Minitran 15 transdermal patches

Main information

  • Trade name:
  • Minitran 15 transdermal patches
  • Dosage:
  • 15mg/ 24hour
  • Pharmaceutical form:
  • Transdermal patch
  • Administration route:
  • Transdermal
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Minitran 15 transdermal patches
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02060100; GTIN: 5000485085542

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15142/0087
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

2.75”

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No Copy / Copy Area

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8.25” W x 15.5” H leaflet, Front

08 APR 2008

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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

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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

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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:

What Minitran patches are and what they

are used for

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

Contents of the pack and other information

What Minitran patches are and what

they are used for

Minitran patches contain the active substance

glyceryl trinitrate and belong to a group of

medicines called vasodilators which work

by widening blood vessels. This helps blood

which is carrying oxygen reach the muscle

in your heart.

When you apply a Minitran patch to your

skin the medicine passes through your skin

and into your bloodstream.

Minitran patches are used to help prevent

angina attacks (chest pains). Minitran patches

may be used on their own, or with other treat

­

ments for angina prescribed by your doctor.

The Minitran 5 mg patch is also used by

doctors and nurses to keep veins open and

improve blood flow when you are given a

drip (intravenous infusion).

If you have angina it is important that you

receive effective treatment. If angina is left

untreated the muscle in your heart can

become starved of oxygen and this could

cause a potentially fatal heart attack

(myocardial infarction).

What you need to know before you

use Minitran patches

Do not use Minitran patches if:

You are taking Viagra (sildenafil) for

male erection problems. A severe and

potentially fatal drop in blood pressure

can occur if these two medicines are

used together

You are allergic to glyceryl trinitrate or any

of the other ingredients in Minitran patches

(see Section 6)

You have severe anaemia

You have glaucoma (high pressure in your

eye) or you have been told that you have

high pressure inside the skull

You have heart valve disease or percarditis

(inflammation of the lining of the heart)

You have an angina attack. Your doctor will

give you a different medicine such as a GTN

spray for this

Severe hypotension (systolic blood

pressure less than 90 mmHg)

Severe hypovolemia

You are taking Riociguat a medicine used

to treat some types of hypertension.

If any of the above apply to you, talk to your

doctor or pharmacist.

Children and adolescents

Minitran patches are not recommended for

use in children.

Check with your doctor before using

Minitran patches if:

You suffer from any heart or lung problems.

Minitran patches may have to be used under

your doctor’s supervision

You are pregnant, or are trying to become

pregnant.

Other medicines and Minitran patches

Tell your doctor if you are taking any of the

following medicines:

Medicines for failure to achieve an

erection such as Viagra. Using Minitran

with these medicines could cause a

severe drop in your blood pressure.

This could make you unconscious and

may be fatal

Other vasodilators such as nitrates, hydrala­

e or minoxidil (used to treat high blood

pressure and angina)

Medicines used to lower blood pressure

such as beta­blockers, ACE inhibitors and

diuretics (water tablets)

Medicines to treat depression such as

amitriptyline and dothiepin

Medicines to treat psychiatric illnesses

such as neuroleptics

Medicines to treat pain, fever and inflam­

mation such as aspirin or any other

non­steroidal anti­inflammatory drug

Dihydroergotamine, a medicine used to

treat migraines

Any other medicine, including medicines

obtained without a prescription.

Riociguat a medicine used to treat some

types of hypertension.

These medicines can interfere with how well

your treatment works.

Using Minitran patches with food and

drink

Do not drink alcohol whilst using Minitran

patches as this can cause your blood

pressure to drop. This may make you feel

dizzy or faint.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast­feeding, think

you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist

for advice before taking this medicine.

Driving and using machines

Minitran patches may make you feel dizzy

and faint when you stand up. If this happens

to you, do not drive or use machinery.

3. How to use Minitran patches

Always use Minitran patches exactly as your

doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not

sure.

The usual starting dose is one Minitran 5 mg

patch per day.Your doctor or pharmacist will

have chosen the strength which best suits

your condition. You should check with your

doctor or pharmacist if you are unsure.

Remember: Each Minitran patch is con­

tained in a sealed pouch. The sticky side of

the patch is covered by a disposable liner

which must be removed and thrown away

before the patch is applied to your skin.

How many patches to use

Normally one patch per day is sufficient.

When to apply the patches

At the start of your treatment, put on a

patch in the morning

Remove the patch before you go to bed.

You should have 8 to 12 hours without a

patch on. This will prevent you from becom­

ing tolerant to the medicine and will ensure

the treatment remains effective

Each morning put on a new patch

You can keep the patch in place whilst

bathing, showering or swimming.

How and where to apply the patch

Choose a smooth area of skin to apply

the patch. The area should be hairless to

ensure good contact of the patch with the

skin. The chest, upper arm or shoulders

are suitable

Your hands and the skin where you will

apply the patch should be clean and dry.

Do not use powder or moisturiser.

034872010367

034872010367

Minitran

Glyeryl trinitrate

5 mg, 10 mg or 15 mg

transdermal patches

Package leaflet: Information for the patient

MANUFACTURER: Meda Pharma GmbH & Co. KG

PRODUCT:

Minitran 5 mg

MEDA-NO.:

56UK1814110-03

MFS-NO.:

34-8720-1036-7

LAETUS-CODE:

PACK SIZE:

8,25 x 15,5 inch

FONT SIZE:

10 pt / 12,5 pt

PAGE 1/2

COLOURS USED:

Black

COUNTRY:

United Kingdom UK

LANGUAGE:

English

CORRECTION: 4.

DATE:

09. 02. 2017

Studio Oberländer GmbH · Rubensstr. 33 · 60596 Frankfurt a. M. · Germany

Phone: +49 69 631520-85 · Fax: -87 · E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet

Minitran

Glyeryl trinitrate

5 mg, 10 mg or 15 mg

transdermal patches

Package leaflet: Information for the patient

1216_GI_Minitran_56UK1814110-03.indd 1

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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”

Instructions for applying a Minitran

patch

Starting at the notched corner of the pouch,

tear along the dotted line. Open the

pouch and remove the patch.

Fold the patch along the dotted line, so

that the backing comes apart.

Hold the patch on one side and peel off

the backing on the other side to expose

the sticky patch. Discard the liner. Place

the sticky side of the patch directly onto

the skin.

Peel off the remainder of the backing and

discard the liner. Press down firmly on the

patch with the palm of your hand.

Occasionally a patch may not stick or it may

fall off. If this happens apply a new patch to

a different area of the skin.

When applying the patch you must not:

Stretch the skin

Place the patch on a cut or reddened area

of skin

Stick the same patch back on once it has

been removed from the skin.

When applying the patch you should

always:

Place the new patch on a different area of

skin

Allow several days to pass before applying

a fresh patch to the same area of skin.

For patients receiving an intravenous

infusion (drip)

Minitran patches can be used when you are

being given a drip. Your doctor or nurse will

decide on the strength of the patch required

and apply the patch next to the needle that

goes into the vein. The patch will be

changed daily. It will be removed once your

drip is stopped.

If you use more Minitran patches than

you should

Do not use more Minitran patches than you

should. If you accidentally apply too many

patches, remove the patches straight away

and immediately contact the nearest hospital

casualty department or your doctor.

An overdose of Minitran patches can cause

a rapid drop in blood pressure causing

dizziness or fainting.

If you forget to use Minitran patches

If you forget to use a new patch apply it as

soon as you remember. If you are not sure

when to use your patch please ask your

doctor or pharmacist.

If you stop using Minitran patches

Do not stop using Minitran patches without

first talking to your doctor or pharmacist.

4. Possible side effects

Like all medicines Minitran patches can

cause side effects, although not everybody

gets them.

Possible side effects include:

Very common (affects more than 1 in

10 people):

Feeling and being sick.

Common (affects 1 in 100 people):

Headache. This usually disappears after a

few days. If you have a lasting headache

you should talk to your doctor

Uncommon (affects 1 in 1,000 people):

Slight reddening, itching or burning sen­

sation on the skin where you have applied

the patch. This usually disappears after

the patch has been removed

Rare (affects 1 in 10,000 people):

An abnormally fast heart beat

Hot flushes

Very rare (affects less than 1 in 10,000 people)

Dizziness

Not known (frequency cannot be estimated

from the available data)

Skin rash

Palpitations (noticeable pounding,

fluttering or irregular heartbeat)

Fainting

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

You can also report side effects directly via

the Yellow Card Scheme at: www.mhra.gov.

uk/yellowcard.

By reporting side effects you can help pro­

vide more information on the safety of this

medicine.

5. How to store Minitran patches

Keep this medicine out of the sight and

reach of children.

Do not use Minitran patches after the expiry

date on the sachet. The expiry date refers to

the last day of that month. Store Minitran

patches at room temperature (below 25 °C)

in a dry place. Do not expose to light.

The shelf life for Minitran patches is three

years.

Do not throw away any medicines via waste­

water or household waste. Ask your phar­

macist how to throw away medicines you no

longer use. These measures will help pro­

tect the environment.

Contents of the pack and other

information

What Minitran patches contain

The active substance in Minitran patches is

glyceryl trinitrate.

The Minitran 5 mg patch contains 18 mg

of glyceryl trinitrate. The average amount

delivered into the bloodstream in 24 hours

is 5 mg

The Minitran 10 mg patch contains 36 mg

of glyceryl trinitrate. The average amount

delivered into the bloodstream in 24 hours

is 10 mg

The Minitran 15 mg patch contains 54 mg

of glyceryl trinitrate. The average amount

delivered into the bloodstream in 24 hours

is 15 mg.

The other ingredients are: isooctyl acrylate/

acrylamide copolymer, ethyl oleate, glyceryl

monolaurate.

What Minitran patches look like

Minitran patches are oval shaped and come

in a square pouch or sachet with a tear­off

top. Each patch is protected by a clear,

disposable, plastic film liner that must be

removed before use. The liner is split and

comes off as two pieces of film.

Minitran patches come in packs of 30.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford, CM22 6PU.

United Kingdom.

Manufacturer:

3M Health Care Ltd

1 Morley Street

Loughborough

Leics LE11 1EP

United Kingdom.

This leaflet was last revised in

February 2017

If this leaflet is difficult to

see or read, or you would

like it in a different format,

please contact

Meda Pharmaceuticals Ltd,

Skyway House, Parsonage

Road, Takeley,

Bishop’s

Stortford, CM22 6PU.

Minitran is a trademark of MEDA AB.

The Triangle Logo on the packaging is

a trademark of 3M and is used under license.

34­8720­1036­7

56UK1814110­03

MANUFACTURER: Meda Pharma GmbH & Co. KG

PRODUCT:

Minitran 5 mg

MEDA-NO.:

56UK1814110-03

MFS-NO.:

34-8720-1036-7

LAETUS-CODE:

PACK SIZE:

8,25 x 15,5 inch

FONT SIZE:

10 pt / 12,5 pt

PAGE 2/2

COLOURS USED:

Black

COUNTRY:

United Kingdom UK

LANGUAGE:

English

CORRECTION: 4.

DATE:

09. 02. 2017

Studio Oberländer GmbH · Rubensstr. 33 · 60596 Frankfurt a. M. · Germany

Phone: +49 69 631520-85 · Fax: -87 · E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet

1216_GI_Minitran_56UK1814110-03.indd 2

09.02.17 12:52