DEPONIT 5 PATCH - patient leaflet, side effects, dosage

Patient leaflet - DEPONIT 5 PATCH

Package leaflet: Information for the patient

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 only. 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.

The name of your medicine is Deponit 5 Patch, but will be referred to as Deponit 5 throughout the remainder of the leaflet.

What is in this leaflet:

1. What Deponit 5 is and what it is used for
2. What you need to know before you use Deponit 5
3. How to use Deponit 5
4. Possible side effects
5. How to store Deponit 5
6. Contents of the pack and other information

1. what deponit 5 is and what it is used 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. what you need to know before you use deponit 5do not use deponit 5: if you are allergic to glyceryl trinitrate, to other nitro compounds or to any of the other ingredients of this medicine (listed in section 6)

If you are taking medicines for failure to achieve an erection such as Viagra or any other phosphodiesterase inhibitors. 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
If 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
If you suffer from a heart condition which is associated with low blood pressure leading to shock
If you suffer from low blood pressure
If you suffer from low blood volume
If you suffer from anaemia (low iron levels in your blood)
If you have an eye disease called glaucoma
If you have a heart valve disorder
If you suffer from inflammation of the heart lining
If you suffer from increased fluid around the heart (cardiac

tamponade)

If you suffer from a heart condition called hypertrophic obstructive cardiomyopathy
If 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
If you have an acute angina attack. Your doctor will give you a different medicine such as a GTN spray for this.
If you are using riociguat, a medicine used in treating pulmonary hypertension

Warnings and precautions

Talk to your doctor or pharmacist before using Deponit 5:

If you have an underactive thyroid gland
If you have any diseases of the lungs, liver or kidneys
If you have recently had a heart attack or you suffer from heart failure
If you suffer from hypoxaemia (insufficient oxygen in your blood) due

to lung disease, heart failure or severe anaemia (low haemoglobin)

If you have hypothermia (very low body temperature)
If you are malnourished (severe lack of food)
If you have a condition called Angina pectoris (chest pain)
If you have had a heart attack
If you have a condition in which there is insufficient blood flow to the

brain (cerebral ischemia)

Other medicines and Deponit 5

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 or pharmacist if you are taking, have recently taken or might take 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, monoamine oxidase 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.

Deponit 5 with alcohol

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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Deponit 5 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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.

Use in children

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 10 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.
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 heartbeats (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 forgotten 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

Stop using Deponit 5 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 (may affect 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 (may affect up to 1 in 10 people)

Low blood pressure (hypotension) and light-headedness 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 (may affect up to 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
Feeling sick
Being sick

Very rare side effects (may affect up to 1 in 10,000 people)

Heartburn.

Not known (frequency cannot be estimated from the available data)

Palpitations
Flushing of the face
Low blood pressure
Very red skin with scaling and thickened itchy skin (exfoliative

dermatitis)

Rash
Heart rate increase

5. how to store deponit 5

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the carton. 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. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other informationwhat deponit 5 contains:the active ingredient is glyceryl trinitrate.

Each patch contains 18.7mg of glyceryl trinitrate, designed to release 5mg of glyceryl trinitrate in 24hrs.

Also contains: acrylate/vinyl acetate copolymer (adhesive matrix) and polypropylene (backing layer).

What Deponit 5 looks like:

Deponit 5 is a white, translucent square patch with round corners. Each patch is supplied in a foil sachet.

Each carton contains 28 patches.

Manufactured by: Aesica Pharmaceuticals GmbH, Alfred-Nobel-Stralie 10, Monheim, Germany. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by: Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.

PL 20774/1540 Deponit 5 Patch

Leaflet revision date: 18th April 2019 p

Deponit is a registered trademark.

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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471 269

L-02–1540–01