Acnamino MR 100mg capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
01-08-2014
Shusha Tabia za bidhaa (SPC)
11-12-2014

Viambatanisho vya kazi:

Minocycline hydrochloride

Inapatikana kutoka:

Dexcel-Pharma Ltd

ATC kanuni:

J01AA08

INN (Jina la Kimataifa):

Minocycline hydrochloride

Kipimo:

100mg

Dawa fomu:

Modified-release capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 05010300; GTIN: 5033847000693

Taarifa za kipeperushi

                                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 
                                
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Tabia za bidhaa

                                OBJECT 1
ACNAMINO MR 100MG CAPSULES
Summary of Product Characteristics Updated 07-Jul-2017 | Dexcel Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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.
Elde
                                
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