Erythromycin 250mg gastro-resistant tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
01-03-2018
Prenos Lastnosti izdelka (SPC)
31-01-2018
Prenos Javno poročilo o oceni (PAR)
20-04-2020

Aktivna sestavina:

Erythromycin

Dostopno od:

Noumed Life Sciences Ltd

Koda artikla:

J01FA01

INN (mednarodno ime):

Erythromycin

Odmerek:

250mg

Farmacevtska oblika:

Gastro-resistant tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010500; GTIN: 05060453460153

Navodilo za uporabo

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
GASTRO-RESISTANT TABLETS
ERYTHROMYCIN 250 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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 symptoms 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 Erythromycin Gastro-resistant Tablets are and what they are used
for
2.
What you need to know before you take Erythromycin Gastro-resistant
Tablets
3.
How to take Erythromycin Gastro-resistant Tablets
4.
Possible side effects
5.
How to store Erythromycin Gastro-resistant Tablets
6.
Contents of the pack and other information
1.
WHAT ERYTHROMYCIN GASTRO-RESISTANT TABLETS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Erythromycin 250 mg Gastro-resistant
Tablets. Erythromycin belongs to a group of medicines called
antibiotics
which act by preventing the growth and multiplication of bacteria.
Erythromycin is used for the treatment and prevention of infections
caused
by erythromycin-sensitive organisms, such as:
•
Upper and lower respiratory tract infections
•
Eye and ear infections
•
Oral infections
•
Skin and soft tissue infections
•
Gastrointestinal infections
•
Prophylaxis pre- and post- operative trauma, burns, rheumatic fever
•
Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis,
lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ERYTHROMYCIN GASTRO-RESISTANT TABLETS
DO NOT TAKE ERYTHROMYCIN GASTRO-RESISTANT TABLETS IF:
•
You are allergic (hypersensitive) to erythromycin or any of the other
ingredients of this medicine (listed in section 6).
•
You are taking simvastatin (for reducing blood cholesterol),
domperidone (for
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Erythromycin 250mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 250mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablets;
Reddish orange coloured round biconvex tablets, plain on both sides.
They are
made Gastro-resistant by enteric coating.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of infections caused by
Erythromycin-sensitive
organisms.
Erythromycin is highly effective in the treatment of a great variety
of clinical
infections such as:
1.
Upper respiratory tract infections: Tonsillitis, peritonsillar
abscess,
pharyngitis, laryngitis, sinusitis, secondary infections in influenza
and
common colds.
2.
Lower respiratory tract infections: Tracheitis, acute and chronic
bronchitis,
pneumonia (lobar pneumonia, bronchopneumonia, primary atypical
pneumonia), bronchiectasis, Legionnaire's disease
3.
Ear infections: Otitis media and otitis externa, mastoiditis.
4.
Eye infections: Blepharitis
5.
Oral infections: Gingivitis, Vincent's angina
6.
Skin and soft tissue infections: Boils and carbuncles, paronychia,
abscesses,
pustular acne, impetigo, cellulitis, erysipelas
7.
Gastro-intestinal infections: cholecystitis, staphylococcal
enterocolitis
8.
Prophylaxis: pre- and post- operative trauma, burns, rheumatic fever
9.
Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis,
lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever
Note:
Erythromycin has also proved to be of value in endocarditis and
septicaemia,
but in these conditions initial administration of erythromycin
lactobionate by the
intravenous route is advisable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
Adults and children over 8 years: For mild to moderate infections 2g
daily in
divided doses Up to 4g daily in severe infections.
Elderly: No special dosage recommendations.
Note: For younger children, infants and babies, Erythroped,
ery
                                
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