Epinitril 5 mg/24 h transdermal patches

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Epinitril 5 mg/24 h transdermal patch

Glyceryl trinitrate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What EPINITRIL is and what it is used for

Epinitril patches contain the active substance glyceryl trinitrate, a vasodilator used in heart diseases, and belong to a group of medicines known as organic nitrates.

Epinitril patches are applied to the skin, and the active substance then passes continuously through the skin into the body.

Epinitril is indicated for the preventive treatment of angina pectoris, taken alone or in combination with other antianginal therapy.

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

The pain occurs when the heart is not receiving sufficient oxygen. Epinitril is not indicated for the treatment of acute attacks. Use your sublingual tablet or spray 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 glyceryl trinitrate, related organic nitrates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have recently had 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 have obstructive heart failure, for example, in the presence of narrowing of the aortic orifice or the auriculoventricular orifice of the heart (aortic stenosis or mitral stenosis, respectively), or fibrotic thickening of the thin membrane lining the heart (constrictive pericarditis);
• if you are taking medications for erectile dysfunction (e.g., sildenafil or any other PDE-5 inhibitor). Nitrates must not be administered to patients being treated with sildenafil or any other medication used to treat erectile dysfunction. Patients currently receiving nitrates must not take sildenafil or any other medication for the treatment of erectile dysfunction. The combination of a nitrate with sildenafil or any other PDE-5 inhibitor may cause a profound and sudden drop in blood pressure, which may lead to fainting, loss of consciousness, or even a heart attack (see also “Use with other medicines”);
• if you are taking medications containing riociguat, a soluble guanylate cyclase stimulator;
• if you have severe low blood pressure (blood pressure less than 90 mmHg);
• if you have severe reduction in blood volume due to blood or fluid loss (severe hypovolemia);
• if you have severe anemia;
• if you have toxic fluid accumulation in the lungs (toxic pulmonary edema).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Epinitril:

• if you are discontinuing treatment. Withdrawal from Epinitril therapy should be gradual, with replacement by decreasing doses of long-acting oral nitrates;
• if you are scheduled for magnetic resonance imaging, electrical stimulation of the heart to restore normal heart rhythm (defibrillation or cardioversion), or prior to heat treatment (diathermy). Remove Epinitril patches before undergoing these procedures;
• if you have or have recently had a heart attack (myocardial infarction) or if symptoms of acute heart failure develop rapidly, such as difficulty breathing, extreme fatigue, or leg swelling. Your doctor may request laboratory tests to assess your cardiovascular function;
• if you experience severe hypotension during treatment with Epinitril, removal of the patch should be considered. In case of collapse or shock, the patch must be removed;
• if you experience chest pain (acute angina attack) or if your heart is not pumping enough blood and oxygen (unstable angina), or in case of heart attack (myocardial infarction), Epinitril must not be used as immediate treatment;
• if you experience severe headache or abnormally low blood pressure (hypotension). This may occur if the initial dose is too high. It is advisable to increase the dose gradually until the optimal effect is achieved;
• if you are taking other nitrates or sublingual glyceryl trinitrate, because your body may develop resistance to the effects of these substances after repeated exposure (cross-tolerance);
• if you have or have previously experienced abnormally low blood pressure caused by glyceryl trinitrate. In such cases, you may develop a slow heart rate (paradoxical bradycardia) and worsening of angina;
• if you have optic nerve disease (angle-closure glaucoma);
• if you have inadequate blood oxygenation (hypoxemia) due to severe anemia, lung disease, or reduced blood flow to the heart (ischemic heart failure); patients with these medical conditions may experience an imbalance in the ventilation/perfusion ratio, which is an index of respiratory function. In such patients, glyceryl trinitrate may worsen this imbalance and cause decreased blood oxygenation;
• if your angina is caused by thickening of the heart muscle (hypertrophic cardiomyopathy). Nitrates may worsen this type of angina;
• if you experience increased frequency of angina attacks during patch-free intervals. Your doctor may wish to re-evaluate your coronary disease and consider adjusting your treatment;
• treatment must be discontinued and you should consult your doctor if you experience skin sensitization reactions (itching, burning, inflammation).

Use of Epinitril with other medicines

Concomitant administration of medications for erectile dysfunction (e.g., sildenafil or any other PDE-5 inhibitor) enhances the blood pressure-lowering effects of nitrates and must therefore be avoided (see also “Do not use Epinitril”).

Concurrent treatment with riociguat, a soluble guanylate cyclase stimulator, should be avoided, as simultaneous use may cause hypotension (see also “Do not use Epinitril”).

Concomitant treatment with:

• medications used to lower blood pressure, such as calcium antagonists, ACE inhibitors (used for congestive heart failure), beta-blockers (used to prevent cardiac arrhythmias), diuretics (which increase water excretion from the body), and other antihypertensives;
• neuroleptics (medications used to treat psychosis);
• tricyclic antidepressants (medications used to treat depression);
• major tranquilizers (sedatives), as well as alcohol consumption, and in combination with amifostine (a cytoprotective agent used in chemotherapy and radiotherapy);
• acetylsalicylic acid (an NSAID),

may enhance the blood pressure-lowering effects of Epinitril.

Concurrent use of dihydroergotamine may reduce the effect of Epinitril.

Non-steroidal anti-inflammatory drugs (NSAIDs), except acetylsalicylic acid, may reduce the therapeutic response to Epinitril.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

Epinitril must not be used during pregnancy, especially during the first three months, unless specifically prescribed by your doctor.

Since there is almost no information on whether glyceryl trinitrate is excreted in breast milk, a risk during breastfeeding cannot be excluded. Your doctor will decide whether you should discontinue breastfeeding or Epinitril treatment.

There are no data on the effect of Epinitril on fertility in humans.

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

Driving and using machines

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

If you experience these effects, you must refrain from driving or using machines.

3. How to use Epinitril

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Epinitril patch once daily. Apply the patch carefully to the skin and wear it for 12–16 hours. Then remove the patch and have a patch-free period of 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 wear the patch and the duration of the patch-free interval.

Use in children and adolescents

Epinitril must not be used in children or adolescents under 18 years of age.

How long you should use Epinitril

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, dry skin, but not over cuts, rashes, or skin defects, or on areas where cream, moisturizer, or talcum powder has recently been applied. It is recommended to apply Epinitril transdermal patches to the skin on the chest (see Figure 1) or the outer upper arm, free from redness or irritation, and to rotate application sites. If necessary, you may 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 site.

Apply one Epinitril patch to the skin immediately after removing it from the pouch, as follows:

(I) Tear the pouch 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 tab to be removed

(see Figure 3).

Figure 3

(III) Remove the protective liner with the other

hand (see Figure 4). Do not touch the sticky

side of the patch; otherwise, it may not adhere properly.

Figure 4

(IV) Apply the open side of the patch to the skin

and remove the remaining part of the protective liner.

Press firmly for about 10 seconds over the entire

surface of the patch. Run your fingers along the

edges to ensure they adhere properly.

Wash your hands before and after applying Epinitril.

To remove a patch, lift the edge and gently pull the patch off. After use, fold the patch in half with the sticky side inward and dispose of it in the trash, out of the reach of children.

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 does fall off, replace it with a new one and then resume changing the patch according to your original schedule.

If you use more Epinitril than you should

If high doses of glyceryl trinitrate are administered, you may experience severe hypotension and reflex tachycardia, or collapse and syncope, as well as alterations in hemoglobin (methemoglobinemia). If too many patches are applied at once, remove the patches carefully and thoroughly wash the skin underneath to reduce absorption. If you experience hypotension or collapse, it is advisable 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 right away, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used. Show the medication or the empty packaging to your doctor.

If you forgot to change the patch

If you forget to change the patch at the correct time, replace it as soon as possible and then continue following the original schedule for applying the next patch.

If you stop using Epinitril

When stopping treatment with Epinitril, you may experience a recurrence of angina attacks.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Epinitril may cause adverse effects, although not everyone experiences them.

The following side effects have been reported:

Very common adverse effects (occur in more than 1 in 10 patients):

• Nausea
• Vomiting

Common adverse effects (occur in more than 1 and less than 10 in 100 patients):

• Headache

Uncommon adverse effects (occur in more than 1 and less than 10 in 1,000 patients):

• Inflammation at the skin contact site (contact dermatitis)
• Redness and irritation at the patch application site
• Itching
• Burning sensation

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

• Tachycardia
• Orthostatic hypotension (drop in blood pressure upon standing), which may be experienced as transient episodes of dizziness
• Skin redness
• Increased heart rate

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

• Dizziness
• Syncope

Adverse effects of unknown frequency:

• Cardiac disorders (palpitations)
• Generalized skin rash (generalized rash)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of EPINITRIL

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

Do not store above 25°C. Epinitril should be kept in its original intact foil pouch.

Do not use this medicine after the expiry date stated on the packaging and pouch after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Epinitril

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

Epinitril 5 mg/24 h: contains 15.70 mg of the active substance glyceryl trinitrate and releases approximately 5 mg of glyceryl trinitrate per day (0.2 mg/h); the release area of the patch is 6.38 cm². The identification code printed on the backing film is NR5.

The other components are an adhesive (acrylate-vinyl acetate copolymer), a tackifier (hydroabietic acid phthalate), and a cross-linking agent (polybutyl titanate), which have been spread together with the active substance onto a backing film (lacquered polypropylene film). The adhesive layer is covered on both sides by a protective liner made of aluminum and silicone, which is removed before use.

Appearance of the Product and Contents of the Package

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

Package sizes: 15 and 30 patches. Only certain package sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

ROTTAPHARM Ltd.
Damastown Industrial Park, Mulhuddart
Dublin 15
Ireland

Or

LTS Lohmann Therapie Systeme AG
Lohmannstraße 2
56626 Andernach
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/