VIBRAMYCIN 100 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXYCYCLINE HYDROCHLORIDE

Available from:

Pfizer Limited

ATC code:

J01AA02

INN (International Name):

DOXYCYCLINE HYDROCHLORIDE

Dosage:

100 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

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

Therapeutic area:

Tetracyclines

Authorization status:

Authorised

Authorization date:

1977-10-14

Patient Information leaflet

Page 1 of 7
2017-0033012
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), 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 NEED TO KNOW BEFORE YOU TAKE VI

Summary of Product characteristics

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, coded 'Pfizer' and 'Vibracina' in grey
ink.
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, Moraxella catarrhalis_
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 or rectal infections. Non-
gonococcal urethritis caused by_ Ureaplasma urealyticum_
(T-mycoplasma). Vibramycin is also indicated in infections
due to_ Calymmatobacterium granulomatis_. 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 to be 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 not always eliminated, as judged
by immunofluorescence. Inclusion conjunctivitis may be treated with
oral Vibramycin alone or in combination with
topical agents.
_RICKETTSIAL INFECTIONS_:
Rocky Mountain spot