Clindamycin EQL Pharma 300 mg Kapsel, hård

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

klindamycinhydroklorid

Dostupné s:

EQL Pharma AB

ATC kód:

J01FF01

INN (Mezinárodní Name):

clindamycin

Dávkování:

300 mg

Léková forma:

Kapsel, hård

Složení:

laktosmonohydrat Hjälpämne; klindamycinhydroklorid 325,8 mg Aktiv substans

Druh předpisu:

Receptbelagt

Přehled produktů:

Förpacknings: Blister, 21 kapslar; Blister, 32 kapslar; Burk, 100 kapslar; Burk, 105 kapslar

Stav Autorizace:

Godkänd

Datum autorizace:

2018-11-01

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLINDAMYCIN EQL PHARMA 150 MG CAPSULES, HARD
CLINDAMYCIN EQL PHARMA 300 MG CAPSULES, HARD
clindamycin
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 Clindamycin EQL Pharma is and what it is used for
2.
What you need to know before you take Clindamycin EQL Pharma
3.
How to take Clindamycin EQL Pharma
4.
Possible side effects
5.
How to store Clindamycin EQL Pharma
6.
Contents of the pack and other information
1.
WHAT CLINDAMYCIN EQL PHARMA IS AND WHAT IT IS USED FOR
Clindamycin EQL Pharma is a bactericidal agent (antibiotic).
Clindamycin EQL Pharma is used for the
treatment of infections in the pharynx and in skin and soft tissues.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLINDAMYCIN EQL PHARMA
DO NOT TAKE CLINDAMYCIN EQL PHARMA
•
if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6);
•
if you are allergic to lincomycin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Clindamycin EQL
Pharma:
•
if you have, or have previously had, a bowel disease. If you have,
tell your doctor about this before
you start treatment with Clindamycin EQL Pharma.
•
if you have impaired liver or kidney function
In case of long-term treatment, liver and kidney function and blood
should be examined regularly by the
physician.
Acute kidney disorders may occur. Please inform your doctor about any
medication you currently take and
if you have any existing problems with your kidneys. If y

Charakteristika produktu

1
1.
NAME OF THE MEDICINAL PRODUCT
Clindamycin EQL Pharma 150 mg capsules, hard
Clindamycin EQL Pharma 300 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains:
Clindamycin hydrochloride, equivalent to 150 mg or 300 mg clindamycin.
Excipients with known effect: one hard capsule contains lactose
monohydrate of 0.6 mg or 1 mg (see
section 4.4).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules, hard
150 mg: hard cylindrical gelatin capsules, 17,5 mm with blue body and
blue cap.
300 mg: hard cylindrical gelatin capsules, 21,7 mm with white body and
blue cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the following indications, Clindamycin EQL Pharma should be
reserved for patients who are
hypersensitive to beta-lactam antibiotics or where they are unsuitable
for other reasons:
Pharyngotonicillitis. Skin and soft tissue infections, including
recurrent hidroadenitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
_Adults:_
300 mg 2 times daily or 150 mg 3-4 times daily. If necessary, the dose
can be increased to 300
mg 3-4 times daily.
_Pediatric population:_
The capsules should only be used for children who are able to swallow
capsules.15 mg / kg and day divided into 3 doses. Children weighing 30
- 45 kg are given 150 mg 3
times a day. The maximum dose is 20 mg / kg / day. At this dose,
dosing should be done 4 times daily.
As capsules cannot always be used to give the exact dose in mg / kg as
desired in the treatment of
children, it may be necessary to use other products and formulations
with clindamycin instead.
_Treatment control:_
In long-term treatment, liver and renal function tests should be
performed and the
blood image monitored. If diarrhea occurs during treatment, the
product should be discontinued. If
rapid improvement does not occur, study on
_Clostridium difficile_
should be performed.
Method of administration
The capsules should be taken whole with at least ½ glass of liquid
and in upright position (not in the
lying positio