Clarithromycin 500mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Clarithromycin

Dostupno od:

Phoenix Healthcare Distribution Ltd

ATC koda:

J01FA09

INN (International ime):

Clarithromycin

Doziranje:

500mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05010500

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
Clarithromycin is an antibiotic which belongs to the group of
macrolide antibiotics. It stops the growth of certain bacteria.
Clarithromycin is used to treat:
•
Infections of the respiratory tract (nose, throat and lungs)
such as pneumonia, bronchitis, sinusitis and pharyngitis.
•
Mild to moderate skin and soft tissue infections.
•
It can also be used, in combination with other antibacterials
and appropriate ulcer healing agents, to eradicate
H. pylori infections.
DO NOT TAKE CLARITHROMYCIN
•
if you are ALLERGIC to clarithromycin, other macrolide
antibiotics or to any of the other ingredients of this
medicine (listed in section 6).
•
if you or someone in your family has a history of certain
abnormal HEART RHYTHMS (ventricular arrhythmia, including
torssades de pointes) or changes in the heart activity as
measured in the electro-cardiogram called “QT
prolongation”
•
if you suffer from severe LIVER failure and KIDNEY problems
AT THE SAME TIME
•
if your BLOOD POTASSIUM OR MAGNESIUM level is low
(hypolalaemia or hypomagnesemia).
•
if you are taking
-
ticagrelor (to prevent blood clotting)
-
ranolazine (used to treat angina pectoris)
-
ERGOTAMINE, DIHYDROERGOTAMINE (medicines to treat migraine)
-
CISAPRIDE (gastric medicine)
-
PIMOZIDE (antipsychotic)
-
TERFENADINE or ASTEMIZOLE (antiallergics)
-
LOVASTATIN, SIMVASTATIN (medicines to lower cholesterol)
-
COLCHICINE (to treat gout).
-
other medicines which are know

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 500mg Clarithromycin
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
light yellow, film-coated, oval shaped tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin film-coated tablets are indicated in adults and
adolescents
12 years and older for the treatment of the following bacterial
infections, when
caused by clarithromycin susceptible bacteria(see section 4.4 and
5.1).
•
Acute bacterial exacerbation of chronic bronchitis
•
Mild to moderate community acquired pneumonia
•
Acute bacterial sinusitis
•
Bacterial pharyngitis
•
Skin infections and soft tissue infections of mild to moderate
severity,
such as folliculitis, cellulitis and erysipelas
Clarithromycin film-coated tablets can also be used 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
The dosage of Clarithromycin film-coated Tablets depends on the
clinical
condition of the patient and has to be defined in any case by the
physician.
_Children older than 12 years and adults: _
•
Standard dosage: The usual dose is 250 mg twice daily.
•
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice daily in severe infections.
•
Clinical trials have been conducted using clarithromycin pediatric
suspension in children 6 months to 12 years of age. Therefore,
children
under 12 years of age should use clarithromycin pediatric suspension
(granules for oral suspension).
_Elimination of Helicobacter pylori in adults: _
In patients with gastro-duodenal ulcers due to H. py