Azithromycin 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azithromycin dihydrate

Available from:

Somex Pharma

ATC code:

J01FA10

INN (International Name):

Azithromycin dihydrate

Dosage:

250mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 15060089611117 15060089611100

Patient Information leaflet

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 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 Azithromycin is and what it is used for
2. What you need to know before you take Azithromycin
3. How to take Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1.What Azithromycin is and what it is used for
This medicine contains azithromycin, which is one of a group of
antibiotics called macrolides. It is used to treat infections caused
by certain bacteria and other micro-organisms, which include:
• Chest, throat or nasal infections (such as bronchitis, pneumonia,
tonsillitis, sore throat (pharyngitis) and sinusitis)
• ear infections
• skin and soft tissue infections (such as an abscess or boil)
• sexually transmitted diseases caused by an organism called
_Chlamydia trachomatis_ and _Neisseria gonorrhoea_.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. What you need to know before you take
Azithromycin
Do not take Azithromycin:
• if you are allergic to Azithromycin or any other macrolide
antibiotic such as erythromycin or clarithromycin or any of the
ingredients of this medicine (listed in section 6). An allergic
reaction may cause skin rash or wheezing.
• if you are taking any ergot derivatives such as ergotamine
(used to treat migraine) as these medicines should not be taken
together with Azithromycin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Azithromycin
Your doctor needs to know before you take Azithro

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azithromycin 250mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains azithromycin dihydrate equivalent to 250mg of
azithromycin.
Excipients with known effect:
Each capsule contains 226.70 mg lactose.
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Capsule
White, opaque hard gelatin capsules. The capsule shells are printed in
black with “SOMEX”
on white opaque body and “250” on white opaque cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following
infections when known or likely
to be due to one or more susceptible microorganisms (see Section 5.1
Pharmacodynamic
properties):
- bronchitis
- community-acquired pneumonia
- sinusitis
- pharyngitis/tonsillitis (see 4.4 regarding streptococcal infections)
- otitis media
- skin and soft tissue infections
- uncomplicated genital infections due to _Chlamydia trachomatis._
Considerations
should
be
given
to
official
guidance
regarding
the
appropriate
use
of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Azithromycin should be given as a single daily dose. In common with
many other antibiotics
Azithromycin Capsules should be taken at least 1 hour before or 2
hours after food.
CHILDREN OVER 45 KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY
PATIENTS: The total dose of
azithromycin is 1500 mg which should be given over three days (500 mg
once daily).
In uncomplicated genital infections due to Chlamydia trachomatis, the
dose is 1000 mg as a
single oral dose. For susceptible Neisseria gonorrhoeae the
recommended dose is 1000 mg or
2000 mg of azithromycin in combination with 250 or 500 mg of
ceftriaxone according to local
clinical treatment guidelines. For patients who are allergic to
penicillin and/or cephalosporins,
prescribers should consult local treatment guidelines.
IN CHILDREN UNDER 45 KG BODY WEIGHT: Azithromycin Capsules are not
suitable for children
under 4