Nitroplast 5 transdermal patches

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Nitroplast 5 mg transdermal patches

Nitroglycerin

Read this leaflet carefully before you start using this medicine, because 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2.- What you need to know before using Nitroplast

3.- How to use Nitroplast

4.- Possible side effects

5.- How to store Nitroplast

6.- Contents of the pack and other information

1. What Nitroplast is and what it is used for

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

Nitroglycerin dilates blood vessels and improves heart performance.

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

Nitroplast is indicated for the preventive treatment of angina pectoris, either as monotherapy or in combination with other antianginal treatments.

2. What you need to know before using Nitroplast

Do not 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 below 90 mmHg).

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

? If you have conditions associated with increased intracranial pressure.

? If you suffer from heart failure due to valvular obstruction (narrowing of heart valves) or pericarditis compressing the heart.

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

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

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

? If you suffer from obstructive hypertrophic cardiomyopathy (thickening of the heart muscle impairing circulation).

? If you are taking medicines containing sildenafil, tadalafil, or vardenafil (medicines used to treat erectile dysfunction or pulmonary arterial hypertension).

? Do not use Nitroplast simultaneously with medicines containing riociguat (a medicine used to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension).

Warnings and precautions

? If you have reduced cardiac filling pressure, for example, acute myocardial infarction, left ventricular failure. Systolic blood pressure reduction below 90 mmHg should be avoided.

? If you suffer from orthostatic hypotension (drop in blood pressure upon standing).

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

? If you have or have had any lung or heart disease. Patients with angina pectoris, myocardial infarction, or cerebral ischemia may experience disturbances in small airways.

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

? There is a possibility of increased frequency of angina during the patch-free interval. Your doctor may consider additional antianginal therapy alongside Nitroplast.

? Loss of effectiveness may occur with continuous treatment using other nitrate-containing medicines (tolerance).

? Methemoglobinemia may occur, a condition caused by increased levels of methemoglobin—an oxidized form of hemoglobin (blood pigment).

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

Treatment with Nitroplast must not be stopped abruptly. Your doctor will gradually reduce the dose and increase the dosing intervals. If starting another treatment for angina pectoris, you may need to use both medicines for a period of time.

Nitroplast contains no aluminum or other metals, and therefore there is no need to remove the patch before undergoing magnetic resonance imaging (MRI) or cardioversion procedures (methods to restore normal heart rhythm), as there is no risk of skin burns due to the patch.

Children and adolescents

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

Using Nitroplast with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Using nitrates together with other vasodilating agents—such as antihypertensive medicines, PDE5 inhibitors, calcium antagonists, ACE inhibitors, beta-blockers, diuretics, certain antidepressants, and major tranquilizers—may excessively lower blood pressure.

Patients being treated with Nitroplast must never (even after removing the patch) take phosphodiesterase-5 (PDE5) inhibitors such as those containing sildenafil, tadalafil, or vardenafil (medicines used to treat erectile dysfunction and pulmonary arterial hypertension), as this may lead to life-threatening cardiovascular complications. For further information, consult your doctor or pharmacist.

Non-steroidal anti-inflammatory drugs (NSAIDs), except acetylsalicylic acid (aspirin), may reduce the effect of Nitroplast.

Concomitant administration of acetylsalicylic acid (aspirin) may enhance the effect of Nitroplast.

Using Nitroplast together with riociguat (a medicine used to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension) may cause hypotension.

Using Nitroplast together with dihydroergotamine (a medicine used to treat migraine) may increase blood levels of dihydroergotamine. This is particularly important in patients with coronary artery disease, as dihydroergotamine counteracts the effect of Nitroplast, causing coronary vasoconstriction.

Concomitant administration of Nitroplast with amifostine (a drug used to reduce unwanted side effects of certain chemotherapies and radiotherapies) and acetylsalicylic acid may excessively lower blood pressure.

Simultaneous administration with sapropterin, 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 be partially reduced.

Using Nitroplast with food, drinks, and alcohol

Concomitant use of Nitroplast and alcohol may increase the hypotensive effect (lowering of blood pressure) of Nitroplast.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy
If you are pregnant or suspect you may be pregnant, inform your doctor. Nitroplast should be used with caution during pregnancy, especially during the first three months.

Breastfeeding

If you are breastfeeding, inform your doctor, as a decision must be made whether to discontinue breastfeeding or discontinue the treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Fertility

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

Driving and use of machines

Nitroplast may impair reaction ability or, rarely, cause orthostatic hypotension (drop in blood pressure upon standing) and dizziness (and exceptionally, syncope following overdose). Patients experiencing any of these effects should avoid driving vehicles or operating machinery.

3. How to use Nitroplast

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

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

The patch should be applied daily to the skin for 12 to 16 hours, ensuring a nitrate-free interval of 8 to 12 hours.

For application of Nitroplast, any skin area that is not too thick or poorly irrigated may be suitable, provided it is healthy, clean, relatively free of wrinkles, and without hair. The most recommended application sites are the front and side areas of the chest. However, it may also be applied to the forearm, thigh, abdomen, and shoulder**. Figure 1**

To avoid skin irritation, Nitroplast should be applied to different areas each day, avoiding the same site until at least 2–3 days have passed. Nitroplast should not be applied to the distal parts of the limbs, skin folds, large scars, or to burned or irritated skin areas.

Nitroplast does not adhere well to wet or dirty skin; therefore, it is important to clean and dry the skin thoroughly before application. Do not use skin care products prior to applying the patch. Nitroplast maintains its function during bathing, showering, or physical exercise.

Each patch is individually packaged in a sealed pouch and should not be removed until ready for use. The sealed pouch can be easily opened by tearing along the slit at the edge. Figure 2

Remove the patch from the pouch and hold it with both hands, the protective liner facing up. Then, lower one half of the patch to open the S-shaped cut. One half of the protective liner can then be peeled away. The adhesive surface must not be touched. Figure 3

Next, apply the patch to the chosen area and remove the remaining half of the protective liner. Figure 4

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

Nitroplast patches must not be cut.

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

If you use more Nitroplast than you should

Symptoms of overdose are unlikely due to the transdermal patch formulation of Nitroplast. If symptoms do occur, they can be rapidly resolved by removing the patch.

Symptoms may include decreased blood pressure (≤90 mm Hg), pallor, sweating, weak pulse, increased heart rate (tachycardia), postural dizziness, headache (cephalalgia), 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 reported (since nitrite ions can cause methemoglobinemia and cyanosis, leading to tachypnea, anxiety, loss of consciousness, and heart attack). Although unlikely with the transdermal delivery method, at high doses increased intracranial pressure may occur, leading to cerebral symptoms.

• General procedure:

Discontinue administration of the medication by removing the patch.

• General procedure for nitrate-related hypotension events:

Place the patient in a horizontal position with legs elevated, or if necessary, apply a compression bandage to the patient’s legs.

Administer oxygen.

Plasma volume expanders (intravenous fluids).

Treat shock appropriately (admit 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 therapy of choice with vitamin C, methylene blue, or toluidine blue.

Oxygen administration (if necessary).

Initiate artificial ventilation.

Hemodialysis (if necessary).

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

Resuscitation measures:

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to use Nitroplast

Do not use a double dose to make up for missed doses. Contact your doctor.

If you stop using Nitroplast

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

4. Possible adverse effects

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

The adverse effects observed during treatment with Nitroplast are listed below:

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

? Common: may affect up to 1 in 10 patients: dizziness (including postural dizziness), somnolence, tachycardia, postural hypotension, feeling of weakness (asthenia).

? Uncommon: may affect up to 1 in 100 patients: worsening of angina pectoris symptoms, circulatory collapse (sometimes accompanied by bradycardia and syncope), nausea, vomiting, pruritus, skin irritation (itching or burning at the application site, redness, irritation), contact dermatitis (which resolves spontaneously within a few hours after removing the patch or with the use of topical corticosteroids), skin allergic reactions (e.g. rash).

? Very rare: may affect up to 1 in 10,000 patients: stomach burning.

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

Like some other medicines used to treat heart conditions, Nitroplast frequently causes dose-dependent headaches due to dilation of blood vessels in the brain. These headaches usually 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 continue despite this, your doctor may need to reduce your dose or discontinue treatment with Nitroplast.

Any skin redness typically resolves within a few hours after removing the patch.

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

Your doctor may prescribe additional treatment to manage a slight increase in heart rate.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

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

5. Storage of Nitroplast

Keep out of the reach and sight of children.

Do not store above 25 °C.

Do not use Nitroplast 5 mg after the expiry date stated on the packaging and sachet, following “Exp”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Return any unused medicines and their packaging to the Sigre point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nitroplast 5 mg transdermal patches

The active substance is glyceryl trinitrate. One patch contains 18.7 mg of glyceryl trinitrate in a 9 cm² patch, which releases 5 mg per 24 hours.

The other components are acrylate/vinyl acetate copolymer, polypropylene backing layer, silicone-coated polyethylene terephthalate film, and ink.

Appearance of the product and contents of the pack

Nitroplast is a translucent white, square transdermal patch with rounded edges. Packs containing 7 and 30 transdermal patches are available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain

Manufacturer

Aesica Pharmaceuticals GmbH
Alfred-Nobel Strasse 10
40789 Monheim - Germany

or

LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain

Date of the most recent revision of this leaflet: June 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/