CORDIPLAST 10 mg/24 h TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the Patient

Cordiplast 10mg/24 h Transdermal Patches

Nitroglycerin

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Cordiplast is and what it is used for

Preventive treatment of angina pectoris, as monotherapy or in combination with other anti-anginal treatments.

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

Nitroglycerin dilates blood vessels and improves heart performance.

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

2. What you need to know before you use Cordiplast

Do not use Cordiplast:

• do not use Cordiplast simultaneously with medicines that contain riociguat (medicine used to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension).

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Cordiplast:

• in patients with angina pectoris produced by thickening of the heart (hypertrophic cardiomyopathy), treatment with Cordiplast may worsen it,
• there is a possibility of an increase in the frequency of angina pectoris during the patch-free interval. Your doctor may consider it necessary to use another anti-anginal treatment in addition to Cordiplast,
• there may be a loss of efficacy due to continuous treatment with other medicines that contain 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 surveillance and/or hemodynamic monitoring in patients with acute myocardial infarction or congestive heart failure.

Treatment with Cordiplast should not be stopped abruptly. Your doctor will gradually reduce the dose and increase the administration intervals. If you start another treatment for angina pectoris, during a period of time, you may need to use both medicines.

Cordiplast does not contain aluminum or other metals, and therefore, it is not necessary to remove the patch before a magnetic resonance imaging or maneuvers to restore the normal heart rhythm (cardioversion), because there is no risk of skin burns from having the patch attached.

Children and adolescents

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

Using Cordiplast with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Patients being treated with Cordiplast should never (not even if the patch has been removed) take phosphodiesterase 5 inhibitors (PDE5) such as those containing sildenafil, vardenafil, or tadalafil (medicines 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., sildenafil, vardenafil, tadalafil) should not be treated with nitroglycerin solutions for the next 24 hours (48 hours for tadalafil).

Non-steroidal anti-inflammatory medicines (NSAIDs), except for acetylsalicylic acid (aspirin), may reduce the effect of Cordiplast.

Administration with acetylsalicylic acid (aspirin) may enhance the effect of Cordiplast.

The use of Cordiplast at the same time as riociguat (medicine used to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension) may cause hypotension.

The use of Cordiplast at the same time as dihydroergotamine (medicine used to treat migraine) may increase the amount of dihydroergotamine in the blood. This is important in patients with coronary artery disease, as dihydroergotamine counteracts the effect of Cordiplast, causing coronary vasoconstriction.

The simultaneous administration of Cordiplast with amifostine (a drug used to reduce unwanted side effects of some chemotherapies and radiotherapies) and acetylsalicylic acid may lower blood pressure too much.

The simultaneous administration with sapropterin, 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.

Using Cordiplast with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

In case of pregnancy or suspected pregnancy, the doctor should be informed. Cordiplast should be used with caution during pregnancy, especially in the first three months.

Breastfeeding

If you are breastfeeding, you should inform your doctor, as it will be necessary to 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

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

Driving and using machines

Cordiplast may reduce reaction capacity or, rarely, may cause orthostatic hypotension (drop in blood pressure when standing up) and dizziness (as well as, exceptionally, syncope after overdose). Patients who suffer from any of these effects should avoid driving vehicles or using machines.

3. How to use Cordiplast

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

The doctor will establish the appropriate doses, both at the start of treatment and for maintenance, and determine the frequency and duration of the same. Normally, treatment is started 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 nitrate-free period of 8 to 12 hours, respectively.

The 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 absence of data.

If you use more Cordiplast than you should

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

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

After accidental overdoses, cases of methemoglobinemia (accumulation in the blood of methemoglobin, 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 unlikely with the transdermal release method, high doses may cause an increase in intracranial pressure, leading to cerebral symptoms.

General procedure:

Interrupt the administration of the medicine by removing the patch.

General procedure in cases of nitrate-related hypotension.

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 (admission to an intensive care unit).

Special procedures:

Increasing blood pressure if it is too low.

Administration of a vasoconstrictor, e.g., norepinephrine hydrochloride.

Treatment of methemoglobinemia:

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

Administration of oxygen (if necessary).

Initiation of artificial respiration.

Hemodialysis (if necessary).

Treatment of methemoglobinemia with methylene blue is contraindicated in patients with glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency. For cases where treatment is contraindicated or not effective, blood transfusion or transfusion of red blood cell concentrate is recommended.

Resuscitation measures:

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

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

If you forget to use Cordiplast

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

If you stop treatment with Cordiplast

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

4. Possible side effects

Like all medicines, Cordiplast can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following side effects:

• allergic reactions with swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, urticaria, and itching.
• fainting, loss of consciousness.

The following side effects have been reported during treatment with Cordiplast:

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

Common (may affect up to 1 in 10 patients): dizziness (including dizziness when standing up), feeling of dizziness, tachycardia, low blood pressure when standing up (orthostatic hypotension), feeling of weakness (asthenia).

Uncommon (may affect up to 1 in 100 patients): worsening of angina pectoris (oppressive pain in the chest, neck, or arm), circulatory collapse (sometimes accompanied by slow and abnormal heart rate and fainting), malaise, vomiting, itching, skin irritation (itching or burning in the patch application area, redness, irritation), contact dermatitis (which disappears spontaneously a few hours after removing the patch or with the use of topical corticosteroids).

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

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

As with some medicines used to treat heart diseases, Cordiplast causes frequent headaches that depend on the administered dose, due to the dilation of cerebral blood vessels. These headaches disappear after a few days, even if treatment with Cordiplast continues. 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 reduce the dose or remove the Cordiplast patch.

Any mild redness of the skin will normally disappear within a few hours after removing the patch.

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

Your doctor may indicate another treatment simultaneously to avoid a small increase in your heart rate.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cordiplast

Store below 25°C.

Store in the original packaging.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofCordiplast10mg/24 h transdermal patches

• The active ingredient is nitroglycerin. One patch contains 37.4 mg of nitroglycerin, in an 18 cm2 patch that releases 10 mg every 24 hours.
• The other components are: acrylate/vinyl acetate copolymer.

Appearance of the Product and Package Contents

Packages containing 30 transdermal adhesive patches, individually packaged in heat-sealed pouches.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Merus Labs Luxco II S.à.r.l.

208, Val des Bons Malades

L-2121 Luxembourg

Luxembourg

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Str. 10

40789-Monheim (Germany)

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

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

Date of the Last Revision of this Leaflet:May 2019

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