Minocin SA 100 mg Modified Release Capsules

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Minocycline

Saatavilla:

IMED Healthcare Ltd.

ATC-koodi:

J01AA; J01AA08

INN (Kansainvälinen yleisnimi):

Minocycline

Annos:

100 milligram(s)

Lääkemuoto:

Modified-release capsule, hard

Prescription tyyppi:

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

Terapeuttinen alue:

Tetracyclines; minocycline

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-07-11

Pakkausseloste

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 following

Valmisteyhteenveto

Health Products Regulatory Authority
10 September 2019
CRN0096QG
Page 1 of 2
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 PA2010/060/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/060/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Croscarmellose sodium
Hypromellose phthalate 50
Hypromellose
Light liquid paraffin
Opaspray White K-1-7000
(Containing titanium dioxide E171 and hydroxypropylcellulose)
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.
Health Products Regulatory Authority
10 September 2019
CRN0096QG
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C. Store in the original package.
Keep the container in the outer carton.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PVDC aluminium blister packs containing 56 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/097/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first author