Nitroglycerin Doc Generici

Package leaflet: Information for the user

NITROGLICERINA DOC Generici 5 mg/24 hours transdermal patches, 10 mg/24 hours transdermal patches, 15 mg/24 hours transdermal patches

Generic Medicinal Product
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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What NITROGLICERINA DOC Generici is and what it is used for
  2. What you need to know before using NITROGLICERINA DOC Generici
  3. How to use NITROGLICERINA DOC Generici
  4. Possible side effects
  5. How to store NITROGLICERINA DOC Generici
  6. Contents of the pack and other information

1. What NITROGLICERINA DOC Generici is and what it is used for

NITROGLICERINA DOC Generici contains the active substance nitroglycerin, which belongs to the group of vasodilator medicines used in the treatment of certain heart diseases. This medicine works by dilating blood vessels and improving blood circulation.
The transdermal patches of NITROGLICERINA DOC Generici are indicated for the prevention and treatment of chest pain caused by heart circulation problems (angina pectoris on exertion or at rest associated with or due to coronary insufficiency).
Angina typically manifests as pain or a feeling of pressure in the chest that may radiate to the neck or arm. The pain occurs when the heart is not receiving sufficient oxygen.
NITROGLICERINA DOC Generici patches are for external use only.

2. What you need to know before using NITROGLICERINA DOC Generici

Do not use NITROGLICERINA DOC Generici

• if you are allergic to nitroglycerin or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines similar to nitroglycerin (organic nitrates);
• if you have low levels of red blood cells in the blood (anemia);
• if you suffer from conditions associated with increased pressure inside the eye or skull, such as cerebral hemorrhage, head trauma, or closed-angle glaucoma;
• if you suffer from circulatory problems with a severe drop in blood pressure (shock);
• if you have heart problems such as heart failure due to obstruction, such as narrowing (stenosis) of the aortic or mitral valve, if you have a chronic inflammatory condition causing thickening of the membrane surrounding the heart (constrictive pericarditis), if you have a condition causing thickening of the heart muscle (hypertrophic cardiomyopathy), or if you have fluid accumulation within the pericardial cavity (pericardial tamponade);
• 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 are taking medicines for erectile dysfunction, sometimes called impotence (see section "Other medicines and NITROGLICERINA DOC Generici");
• if you have very low blood pressure (hypotension);
• if you experience a severe reduction in circulating blood volume (severe hypovolemia);
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section "Other medicines and NITROGLICERINA DOC Generici").

Warnings and precautions
Talk to your doctor or pharmacist before using NITROGLICERINA DOC Generici.
This medicine is not indicated for acute angina attacks requiring rapid intervention.
Use this medicine with caution and under direct medical supervision in the following situations:

• if you have recently suffered from heart problems such as myocardial infarction or acute heart failure;
• if you have low levels of oxygen in the blood (hypoxemia) due to reduced red blood cells (anemia), lung problems (hypoventilation), or heart problems (ischemic heart failure);
• if you suffer from chest pain (angina) caused by an enlarged heart (hypertrophic cardiomyopathy), because nitroglycerin may worsen these conditions. Prolonged use of this medicine may cause allergic reactions, which resolve upon removal of the patch, or a decrease/loss of effectiveness of nitroglycerin or similar medicines (tolerance and cross-tolerance), which can be avoided by applying the patch intermittently (see section "How to use NITROGLICERINA DOC Generici"). Remove the patch if you experience excessive lowering of blood pressure (hypotension) or if you need to undergo electrical stimulation of the heart to restore normal rhythm (defibrillation or cardioversion) or procedures involving magnetic fields (magnetic resonance imaging). If you are taking other nitrates (e.g., sublingual nitroglycerin), because your body may develop resistance to the effects of these substances after repeated exposure. This can be prevented by intermittent therapy (see section "How to use NITROGLICERINA DOC Generici"). If you discontinue treatment or need to switch to another therapy, discontinuation of NITROGLICERINA DOC Generici should be done gradually and under strict medical supervision. If you temporarily stop treatment with this medicine, it is recommended to follow alternative therapies to prevent an increase in the frequency of chest pain due to heart problems (angina pectoris). If you are elderly, avoid sudden changes in posture, as this medicine may initially cause dizziness upon standing due to a rapid drop in blood pressure (orthostatic hypotension). This medicine may increase levels of certain substances in the urine, such as catecholamines and vanillylmandelic acid, thereby altering the results of related laboratory tests.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established.

Other medicines and NITROGLICERINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not use NITROGLICERINA DOC Generici together with medicines used to facilitate erection, such as sildenafil (Viagra), as they increase the blood pressure-lowering effect.

The use of NITROGLICERINA DOC Generici with riociguat, a soluble guanylate cyclase stimulator, is contraindicated because concomitant use may cause hypotension (see section "Do not use NITROGLICERINA DOC Generici").
Use caution if you are taking the following medicines, as they may increase the blood pressure-lowering effect of NITROGLICERINA DOC Generici:

• medicines used to regulate blood pressure or heart function, such as calcium antagonists, beta-blockers, ACE inhibitors, and other antihypertensives;
• medicines used to increase urine elimination (diuretics);
• medicines used in central nervous system disorders, such as neuroleptics, antidepressants, and major tranquilizers;
• a medicine called amifostine, used in certain types of cancer;
• a medicine called acetylsalicylic acid, used to relieve inflammation and pain.
  Use caution if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), except acetylsalicylic acid, as they may reduce the effectiveness of nitroglycerin.
  Use caution and inform your doctor if you are taking a medicine for headache called dihydroergotamine, because nitroglycerin may increase its blood levels.

NITROGLICERINA DOC Generici and alcohol
Avoid drinking alcohol during treatment with NITROGLICERINA DOC Generici, as it may cause an excessive drop in blood pressure.

Fertility, pregnancy and breastfeeding
Fertility
No data are available on the effect of NITROGLICERINA DOC Generici on fertility in humans.

Pregnancy
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. Do not use this medicine during pregnancy, especially during the first trimester, or while breastfeeding, unless absolutely necessary and only after your doctor has evaluated the risks and benefits for you and the fetus or newborn.

Breastfeeding
There is insufficient information on the passage of nitroglycerin into breast milk. Risk to newborns/infants cannot be ruled out. You must decide whether to discontinue breastfeeding or discontinue/abstain from treatment with NITROGLICERINA DOC Generici, taking into account the benefit of breastfeeding for the child and the benefit of therapy for you.

Driving and using machines
Avoid driving or operating machinery if you experience any of the following symptoms: reduced ability to respond to stimuli, dizziness, lightheadedness upon standing due to a rapid drop in blood pressure (orthostatic hypotension), which may occur especially at the beginning of treatment or after dose adjustments.

3. How to use NITROGLICERINA DOC Generici

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

The recommended starting dose is 5 mg per day, increasing if necessary to 10 mg per day or, if needed, up to 15 mg per day.

The patch may be applied either continuously for 24 hours or intermittently, by removing it for several hours, usually during sleep.

If you notice a decrease in the effectiveness of the medicine, it is recommended to remove the patch daily for a period of 8–12 hours.

Duration of treatment with NITROGLICERINA DOC Generici

Treatment with NITROGLICERINA DOC Generici may continue for several years. However, your doctor will want to examine you regularly to decide whether to continue treatment or modify your therapy.

How to apply the patch

Wash your hands before applying the patch. Apply it to a clean, dry, and undamaged area of skin on the chest or arms, free of hair or any residue from ointments or creams.

Do not apply consecutive patches to the same skin area.

Do not remove the patch during bathing or physical exercise, as it remains firmly adhered to the skin.

Apply the patch according to the following instructions:

• Open the sachet by tearing it at the marked notch (do not use scissors, to avoid damaging the patch) and remove the patch (Fig. 1);
• Hold the patch between your thumb and index finger. With the other hand, peel off the protective liner and discard it (Fig. 1);
• Avoid touching the adhesive side of the patch. Apply the patch to the skin, holding the part still covered by the protective liner between your thumb and index finger;
• Remove the remaining part of the protective liner and press firmly for about 10 seconds over the entire surface of the patch (Fig. 2);
• Press along the edges with one finger to ensure good adhesion (Fig. 2).

If you use more NITROGLICERINA DOC Generici than you should

Due to its slow-release formulation, overdose is rare. However, if you experience any of the following symptoms, remove the patch immediately and contact your doctor right away or go to the nearest hospital:

• Severe drop in blood pressure leading to increased heart rate (hypotension with reflex tachycardia);
• Loss of consciousness (collapse or syncope);
• Bluish discoloration of the skin (cyanosis);
• Coma, seizures;
• Changes in hemoglobin structure (methemoglobinemia).

Treatment includes immediate removal of the patch, elevation of the patient’s legs or compression bandaging to increase blood pressure and restore consciousness. In cases of methemoglobinemia, intravenous administration of medications such as methylthioninium or toluidine blue may be required.

If you stop using NITROGLICERINA DOC Generici

Discontinuation of treatment with this medicine should be done gradually, especially if starting a new therapy with other medications.

If you have any doubts 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.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• nausea and vomiting. Common (may affect up to 1 in 10 people)
• temporary headache, which can be relieved by taking painkillers (mild analgesics), reducing the dose of nitroglycerin, or stopping treatment. Uncommon (may affect up to 1 in 100 people)
• itching, burning, irritation, and skin problems such as contact dermatitis and erythema, which can be resolved by changing the patch application site or removing the patch. Rare (may affect up to 1 in 1,000 people)
• increased heart rate (tachycardia), which can be managed by administering medications that regulate heart activity, such as beta-blockers;
• drop in blood pressure upon changing position (orthostatic hypotension);
• hot flushes. Very rare (may affect up to 1 in 10,000 people)
• dizziness. Not known (frequency cannot be estimated from available data)
• increased awareness of heartbeats (palpitations);
• skin problems such as rashes;
• syncope. 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 NITROGLICERIN DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
Store this medicine in its original packaging.
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 DOC Generici contains
NITROGLICERINA DOC Generici 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 DOC Generici 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.
• The other components are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

NITROGLICERINA DOC Generici 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 DOC Generici and contents of the pack
Pack containing 15 transdermal patches.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati, 40
20121, Milan (MI)
Italy

Manufacturer
SPA ITALIANA LABORATORI BOUTY
S.S. n. 11, Padana Superiore Km 160
20060 Cassina de' Pecchi (MI)
Italy

Altergon Italia S.r.l.
Zona Industriale ASI
83040 Morra De Sanctis (AV)
Italy