Minitran 10mg/24 hour Transdermal Patch

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLYCERYL TRINITRATE

Available from:

Meda Pharmaceuticals Limited Skyway House, Parsonage Road, Takeley, Bishop''s Stortford, CM22 6PU, United Kingdom

ATC code:

C01DA02

INN (International Name):

GLYCERYL TRINITRATE

Pharmaceutical form:

TRANSDERMAL PATCH

Composition:

GLYCERYL TRINITRATE milligram(s)

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2006-03-29

Patient Information leaflet

2.75”
2.75”
8.25”
2.75”
Die Line
Fold Line
Registration
No Copy / Copy Area
(0.125” L and R, 0.25” T and B)
8.25” W x 15.5” H leaflet, Front
08 APR 2008
2.5”
2.5”
15.5”
2.5”
2.5”
2.5”
2.5”
0.25”
0.25”
Bar Code FPO
Bar Code (BC)/BC FPO is 1” W x 0.438” H
Artwork (AW) ID #/AW ID place holder area
is 1” W x 0.125” H
AW ID #/AW ID place holder is to be Arial or Helvetica
AW ID #/AW ID place holder is to be a minimum 6pt,
but must fit in AW ID area
BC, AW ID #, and AW ID place holders print black
AW ID place holder (X’s) is to be replaced with AW ID #
BC area is 1.5” W x 0.938” H (0.25” QZ L, R;
0.188 QZ T, B)
No copy other than BC, AW ID #, or place holders
in BC area
BC area is centered in the panel
BC area top, as the BC/BC FPO reads, is flush to
the first fold
BC
FPO
XXXXXX
BC
FPO
XXXXXX
BC
FPO
XXXXXX
2.75”
2.75”
8.25”
2.75”
Die Line
Fold Line
Registration
No Copy / Copy Area
(0.125” L and R, 0.25” T and B)
8.25” W x 15.5” H leaflet, Back
08 APR 2008
2.5”
2.5”
15.5”
2.5”
2.5”
2.5”
2.5”
0.25”
0.25”
Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
•
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
•
In this leaflet, Minitran 5 mg, 10 mg or
15 mg transdermal patches will be called
Minitran patches.
What is in this leaflet:
1.
What Minitran patches are and what they
are used for
2.
What you need to know before you use
Minitran patches
3. How to use Minitran patches
4. Possible side effects
5. How to store Minitran patches
6.
Contents of the pack and other information
1.
What Minitran patches are

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minitran 10 mg/ 24 h, transdermal patch
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minitran 10 has a surface area of 13.3 sq cm and contains 36 mg of
glyceryl trinitrate. The
average amount delivered in 24 hours is 10 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Adhesive transdermal patch.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minitran 10 is indicated for:
Prophylaxis of angina pectoris either alone or in combination with
other anti-anginal
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
PROPHYLAXIS OF ANGINA PECTORIS
_Adults: _
The response to nitrates differs between individuals, and the minimum
effective dose
should be prescribed in each case. It is therefore recommended that
treatment is started
with one Minitran 5 patch per day, with upward dosage titration when
necessary.
Application can either be for a continuous period of 24 hours or
intermittently,
incorporating a patch free interval (usually at night). Attenuation of
effect has occurred in
some patients being treated with sustained release nitrate
preparations. On the basis of
current clinical studies it is recommended that in such cases Minitran
should be applied
daily with a patch free interval of 8 - 12 hours.
Special populations
_Elderly _
No specific information on use in the elderly is available, but there
is no evidence to
suggest that an alteration in dose is required.
_Paediatric population: _
The safety and efficacy of Minitran in children has yet to be
established, and therefore
recommendations for its use cannot be made.
Method of administration
Each Minitran patch is contained in a sealed sachet. The adhesive
layer is covered by a
protective film, which should be removed before application. The
Minitran patch should
be applied to a clean, dry healthy area of skin on the torso or the
arms.
Subsequent patches should not be applied to the same area of skin
until several days have
elapsed. The Minitran patch adheres easily