Amoxil 3g oral powder sachets sucrose free

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
18-11-2017
Prenos Lastnosti izdelka (SPC)
18-11-2017

Aktivna sestavina:

Amoxicillin trihydrate

Dostopno od:

GlaxoSmithKline UK Ltd

Koda artikla:

J01CA04

INN (mednarodno ime):

Amoxicillin trihydrate

Odmerek:

3gram

Farmacevtska oblika:

Powder for oral suspension

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010103; GTIN: 5010005051247

Navodilo za uporabo

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXIL

SACHETS 3 G SUCROSE-FREE
AMOXICILLIN
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 (or for your child) 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 Amoxil is and what it is used for
2.
What you need to know before you take Amoxil
3.
How to take Amoxil
4.
Possible side effects
5.
How to store Amoxil
6.
Contents of the pack and other information
1 WHAT AMOXIL IS AND WHAT IT IS USED FOR
WHAT AMOXIL IS
Amoxil is an antibiotic. The active ingredient is amoxicillin. This
belongs to a group of medicines called
‘penicillin’.
WHAT AMOXIL IS USED FOR
Amoxil is used to treat infections caused by bacteria in different
parts of the body. Amoxil may also be
used in combination with other medicines to treat stomach ulcers.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXIL
DO NOT TAKE AMOXIL:
•
if you are allergic to amoxicillin, penicillin or any of the other
ingredients of this medicine (listed in
section 6).
•
if you have ever had an allergic reaction to any antibiotic. This can
include a skin rash or swelling of
the face or throat.
Do not take Amoxil if any of the above apply. If you are not sure,
talk to your doctor or pharmacist before
taking Amoxil.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Amoxil if you:
•
have glandular fever (fever, sore throat, swollen glands, and extreme
tiredness)
•
have kidney problems
•
are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking
Amoxi
                                
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Lastnosti izdelka

                                AMOXIL 3G SACHET
Summary of Product Characteristics Updated 05-Apr-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Amoxil® Sachets 3 G Sucrose-Free
2. Qualitative and quantitative composition
Amoxil Sachets 3 G Sucrose-Free contain 3 G amoxicillin per sachet
The amoxicillin is present as the trihydrate.
3. Pharmaceutical form
Amoxil Sachets SF: sucrose-free sachets in a sorbitol base, for
reconstitution in water.
Each sachet carries instructions for preparation.
4. Clinical particulars
4.1 Therapeutic indications
Amoxil is indicated for the treatment of the following infections in
adults and children (see sections 4.2,
4.4 and 5.1):
• Acute bacterial sinusitis
• Acute otitis media
• Acute streptococcal tonsillitis and pharyngitis
• Acute exacerbations of chronic bronchitis
• Community acquired pneumonia
• Acute cystitis
• Asymptomatic bacteriuria in pregnancy
• Acute pyelonephritis
• Typhoid and paratyphoid fever
• Dental abscess with spreading cellulitis
• Prosthetic joint infections
• _Helicobacter pylori_ eradication
• Lyme disease
Amoxil is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The dose of Amoxil that is selected to treat an individual infection
should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection
and the response of the patient, and
should generally be as short as possible. Some infections require
longer periods of treatment (see section
4.4 regarding prolonged therapy).
ADULTS AND CHILDREN ≥40 KG
INDICATION*
DOSE*
Acute bacterial sinusitis
250 mg to 500 mg every 8 hours or 750 mg to 1 g
every 12 hours
For severe infections 750 mg to 1 g every 8 hours

                                
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