Minocin SA 100 mg Modified Release Capsules

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Minocycline hydrochloride dihydrate

제공처:

PCO Manufacturing Ltd.

ATC 코드:

J01AA; J01AA08

INN (국제 이름):

Minocycline hydrochloride dihydrate

복용량:

100 milligram(s)

약제 형태:

Capsules Modified Release

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Tetracyclines; minocycline

승인 상태:

Authorised

승인 날짜:

2014-01-24

환자 정보 전단

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINOCIN
® SA
100 MG MODIFIED RELEASE CAPSULES
Minocycline
_THE NAME OF THIS PRODUCT IN THE UK IS MINOCIN MR 100MG MODIFIED _
_RELEASE CAPSULES. _
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 or
nurse.
This includes any possible side effects not listed in this leaflet.
The name of your medicine is Minocin SA 100 mg modified release
capsules, which will be called Minocin SA capsules throughout this
leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Minocin SA capsules are and what they are used for
2.
What you need to know before you take Minocin SA capsules
3.
How you take Minocin SA capsules
4.
Possible side effects
5.
How to store Minocin SA capsules
6.
Contents of the pack and further information
1.
WHAT MINOCIN SA CAPSULES ARE AND WHAT THEY ARE USED FOR
Minocin SA capsules contain the active ingredient minocycline, which
is
an antibiotic. Minocin SA capsules are used to treat acne.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINOCIN SA CAPSULES
DO NOT TAKE MINOCIN SA CAPSULES:
–
If you are allergic to minocycline, other similar drugs, or any of the
other ingredients of Minocin SA capsules (see list of ingredients in
Section 6). An allergic reaction may include rash, itching, difficulty
breathing or swelling of the face, lips, throat or tongue.
–
If you are pregnant or breast feeding
–
If you have renal (kidney) failure
–
If you have severe liver disease
–
Minocin SA capsules should not be used in children under 12 years
of age.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Minocin SA capsules if
you have any of the followi

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minocin SA 100 mg Modified Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg of minocycline equivalent to 116 mg of
minocycline hydrochloride dihydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified release hard capsules
_Product imported from the UK:_
Two piece, hard shell, size 2 capsule with an orange opaque body and a
brown cap containing a mixture of off white
and coloured (yellow, green, brown/black) spherical pellets
4 CLINICAL PARTICULARS
As per PA 1332/023/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 1332/023/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Croscarmellose sodium
Hypromellose phthalate 50
Hypromellose
Light liquid paraffin
Capsule body:
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Gelatin
Capsule cap:
Titanium dioxide (E171)
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)
Gelatin
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
24 months.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PVDC aluminium blister packs containing 56 capsules.
6.6 SPECIAL PRECAUTIONS FOR DIS