OSPAMOX 1000MG FILM-COATED TABLET

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

AMOXYCILLIN TRIHYDRATE

Dostępny od:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Nazwa):

AMOXYCILLIN TRIHYDRATE

Sztuk w opakowaniu:

14Tablet Tablets; 12Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 1000Tablet Tablets; 80 Tablets

Wyprodukowano przez:

SANDOZ GMBH

Ulotka dla pacjenta

OSPAMOX FILM-COATED
TABLET
Amoxicillin Trihydrate (1000mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET:
1. What is Ospamox used for
2. How Ospamox works
3. Before you use Ospamox
4. How to use Ospamox
5. While you are using Ospamox
6. Side effects
7. Storage and disposal of Ospamox
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT IS OSPAMOX USED FOR
Ospamox is used to treat infections
caused by bacteria in different parts
of the body such as:
•
Infections of the ear, throat, nose
and sinuses
•
Chest infections such as
bronchitis and pneumonia
•
Infections affecting urinary and
genital tract
•
Prevention of heart infections
during mouth or throat surgery
•
Gastrointestinal infections
_ _
•
Skin and soft tissues infections
_ _
Your doctor may have prescribed
Ospamox for another reason.
_ _
HOW OSPAMOX WORKS
Ospamox is an antibiotic. It belongs
to a group of antibiotics called
penicillins which is amoxycillin. It is
used to treat infections caused by
bacteria which are sensitive to
amoxicillin.
BEFORE YOU USE OSPAMOX
-
_When you must not use it _
•
If you are allergic
(hypersensitive) to amoxicillin,
penicillins, cephalosporins or to
any of the other ingredients of
this medicine
_Pregnancy _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice
before using this medicine.
As a precautionary measure,
amoxicillin should only be used
during pregnancy if in the judgement
of the physician the potential benefits
outweigh the possible hazards.
_ _
_Breast-feeding _
This medicine passes into breast
milk in small quantities, therefore
in some cases it may be necessary
to stop breastfeeding.
-
_Before you start use it _
Talk to your doctor or pharmacist
before taking Ospamox if you have:
•
any allergic conditions
•
fits/ convulsions
•
kidney disease
•
severe and persistent diarrhea
-
_Taking other medicines _
Tell your doctor or pharmacist, i

Charakterystyka produktu

OSPAMOX
®
1000 MG FILM-COATED TABLETS
__________________________________________________________________________________
1.
NAME OF THE MEDICINAL PRODUCT
Ospamox 1000 mg Film-Coated Tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Amoxicillin 1000 mg.
White to off-white, oval, biconvex, scored on both sides. Size is
approx. 11 x 22.5 mm.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ospamox is useful in the treatment of infections caused by
amoxicillin-susceptible organisms:
_ _
_Respiratory tract infections_
•
Upper airways and ENT infections
•
Lower airways infections, e.g. acute and chronic bronchitis,
pneumonia, Iung abscesses, pertussis
(incubation period and early stages)
_Urogenital Infections_
•
Acute and chronic pyelonephritis, pyelitis, prostatitis, epididymitis
•
Cystitis, urethritis, asymptomatic bacteriuria during pregnancy
•
Gonorrhea
_Gynecologic infections _(septic abortion, adnexitis, endometritis,
etc.)
_ _
_Gastro-intestinal infections_
•
Typhoid fever, paratyphoid, particularly if complicated by septicemia
(in combination with
an aminoglycoside antibiotic); control of Salmonella carriers
•
Shigellosis
•
Infections of the biliary system (cholangitis, cholecystitis)
_Skin and soft tissue infections_
_ _
_Leptospirosis_
_ _
_Acute and latent listeriosis_
_ _
Unless parenteral treatment (e.g. with ampicillin) is required,
Ospamox is also active in the conditions
below:
•
Short-term (24 to 48 hours) prophylactic treatment of patients
undergoing surgery (e.g. in the
oral cavity)
•
Endocarditis, e.g. enterococcal endocarditis (alone or in combination
with an aminoglycoside
antibiotic)
•
Bacterial meningitis (pending the outcome of susceptibility tests;
particularly in children)
•
Septicemias caused by amoxicillin-susceptible pathogens.
Infections caused by pathogens with established with penicillin G
susceptibility should preferentially be
treated with penicillin G.
Consideration should be gi