Cordiplast 5 mg/24 h transdermal patches
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Cordiplast 5 mg/24 h transdermal patches
Nitroglycerin
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Cordiplast is and what it is used for
- What you need to know before using Cordiplast
- How to use Cordiplast
- Possible adverse effects
- How to store Cordiplast
- Contents of the pack and other information
1. What Cordiplast is and what it is used for
Preventive treatment of angina pectoris, either as monotherapy 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 dilates blood vessels and improves heart performance.
When applied to the skin, Cordiplast releases nitroglycerin at a uniform rate throughout the recommended application period.
2. What you need to know before using Cordiplast
Do not use Cordiplast:
- if you are allergic to nitroglycerin, nitrates, or any of the other ingredients of this medicine, listed in section 6,
- if you have diseases associated with increased intracranial pressure,
- if you have heart failure due to valvular obstruction (narrowing of the heart valves) or pericarditis compressing the heart,
- if you have obstructive hypertrophic cardiomyopathy (thickening of the heart muscle that hinders blood flow),
- 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 (decreased total blood volume),
- in cases of severe anemia,
- in cases of cardiogenic shock (circulatory collapse of cardiac origin), unless adequate measures maintain diastolic filling pressure,
- in cases of cardiac tamponade (acute compression of the heart),
- if you are taking medicines containing sildenafil, tadalafil, or vardenafil (medicines used to treat impotence or pulmonary arterial hypertension).
- do not use Cordiplast simultaneously with medicines containing riociguat (a 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.
- if you have reduced cardiac filling pressure, e.g., acute myocardial infarction or left ventricular failure. Systolic blood pressure should be maintained above 90 mm Hg,
- if you suffer from orthostatic hypotension (drop in blood pressure upon standing),
- if you have anemia, consult your doctor, as Cordiplast 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 the small airways,
- in patients with angina pectoris caused by thickening of the heart muscle (hypertrophic cardiomyopathy), treatment with Cordiplast 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 Cordiplast,
- loss of efficacy may occur with continuous treatment with other nitrate-containing medicines,
- an increase in methemoglobin may occur, an oxidized form of hemoglobin (blood pigment), leading to methemoglobinemia.
Cordiplast should only be used under strict clinical supervision and/or hemodynamic monitoring in patients with acute myocardial infarction or congestive heart failure.
Treatment with Cordiplast must not be stopped abruptly. Your doctor will gradually reduce the dose and increase the dosing intervals. If starting another treatment for angina, you may need to use both medicines for a period of time.
Cordiplast does not contain aluminum or other metals and therefore does not need to be removed before magnetic resonance imaging or procedures to restore normal heart rhythm (cardioversion), as there is no risk of skin burns due to the patch being attached.
Children and adolescents
The safety and efficacy in children and adolescents (under 18 years of age) have not been established.
Using Cordiplast with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
The use of nitrates together with other vasodilating agents, such as medicines for treating hypertension, phosphodiesterase-5 (PDE5) inhibitors, calcium antagonists, ACE inhibitors, monoamine oxidase inhibitors, beta-blockers, diuretics, certain antidepressants, and major tranquilizers, may excessively lower blood pressure.
Patients receiving Cordiplast must never (even after removing the patch) take PDE5 inhibitors such as those containing sildenafil, vardenafil, or tadalafil (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.
Patients who have recently taken phosphodiesterase inhibitors (e.g., sildenafil, vardenafil, tadalafil) must not be treated with nitroglycerin solutions within the following 24 hours (48 hours for tadalafil).
Non-steroidal anti-inflammatory drugs (NSAIDs), except acetylsalicylic acid (aspirin), may reduce the effect of Cordiplast.
Administration with acetylsalicylic acid (aspirin) may enhance the effect of Cordiplast.
Concomitant use of Cordiplast with riociguat (a medicine used to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension) may cause hypotension.
Concomitant use of Cordiplast 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 Cordiplast, causing coronary vasoconstriction.
Simultaneous administration of Cordiplast with amifostine (a drug used to reduce unwanted side effects of certain chemotherapy and radiotherapy) 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 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 (blood pressure-lowering) and vasodilatory effects of Cordiplast.
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 pregnancy, inform your doctor. Cordiplast 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 therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Fertility
There are no available data on the effect of nitroglycerin on fertility in humans.
Driving and using machines
Cordiplast may reduce reaction ability or, rarely, may cause orthostatic hypotension (drop in blood pressure upon standing), dizziness (and, exceptionally, syncope after overdose). Patients experiencing any of these effects should avoid driving vehicles or operating machinery.
3. How to use Cordiplast
Follow exactly the administration instructions for Cordiplast as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the appropriate doses, both at the beginning of treatment and for maintenance, and will establish the frequency and duration of treatment. Normally, treatment starts with one patch per day. If necessary, this may be increased to two patches applied simultaneously, but only upon medical recommendation. The maximum recommended daily dose is 20 mg.
The patch should be applied to the skin daily for a period of 12 to 16 hours, thus ensuring a nitrate-free interval of 8 to 12 hours, respectively.
| For the application of Cordiplast, any area of skin that is not excessively thick and poorly irrigated may be suitable, provided it is intact, clean, relatively free of wrinkles, and hairless. The most recommended areas for patch application are the front and side of the chest. However, it may also be applied to the forearm, thigh, abdomen, and shoulder (Figure 1). To avoid any skin irritation, Cordiplast should be applied to different areas each day, ensuring that the same site is not reused for at least 2–3 days. Cordiplast should not be applied to the distal parts of the limbs, skin folds, large scars, or burned or irritated areas. Cordiplast does not adhere well to wet or dirty skin, so it is important to clean and dry the skin thoroughly before application. Do not use skin care products before placing the patch. Cordiplast maintains its function during bathing, showering, or physical exercise. Each patch is individually packaged and should not be removed from its pouch 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, peel back one half of the patch, opening the S-shaped cut (Figure 3). Next, apply the patch to the prepared area and remove the other half of the protective liner (Figure 4). Press the patch firmly with the hand to ensure that the entire adhesive surface adheres securely to the skin (Figure 5). After application, wash your hands thoroughly. |
Cordiplast patches must not be cut.
Use in elderly patients: dose adjustment is not required in elderly patients.
Use in children: Cordiplast is not recommended for use in children due to lack of data.
If you use more Cordiplast than you should
Symptoms of overdose are unlikely due to the type of formulation of the Cordiplast transdermal patch. If symptoms do occur, they can be rapidly eliminated by removing the patch.
Symptoms may include decreased blood pressure (less than or equal to 90 mm Hg), pallor, sweating, weak pulse, increased heart rate (tachycardia), dizziness upon standing, headache (cephalalgia), collapse, syncope with postural dizziness, weakness (asthenia), nausea, vomiting, and diarrhea.
Cases of methemoglobinemia (accumulation in the blood of methemoglobin, a form of hemoglobin that cannot carry oxygen) have been reported following accidental overdoses, which may cause cyanosis (purple discoloration of the skin and mucous membranes), rapid breathing, anxiety, loss of consciousness, and infarction, possibly requiring immediate resuscitation. Although unlikely with the transdermal delivery method, high doses may lead to increased intracranial pressure, resulting in cerebral symptoms.
General procedure:
Discontinue administration of the medicinal product by removing the patch.
General management of nitrate-related hypotension:
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).
Treatment for shock (admission 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 respiration.
Hemodialysis (if necessary).
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 red blood cell concentrate is recommended.
Resuscitation measures:
In case of respiratory and circulatory arrest, initiate resuscitation measures immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicinal product and the amount ingested.
If you forget to use Cordiplast
Do not use a double dose to make up for a missed dose. Contact your doctor.
If you stop using Cordiplast
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cordiplast can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately if you experience any of the following adverse effects:
- allergic reactions with swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, urticaria and itching.
- fainting, loss of consciousness.
The adverse effects observed during treatment with Cordiplast are listed below:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): dizziness (including dizziness upon standing), feeling of dizziness, tachycardia, low blood pressure upon standing (postural hypotension), feeling of weakness (asthenia).
Uncommon (may affect up to 1 in 100 people): worsening of angina pectoris (crushing pain in the chest, neck or arm), circulatory collapse (sometimes accompanied by abnormally slow heart rate and fainting), malaise, vomiting, itching, allergic skin rashes, which may be severe, skin irritation (itching or burning at the site of patch application, redness, irritation), contact dermatitis (which resolves spontaneously within a few hours after removing the patch or with the use of topical corticosteroids).
Very rare (may affect up to 1 in 10,000 people): stomach burning.
Frequency not known (cannot be estimated from available data): palpitations, flushing, hypotension, exfoliative dermatitis (a serious condition with generalized redness of the skin, accompanied by skin peeling, and may include itching and hair loss), generalized skin rash, increased heart rate.
Like some other medicines used to treat heart conditions, Cordiplast commonly causes headaches that are dose-dependent, due to dilation of blood vessels in the brain. These headaches disappear after a few days, even while continuing treatment with Cordiplast. 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 the Cordiplast patch.
Any mild skin redness will usually disappear within a few hours after removing the patch.
You should regularly change the application site to prevent local irritation.
Your doctor may advise you to receive additional treatment simultaneously to prevent a slight increase in heart rate.
Severe decreases in blood pressure have been reported with medicines 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 increased chest pain due to lack of oxygen in the heart muscle and surrounding areas.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect 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 more information on the safety of this medicine.
5. Storage of Cordiplast
Store below 25°C.
Keep in the original packaging.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cordiplast 5 mg/24 h transdermal patches
- The active substance is nitroglycerin. One patch contains 18.7 mg of nitroglycerin, in a 9 cm² patch, which releases 5 mg every 24 hours.
- The other components are: acrylate/vinyl acetate copolymer and silicone-coated polyethylene terephthalate film (protective layer).
Appearance of the medicinal product and contents of the pack
Packs containing 30 transdermal adhesive patches, individually packed in heat-sealed sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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)
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Norgine de España, S.L.U.
Paseo de la Castellana, 91, 2nd Floor
28046 Madrid
Spain
Date of the most recent revision of this leaflet: September 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/