Thursday, September 8, 2016

Minitran 5, Minitran 10, Minitran 15





Minitran



Glyceril trinitrate





What You Need To Know About Minitran Patches


Please read this carefully before you start to use your medication. This leaflet only provides a summary of the information available

on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.



Your medication is called a Minitran patch


It consists of a clear patch containing glyceryl trinitrate which is applied to the skin. The clear film consists of low density

polyethylene and silicone-coated polyester. The patch also contains the following ingredients: isooctyl acrylate/acrylamide copolymer,

ethyl oleate, glyceryl monolaurate. There are three strengths available ; your doctor will have chosen the strength which best suits your

condition.


A Minitran 5 patch contains 18mg of glyceryl trinitrate. The average amount delivered in 24 hours is 5mg.


A Minitran 10 patch contains 36mg of glyceryl trinitrate. The average amount delivered in 24 hours is 10mg.


A Minitran 15 patch contains 54mg of glyceryl trinitrate. The average amount delivered in 24 hours is 15mg.


Each pack (all strengths) contains 30 patches.




Who produces your medication


Name and address of manufacturer:



3M Santé

Zone industrielle

Avenue du 11 Novembre

F-45312 Pithiviers Cedex

France



3M Health Care,

Derby Road Loughborough

Leicestershire

LE11 5SF

United Kingdom


Batch numbers Fxxxxxx are batch released at 3M Santé, Batch numbers Uxxxxxx are batch released at 3M Health Care.


Name and address of product licence holder:



Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK




What your medication is prescribed for


Glyceryl trinitrate is one of a group of medicines called vasodilators which widen blood vessels and improve blood flow to the tissues

and muscle (including heart muscle). When you apply a patch to your skin the glyceryl trinitrate passes slowly through your skin and into

your blood stream.


Minitran patches may be used to help prevent attacks of angina (chest pain). They reduce the need for under-the-tongue glyceryl

trinitrate tablets or spray.


Minitran 5 patches may also be used to improve blood flow to the site of an intravenous cannula. In patients receiving injections or

infusions via their arm or leg veins, they help to keep the veins open.





Important points to note before using Minitran patches



If medication for erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis) or vardenafil (Levitra), is being used by

patients taking nitrate preparations such as Minitran a severe and possibly dangerous fall in blood pressure may occur. This would result

in collapse, unconsciousness, and could be fatal. You should not take Viagra, Cialis or Levitra whilst using Minitran.



If you are pregnant, think you might be pregnant or are trying to become pregnant, or are taking other medications, please tell your

doctor before using Minitran patch.


You should not use these patches if you are known to be allergic to glyceryl trinitrate, or other medicines containing nitrates.


These patches should not be used by patients with glaucoma, low blood pressure, severe anaemia, aortic or mitral stenosis (heart valve

disease), pericarditis (inflammation of the lining of the heart) or raised intracranial pressure (high pressure within the skull).


Please tell your doctor if you suffer from any heart or lung conditions.


Minitran patches may be used to help prevent angina attacks. If you do have an attack of chest pain you should use under-the-tongue

glyceryl trinitrate tablets or a similar medication as instructed by your doctor.


Glyceryl trinitrate may lower your blood pressure and make you feel dizzy or light-headed, particularly when changing position

suddenly. You should be especially careful if you are driving, operating machinery or drinking alcohol.


Minitran patches are not recommended for use in children.


If you see any other doctor or dentist, please tell them that you are using Minitran patch.



What to do if you are taking other medicines


Please tell your doctor if you are receiving any of the following medicines:


  • vasodilators (medicines used, for example, for angina (e.g. nitrates) or to reduce blood pressure (e.g. hydralazine,

    minoxidil).

  • calcium antagonists or beta-blockers (medicines used, for example, for angina, heart arrhythmia's (irregular heart beat) or to

    reduce blood pressure).

  • ACE inhibitors (medicines used, for example, for heart failure or to reduce blood pressure).

  • neuroleptics (medicines for psychiatric illness).

  • diuretics (water tablets).

  • anti-hypertensives (medicines for reducing blood pressure).

  • tricyclic anti-depressants.

  • dihydroergotamine.

  • aspirin or other non-steroidal anti-inflammatory drugs.


Your doctor or pharmacist will advise you about these medicines.




Use of Minitran patches during pregnancy and breast feeding


Glyceryl trinitrate should not normally be used if you are pregnant or if you are breast feeding, unless your doctor tells you to.





When to apply Minitran patches



For angina patients.


The usual starting dose is one Minitran 5 patch each day. Your doctor will have chosen the strength which best suits your condition and

will advise you on how long to wear the patch each day. Your patch may be worn for either 24 hours or for only part of each day. A new

patch must be applied at approximately the same time each day. Please follow your doctor's instructions.


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.



For patients with an intravenous cannula.


Usually your doctor or nurse will apply one Minitran 5 patch next to your intravenous cannula. The patch will be left on for 24 hours

and then changed. It will be removed once your intravenous treatment is stopped.


Minitran patches should not be used by children.




Where to apply Minitran patches



For angina patients.


You can apply the patch to the chest, shoulders or upper arm. You should apply the patch to a hairless area of the skin to ensure that

good contact is made.


Do not apply the patch to broken skin such as cuts or grazes.


Use a different area of skin every time you apply a patch. It is best to let a few days pass before putting another patch on the same

area of skin.


The skin should be clean and dry before applying a patch. This is to make sure that the patch sticks properly.


Do not use dusting powder or any greasy substance e.g. ointments or creams on the skin before applying a patch.


A Minitran patch sticks well to the skin during showering, bathing and swimming.



For patients with an intravenous cannula.


Your doctor or nurse will apply the patch next to your intravenous cannula.




How to apply a Minitran patch



  • 1. Start at notched corner. Tear pouch along dotted line. Remove patch from pouch.


  • 2. Bend patch so that the oval patterned liner notch pops up ; remove tab and discard liner.


  • 3. Apply sticky side of patch to upper arm or chest. Remove and discard oval patterned liner.


  • 4. Press patch firmly in place.

In the unlikely event of a patch not sticking or falling off, simply apply a new patch on a different area of the skin.


Do not re-apply a patch once it has been removed from the skin.



What to do in case of accidental swallowing or application of too many patches


Please contact your nearest hospital casualty department, or tell your doctor, immediately.





What might happen when you are using Minitran patches


Like most medicines, glyceryl trinitrate may cause some side-effects.


When you first use Minitran patches you may notice some side-effects. These include headache, hypotension (low blood pressure),

tachycardia (fast heart rate), fainting, palpitations (fast heart beat), hot flushes and dizziness.


Sometimes your skin may become red and/or itchy where you have used the patch. This will usually disappear after you have removed the

patch. Please make sure that you use a different area of skin every time you apply a patch.


Other side-effects which may occur include feeling or being sick.


As with other skin preparations, use of Minitran patches over a long period of time may result in your skin becoming sensitive to this

product. If this happens to you, please consult your doctor.


If you notice any other side-effects, please tell your doctor or pharmacist.


If any side-effects continue for more than a few days, please tell your doctor.




Storing your medication


Keep Minitran patches in a safe place where children cannot reach them.


Store the patches below 25ºC in a dry place and out of direct sunlight.


Do not use this product after the expiry date printed on the original container.


If your doctor decides to stop treatment, return any unused patches to your pharmacist.



Date of update of leaflet : December 2009



REMEMBER: This medication is only for YOU. Never give it to others. It may harm them even if their symptoms seem to be

the same as yours.


The information provides a summary of the information available on Minitran patches.


Further information is available from your doctor or pharmacist.



Minitran is a trademark of MEDA AB.


The Triangle Logo on the packaging is a trademark of 3M and is used under license.


562l97M2110UK00





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