Prospect: Patient Information

Nitroplast 5 mg Transdermal Patches

Nitroglycerin

Read the prospect carefully before starting to use this medication, 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 medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.- What is Nitroplast and what is it used for

2.- What you need to know before starting to use Nitroplast

3.- How to use Nitroplast

4.- Possible adverse effects

5.- Storage of Nitroplast

6.- Contents of the package and additional information

Nitroplast is a transdermal patch containing nitroglycerin, used to prevent chest pain, but not to treat acute attacks.

Nitroglycerin dilates blood vessels and improves heart function.

Applied to the skin, Nitroplast releases nitroglycerin at a uniform rate throughout the recommended application period.

Nitroplast is indicated for the preventive treatment of chest pain, as a single treatment or in combination with other anti-anginal treatments.

No use Nitroplast

? If you are allergic (hypersensitive) to nitroglycerin, to organic nitrates in general, or to any of the other components of Nitroplast (listed in section 6).

? If you have very low blood pressure (systolic blood pressure less than 90 mmHg).

? In case of acute circulatory failure associated with marked hypotension (shock, collapse).

? If you have diseases associated with an increase in intracranial pressure.

? If you have heart failure due to valvular obstruction (narrowing of the heart valves) or pericardial inflammation that compresses the heart.

? In cases of severe hypovolemia (decrease in total blood volume).

? In cases of cardiogenic shock (circulatory collapse of cardiac origin), unless a diastolic final pressure is maintained with appropriate measures.

? In cases of cardiac tamponade (acute compression of the heart).

? If you have hypertrophic obstructive cardiomyopathy (thickening of the heart that hinders circulation).

? If you are taking medications containing sildenafilo, tadalafilo, or vardenafilo (medications used to treat impotence or pulmonary arterial hypertension).

? Do not use Nitroplast simultaneously with medications containing riociguat (medication used for the treatment of pulmonary arterial hypertension and chronic pulmonary thromboembolic hypertension).

Warnings and precautions

? If you have a decrease in left ventricular filling pressure, for example, acute myocardial infarction, left ventricular failure. Avoid reducing systolic pressure below 90 mmHg.

? If you have orthostatic hypotension (decrease in blood pressure when standing up).

? If you have anemia, consult your doctor, as Nitroplast may not be an appropriate treatment for you.

? If you have or have had any lung or heart disease. Patients with angina pectoris, myocardial infarction, or cerebral ischemia may suffer from small respiratory tract alterations.

? In patients with angina pectoris caused by heart thickening (hypertrophic cardiomyopathy), treatment with Nitroplast may worsen it.

? There is a possibility of an increase in angina pectoris during the time without the patch. Your doctor may consider another anti-anginal treatment in addition to Nitroplast.

? There may be a decrease in efficacy due to continued treatment with other medications containing nitrates (tolerance).

? Metahemoglobinemia (a form of hemoglobin oxidation) may occur.

Nitroplast will only be used under strict clinical supervision and/or hemodynamic monitoring in patients with acute myocardial infarction or congestive heart failure.

The treatment with Nitroplast should not be interrupted abruptly. Your doctor will gradually reduce the dose and increase the administration intervals. If you start another treatment for angina pectoris, you may need to use both medications for a period of time.

Nitroplast does not contain aluminum or other metals, and therefore it is not necessary to remove the patch before a magnetic resonance imaging or procedures to restore normal heart rhythm (cardioversion), as there is no risk of skin burns with the patch adhered.

Children and adolescents

The safety and efficacy in children and adolescents (under 18 years) have not been established.

Use of Nitroplast with other medications

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription.

The use of nitrates at the same time as other vasodilators, such as medications for hypertension, PDE5 inhibitors, calcium channel blockers, ACE inhibitors, beta-blockers, diuretics, some antidepressants, and tranquilizers, may lower blood pressure excessively.

Patients treated with Nitroplast, never (not even after removing the patch), should take PDE5 inhibitors such as those containing sildenafilo, tadalafilo, or vardenafilo (medications used to treat impotence and pulmonary arterial hypertension), as they may cause cardiovascular complications that put the patient's life at risk. For more information, consult your doctor or pharmacist.

Nonsteroidal anti-inflammatory drugs (NSAIDs), except for aspirin, may reduce the action of Nitroplast.

The administration with aspirin may potentiate the action of Nitroplast.

The simultaneous use of Nitroplast with riociguat (medication used for the treatment of pulmonary arterial hypertension and chronic pulmonary thromboembolic hypertension) may cause hypotension.

The simultaneous use of Nitroplast with dihidroergotamina (medication used to treat migraine) may increase the amount of dihidroergotamina in the blood. This is important in patients with coronary artery disease, as dihidroergotamina counteracts the action of Nitroplast, causing coronary vasoconstriction.

The simultaneous administration of Nitroplast with amifostina (medication used to reduce the unwanted effects of some chemotherapy and radiation therapy) and aspirin may lower blood pressure too much.

The simultaneous administration with sapropterina, a cofactor of an enzyme called nitric oxide synthase, may increase the hypotensive effect of Nitroplast.

Due to the development of tolerance to nitroglycerin, the effect of sublingual nitroglycerin may decrease partially.

Use of Nitroplast with food, drinks, and alcohol

The concomitant use of Nitroplast and alcohol may increase the hypotensive effect of Nitroplast.

Pregnancy, lactation, and fertility

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

PregnancyIn case of pregnancy or suspected pregnancy, inform your doctor. Nitroplast should be used with caution during pregnancy, especially in the first three months.

Lactation

If you are breastfeeding, inform your doctor, as you should decide whether to interrupt breastfeeding or interrupt treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Fertility

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

Driving and operating machinery

Nitroplast may decrease reaction time or rarely cause orthostatic hypotension (decrease in blood pressure when standing up) and dizziness (as well as occasionally syncope after an overdose). Patients who experience any of these effects should avoid driving vehicles or operating machinery.

Follow exactly the administration instructions for Nitroplast indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will establish the appropriate doses, both at the beginning of treatment and for maintenance, and will determine the frequency and duration of treatment.

The patch will be applied daily to the skin for 12 to 16 hours, ensuring a period of 8 to 12 hours free of nitrates.

For the application of Nitroplast, any area of the skin that is not too thick and poorly irrigated can be suitable, as long as it is healthy, clean, relatively wrinkle-free, and hairless. The most recommended areas for application are the front and lateral chest. However, it can also be applied to the forearm, thigh, abdomen, and shoulder. Figure 1

To avoid any skin irritation, Nitroplast should be applied to different areas each day, making sure not to use the same area for at least 2-3 days. Nitroplast should not be applied to the distal part of the limbs, in skin folds, wide scars, or in burned or irritated areas.

Nitroplast does not adhere well to wet or dirty skin, so it is essential to clean and dry the skin before application. Do not use skin care products before placing the patch. Nitroplast retains its function with bathing, showering, or physical exercise.

Each patch is packaged in an individual bag and should not be removed from it until it is to be used. The sealed bag can be easily torn through a slit on the edge.Figure 2

Remove the patch from the bag and hold it with both hands with the protective layer facing upwards. Then, lower one half of the patch, which opens the S-shaped cut. One half of this layer can then be separated. The adhesive surface should not be touched.Figure 3

Subsequently, apply the patch to the chosen area and remove the other half of the protective layer.Figure 4

Press the patch with your hand to ensure that the entire adhesive surface adheres strongly to the skin.Figure 5.After application, wash your hands thoroughly.

Nitroplast patches should not be cut.

Use in the elderly: No dose adjustment is required in elderly patients.

If you use more Nitroplastthan you should

It is unlikely that symptoms of overdose will occur due to the type of formulation of the transdermal patch of Nitroplast. If they appear, they can be quickly eliminated by removing the patch.

The symptoms are a decrease in blood pressure (less than or equal to 90 mmHg), pallor, sweating, weak pulse, increased heart rate (tachycardia), postural dizziness, headache (cephalgia), collapse, syncope with postural dizziness, feeling of weakness (asthenia), nausea, vomiting, and diarrhea.

In patients treated with other organic nitrates, cases of methemoglobinemia have been described (since nitrite ions cause methemoglobinemia and cyanosis, with the consequent tachypnea, anxiety, loss of consciousness, and cardiac arrest). Although it is unlikely with the transdermal release method, in high doses it can cause an increase in intracranial pressure, leading to cerebral symptoms.

- General procedure:

Interrupt the administration of the medication, removing the patch.

- General procedure for nitrate-related hypotension events:

The patient should be placed in a horizontal position with the legs elevated, or if necessary, a compression bandage should be applied to the patient's legs.

Oxygen supply.

Plasma volume expanders (intravenous fluids).

Specific treatment for shock (admit the patient to an intensive care unit).

- Special procedures:

Increase blood pressure if it is very low.

Additional administration of a vasoconstrictor, e.g., norepinephrine hydrochloride.

Treatment of methemoglobinemia:

Reduction of choice treatment with vitamin C, methylene blue, or toluidine blue.

Administration of oxygen (if necessary).

Initiate artificial respiration.

Hemodialysis (if necessary).

The treatment of methemoglobinemia with methylene blue is contraindicated in patients with glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency. In cases where treatment is contraindicated or ineffective, it is recommended to perform a blood transfusion or a transfusion of a red blood cell concentrate.

Resuscitation measures:

In the event of respiratory and circulatory arrest, initiate resuscitation measures immediately.

In the event of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forget to useNitroplast

Do not use a double dose to compensate for the missed doses.Consult your doctor.

If you interrupt treatment withNitroplast

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

Like all medications,Nitroplastmay cause side effects, although not everyone will experience them.

The following side effects have been reported during treatment withNitroplast:

? Very common:may affectmore than 1 in 10 patients:headache.

? Common:may affect up to1 in 10 patients: dizziness (including postural dizziness), drowsiness, tachycardia, postural hypotension, feeling of weakness (asthenia).

? Uncommon:may affect up to1 in 100 patients: worsening of angina pectoris symptoms, circulatory collapse (sometimes accompanied by bradycardia and syncope), nausea, vomiting, pruritus, skin irritation (itching or burning sensation at the application site, redness, irritation), contact dermatitis (which resolves spontaneously within a few hours of removing the patch or with the use of topical corticosteroids), skin allergic reactions (e.g. rash).

? Rare:may affect up to 1 in 10,000 patients: heartburn.

? Frequency not known:cannot be estimated from available data: palpitations, flushing, hypotension, exfoliative dermatitis, generalized skin eruption, increased heart rate.

Like some medications used to treat heart disease, Nitroplast causescommon headaches that depend on the dose administered, due to dilation of cerebral blood vessels. These headaches disappear after a few days, even if treatment with Nitroplast continues. If headaches persist during intermittent treatment, they should be treated with mild analgesics. If headaches persist despite this, your doctor may need to reduce your dose or discontinue treatment with Nitroplast.

Any redness that appears on the skin usually resolves within a few hours after removing the patch.

You should change the application site regularly to prevent local irritation.

Your doctor may prescribe another treatment simultaneously to prevent a slight increase in your heart rate.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

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

Keep out of reach and sight of children.

Do not store at a temperature above 25 °C.

Do not use Nitroplast 5 mg after the expiration date shown on the packaging and the overwrap after “Exp”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and the

medicines you no longer need at the pharmacy's Take-Back Point. If in doubt, ask your pharmacist how to dispose of the containers and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nitroplast 5 mg transdermal patches

The active ingredient is nitroglycerin. A patch contains 18.7 mg of nitroglycerin in a 9 cm2patch, which releases 5 mg every 24 hours

The other components are acrylate/vinyl acetate copolymer.

Appearance of the product and content of the packaging

Nitroplast are white translucent, square, and rounded-edged transdermal patches. Packaging is available with 7 and 30 transdermal patches.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Responsible manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel Strasse 10

40789 Monheim - Germany

or

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Last review date of this leaflet: June 2017

The detailed and updated information on this medication is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/