Clarithromycin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clarithromycin

Available from:

HEC Pharm GmbH

ATC code:

J01FA09

INN (International Name):

Clarithromycin

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 05060630240011

Patient Information leaflet

PACKAGE LEAFLET – INFORMATION FOR THE USER
CLARITHROMYCIN 250MG FILM-COATED TABLETS
CLARITHROMYCIN 500MG FILM-COATED TABLETS
(Clarithromycin)
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, please ask your doctor or your
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 you doctor or pharmacist. This
includes any possible side _
_effects not listed in the leaflet. See section 4. _
WHAT IS IN THIS LEAFLET:
1. What Clarithromycin Tablets are and what they are used for
2. What you need to know before you take Clarithromycin Tablets
3. How to take Clarithromycin Tablets
4. Possible side effects
5. How to store Clarithromycin Tablets
6. Contents of the pack and other Information
1. WHAT CLARITHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR
Clarithromycin belongs to a group of medicine called macrolide
antibiotics. Antibiotics stop the
growth of bacteria (bugs) which cause infections.
Clarithromycin tablets are 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.
Clarithromycin tablets are indicated in adults and children 12 years
and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN
DO NOT TAKE CLARITHROMYCIN TABLETS IF YOU:

know
that
you
are
ALLERGIC
to
clarithromycin
or
other
macrolide
antibiotics
such
as
erythromycin or azithromycin, or any of the other ingredients of
Clarithromycin Tablets.

are taking medicines called ergot alkaloid tablets (e.g. ergotamine or
dihydroergotamine) or
use ergotamine inhalers for migraine.

are
taking
medicines
called
terfenadine
or
astemizole
(widely
ta

Summary of Product characteristics

OBJECT 1
CLARITHROMYCIN 500MG TABLETS
Summary of Product Characteristics Updated 23-Feb-2019 | Accord
Healthcare Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Clarithromycin 500mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains Clarithromycin 500 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated Tablets
Clarithromycin tablets 500 mg are Light yellow coloured, oval shaped,
biconvex, film-coated tablets, with 'C'
and '2' debossed on either side of breakline on one side.
4. Clinical particulars
4.1 Therapeutic indications
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Clarithromycin is indicated in adults and children 12 years and older.
(Adult only formulations, e.g. tablets,
IV)
Clarithromycin Tablets are indicated for treatment of the following
infections caused by susceptible
organisms Indication include:
Lower respiratory tract infec