Minocin MR 100mg Modified Release Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MINOCYCLINE HYDROCHLORIDE

Available from:

Meda Pharmaceuticals Limited

ATC code:

J01AA08

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Pharmaceutical form:

MODIFIED-RELEASE CAPSULE

Composition:

MINOCYCLINE HYDROCHLORIDE 100 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-12-19

Patient Information leaflet

MED
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P
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INOCIN MR 100 MG
M
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56UK1842110-02
MEDA
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UK
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Dimension 
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Typopharma #  
109464
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

Summary of Product characteristics

Page 1 of 11 

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 Minoc