NITRODERM TTS 5

Israel - English - Ministry of Health

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Active ingredient:
GLYCERYL TRINITRATE
Available from:
NOVARTIS ISRAEL LTD
ATC code:
C01DA02
Pharmaceutical form:
PATCHES
Composition:
GLYCERYL TRINITRATE 25 MG/PATCH
Administration route:
TRANSDERMAL
Prescription type:
Required
Manufactured by:
NOVARTIS PHARMA STEIN AG, SWITZERLAND
Therapeutic group:
GLYCERYL TRINITRATE
Therapeutic area:
GLYCERYL TRINITRATE
Therapeutic indications:
Prophylaxis of angina pectoris.
Authorization number:
118 55 22967 00
Authorization date:
2015-04-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

26-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986

The medicine is dispensed with a doctor’s prescription only

Nitroderm TTS 5

Transdermal Patch

Active ingredient:

Each patch contains 25 mg nitroglycerin.

Nitroderm TTS 10

Transdermal Patch

Active ingredient:

Each patch contains 50 mg nitroglycerin.

Inactive ingredients: See section 6 “Further information”.

Read this leaflet carefully in its entirety before using

the medicine. This leaflet contains concise information about

the medicine. If you have further questions, refer to the doctor

or pharmacist.

This medicine has been prescribed for the treatment of your

ailment.

Do not pass it on to others. It may harm them, even if it seems

to you that their ailment is similar.

This medicine is not intended for children.

If an angina attack has already started, you should use

fast-acting nitrate preparations (sublingual tablets or spray)

instead of Nitroderm TTS patches.

1. WHAT IS THE MEDICINE INTENDED FOR?

This medicine is used to prevent or reduce the frequency of

angina pectoris attacks.

Therapeutic group: A vasodilator belonging to a group of

medicines called nitrates.

Nitroderm TTS is an adhesive patch containing the active

substance nitroglycerin, which is delivered through the skin

into the bloodstream. Nitroglycerin widens the blood vessels,

which makes it easier for the heart to do its work.

2. BEFORE USING THE MEDICINE

X

Do not use this preparation if:

you are sensitive (allergic) to the active ingredient or any of

the additional ingredients contained in the medicine, listed in

section 6 “Further information” or to nitrates or nitrites.

you suffer from a breakdown of the blood circulation, with

very low blood pressure, such as in a state of shock.

you suffer from increased intracranial pressure (a condition

that your doctor will recognize and inform you about).

you suffer from a disease of the valves of the heart or an

inflammatory disease of the heart.

you are currently taking a medicine to treat erectile dysfunction

from the group of phosphodiesterase type 5 inhibitors

(e.g., sildenafil), in light of the severe side effects that could

occur (such as: fainting, myocardial infarction).

you suffer from very low blood pressure (systolic blood

pressure under 90 mm/Hg).

you suffer from hypovolemia.

Do not use Nitroderm TTS for acute attacks of angina

pectoris.

If one or more of these conditions apply to you, inform the

doctor without taking Nitroderm TTS.

Special warnings regarding use of the medicine

Before treatment with Nitroderm TTS, tell the doctor if:

∙ You have anemia.

∙ You have a lung disease.

∙ You have a heart disease or a blood vessel disorder other than

angina.

∙ You have recently had a heart attack, stroke or head injury.

Follow all of the doctor’s instructions carefully. They may differ

from the general information contained in this leaflet.

If you have been using this medicine for several weeks or more,

do not suddenly stop using it. Stopping suddenly may bring

on attacks of angina.

Your doctor will tell you the best way to stop treatment.

!

Important information about one of the medicine’s

ingredients

Before any surgery, hospital admission, emergency unit visit,

or imaging procedure, inform the doctors and nurses that you

are wearing a Nitroderm TTS patch which contains an aluminum

layer.

!

Taking other medicines:

If you are taking, or have recently taken, other medicines,

including non-prescription medicines or nutritional

supplements, tell the doctor or pharmacist. In particular,

if you are taking:

∙ Medicines used to lower blood pressure

∙ Medicines that widen blood vessels such as other nitrates and

hydralazine

∙ Diuretics

∙ Medicines used to treat depression or mood disturbances

∙ Medicines used to treat mental disorders (tranquilizers)

∙ Medicines used to treat migraine (dihydroergotamine)

∙ Medicines used to treat erectile dysfunction (inhibitors

of an enzyme called phosphodiesterase type 5, including

sildenafil)

∙ Aspirin and medicines from the non-steroidal anti-inflammatory

group

!

Taking the medicine with food, alcohol consumption

Be careful when drinking alcohol as your blood pressure may fall

more than usual and cause a feeling of dizziness or fainting.

!

Elderly patients (65 years of age or older)

There is no specific information regarding use of Nitroderm TTS

in elderly patients (65 years of age or older). Your doctor will

advise you about this.

!

Children and adolescents

This medicine is not intended for children.

!

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, or if you plan to

become pregnant. Your doctor will discuss with you the potential

risks of taking Nitroderm TTS during pregnancy.

It is not known whether nitroglycerin passes into the breast milk.

You should tell your doctor if you are breast-feeding.

!

Driving and using machines

Use of this medicine may cause dizziness or fainting, especially

at the start of treatment. You should, therefore, be careful when

driving a car, operating dangerous machinery or doing other

activities that require you to be alert.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions. Check with

the doctor or pharmacist if you are uncertain.

Dosage:

The dosage and treatment regimen will be determined by the

doctor only.

Do not exceed the recommended dose.

Your doctor will determine which type of patch you should use

(Nitroderm TTS 5 or 10) and how many patches you should

apply, depending on your individual needs. Your doctor will also

tell you when and how often to change your patch.

Directions for use:

You should normally put on a new patch once a day, usually

in the morning.

Your doctor may tell you to remove the patch for 8-12 hours out

of every 24 hours, usually at night (called patch-off period).

If you feel your medicine is not helping you, please tell your

doctor.

Depending on how you respond to the treatment, your doctor

may suggest a higher or lower dosage of the medicine.

Use this medicine at set intervals as determined by the

attending doctor.

Where to apply the patch?

Choose any area of skin on the upper half of your body (from

the waist until the shoulders) or the upper arm. The skin should

be healthy (not inflamed, broken, or irritated). To help the

patch stick, the skin should be clean, non-hairy, dry, and free

of creams, lotions, oil, or powder. You should apply the patch

to a different area of skin each day. Wait several days before

using the same area again.

Opening the sachets:

Each Nitroderm TTS patch is packed in a separate sachet.

The sticky surface is covered with a white plastic protective

backing.

Tear open the sachet where marked. Remove the patch from

the sachet. Carefully hold the patch with the opening tab facing

upwards and the white protective backing facing you.

Removing the protective backing:

Firmly bend the tab with your thumb. Peel off the white

protective backing from the patch starting at the tab. Do not

touch the sticky surface of the patch.

Applying the patch:

Press the sticky side of the patch firmly to the area of skin you

have chosen (upper half of your body or upper arm) with the

palm of your hand for 10-20 seconds.

Make sure that the patch sticks well, especially around the edges.

Do not test the patch by pulling it once it is on your skin.

When and how to remove the patch:

Leave the patch in place on your skin for as long as the doctor

tells you to. Peel it off and fold it in half, pressing the sticky

sides together.

Do not cut or tear the patch.

Throw the used patch away, ensuring that it is out of the reach

of children.

Any adhesive left on the skin can be removed with alcohol.

Stick a new patch on a different area of your skin.

If the patch becomes wet:

Bathing or showering, swimming or exercising will not usually

affect the patch if it has been correctly applied.

If the patch falls off:

It is unlikely that the patch will fall off, but if it does, discard it

and put on a new patch as soon as possible. You should put on

your next patch at your regular time.

If you forget to apply Nitroderm TTS patch

If you forget to change a patch at the correct time, do not

worry. Change it as soon as you remember, respecting any

prescribed patch-off period, if you have been instructed to do

so by the doctor. However, if the time to change the next patch

is approaching, skip the forgotten patch and apply the next

patch at the correct time.

If you use more Nitroderm TTS patches than you should

If you have accidentally used more patches than your doctor

prescribed, contact a doctor immediately. You may require

medical attention.

If you stop using Nitroderm TTS patches

Even if there is an improvement in your health, do not stop

treatment with the medicine without consulting the doctor.

If you have been using Nitroderm TTS for several weeks or more,

do not suddenly stop using it. Stopping suddenly may bring on

attacks of angina. Adhere strictly to the doctor’s instructions.

If you have further questions regarding use of the medicine,

consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Nitroderm TTS may cause side

effects in some users. Do not be alarmed by the list of side

effects. You may not suffer from any of them.

These effects usually disappear within a short time following the

period of adaptation to the preparation. If they continue for more

than a few days or worsen, refer to the attending doctor.

Side effects that require special attention:

In the event that one of the effects listed below occurs, remove

the patch and contact the doctor immediately:

Headache, dizziness, tiredness, difficulty breathing, bluish

skin discoloration, weak and very fast heart beats, unusual

weakness.

Signs of allergy such as skin rash and/or prickling, swelling of the

face, lips, tongue and/or other parts of the body, fainting.

Very common side effects - effects that occur in more than

1 user in 10:

∙ Nausea

∙ Vomiting

Common side effects - effects that occur in 1-10 in 100 users:

∙ Headache, which may need treatment with an analgesic.

Uncommon side effects - effects that occur in 1-10 in 1,000

users:

∙ Skin irritation: the skin under the patch may become red

and itchy. This will disappear within a day of removing the

patch.

∙ Skin allergies: the skin under the patch may become very red

and swollen, or form blisters. If you develop a generalized rash

covering extensive areas of skin in your body, report this to

your doctor.

Rare side effects - effects that occur in 1-10 in 10,000 users:

∙ Reddening of the face or feeling dizzy when you get up

quickly from a lying or sitting position, due to low blood

pressure. Getting up slowly may help. If you feel dizzy, sit or

lie down.

∙ Fast heartbeat.

Very rare side effects - effects that occur in less than 1 user

in 10,000:

∙ Dizziness.

Other side effects (unknown frequency):

∙ Heart-related effects: feeling of especially strong, fast or

irregular heart beats (palpitations). Contact your doctor if

this affects you severely.

∙ Skin-related effects: rash.

If the side effects affect you severely, inform the doctor.

If a side effect occurs, if one of the side effects worsens or

if you suffer from a side effect not mentioned in this leaflet,

consult with the doctor.

Side effects can be reported to the Ministry of Health using the

online form at the following link:

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?f

ormType=AdversEffectMedic%40moh.health.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine, and any other medicine,

should be kept in a safe place out of the reach and sight of

children and/or infants in order to avoid poisoning. Do not

induce vomiting unless explicitly instructed to do so by the

doctor.

∙ Do not use the medicine after the expiry date (exp. date) that

appears on the package. The expiry date refers to the last

day of that month.

∙ Storage conditions: Store below 25°C.

∙ Use the patch immediately after removing it from the

sachet.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine also

contains:

Silica aerogel, silicone oil, ethylene-vinylacetate copolymer,

medical adhesive CH 15.

What does the medicine look like and what are the contents

of the package:

Nitroderm TTS 5: Flat patch with “CG DOD” printed on the

orange-grey side; the other side is off-white colored.

Nitroderm TTS 10: Flat patch with “CG DPD” printed on the

orange-grey side; the other side is off-white colored.

Package sizes:

10 sachets in each package

License Holder and address:

Novartis Israel Ltd., 36 Shacham St., Petach-Tikva.

Manufacturer and address:

Novartis Pharma Stein AG, Stein, Switzerland

for Novartis Pharma AG, Basel, Switzerland.

This leaflet was checked and approved by the Ministry of Health

in July 2015.

Registration number of the medicine in the National Drug

Registry of the Ministry of Health:

Nitroderm TTS 5

118 55 22967

Nitroderm TTS 10

118 56 21607

SH NIT APL JUL15 CL V5 COR CPO CL

SH NIT APL JUL15 CL V5 COR CPO CL

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ﺍﺪﻴﺟ ﺔﻘﺼﻠﻟﺍ ﻕﺎﺼﺘﻟﺇ ﻦﻣ ﺪﻛﺄﺘﻟﺍ ﺐﺠﻳ .ﻙﺪﻠﺟ ﻰﻠﻋ

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ﺍﺪﺣﺍﻭ ﺔﻘﺻﻼﻟﺍ ﺀﺍﺰﺟﻷﺍ ﻰﻠﻋ ﻂﻐﻀﻟﺍ ﻝﻼﺧ ﻦﻣ ﻒﺼﻨﻟﺍ ﻰﻟﺇ ﻲﻨﺜﻟﺍﻭ ﺮﺸﻘﻟﺍ ﺐﺠﻳ .ﺮﺧﻵﺍ ﻰﻟﺇ .ﺔﻘﺼﻠﻟﺍ ﻖﻳﺰﻤﺗ ﻭﺃ ﺺﻗ ﺯﻮﺠﻳ ﻻ ﻱﺪﻳﺃ ﻝﻭﺎﻨﺘﻣ ﻦﻋ ﺓﺪﻴﻌﺑ ﺎﻬﻧﺃ ﻦﻣ ﺪﻛﺄﺘﻟﺍﻭ ،ﺔﻠﻤﻌﺘﺴﻤﻟﺍ ﺔﻘﺼﻠﻟﺍ ﻲﻣﺭ ﺐﺠﻳ .ﻝﺎﻔﻃﻷﺍ .ﻝﻮﺤﻜﻟﺍ ﺔﻄﺳﺍﻮﺑ ﺪﻠﺠﻟﺍ ﻦﻋ ﺔﻘﺻﻼﻟﺍ ﺓﺩﺎﻤﻟﺍ ﺎﻳﺎﻘﺑ ﺔﻟﺍﺯﺇ ﻥﺎﻜﻣﻹﺎﺑ .ﺪﻠﺠﻟﺍ ﻦﻣ ﺓﺪﻳﺪﺟ ﺔﻘﻄﻨﻣ ﻰﻠﻋ ﺓﺪﻳﺪﺟ ﺔﻘﺼﻟ ﻖﺼﻟ ﺐﺠﻳ :ﺔﻘﺼﻠﻟﺍ ﺖﻠﻠﺒﺗ ﺍﺫﺇ ﺓﺩﺎﻋ ﺮﺛﺆﺗ ﻦﻟ ﺔﺿﺎﻳﺮﻟﺍ ﻭﺃ ﺔﺣﺎﺒﺴﻟﺍ ،ﺵﻭﺪﻟﺍ ﻭﺃ ﻡﺎﻤﺤﺘﺳﻹﺍ ﺽﻮﺣ ﻲﻓ ﻝﺎﺴﺘﻏﻹﺍ ﻥﺇ .ﻲﻐﺒﻨﻳ ﺎﻤﻛ ﺎﻬﻘﺼﻟ ﻢﺗ ﺍﺫﺇ ﻚﻟﺫﻭ ﺔﻘﺼﻠﻟﺍ ﻰﻠﻋ :ﺔﻘﺼﻠﻟﺍ ﺖﻄﻘﺳ ﺍﺫﺇ ﺔﻘﺼﻟ ﻖﺼﻟﻭ ﺎﻬﻴﻣﺭ ﺐﺠﻳ ،ﺖﻄﻘﺳ ﺍﺫﺇ ﻦﻜﻟﻭ ،ﺔﻘﺼﻠﻟﺍ ﻂﻘﺴﺗ ﻥﺃ ﻞﻤﺘﺤﻤﻟﺍ ﺮﻴﻏ ﻦﻣ .ﻱﺩﺎﻴﺘﻋﻹﺍ ﺖﻗﻮﻟﺍ ﻲﻓ ﺔﻴﻟﺎﺘﻟﺍ ﺔﻘﺼﻠﻟﺍ ﻊﺿﻭ ﺐﺠﻳ .ﻦﻜﻤﻳ ﺎﻣ ﻉﺮﺳﺄﺑ ﺓﺪﻳﺪﺟ

TTS

ﻡﺭﺩﻭﺮﺘﻴﻧ ﺔﻘﺼﻟ ﻝﺎﻤﻌﺘﺳﺇ ﺖﻴﺴﻧ ﺍﺫﺇ ﻙﺮﻛﺬﺗ ﻝﺎﺣ ﺎﻬﻠﻳﺪﺒﺗ ﺐﺠﻳ .ﻖﻠﻘﻠﻟ ﺔﺟﺎﺣ ﻼﻓ ،ﺖﻗﻮﻟﺍ ﻲﻓ ﺔﻘﺼﻠﻟﺍ ﻞﻳﺪﺒﺗ ﺖﻴﺴﻧ ﺍﺫﺇ ﺍﺫﺇ ﻦﻜﻟﻭ .ﻚﻟﺬﺑ ﺐﻴﺒﻄﻟﺍ ﻙﺎﺻﻭﺃ ﺍﺫﺇ ﺔﻘﺼﻠﻟﺍ ﻥﻭﺪﺑ ﺖﻗﻮﻟﺍ ﻰﻠﻋ ﻅﺎﻔﺤﻟﺍ ﻝﻼﺧ ﻦﻣ ﻊﺿﻭﻭ ﺔﻴﺴﻨﻤﻟﺍ ﺔﻘﺼﻠﻟﺍ ﺖﻳﻮﻔﺗ ﺐﺠﻴﻓ ﺔﻣﺩﺎﻘﻟﺍ ﺔﻘﺼﻠﻟﺍ ﻞﻳﺪﺒﺗ ﺪﻋﻮﻣ ﺏﺮﺘﻗﺇ .ﺢﻴﺤﺼﻟﺍ ﺖﻗﻮﻟﺍ ﻲﻓ ﺔﻣﺩﺎﻘﻟﺍ ﺔﻘﺼﻠﻟﺍ ﺏﻮﻠﻄﻤﻟﺍ ﻦﻣ ﺮﺜﻛﺃ

TTS

ﻡﺭﺩﻭﺮﺘﻴﻧ ﺕﺎﻘﺼﻟ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ .ﺐﻴﺒﻄﻟﺍ ﻰﻟﺇ

ﻻﺎﺣ ﻪﺟﻮﺗ ،ﺐﻴﺒﻄﻟﺍ ﻙﺎﺻﻭﺃ ﺎﻤﻣ ﺮﺜﻛﺃ ﺕﺎﻘﺼﻟ ﺄﻄﺨﻟﺎﺑ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ .ﻲﺒﻃ ﺝﻼﻌﻟ ﺝﺎﺘﺤﺗ ﻥﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ

TTS

ﻡﺭﺩﻭﺮﺘﻴﻧ ﺕﺎﻘﺼﻟ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻋ ﺖﻔﻗﻮﺗ ﻝﺎﺣ ﻲﻓ ﻦﺴﺤﺗ ﺃﺮﻃ ﻮﻟﻭ ﻰﺘﺣ ،ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ﻥﻭﺪﺑ ﺀﺍﻭﺪﻟﺎﺑ ﺝﻼﻌﻟﺍ ﻦﻋ ﻒﻗﻮﺘﻟﺍ ﺯﻮﺠﻳ ﻻ .ﺔﻴﺤﺼﻟﺍ ﻚﺘﻟﺎﺣ ﻰﻠﻋ ﻝﺎﻤﻌﺘﺳﻹﺍ ﻦﻋ ﻒﻗﻮﺘﺗ ﻼﻓ ،ﺮﺜﻛﺃ ﻭﺃ ﻊﻴﺑﺎﺳﺃ ﺓﺪﻋ ﺓﺮﺘﻔﻟ

ﻡﺭﺩﻭﺮﺘﻴﻧ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ ﺔﺤﺑﺬﻟﺍ ﻦﻣ ﺕﺎﺑﻮﻧ ﺙﻭﺪﺤﻟ ﻱﺩﺆﻳ ﺪﻗ ﺊﺟﺎﻔﻤﻟﺍ ﻒﻗﻮﺘﻟﺍ ﻥﺇ .ﺊﺟﺎﻔﻣ ﻞﻜﺸﺑ .ﺐﻴﺒﻄﻟﺍ ﺕﺎﻤﻴﻠﻌﺗ ﺐﺴﺤﺑ ﺹﺮﺤﺑ ﻑﺮﺼﺗ .ﺔﻳﺭﺪﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﺮﺸﺘﺳﺇ ،ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﻝﻮﺣ ﺔﻴﻓﺎﺿﺇ ﺔﻠﺌﺳﺃ ﻚﻳﺪﻟ ﺕﺮﻓﻮﺗ ﺍﺫﺇ .ﻲﻟﺪﻴﺼﻟﺍ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ

ﺾﻌﺑ ﺪﻨﻋ ﺔﻴﺒﻧﺎﺟ

ﺎﺿﺍﺮﻋﺃ ﺐﺒﺴﻳ ﺪﻗ

ﻡﺭﺩﻭﺮﺘﻴﻧ ﻝﺎﻤﻌﺘﺳﺇ ﻥﺇ ،ﺀﺍﻭﺩ ﻞﻜﺑ ﺎﻤﻛ ﻲﻧﺎﻌﺗ ﻻﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ .ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺔﻤﺋﺎﻗ ﻦﻣ ﺶﻫﺪﻨﺗ ﻻ .ﻦﻴﻠﻤﻌﺘﺴﻤﻟﺍ .ﺎﻬﻨﻣ

ﺎﻳﺃ .ﺮﻀﺤﺘﺴﻤﻟﺍ ﻰﻠﻋ ﺩﻮﻌﺘﻟﺍ ﺓﺮﺘﻓ ﺪﻌﺑ ﺓﺰﻴﺟﻭ ﺓﺮﺘﻓ ﻝﻼﺧ ﺓﺩﺎﻋ ﺽﺍﺮﻋﻷﺍ ﻩﺬﻫ ﻝﻭﺰﺗ .ﺞﻟﺎﻌﻤﻟﺍ ﺐﻴﺒﻄﻟﺍ ﺔﻌﺟﺍﺮﻣ ﺐﺠﻴﻓ ﺖﻤﻗﺎﻔﺗ ﺍﺫﺇ ﻭﺃ ﻡﺎﻳﺃ ﺓﺪﻋ ﻦﻣ ﺮﺜﻛﻷ ﺕﺮﻤﺘﺳﺇ ﺍﺫﺇ

:

ﺎﺻﺎﺧ

ﺎﻣﺎﻤﺘﻫﺇ ﺐﻠﻄﺘﺗ ﻲﺘﻟﺍ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻪﺟﻮﺗﻭ ﺔﻘﺼﻠﻟﺍ ﻉﺰﻧﺇ ،

ﺎﻘﺣﻻ ﺔﻧﻭﺪﻤﻟﺍ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻯﺪﺣﺇ ﺭﻮﻬﻇ ﻝﺎﺣ ﻲﻓ :ﺐﻴﺒﻄﻟﺍ ﻰﻟﺇ

ﻻﺎﺣ ﺕﺎﺑﺮﺿ ،ﻕﺭﺯﻸﻟ ﻞﺋﺎﻣ ﻰﻟﺇ ﺪﻠﺠﻟﺍ ﻥﻮﻟ ﺮﻴﻐﺗ ،ﺲﻔﻨﺘﻟﺍ ﻲﻓ ﺕﺎﺑﻮﻌﺻ ،ﻕﺎﻫﺭﺇ ،ﺭﺍﻭﺩ ،ﻉﺍﺪﺻ .ﻱﺩﺎﻋ ﺮﻴﻏ ﻒﻌﺿ ،

ﺍﺪﺟ ﺔﻌﻳﺮﺳﻭ ﺔﻔﻴﻌﺿ ﺐﻠﻗ ،ﻦﻴﺘﻔﺸﻟﺍ ،ﻪﺟﻮﻟﺍ ﺥﺎﻔﺘﻧﺇ ،ﺪﻠﺠﻟﺍ ﻲﻓ ﺰﺧﻭ ﻭﺃ/ﻭ ﺢﻔﻃ ﻞﺜﻣ ،ﺔﻴﺳﺎﺴﺤﻟ ﺕﺎﻣﻼﻋ .ﺀﺎﻤﻏﺇ ،ﻢﺴﺠﻟﺍ ﻦﻣ ﻯﺮﺧﺃ ﺀﺍﺰﺟﺃ ﻭﺃ/ﻭ ﻥﺎﺴﻠﻟﺍ ﻦﻣ ﺮﺜﻛﺃ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ (

very common

ﺍﺪﺟ ﺔﻌﺋﺎﺷ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :١٠ ﻦﻴﺑ ﻦﻣ ١ ﻞﻤﻌﺘﺴﻣ ﻥﺎﻴﺜﻏ ∙ ﺆﻴﻘﺗ ∙ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠-١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ (

common

) ﺔﻌﺋﺎﺷ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :١٠٠ ﻦﻴﺑ ﻦﻣ .ﻡﻻﻶﻟ ﻦﻜﺴﻤﺑ

ﺎﺟﻼﻋ ﺐﻠﻄﺘﻳ ﻥﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ ﻱﺬﻟﺍ ،ﻉﺍﺪﺻ ∙ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠-١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ (

uncommon

) ﺔﻌﺋﺎﺷ ﺮﻴﻏ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :١٠٠٠ ﻦﻴﺑ ﻦﻣ ﺮﻣﻷﺍ ﺍﺬﻫ ﻝﻭﺰﻳ .ﻙﺎﺣﻭ ﺮﻤﺣﺃ ﺔﻘﺼﻠﻟﺍ ﺖﺤﺗ ﻦﻣ ﺪﻠﺠﻟﺍ ﺢﺒﺼﻳ ﺪﻗ :ﺪﻠﺠﻟﺍ ﺞﻴﻬﺗ ∙ .ﺔﻘﺼﻠﻟﺍ ﻉﺰﻧ ﺬﻨﻣ ﻡﻮﻳ ﻝﻼﺧ ﺪﻳﺪﺷ ﻞﻜﺸﺑ ﺮﻤﺣﺃ ﺔﻘﺼﻠﻟﺍ ﺖﺤﺗ ﻦﻣ ﺪﻠﺠﻟﺍ ﺢﺒﺼﻳ ﺪﻗ :ﺪﻠﺠﻟﺍ ﺔﻴﺳﺎﺴﺣ ∙ ﻲﻄﻐﻳ ﻞﻣﺎﺷ ﺢﻔﻃ ﻚﻳﺪﻟ ﺭﻮﻄﺗ ﺍﺫﺇ .ﺕﻼﺼﻳﻮﺣ ﻞﻜﺸﺘﺑ ﻖﻓﺍﺮﺘﻳ ﻭﺃ ،ﺦﻔﺘﻨﻣﻭ .ﻚﻟﺫ ﻦﻋ ﺐﻴﺒﻄﻟﺍ ﻍﻼﺑﺇ ﺐﺠﻳ ،ﻚﻤﺴﺟ ﺪﻠﺟ ﻦﻣ ﺔﻌﺳﺍﻭ ﻖﻃﺎﻨﻣ ﻦﻴﺑ ﻦﻣ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠-١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ (

rare

) ﺓﺭﺩﺎﻧ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :١٠٠٠٠ ﺱﻮﻠﺟ ﻭﺃ ﺀﺎﻘﻠﺘﺳﺇ ﺔﻟﺎﺣ ﻦﻣ ﺔﻋﺮﺴﺑ ﺽﻮﻬﻨﻟﺍ ﺪﻨﻋ ﺭﺍﻭﺪﺑ ﺭﻮﻌﺸﻟﺍ ﻭﺃ ﻪﺟﻮﻟﺍ ﺭﺍﺮﻤﺣﺇ ∙ ﺖﻨﻛ ﺍﺫﺇ .ﺪﻋﺎﺴﻳ ﻥﺃ ﻪﻧﺄﺷ ﻦﻣ ﺀﻂﺒﺑ ﻡﺎﻴﻘﻟﺍ ﻥﺇ .ﻡﺪﻟﺍ ﻂﻐﺿ ﺽﺎﻔﺨﻧﺇ ﺔﺠﻴﺘﻧ .ﻖﻠﺘﺳﺇ ﻭﺃ ﺲﻠﺟﺇ ،ﺭﺍﻭﺪﺑ ﺮﻌﺸﺗ .ﺾﺒﻨﻟﺍ ﻉﺮﺴﺗ ∙ ﻞﻤﻌﺘﺴﻣ ﻦﻣ ﻞﻗﺃ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ (

very rare

ﺍﺪﺟ ﺓﺭﺩﺎﻧ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :١٠٠٠٠ ﻦﻴﺑ ﻦﻣ ﺪﺣﺍﻭ .ﺭﺍﻭﺩ ∙ :(ﻑﻭﺮﻌﻣ ﺮﻴﻏ ﺎﻬﻋﻮﻴﺷ) ﻯﺮﺧﺃ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻭﺃ ﺔﻌﻳﺮﺳ ،ﺹﺎﺧ ﻞﻜﺸﺑ ﺔﻳﻮﻗ ﺐﻠﻗ ﺕﺎﺑﺮﻀﺑ ﺭﻮﻌﺸﻟﺍ :ﺐﻠﻘﻟﺎﺑ ﻖﻠﻌﺘﺗ ﺽﺍﺮﻋﺃ ∙ ﻚﻴﻠﻋ ﺮﺛﺆﻳ ﺮﻣﻷﺍ ﺍﺬﻫ ﻥﺎﻛ ﺍﺫﺇ ﺐﻴﺒﻄﻟﺍ ﺔﻌﺟﺍﺮﻣ ﺐﺠﻳ .(ﻥﺎﻘﻔﺧ) ﺔﻤﻈﺘﻨﻣ ﺮﻴﻏ .ﺪﻳﺪﺷ ﻞﻜﺸﺑ .ﺢﻔﻃ :ﺪﻠﺠﻟﺎﺑ ﻖﻠﻌﺘﺗ ﺽﺍﺮﻋﺃ ∙ .ﺐﻴﺒﻄﻟﺍ ﻎﻠﺑ ،ﺮﻴﻄﺧ ﻞﻜﺸﺑ ﻚﻴﻠﻋ ﺮﺛﺆﺗ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺖﻧﺎﻛ ﺍﺫﺇ ﻦﻣ ﻲﻧﺎﻌﺗ ﺎﻣﺪﻨﻋ ﻭﺃ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻯﺪﺣﺇ ﺖﻤﻗﺎﻔﺗ ﺍﺫﺇ ،ﻲﺒﻧﺎﺟ ﺽﺮﻋ ﺮﻬﻇ ﺍﺫﺇ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﻚﻴﻠﻋ ،ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﻲﻓ ﺮﻛﺬﻳ ﻢﻟ ﻲﺒﻧﺎﺟ ﺽﺮﻋ ﻰﻠﻋ ﺓﺭﺎﻤﺘﺳﻹﺍ ﺔﻄﺳﺍﻮﺑ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻮﻟ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﻦﻜﻤﻳ :ﻲﻟﺎﺘﻟﺍ ﻂﺑﺍﺮﻟﺍ ﻰﻠﻋ ﺖﻧﺮﺘﻧﻹﺍ

http://forms.gov.il/globaldata/getsequence/getsequence.asp

x?formType=AdversEffectMedic%40moh.health.gov.il

؟ﺀﺍﻭﺪﻟﺍ ﻦﻳﺰﺨﺗ ﺔﻴﻔﻴﻛ (٥ ﻦﻋ

ﺍﺪﻴﻌﺑ ﻖﻠﻐﻣ ﻥﺎﻜﻣ ﻲﻓ ﺀﺍﻭﺩ ﻞﻛﻭ ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻆﻔﺣ ﺐﺠﻳ !ﻢﻤﺴﺘﻟﺍ ﺐﻨﺠﺗ ∙ .ﻢﻤﺴﺘﻟﺎﺑ ﻢﻬﺘﺑﺎﺻﺇ ﻱﺩﺎﻔﺘﻟ ﻚﻟﺫﻭ ،ﻊﺿﺮﻟﺍ ﻭﺃ/ﻭ ﻝﺎﻔﻃﻷﺍ ﺔﻳﺅﺭ ﻝﺎﺠﻣﻭ ﻱﺪﻳﺃ ﻝﻭﺎﻨﺘﻣ .ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺔﺤﻳﺮﺻ ﺕﺎﻤﻴﻠﻌﺗ ﻥﻭﺪﺑ ﺆﻴﻘﺘﻟﺍ ﺐﺒﺴﺗ ﻻ ﻱﺬﻟﺍ (

exp. date

) ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺀﺎﻀﻘﻧﺇ ﺪﻌﺑ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺯﻮﺠﻳ ﻻ ∙ ﺲﻔﻧ ﻦﻣ ﺮﻴﺧﻷﺍ ﻡﻮﻴﻟﺍ ﻰﻟﺇ ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺮﻴﺸﻳ .ﺔﺒﻠﻌﻟﺍ ﺮﻬﻇ ﻰﻠﻋ ﺮﻬﻈﻳ .ﺮﻬﺸﻟﺍ .ﺔﻳﻮﺌﻣ ﺔﺟﺭﺩ ٢٥ ﻥﻭﺩ ﻦﻳﺰﺨﺘﻟﺍ ﺐﺠﻳ :ﻦﻳﺰﺨﺘﻟﺍ ﻁﻭﺮﺷ ∙ .ﺲﻴﻜﻟﺍ ﻦﻣ ﺎﻬﺟﺍﺮﺧﺇ ﺪﻌﺑ

ﻻﺎﺣ ﺔﻘﺼﻠﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺐﺠﻳ ∙ :ﺔﻴﻓﺎﺿﺇ ﺕﺎﻣﻮﻠﻌﻣ (٦

ﺎﻀﻳﺃ ﺔﻟﺎﻌﻔﻟﺍ ﺓﺩﺎﻤﻠﻟ ﺔﻓﺎﺿﻹﺎﺑ ﺀﺍﻭﺪﻟﺍ ﻱﻮﺘﺤﻳ :ﺔﺒﻠﻌﻟﺍ ﻯﻮﺘﺤﻣ ﻮﻫ ﺎﻣﻭ ﺀﺍﻭﺪﻟﺍ ﻭﺪﺒﻳ ﻒﻴﻛ ﻱﺩﺎﻣﺮﻠﻟ ﻞﺋﺎﻤﻟﺍ ـ ﻲﻟﺎﻘﺗﺮﺒﻟﺍ ﺎﻬﺒﻧﺎﺟ ﻰﻠﻋ ﻉﻮﺒﻄﻣ ﺔﺤﻄﺴﻣ ﺔﻘﺼﻟ :٥

ﻡﺭﺩﻭﺮﺘﻴﻧ

off-white

ـ ﺖﻳﺍﻭ ﻑﻭﺃ) ﺞﻴﺑ ﻪﻧﻮﻟ ﺮﺧﻵﺍ ﺐﻧﺎﺠﻟﺍﻭ ،«

CG DOD

ﻞﺋﺎﻤﻟﺍ ـ ﻲﻟﺎﻘﺗﺮﺒﻟﺍ ﺎﻬﺒﻧﺎﺟ ﻰﻠﻋ ﻉﻮﺒﻄﻣ ﺔﺤﻄﺴﻣ ﺔﻘﺼﻟ :١٠

ﻡﺭﺩﻭﺮﺘﻴﻧ

off-white

ـ ﺖﻳﺍﻭ ﻑﻭﺃ) ﺞﻴﺑ ﻪﻧﻮﻟ ﺮﺧﻵﺍ ﺐﻧﺎﺠﻟﺍﻭ ،«

CG DPD

» ﻱﺩﺎﻣﺮﻠﻟ :ﺔﺒﻠﻌﻟﺍ ﻡﺎﺠﺣﺃ ﺔﺒﻠﻋ ﻞﻜﺑ ﺱﺎﻴﻛﺃ ١٠ :ﻪﻧﺍﻮﻨﻋﻭ ﺯﺎﻴﺘﻣﻹﺍ ﺐﺣﺎﺻ .ﺎﭭﻜﺗ ـ ﺢﺘﻴﭘ ،٣٦ ﻡﺎﺣﺎﺷ ﻉﺭﺎﺷ ،.ﺽ.ﻡ ﻞﻴﺋﺍﺮﺳﺇ ﺲﻴﺗﺭﺎﭬﻮﻧ :ﻪﻧﺍﻮﻨﻋﻭ ﺞﺘﻨﻤﻟﺍ ﻢﺳﺇ .ﺍﺮﺴﻳﻮﺳ ﻦﻳﺎﺘﺷ ،ﻲﺟ ﻲﻳﺍ ﻦﻳﺎﺘﺷ ﺎﻣﺭﺎﻓ ﺲﻴﺗﺭﺎﭬﻮﻧ .ﺍﺮﺴﻳﻮﺳ ،ﻝﺯﺎﺑ ،ﻲﺟ ﻲﻳﺍ ﺎﻣﺭﺎﻓ ﺲﻴﺗﺭﺎﭬﻮﻧ :ﻞﺟﺃ ﻦﻣ :ﺦﻳﺭﺎﺗ ﻲﻓ ﺺﺧ

ﺭﻭ ﺺﺤ

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ﻡﺭﺩﻭﺮﺘﻴﻧ ١١٨ ٥٦ ٢١٦٠٧ - ١٠

ﻡﺭﺩﻭﺮﺘﻴﻧ ﻰﻠﻋ .ﺮﻛﺬﻤﻟﺍ ﺔﻐﻴﺼﺑ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻏﺎﻴﺻ ﺖﻤﺗ ،ﺓﺀﺍﺮﻘﻟﺍ ﻦﻳﻮﻬﺗﻭ ﺔﻟﻮﻬﺳ ﻞﺟﺃ ﻦﻣ .ﻦﻴﺴﻨﺠﻟﺍ ﻼﻜﻟ ﺺﺼﺨﻣ ﺀﺍﻭﺪﻟﺍ ﻥﺈﻓ ،ﻚﻟﺫ ﻦﻣ ﻢﻏﺮﻟﺍ

Silica aerogel, silicone oil, ethylene-vinylacetate copolymer,

medical adhesive CH 15.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ יאמב

2015

NITRODERM

®

TTS

(nitroglycerin)

25 mg or 50 mg transdermal patch

Prescribing Information

1

Trade name

NITRODERM

TTS 5

NITRODERM

TTS 10

2

Description and composition

Active substance

Nitroderm TTS contains Nitroglycerin (25mg or 50mg) in a transdermal therapeutic system

(TTS).

List of excipients

Silica aerogel, silicone oil 360, ethylene-vinylacetate copolymer, medical adhesive CH 15 .

Pharmaceutical form

Transdermal Patch

Flat multilayer system designed to deliver nitroglycerin continuously through a release

membrane following application to the skin. The release membrane limits delivery through

hyperpermeable skin. The active substance penetrates the skin and thus becomes directly

bioavailable to the systemic circulation at relatively constant concentrations during the

recommended application period. The following two systems are available:

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

Table 2-1

Nitroderm TTS pharmaceutical forms

Nitroderm TTS 5

Nitroderm TTS 10

Nitroglycerin content

25 mg

50 mg

Drug-releasing area

10 cm

20 cm

Imprint (backing side)

Colour

release

liner

off-white to yellowish

The numeric components of the product designations TTS 5 and TTS 10 denote the nominal

amount of nitroglycerin in mg delivered by the system per 24 hours.

The remainder of the nitroglycerin in each system serves as a reserve and is not delivered

during normal use. After 12 hours, for example, each system has delivered 10% of its original

nitroglycerin content. Since nitroglycerin is released from Nitroderm TTS at a constant rate

per cm

, the dose administered is related to the size of the drug-releasing area. The nominal

rate of nitroglycerin release in vivo is approximately 20-25 microgram/cm

The following cross-sectional diagram shows the composition of Nitroderm TTS.

3

Indications

Prophylaxis of angina pectoris

4

Dosage and administration

General rules

Nitroderm TTS is not intended for the immediate relief of acute attacks of angina pectoris; if

these occur, rapid-acting nitrate preparations should be used.

The response to nitrate preparations varies from patient to patient; the lowest effective dose

should be prescribed. The application site should be changed regularly to prevent local

irritation.

Development of tolerance or attenuation of therapeutic effect commonly occurs with

prolonged or frequent administration of long-acting nitrates, including Nitroderm TTS or

other transdermal systems. A patch-off period of 8-12 hours, usually at night, every 24 hours

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

is recommended to overcome tolerance. Clinical trials have shown that in most patients

intermittent therapy is more effective than continuous administration. Continuous application

of Nitroderm TTS may be appropriate for patients in whom long-term clinical responsiveness

can be reliably assessed.

Prophylaxis of angina pectoris

Treatment should be initiated with one Nitroderm TTS 5 daily. According to the clinical

response the daily dose can then be titrated upwards to:

one Nitroderm TTS 10 (normal maintenance dose)

one Nitroderm TTS 10 plus one Nitroderm TTS 5

two Nitroderm TTS 10

Special populations

Geriatric patients (above 65 years age)

No specific information on use in the elderly is available; however, there is no evidence to

suggest that the dosage needs to be adjusted in elderly patients.

Pediatric patients

Not enough is known about the effects of Nitroderm TTS in children, which means that it

cannot be recommended for use in this age group.

5

Contraindications

Known hypersensitivity to nitroglycerin and related organic nitrates or any excipient of

Nitroderm TTS.

Acute circulatory failure associated with marked hypotension (shock).

Conditions associated with elevated intracranial pressure.

Myocardial insufficiency due to obstruction,

as in aortic or mitral stenosis or constrictive

pericarditis.

Concomitant use of Nitroderm TTS and phosphodiesterase type 5 (PDE5) inhibitors such as

sildenafil is contraindicated, because PDE5 inhibitors may amplify the vasodilatory effects of

Nitroderm TTS resulting in severe hypotension. The time course and dose dependence of this

interaction have not been studied. Appropriate supportive care has not been studied, but it

seems reasonable to treat this as a nitrite overdose, with elevation of the extremities and with

central volume expansion.

Severe hypotension (systolic blood pressure less than 90 mmHg).

Severe hypovolemia.

The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be

useful in aborting an acute attack.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly

constitutes a contraindication to the use of this product.

6

Warnings and precautions

Warnings

As with other nitrate preparations, when switching the patient on long-term therapy to another

form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment

started.

The Nitroderm TTS patch contains an aluminium layer. Therefore, Nitroderm TTS must be

removed before applying magnetic or electrical fields to the body during procedures such as

MRI (Magnetic Resonance Imagining), cardioversion or DC defibrillation, or diathermy

treatment.

In cases of recent myocardial infarction or acute heart failure, treatment with Nitroderm TTS

should be carried out cautiously under strict medical surveillance and/or hemodynamic

monitoring.

A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a

Nitroderm TTS patch. The arching that may be seen in this situation is harmless in itself, but it

may be associated with local current concentration that can cause damage to the paddles and

burns to the patient.

Precautions

Hypoxaemia

Caution should be exercised in patients with arterial hypoxemia (including G6PD deficiency

induced forms) due to severe anemia, because in such patients the biotransformation of

nitroglycerin is reduced. Similarly, caution is called for in patients with hypoxemia and

ventilation/perfusion imbalance due to lung disease or ischemic heart failure. In patients with

alveolar hypoventilation a vasoconstriction occurs within the lung to shift perfusion from

areas of alveolar hypoxia to better ventilated regions of the lung (Euler–Liljestrand

mechanism). Patients with angina pectoris, myocardial infarction, or cerebral ischemia

frequently suffer from abnormalities of the small airways (especially alveolar hypoxia). Under

these circumstances vasoconstriction occurs within the lung to shift perfusion from areas of

alveolar hypoxia to better ventilated regions of the lung. As a potent vasodilator, nitroglycerin

could reverse this protective vasoconstriction and thus result in increased perfusion of poorly

ventilated areas, worsening of the ventilation/perfusion imbalance, and a further decrease in

the arterial partial pressure of oxygen.

Hypertrophic cardiomyopathy

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

Increased angina

The possibility of increased frequency of angina during patch-off periods should be

considered. In such cases the use of additional anti-anginal therapy is desirable.

Tolerance to sublingual nitroglycerin

As tolerance to nitroglycerin patches develops, the effect of sublingual nitroglycerin on

exercise tolerance may be partially diminished.

In industrial workers who have had long-term exposure to unknown (presumably high) doses

of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even

sudden death have occurred during temporary withdrawal of nitrates from these workers,

demonstrating the existence of true physical dependence.

Driving and using machines

Nitroderm TTS, especially at the start of treatment or dose adjustments, may impair the

reactions or might rarely cause orthostatic hypotension and dizziness (as well as exceptionally

syncope after overdosing). Patients experiencing these effects should refrain from driving or

using machines.

Information for Patients

Daily headaches sometimes accompany treatment with nitroglycerin. In patients who get these

headaches, the headaches may be a marker of the activity of the drug. Patients should resist

the temptation to avoid headaches by altering the schedule of their treatment with

nitroglycerin, since loss of headache may be associated with simultaneous loss of antianginal

efficacy.

Treatment with nitroglycerin may be associated with lightheadedness on standing, especially

just after rising from a recumbent or seated position. This effect may be more frequent in

patients who have also consumed alcohol.

After normal use, there is enough residual nitroglycerin in discarded patches that they are a

potential hazard to children and pets.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

7

Adverse drug reactions

Adverse drug reactions from multiple sources (Table 7-1) are listed by MedDRA System-

Organ Class (SOC). Within each System-Organ Class the adverse drug reactions are ranked

by frequency, with the most frequent first. Within each frequency grouping, adverse drug

reactions are ranked in order of decreasing seriousness. In addition, the corresponding

frequency category, using the following convention (CIOMS III: Very common (≥ 1/10);

common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very

rare (< 1/10,000), including isolated reports

Table 7-1 Adverse drug reactions from multiple sources

Nervous system disorders

Common:

Headache

Very rare:

Dizziness

Cardiac disorders

Rare:

Tachycardia

Vascular disorders

Rare:

Orthostatic hypotension, flushing

Gastrointestinal disorders

Very common:

Nausea, vomiting

Skin and subcutaneous tissue disorders

Uncommon:

Dermatitis contact

General disorders and administration site conditions

Uncommon:

Application site erythema, pruritus, burning, irritation

Investigations

Rare:

Heart rate increased

Like other nitrate preparations, Nitroderm TTS commonly causes dose-dependent headaches

due to cerebral vasodilatation. These often regress after a few days despite the maintenance of

therapy. If headaches persist during intermittent therapy, they should be treated with mild

analgesics. Unresponsive headaches are an indication for reducing the dosage of nitroglycerin

or discontinuing treatment.

A slight reflex-induced increase in heart rate can be avoided by resorting, if necessary, to

combined treatment with a beta-blocker.

Upon removal of the patch, any slight reddening of the skin will usually disappear within a

few hours. The application site should be changed regularly to prevent local irritation.

There have been a few reports of genuine anaphylactoid reactions, and these reactions can

probably occur in patients receiving nitroglycerin by any route.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinenia in

normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further

discussion of its diagnosis and treatment is deferred (see overdosage).

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

Adverse drug reactions from spontaneous reports and literature cases

The following adverse drug reactions have been derived from post-marketing experience with

Nitroderm TTS via spontaneous case reports and literature cases. Because these reactions are

reported voluntarily from a population of a certain size, it is not possible to reliably estimate

their frequency which is therefore categorized as not known. Within each System-Organ

Class, adverse drug reactions are presented in order of decreasing seriousness.

Table 7-2 Adverse drug reactions from spontaneous reports and literature (frequency

not known)

Cardiac disorders:

Palpitation.

Skin and subcutaneous tissue disorders

Rash generalized.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic

@moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).

8

Interactions

Interactions resulting in concomitant use contraindicated

Concomitant administration of Nitroderm TTS and other vasodilators e.g PDE5 inhibitors

such as sildenafil potentiates the blood-pressure-lowering effect of Nitroderm TTS.

Interactions to be considered

Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics,

antihypertensives, tricyclic antidepressants and major tranquilizers may potentiate the blood

pressure-lowering effect of Nitroderm TTS, as may alcohol.

Concurrent administration of Nitroderm TTS with dihydroergotamine may increase the

bioavailability of dihydroergotamine. This warrants special attention in patients with coronary

artery disease, because dihydroergotamine antagonizes the effect of nitroglycerin and may lead

to coronary vasoconstriction.

The non-steroidal anti-inflammatory drugs except acetyl salicylic acid may diminish the

therapeutic response of Nitroderm TTS.

Concurrent administration of Nitroderm TTS.with amifostine and acetyl salicylic acid may

potentiate the blood pressure lowering effects of Nitroderm TTS.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

9

Women

of

child-bearing

potential,

pregnancy,

breast-

feeding and fertility

Women of child-bearing potential

There is no data supporting any special recommendations in women of child-bearing potential.

Pregnancy

Like any drug, Nitroderm TTS should be employed with caution during pregnancy, especially

in the first 3 months.

Breast-feeding

It is not known whether the active substance passes into the breast milk. The benefits for the

mother must be weighed against the risks for the child.

Fertility

There is no data available on the effect of Nitroderm TTS on fertility in humans.

In rats, there were no effects on fertility, viability, growth or development of offspring at

doses up to approximately 38mg/kg/day (see section 13 Non-clinical safety data).

10

Overdosage

Hemodynamic effects

The ill effects of nitroglycerin overdose are generally the results of nitroglycerin’s capacity to

induce vasodilation, venous pooling, reduced cardiac output, and hypotension. These

hemodynamic changes may have protean manifestations, including increased intracranial

pressure, with any or all of persistent throbbing headache, confusion, and moderate fever;

vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even

bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later

followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and

clammy; heart block and bradycardia; paralysis; coma; seizures; and death.

Methaemoglobinaemia has also been reported following accidental overdosage.

Laboratory determinations of serum levels of nitroglycerin and its metabolites are not widely

available, and such determinations have, in any event, no established role in the management

of nitroglycerin overdose.

No data are available to suggest physiological maneuvers (e.g. maneuvers to change the pH of

the urine) that might accelerate elimination of nitroglycerin and its active metabolites.

Similarly, it is not known which – if any – of these substances can usefully be removed from

the body by hemodyalysis.

No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention

has been subject to controlled study as a therapy of nitroglycerin overdose. Because the

hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

hypovolemia, prudent therapy in this situation should be directed toward increase in central

fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous

infusion of normal saline or similar fluid may also be necessary.

The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more

harm than good.

Hypotension or collapse can be treated by elevation or, if necessary, compression bandaging

of the patient's legs.

In patients with renal disease or congestive heart failure, therapy resulting in central volume

expansion is not without hazard. Treatment of nitroglycerin overdose in these patients may be

subtle and difficult, and invasive monitoring may be required.

Methemoglobinemia:

Nitrate ions liberated during metabolism of nitroglycerin can oxidize hemoglobin into

methemoglobin. Even in patients totally without cytochrome B

reductase activity, however,

and even assuming that the nitrate moieties of nitroglycerin are quantitatively applied to

oxidation of hemoglobin, about 1mg/kg of nitroglycerin should be required before any of

these patients manifests clinically significant (≥ 10%) methemogolobinemia. In patients with

normal reductase function, significant production of methemoglobin should required even

larger doses of nitroglycerin. In one study in which 36 patients received 2-4 weeks of

continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr, the average methemoglobin level

measured was 0.2%; this was comparable to that observed in parallel patients who received

placebo.

Notwithstanding these observations, there are case reports of significant methemoglobinemia

in association with moderate overdoses of organic nitrates. None of the affected patients had

been thought to be unusually susceptible.

Methemoglobin levels are available from most clinical laboratories. The diagnosis should be

suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac

output and adequate arterial PO

. Classically, methemoglonibemic blood is described as

chocolate brown, without color change n exposure to air.

When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1-2 mg/kg

intravenously.

11

Clinical pharmacology

Pharmacodynamic properties (PD)

Pharmacotherapeutic group: Vasodilators used in cardiac diseases, ATC code: C01DA02

Nitroglycerin relaxes smooth muscle throughout the body. In the vascular system it mainly

acts on the systemic veins and accessorily on the large coronary arteries. At low dose

nitroglycerin is bioactivated by mitochondrial aldehyde dehydrogenase activity, and is

converted to nitrites and denitrated metabolites (1,2-glyceryl dinitrate, 1-3-glyceryl dinitrate)

by glutathione-dependent organic nitrate reductase. Nitrite is further activated by cytochrome

oxidase or acidic disproportionation in the intermembrane space (H

), finally yielding nitric

oxide (NO) or a related species, which activate soluble guanylyl cyclase and trigger cyclic

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

guanosine monophospate (cGMP) signaling via cGMP dependent protein kinase, which

causes relaxation. At high doses glyceryl dinitrate, mononitrate and nitroglycerin are

bioactivated by P450 enzyme(s) in the smooth endoplamic reticulum directly yielding NO

which causes relaxation.

In angina pectoris, a fundamental mechanism of action of nitroglycerin is an increase in

venous capacitance (venous pooling) leading to a decreased return of blood to the heart. This

lowers left ventricular end-diastolic pressure (preload) and hence filling volume, which in turn

lowers the myocardial oxygen requirement at rest and especially during exercise, hence

enhancing the exercise capacity.

In the coronary arterial circulation, nitroglycerin dilates both extramural conductance and

small resistance vessels. The drug appears to redistribute coronary blood flow to ischaemic

subendocardium by selectively dilating large epicardial vessels. It can also dilate stenoses

caused by eccentric atheroma. In addition, nitroglycerin relaxes vasospasm, whether

spontaneous or induced by ergonovine.

Nitroglycerin dose-dependently dilates the arteriolar vascular bed, thereby lowering systemic

vascular resistance (afterload) and left ventricular systolic wall tension, and further reducing

myocardial oxygen consumption.

Dosing regimens for most chronically used drugs aim for plasma concentrations that

continuously exceed the minimally effective concentration, but this strategy is probably

inappropriate for organic nitrates. Although some well-controlled clinical trials using exercise

tolerance testing showed that efficacy is maintained when patches are worn continuously,

most of them reported the development of tolerance (i.e. attenuation of effect as measured by

exercise testing) within the first day. As might be expected on pharmacological grounds,

tolerance is also observed with high transdermal doses exceeding 4 mg/h.

Efficacy of organic nitrates is restored after a nitrate-free interval. The shortest drug-free

interval sufficient to restore response has not been defined. Intervals of 8 to 12 hours are

known to be sufficient, shorter intervals have not been fully studied. When administered

according to an intermittent regimen, doses of Nitroderm TTS delivering 0.4-0.8 mg/h (20-

40 cm

) have shown increased exercise capacity for 8 to 12 hours.

Controlled clinical trial data suggest that intermittent use of nitrates may be associated with a

decrease in exercise tolerance compared with placebo during the last part of the nitrate-free

interval; the clinical relevance of this observation is unknown (see section “Warnings and

precautions”).

In chronic heart failure the venodilator action of nitroglycerin lowers the elevated left

ventricular filling pressure, while maintaining or slightly increasing cardiac output. In this

indication, the beneficial effects of nitroglycerin are restricted to severe heart failure with

predominant symptoms of pulmonary venous congestion due to a pronounced increase in left

ventricular filling pressure. Where improve stroke volume is desired, combined treatment with

an arterial vasodilator such as hydralazine is recommended.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

Pharmacokinetic properties (PK)

Nitroderm TTS

Absorbtion

Following single application of Nitroderm TTS, the plasma concentrations of nitroglycerin

reach a plateau within 2 hours, which is maintained over the recommended application period.

The height of this plateau is directly proportional to the size of the system's drug-releasing

area. The same plasma levels are attained regardless of whether the system is applied to the

skin of the upper arm, pelvis, or chest. Levels fall rapidly after patch removal. Accumulation

does not occur on repeated application of Nitroderm TTS.

Nitroglycerin

Distribution

The plasma protein binding is 61-64%, for nitroglycerin, 23% and 11% for 1, 2-glyceryl

dinitrate and 1, 3-glyceryl dinitrate, respectively.

Metabolism

The active substance is rapidly biotransformed to glyceryl dinitrates and mononitrates by

glutathione-dependent organic nitrate reductase in the liver. In addition, and probably more

importantly, in vitro studies have shown that the human erythrocyte is also a site of

biotransformation via a sulfhydryl-dependent enzymatic process and interaction with reduced

hemoglobin. In human erythrocytes, the reduced haemoglobin level seems to play a major role

in metabolic activity, and caution should therefore be exercised in patients with anemia. In

animal studies it has been found that extrahepatic vascular tissues (femoral vein, inferior vena

cava, aorta) also play an important role in nitroglycerin metabolism, a finding which is

consistent with the large systemic clearance seen with nitrates. It has also been shown in vitro

that the biotransformation of nitroglycerin occurs concurrently with vascular smooth muscle

relaxation; this observation is consistent with the hypothesis that nitroglycerin

biotransformation is involved in the mechanism of nitroglycerin-induced vasodilatation.

Excretion

Nitroglycerin is excreted renally as dinitrate and mononitrate metabolites, glucuronide

conjugates and glycerol. The elimination half-lives of nitroglycerin, 1,2-glyceryl dinitrate and

glyceryl mononitrates are 10, 30-60, 5-6 minutes respectively.

12

Clinical studies

Nitroderm TTS is an established product.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

13

Non-clinical safety data

Mutagenicity

Standard mutagenicity tests provided contradictory results in vitro. Cell culture and in vivo

studies revealed no evidence of mutagenic activity of nitroglycerin, and therefore its use is

considered devoid of genotoxic potential at exposures relevant to men. .

Carcinogenicity

Dietary studies in rodents led to the conclusion that nitroglycerin has no carcinogenic effects

relevant for the therapeutic dose range in man. .

Reproduction toxicity

Animal teratology studies have not been conducted with nitroglycerin transdermal systems.

Conventional reproduction studies involving the oral, intravenous, intraperitoneal and dermal

(as ointment) administration routes of nitroglycerin have been performed in rats and rabbits.

Nitroglycerin showed no teratogenic potential in these animals.

Fertility

A three-generation reproduction study was performed in CD rats. In this study, the rats

received dietary nitroglycerin at doses of up to 363 mg/kg/day in males and of up to 434

mg/kg/day in females (i.e. 0.01, 0.1 or 1% of nitroglycerin) for six months prior to mating of

the F

generation, with treatment continuing through successive F

and F

generations. Control

groups received diets free of nitroglycerin. Matings consisted of 10 males and 20 females

from each group for the F

generation. Twenty to 24 pups from the second litters were

randomly chosen in equal numbers from each treatment group and maintained in each

respective treatment. At 3 months of age, each male was mated with a female from each group

and again, only the second-generation offspring were selected for continued treatment. This

was repeated until the animals from the 3rd generation were weaned.

No specific effect on the fertility of the F

generation was seen. Infertility noted in subsequent

generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis

in the high-dose males. There were no effects on fertility, viability, growth or development of

offspring at doses of up to approximately 38 mg/kg/day. The latter was confirmed in an

intraperitoneal fertility study in rats receiving nitroglycerin doses of up to 20 mg/kg/day for 63

days (Oketani et al., 1981b, English summary) (see section 9 Women of child-bearing

potential, pregnancy, breast-feeding and fertility).

14

Pharmaceutical information

Incompatibilities

Not applicable.

NIT API MAY15 CL V4 COR CPO CL REF CDS 4Nov2014 & UK SmPC 19Nov2012

Special precautions for storage

Store below 25°C.

Nitroderm TTS should be kept out of the sight and reach of children both before and after use.

Nature and contents of container

Nitroderm TTS 5, Nitroderm TTS 10: individually packaged in sealed sachets:

paper/PE/Al/Surlyn Worldwide.

Instructions for use and handling

Each Nitroderm TTS patch is sealed in a separate sachet with a tear-off edge to facilitate

removal. After removing the white protective backing, apply the Nitroderm TTS patch to a

clean, non-hairy, dry area of intact skin on the trunk or upper arm. Hold the patch in position

for 10-20 seconds with the palm of the hand. Switch application sites daily, wait several days

before using the same area again.

Each transdermal patch must be removed from the individual package immediately prior to

use.

Manufacturer:

Novartis Pharma Stein AG, Stein, Switzerland

for Novartis Pharma AG, Basel, Switzerland.

Registration Holder:

Novartis Israel Ltd.,

36 Shacham St., Petach-Tikva.

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ(

05.2013

)

:ךיראת

29.3.2015

:תילגנאב רישכת םש

Nitroderm TTS 5; Nitroderm TTS 10

:םושירה רפסמ

[

22967

;

21607

]

:םושירה לעב םש י'ג ייא ססיורס המראפ סיטרבונ !דבלב תורמחהה טוריפל דעוימ הז ספוט רשואמ טסקט – רוחש טסקט יתחת וק םע טסקט

ןולעל טסקט תפסוה – רשואמה הצוח וק םע טסקט

ןולעהמ טסקט תקיחמ – רשואמה בוהצב ןמוסמה טסקט הרמחה – תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

Contraindications

…..

Severe

hypotension

(systolic

blood

pressure less than 90 mmHg).

Severe hypovolemia.

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ(

05.2013

)

:ךיראת

29.3.2015

:תילגנאב רישכת םש

Nitroderm TTS 5

Nitroderm TTS 10

:םושירה רפסמ

[

22967

;

21607

]

:םושירה לעב םש י'ג ייא ססיורס המראפ סיטרבונ !דבלב תורמחהה טוריפל דעוימ הז ספוט רשואמ טסקט – רוחש טסקט יתחת וק םע טסקט

ןולעל טסקט תפסוה – רשואמה הצוח וק םע טסקט

ןולעהמ טסקט תקיחמ – רשואמה בוהצב ןמוסמה טסקט הרמחה – תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

2

שומיש ינפל . הפורתב שמתשהל ןיא :םא הפורתב

..…

דואמ ךומנ םד ץחלמ לבוס ךניה -ל תחתמ ילוטסיס םד ץחל(

מ לבוס ךניה

םדה חפנ-תת .)הימלוופיה(

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