Trinipatch 5 mg/24 hours transdermal patches

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRINIPATCH 5 mg/24 hours transdermal patches

Nitroglycerin

Read the entire leaflet carefully before you start using this medicine.

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any serious adverse effects or any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What TRINIPATCH 5 mg/24 hours transdermal patches are and what they are used for
2. Before you use TRINIPATCH 5 mg/24 hours transdermal patches
3. How to use TRINIPATCH 5 mg/24 hours transdermal patches
4. Possible adverse effects
5. How to store TRINIPATCH 5 mg/24 hours transdermal patches
6. Further information

1. What TRINIPATCH 5 mg/24 hours TRANSDERMAL PATCHES is and what it is used for

TRINIPATCH 5 mg/24 hours are transdermal patches that deliver 5 mg of nitroglycerin over 24 hours.

TRINIPATCH 5 mg/24 hours is an antianginal medication that reduces the heart's oxygen demand, thereby improving exercise tolerance in patients with angina. It is indicated for the preventive treatment of angina pectoris, either as monotherapy or in combination with other antianginal therapies.

2. BEFORE USING TRINIPATCH 5 mg/24 HOURS TRANSDERMAL PATCHES

Do not use TRINIPATCH 5 mg/24 hours transdermal patches:

• If you are allergic (hypersensitive) to nitroglycerin or to any of the other components of TRINIPATCH 5 mg/24 hours.

• If you suffer from:

• Hypersensitivity to nitrate derivatives,

• Acute circulatory failure, shock, collapse,

• Certain severe heart diseases,

• Severe anemia,

• Glaucoma (elevated intraocular pressure).

Patients being treated with this medicine must never take medications containing sildenafil (a medicine used for erectile dysfunction) concomitantly. For further information, consult your doctor or pharmacist.

Take special care with TRINIPATCH 5 mg/24 hours transdermal patches:

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

If hypotension occurs, especially when standing, or if you experience dizziness or weakness, 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 seek advice from your doctor or pharmacist.

Use with other medicines:

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

It is very important that your doctor knows all the medicines you are taking to avoid the risk of interactions, particularly if you are being treated with:

• Vasodilators,
• Antihypertensives,
• Diuretics,
• Antidepressants,
• Tranquilizers,
• Dihydroergotamine.

Concomitant intake of acetylsalicylic acid and other anti-inflammatory drugs may reduce the response to nitroglycerin. The effect of this medicine on the heart may be altered if used together with preparations containing sildenafil (medicine used for erectile dysfunction) (see contraindications in section 2).

Use of TRINIPATCH 5 mg/24 hours transdermal patches with food and drink:

Alcohol consumption should be avoided during treatment.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

It is advisable to avoid using this medicine during pregnancy and breastfeeding. However, your doctor will assess the appropriateness of this treatment in specific cases.

Driving and use of machines:

TRINIPATCH 5 mg/24 hours may cause dizziness, especially at the beginning of treatment, due to the risk of orthostatic hypotension and vertigo. If you experience any of these effects, avoid driving vehicles or operating machinery.

3. HOW TO USE TRINIPATCH 5 mg/24 hours TRANSDERMAL PATCHES

Follow exactly the administration instructions for TRINIPATCH 5 mg/24 hours provided by your doctor. 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 in an area with little hair (e.g., the lateral chest area). Areas such as below the knees and elbows, skin folds, large scars, and burned or irritated areas should be avoided.

Method of application (see attached diagram):

• Remove the patch from its protective pouch by tearing along the slit.
• Peel off the first tab of the outer protective layer.
• Apply the adhesive side to the skin.
• Remove the second part of the outer protective layer.
• Press the patch onto the skin for a few seconds with the palm of your hand or your fingers, especially around the edges, to ensure proper adhesion.

Wash your hands thoroughly after application to remove any possible residue of the product.

After the prescribed wearing time has elapsed, remove the used patch and dispose of it, taking care not to apply a new patch to the same site until several days have passed, to avoid local irritation. If the patch detaches spontaneously, it is advisable to apply a new patch at a different site.

According to your doctor's instructions, the patch may be applied continuously for 24 hours, or intermittently, with a patch-free interval of 8 to 12 hours (usually at night).

Your doctor will determine the duration of your treatment with TRINIPATCH 5 mg/24 hours. Do not discontinue treatment prematurely.

If you use more TRINIPATCH 5 mg/24 hours transdermal patches than you should:

If you have applied too much TRINIPATCH 5 mg/24 hours, remove the patch immediately and contact your doctor right away or go to the nearest hospital.

Thanks to the controlled release of nitroglycerin, the risk of overdose is very low. However, if multiple patches are applied, side effects may occur, such as nausea, vomiting, collapse, and methemoglobinemia. In such cases, these symptoms can be rapidly treated by removing the patches and thoroughly cleaning the skin. Decreased blood pressure or signs of shock, if they occur, can be managed with general supportive or resuscitation measures, starting with leg elevation.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately. Telephone: 91 562 04 20, providing information about the medication and the amount used.

If you forget to use TRINIPATCH 5 mg/24 hours transdermal patches

Do not use a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, TRINIPATCH 5 mg/24 hours transdermal patches can cause adverse effects, although not everyone experiences them.

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

Sometimes nausea, vomiting, dizziness, vertigo, and fatigue may occur.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of TRINIPATCH 5 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 their wrapper until you are ready to apply the medication.

Do not use TRINIPATCH 5 mg/24 hours transdermal patches after the expiry date stated on the packaging 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. Return any unused medicines and their packaging to a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of TRINIPATCH 5 mg/24 hours transdermal patches

The active substance is Nitroglycerin (INN). Each patch contains 22.4 mg of nitroglycerin (INN), with a release of 5 mg of nitroglycerin over 24 hours.

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

Appearance of the product and contents of the pack

TRINIPATCH 5 mg/24 hours is presented as transdermal patches. It is marketed in packs of 30 patches, each individually contained in a single-unit pouch.

Other presentations

TRINIPATCH 10 mg/24 hours transdermal patches, pack of 30 patches.

TRINIPATCH 15 mg/24 hours transdermal patches, pack of 30 patches.

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 (Barcelona) - Spain

Manufacturer

Lavipharm, S.A.

Agias Marinas, St.

Peania Attica – Greece

This leaflet was approved in: April 2002.

Version: June 2011

Detailed and up-to-date 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/.