Patient Information Leaflet

Cordiplast 10mg/24 h Transdermal Patches

Nitroglycerin

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Cordiplast and what it is used for

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

3. How to use Cordiplast

4. Possible side effects

5. Storage of Cordiplast

6. Contents of the pack and additional information

Preventive treatment of angina pectoris, as a single treatment or in combination with other antianginal treatments.

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

Nitroglycerin in Cordiplast dilates blood vessels and improves heart performance.

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

No use Cordiplast:

• If you are allergic to nitroglycerin, nitrates, or any of the other components of this medication, as listed in section 6,
• If you have conditions associated with increased intracranial pressure,
• If you have heart failure due to valvular obstruction (narrowing of the heart valves) or pericardial inflammation that compresses the heart,
• If you have hypertrophic obstructive cardiomyopathy (thickening of the heart that hinders circulation),
• In cases of severe hypotension (systolic blood pressure below 90 mm Hg),
• In cases of acute circulatory failure associated with marked hypotension (shock, collapse),
• In cases of severe hypovolemia (decrease in total blood volume),
• In cases of severe anemia,
• In cases of cardiogenic shock (circulatory collapse of cardiac origin), unless a diastolic blood pressure is maintained with appropriate measures,
• In cases of cardiac tamponade (acute compression of the heart),
• If you are taking medications containing sildenafilo, tadalafilo, or vardenafilo (medications used to treat impotence or pulmonary arterial hypertension).
• Do not use Cordiplast simultaneously with medications containing riociguat (medication used for the treatment of pulmonary arterial hypertension and chronic pulmonary thromboembolic hypertension).

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Cordiplast:

• If you have a decrease in left ventricular filling pressure, e.g., acute myocardial infarction or left ventricular failure. Avoid reducing systolic blood pressure below 90 mm Hg,
• If you have orthostatic hypotension (blood pressure drop when standing up),
• If you have anemia, consult your doctor, Cordiplast 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 experience small airway alterations,
• In patients with angina pectoris caused by heart thickening (hypertrophic cardiomyopathy), treatment with Cordiplast may worsen the condition,
• There is a possibility of an increase in angina pectoris during the time without a patch. Your doctor may consider another anti-anginal treatment in addition to Cordiplast,
• There may be a decrease in efficacy due to continued treatment with other medications containing nitrates.
• There may be an increase in methemoglobin, an oxidized form of hemoglobin (blood pigment) that causes methemoglobinemia.

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

Do not stop Cordiplast treatment 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.

Cordiplast does not contain aluminum or other metals and, therefore, does not need to be removed before an MRI or procedures to restore normal heart rhythm (cardioversion), as there is no risk of skin burns from having the patch adhered.

Children and adolescents:

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

Use of Cordiplast with other medications:

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

The use of nitrates at the same time as other vasodilators, such as medications for hypertension, phosphodiesterase 5 inhibitors, calcium channel blockers, ACE inhibitors, monoamine oxidase inhibitors, beta-blockers, diuretics, some antidepressants, and major tranquilizers, may lower blood pressure excessively.

Patients treated with Cordiplast (even if the patch has been removed) should not take phosphodiesterase 5 inhibitors (PDE5) simultaneously, such as those containing sildenafilo, vardenafilo, or tadalafilo (medications used to treat impotence and pulmonary arterial hypertension), as this may cause life-threatening cardiovascular complications. For more information, consult your doctor or pharmacist.

Patients who have recently taken phosphodiesterase inhibitors (e.g., sildenafilo, vardenafilo, tadalafilo) should not be treated with sublingual nitroglycerin in the following 24 hours (48 hours for tadalafilo).

Non-steroidal anti-inflammatory drugs (NSAIDs), except for aspirin, may reduce the action of Cordiplast.

The administration of aspirin may potentiate the action of Cordiplast.

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

The simultaneous use of Cordiplast 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 Cordiplast, causing coronary vasoconstriction.

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

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

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

Use of Cordiplast with food, beverages, and alcohol:

Alcohol should be avoided during treatment with Cordiplast, as it may increase the hypotensive and vasodilatory effects of Cordiplast.

Pregnancy, lactation, and fertility:

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

Pregnancy

In case of pregnancy or suspected pregnancy, inform your doctor. Cordiplast 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 stop breastfeeding or stop 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:

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

Follow exactly the administration instructions for Cordiplast indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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.Normally, treatment begins with one patch per day. If necessary, it can be increased to 2 patches applied simultaneously, but only on medical recommendation.The maximum recommended daily dose is 20 mg.

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

Cordiplast patches should not be cut.

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

Use in children: Cordiplast is not recommended for use in children due to the lack of data.

If you use more Cordiplast than you should

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

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

After accidental overdoses, cases of methemoglobinemia (accumulation of methemoglobin in the blood, a form of hemoglobin that cannot transport oxygen) have been described, which can cause cyanosis (purple discoloration of the skin and mucous membranes), rapid breathing, anxiety, loss of consciousness, and infarction, which may require immediate resuscitation. Although with the transdermal release method it is unlikely, in high doses it can cause increased intracranial pressure, leading to cerebral symptoms.

General procedure:

Interrupt medication administration, removing the patch.

General procedure for hypotension-related events with nitrates.

The patient should be placed in a horizontal position with elevated legs or, if necessary, a compression bandage 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:

Increasing 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 deficiency or methemoglobinemia-reductase deficiency. For 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 case of respiratory and circulatory arrest, initiate resuscitation measures immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Cordiplast

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

If you interrupt treatment with Cordiplast

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

Like all medicines, Cordiplast can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you experience any of the following side effects:

- Allergic reactions with swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, hives, and itching.

- Fainting, loss of consciousness.

The following side effects are detailed below, which occurred during treatment with Cordiplast:

Very common (may affect more than one in 10 patients): headache.

Common (may affect up to one in 10 patients): dizziness (including dizziness when standing up), feeling of dizziness, palpitations, low blood pressure when standing up (postural hypotension), feeling of weakness (asthenia).

Uncommon (may affect up to one in 100 patients): worsening of angina pectoris (oppressive pain in the chest, neck, or arm), circulatory collapse (sometimes accompanied by abnormal and slow heart rate and fainting), discomfort, vomiting, itching, skin irritation (itching or burning sensation in the area where the patch is applied, redness, irritation), contact dermatitis (which disappears spontaneously a few hours after removing the patch or with the use of topical corticosteroids).

Very rare (may affect up to one in 10,000 patients): heartburn.

Unknown frequency (cannot be estimated from available data): palpitations, flushing, hypotension, exfoliative dermatitis (a serious disease with generalized redness of the skin, accompanied by skin peeling, and may include itching and hair loss), generalized skin eruption, increased heart rate.

Like some medicines used to treat heart disease, Cordiplast causes frequent headaches that depend on the administered dose, due to the dilation of blood vessels in the brain.These headaches disappear after a few days, even if you continue treatment with Cordiplast. If the headache persists during intermittent treatment, it should be treated with mild analgesics. If, despite this, the headaches persist, your doctor may need to lower your dose or remove the Cordiplast patch.

Any mild skin redness usually disappears within a few hours after removing the patch.

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

Your doctor may indicate another simultaneous treatment to prevent a small increase in your heart rate.

Severe decreases in blood pressure have been reported with medications of the same class as Cordiplast and may include nausea, vomiting, restlessness, pallor, and excessive sweating.

During treatment with these patches, you may also experience an increase in chest pain due to a lack of oxygen in the heart muscle and surrounding areas.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 25°C.

Store in the original packaging.

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

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

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

Composition ofCordiplast10mg/24 h transdermal patches

• The active ingredient is nitroglycerin. A patch contains 37.4mg of nitroglycerin, in a patch of 18cm2that releases 10mg every 24h.
• The other components are: acrylate/vinyl acetate copolymer.

Appearance of the product and contents of the packaging

Packaging with 30 transdermal adhesive patches, individually packaged in thermosealed sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Merus Labs Luxco II S.à.r.l.

208, Val des Bons Malades

L-2121 Luxembourg

Luxembourg

Responsible for manufacturing

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Str. 10

40789-Monheim (Germany)

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

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

Last review date of this leaflet:May 2019

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