Erythromycin 250mg gastro-resistant tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
01-03-2018
Shusha Tabia za bidhaa (SPC)
31-01-2018

Viambatanisho vya kazi:

Erythromycin

Inapatikana kutoka:

Noumed Life Sciences Ltd

ATC kanuni:

J01FA01

INN (Jina la Kimataifa):

Erythromycin

Kipimo:

250mg

Dawa fomu:

Gastro-resistant tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 05010500; GTIN: 05060453460153

Taarifa za kipeperushi

                                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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Tabia za bidhaa

                                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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