Doxy-Denk 100 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

doxycycline (doxycycline hyclate)

Available from:

Artesan Pharma GmbH & Co. KG

ATC code:

J01AA02

INN (International Name):

doxycycline (doxycycline hyclate)

Dosage:

100mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-08-08

Patient Information leaflet

_Doxy-Denk 100 _
Tablet – oral use
Antibiotic
Active substance: Doxycycline
Package leaflet: Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMA-
TION FOR YOU.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
WHAT DOXY-DENK 100 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE DOXY-DENK 100
3.
HOW TO TAKE DOXY-DENK 100
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DOXY-DENK 100
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Doxy-Denk 100 is_ _and what it is
used for
Doxy-Denk
100
is
a
medicine
(antibiotic)
from
the
tetracycline group. Doxycycline works by preventing the
growth and spread of bacteria that cause infections in your
body and which are sensitive to doxycycline.
Doxy-Denk 100 is used in:
• Infections of the respiratory tract and ears, nose and
throat:
– acute attacks of chronic bronchitis,
– infections of the nasal sinuses,
– tympanitis (otitis media),
– certain types of lung infections (pneumonia).
• Urogenital infections:
– inflammation of the urethra,
– inflammation of the prostate gland,
– uncomplicated gonorrhoea (the clap),
– infections of the female sex organs,
– syphilis in patients who are allergic to penicillin,
– urinary tract infections.
• Gastrointestinal infections.
• Outpatient therapy of infections of the biliary tract.
• Skin disease, including infected severe forms of common
acne and rosacea.
• Conjunctivitis and trachoma.
• Illnesses caused by _Borrelia_, such as erythema chroni
-
cum migrans und Lyme disease (primarily caused by
infections trigger

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doxy-Denk 100
Doxy-Denk 200
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: doxycycline
_Doxy-Denk 100_
Each tablet contains 100 mg doxycycline (as doxycycline hyclate).
Excipient with known effect: each tablet contains 21 mg of lactose
monohydrate and less than 1 mmol
(23 mg) sodium.
_Doxy-Denk 200_
Each film-coated tablet contains 200 mg doxycycline (as doxycycline
hyclate).
Excipient with known effect: each film-coated tablet contains 55 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Doxy-Denk 100 _
Tablet
Pale yellow, round, convex tablet without breaking notch.
_Doxy-Denk 200_
Film-coated tablet
Greenish-yellow, biconvex, round tablets with a score line.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doxycycline is indicated in infections caused by disease pathogens
susceptible to doxycycline (see
section 5.1), especially:
●
infections of the respiratory tract and ENT region
-
acute episodes of chronic bronchitis
-
sinusitis
-
otitis media
-
pneumonia due to mycoplasmas, Rickettsia or Chlamydia
●
urogenital tract infections
-
urethritis due to Chlamydia and Ureaplasma urealyticum
-
acute prostatitis
-
uncomplicated gonorrhoea (especially with concomitant Chlamydia
infection)
-
infections of the female reproductive organs
-
syphilis in the presence of penicillin allergy
-
urinary tract infections (only when the susceptibility of the pathogen
has been confirmed)
2
●
gastrointestinal tract infections
-
cholera
-
Yersinia or Campylobacter infection
-
Shigella infection when susceptibility has been confirmed
●
outpatient therapy of biliary tract infections
●
skin disorders, including infected severe forms of acne vulgaris and
rosacea
●
chlamydial conjunctivitis with trachoma
●
borreliosis (erythema chronicum migrans or Lyme disease)
●
rare infections such as brucellosis, ornithosis, bartonellosis,
listerio