PROSPECTO: INFORMATION FOR THE USER

Epinitril 10 mg/24 h transdermal patch

Glyceryl trinitrate

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Epinitril and for what it is used

2. What you need to know before starting to use Epinitril

3. How to use Epinitril

4. Possible adverse effects

5. Storage of Epinitril

6. Contents of the package and additional information

EPINITRIL patches contain the active ingredient glyceryl trinitrate, a vasodilator used in heart diseases and belongs to a group of drugs called organic nitrates.

EPINITRIL patches are applied to the skin and the active ingredient will then pass continuously through the skin and into the body.

EPINITRIL is indicated for the preventive treatment of angina pectoris taken alone or in combination with another antianginal treatment.

Angina typically presents as a pain or pressure in the chest, although it may be felt in the neck or arm.

The pain appears when the heart is not sufficiently oxygenated. EPINITRIL is not indicated for the treatment of acute attacks. Use your tablet or sublingual spray for the treatment of acute attacks.

EPINITRIL patches are for external use only.

Do not useEpinitril:

- if you are allergic (hypersensitive) to glyceryl trinitrate, organic nitrates related or to any of the other components of this medication (listed in section 6);

- if you have or have recently had a collapse associated with hypotension;

- if you suffer from headaches, vomiting or seizures associated with increased intracranial pressure, including those caused by head trauma;

- if you suffer from heart failure due to obstruction, for example, in the presence of aortic orifice narrowing or atrioventricular orifice narrowing of the heart (aortic stenosis or mitral stenosis, respectively) or a fibrotic thickening of the thin membrane that covers the heart (constrictive pericarditis);

- if you are taking medications for the treatment of erectile dysfunction (e.g., sildenafil or any other PDE-5 inhibitor). Nitrates should not be administered to patients treated with sildenafil or any other medication used to treat erectile dysfunction. Patients currently treated with nitrates should not take sildenafil or any other medication for erectile dysfunction. The combination of a nitrate with sildenafil or any other PDE-5 inhibitor may cause a deep and sudden drop in blood pressure, which can cause dizziness, loss of consciousness or even a heart attack (see also "Use of other medications");

- if you are taking riociguat, a soluble guanylate cyclase stimulator;

- if you suffer from severe low blood pressure (blood pressure less than 90 mmHg),

- if you suffer from severe blood volume loss due to blood or fluid loss (severe hypovolemia),

- if you suffer from severe anemia,

- if you suffer from toxic fluid retention in the lungs (toxic pulmonary edema).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Epinitril:

- if you are withdrawing from treatment. Withdrawal from Epinitril treatment should be gradual, substituting with decreasing doses of long-acting oral nitrates;

- if you need to undergo magnetic resonance imaging, electrical stimulation of the heart to restore normal heart rhythm (defibrillation or cardioversion) and before heat treatment (diathermy). Remove Epinitril patches before undergoing these treatments;

- if you suffer or have recently suffered a heart attack (myocardial infarction) or if you experience rapidly developing symptoms of heart failure (acute heart failure) such as difficulty breathing, feeling extremely tired, swelling of the legs. Your doctor may request laboratory tests of your cardiovascular functions;

- if you suffer from severe hypotension during Epinitril treatment, consider removing the patch. In case of collapse or shock, the patch should be removed;

- if you experience chest pain (acute angina attack) or if your heart does not pump enough blood and oxygen (unstable angina) or in case of heart attack (myocardial infarction), do not use Epinitril as immediate treatment;

- if you suffer from severe headache or abnormal low blood pressure (hypotension). This may occur if the initial dose is too high. It is recommended to gradually increase the dose to achieve optimal effect;

- if you are taking other nitrates or sublingual glyceryl trinitrate, as your body may develop resistance to the effects of these substances after repeated exposure (cross-tolerance);

- if you suffer or have suffered from abnormal low blood pressure caused by glyceryl trinitrate. In this case, you may experience low heart rate (bradycardia paradoxica) and increased angina;

- if you suffer from optic nerve disease (angle-closure glaucoma);

- if you have severe oxygen deficiency in the blood (hypoxemia) due to severe anemia or lung disease or reduced blood flow to the heart (ischemic heart failure); patients with these medical conditions may experience a balance disorder in the ventilation/perfusion ratio, which is an index of respiratory function. In these patients, glyceryl trinitrate may worsen this disorder and cause a decrease in blood oxygenation;

- if angina has been caused by heart thickening (hypertrophic cardiomyopathy). Nitrates may worsen this type of angina;

- if you experience more frequent angina attacks during periods without patches. Your doctor may want to re-evaluate your coronary disease and consider adapting your treatment;

- if you experience skin sensitization phenomena (itching, burning, inflammation). You should consult your doctor if you experience these symptoms.

Use of Epinitril with other medications

The concomitant administration of medications for the treatment of erectile dysfunction (e.g., sildenafil or any other PDE-5 inhibitor) potentiates the blood pressure-lowering effects of nitrates and should be avoided (see also "Do not use Epinitril").

The concomitant treatment with riociguat, a soluble guanylate cyclase stimulator, should be avoided, as concomitant use may cause hypotension (see also "Do not use Epinitril").

The concomitant treatment with

-blood pressure-lowering medications, such as calcium channel blockers, ACE inhibitors (for the treatment of congestive heart failure), beta-blockers (used to prevent cardiac arrhythmias), diuretics, (increase water excretion from the body), and other anti-hypertensives,

-tricyclic antidepressants (medications used to treat depression),

-neuroleptics (medications used to prevent psychosis),

-major tranquilizers (sedatives), as well as alcohol consumption and in association with amifostine (a cytoprotective medication in chemotherapy and radiation therapy),

-aspirin (a nonsteroidal anti-inflammatory drug),

may potentiate the blood pressure-lowering effects of Epinitril.

The concomitant treatment with dihydroergotamine may decrease the effect of Epinitril.

Nonsteroidal anti-inflammatory drugs, except aspirin, may decrease the therapeutic response of Epinitril.

Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medication.

Pregnancy, breastfeeding and fertility

Epinitril should not be used during pregnancy, especially during the first three months unless your doctor has indicated it.

Since almost no information is available on whether glyceryl trinitrate is excreted in breast milk, it cannot be ruled out that there is a risk in breastfeeding. Your doctor will evaluate whether you should stop breastfeeding or the Epinitril treatment.

No data are available on the effect of Epinitril on human fertility.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

At the beginning of treatment, or during dose adjustment, Epinitril may affect your ability to drive or operate machinery, reduce your reaction time or cause orthostatic hypotension and dizziness, as well as rarely, syncope after overdose.

If you experience these effects, you should refrain from driving or operating machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one Epinitril patch per day. Apply the patch carefully to the skin and keep it for 12-16 hours. Then, remove the patch and maintain a patch-free period for the remaining 8-12 hours.

You must change your Epinitril patch according to the instructions given by your doctor. Your 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 or adolescents under 18 years old.

For how long should you use Epinitril

The treatment with Epinitril may continue for several years; however, your doctor will want to see you periodically to decide whether to continue treatment or modify the therapeutic regimen.

How to apply the patch

Apply the patch to clean and dry skin, but not on cuts, stains, or defects, or in areas where cream, moisturizer, or talcum powder has been applied. It is recommended to apply Epinitril transdermal patches to the skin of the chest (see Figure 1) or the outer upper arm, free of redness or irritation, and rotate the application points. If necessary, you can shave the area. Avoid areas that form folds or are subject to friction during movement.

Figure 1

Do not apply two consecutive patches to the same place.

Apply an Epinitril patch to the skin as soon as you take it out of the package, as follows:

(I)Break the package along the dotted line.

Do not use scissors (see Figure 2).

Figure 2

(II)Hold the patch between your thumb and index finger by the label that is removed

(see Figure 3).

Figure 3

(III)Remove the protective covering with the other hand (see Figure 4). Do not touch the adhesive side of the patch; otherwise, it will not stick well.

Figure 4

(IV)Apply the open side of the patch to the skin and remove the remaining protective covering.

Press firmly for 10 seconds on the entire surface of the patch. Run your fingers along the edges to make sure it sticks well.

Wash your hands before and after applying Epinitril.

To remove a patch, lift the edge and gently pull the patch until it comes off. After using the patch, fold it in half with the adhesive side in and throw it away, where children cannot get it.

What to do if the patch falls off

If Epinitril is applied correctly, it is very unlikely that the patch will fall off. However, if the patch falls off, replace it with a new one and then change the patch in the usual way according to your original schedule.

If you use more Epinitril than you should

If you administer high doses of glyceryl trinitrate, you may experience severe hypotension and reflex tachycardia or collapse and syncope, as well as hemoglobin alteration (methemoglobinemia).
If you apply too many patches at once, carefully remove the patches and wash the skin underneath thoroughly to reduce absorption. If you experience hypotension or collapse, it is recommended to elevate the patient's legs or, if necessary, apply a compressive bandage to the legs.

In case of overdose, inform your doctor immediately, contact the nearest emergency service or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount used. Show your doctor the medication or the empty package.

If you forget to change the patch

If you forget to change the patch at the right time, replace it as soon as possible and then follow the original schedule to apply the next patch.

If you interrupt treatment with Epinitril

When interrupting treatment with Epinitril, you may experience angina attacks again.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Epinitril may produce adverse effects, although not all people will experience them.

The following side effects have been reported:

Very frequent adverse effects (occurring in more than 1 in 10 patients):

-Nausea.

- Vomiting.

Frequent adverse effects (occurring in more than 1 and less than 10 in 100 patients):

- Headache.

Rare adverse effects (occurring in more than 1 and less than 10 in 1,000 patients):

- Contact dermatitis (inflammation in the skin contact area).

- Redness and irritation in the patch application area.

- Itching.

- Burning sensation.

Adverse effects occurring in rare cases (occurring in more than 1 and less than 10 in 10,000 patients):

-Tachycardia.

- Orthostatic hypotension (blood pressure drop when standing), which may be described as transient episodes of dizziness.

- Skin redness.

- Increased heart rate.

Very rare adverse effects (occurring in less than 1 in 10,000 patients):

- Dizziness.

- Syncope.

Adverse effects of unknown frequency:

-Cardiac disorders (palpitations).

- Generalized skin rash.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usewww.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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Keep this medication out of the sight and reach of children.

Do not store at a temperature above25°C. Epinitril should be stored in its intact packaging.

Do not use this medication after the expiration date that appears on the packaging and the overwrap after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Epinitril

The active ingredient of Epinitril patches is glyceryl trinitrate and are available in three concentrations: Epiniril 5mg/24h, 10 mg/24h and 15 mg/24h.

Epinitril 10 mg/24 h: contains 31.37 mg of the active ingredient glyceryl trinitrate and releases approximately 10 mg of glyceryl trinitrate per day (0.4 mg/h); the release area of the patch is 12.75 cm2. The identification code printed on the backing film is NR10.

The other components are an adhesive substance (acrylate-vinylacetate copolymer), a plasticizer (hydroabietic acid phthalate) and a cross-linking agent (polybutyl titanate), which have been extended together with the active ingredient on a backing film (laminated polypropylene film). The adhesive layer is covered with a protective coating of aluminum and silicone on both sides, which is removed before use.

Appearance of the product and contents of the packaging

Epinitril are transdermal patches with an adhesive backing. Each patch is individually sealed in a protective pouch.

Packaging sizes: 15 and 30 patches. Some packaging sizes may only be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer

ROTTAPHARM Ltd.

Damastown, Industrial Park, Mulhuddart

Dublin 15

Ireland.

Or

LTS Lohmann Therapie Systeme AG

Lohmannstraße 2

56626 Andernach

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:December 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/