By-Mycin 50 mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxycycline hyclate

Available from:

Fannin Limited

ATC code:

J01AA; J01AA02

INN (International Name):

Doxycycline hyclate

Dosage:

50 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Tetracyclines; doxycycline

Authorization status:

Marketed

Authorization date:

1994-09-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BY-MYCIN
50MG, 100MG CAPSULES
Doxycycline (as hyclate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. 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 of the 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 By-Mycin Capsules are and what they are used for
2.
What you need to know before you take By-Mycin Capsules
3.
How to take By-Mycin Capsules
4.
Possible side effects
5.
How to store By-Mycin Capsules
6.
Contents of the pack and other information
1.
WHAT BY-MYCIN IS AND WHAT IS IT USED FOR
The name of your medicine is By-Mycin and the active substance is
doxycycline present
as doxycycline hyclate. It is available in two strengths: 50mg and
100mg capsules.
By-Mycin Capsules is a tetracycline antibiotic which may be used to
treat infections due
to gram positive and gram negative bacteria sensitive to this
medicine.
IT IS USED TO TREAT MANY DIFFERENT TYPES OF INFECTIONS INCLUDING:
•
Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis.
•
Urinary tract infections (the passage through which urine passes) e.g.
cystitis, urethritis.
•
Eye infections.
•
Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia.
•
Fevers associated with louse or tick bites.
•
Malaria, when chloroquine is not effective.
•
Acne - 50mg strength only
By-Mycin is also used to prevent certain infections developing; these
are scrub typhus (a
disease carried by small insects), travellers’ diarrhoea, malaria,
cholera and leptospirosis
(a bacterial infection from contaminated water).
YOUR DOCTOR MAY WANT YOU TO TAKE BY-MYCIN TO TR

Summary of Product characteristics

Health Products Regulatory Authority
17 August 2021
CRN00CFL3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
By-Mycin 50 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Doxycycline base 50 mg
(as doxycycline hyclate)
Excipient with known effect:
Each capsule contains 12.13mg of sucrose.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard (Capsules)
Size 4, opaque pale green cap and opaque white body, hard gelatin
capsules, containing spherical yellow to yellowish micro
granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
By-Mycin has been found clinically effective in the treatment of a
variety of infections caused by susceptible strains of
Gram-positive and Gram-negative bacteria and certain other
micro-organisms.
RESPIRATORY TRACT INFECTIONS:
Pneumonia and other lower respiratory tract infections due to
susceptible strains of _Streptococcus pneumoniae, Haemophilus _
_influenzae, Klebsiella pneumoniae, Moraxella catarrhalis_ and other
organisms_. Mycoplasma pneumonia _pneumonia. Treatment
of chronic bronchitis, sinusitis.
URINARY TRACT INFECTIONS:
Infections caused by susceptible strains of Klebsiella species,
Enterobacter species, _Escherichia coli, Streptococcus faecalis _and
other organisms.
SEXUALLY TRANSMITTED DISEASES:
Infections due to _Chlamydia trachomatis _including uncomplicated
urethral, endocervical or rectal infections. Non-gonococcal
urethitis caused by _Ureaplasma urealyticum _(Tmycoplasma).
By-Mycin is also indicated in infections due to _Calymmatobacterium
granulomatis_. By-Mycin is an alternative drug in the
treatment of gonorrhoea and syphilis.
DERMATOLOGICAL INFECTIONS:
Acne vulgaris and acne conglobata.
Since By-Mycin is a member of the tetracycline series of antibiotics,
it may be expected to be useful in the treatment of
infections, which respond to other tetracyclines such as:
OPHTHALMIC INFECTIONS:
By-Mycin is indicated in the treatment of trachoma, although the
infectious agent is not