TRINIPATCH 10 mg/24 HOURS TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

TRINIPATCH 10 mg/ 24 hours Transdermal Patches

Nitroglycerin

Read the entire package leaflet carefully before starting to use this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience serious side effects or any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What TRINIPATCH 10 mg/24 hours Transdermal Patches are and what they are used for
2. Before using TRINIPATCH 10 mg/24 hours Transdermal Patches
3. How to use TRINIPATCH 10 mg/24 hours Transdermal Patches
4. Possible side effects
5. Storage of TRINIPATCH 10 mg/24 hours Transdermal Patches
6. Additional information

1. What TRINIPATCH 10 mg/ 24 hours Transdermal Patches are and what they are used for

TRINIPATCH 10 mg/ 24 hours are transdermal patches, with a release of 10 mg of nitroglycerin in 24 hours.

TRINIPATCH 10 mg/ 24 hours is an antianginal medication that decreases cardiac oxygen needs by improving the exercise capacity of anginal patients, indicated for the preventive treatment of angina pectoris, either as monotherapy or in combination with other antianginal treatments.

2. Before using TRINIPATCH 10 mg/ 24 hours Transdermal Patches

Do not use TRINIPATCH 10 mg/ 24 hours Transdermal Patches:

• If you are allergic (hypersensitive) to nitroglycerin or any of the other components of TRINIPATCH 10 mg/24 hours.
• If you suffer from:

• Hypersensitivity to nitrated derivatives,
• Acute circulatory failure, shock, collapse,
• Certain severe heart diseases,
• Severe anemia,
• Glaucoma (increased intraocular pressure).

Patient's using this medication should never take medications containing sildenafil (used for erectile dysfunction) concomitantly. For more information, consult your doctor or pharmacist.

Be cautious when using TRINIPATCH 10 mg/ 24 hours Transdermal Patches:

In cases of myocardial infarction, acute heart failure, and acute and chronic respiratory disorders.

If hypotension, dizziness, or weakness occur, consult your doctor.

Do not abruptly stop treatment to avoid the risk of angina attack.

Severe hypotension may occur with postural changes.

Remove the patch in case of collapse or shock.

In case of any doubt, it is essential to consult your doctor or pharmacist.

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 crucial that your doctor knows the medications you are taking to avoid the risk of interactions, particularly if you are being treated with:

• Vasodilators,
• antihypertensives,
• diuretics,
• antidepressants,
• tranquilizers,
• dihydroergotamine

Concomitant use of acetylsalicylic acid and other anti-inflammatory medications may decrease the response to nitroglycerin. The action of this medication on the heart may be altered if used concomitantly with preparations containing sildenafil (used for erectile dysfunction) (see contraindications in section 2).

Use of TRINIPATCH 10 mg/ 24 hours Transdermal Patches with food and beverages:

Alcohol consumption should be avoided during treatment.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

The use of this medication is not recommended during pregnancy and breastfeeding. However, your doctor will evaluate the convenience of this treatment in particular cases.

Driving and using machines:

TRINIPATCH 10 mg/ 24 hours may cause dizziness, especially at the start of treatment due to the risk of orthostatic hypotension and vertigo. If you experience any of these effects, avoid driving or using machines.

3. How to use TRINIPATCH 10 mg/ 24 hours Transdermal Patches

Follow your doctor's instructions for administering TRINIPATCH 5 mg/ 24 hours exactly. Consult your doctor or pharmacist if you have any doubts. The usual dose is one transdermal patch per day.

The patch should be applied to healthy, dry, and clean skin with minimal hair (e.g., the lateral part of the thorax). Areas such as below the knees and elbows, skin folds, wide scars, and burned or irritated areas should be avoided.

Application method (see attached diagram):

• Remove the patch from the protective bag by tearing along the notch.
• Remove the first flap of the external protective layer.
• Apply the adhesive part to the skin.
• Remove the second part of the external protective layer.
• Press the patch onto the skin for a few seconds with the palm of your hand or fingers, especially around the edges to ensure good adhesion.

Wash your hands carefully after application to remove any remaining product.

Once the prescribed application time has ended, remove the used patch and discard it, taking care not to apply a new patch to the same area for several days to avoid local irritation. If the patch comes off spontaneously, it is advisable to apply a new patch to a different area.

According to your doctor's judgment, the application may be continuous for 24 hours or intermittent, with an 8- to 12-hour patch-free interval (usually at night).

Your doctor will indicate the duration of your treatment with TRINIPATCH 10 mg/ 24 hours. Do not stop treatment before.

If you use more TRINIPATCH 10 mg/ 24 hours Transdermal Patches than you should:

If you have applied too much TRINIPATCH 10 mg/ 24 hours, remove the patch, contact your doctor immediately, or go to the nearest hospital.

Thanks to the controlled release of nitroglycerin, the risk of overdose is very small. In case of application of several patches, side effects such as nausea, vomiting, collapse, and methemoglobinemia may occur. In this case, these manifestations can be quickly treated by removing the patches and performing a thorough skin cleaning. The decrease in blood pressure or signs of shock that may occur can be controlled with general supportive measures or resuscitation, starting with elevation of the legs.

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

If you forget to use TRINIPATCH 10 mg/ 24 hours Transdermal Patches

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

If you accidentally miss the daily patch, apply it as soon as you can. Unless you have previously consulted your doctor, do not use two patches at the same time.

4. Possible side effects

Like all medications, TRINIPATCH 10 mg/ 24 hours Transdermal Patches may cause side effects, although not everyone experiences them.

At the beginning of treatment, headaches may occur, which usually disappear within a few days.

Nausea, vomiting, dizziness, and fatigue may occasionally occur.

Facial flushing and mild itching and redness at the patch application site may occur, which will disappear spontaneously a few hours after removing the patch. Allergic skin reactions to nitroglycerin, including contact dermatitis, may occur, although they are very rare.

If you consider any of the side effects you experience to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of TRINIPATCH 10 mg/ 24 hours Transdermal Patches

Keep out of the reach and sight of children.

Store in the original packaging.

Do not remove the patches from the packaging until you are ready to apply the medication.

Do not use TRINIPATCH 10 mg/ 24 hours Transdermal Patches after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of TRINIPATCH 10 mg/ 24 hours Transdermal Patches

The active ingredient is Nitroglycerin (D.C.I.). Each patch contains 44.8 mg of nitroglycerin (D.C.I.), with a release of 10 mg of nitroglycerin in 24 hours.

The other components are sorbitan monooleate, acrylic adhesive copolymer, protective membrane (polyethylene film), and protective sheet (siliconized polyester).

Appearance of the product and packaging contents

TRINIPATCH 10 mg/ 24 hours is presented in the form of transdermal patches. It is marketed in packages of 30 patches, each individually packaged in a unit bag.

Other presentations

TRINIPATCH 5 mg/ 24 hours Transdermal Patches, package with 30 patches.

TRINIPATCH 15 mg/ 24 hours Transdermal Patches, package with 30 patches.

Marketing authorization holder

Ferrer International, S.A.

Gran Vía Carlos III, 94

08028 (Barcelona) - Spain

Manufacturer

Lavipharm, S.A.

Agias Marinas, St.

Peania Attica – Greece

This package leaflet was approved in: April 2002.

Version: June 2011

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/.