MOXYPEN FORTE 500 MG CAPSULES

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

AMOXICILLIN TRIHYDRATE

Commercializzato da:

TEVA ISRAEL LTD

Codice ATC:

J01CA04

Forma farmaceutica:

CAPSULES

Composizione:

AMOXICILLIN TRIHYDRATE 500 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

TEVA CANADA LIMITED

Gruppo terapeutico:

AMOXICILLIN

Area terapeutica:

AMOXICILLIN

Indicazioni terapeutiche:

Infections caused by amoxycillin - susceptible organisms. Prevention of bacteremia in patients at risk of developing bacterial endocarditis.

Data dell'autorizzazione:

2024-01-31

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
MOXYPEN
® FORTE 500 MG
CAPSULES
COMPOSITION:
Each capsule contains:
Amoxicillin (as trihydrate) 500 mg
For information on the inactive and allergenic ingredients, see
section 2 – “Important
information about some of the ingredients of the medicine” and
section 6 – “Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them even if it seems to you that
their medical
condition is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is intended for the treatment of infections caused by
bacteria
susceptible to amoxicillin. In addition, it is intended for the
prevention of bacterial
infections in patients who are at risk for developing bacterial
endocarditis.
THERAPEUTIC GROUP
Antibiotic of the penicillins group.
There are infections caused by viruses, such as the common cold.
Moxypen Forte
500 mg Capsules does not affect viruses.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient or to any of
the additional
ingredients contained in the medicine.
• You are sensitive to the packaging components of the medicine.
• You are sensitive to other medicines from the penicillin or
cephalosporin group
or to similar antibiotics such as amoxicillin, ampicillin, cephalexin
and others.
• You are suffering from mononucleosis (either suspected or
confirmed).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH MOXYPEN FORTE 500 MG CAPSULES, TELL THE DOCTOR
IF:
• You have suffered in the past from an allergic reaction to
beta-lactam antibiotics
(such as ampicillin, piperacillin). See section 4 – “S

Scheda tecnica

Moxypen forte 500mg capsules & 250mg powder for suspension SPC, NA&
OKD 08/2023
1
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Moxypen Forte 500 mg Capsules
Each capsule contains:
Amoxicillin (as Trihydrate) 500 mg
Moxypen Forte 250 mg Powder for Suspension
Each teaspoonful (5 ml) of suspension contains:
Amoxicillin (as Trihydrate) 250 mg
1. THERAPEUTIC INDICATIONS
Infections caused by amoxicillin ‐ susceptible organisms.
Prevention of bacteremia
in patients at risk of developing bacterial endocarditis.
THERAPEUTIC CLASSIFICATION
Antibiotic
2
CONTRAINDICATIONS
Moxypen Forte is contraindicated in:

patients who are hypersensitive to this drug or to any ingredient in
the formulation or
component of the container.
•
patients with a history of a previous hypersensitivity reaction to any
of the penicillins or
cephalosporins.
•
in cases where infectious mononucleosis is either suspected or
confirmed.
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
Serious Warnings and Precautions Box
Hypersensitivity: Serious and occasionally fatal hypersensitivity
(anaphylactic) and severe
cutaneous adverse reactions (SCAR) have been reported in patients
receiving therapy
with beta‐lactams, including amoxicillin. (See _7_ WARNINGS AND
PRECAUTIONS,
Hypersensitivity and 7 WARNINGS AND PRECAUTIONS, Skin).
Moxypen forte 500mg capsules & 250mg powder for suspension SPC, NA&
OKD 08/2023
2
4
DOSAGE AND ADMINISTRATION
With the exception of gonorrhea, treatment with Moxypen should be
continued for a minimum
of 48‐72 hours beyond the time at which the patient becomes
asymptomatic or evidence of
bacterial eradication has been obtained.
In the treatment of group A β‐hemolytic streptococcal infections,
therapy with this drug should
be continued for at least 10 days to help prevent the occurrence of
acute rheumatic fever or
glomerulonephritis.
Upper Respiratory Tract and Chest Infections
_Adults and Children over 10 Years of Age: _
The recommended dosage is 250‐500 mg 3 times daily, every 8 hours.
_Infants and Children