Relief Advance suppositories rectal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

benzocaine

Available from:

Istituto De Angeli S.r.l.

ATC code:

C05AD03

INN (International Name):

benzocaine

Dosage:

206mg

Pharmaceutical form:

suppositories rectal

Units in package:

(12/2x6/) in strip

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-04-03

Summary of Product characteristics

Page 1 of 3
Summary of Product Characteristics
Relief
®
Advance rectal suppositories
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RELIEF
®
ADVANCE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of the product contains:
Benzocaine
206 mg
3.
PHARMACEUTICAL FORM
Rectal suppositories
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
A symptomatic remedy in the multimodality therapy of hemorrhoids and
anal
fissures.
4.2
Posology and Method of Administration
The product should be applied after the performance of hygienic
procedures.
Place one suppository into the anus up to 4 times daily, especially at
night, in the
morning or after every defecation.
The duration of a treatment course should be determined by the doctor
with due
regard to disease characteristics, tolerance to the medicine, and
effect achieved.
4.3
Contraindications
This medical product must not be used in patients who have:
•
hypersensitivity to any components of the product;
•
recurrent thromboembolism;
•
granulocytopenia.
4.4
Special Warnings and Precautions for Use
You should consult your doctor in the following cases:
•
severe arterial hypertension,
•
rough cardiac rhythm disturbance,
•
clinically apparent thyrotoxicosis,
•
urination disorder.
In case of profuse bloody anal discharge, or if symptoms persist for
more than
7 days, consult a proctologist.
Children under 12: the medicine should be administered only by a
doctor.
Use the lowest amount of drug needed. 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,
patients with heart disease, and patients who smoke are at greater
risk for
complications r