Clarithromycin 500mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Clarithromycin

Disponible depuis:

Milpharm Ltd

Code ATC:

J01FA09

DCI (Dénomination commune internationale):

Clarithromycin

Dosage:

500mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05010500; GTIN: 8901175023189

Notice patient

CLARITHROMYCIN 250 MG FILM-COATED TABLETS
CLARITHROMYCIN 500 MG FILM-COATED TABLETS
Clarithromycin
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Clarithromycin is and what it is used for
2.
What you need to know before you take Clarithromycin
3.
How to take Clarithromycin
4.
Possible side effects
5.
How to store Clarithromycin
6.
Contents of the pack and other information.
Clarithromycin belongs to a group of medicine called macrolide
antibiotics. Antibiotics stop the growth of bacteria which cause
infections.
Clarithromycin is used to treat following infections:
•
Chest infections such as bronchitis and pneumonia,
•
Throat and sinus infections,
•
Skin and soft tissue infections,
•
Helicobacter pylori infections associated with duodenal ulcers.
DO NOT TAKE CLARITHROMYCIN IF:
•
you are ALLERGIC to clarithromycin, other macrolide antibiotics or
any of the other ingredients of this medicine (listed in section 6).
•
you have a history of certain abnormal HEART RHYTHMS
(ventricular arrhythmia, including torsades de pointes) or
changes in the heart activity as measured in the electro-
cardiogram called “QT prolongation”,
•
you suffer from severe liver failure and kidney problems at the
same time,
•
You are taking medicines called terfenadine or astemizole (for
hay fever or allergies) or cisapride or pimozide tablets as
combining these drugs can sometimes cause serious
disturbances in heart rhythm. Consult your doctor for advice on
altern

Résumé des caractéristiques du produit

OBJECT 1
CLARITHROMYCIN 500 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 19-Jun-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Clarithromycin 500 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 500 mg of clarithromycin
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Light yellow coloured, oval shaped, biconvex film-coated tablets, with
'D' debossed on one side and '63'
on the other side. The size is 18.5 mm x 8.1 mm.
4. Clinical particulars
4.1 Therapeutic indications
Clarithromycin film-coated tablets are indicated for the treatment of
the following bacterial infections,
when caused by clarithromycin-susceptible bacteria (see section 4.4
and 5.1).
• Bacterial pharyngitis
• Mild to moderate community acquired pneumonia
• Acute bacterial sinusitis (adequately diagnosed)
• Acute exacerbation of chronic bronchitis
• Skin infections and soft tissue infections of mild to moderate
severity,
• In appropriate combination with antibacterial therapeutic regimens
and an appropriate ulcer healing
agent for the eradication of Helicobacter pylori in patients with
Helicobacter pylori associated ulcers (see
section 4.2).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The dosage of Clarithromycin film-coated tablets depends on the type
and severity of the infection and
has to be defined in any case by the physician.
_Clarithromycin 500 mg film-coated tablet is not suitable for doses
below 500 mg. There are other options_
_for this strength available on the market._
Adults and adolescents (12 years and older)
• Standard dosage: The usual dose is 250 mg twice daily (in the
morning and in the evening)
• High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice daily in
severe infections.
Children younger than 12 years:
Use of Clarithromycin fi