Clarithromycin 125mg/5ml oral suspension

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Clarithromycin

Saatavilla:

Sun Pharma UK Ltd

ATC-koodi:

J01FA09

INN (Kansainvälinen yleisnimi):

Clarithromycin

Annos:

25mg/1ml

Lääkemuoto:

Oral suspension

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 05010500; GTIN: 5015525037375 5015525037368

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 125 MG/5 ML ORAL SUSPENSION
CLARITHROMYCIN 250 MG/5 ML ORAL SUSPENSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS
MEDICINE TO YOUR CHILD
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD.

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 your child
_ _
only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as your
child’s.

If your child gets 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 Clarithromycin Oral Suspension is and what it is used for
2.
What you need to know before you give Clarithromycin Oral Suspension
3.
How to give Clarithromycin Oral Suspension
4.
Possible side effects
5.
How to store Clarithromycin Oral Suspension
6.
Contents of the pack and other information
1.
WHAT CLARITHROMYCIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
_ _
Clarithromycin is part of a group of antibiotics called macrolides.
Clarithromycin works by
destroying some types of bacteria that cause certain infections.
Clarithromycin may be used
to treat infections that are caused by bacteria in the chest, throat,
sinuses and ear
[particularly inflammation of middle ear (otitis media)] and
infections of the skin and the
layers of flesh just under the skin.
Clarithromycin Oral Suspension is used in children 6 months to 12
years old.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE CLARITHROMYCIN ORAL SUSPENSION
DO NOT GIVE CLARITHROMYCIN ORAL SUSPENSION, IF YOUR CHILD:
-
is allergic to clarithromycin, other macrolide antibiotics such as
erythromycin or
azithromycin, or any of the other ingredients of this medicine (listed
in section 6).
-
has abnormally low levels of potassium in your blood (hypokalaemia)
-
has severe liver disorders combined with kidney disorders
-
or so

Valmisteyhteenveto

OBJECT 1
CLARITHROMYCIN 125MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 06-Apr-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Clarithromycin 125mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Each 5 ml of the constituted suspension contains clarithromycin 125 mg
Excipients with known effect
Each 5ml constituted suspension contains:
2928.50mg of sucrose
20mg of aspartame
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules for oral suspension
White to off-white granular powder forming white to off-white
suspension on reconstitution with water.
4. Clinical particulars
4.1 Therapeutic indications
Clarithromycin 125mg/5ml Oral Suspension is indicated in children, 6
months to 12 years.
Clarithromycin 125mg/5ml Oral Suspension is indicated for treatment of
the following infections in
children when caused by clarithromycin-susceptible organisms:
- Lower respiratory tract infections (e.g. bronchitis, pneumonia) see
section 4.4 and 5.1 regarding
Sensitivity Testing).
- Upper respiratory tract infections (e.g. pharyngitis, sinusitis).
- Skin and skin structure infections (e.g. folliculitis, cellulitis,
erysipelas) see section 4.4 and 5.1 regarding
Sensitivity Testing).
- Acute otitis media.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
POSOLOGY
Paediatric patients under 12 years of age
Clinical trials have been conducted using clarithromycin paediatric
suspension in children 6 months to 12
years of age. Therefore, children under 12 years of age should use
clarithromycin pediatric suspension
The dosage of clarithromycin depends on the clinical condition of the
patient and has to be defined in any
case by the physician.
Clarithromycin 125mg/5ml Oral Suspension
The usual duration of treatment is 5 to 10 days depending on the
pathogen involved and the severity of
the condition.
The recommended daily dose of Clarithromycin 1