Vibramycin Capsules 100 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxycycline

Available from:

Pfizer Healthcare Ireland

ATC code:

J01AA; J01AA02

INN (International Name):

Doxycycline

Dosage:

100 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:

1977-10-14

Patient Information leaflet

Page 1 of 7
2020-0063461
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIBRAMYCIN
TM
CAPSULES 100 MG
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 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 Vibramycin is and what it is used for
2.
What you need to know before you take Vibramycin
3.
How to take Vibramycin
4.
Possible side effects
5.
How to store Vibramycin
6.
Contents of the pack and other information
1.
WHAT VIBRAMYCIN IS AND WHAT IS IT USED FOR
This medicine contains doxycycline, which is an antibiotic belonging
to a group of medicines called
tetracyclines. 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.
Vibramycin is also used to prevent certain infections developing,
these are scrub typhus (a disease carried
by small insects), Rocky Mountain spotted fever, travellers’
diarrhoea, malaria, cholera and leptospirosis
(a bacterial infection from contaminated water).
Your doctor may want you to take Vibramycin to treat another infection
not listed above. You may also be
prescribed an additional medicine to take with Vibramycin to treat
your infection. You must talk to a
doctor if you do not feel better or if you feel worse.
2.
WHAT YOU N

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2021
CRN00CG29
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vibramycin Capsules 100 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg doxycycline as doxycycline hyclate.
Excipients with known effect:
Each capsule contains 104 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Dark green opaque capsules, printed “Pfizer Vibracina” in
off-white colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vibramycin 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, Moraxellacatarrhalis _and other
organisms. _Mycoplasma pneumoniae. _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 orrectal infections. Non-gonococcal
urethritis caused by _Ureaplasma urealyticum _(Tmycoplasma).Vibramycin
is also indicated in infections due to
_Calymmatobacteriumgranulomatis._ Vibramycin is an alternative drug in
the treatment of gonorrhoea and syphilis.
Since Vibramycin is a member of the tetracycline series of
antibiotics, it may be expected tobe useful in the treatment of
infections which respond to other tetracyclines such as:
_OPHTHALMIC INFECTIONS:_
Vibramycin is indicated in the treatment of trachoma, although the
infectious agent is notalways eliminated, as judged by
immunofluorescence. Inclusion conjunctivitis may be treatedwith oral
Vibramycin alone or in combin