Nitroderm TTS

Package leaflet: Information for the patient

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

nitroglycerin
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including 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 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

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

Nitroderm TTS is an adhesive patch containing the active substance nitroglycerin, which is released into the body through the skin. Nitroglycerin belongs to a group of medicines called nitrates that widen blood vessels and improve blood flow.
Nitroderm TTS is used to treat angina pectoris, a painful chest tightness that occurs when the heart muscles do not receive enough blood and oxygen.
Nitroderm TTS can be used alone or in combination with other medicines such as beta-blockers and/or calcium antagonists for the treatment of angina pectoris.
Nitroderm TTS 5 mg/day is also used for:

• preventing phlebitis (blockage of a vein, usually in the legs, causing swelling);
• preventing extravasation (leakage of fluids from veins) due to intravenous treatments 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 failure associated with a severe drop in blood pressure (shock)

• if you have any of the following conditions:
  o increased pressure inside the head
  o cerebral hemorrhage
  o head trauma
  o increased pressure inside the eye (closed-angle glaucoma)

• if you have 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 leaving the heart, such as narrowing (stenosis) of the
  aortic valve;
  o heart wall thickening disease (hypertrophic cardiomyopathy);
  o fluid accumulation 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 have very low blood pressure (systolic pressure below 90 mmHg)

• if you have low circulating blood volume (severe hypovolemia)

• if you are taking a medicine containing the active substance 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 apply to you:

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

Take particular care:

• and inform your doctor that you are using Nitroderm TTS if you are undergoing procedures involving 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 (heat production in body tissues by radiation to treat or relieve certain conditions), because the patch must be removed before these procedures.
• if you are using the therapy intermittently, as during periods when the transdermal patch is not applied, the frequency of angina attacks may increase. In such cases, your doctor will assess whether to prescribe 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, consult your doctor, who will advise whether to continue using Nitroderm TTS or to remove the patch.

If you are using Nitroderm TTS to prevent phlebitis, your doctor will regularly check the site where the infusion is administered.
Children and adolescents
Nitroderm TTS must not be used in pediatric patients.
Other medicines and Nitroderm TTS
Inform 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 may cause a severe drop in blood pressure.
• medicines containing the active substance riociguat, used to treat high blood pressure in the lungs;

Inform your doctor if you are taking:

• calcium antagonists, ACE inhibitors, beta-blockers, diuretic antihypertensives (medicines used to lower blood pressure, for fluid retention, or 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 side effects of certain cancer treatments or radiotherapy)
• acetylsalicylic acid
• non-steroidal anti-inflammatory drugs, NSAIDs (used to treat pain and inflammation).

Nitroderm TTS and alcohol
Do not drink alcohol when using Nitroderm TTS, as alcohol may enhance the blood pressure lowering effect that may occur when using the patch.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, your doctor will assess whether the benefits to 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.
Your doctor will decide whether to discontinue breastfeeding or to stop treatment with Nitroderm TTS, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Fertility
There are no data available on the effect of Nitroderm TTS on male fertility.
There are no data supporting special recommendations for women of childbearing age.
Driving and using machines
Nitroderm TTS may affect your reactions or may rarely cause dizziness or low blood pressure when standing up, especially at the beginning of treatment or when the dose is changed. If you experience these symptoms, do not drive and do not operate machinery.

3. How to use Nitroderm TTS

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The response to Nitroderm TTS varies from patient to patient; therefore, use only the dose prescribed by your doctor.

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

Prevention of phlebitis and extravasation
Your doctor will apply one Nitroderm TTS 5 mg/day patch to an area of skin distant from the vein where the cannula is inserted, at the same time the cannula is placed.
Daily replacement of the patch is recommended. Treatment with Nitroderm should be discontinued at the end of the intravenous therapy.

Prolonged or frequent administration of long-acting nitrates, including Nitroderm TTS or other transdermal patches, may lead to loss of response (tolerance) or reduced therapeutic efficacy.
Therapeutic efficacy can be maintained by removing the patch for 8–12 hours each day, usually at night.

Instructions for using Nitroderm TTS
Each Nitroderm TTS transdermal patch is sealed in individual sachets with a tear-off opening on one side. The adhesive layer of the patch is protected by a removable membrane, which should be removed at the time of application to the skin.

How to apply the patch

1. Apply Nitroderm TTS to healthy, dry, clean skin (e.g. free of ointment residues) and with minimal hair.
2. To apply Nitroderm TTS correctly:
   a) Tear the sachet at the notch, remove the patch, and carefully peel off the white protective membrane covering the adhesive layer of the transdermal patch (grasp the tab and pull gently);
   b) Apply the adhesive side of the transdermal patch to the chosen area of skin (e.g. on one side of the chest, along the ribs), and hold the patch in place for 10–20 seconds, applying light pressure with the palm of your hand over the patch.

How to replace the patch

1. Remove Nitroderm TTS as instructed by your doctor and dispose of the used transdermal patch safely, ensuring it cannot be accessed by a child.
2. Apply a new Nitroderm TTS transdermal patch following the instructions above. Apply the new patch to a different site, for example on the opposite side of the chest. Do not apply the new patch to the same area for several days. You may remove any adhesive residue from the skin using an appropriate solvent (e.g. nail polish remover or alcohol). Nitroderm TTS adheres well to the skin and remains effective during bathing, showering, or physical exercise.

Do not cut the patch.
Regularly change the application site to avoid local irritation.

Use in elderly patients
Dose adjustment is normally not required; your doctor will prescribe the dose most suitable for you.

If you use more Nitroderm TTS than you should
If you accidentally apply too many patches, remove them immediately and contact your doctor or go to the nearest hospital without delay.
While waiting for medical help, raise your legs to counteract low blood pressure or bend your legs to apply pressure.
High doses of nitroglycerin may cause:

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

If you forget to use Nitroderm TTS
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 miss a day, do not apply two or more patches at the same time to make up for the missed dose.

If you stop using Nitroderm TTS
Do not stop treatment abruptly.
If switching from chronic therapy to another type of treatment, nitroglycerin should be discontinued gradually (over 4–6 weeks), while initiating the new treatment.
If you have any questions about how to use 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. Headache often improves after a few days, without the need to stop treatment. If you experience headache also during intermittent therapy, you may use mild analgesics. If headache does not respond to this type of treatment, consult your doctor, who will evaluate whether it is appropriate to reduce the nitroglycerin dose or discontinue treatment.

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

• Contact dermatitis (skin inflammation with symptoms such as redness, itching, and skin peeling)
• Skin rash at the site of patch application, with itching, redness, burning sensation, and skin irritation. Mild skin redness usually disappears within a few hours after removing the patch. Regularly change the application site of the patch 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 standing up
• Hot flushes

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

• Dizziness

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Palpitations
• Rash affecting large areas of skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 below 25°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nitroderm TTS contains

• The active substance is glyceryl trinitrate.
• The other components are silicone fluid, anhydrous colloidal silica.
• Nitroderm TTS 5 mg/day which releases 5 mg of glyceryl trinitrate over 24 hours contains: 250 mg of glyceryl trinitrate adsorbed onto lactose corresponding to 25 mg of free glyceryl trinitrate.
• Nitroderm TTS 10 mg/day which releases 10 mg of glyceryl trinitrate over 24 hours contains: 500 mg of glyceryl trinitrate adsorbed onto lactose corresponding to 50 mg of free glyceryl trinitrate.
• Nitroderm TTS 15 mg/day which releases 15 mg of glyceryl trinitrate over 24 hours contains: 750 mg of glyceryl trinitrate adsorbed onto lactose corresponding to 75 mg of free glyceryl trinitrate.

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

Marketing Authorization 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