Minocin SA 100 mg Modified Release Capsules

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

MINOCYCLINE HYDROCHLORIDE

Fáanlegur frá:

Meda Health Sales Ireland Limited

ATC númer:

J01AA; J01AA08

INN (Alþjóðlegt nafn):

MINOCYCLINE HYDROCHLORIDE

Skammtar:

100 mg milligram(s)

Lyfjaform:

Capsule

Gerð lyfseðils:

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

Lækningarsvæði:

Tetracyclines; minocycline

Leyfisstaða:

Marketed

Leyfisdagur:

1993-06-23

Upplýsingar fylgiseðill

PACKAGE LEAFLET:
INFORMATION FOR THE USER
MINOCIN SA
100 MG MODIFIED RELEASE CAPSULES
Minocycline
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
conditions:
-
If you have liver disease
-
If you have sever kidney disease
-
If you are taking another drug th

Vara einkenni

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
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
4.1 THERAPEUTIC INDICATIONS
Minocin SA capsules are indicated for the treatment of acne.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE:
Adults:
One 100mg capsule every 24 hours.
Children over 12 years:
One 100mg capsule every 24 hours.
Children under 12 years:
Minocin is not recommended.
Elderly:
No special dosing requirements.
ADMINISTRATION:
To reduce the risk of oesophageal
irritation and ulceration,
the capsules should be swallowed whole with plenty of
fluid, while sitting or standing. Unlike earlier tetracyclines,
absorption of minocycline is not significantly impaired by
food or moderate amounts of milk.
Treatment of acne should be continued for a minimum of 6 weeks and
where possible limited to a maximum of six
months. If, after six months, there is no satisfactory response
Minocin SA should be discontinued and other therapies
considered.
If Minocin SA is to be continued for longer than six months,
patients should be monitored (including
laboratory investigations)
at
least
three monthly thereafter
for
signs and symptoms of
hepatitis or
systemic lupus
erythematosus (SLE) or unusual pigmentation (see Special warnings and
precautions for use).
4.3 CONTRAINDICATIONS
Known hypersensitivity to tetracyclines or to any of the components of
Minocin SA, use in pregnancy, lactation, children
under the age of 12 years, complete renal failure. Severe liver
disease. Minocin SA contains a small quantity of soya oil
and is, therefore, contraindicated in patients who are a