drug (allergic reactions), specific (bacterial, fungal, viral, tuberculosis) lesions of the anorectal zone, new growth in the anus, thromboembolic disease, intestinal obstruction, abscesses, risk of perforation, peritonitis, common fistulas, fresh intestinal anastomoses or fistulous passages.
on the part of the immune system: rarely allergic reactions can occur, including hyperemia (redness), swelling, itching; dry mucous membranes.
Although systemic action was not reported with the use of Relif ® Ultra, endocrine disorders are possible with prolonged use in high doses: adrenocortical suppression, Cushing syndrome, hyperglycemia, glycosuria, growth retardation, intracranial hypertension.
On the part of the digestive tract: rectal bleeding.
On the part of the skin and subcutaneous tissue: perianal dermatitis, accompanied or not accompanied by atrophy of the skin; irritation, pain at the site of application, burning, rash, dry skin, pustular acne; “Rebound effect”, which can lead to steroid dependence; slow wound healing.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions (possibly delayed) and in some cases bronchospasm.
in case of significant bleeding from the anus, in the presence of symptoms of the disease within 7 days of treatment or in case of worsening of the condition, it is necessary to consult an additional proctologist.
Avoid accidental contact with the eyes.
Rectal corticosteroids should be used with caution in patients with severe peptic ulcer and only after proctological examination because of the risk of intestinal perforation.
When using any topical steroids, be aware of the possibility of systemic absorption.
In order to minimize systemic effects, the recommended dose should not be exceeded, unless otherwise recommended by a physician.
Use during pregnancy and lactation. The safety of using Relif ® Ultra (hydrocortisone acetate, zinc sulfate) during pregnancy has not been studied.
Current data on the safety of topical corticosteroids during pregnancy indicate the lack of a link between their use by the mother and the development of the cleft palate, premature birth and fetal death.
Modern data show that the use of strong / very strong topical corticosteroids during pregnancy cannot be associated with placental insufficiency and low birth weight of the newborn. However, this is the data of one large and small cohort studies. A large population-based cohort study (84 133 pregnant women from the database of general practice studies) revealed a significant association of fetal growth retardation with the use of pregnant strong / very strong topical GCS, but not with weak / moderate topical GCS. The relationship between the use of pregnant topical corticosteroids of any force with the development of the wolf mouth, premature birth and fetal death was not revealed. Also, another cohort study in Denmark did not reveal a causal link between the use of topical corticosteroids and the wolf mouth.
It is not known whether the active ingredients Relief ® Ultra (hydrocortisone acetate, zinc sulfate) get into breast milk. Trace amounts of endogenous hydrocortisone (cortisol) are excreted into breast milk. The amount of corticosteroids in milk ranges from