Minitran 15 transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glyceryl trinitrate

Available from:

Viatris UK Healthcare Ltd

ATC code:

C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

15mg/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5000485085542

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

OBJECT 1
MINITRAN 15
Summary of Product Characteristics Updated 15-Feb-2017 | Meda
Pharmaceuticals
1. Name of the medicinal product
Minitran 15 mg/ 24 h, transdermal patch
2. Qualitative and quantitative composition
Minitran 15 has a surface area of 20 sq cm and contains 54 mg of
glyceryl trinitrate. The average amount
delivered in 24 hours is 15 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 15 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