Leaflet: information for the user

NITROFIX 15mg transdermal patches EFG

Nitroglycerin

Read this 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, 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 NITROFIX 15 mg is and what it is used for

2. What you need to know before you start taking NITROFIX 15 mg

3. How to use NITROFIX 15 mg

4. Possible side effects

5. Storage of NITROFIX 15 mg

6. Contents of the pack and additional information

NITROFIX15mg patches are transdermal systems consisting of a thin and transparent low-density polyethylene film, covered by an adhesive matrix containing nitroglycerin. The matrix controls the release rate of the active ingredient. The patch is covered by a protective polyester film that is peeled off and discarded before use.

NITROFIX15mg is indicated for the prevention of angina pectoris on exertion and at rest, associated with coronary insufficiency.

Do not use NITROFIX15mg

• If you are allergic (hypersensitive) to organic nitrates or any of the other components of NITROFIX15mg.
• If you have severe anemia, cerebral hemorrhage, or head trauma with increased intracranial or intraocular pressure (glaucoma).
• In case of acute circulatory failure (shock, states of collapse).
• If you are being treated with medications containing sildenafil. Patients being treated with this medicationmust nevertake medications containing sildenafil (medication used for penile erection disorders) simultaneously. For more information, consult your doctor or pharmacist.

Be especially careful with NITROFIX15mg

NITROFIX15mg should be used under strict medical supervision in cases of myocardial infarction or congestive heart failure. It is recommended to exercise extreme caution when using NITROFIX15mg in patients with hypoxemia or ventilation perfusion imbalance.

NITROFIX15mg is not indicated for the treatment of acute angina attacks. In this case, your doctor will prescribe rapid-acting nitroderivatives sublingually.

If you are going to discontinue treatment, the dose and frequency of application of the NITROFIX15mg patch should be gradually reduced over a period of 4-6 weeks to avoid withdrawal reactions of this type of vasodilator medication.

This medication may cause postural hypotension, especially in anxious patients, so avoid sudden changes in posture.

It is recommended to remove the patch before cardioversion or defibrillation.

The appearance of habituation to the preparation or other nitroderivatives is possible. For this reason, your doctor may recommend applying NITROFIX15mg daily with a patch-free interval of8 to12 hours to maintain low plasma levels.

Nitroglycerin may interfere with the measurement of certain clinical analyses (catecholamines and vanillylmandelic acid in urine, increasing their excretion).

Inform your doctor immediately if any of the following situations occurwhile using NITROFIX15mg. Your doctor will decide whether to discontinue treatment withNITROFIX15mg.

Use of other medications

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

It is advisable for your doctor to know if you are being treated with other medications, as they may potentiate the blood pressure-lowering effect of NITROFIX15mg (calcium channel blockers, beta blockers, diuretics, antihypertensives, tricyclic antidepressants, major tranquilizers, and dihydroergotamine).

The administration of other vasodilators should be done with caution, in order to avoid the addition of effects.

The possibility of the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory substances decreasing the therapeutic response to NITROFIX15 mgcannot be ruled out.

The action of this medication on the heart may be altered if used simultaneously with preparations containing sildenafil for penile erection disorders (see contraindications).

The use of topical application products, especially if prolonged, may cause sensitization phenomena. In this case, treatment should be suspended, and appropriate therapeutic measures should be taken.

Use of NITROFIX15mg with food and beverages

Excessive alcohol consumption should be avoided.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

NITROFIX15mg should be used with caution during pregnancy and lactation. In these circumstances, the product is only suitable in cases of necessity and under direct medical supervision. If you are pregnant, notify your doctor immediately if you are regularly using this medication.

Use in children:The safety and efficacy in children under 18 years have not been established. Therefore, its use is not recommended.

Use in the elderly:Geriatric patients are usually more sensitive to the hypotensive effects.

Driving and operating machinery

Due to the potential for many side effects (dizziness, hypotension, etc...) to impair reaction time, maximum precautions should be taken when driving or operating machinery at the beginning of treatment.

Follow exactly the administration instructions forNITROFIX15mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The response to nitroderivatives varies from individual to individual and should be prescribed in each case the minimum effective dose. Since the amount of nitroglycerin released by the NITROFIX15mg patch is constant, the administered dose depends solely on the area of contact of the patch.

The normal dose is to start treatment with a NITROFIX5 mg patch per day. If necessary, and based on demonstrated tolerance, treatment can be increased to a NITROFIX10 mg or even NITROFIX15 mg patch per day.

The application can be for a continuous period of 24 hours, or intermittently, incorporating an interval without a patch of8 to12 hours (usually at night).

INSTRUCTIONS FORCORRECT ADMINISTRATION

Each NITROFIX15mg patch is contained in a small protective bag sealed. The adhesive area is covered by a protective film, which must be removed just before application to the skin.

Apply the NITROFIX15mg patch to the skin on a clean, dry, healthy (without residue) and relatively hairless area.

The correct application procedure is as follows:

1.- Open the bag, tearing it along the mark and remove the patch from its interior.

2.- Gently fold the patch with the dotted marks facing you, pull the tab and discard the protective film.

3.- Apply the adhesive surface to the upper arm or chest. Carefully separate the other dotted part from the protective film.

4.- Press the patch firmly in place to ensure good positioning.

Remove the NITROFIX15mg patch at 24 hours, unless otherwise recommended by your doctor. NITROFIX15mg patches are disposable. Keep them out of the reach of children.

Apply a new NITROFIX15mg patch following the method described. This new patch should be applied to a different area from the previous one, for example, on the opposite side of the chest.

Do not apply the system to the same area for consecutive days. The NITROFIX15mg patch adheres easily to the skin and does not come off with a bath, shower, or physical exercise.

If you use more NITROFIX15mg than you should

High doses of nitroglycerin may, in some cases, cause a rapid drop in blood pressure and lead to shock, tachycardia, methemoglobinemia, cyanosis, coma, and seizures. Due to the controlled release of nitroglycerin with NITROFIX15mg, the risk of overdose is very rare. Any reduction in blood pressure and collapse symptoms can be treated by elevating the lower extremities. Severe methemoglobinemia can be treated with a methylene blue or thionine injection.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: (91) 562 04 20.

If you forgot to use NITROFIX15mg

Do not take a double dose to compensate for the missed doses. Make sure to complete the treatment cycle.

If you interrupt treatment with NITROFIX15mg

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

Like all medications,NITROFIX15mgmay cause adverse effects, although not everyone will experience them.

The tolerance to nitroglycerin is generally good. Headache is the most frequent side effect, especially when high doses are used. This side effect is usually counteracted with common pain relievers, although in particularly intense cases it may be necessary to reduce the dose or discontinue treatment.

Other possible side effects that appear, especially at the beginning of treatment, are: arterial hypotension (especially postural), weakness, tachycardia, dizziness, palpitations, hot flashes, dizziness, nausea, vomiting, and dermatitis. Except for dermatitis, all of these are attributable to the pharmacological action of nitroglycerin. The doctor should be immediately informed of side effects and thus have the opportunity to suspend treatment with NITROFIX15mg, at least temporarily.

The local tolerance is also generally good. Occasionally, it presents, and always depending on the level of application, itching, stinging, and mild reactions of redness appear. However, these effects usually disappear a few hours after removing the patch without the need to take any other measures.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

No requires special conditions for conservation

Keep out of reach and sight of children.

Do not useNITROFIX15mg after the expiration date that appears on the package or box, after “CAD”. The expiration date is the last day of the month indicated.

Do not use NITROFIX15mg if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need.This will help protect the environment..

Composition of NITROFIX 15 mg

The active ingredient is Nitroglycerin 80 mg releasing 15 mg/24 hours.

The other components are, DURO-tak 872852, sorbitan monooleate, propylene glycol, low-density polyethylene oval film, transparent polyester film.

Appearance of NITROFIX 15 mg and content of the packaging

NITROFIX are transparent transdermal patches with a surface area of 20cm2and are presented in packaging of 7 or 30 transdermal patches.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo (Guadalajara). Spain.

Responsible for manufacturing:

IBSA FARMACEUTICI ITALIA SRL

Strada Statale Nº 11, Padana Superiore, km 160

20051-Cassina de’ Pecchi (MI)

Italy

Or

ALTERGON ITALIA SRL

Zona Industriale ASI,

Morra de Sanctis - 83040 (Av)

Italy

This leaflet was approved in April 2019.