Relief Advance ointment rectal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

benzocaine

Available from:

Famar S.A.

ATC code:

CO5AX03

INN (International Name):

benzocaine

Dosage:

200mg/g

Pharmaceutical form:

ointment rectal

Units in package:

28.4g laminated tube and applicator

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-12-08

Summary of Product characteristics

Page 1 of 3
Summary of Product Characteristics
Relief
®
Advance ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RELIEF
®
ADVANCE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of the product contains:
Benzocaine
200.0 mg
3.
PHARMACEUTICAL FORM
Rectal ointment
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
The product is used as local anesthetic agent in case of hemorrhoids,
anal
fissures, after proctologic operations and during diagnostic
manipulations.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
The product should be applied after the performance of hygienic
procedures.
Remove cover from applicator. Attach applicator to tube and squeeze
out a small
amount of ointment to lubricate applicator. The ointment is carefully
applied
through applicator to affected areas outside or inside the anus up to
4 times daily,
especially at night, in the morning and after each bowel movement.
Thoroughly
cleanse applicator after each use and replace cover.
Children under 12 years of age: only if directed by a doctor.
_4.3 _
_CONTRAINDICATIONS _
Individual hypersensitivity to any of the product’s ingredients,
thromboembolic
disease, granulocytopenia.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
In case of blood-tinged discharge from anus or in case of failing of
therapeutic
effect after using of preparation during 7 days consult a proctologist
promptly.
A doctor should be consulted in the following cases:
severe arterial hypertension,
rough cardiac rhythm disturbance,
clinically apparent thyrotoxicosis,
urination disorder.
Case reports suggest that administration of benzocaine products may
cause
methemoglobinemia. Symptoms such as cyanosis (pale, gray or blue
colored skin,
lips, and nail beds), headache, lightheadedness, dyspnea (shortness of
breath),
fatigue, and tachycardia occurring under treatment may indicate a
potentially life
threatening methemoglobinemia and require immediate medical attention.
Patients who have breathing problems such as asthma, bronchitis, or
emphysema