Acnamino MR 100mg Capsules capsules hard

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

minocycline (minocycline hydrochloride)

Available from:

Dexcel-Pharma Ltd.

ATC code:

J01AA08

INN (International Name):

minocycline (minocycline hydrochloride)

Dosage:

100mg

Pharmaceutical form:

capsules hard

Units in package:

(56/8x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-10-09

Patient Information leaflet

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE. IT IS AN IMPORTANT SOURCE OF INFORMATION ABOUT
YOUR MEDICINE AND HOW TO TAKE IT SAFELY.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
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 gets serious, or you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. WHAT ACNAMINO MR IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE ACNAMINO MR
3. HOW TO TAKE ACNAMINO MR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ACNAMINO MR
6. FURTHER INFORMATION
1. WHAT ACNAMINO MR IS AND WHAT IT IS USED FOR
THE NAME OF YOUR MEDICINE is Acnamino MR 100mg
Capsules (referred to as Acnamino MR throughout this
leaflet).
THE ACTIVE INGREDIENT in your medicine is minocycline.
Minocycline
is
one
of
a
group
of
antibiotics
called
Tetracyclines.
ACNAMINO MR IS USED for the treatment of acne. It is thought
that acne is partly due to, or made worse by, infection with
a type of bacteria called Propionibacterium Acnes. Treating
acne with Acnamino MR is intended to reduce the infection
with this bacterium and so help in the overall treatment of acne
2. BEFORE YOU TAKE ACNAMINO MR
DO NOT TAKE ACNAMINO MR IF:
• You are allergic (hypersensitive) to minocycline or any of
the other ingredients of Acnamino MR (these are listed
below in Section 6).
• You are allergic to any medicines from the group of antibiotics
called
Tetracycline
(e.g.
oxytetracycline,
tetracycline,
doxycycline).
• You have kidney failure
• You are pregnant, think you might be pregnant or are trying to
become pregnant. Acnamino MR may cause harm to the foetus
• You are breastfeeding. Medicines from the Tetracycline group
(as Acnamino MR) passes through the breast milk.
• You are less than 12 years old.
The use of Acnamino

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acnamino™ MR 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg minocycline (as minocycline
hydrochloride).
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard.
Minocycline 100 mg is a hard gelatin capsule, with an opaque-buff body
and an
opaque-brown cap, containing one pink film-coated tablet, and one
peach enteric-
coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minocycline 100 mg capsules are indicated for the treatment of acne.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults:
One 100 mg capsule every 24 hours
Children over 12 years:
One 100 mg capsule every 24 hours
Children under 12 years:
Minocycline is not recommended.
Elderly:
Dose selection for an elderly patient should be
cautious, reflecting the greater frequency of
decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy.
Renal insufficiency:
Minocycline must not be given to persons in renal
failure. In lesser degrees of renal insufficiency,
reduction of dosage and monitoring of renal function
may be required (see sections 4.3 and 4.4).
Hepatic insufficiency:
Minocycline should be used with caution in patients
with hepatic dysfunction (see section 4.4).
Treatment of acne should be continued for a minimum of 6 weeks. If,
after six
months, there is no satisfactory response, Minocycline should be
discontinued and
other therapies considered. If Minocycline 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 section
4.4).
_METHOD OF ADMINISTRATION: _
To reduce the risk of oesophageal irritation and ulceration, the
capsules should be
swallowed whole with plenty of fluid, while sitting or standing. The
absorption of
minocycline is not significant