TRINIPATCH 5 mg/24 HOURS TRANSDERMAL PATCHES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRINIPATCH 5 mg/24 hours transdermal patches

Nitroglycerin

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any serious side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

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 side effects
5. Storing TRINIPATCH 5 mg/24 hours transdermal patches
6. Further information

1. What TRINIPATCH 5 mg/24 hours TRANSDERMAL PATCHES are and what they are used for

TRINIPATCH 5 mg/24 hours are transdermal patches, with a release of 5 mg of nitroglycerin in 24 hours.

TRINIPATCH 5 mg/24 hours is an anti-anginal medication that decreases cardiac oxygen demand by improving exercise capacity in anginal patients, indicated for the preventive treatment of angina pectoris, either as monotherapy or in combination with other anti-anginal treatments.

2. Before you use 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 any of the other components of TRINIPATCH 5 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 on treatment with this medication should never take concomitantly medications containing sildenafil (medication used for erectile dysfunction). For more information, consult your doctor or pharmacist.

Be cautious when using TRINIPATCH 5 mg/24 hours transdermal patches:

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

If hypotension occurs, especially when standing, 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 consult your doctor or pharmacist.

Using other medications:

Tell 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 (medication used for erectile dysfunction) (see contraindications in section 2).

Using TRINIPATCH 5 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 advised against during pregnancy and breastfeeding. However, your doctor will evaluate the convenience of this treatment in particular cases.

Driving and using machines:

TRINIPATCH 5 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 vehicles or using machines.

3. How to use TRINIPATCH 5 mg/24 hours TRANSDERMAL PATCHES

Follow exactly the administration instructions of TRINIPATCH 5 mg/24 hours indicated 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 where hair is scarce (lateral part of the thorax, for example). Areas such as below the knees and elbows, skin folds, wide scars, and burned or irritated areas should be avoided.

Mode of application (see attached diagram):

• Remove the patch from the protective bag by tearing along the notch.
• Remove the first flap of the external protective layer.
• Stick 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 until several days have passed to avoid local irritation phenomena. 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 8-12 hour patch-free interval (usually at night).

Your doctor will indicate the duration of your treatment with TRINIPATCH 5 mg/24 hours. Do not stop treatment before.

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, 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, it is possible to experience side effects: nausea, vomiting, collapse, methemoglobinemia. In this case, these manifestations can be quickly treated by removing the patches and proceeding to a thorough cleaning of the skin. 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 5 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 5 mg/24 hours transdermal patches can cause side effects, although not everyone will experience them.

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

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

Facial flushing may appear, and at the patch application site, a slight itching and redness 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 that any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storing 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 the packaging until you are ready to apply the medication.

Do not use TRINIPATCH 5 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 medications you no longer need at 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. Further information

Composition of TRINIPATCH 5 mg/24 hours transdermal patches

The active ingredient is Nitroglycerin (D.C.I.). Each patch contains 22.4 mg of nitroglycerin (D.C.I.), with a release of 5 mg of nitroglycerin in 24 hours.

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

Appearance and packaging of the product

TRINIPATCH 5 mg/24 hours is presented in the form of transdermal patches. It is marketed in packages of 30 patches, each packaged in a single bag.

Other presentations

TRINIPATCH 10 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 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/.