Package Insert: Information for the User

TRINIPATCH 15 mg/ 24 hours Transdermal Patches

Nitroglycerin

Read this package insert carefully before starting to take the medication.

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

TRINIPATCH 15 mg/ 24 hours are transdermal patches, with a release of 15 mg of

nitroglycerin in 24 hours.

TRINIPATCH 15 mg/ 24 hours is an antianginal medication that reduces cardiac oxygen needs by improving the exercise capacity of angina patients, indicated for the preventive treatment of angina pectoris, whether as monotherapy or in combination with other antianginal treatments.

Do not use TRINIPATCH 15 mg/ 24 hours transdermal patches:

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

Patients undergoing treatment with this medicationmust nevertake concurrently medications containing sildenafil (medication used for erectile dysfunction). For further information, consult your doctor or pharmacist.

Be especially careful with TRINIPATCH 15 mg/ 24 hours transdermal patches:

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

If hypotension appears, especially in a standing position, dizziness, or weakness, consult your doctor.

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

Severe hypotension may occur in postural changes.

Remove the patch in case of collapse or shock.

In case of any doubt, it is essential to ask your doctor or pharmacist for advice.

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 very important that the doctor knows the medications the patient is taking to avoid the risk of interactions, particularly if they are undergoing treatment with:

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

The simultaneous ingestion 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 concurrently with preparations containing sildenafil (medication used for erectile dysfunction) (see contraindications in section 2).

Use of TRINIPATCH 15 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.

It is recommended to avoid using this medication during pregnancy and breastfeeding. However, the doctor will evaluate the convenience of this treatment in individual cases.

Driving and operating machinery:

TRINIPATCH 15 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.

Follow exactly the administration instructions for TRINIPATCH 15 mg/ 24 hours as 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 the skin on a healthy, dry, and clean area with minimal hair (such as the lateral side of the chest, for example). Areas to be avoided include below the knees and elbows, skin folds, wide scars, and burned or irritated areas.

Application method (see attached diagram):

• Remove the patch from the protective pouch by tearing along the perforation.
• Peel off the first tab from the outer protective layer.
• Apply the adhesive side to the skin.
• Peel off 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 fingers, especially around the edges, to ensure good adhesion.

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

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

Your doctor may recommend continuous application for 24 hours or intermittent application, with an 8- to 12-hour patch-free interval (usually at night).

Your doctor will inform you of the duration of your treatment with TRINIPATCH 15 mg/ 24 hours. Do not discontinue treatment prematurely.

If you use more TRINIPATCH 15 mg/ 24 hours transdermal patches than you should:

If you have applied too much TRINIPATCH 15 mg/ 24 hours, remove the patch, contact your doctor immediately, or go to the nearest hospital.

Due to the controlled release of nitroglycerin, the risk of overdose is very small. In the event of multiple patch application, possible side effects may include nausea, vomiting, collapse, and methemoglobinemia. In this case, these symptoms can be quickly treated by removing the patches and thoroughly cleaning the skin. Decreased blood pressure or signs of shock that may occur can be controlled with general supportive measures or resuscitation, starting with elevating 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 15 mg/ 24 hours transdermal patches

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

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

Like all medications, TRINIPATCH 15 mg/ 24 hours transdermal patches, may produce adverse effects, although not everyone will experience them.

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

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

A red face may appear, and a mild itching and redness may occur at the patch application site, 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 adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original packaging.

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

Do not use TRINIPATCH 15 mg/ 24 hours transdermal patches after the expiration date shown on the packaging after "Cad." 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 the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition of TRINIPATCH 15 mg/ 24 hours transdermal patches

The active ingredient is Nitroglycerin (D.C.I.). Each patch contains 67.2 mg of nitroglycerin (D.C.I.), with a release of 15 mg of nitroglycerin in 24 hours.

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

Appearance of the product and contents of the package

TRINIPATCH 15 mg/ 24 hours is presented in the form of transdermal patches. It is marketed in packages of 30 patches, each of which is packaged in a single unit bag.

Other presentations

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

TRINIPATCH 10 mg/ 24 hours transdermal patches, package with 30 patches.

Holder of the marketing authorization

Ferrer International, S.A.

Gran Vía Carlos III, 94

08028 (Barcelona) - Spain

Responsible for manufacturing

Lavipharm, S.A.

Agias Marinas, St.

Peania Attica – Greece

This leaflet was approved in: April 2002.

Version: June 2011

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

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