MINITRAN 15 mg/24 H TRANSDERMAL PATCHES

2. What you need to know before you use MINITRAN

Do not use MINITRAN

• If you are allergic to glyceryl trinitrate and organic nitrates, or to any of the other components of this medicine (listed in section 6).
• If you have cardiac insufficiency due to valvular obstruction (narrowing of the heart valves) or pericardial inflammation that compresses the heart.
• If you have diseases associated with intracranial hypertension (such as cerebral hemorrhage or cranioencephalic 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 (below 90 mm Hg).
• In cases of severe hypovolemia (if you have recently lost a lot of blood).
• If you are taking medicines from the group of phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil (medicines used to treat impotence or pulmonary arterial hypertension). These medicines should never be taken together with Minitran.
• If you are taking medicines with 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).
• Tell your doctor if you have or have had:
• any heart disease or vascular disorders other than angina,
• any lung disease. In patients with angina pectoris, myocardial infarction, or cerebral ischemia, alterations of the small airways may occur,
• anemia.
• In patients with angina pectoris 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 nitro derivatives by sublingual route.
• In case of stopping treatment, the dose and frequency of application of the MINITRAN patch should be gradually reduced over a period of 4-6 weeks to avoid withdrawal reactions from this class of vasodilator drugs. If you start with another treatment for angina pectoris, during a period of time, you may need to use both medicines.
• 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 for the patient to become accustomed to the medicine or to other nitro derivatives. For this reason, the doctor may recommend applying MINITRAN daily with a patch-free interval of 8 to 12 hours a day.

Using MINITRAN with other medicines

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

Patients being treated with Minitran should never take (even if they have removed the patch) phosphodiesterase 5 inhibitor medicines (PDE5) such as those containing sildenafil, vardenafil, or tadalafil (medicines used to treat impotence and pulmonary arterial hypertension). For more information, consult your doctor or pharmacist.

Concomitant treatment with riociguat, a soluble guanylate cyclase stimulator, should be avoided, as concomitant use may cause hypotension (see "Do not use Minitran").

It is advisable for the doctor to know if you are being treated with other medicines, as they may increase or decrease the effect of lowering blood pressure of MINITRAN.

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

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

Concomitant use of Minitran with dihydroergotamine (a 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 action of Minitran.

Concomitant administration of Minitran with amifostine and acetylsalicylic acid may potentiate the hypotensive effects of MINITRAN.

Interference with diagnostic tests

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

Using MINITRAN with food and drinks

Consumption of alcoholic beverages is not recommended during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

MINITRAN should be used with caution during pregnancy, especially during the first three months of pregnancy. In these circumstances, the medicine is only suitable in case of need and under the direct control of a doctor. If you become pregnant while using this medicine, inform your doctor immediately.

If you are breastfeeding, you should inform your doctor, as it will be necessary to decide whether to interrupt breastfeeding or interrupt treatment, after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

MINITRAN may cause hypotension and dizziness, especially at the start of treatment. If you notice any of these effects, avoid driving vehicles or using machines.

3. How to use MINITRAN

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

The response to nitro derivatives varies from person to person 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 contact area 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 depending on the demonstrated tolerance, the treatment can be increased to a MINITRAN 10 mg/24 h patch or even a MINITRAN 15 mg/24 h patch per day.

Application can be for a continuous period of 24 hours or intermittently, incorporating a patch-free interval of 8 to 12 hours (usually at night).

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

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

Instructions for correct administration

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

Apply the MINITRAN patch to the skin in a clean, dry, healthy area (without cream residues) and with little hair.

The correct application procedure is as follows:

1. Open the bag by tearing it at the mark and remove the patch from the inside.

1. Fold the patch slightly with the dotted marks facing 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 of the protective film.

1. Press on the patch to ensure its good placement.

Remove the MINITRAN patch after 24 hours, unless otherwise recommended by your doctor. MINITRAN patches are disposable. They should be kept 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 than 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 come off with bathing, showering, or physical exercise.

If you use more MINITRAN than you should

High doses of glyceryl trinitrate can, 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's nitrate can be quickly eliminated by simply removing the transdermal patch(es).

Any reduction in blood pressure and symptoms of collapse 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 toluidine blue.

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

If you forget to use MINITRAN

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

If you stop using MINITRAN

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

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

4. Possible side effects

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

Tolerance to glyceryl trinitrate is generally good. The following side 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 after a few days and can be treated with mild analgesics. In particularly intense cases, it may be necessary to reduce the dose or interrupt treatment.

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

Rare (may affect up to 1 in 1,000 people): flushing of the face. Dizziness, especially when standing up quickly, so it is recommended to do so slowly and, if you feel dizzy, sit or lie down. Low blood pressure. Fainting. Acceleration of 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 sensation of heart rhythm), skin rash, and fainting.

It is important that you inform your doctor, as you may need to lower the dose or stop treatment, at least temporarily.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MINITRAN

Do not store above 25°C. Keep in a cool, dry place.

Keep out of the reach and sight of children.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of MINITRAN 15 mg/24 h

• The active substance is glyceryl trinitrate, 54 mg per patch. The average amount released in 24 hours is 15 mg.
• The other components are:

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

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

Appearance of the product and contents of the pack

MINITRAN 15 mg are transdermal patches consisting of a thin, transparent polyethylene film of low density, covered by an adhesive matrix containing glyceryl trinitrate. The matrix controls the rate of release of the active substance. The patch is covered by a protective film of polyester that is removed and discarded before use.

Each patch has a surface area of 20 cm2 and is presented in boxes of 7 and 30 patches.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

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 medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet:October 2017

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