Minocin MR 100mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Minocycline hydrochloride

Saatavilla:

Waymade Healthcare Plc

ATC-koodi:

J01AA08

INN (Kansainvälinen yleisnimi):

Minocycline hydrochloride

Annos:

100mg

Lääkemuoto:

Modified-release capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 05010300

Pakkausseloste

PATIENT INFORMATION LEAFLET
®
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 is and what it is 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 water
content);
�

Valmisteyhteenveto

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
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 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
Rare, anaphylaxis/anaphylactoid reactions including shock and
fatalities have
been associated with the administration of Minocin MR ( See section
4.8
Undesirable effects).
Minocin MR should be used with caution in patients with hepatic
dysfunction
and in conjunction with alcohol