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Instructions for medical use of
Relief® Ultra
Trade name:
Relief® Ultra
International nonproprietary name
None
Dosage form
Suppositories rectal
Composition
1 suppository contains
Active substance:zinc sulfate monohydrate 11 mg, hydrocortisone acetate 10 mg;
Adjuvants: cocoa butter (theobromine oil), calcium hydrogen phosphate anhydrous, magnesium stearate, methyl parahydroxybenzoate, propyl parahydroxybenzoate.
Description
Non-transparent suppositories, colored from pale white to light yellow, torpedo-shaped.
Pharmacotherapeutic group
Other drugs for the treatment of hemorrhoids and anal fissures, to use locally.
Code ATC C05АX
Pharmacological properties
Pharmacokinetics
The drug Relief® Ultra is assigned to use locally. The pharmacokinetics data are absent.
Pharmacodynamics
Hydrocortisone acetate inhibits the release of inflammatory mediators, inhibits the metabolism of arachidonic acid. At local use, it makes anti-inflammatory, anti-allergic, vasoconstrictive and antipruritic effects.
Zinc sulphate monohydrate promotes healing of wounds and erosions, normalizes the skin hydration.
Indications
Dosage and methods of use
To enter it into the rectum per 1 suppository up to 4 times a day (morning, night and after each bowel emptying). To use the drug after hygienic procedures. For hygienic procedures to use warm water or soft wet wipes, then to soak with dry cloth. The duration of treatment makes 7 days.
Adverse reaction
- rectal bleeding
- allergic dermatitis, irritation, pain, dryness, swelling in the place of application of the drug
- hypersensitivity to the components of the drug
Contraindications
– increased individual sensitivity to any of the components of the drug
– specific (bacterial, fungal, viral) lesions of the anorectal area
– intestinal obstruction, abscess, perforations, peritonitis, extensive fistula
– children under 12 years old.
Drug interaction
The possibility of systemic effect development may increase at use in combination with other corticosteroid drugs, due to the possible additive effect.
To be careful when using drugs, which reduce blood sugar, anticoagulants, barbiturates, diuretics and cardiac glycosides. The drug competes with other corticosteroid drugs of local and systemic effect; it can enhance their systemic effect.
Special indications
As all products containing local steroids, systemic absorption is possible, therefore the patient should not exceed frequency of application (no more than 4 times a day) and the duration of treatment.
Patients with severe ulcerative disease should use the drug carefully because of the risk to the intestine perforation.
If necessary to use other steroid drugs in conjunction jointly with local drugs, a doctor's consultation is indicated.
It is necessary to consult a doctor and stop using suppositories at development of skin infection in the place of the drug application.
If the patient's state of health does not improve after using the drug for 7 days, the patient should consult with a proctologist.
Zinc oxide is a relatively non-toxic substance, but it is not recommended to take for a long time above the recommended daily doses, even at local application.
The drug contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Pregnancy and lactation
This product should be used during pregnancy only if the potential benefit justifies the potential risk to both the mother and her fetus.
During pregnancy and lactation, the drug should be used only under a doctor's prescription.
The drug effect features upon the ability to drive a car or potentially dangerous mechanisms.
It does not effect.
Overdosage
It is need to consider the risk of systemic action of hydrocortisone in the form of adrenal insufficiency, menstrual irregularities, high blood pressure, hirsutism, hyperglycemia, glaucoma, muscle weakness, insomnia while using the drug in high doses for a long time. There are possible disorders of the gastrointestinal tract (nausea, stomach pain).
If the aforementioned symptoms occur, the patient should stop using the drug and seek medical aid.
Treatment: symptomatic treatment.
Form of output and packing
Per 6 suppositories in a contour cell package made of polyvinyl chloride / polyethylene film.
Per 2 contour packing together with the instruction on medical use in the state and Russian languages placed in a cardboard pack.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf live
2 years
Do not use after the expiration date.
Conditions for drug supply
Over the counter.
Name of the firm-manufacturer, country, and address:
Istituto De Angeli S. R. L.,
50066 Reggello (Florence), Locke. Prulli 103/s, Italy
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact details of the organization in the territory of the Republic of Kazakhstan accepting claims (offers) from consumers concerning the drug quality:
«Bayer KAZ» LLP
Timiryazev Street, 42, Pav. 15, office 301
050057 Almaty, Republic of Kazakhstan
Tel: +7 727 258 80 40
Fax.: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
«Bayer KAZ» LLP
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax.: +7 727 2588 039
e-mail: pv.centralasia@bayer.com