Dermatrans 10 mg/24 h parche transdermico

PROSPECTO:INFORMATION FOR THE USER

Dermatrans 5 mg/24 h, transdermal patch

Dermatrans 10 mg/24 h, transdermal patch

Dermatrans 15 mg/24 h, transdermal patch

Glyceryl Trinitrate

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

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

Dermatrans is indicated for the prevention of angina attacks, either alone or in combination with other antianginal therapy.

Angina usually manifests as chest pain or tightness, although it may be felt in the neck or arm.The pain occurs when the heart is not sufficiently oxygenated.Dermatrans is not indicated for the treatment of acute attacks.For the treatment of acute attacks, you should use your usual sublingual tablet or spray.

The Dermatrans patches are exclusively for external use.

Do not useDermatrans:

-if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

-if you have or have had a shock associated with very low blood pressure;

-if you experience headaches (cephalalgias), vomiting, or convulsions associated with increased intracranial pressure, including those caused by a head trauma;

-if you suffer from heart failure due to an obstruction, such as, for example, in the presence of aortic orifice narrowing or atrioventricular orifice narrowing of the heart (aortic stenosis or mitral stenosis, respectively), or of a fibrotic thickening of the thin membrane, in the form of a sac, that surrounds 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 receiving 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 sudden and deep drop in blood pressure, which can lead to dizziness, loss of consciousness, or even a heart attack (see also "Use of other medications");
• if you are taking medications containing riociguat, a soluble guanylate cyclase stimulator.
• if you have a severe drop in blood pressure (systolic blood pressure of 90 mmHg);
• if you suffer from a severe decrease in blood volume in your body due to significant blood or fluid losses (severe hypovolemia);
• if you have severe anemia;
• if you have toxic fluid retention in the lungs (toxic pulmonary edema).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Dermatrans:

• if you discontinue treatment.Discontinuation of treatment with Dermatrans should be gradual, by substituting with decreasing doses of long-acting oral nitrates;
• if you are about to undergo magnetic resonance imaging, electrical stimulation of your heart to restore normal heart rhythm (defibrillation or cardioversion), and before a heat treatment (diathermy), you should remove the Dermatrans patch before undergoing these treatments.

-if you have or have had a heart attack (myocardial infarction) or if you develop rapidly symptoms of heart failure (acute heart failure) such as difficulty breathing, feeling very tired, swelling of the legs. Your doctor may ask you to perform laboratory tests to see your cardiovascular function.

• if you have a severe drop in blood pressure or if you experience a collapse or shock while under treatment with Dermatrans, the patch should be removed;
• if you experience chest pain (acute angina) or if your heart is not getting enough blood flow and oxygen (unstable angina) or if you have a heart attack (myocardial infarction).Dermatrans should not be used as immediate treatment for these conditions.
• if you experience a severe headache or abnormally low blood pressure (hypotension).This may occur if the initial dose is too high.It is recommended to gradually increase the dose until the optimal effect is achieved;
• 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 have or have had abnormally low blood pressure induced by glyceryl trinitrate.In this case, you may experience a low heart rate (bradycardia paradoxica) and increased angina;
• if you have a disease of the optic nerve (angle-closure glaucoma);
• if you have inadequate oxygenation of the blood (hypoxemia) due to severe anemia or lung disease or reduced blood flow to your heart (ischemic heart failure).

• Patients with these medical conditions often suffer from a ventilation/perfusion imbalance, which is an index of respiratory function. In these patients, glyceryl trinitrate could worsen the ventilation/perfusion imbalance and cause further decrease in blood oxygenation;

• if the angina is caused by thickening of your 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 wish to evaluate the possibility of additional anti-anginal therapy.
• if you experience skin sensitization (itching, burning, inflammation), treatment should be interrupted and your doctor consulted.

Use of other medications

The simultaneous 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 therefore be avoided (see also "Do not use Dermatrans”).

The simultaneous treatment with riociguat, a soluble guanylate cyclase stimulator, should be avoided, as its use with nitrates may cause hypotension (see also "Do not use Dermatrans”).

The simultaneous treatment with

• medications used to lower high blood pressure, such as, for example, calcium antagonists, ACE inhibitors (for the treatment of congestive heart failure), beta-blockers (used to manage cardiac arrhythmias), diuretics (to increase water elimination from the body), and other antihypertensives,
• tricyclic antidepressants (medications for the treatment of depressive disorders),
• neuroleptics (medications used to treat psychosis) and
• major tranquilizers (sedatives),
• as well as alcohol consumption and with the association of amifostine (a cytoprotective medication in chemotherapy and radiation therapy) and
• acetylsalicylic acid (a nonsteroidal anti-inflammatory drug),

may potentiate the blood pressure-lowering effects of Dermatrans.

The simultaneous treatment with dihydroergotamine may reduce the effect of Dermatrans.

Nonsteroidal anti-inflammatory drugs, except acetylsalicylic acid, may decrease the therapeutic response of Dermatrans.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Fertility, pregnancy, and breastfeeding

Dermatrans should not be used during pregnancy, especially in the first three months, unless your doctor advises you to do so.

Due to limited information on the presence of glyceryl trinitrate in breast milk, it should not be excluded that there is a risk to the baby. Your doctor will decide whether to interrupt breastfeeding or the use of Dermatrans.

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

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

Driving and operating machinery

Especially at the beginning of treatment or when adjusting the dose, Dermatrans may affect your ability to drive or operate machinery, as it may decrease your reaction time or rarely cause hypotension when standing up and dizziness, as well as in exceptional cases, fainting after an overdose.

If you experience these effects, you should not drive or operate machinery.

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

The recommended dose is one Dermatrans patch per day. You should apply the patch to your skin carefully and keep it for 12-16 hours, then remove the patch and leave a free patch period for the remaining 8-12 hours. You should change your Dermatrans patch according to the instructions given by your doctor. Your doctor will tell you how long to keep the patch on your skin and the duration of the patch-free interval.

Use in children and adolescents

Dermatrans should not be used in children and adolescents under 18 years old.

For how long should you use Dermatrans

The treatment with Dermatrans can be maintained for several years, however, your doctor should see you periodically to decide if you continue with the treatment or change the therapeutic schedule.

How to apply the patch

The patch should be applied on clean and dry skin, avoiding applying it over cuts, spots or imperfections or over an area where cream, moisturizer or talc has been applied recently.It is recommended to apply the transdermal patches of Dermatrans on the skin of the chest (see Figure 1) or the outer upper part of the arm, in areas without redness or irritation and change the application sites.The suitable area can be shaved if necessary.Avoid areas that form folds or are subject to friction during movement.

Figure 1

Do not apply two consecutive patches in the same place.

Once the Dermatrans patch is taken out of the package, it should be applied immediately to the skin, as explained below:

(I)Openthe package by the notch.

Do not use scissors (see Figure 2).

Figure 2

(II)Hold the patch with the thumb and the

index finger on the tab that will come off

(see Figure 3).

Figure 3

(III)Peel off the protective layer with the other

hand (see Figure 4).Do not touch the

adhesive side of the patch, because if you do,

it will not stick well.

Figure 4

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

and remove the remaining protective layer.Press firmly for 10 seconds on the entire surface of the patch.Pass your fingers over the edges of the patch to make sure it sticks firmly.

Wash your hands before and after applying Dermatrans.

To remove a patch, simply peel it off by the edge and pull the patch gently until it comes off.After use, fold the patch in half with the adhesive side inwards and throw it away in a trash can where children cannot get it.

What to do if the patch falls off

If Dermatrans 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 follow the usual periodic schedule with the next patch.

If you use more Dermatrans than you should

If you applyhigh doses of glyceryl trinitrate, you may experience a severe drop in blood pressure, increased heart rate or collapse and fainting, as well as alteration in hemoglobin (methemoglobinemia).

If you or someone else applies too many patches at the same time, carefully remove the patches and wash the underlying skin carefully to reduce absorption. In case you experience a drop in blood pressure or collapse, it is recommended that you elevate or, if necessary, apply compression bandages on your legs.

If you forget to change the patch

If you forget to change the patch at the right time, you should change it as soon as possible and then follow your original periodic schedule by applying the next patch.

If you interrupt treatment with Dermatrans

When you stop treatment with Dermatrans, you may experience a recurrence of angina attacks.

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

Like all medications, Dermatrans may have adverse effects, although not all people may experience them.

The following adverse effects have been reported:

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

• Nausea.
• Vomiting.

Frequent adverse effects (affecting between 1 and 10 in 100 patients)

-Headache.

Less frequent adverse effects (affecting between 1 and 10 in 1,000 patients)

• Contact dermatitis (skin inflammation due to contact).

• Redness and irritation of the skin at the patch application site.
• Itching.
• Burning sensation.

Rare adverse effects (affecting between 1 and 10 in 10,000 patients)

• Increased heart rate (tachycardia).
• Orthostatic hypotension (decreased blood pressure when standing) that may be described as transient episodes of dizziness.
• Redness.
• Increased heart rate as an analytical parameter.

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

• Dizziness.
• Fainting (syncope).

Adverse effects of unknown frequency:

• Abnormal heartbeats (palpitations).
• Generalized skin eruption (generalized eruption).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines for Human Use: https// www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Medicines should not be disposed of through drains or in the trash. Disposeof the packaging and medicines that you no longer need at the SIGRE collection pointatthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Dermatrans

Dermatrans patches contain the active ingredientglyceryl trinitrateand are available in three concentrations:

Dermatrans5 mg/24 h:contains 15.70 mg of the active ingredientglyceryl trinitrateand releases approximately 5 mg ofglyceryl trinitrateper day (0.2 mg/h); the release area of the patch is 6.38 cm2. The printed identification code on the backing is NR5.

Dermatrans10 mg/24 h:contains 31.37 mg of the active ingredientglyceryl trinitrateand releases approximately 10 mg ofglyceryl trinitrateper day (0.4 mg/h); the release area of the patch is 12.75 cm2. The printed identification code on the backing is NR10.

Dermatrans15 mg/24 h:contains 47.04 mg of the active ingredientglyceryl trinitrateand releases approximately 15 mg ofglyceryl trinitrateper day (0.6 mg/h); the release area of the patch is 19.12 cm2. The printed identification code on the backing is NR15.

The other ingredients are an adhesive substance (acrylate-vinylacetate copolymer), an adhesion promoter (hydroabietic acid phthalate), and a cross-linking agent (butyl titanate polymer), which have been extended along with the active ingredient in a backing (laminated polypropylene backing).The adhesive layer is covered by a two-sided aluminum and siliconized protective coating, which is removed before use.

Appearance of the product and contents of the package

Dermatrans are transdermal adhesive patches.Each patch is individually sealed in a protective pouch.

Package sizes:15 and 30 patches.Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CASEN RECORDATI S.L.

Autovía de Logroño, km. 13,300 UTEBO

50180 (ZARAGOZA)

Manufacturer:

ROTTAPHARM LTD.

Damaastown, Industrial Park

15 Mulhuddart, County Dublin, Ireland

or

LTS Lohmann Therapie Systeme AG

Lohmannstraße 2

56626 Andernach

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

CountryName

IrelandDermatrans

ItalyDermatrans

SpainDermatrans

Last review date of this leaflet: December 2022.

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/