Minocin MR 100mg Modified Release Capsules

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

MINOCYCLINE

זמין מ:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

קוד ATC:

J01AA08

INN (שם בינלאומי):

MINOCYCLINE 100 mg

טופס פרצבטיות:

MODIFIED-RELEASE CAPSULE

הרכב:

MINOCYCLINE 100 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIBACTERIALS FOR SYSTEMIC USE

מצב אישור:

Authorised

תאריך אישור:

2006-12-19

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
MINOCIN MR ®100MG MODIFIED RELEASE CAPSULES
(Minocycline)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist
• This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm
them even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell
your doctor or pharmacist
IN THIS LEAFLET:
1.
What Minocin MR are and what they are used for
2.
Before you take MINOCIN MR
3.
How to take Minocin MR
4.
Possible side effects
5.
How to store Minocin MR
6.
Further information
1.
WHAT MINOCIN MR IS AND WHAT IT IS USED FOR
Minocycline, the active ingredient in MINOCIN MR, is a tetracycline
antibiotic used in the treatment of
acne. Acne results from clogging of skin pores. In its mildest form
this causes whiteheads and blackheads. If
these become infected, spots appear. MINOCIN MR reduces the infection
and allows the spots to heal.
2. BEFORE YOU TAKE MINOCIN MR
Do not take these capsules if any of the following apply to you unless
you have told your doctor or
pharmacist:
•
you have had an allergic reaction to any tetracycline antibiotic in
the past (e.g. oxytetracycline,
tetracycline, doxycycline
•
or minocycline), or any of the components of MINOCIN MR;
•
you are pregnant, breastfeeding or trying for a baby;
•
the person that the medicine has been prescribed for is under the age
of 12;
•
you have kidney disease;
Tell your doctor or pharmacist if:
•
you are taking any of the following:
anticoagulants e.g. warfarin; penicillin antibiotics e.g. amoxicillin;
isotretinoin (or other
retinoids or retinol); quinapril, ergotamine, methysergide,
indigestion remedies, vitamins or any
preparations containing iron, calcium, aluminium, magnesium, bismuth
or zinc salts; diuretics (to
regulate body w

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MINOCIN MR 100mg Modified Release Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MINOCIN MR Capsules contain 100mg of the active ingredient minocycline
(equivalent to 116
mg of minocycline hydrochloride as the dehydrate salt).
For a full list of excipients see 6.1
3.
PHARMACEUTICAL FORM
Modified release capsule.
Two piece, hard shell, size 2 capsules with an orange opaque body and
a brown opaque cap.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MINOCIN MR Capsules are indicated for the treatment of acne.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE:
Adults: One 100 mg capsule every 24 hours.
Children over 12 years: One 100 mg 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 Minocin MR
is not significantly impaired by food or moderate amounts of milk.
Treatment of acne should be continued for a minimum of 6 weeks. If,
after six months, there is no
satisfactory response Minocin MR should be discontinued and other
therapies considered. If Minocin
MR is to be continued for longer than six months, patients should be
monitored at least three monthly
thereafter for signs and symptoms of hepatitis or SLE or unusual
pigmentation (see Special Warnings
and Precautions).
4.3 CONTRAINDICATIONS
Known hypersensitivity to tetracyclines, or to any of the components
of Minocin MR. Use
in pregnancy, lactation, children under the age of 12 years, complete
renal failure.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Minocin MR should be used with caution in patients with hepatic
dysfunction and in conjunction with
alcohol and other hepatotoxic drugs. It is recommended that alcohol
consumption should remain
within the Government's recommended limits.
Rare cases of auto-immune hep