Nitroglycerin Zentiva

Package leaflet: Information for the patient

Nitroglycerin Zentiva 5 mg/24 hours transdermal patches, 10 mg/24 hours transdermal patches, 15 mg/24 hours transdermal patches

Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nitroglicerina Zentiva is and what it is used for

Nitroglicerina Zentiva patches contain the active substance nitroglycerin, a vasodilator used for heart conditions and belonging to a group of medicines called organic nitrates.
Nitroglicerina Zentiva is indicated for the prevention and treatment of angina attacks occurring both at rest and after exertion in adults.
Angina typically manifests as pain or a feeling of pressure in the chest, which may spread to the neck or arm. The pain occurs when the heart does not receive sufficient oxygen. Nitroglicerina Zentiva is not indicated for the treatment of acute episodes of angina.
Nitroglicerina Zentiva patches are for external use only.
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using Nitroglycerin Zentiva

Do not use Nitroglycerin Zentiva

• if you are allergic to nitroglycerin or to similar substances (related organic nitrates) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe anemia;
• if you have increased intracranial pressure, if you have a head injury, cerebral hemorrhage, or suffer from closed-angle glaucoma;
• if you are currently experiencing or have recently experienced circulatory collapse (acute circulatory failure associated with marked hypotension);
• if you are pregnant or breastfeeding (see section “Fertility, pregnancy and breastfeeding”);
• if you are under 18 years of age (see section “Children and adolescents”);
• if you suffer from heart failure due to obstruction, such as narrowing of the aortic orifice or the atrioventricular orifice of the heart (aortic stenosis or mitral stenosis, respectively), or thickening of the thin sac-like membrane surrounding the

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heart (constrictive pericarditis), thickening of the heart muscle (hypertrophic cardiomyopathy), accumulation of
fluid or blood in the space between the heart muscle and the surrounding sac-like tissue
(pericardial tamponade);

• if you are taking medicines for erectile dysfunction (e.g., sildenafil or other PDE-5 inhibitors). Patients undergoing treatment with nitrates must not take sildenafil or other medicines for erectile dysfunction. The combination of a nitrate with sildenafil or other PDE-5 inhibitors may cause a sudden and severe drop in blood pressure, which may lead to fainting, loss of consciousness, or even heart attack (see section “Other medicines and Nitroglycerin Zentiva”);
• if you suffer from a condition causing a severe drop in blood pressure (systolic blood pressure below 90 mmHg);
• if you suffer from a severe reduction in blood volume due to blood loss or loss of body fluids (severe hypovolemia);
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and Nitroglycerin Zentiva”).

Warnings and precautions
Talk to your doctor or pharmacist before using Nitroglycerin Zentiva:

• if your blood oxygen level is low (hypoxemia) due to severe anemia, lung disease, or reduced blood flow to the heart (ischemic heart failure);
• if your angina is caused by thickening of the heart muscle (hypertrophic cardiomyopathy). Nitrates may worsen this type of angina;
• if you notice an increase in the frequency of angina attacks during periods without the patch (intermittent therapy). Your doctor may wish to reassess your coronary condition and consider adjusting your treatment by simultaneously administering an antianginal drug (see section “How to use Nitroglycerin Zentiva”);
• if you are taking other nitrates (e.g., sublingual nitroglycerin), as your body may develop resistance to the effects of these substances after repeated exposure. This can be prevented by using intermittent therapy (see section “How to use Nitroglycerin Zentiva”);
• if you stop treatment or need to switch to another treatment. Discontinuation of Nitroglycerin Zentiva therapy must be done gradually and under close medical supervision;
• if you have had, or have recently had, a heart attack (myocardial infarction) or acute heart failure. Treatment must be carried out cautiously and under strict medical supervision;
• if you need to undergo electrical stimulation of the heart to restore normal heart rhythm (defibrillation or cardioversion) or procedures involving magnetic fields (magnetic resonance imaging). You must remove the Nitroglycerin Zentiva patch before undergoing such treatments or procedures;
• if your blood pressure values are below normal (hypotension) or if you experience collapse while being treated with Nitroglycerin Zentiva. In such cases, removal of the patch should be considered;
• if you need to undergo laboratory testing for catecholamines, you should be cautious, as nitroglycerin may alter test results (higher than actual values or false positives).

During treatment with Nitroglycerin Zentiva, avoid changing positions too quickly: Nitroglycerin Zentiva may, especially in elderly patients, cause an excessive drop in blood pressure when moving abruptly from lying down to standing (orthostatic hypotension).
Children and adolescents
Nitroglycerin Zentiva must not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established.
Other medicines and Nitroglycerin Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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Avoid concomitant administration of medicines for erectile dysfunction (e.g.,
sildenafil or other PDE-5 inhibitors), as they may enhance the blood pressure-lowering effect of nitrates (see also section “Do not use Nitroglycerin Zentiva”).
You may experience a further drop in blood pressure if you are simultaneously taking medicines indicated for:

• treatment of high blood pressure (such as calcium antagonists, beta-blockers, ACE inhibitors, diuretics),
  • treatment of mental disorders (neuroleptics, major tranquilizers),
  • treatment of depression (tricyclic antidepressants).

The effect of nitroglycerin may be reduced if you take dihydroergotamine (a medicine used to treat headache) simultaneously, resulting in narrowing of the heart's blood vessels.
I f you are taking non-steroidal anti-inflammatory drugs (NSAIDs) at the same time, except for acetylsalicylic acid, you may experience a reduced therapeutic response to Nitroglycerin Zentiva.
You may experience a further drop in blood pressure if you are taking acetylsalicylic acid and amifostine simultaneously.
Nitroglycerin Zentiva and alcohol
If you consume alcohol, the blood pressure-lowering effect of Nitroglycerin Zentiva may increase.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Fertility
No data are available on the effect of Nitroglycerin Zentiva on fertility in humans.
Pregnancy
You should not take Nitroglycerin Zentiva during pregnancy, especially during the first three months. If pregnancy occurs during regular use of Nitroglycerin Zentiva, inform your doctor immediately; your doctor will decide whether and how to continue treatment.
Breastfeeding
There is insufficient information on the passage of nitroglycerin into breast milk.
The risk to newborns/infants cannot be excluded.
You must decide whether to discontinue breastfeeding or discontinue/abstain from treatment with Nitroglycerin Zentiva, taking into account the benefit of breastfeeding for the child and the benefit of the treatment for you.
Driving and using machines
Nitroglycerin Zentiva, especially at the beginning of treatment or during dose adjustments, may impair your reaction ability or may rarely cause orthostatic hypotension and dizziness (and exceptionally, fainting due to excessive dosing). If these effects occur, you must refrain from driving or using machinery.
Nitroglycerin Zentiva contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.
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3. How to use Nitroglicerina Zentiva

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

The recommended dose is the application of one transdermal patch per day.
Your doctor will determine the daily duration of application and will advise you whether to apply the transdermal patch continuously for 24 hours or to interrupt the application for several hours (for example, during the night) to prevent the development of tolerance to the drug (intermittent therapy).
Intermittent therapy is particularly recommended if you are also taking other nitrates (e.g., sublingual nitroglycerin); it is recommended to apply Nitroglicerina Zentiva daily with a nitrate-free interval of 8–12 hours.

Duration of treatment with Nitroglicerina Zentiva
Treatment with Nitroglicerina Zentiva may continue for several years. However, your doctor will want to review your condition regularly to decide whether to continue treatment or modify the therapeutic regimen.

How to apply the patch
Apply the patch to clean, dry skin, avoiding wounds, birthmarks, moles, or areas where you have recently applied cream, moisturizer, or talcum powder. Apply Nitroglicerina Zentiva transdermal patches to the skin of the chest or the outer upper part of the arm (see Figure 2), on an area free of redness or irritation, and rotate application sites. You may shave the application area if necessary.
Avoid areas that form folds or are subject to friction during movement.
Do not apply two patches consecutively to the same area.

Follow these instructions when applying the Nitroglicerina Zentiva patch immediately after removing it from its pouch:
(I) Each patch is individually packaged in a sealed pouch and should remain in it until use. The sealed pouch can be easily opened by tearing from the notch on its edge. Open the pouch by tearing from the notch. Do not use scissors (see Figure 1).
(II) Remove the patch from the pouch and hold it with both hands, with the protective layer (the shiny side) facing upwards.
(III) Fold the patch so that the central wavy opening line opens. Peel off half of the protective layer, taking care not to touch the adhesive surface with your fingers.
(IV) Apply the patch to the prepared skin area and remove the other half of the protective layer (see Figure 2).
(V) Press firmly on the patch with the palm of your hand to ensure that the entire adhesive surface is securely attached to the skin.

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Wash your hands before and after applying Nitroglicerina Zentiva.
To remove the patch, simply lift one edge and gently peel it off.

If you use more Nitroglicerina Zentiva than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
The risk of overdose is very low due to the controlled release of nitroglycerin.
Symptoms
If you take excessive doses of nitroglycerin, you may experience severe drop in blood pressure, increased heart rate, circulatory collapse, fainting, bluish discoloration of the skin and mucous membranes (cyanosis), coma, and seizures.
Alterations in hemoglobin (methemoglobinemia) have also been reported following accidental overdose.
Treatment
In case of accidental overdose, the effect of nitroglycerin can be rapidly stopped by removing the patch from the skin.
Hypotension or collapse may be treated by elevating the patient’s legs while lying down, or, if necessary, by applying compression bandages to the legs. If needed, this initial measure may be followed by appropriate therapy, according to the judgment of the treating physician.
In case of methemoglobinemia, your doctor will administer appropriate treatment.

If you stop treatment with Nitroglicerina Zentiva
When you stop treatment with Nitroglicerina Zentiva, you may experience a recurrence of angina attacks.
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 will experience them.
Side effects are classified in order of decreasing frequency:
Very common (may affect more than 1 in 10 people):

• stomach disturbances (nausea and vomiting).

Common (may affect up to 1 in 10 people):

• headache (cephalalgia).

Uncommon (may affect up to 1 in 100 people):

• skin inflammation (dermatitis) due to contact
• skin redness (erythema) at the patch application site
• itching, burning, and irritation.

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

• increased heart rate (tachycardia), which could also interfere with diagnostic tests
• sudden drop in blood pressure following abrupt change from sitting or lying position to upright position (orthostatic hypotension), hot flushes.

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

• dizziness.

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Like all nitrate-containing preparations, Nitroglycerin Zentiva commonly causes headaches, varying in intensity according to the dose, due to cerebral vasodilation: these usually occur at the beginning of treatment and disappear after a few days without discontinuing therapy. If headaches persist even during intermittent treatment, mild analgesics may be used. If headaches do not respond to this type of treatment, it is advisable to reduce the nitroglycerin dosage or discontinue treatment.
A slight increase in heart rate can be avoided, if necessary, by using concomitant treatment with a beta-blocker.
After removal of the transdermal patch, any slight skin redness usually disappears within a few hours. The application site should be changed regularly to prevent local irritation.
Regarding possible side effects affecting the heart and circulatory system, orthostatic hypotension, tachycardia, palpitations, hot flushes, and dizziness are side effects that mainly occur at the beginning of treatment.
The use, especially if prolonged, of topical medicines may lead to sensitization phenomena; in such cases treatment should be discontinued and appropriate therapeutic measures adopted.
The following adverse reactions are derived from post-marketing experience with Nitroglycerin Zentiva through spontaneous reports and literature cases. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency; therefore, their frequency is classified as not known:

• effects affecting the heart: palpitations
• effects affecting the skin: skin redness not limited to the application site. 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 the website http://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 Nitroglycerin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the sachets after Exp.
The expiry date refers to the last day of that month.
Nitroglycerin Zentiva must be stored in its original intact sachet.
Do not dispose of any medicine 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 Nitroglicerina Zentiva contains
Nitroglicerina Zentiva 5 mg/24 hours transdermal patches

• The active substance is nitroglycerin. Each patch contains 26.60 mg of nitroglycerin, released over 24 hours at a rate of 0.2 mg/hour.
• The other components are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

Nitroglicerina Zentiva 10 mg/24 hours transdermal patches

• The active substance is nitroglycerin. Each patch contains 53.00 mg of nitroglycerin, released over 24 hours at a rate of 0.4 mg/hour. Page 6 of 7
• The other components are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

Nitroglicerina Zentiva 15 mg/24 hours transdermal patches

• The active substance is nitroglycerin. Each patch contains 80.00 mg of nitroglycerin, released over 24 hours at a rate of 0.6 mg/hour.
• The other components are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

Description of the appearance of Nitroglicerina Zentiva and package contents
Nitroglicerina Zentiva 5 mg/24 hours transdermal patch is a transparent, rectangular patch.
It is available in packs of 15 transdermal patches.
Nitroglicerina Zentiva 10 mg/24 hours transdermal patch is a transparent, rectangular patch.
It is available in packs of 15 transdermal patches.
Nitroglicerina Zentiva 15 mg/24 hours transdermal patch is a transparent, square-shaped patch.
It is available in packs of 15 transdermal patches.

Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale L. Bodio n. 37/B, 20158 Milano
Manufacturer
SPA Italiana Laboratori Bouty, S.S. n. 11, Padana Superiore Km 160, Cassina de' Pecchi (MI)
Altergon Italia S.r.l., Zona Industriale, 83040 Morra de Sanctis (AV)
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