Acnamino MR 100mg Capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

minocycline (minocycline hydrochloride)

Available from:

Dexcel-Pharma Ltd.

INN (International Name):

minocycline (minocycline hydrochloride)

Dosage:

100mg

Pharmaceutical form:

capsules hard

Prescription type:

Prescription

Patient Information leaflet

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 Tetracyclines
(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 yea

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