NITRODERM 5 mg Transdermal Patch

Зміст інструкції

1. Nitroderm TTS 5 mg/day transdermal patch, 10 mg/day transdermal patch, 15 mg/day transdermal patch
   1. What is Nitroderm TTS and what is it used for
   2. What you need to know before using Nitroderm TTS
   3. How to use Nitroderm TTS
   4. Possible side effects
   5. How to store Nitroderm TTS
   6. Contents of the pack and other information

Nitroderm TTS 5 mg/day transdermal patch, 10 mg/day transdermal patch, 15 mg/day transdermal patch

nitroglycerin

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Nitroderm TTS and what is it used for

Nitroderm TTS is an adhesive patch that contains the active ingredient nitroglycerin, which is released into the
body through the skin. Nitroglycerin belongs to the group of medicines called nitrates that dilate the
blood vessels and make blood flow easier.
Nitroderm TTS is used for the treatment of angina pectoris, a painful constriction of the chest that occurs
when the heart muscles do not receive enough blood and oxygen.
Nitroderm TTS can be used for the treatment of angina pectoris alone or with other medicines
belonging to the class of beta-blockers and/or calcium antagonists.

Nitroderm TTS 5 mg/dayis also used for

• preventing phlebitis (obstruction of a vein, usually in the legs, that causes swelling);
• preventing extravasation (leakage of fluids from the veins) due to treatments administered intravenously that are expected to last 2 or more days.

2. What you need to know before using Nitroderm TTS

Do not use Nitroderm TTS

• if you are allergic to nitroglycerin, to any organic nitrate or to any of the other ingredients of this medicine (listed in section 6).
• if you have a severe form of circulatory system failure associated with a severe drop in blood pressure (shock)
• if you have a condition associated with: o high pressure inside the head or cerebral hemorrhage o head trauma o high pressure inside the eye (closed-angle glaucoma)
• if you have a severe anemia
• if you have heart failure due to:

o narrowing (stenosis) of the mitral valve;
o inflammation of the heart lining (constrictive pericarditis);
o obstruction to blood outflow from the heart, such as in the case of narrowing (stenosis) of the
aortic valve;
o disease with thickening of the heart walls (hypertrophic cardiomyopathy);
o fluid collection around the heart (pericardial tamponade);

• if you are taking medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors) such as sildenafil (Viagra®), as a severe drop in blood pressure may occur
• if you suffer from very low blood pressure (systolic pressure below 90 mmHg)
• if you have a low circulating blood volume (severe hypovolemia)
• if you are taking a medicine containing the active ingredient riociguat used to treat high blood pressure in the lungs.

Warnings and precautions
Talk to your doctor or pharmacist before using Nitroderm TTS if any of the following conditions
apply to you:

• if you suffer from hypoxemia (reduction of oxygen content in arterial blood) due to severe anemia
• if you suffer from hypoxemia due to a lung disease or a severe heart disease (ischemic heart failure)
• if you have thickening of the heart muscle (hypertrophic cardiomyopathy)
• if you have had a recent heart attack or if you suffer from acute heart failure

Pay particular attention:

• and inform your doctor that you are using Nitroderm TTS if you need to undergo procedures that use magnetic or electric fields such as magnetic resonance imaging (MRI), cardioversion or defibrillation (an electric shock used to restore the heart to its normal rhythm) or diathermy (production of heat in body tissues by irradiation to treat or relieve certain conditions), because the patch must be removed before these procedures.
• if you are using the therapy intermittently, because during the periods when the transdermal patch is not applied, an increase in the frequency of angina attacks may occur. In these cases, the doctor will assess whether to give you another medicine.
• a loss of response (tolerance) to nitroglycerin patches may occur, if this happens the effect of sublingual nitroglycerin may also be reduced.
• if your blood pressure becomes very low, contact your doctor who will tell you whether to continue using Nitroderm TTS or to remove the patch.

If you are using Nitroderm TTS to prevent phlebitis, the doctor will regularly check the infusion site.

Children and adolescents
Nitroderm TTS should not be used in pediatric patients.

Other medicines and Nitroderm TTS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use Nitroderm TTS together with:

• medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors) such as sildenafil (Viagra®), as, when taken together with Nitroderm TTS, they can cause a severe drop in blood pressure.
• medicines containing the active ingredient riociguat, used to treat high blood pressure in the lungs;

Tell your doctor if you are taking:

• calcium antagonists, ACE inhibitors, beta-blockers, diuretic antihypertensives (medicines used to lower blood pressure, for fluid retention or for heart problems)
• tricyclic antidepressants and major tranquilizers (medicines used to treat anxiety or depression)
• dihydroergotamine, used for example for migraine
• amifostine (a medicine used to reduce the side effects of certain cancer treatments or radiotherapy)
• acetylsalicylic acid
• non-steroidal anti-inflammatory drugs, NSAIDs (used to treat pain and inflammation).

Nitroderm TTS with alcohol
Do not drink alcohol when using Nitroderm TTS, as alcohol can enhance the drop in
blood pressure that can occur when using the patch.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
If you are pregnant, the doctor will assess whether the benefits for you clearly outweigh the risks to the fetus before
prescribing Nitroderm TTS, especially during the first three months of pregnancy.

Breastfeeding
There is insufficient information on the passage of nitroglycerin into breast milk.
The doctor will decide whether to stop breastfeeding or discontinue therapy with Nitroderm TTS taking
into account the benefit of breastfeeding for the child and the benefit of therapy for the
woman.

Fertility
No data are available regarding the effect of Nitroderm TTS on fertility in men.
There are no data to support special recommendations in women of childbearing potential.

Driving and using machines
Nitroderm TTS may alter your reactions or may rarely cause dizziness or low blood pressure
when you stand up, especially at the beginning of treatment or when the dose is changed. If you
experience these symptoms, do not drive and do not use machines.

3. How to use Nitroderm TTS

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist.
The response to Nitroderm TTS varies from patient to patient; therefore, you must use the dose prescribed by
your doctor.

Treatment of angina pectoris
Nitroderm TTS is used to prevent angina and not to treat a sudden attack. In case of a sudden
attack of angina, you should use another medicine prescribed by your doctor.
The normally recommended initial dose is 1 Nitroderm TTS 5 mg/day patch per day.
For maintenance therapy, your doctor will prescribe 1 Nitroderm TTS 10 mg/day patch (normal maintenance dose) or 1 Nitroderm TTS 15 mg/day patch.

Prevention of phlebitis and extravasation suffusion
Your doctor will apply a Nitroderm TTS 5 mg/day patch to a point away from the vein into which the
cannula is inserted, at the same time as the cannula is inserted.
It is advisable to replace the patch daily. Treatment with Nitroderm should be discontinued at the
end of the therapy administered into the vein.
Prolonged or frequent administration of long-acting nitrates, including Nitroderm TTS or
other transdermal patches, may cause a loss of response (tolerance) or a reduction in the effectiveness
of therapy.
The effectiveness of therapy can be maintained by removing the patch for 8-12 hours each day, generally
at night.

How to use Nitroderm TTS
Each Nitroderm TTS transdermal patch is sealed in separate sachets with a tear-open opening on one side. The
adhesive layer of the patch is covered by a protective membrane, which must be removed when applying
to the skin.
How to apply the patch

• 1. Apply Nitroderm TTS to the skin in a healthy, dry, clean area (e.g. without ointment residue) and where there is little hair.
• 2. To apply Nitroderm TTS correctly: a) tear the sachet at the notch, remove the patch and carefully remove the white membrane protecting the adhesive layer of the transdermal patch (grasp the tab and pull gently); b) apply the adhesive part of the transdermal patch to the chosen skin area (e.g. on one side of the chest, along the ribs), hold the patch in place for 10-20 seconds, exerting slight pressure on the back of the patch with the palm of your hand.

How to replace the patch

• 1. Remove Nitroderm TTS following your doctor's instructions and discard the used transdermal patch, making sure it does not fall into the hands of a child.
• 2. Apply a new Nitroderm TTS transdermal patch following the instructions above. Apply the patch to a different point than the previous one, for example on the opposite side of the chest. Do not apply the new patch to the same area for a few days. You can remove any adhesive residue from the skin with a suitable solvent (e.g. nail polish remover or alcohol). Nitroderm TTS adheres well to the skin and also works during bathing, showering or when exercising.

Do not cut the patch.
Change the application site regularly to avoid local irritation.

Use in elderly patients
Normally, it is not necessary to change the dose; your doctor will prescribe the most suitable dose for you.

If you use more NitrodermTTS than you should
If you accidentally apply too many patches, remove the patches, then immediately inform your doctor or
go to the nearest hospital.
While awaiting the doctor, you should raise your legs to combat low blood pressure or
bandage your legs so that some pressure is exerted.

• low blood pressure
• increased heart rate
• collapse
• fainting.

If you forget to useNitrodermTTS
If you forget to change the Nitroderm TTS patch at the scheduled time, change it as soon as you remember and
apply the new patch as described above.
If you forget to use the patch one day, do not apply 2 or more patches at the same time to make up for
forgetting the patch from the previous day.

If you stop using NitrodermTTS
Do not abruptly discontinue therapy.
If you switch from chronic treatment to another type of treatment, nitroglycerin must be discontinued
gradually (within 4-6 weeks), while starting the new treatment.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Nausea, vomiting

Common side effects (may affect up to 1 in 10 people)

• headache. The headache often subsides after a few days, without the need to stop therapy. If you have a headache even with intermittent therapy, you can use mild analgesics. If the headache does not respond to this type of treatment, consult your doctor who will evaluate whether it is appropriate to reduce the dose of nitroglycerin or stop treatment.

Uncommon side effects (may affect up to 1 in 100 people)

• contact dermatitis (skin inflammation with symptoms such as redness, itching and scaling of the skin)
• rash on the skin where you applied the patch with itching, redness, burning sensation, skin irritation. Any mild skin redness usually disappears a few hours after you remove the patch. Change the application point of the patch regularly to prevent local irritation.

Rare side effects (may affect up to 1 in 1,000 people)

• increased heart rate
• tachycardia
• sudden drop in blood pressure, especially when getting up
• hot flashes

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

• dizziness

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• palpitations
• rash on large areas of skin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nitroderm TTS

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NitrodermTTS contains

• The active ingredient is nitroglycerin.
• The other ingredients are fluid silicone, anhydrous colloidal silica.
• Nitroderm TTS 5 mg/day which releases 5 mg of nitroglycerin in 24 hours contains: 250 mg of nitroglycerin adsorbed on lactose equivalent to 25 mg of free nitroglycerin.
• Nitroderm TTS 10 mg/day which releases 10 mg of nitroglycerin in 24 hours contains: 500 mg of nitroglycerin adsorbed on lactose equivalent to 50 mg of free nitroglycerin.
• Nitroderm TTS 15 mg/day which releases 15 mg of nitroglycerin in 24 hours contains: 750 mg of nitroglycerin adsorbed on lactose equivalent to 75 mg of free nitroglycerin.

Description of the appearance of NitrodermTTS and contents of the pack
Nitroderm TTS 5 mg/day: pack with 15 transdermal patches
Nitroderm TTS 10 mg/day: pack with 15 transdermal patches
Nitroderm TTS 15 mg/day: pack with 15 transdermal patches

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Novartis Farma S.p.A
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy