NITROGLICERINA 5 mg Трансдермальный Пластырь

Содержание инструкции

1. NITROGLICERINA EG 5 mg/24 hour transdermal patch, 10 mg/24 hour transdermal patch, 15 mg/24 hour transdermal patch
   1. What NITROGLICERINA EG is and what it is used for
   2. What you need to know before using NITROGLICERINA EG
   3. How to use NITROGLICERINA EG
   4. Possible side effects
   5. How to store NITROGLICERINA EG
   6. Package Contents and Other Information

NITROGLICERINA EG 5 mg/24 hour transdermal patch, 10 mg/24 hour transdermal patch, 15 mg/24 hour transdermal patch

Generic medicine

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

1. What NITROGLICERINA EG is and what it is used for

NITROGLICERINA EG patches contain the active ingredient nitroglycerin, a vasodilator
used for heart conditions, which belongs to a group of drugs called organic nitrates.
NITROGLICERINA EG patches are applied to the skin and the active ingredient, passing
through the skin, penetrates the body.
NITROGLICERINA EG is indicated in the prevention of angina attacks, taken in
monotherapy or in association with other anti-anginal therapy.
Angina usually manifests with chest pain or a feeling of tightness that can
spread to the neck or arm. The pain occurs when the heart is not sufficiently
oxygenated.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using NITROGLICERINA EG

Do not use NITROGLICERINA EG:

• if you are allergic to nitroglycerin or to similar molecules (organic nitrates related to nitroglycerin) or to any of the other components of this medicine (listed in section 6);
• if you have recently experienced a collapse (acute circulatory failure associated with a marked decrease in blood pressure);
• if you suffer from severe anemia;
• in cases of conditions associated with increased intracranial pressure or cerebral hemorrhage;
• if you suffer from increased intraocular pressure (closed-angle glaucoma);
• if you suffer from heart failure due to narrowing of the aortic or mitral valve orifice (aortic stenosis or mitral stenosis, respectively), or thickening of the fibrous, sac-like membrane surrounding the heart (constrictive pericarditis); if you are taking phosphodiesterase type 5 (PDE-5) inhibitors. The combination of a nitrate with sildenafil (Viagra) or with other medicines used for the treatment of erectile dysfunction can cause a sudden and severe drop in blood pressure, which can lead to fainting and loss of consciousness (see section “Other medicines and NITROGLICERINA EG”);
• if you have low blood pressure (value below 90 mmHg);
• cardiogenic shock, unless, with appropriate measures, adequate telediastolic pressure is maintained;
• toxic pulmonary edema;
• severe hypovolemia;
• if you are taking riociguat (a medicine used to reduce blood pressure in the lungs)
• head trauma;
• generally contraindicated in pediatric age
• generally contraindicated in pregnancy and breastfeeding (see Special warnings).

Warnings and precautions
Consult your doctor or pharmacist before using NITROGLICERINA EG:

• if the level of oxygen in the blood is insufficient (hypoxemia) due to severe anemia, or a lung disease, or reduced blood supply to the heart (ischemic heart failure);
• if angina is caused by thickening of the heart (hypertrophic cardiomyopathy). Nitrates can worsen this type of angina;
• 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 (cross-tolerance);
• if you have recently had a heart attack (myocardial infarction) or acute heart failure;
• if your blood pressure values are below normal (hypotension); if you experience a collapse while under treatment with NITROGLICERINA EG, removal of the patch should be considered;
• if you suffer from closed-angle glaucoma.

Consult your doctor or pharmacist:

• if you stop treatment or if you need to switch to another treatment. Discontinuation of treatment with NITROGLICERINA EG must be done gradually and under strict medical supervision;
• if you experience an increase in the frequency of angina attacks during periods without a patch (intermittent therapy). Your doctor may want to re-evaluate the coronary disease and consider adjusting the treatment by administering an antianginal drug at the same time.

Patients with nitroglycerin-induced hypotension may experience paradoxical bradycardia and
increased episodes of angina.
NITROGLICERINA EG is not indicated for the treatment of acute angina episodes.
The use, especially if prolonged, of topical application products can lead to sensitization phenomena; in such cases, treatment should be discontinued and appropriate therapeutic measures adopted.

Children and adolescents
NITROGLICERINA EG should not be used in children and adolescents under the age of 18
years.

Other medicines and NITROGLICERINA EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not use NITROGLICERINA EG together with medicines used for erectile dysfunction, such as
sildenafil or others, as these increase the effect of reducing blood pressure (see
the section “Do not use NITROGLICERINA EG”.
Tell your doctor if you are using:
o medicines used to regulate blood pressure or heart activity, such as other
vasodilators, calcium antagonists, beta-blockers, ACE inhibitors and other antihypertensives;
o medicines used to increase urine elimination (diuretics);
o medicines for anxiety or depression (e.g. tricyclic antidepressants, sedatives);
o dihydroergotamine, used for example for migraine
o non-steroidal anti-inflammatory drugs (NSAIDs) e.g. acetylsalicylic acid and indometacin
(used to treat pain and inflammation)
Nitroglycerin may alter the result of the laboratory test for catecholamines and vanillyl-
mandelic acid (with higher values in urine).

SPECIAL WARNINGS
The patch must be removed in case of collapse or shock.
NITROGLICERINA EG must be removed before proceeding with defibrillation or cardioversion,
to avoid the possibility of an electric arc effect, and before a diathermy treatment.

NITROGLICERINA EG with alcohol
Consumption of alcohol can enhance the hypotensive effects of NITROGLICERINA EG.

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.
Do not use this medicine if you are pregnant or breastfeeding, unless absolutely necessary and in any case after the doctor has assessed the risks and benefits for you and the
child.

Driving and using machines
NITROGLICERINA EG, especially at the beginning of treatment, can alter reactions or can
rarely cause postural hypotension, nausea and dizziness. Patients who experience these effects and
especially under the concomitant effect of alcohol, must refrain from driving vehicles or
using machinery.

3. How to use NITROGLICERINA EG

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended initial dose is 5 mg (one patch 5 mg/24 hours) per day. The doctor may
subsequently increase the dose to 10 mg (one patch 10 mg/24 hours) per day or, if necessary, to 15
mg (one patch 15 mg/24 hours) per day.
The maximum daily dose allowed is 15 mg of nitroglycerin.
The duration of daily application must be established by the doctor; as appropriate
the application of the transdermal patch may last continuously for all 24 hours or be
suspended for a few hours (for example during the night), in order to avoid the onset of tolerance
to the drug.
NITROGLICERINA EG must be administered intermittently, i.e. with a daily interval
of suspension that avoids the onset of tolerance to nitrates. This interval must
correspond in the patient to a period free of attacks. Concomitant antianginal therapy
(beta-blockers and/or calcium antagonists) should be provided to maintain therapeutic coverage
during the nitrate suspension interval.
The nitrate suspension interval must be at least 8 hours.
The development of tolerance to nitrates is a widely known phenomenon in the preventive treatment
of angina and an adequate dosage regimen providing a nitrate suspension interval guarantees its
therapeutic efficacy.
Patients suffering from nocturnal angina may benefit from nocturnal treatment with a
nitrate-free interval during the day. In these patients, additional antianginal therapy
may be necessary during the day.
Patients suffering from severe forms of angina may also require additional antianginal therapy
during nitrate-free intervals.
Apply the patch to a clean, dry, residue-free and undamaged area of skin
of the chest or the outermost and upper part of the arms.
If necessary, to improve the adhesion of the patch to the skin, you can shave the application area.
Avoid areas of skin that form folds or are subject to friction during movement.
It is advisable to vary the application area of the patch every day.

Apply the patch following these instructions:
wash your hands;

• open the sachet by tearing it (do not use scissors to avoid damaging the patch) and remove the patch;
• hold the patch between your thumb and forefinger;
• remove the protective sheet with your other hand and discard it;
• avoid touching the adhesive side of the patch and apply it to the skin, holding the part still covered by the protective sheet between your thumb and forefinger;
• remove the remaining part of the protective sheet and press firmly for about 10 seconds over the entire surface of the patch;
• press with a finger along the edges to ensure good adhesion;
• wash your hands after applying the patch;
• after use, the patch must be folded with the adhesive side inwards and discarded.

If you use more NITROGLICERINA EG than you should
In case of accidental intake of an excessive dose of NITROGLICERINA EG, immediately warn
your doctor or go to the nearest hospital.

Symptoms
High doses of nitroglycerin can induce:

• blood pressure drop ≤90 mmHg
• syncope
• pallor
• sweating
• weak pulse
• tachycardia
• mental confusion in upright position
• headache
• cyanosis
• coma
• convulsions
• weakness
• dizziness
• nausea
• vomiting
• diarrhea

Metahemoglobinemia (an abnormal presence of oxidized hemoglobin in the blood) has also been reported
following accidental overdose.

Treatment
In case of accidental overdose, the effect of nitroglycerin can be rapidly suspended
by removing the patch from the skin.
In case of ingestion/accidental intake of an excessive dose of NITROGLICERINA EG
immediately warn your doctor or go to the nearest hospital

If you forget to change the patch
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you stop treatment with NITROGLICERINA EG
Discontinue treatment gradually and under strict medical control.
If you have any doubts about the use of 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 (may affect more than 1 in 10 people):

• headache

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

• mental confusion, dizziness; drowsiness;
• reflex tachycardia;
• hypotension in upright position;
• mild and transient irritation at the application site;
• feeling of weakness.

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

• increase in angina pectoris symptoms;
• collapse (sometimes accompanied by bradyarrhythmia and syncope), tachycardia, palpitations, hot flushes;
• nausea, vomiting
• allergic skin reactions (e.g. rash, itching or burning at the application site, redness), allergic contact dermatitis:

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

• pyrosis

Not known (frequency cannot be estimated from available data):

• exfoliative dermatitis.

Headache may occur at the beginning of treatment which, as a rule, disappears after a few days
and which can be controlled with the administration of mild analgesics.
Adverse effects may occur more frequently in cases of overdose or
patient hypersensitivity.
Sometimes the appearance of mild itching and burning and redness of the skin has been detected in
the area of application of the patch, manifestations that disappeared spontaneously after its
removal.
Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting,
agitation, pallor and excessive sweating.
During treatment with NITROGLICERINA EG, temporary hypoxemia may occur, due to the
relative redistribution of blood flow to poorly ventilated alveolar areas. This can
lead to myocardial hypoxia, particularly in patients with coronary artery disease.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the
national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store NITROGLICERINA EG

Keep this medicine out of the sight and reach of children both before and after use.
Store in the original packaging.
Do not use this medicine after the expiry date which is reported on the carton and sachets after
Exp. The expiry date refers to the last day of that month.
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. Package Contents and Other Information

What NITROGLICERINA EG contains
NITROGLICERINA EG 5 mg/24 hours transdermal patches
One patch with a surface area of 6.670 cm contains:
Active ingredient: nitroglycerin 26.60 mg (releases 5 mg of nitroglycerin in 24 hours, approximately 0.2
mg/hour)

NITROGLICERINA EG 10 mg/24 hours transdermal patches
One patch with a surface area of 13.285 cm contains:
Active ingredient: nitroglycerin 53.00 mg (releases 10 mg of nitroglycerin in 24 hours, approximately 0.4
mg/hour)

NITROGLICERINA EG 15 mg/24 hours transdermal patches
One patch with a surface area of 20.035 cm contains:
Active ingredient: nitroglycerin 80.00 mg (releases 15 mg of nitroglycerin in 24 hours, approximately 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 EG and contents of the pack
NITROGLICERINA EG transdermal patch is a transdermal patch contained in packs of
15 patches.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan

Manufacturer
IBSA FARMACEUTICI ITALIA S.r.l.,
S.S. n. 11, Padana Superiore Km 160, Cassina de' Pecchi (MI)
ALTERGON Italia S.r.l. Zona Industriale A.S.I. 83040 Morra De Sanctis (AV)