Minocin SA 100 mg Modified Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Minocycline hydrochloride

Available from:

Mylan IRE Healthcare Limited

ATC code:

J01AA; J01AA08

INN (International Name):

Minocycline hydrochloride

Dosage:

100 mg milligram(s)

Pharmaceutical form:

Modified-release capsule, hard

Prescription type:

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

Therapeutic area:

Tetracyclines; minocycline

Authorization status:

Marketed

Authorization date:

1993-06-23

Patient Information leaflet

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 severe kidney disease
-
If you are taking another drug t

Summary of Product characteristics

Health Products Regulatory Authority
21 September 2023
CRN00DR6Q
Page 1 of 7
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 tetracyclinesor to any of the components of
Minocin SA, use inpregnancy, lactation, children under
the age of 12 years, complete renal failure. Severe liver disease.
Minocin SA contains a small qu