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| APPROVED By the order of the Chairman of the Pharmacy Committee at the Ministry of Health. Republic of Kazakhstan Dated on «_________ 201___ г. No. _ |
Instructions for medical use of
Relief® Advance
Trade name:
Relief® Advance
International nonproprietary name
Benzocaine
Dosage form
Suppositories rectal
Composition
1 suppository contains
Active substance:Benzocaine 206 mg;
Adjuvants: cocoa butter (theobromine oil), methyl parahydroxybenzoate, propyl parahydroxybenzoate, corn starch.
Description
Non-transparent suppositories, colored from pale white to light yellow, torpedo-shaped.
Pharmacotherapeutic group
Drugs for the treatment of hemorrhoids and anal fissures, to use locally. Local anesthetic. Benzocaine.
Code ATCC05АD03.
Pharmacological properties
Pharmacokinetics
At local use of Benzocaine in the drug Relief® Advance the system absorption is low.
Pharmacodynamics
Benzocaine is an active surface local anesthetic. It does not have a resorptive effect, reduces the permeability of the cell membrane for sodium ions; displaces calcium ions from the receptors located on the inner surface of the membrane; blocks the nerve impulse. Benzocaine takes the expressed analgesic effect.
Indications
– external and internal hemorrhoids
– cracks, erosion and microtrauma of the anus, anal itching, accompanied by severe pain syndrome
– in the postoperative period after proctologic surgeries.
Dosage and methods of use
To use the drug after hygienic procedures. To enter it into the rectum per 1 suppository up to 4 times a day (morning, night and after each bowel emptying). The maximal daily dose includes 4 suppositories. The duration of treatment makes 7 days.
If necessary, under the recommendation of a doctor, the duration of treatment can be extended to 3 weeks.
Adverse reaction
Rarely: hyperemia (erythema), edema, skin rashes in the application of the drug. Allergic dermatitis. Methemoglobinemia.
Contraindications
– increased individual sensitivity to any ingredients of the drug
– children under 12 years old
– pregnancy and lactation
Drug interaction
Benzocaine in the components of the Relief Advance may be the antagonist of the preparations containing aminosalicylic acid.
In cases of significant excess of recommended doses and duration of administration Benzocaine may enhance the effects of monoamine oxidase (MAO) inhibitors, antidepressants and antihypertensives.
Special indications
The patient should not exceed the dose multiplicity (up to 4 times) and the duration of treatment.There are studies demonstrating that the appointment of products containing benzocaine can result to methemoglobinemia.
Such symptoms as cyanosis (paleness, gray or blue skin, lips and nail bed), headache, dizziness, dyspnea (shortness of breath), fatigue, tachycardia at using the drug may indicate a potential threat to life and require immediate medical attention.
In cases of copious bleeding from the anus or if painful symptoms persist for more than 7 days, it is necessary to consult with a proctologist additionally.
A doctor's advice is required before use the drug Relief Advance in children over 12 years.
If there is bleeding from the anus, the patient should consult a doctor.
Pregnancy and lactation
This product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
During pregnancy and lactation, the drug should be used strictly according to the doctor's prescription.
Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms.
It does not effect.
Overdosage
Benzocaine overdose can cause heart rhythm disturbances, seizures, coma, decreased respiratory rate or respiratory failure.
Treatment: withdrawal of the drug and 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
To store at a temperature not exceeding 25 °C.
To keep out of reach of children!
Shelf live
2 years
Do not use after the expiration date.
Conditions for drug supply
Without a prescription.
Name of the firm-manufacturer, country, 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“ LTD.
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“LTD.
Timiryazev Street, 42, „Expo City“Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – 24 hours
Tel.: +7 727 258 80 40 (106) – during working hours
Fax.: +7 727 2588 039
e-mail: pv.centralasia@bayer.com