Clarithromycin 500mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Clarithromycin

Sẵn có từ:

Teva UK Ltd

Mã ATC:

J01FA09

INN (Tên quốc tế):

Clarithromycin

Liều dùng:

500mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 05010500; GTIN: 5017007025504

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 250 MG AND 500 MG
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 further questions, 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
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 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
Each Clarithromycin tablet contains 250 mg of the active
ingredient clarithromycin
Each Clarithromycin tablet contains 500 mg of the active
ingredient clarithromycin.
Clarithromycin belongs to a group of medicines called
macrolide antibiotics. Antibiotics stop the growth of
bacteria (bugs) which cause infections.
Clarithromycin tablets are used to treat infections such as:
•
Chest infections such as bronchitis and pneumonia
•
Throat and sinus infections
•
Skin and tissue infections
•
_Helicobacter pylori_ infection associated with duodenal
ulcer
Clarithromycin tablets are indicated in adults and children
12 years and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CLARITHROMYCIN TABLETS
DO NOT TAKE CLARITHROMYCIN TABLETS IF YOU:
•
know that you are ALLERGIC to clarithromycin, other
macrolide antibiotics such as erythromycin or
azithromycin, or any of the other ingredients in the
tablets (see section 6).
•
are taking medicines called ergot alkaloid tablets (e.g.
ergotamine or dihydroergotamine) or use ergo

Đặc tính sản phẩm

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