EPINITRIL 5 mg /24 H Трансдермальный Пластырь

Содержание инструкции

1. Epinitril 5 mg/24 hours transdermal patch, 10 mg/24 hours transdermal patch, 15 mg/24 hours transdermal patch
   1. What is Epinitril and what is it used for
   2. What you need to know before using Epinitril
   3. How to use Epinitril
   4. Possible side effects
   5. How to store Epinitril
   6. Contents of the pack and other information

Epinitril 5 mg/24 hours transdermal patch, 10 mg/24 hours transdermal patch, 15 mg/24 hours transdermal patch

Nitroglycerin
Read this leaflet carefully before you start to use 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. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What is Epinitril and what is it used for

Epinitril patches contain the active substance nitroglycerin, a vasodilator used for
heart conditions, which belongs to a group of drugs called organic nitrates.
Epinitril patches are applied to the skin and the active substance, passing through the skin,
penetrates into the body.
Epinitril is indicated in the prevention of angina attacks, taken as 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. Epinitril is not indicated for the treatment of acute angina episodes. The usual sublingual tablet or spray should be used for the treatment of acute attacks.
Epinitril patches are for external use only.

2. What you need to know before using Epinitril

Do not use Epinitril

• if you are allergic (hypersensitive) to nitroglycerin, related organic nitrates or any of the excipients of Epinitril (listed in section 6);
• if you are experiencing or have recently experienced shock associated with very low blood pressure;
• if you have medical conditions such as headache, vomiting or convulsions associated with an increase in intracranial pressure, including that caused by head trauma;
• if you suffer from heart failure due to obstruction such as, for example, in the presence of a narrowing of the aortic orifice or the atrioventricular orifice of the heart (aortic stenosis or mitral stenosis, respectively), or a fibrous thickening of the thin sac-shaped membrane surrounding the heart (constrictive pericarditis);
• if you are taking medicines for the treatment of erectile dysfunction (e.g. sildenafil or other PDE-5 inhibitors). Nitrates should not be administered to patients treated with sildenafil or any other medicine for treating erectile dysfunction. Patients undergoing nitrate therapy should not take sildenafil or other medicines for the treatment of erectile dysfunction. The combination of a nitrate with sildenafil or any other PDE-5 inhibitor 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 Epinitril”);
• if you are taking medicines with riociguat, a soluble guanylate cyclase stimulator;
• if you suffer from severe hypotension (systolic blood pressure below 90 mm Hg);
• if you suffer from a severe decrease in blood volume in the body due to blood loss or loss of body fluids (severe hypovolemia);
• if you suffer from severe anemia;
• if you suffer from toxic fluid retention in the lungs (toxic pulmonary edema).

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

• if you stop treatment. Discontinuation of treatment with Epinitril must be done gradually, replacing the patch with decreasing doses of long-acting nitrates orally;
• if you need to undergo magnetic resonance imaging, electrical stimulation of the heart to restore normal heart rhythm (defibrillation or cardioversion), and before thermal therapy (diathermy). You must remove the Epinitril patch before undergoing these treatments;
• if you have, or have recently had a heart attack (myocardial infarction) or if you develop rapidly symptoms of heart failure (acute heart failure) such as shortness of breath, severe fatigue, swelling of the legs. Your doctor may ask you to undergo laboratory tests on your cardiovascular functions;
• if you suffer from severe hypotension during treatment with Epinitril, it may be necessary to remove the patch. If you experience collapse or shock, the Epinitril patch must be removed;
• in case of chest pain (acute angina attacks), or if the heart does not receive enough blood and oxygen (unstable angina) or in case of a heart attack (myocardial infarction). Epinitril should not be used as immediate treatment for these conditions;
• if you experience severe headache or if blood pressure values are below normal (hypotension). This may occur in the case of a too high initial dose. It is recommended to increase the dose gradually until the optimal effect is achieved;
• if you are taking other nitrates or sublingual nitroglycerin, as your body may develop resistance to the effects of these substances after repeated exposure (cross-tolerance);
• if you report or have reported blood pressure values below normal induced by nitroglycerin. In this case, a slowing of the heartbeat (paradoxical bradycardia) and an increase in angina may occur;
• if you suffer from a pathology of the optic nerve (closed-angle glaucoma);
• if the blood oxygenation level is insufficient (hypoxemia) due to severe anemia, or a lung disease, or reduced blood supply to the heart (ischemic heart failure). Patients with these medical conditions frequently suffer from an imbalance in the ventilation/perfusion ratio, which is an index of respiratory function. In these patients, nitroglycerin may worsen the ventilation/perfusion imbalance and cause a further decrease in blood oxygenation;
• if angina is caused by thickening of the heart (hypertrophic cardiomyopathy). Nitrates may worsen this type of angina;
• if you experience an increase in the frequency of angina attacks during periods without a patch. Your doctor may assess the suitability of additional antianginal therapy;
• if you experience skin sensitization phenomena (itching, burning, inflammation), stop treatment and consult your doctor. Other medicines and Epinitril

The concomitant administration of medicines for the treatment of erectile dysfunction (e.g. sildenafil or other PDE-5 inhibitors) potentiates the hypotensive effects of nitrates and therefore must be avoided (see also section “Do not use Epinitril”).
Concomitant treatment with riociguat, a soluble guanylate cyclase stimulator, must be avoided as concomitant use may cause hypotension (see also section “Do not use Epinitril”).
Concomitant treatment with the following medicines may potentiate the hypotensive effects of Epinitril:

• medicines used to lower blood pressure, such as calcium antagonists, ACE inhibitors (for the treatment of congestive heart failure), beta-blockers (used to manage heart arrhythmias), diuretics (to increase the elimination of water from the body) and other antihypertensives,
• tricyclic antidepressants (medicines for the treatment of depressive disorders),
• neuroleptics (medicines used to manage psychoses),
• common tranquilizers (sedatives),
• as well as alcohol consumption,
• and with the association of amifostine (cytoprotective medicine in chemo and radiotherapy) and
• acetylsalicylic acid (an NSAID).

Concomitant treatment with dihydroergotamine may reduce the effect of Epinitril.
Non-steroidal anti-inflammatory drugs, except acetylsalicylic acid, may decrease the therapeutic response of Epinitril.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.

Pregnancy, breastfeeding and fertility
Epinitril should not be used during pregnancy, especially in the first three months, unless your doctor has told you to do so.
Due to limited information on the presence of nitroglycerin in human breast milk, a risk to the infant cannot be excluded. Your doctor will assess whether to discontinue breastfeeding or Epinitril.
No data are available on the effect of Epinitril on fertility in humans.
If you are pregnant, suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Especially at the beginning of treatment or in case of dose adjustments, Epinitril may affect your ability to drive or use machines, as it may alter your reactions or may rarely cause lowering of blood pressure in the upright position and dizziness, as well as, in exceptional cases, fainting following overdose.
If you experience these effects, you must avoid driving or using machines.

3. How to use Epinitril

Use Epinitril always following exactly the doctor's instructions. If you have doubts, consult your doctor
or pharmacist.
The recommended dose is one Epinitril patch once a day. Carefully apply the
patch to the skin and keep it on for 12-16 hours. Then, remove the patch and observe an interval
free from the patch for the remaining 8-12 hours.
It is necessary to replace the Epinitril patch according to the instructions provided by the doctor. The doctor will tell you
how long to keep the patch on the skin and the duration of the patch-free interval.

Use in children and adolescents
Epinitril should not be used in children and adolescents under 18 years of age.
Duration of treatment with Epinitril
Treatment with Epinitril may continue for several years; however, your doctor will want to visit you
regularly to decide whether to continue treatment or to modify the therapeutic regimen.
How to apply the patch
The patch must be applied to clean and dry skin and not on wounds, spots or moles or on
an area to which a cream, a moisturizing lotion or talcum powder has just been applied. It is recommended
to apply the Epinitril transdermal patches to the skin of the chest (see Figure 1), or to the
outermost upper part of the arm, free of redness or irritation, and to vary the sites of
patch application. The application area can be shaved if necessary. Areas that form folds or are subject to friction during movements should be avoided.

Figure 1
Do not apply two patches consecutively to the same area.
The Epinitril patch should be applied to the skin as soon as it is removed from its sachet,
as follows:

• (I) Open the sachet by tearing it starting from the marked notch. Do not use scissors (see Figure 2).

Figure 2
(II) Hold the patch between your thumb and index finger on the smallest part of the protective sheet
delimited by a notch (see Figure 3).

Figure 3
(III) Peel off the larger part of the protective sheet with the other hand and discard it (see
Figure 4).
Do not touch the adhesive side of the patch otherwise it will not adhere properly.

Figure 4
(IV) Apply the patch to the skin, holding between your thumb and index finger the part still covered
by the protective sheet. Peel off the remaining part of the protective sheet and press
firmly for about 10 seconds over the entire surface of the patch. Run a finger
along the edges to ensure good adhesion.
Wash your hands before and after applying Epinitril.
To remove the patch, simply lift a corner and pull gently. After use,
fold the patch in half, with the adhesive sides facing inwards and discard it in a bin out of reach of
children.
What to do if the patch comes off
If Epinitril is applied correctly, it is highly unlikely that the patch will come off.
However, if the patch comes off, you must replace it with a new one and change the patch again
as usual following the original dosage schedule.

If you use more Epinitril than you should
If you take high doses of nitroglycerin, you may experience a severe drop in
blood pressure, increased heart rate or collapse and fainting, as well as alteration
of hemoglobin (methemoglobinemia).
If you or someone else applies too many patches at the same time, you should remove them carefully
and wash the underlying skin thoroughly to reduce absorption. If you experience
hypotension or collapse, it is recommended to raise the legs or, if necessary, apply compressive bandages
to the legs.

If you forget to change the patch
If you forget to change the patch when you should, you should replace it as soon as
possible, then follow the original dosage schedule for applying the next patch.

If you stop using Epinitril
When you stop treatment with Epinitril, you may experience a recurrence of angina attacks.
If you have any doubts about the use of the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Epinitril can cause side effects, although not everybody gets them.
The following side effects have been reported:

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

• Nausea.
• Vomiting.

Common side effects (affect more than 1 in 100 and less than 1 in 10 people):

• Headache.

Uncommon side effects (affect more than 1 in 1,000 and less than 1 in 100 people):

• Contact dermatitis (inflammatory skin reaction).
• Redness and irritation of the skin at the patch application site.
• Itching.
• Burning sensation.

Rare side effects (affect more than 1 in 10,000 and less than 1 in 1,000 people):

• Fast heartbeat (tachycardia).
• Low blood pressure when standing up (orthostatic hypotension) which may be described as transient episodes of dizziness.
• Hot flushes.
• Increased heart rate in diagnostic tests.

Very rare side effects (affect less than 1 in 10,000 people):

• Dizziness.
• Fainting (syncope).

Side effects with unknown frequency:

• Irregular heartbeat (palpitations).
• Generalized skin rash (generalized rash).

If any of these side effects get serious or last for a long time, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at: at
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 Epinitril

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C. Epinitril must be stored in its
intact sachet.
Do not use this medicine after the expiry date which is stated on the carton and on the sachets. The
expiry date refers to the last day of the 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. Contents of the pack and other information

What Epinitril contains
Epinitril patches contain the active ingredient nitroglycerin and are available in three formats:
Epinitril 5 mg/24 hours: contains 15.70 mg of the active ingredient nitroglycerin and releases
approximately 5 mg of nitroglycerin per day (0.2 mg/h); the release area of the
patch is 6.38 cm². The identification code
printed on the protective film is NR5.
Epinitril 10 mg/24 hours: contains 31.37 mg of the active ingredient nitroglycerin and releases
approximately 10 mg of nitroglycerin per day (0.4 mg/h); the release area of the
patch is 12.75 cm². The identification code
printed on the protective film is NR10.
Epinitril 15 mg/24 hours: contains 47.04 mg of the active ingredient nitroglycerin and releases
approximately 15 mg of nitroglycerin per day (0.6 mg/h); the release area of the
patch is 19.12 cm². The identification code
printed on the protective film is NR15.
The excipients are an adhesive substance (acrylic-vinyl acetate copolymer), an adhesion promoter (hydroabietyl phthalate) and a cross-linker (polybutyl titanate); the mixture of these excipients and
the active ingredient has been sprinkled onto a support film (lacquered propylene sheet). The
adhesive layer is covered by an aluminum foil and silicone-coated on both sides
which is removed before use.

Description of the appearance of Epinitril and contents of the pack
Epinitril patches are adhesive transdermal patches. Each patch is individually sealed in a
protective sachet.
Packs: 15 and 30 patches. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
ROTTAPHARM Ltd.
Damastown, Industrial Park, Mulhuddart
Dublin 15
Ireland
LTS Lohmann Therapie Systeme AG
Lohmannstraße 2
56626 Andernach
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

CountryName
France Epinitril
Ireland Epinitril
Italy Epinitril
Portugal Epinitril
Spain Epinitril