Minocin SA 100 mg Modified Release Capsules

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

MINOCYCLINE HYDROCHLORIDE

Commercializzato da:

LTT Pharma Limited

Codice ATC:

J01AA; J01AA08

INN (Nome Internazionale):

MINOCYCLINE HYDROCHLORIDE

Dosaggio:

100 milligram(s)

Forma farmaceutica:

Capsules Modified Release

Tipo di ricetta:

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

Area terapeutica:

Tetracyclines; minocycline

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2014-10-17

Foglio illustrativo

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:
What Minocin SA capsules are and what they are used for
What you need to know before you take Minocin SA capsules
How you take Minocin SA capsules
Possible side effects
How to store Minocin SA capsules
Contents of the pack and further information
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.
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 conditions:
*
If you have liver disease
*
If you have severe kidney disease
*
If you are taking another drug that affects your liver
*
If you have symptoms of liver disease such as yellow eyes or skin
*
If you have systemic lupus er

Scheda tecnica

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 100 mg of minocycline equivalent to 116 mg of
minocycline hydrochloride dihydrate.
For the 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 PA1332/023/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA1332/023/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Capsule body:
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Gelatin
Capsule cap:
Iron oxide black (E172)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Gelatin
Other ingredients:
Microcrystalline cellulose
Croscarmellose sodium
Hypromellose phthalate 50
Hypromellose (E464)
Light liquid paraffin
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for 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