Clarithromycin 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clarithromycin

Available from:

Apotex UK Ltd

ATC code:

J01FA09

INN (International Name):

Clarithromycin

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 5060129470592

Patient Information leaflet

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 HEART
RHYTHM DISORDERS (ventricular arrhythmia, including
torssades de pointes) or abnormality of electro-cardiogram
(ECG, electrical recording of the heart) called “long QT
syndrome”.
•
if you suffer from severe LIVER failure and KIDNEY problems
AT THE SAME TIME
•
if you have abnormally low levels of potassium in your
blood (hypokalaemia)
•
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 (hay fever, antiallergics)
-
LOVASTATIN, SIMVASTATIN (medicines to lower cholesterol)
-
COLCHICINE (to treat gout).
-
other medicines which are

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 250mg Clarithromycin
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
dark yellow, film-coated, capsule 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.