PATIENT INFORMATION LEAFLET

MINITRAN 10 mg/24 h Transdermal Patches

Glyceryl Trinitrate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 MINITRAN is and what it is used for

2.What you need to know before you start using MINITRAN

3.How to use MINITRAN

4.Possible side effects

5Storage of MINITRAN

6.Contents of the pack and additional information

MINTTRAN patchesare transdermal systems consisting of a thin and transparent low-density polyethylene film, covered by an adhesive matrix containing glyceryl trinitrate. The matrix controls the release rate of the active ingredient, allowing for the continuous release of glyceryl trinitrate in sufficient quantities to ensure constant levels over 24 hours. The patch is covered by a protective polyester film that is peeled off and discarded before use.

MINTTRAN is indicated for the prevention of angina pectoris of effort and rest, associated or consequent to coronary insufficiency.

No use MINITRAN

-If you are allergic to glyceryl trinitrate and organic nitrates, or to any of the other components of this medication (listed in section 6).

-If you have heart failure due to valve obstruction (narrowing of the heart valves) or pericarditis that compresses the heart.

-If you have diseases associated with increased intracranial pressure (such as cerebral hemorrhage or head trauma) or increased intraocular pressure (glaucoma).

-In cases of decreased blood circulation associated with very low blood pressure (such as in shock).

-If you have very low blood pressure (less than 90 mmHg).

-In cases of severe hypovolemia (if you have recently lost a lot of blood).

-If you are taking phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, or vardenafil (medications used to treat erectile dysfunction or pulmonary hypertension). These medications should never be taken together with Minitran.

-If you are taking riociguat, a soluble guanylate cyclase stimulator.

For more information, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to use MINITRAN.

-Minitran should be used under strict medical supervision in cases of recent myocardial infarction or congestive heart failure (inability of the heart to pump enough blood to the rest of the body).

-Inform your doctor if you have or have had:

-Any heart disease or vascular disorders other than angina,

-Any lung disease. In patients with chest pain, myocardial infarction, or cerebral ischemia, they may experience alterations in small airways,

-Anemia.

-In patients with chest pain caused by thickening of the heart (hypertrophic cardiomyopathy), treatment with Minitran may worsen it.

-Minitran is not indicated for the treatment of acute angina attacks (chest pain), requiring the association of rapid-acting nitroderivatives by sublingual route.

-In case of discontinuing treatment, the dose and frequency of Minitran patch application should be gradually reduced over a period of 4-6 weeks to avoid withdrawal reactions of this type of vasodilator drugs. If you start another treatment for chest pain, you may need to use both medications for a period of time.

-The product may cause postural hypotension, especially in anxious patients, and it is necessary to warn patients of this risk in order to avoid sudden changes in posture.

-It is possible to develop tolerance to the medication or other nitroderivatives. For this reason, your doctor may recommend applying Minitran daily with a patch-free interval of 8 to 12 hours per day.

Use of MINITRAN with other medications

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

Patients undergoing treatment with Minitran should not takenitroderivatives of phosphodiesterase type 5 (PDE5) such as those containing sildenafil, vardenafil, or tadalafil (medications used to treat erectile dysfunction and pulmonary hypertension). For more information, consult your doctor or pharmacist.

It is advisable to avoid simultaneous treatment with riociguat, a soluble guanylate cyclase stimulator, as simultaneous use may cause hypotension (see "Do not use Minitran").

Your doctor should be aware if you are taking other medications, as they may increase or decrease the effect of blood pressure lowering of Minitran.

Administration with other vasodilators, such as alcohol and some medications (calcium antagonists, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants, major tranquilizers), should be done with caution, in order to avoid the addition of effects.

Nonsteroidal anti-inflammatory drugs (NSAIDs), except for aspirin, may reduce the action of Minitran.

The simultaneous use of Minitran with dihydroergotamine (a medication 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 action of Minitran.

The concomitant administration of Minitran with amifostine and aspirin may potentiate the hypotensive effects of Minitran.

Interference with diagnostic tests

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

Use of MINITRAN with food and beverages

It is not recommended to consume alcoholic beverages during treatment.

Pregnancy, lactation, and fertility

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

Minitran should be used with caution during pregnancy, especially during the first three months of pregnancy. In these circumstances, the medication is only suitable in cases of need and under the direct control of a doctor. If you are regularly using this medication and become pregnant, notify your doctor immediately.

If you are breastfeeding, you should inform your doctor, as they must decide whether to interrupt breastfeeding or interrupt treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery

Minitran may causehypotension and dizziness, especially at the beginning of treatment. If you experience any of these effects, avoid driving vehicles or operating machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again before using this medication.

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

As a general rule, it is advisable to start treatment with a MINITRAN 5 mg/24 h patch per day. If necessary, and based on demonstrated tolerance, treatment can be increased to a MINITRAN 10 mg/24 h patch or even a MINITRAN 15 mg/24 h patch per day.

The application can be for a continuous period of 24 hours, or intermittently, incorporating an interval without a patch of 8 to 12 hours (usually at night).

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

Use in the elderly:Geriatric patients are usually more sensitive to hypotensive effects (blood pressure drops).

Instructions for correct administration

Each MINITRAN 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 MINITRAN patch to the skin on a clean, dry, healthy (without residue of creams) 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.

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

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

4. Press firmly on the patch to ensure good placement.

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

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

Do not apply the system to the same area for consecutive days. The MINITRAN patch adheres easily to the skin and does not detach with bathing, showering, or physical exercise.

If you use more MINITRAN than you should

High doses of glyceryl trinitrate may, in some cases, induce a rapid drop in blood pressure and cause shock, tachycardia, methemoglobinemia, cyanosis, coma, and convulsions.

Due to the controlled release of glyceryl trinitrate with MINITRAN, the risk of overdose is very rare.

The effect of Minitran can be quickly eliminated by simply removing the transdermal patch(es).

Any reduction in blood pressure and collapse symptoms can be treated by elevating the legs and, if necessary, bandaging them.

Severe methemoglobinemia (increase in methemoglobin in the blood) can be treated with an injection of methylene blue or thionion.

In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological Information Service. Phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to use MINITRAN

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

If you interrupt treatment with MINITRAN

In case of suspending treatment, the dose and frequency of patch application should be gradually reduced over a period of 4-6 weeks to avoid withdrawal reactions from this type of vasodilator medication.

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

Like all medications, MINITRAN can produce adverse effects, although not all people will experience them.

The tolerance to glyceryl trinitrate is generally good. The following adverse effects may appear and disappear during treatment.

Very common (may affect more than 1 in 10 people): nausea and vomiting.

Common (may affect up to 1 in 10 people): headache that usually subsides within a few days and can be treated with mild analgesics. In particularly intense cases, it may be necessary to reduce the dose or discontinue treatment.

Uncommon (may affect up to 1 in 100 people): dermatitis (skin inflammation). Skin irritation (itching, stinging, and mild redness) that usually disappears a few hours after removing the patch. If you experience a generalized skin reaction, covering a large area, inform your doctor.

Rare (may affect up to 1 in 1000 people): facial flushing. Dizziness, especially when standing up quickly, so it is recommended to do so slowly and, if you feel dizzy, sit or lie down. Decreased blood pressure.Loss of consciousness.Increased heart rate.

Very rare (may affect up to 1 in 10,000 people): dizziness

Unknown (the number of affected patients cannot be calculated with the available information): palpitations (abnormal heart rhythm sensation), skin rash, and syncope.

It is essential to inform your doctor, as they may need to lower your dose or discontinue treatment, at least temporarily.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usewww.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store above25ºC. Store in a cool and dry place.

Keep out of the reach and sight of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of MINITRAN 10 mg/24 h

• The active ingredient is glyceryl trinitrate, 36 mg per patch. The average amount released in 24 hours is 10 mg.
• The other components are:

Copolymer of isooctyl/acrylamide: ethyl oleate; monolaureate of glycerol.

Backing: oval film of low-density polyethylene; polyester film coated on one side with silicone.

Appearance of the product and contents of the packaging

MINITRAN 10 mg are transdermal patches consisting of a thin and transparent film of low-density polyethylene, covered by an adhesive matrix containing glyceryl trinitrate. The matrix controls the release rate of the active ingredient. The patch is covered by a protective polyester film that peels off and is discarded before use.

Each patch has a surface area of 13.3 cm 2 and is presented in boxes of 7 and 30 patches.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

or

Mylan Hungary Kft.

Mylan utca 1

2900 Komárom

Hungary

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: October 2017

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