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Document: leaflet MAH BRAND_PL 44374-0010 change

• leaflet MAH BRAND_PL 00039-0735
• leaflet MAH BRAND_PL 44374-0010
• leaflet MAH BRAND_PLPI 10256-0865
• leaflet MAH BRAND_PLPI 10383-1345

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deponit® 5_

Transdermal Patch

Glyceryl trinitrate 18.7 mg

Patient Information Leaflet

Read all of this leaflet carefully before

you start using this medicine.

•    Keep this leaflet. You may need to read it again

•    If you have further questions, please 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 symptoms are the same as yours

•    In this leaflet Deponit 5 transdermal patch will be called Deponit 5.

In this leaflet:

1.    What Deponit 5 is for

2.    Before you use Deponit 5

3.    How to use Deponit 5

4.    Possible side effects

5.    How to store Deponit 5

6.    Further information.

1.    What Deponit 5 is for

Deponit 5 belongs to a group of medicines called ‘nitrates’. These are used to widen your blood vessels and reduce the workload of your heart.

Deponit 5 is used to prevent angina pectoris. Angina attacks feel like a tight pain in your chest, neck or arm and are a sign that your heart is not getting enough oxygen for the amount of work it is doing.

2.    Before you use Deponit 5 Do not use Deponit 5 if:

•    You are allergic to glyceryl trinitrate or to any of the other ingredients in Deponit 5 (See section 6)

•    You are taking medicines for failure to achieve an erection such as Viagra. Using Deponit 5 with these medicines could cause a severe

drop in blood pressure and could lead to collapse and unconsciousness, and may be fatal

•    You have a condition in which your heart does not pump enough blood around your body due to obstruction of the arteries in the heart as in a condition called aortic or mitral stenosis.

•    You suffer from a heart condition which is associated with low blood pressure leading to shock.

•    You suffer from low blood pressure

•    You suffer from low blood volume

•    You suffer from anaemia (low iron levels in your blood)

•    You have an eye disease called glaucoma

_•    You have a heart valve disorder

•    You suffer from inflammation of the heart lining

_•    You suffer from increased fluid around the heart (cardiac tamponade)

_•    You suffer from a heart condition called hypertrophic obstructive cardiomyopathy

•    You have ever had a serious head injury, cerebral haemorrhage (bleeding in the brain) or a disease which is accompanied by increased pressure on the brain

•    You have an acute angina attack. Your doctor will give you a different medicine such as a GTN spray for this.

•    You are using riociguat, a medicine used in treating pulmonary hypertension

If any of the above applies to you talk to your

doctor.

If any of the above applies to you talk to

your doctor.

Check with your doctor before using

Deponit 5 if:

•    You have an underactive thyroid gland

•    You have any diseases of the lungs, liver or kidneys

•    You have recently had a heart attack or you suffer from heart failure

•    You suffer from hypoxaemia (insufficient oxygen in your blood) due to lung disease, heart failure or severe anaemia (low haemoglobin)

•    You have hypothermia (very low body temperature)

•    You are malnourished (severe lack of food).

•    You have a condition called Angina pectoris (chest pain).

•    You have had a heart attack.

•    You have a condition in which there is insufficient blood flow to the brain (cerebral ischemia).

Taking other medicines

•    Do not take Deponit 5 with medicines for failure to achieve an erection such as Viagra. Using Deponit 5 with these medicines could cause a severe drop in blood pressure and could lead to collapse and unconsciousness, and may be fatal

Tell your doctor if you are taking any of

the following medicines:

•    Medicines which are used to treat angina, heart failure, or an irregular heartbeat.

A blood condition (methaemoglobinaemia)

can occur when other nitrate treatments are given at the same time. This can result in breathing problems, anxiety, loss of consciousness and heart attack.

•    Medicines which reduce blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators, ACE inhibitors)

•    Diuretics (water tablets)

•    Tricyclic antidepressants (used to treat depression)

•    Neuroleptics (used to treat anxiety)

•    Dihydroergotamine (used to treat migraine)

•    Amifostine (drug used along with anticancer drugs) and Aspirin should not be taken together as they increase the blood pressure lowering effect of Deponit 5.

•    Sapropterine (Tetrahydrobiopterine, BH4)

•    Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you, do not take

Deponit 5. Talk to your doctor.

Using Deponit 5 with food and drink

Do not drink alcohol whilst using Deponit 5

as it can cause your blood pressure to drop.

This may make you may feel dizzy or faint.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast feeding, ask your doctor for advice before using Deponit 5.

Driving and using machines

Deponit 10 may make you feel dizzy, tired or have blurred vision. If this happens to you, do not drive a vehicle or operate machinery.

3. How to use Deponit 5

Always use Deponit 5 exactly as your doctor has advised.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or

you are not sure, ask your doctor or pharmacist.

Deponit 5 is not suitable for children.

Adults and the Elderly

•    Normally one patch per day is enough

•    Your doctor may increase this to two patches depending on how you respond to the medicine

•    At the start of your treatment, put on a patch in the morning

•    Remove the patch before you go to bed

•    You must have 8 to 12 hours each day without a patch on. This will prevent you from becoming tolerant to the medicine.

If you do this it will ensure the treatment remains effective

•    Each morning put on a new patch.

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.

Things to remember:

•    Do not stretch the skin when putting a patch on

•    Do not put the patch on a cut or reddened area of skin

•    Do not pull the patch off the skin and then stick it back on again.

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 abdomen, upper arm, shoulder or thigh is suitable.

•    Your hands and the skin where you will apply the patch should be clean and dry.

Do not use powder or moisturiser.

•    Tear open the wrapper across the top, take out the patch and hold it with the writing facing away from you.

•    Fold the patch along the S-shaped cut so the sides of the backing come apart.

•    Hold the patch on one side and peel off the backing on the other side to expose the sticky patch. Place the sticky side of the patch directly onto the skin.

•    Peel off the remainder of the backing and press down firmly with the palm of your hand.

If you use more Deponit 5 than you should

If you accidentally use more Deponit 5 than you should, remove the patches straight away and immediately go to your doctor or the nearest hospital casualty department.

If you use more Deponit 5 than you should, you may have a fall in blood pressure.This may make you feel dizzy, weak and light-headed on standing. You may also be pale, sweat a lot, have a weak pulse, rapid heart beats (tachycardia), flushed skin, headache, feel sick or be sick, methaemoglobinaemia.

In severe cases of overdose you may get an increase of the pressure of the fluid around the brain.

If you forget to use Deponit 5

•    If you forget to change your patch:Take the old one off and put a new one on as soon as you remember, then carry on as before.

•    If you forget to apply a patch: Put a new one on as soon as possible, then carry on as before.

Do not take a double dose to make up for a missed dose.

If you stop using Deponit 5

Do not stop using Deponit 5 even if you feel better. If you stop taking your medicine your condition may get worse. Keep using Deponit 5 until your doctor tells you to stop.

If your doctor thinks you should stop taking Deponit 5 your dose will gradually be reduced.

Also if you are being transferred to another treatment, your dose will be gradually reduced or withdrawn and the overlapping treatment will be started.

4. Possible side effects

Like all medicines, Deponit 5 can cause side effects, although not everybody gets them.

Stop using Deponit and seek immediate medical help if you have an allergic reaction. This includes any of the following symptoms:

•    Sudden wheeziness

•    Difficulties in breathing

•    Swelling of your eyelids, face or lips

•    Rash or itching especially those covering your whole body.

Very common side effects (affects more than 1 in 10 people)

•    Headaches at the start of treatment. These usually disappear after a few days of continuing to use the patches. If necessary you can take mild painkillers e.g. paracetamol.

Common side effects (affects less than

1 in 10 people)

•    Low blood pressure (hypotension) and

light-headed ness upon standing which you may notice as dizziness, drowsiness, rapid heart beat (reflex tachycardia) and a feeling of weakness at the start of treatment or when the dosage is increased.

Uncommon side effects (affects less than

1 in 100 people)

•    Collapse sometimes with a slow heart beat and fainting

•    Very low blood pressure (severe hypotension) where you are being sick, feeling sick, are restless, have a pale skin and sweat a great deal. This may lead to a worsening of the chest pain you often get with angina

•    Temporary low oxygen level in the blood (temporary hypoxaemia). For people with heart disease this may lead to low oxygen level in the tissue surrounding the heart (myocardial hypoxia)

•    A slight reddening, slight itching or burning sensation on the skin where you have applied the patch. This usually disappears after

the patch has been removed. Be sure to put your patch in a different place each day.

•    Allergic skin rash, which may be severe

•    Flushing of the face

•    Feeling sick

4019398_Gi_MON_Deponit_5_GBR_CiA77101 C.indd 2

•    Being sick

•    Very red skin with scaling and thickened itchy skin (exfoliative dermatitis)

•    Heartburn.

Reporting of suspected adverse reactions If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below:

The Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deponit 5

Keep out of the reach and sight of children.

Do not use Deponit 5 after the expiry date shown on the label.The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return all unused medicine to your pharmacist.

6. Further information What Deponit 5 contains

The active ingredient is glyceryl trinitrate (18.7 mg).

The other ingredients are:acrylate/vinyl acetate copolymer (adhesive matrix); polypropylene (backing foil); and polyethylene (siliconised release liner).

What Deponit 5 looks like

Deponit 5 is a white, translucent square patch with round corners. It has “Deponit 5” marked on the outer face. Each patch is supplied in a foil pouch. There are 28 patches in a box.

Marketing Authorisation Holder

Merus Labs Luxco II S.a r.l.

26-28, rue Edward Steichen L-2540 Luxembourg

Manufacturer

Aesica Pharmaceuticals GmbH,

Alfred-Nobel-StraBe 10,

D-40789 Monheim, Germany.

This leaflet was last updated September 2015

If this leaflet is difficult to read and you would like it in a different format, please contact Merus Labs Luxco II S.a r.l.

26-28, rue Edward Steichen L-2540 Luxembourg

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