NITRODERM TTS 10 TRANSDERMAL PATCHES

Introduction

PACKAGE LEAFLET:INFORMATION FOR THE USER

Nitroderm® TTS 10transdermal patches

Nitroglycerin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Nitroderm TTS 10 transdermal patches are and what they are used for
2. What you need to know before you use Nitroderm TTS 10 transdermal patches
3. How to use Nitroderm TTS 10 transdermal patches
4. Possible side effects
5. Storage of Nitroderm TTS 10 transdermal patches
6. Contents of the pack and further information

1. What NITRODERM TTS 10 transdermal patches are and what they are used for

Nitroderm TTS 10 contains nitroglycerin as the active substance, which belongs to the group of medicines called nitrates.

Nitroderm TTS 10 is presented in the form of transdermal patches (release through the skin into the blood).

Nitroderm TTS 10 is used to prevent or reduce the frequency of angina attacks (chest pain or discomfort). Nitroderm TTS dilates blood vessels, making it easier for the heart to work.

If the angina attack has already started, instead of Nitroderm TTS patches, you should use a rapid-acting nitrate (sublingual tablets or spray).

2. What you need to know before you start using NITRODERM TTS 10 transdermal patches

Follow your doctor's instructions carefully. They may be different from the general information given in this leaflet.

Do not use Nitroderm TTS 10

• If you are allergic (hypersensitive) to nitroglycerin, nitrates or nitrites, or any of the other components of Nitroderm TTS.
• In cases of decreased blood circulation with very low blood pressure, such as in shock.
• If you have increased intracranial pressure (a situation that your doctor will know about and have told you).
• If you have a heart valve disease or an inflammatory heart disease.
• If you are currently taking any medication to treat erection problems or pulmonary hypertension, from the group of phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, or vardenafil.
• If you have very low blood pressure.
• If you have recently lost a lot of blood.

Warnings and precautions

Tell your doctor if you have or have had any of the following conditions:

• If you have anemia.
• If you have any lung disease.
• If you have any heart disease or blood vessel disorder other than angina.
• If you have recently had a heart attack or embolism.

In case of stopping treatment, the dose and frequency of application of the Nitroderm TTS patch should be gradually reduced over several weeks to avoid a withdrawal reaction. If you start another treatment for chest pain, for a period of time, you may need to use both medications.

Nitroderm may produce orthostatic hypotension, dizziness when standing up, so it is recommended to avoid postural changes.

Before an intervention, hospitalization, emergency visit, or before any imaging test (e.g., MRI, cardioversion, or electrical defibrillation, or diathermy), inform your doctor or nurse that the Nitroderm TTS patch you are using contains aluminum in case it needs to be removed.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those bought without a prescription.

It may be necessary to change your dose or, in some cases, stop using one of the medicines. It is especially important that you inform your doctor if you are going to take or are taking any of the following medicines:

• to treat blood pressure,
• to dilate blood vessels such as other nitrates and hydralazine,
• to treat depression or mood disorders,
• to treat mental disorders (major tranquilizers),
• to treat migraines (dihydroergotamine),
• for the treatment of inflammation, pain, and fever (non-steroidal anti-inflammatory drugs)
• to protect the effects of cancer treatment (amifostine)
• to treat erection problems or pulmonary hypertension (phosphodiesterase type 5 inhibitors, such as sildenafil, vardenafil, or tadalafil). If you are being treated with Nitroderm TTS, you should never take these medicines, even if you have removed the patch.

Use of Nitroderm TTS with food and drinks:

Be careful when taking alcoholic beverages, as your blood pressure may drop more than usual.

Use in children

Nitroderm TTS 10 should not be used in children.

Use in elderly patients

Older people (65 years or older) may be more sensitive to the effects of nitrates. Your doctor will inform you about this.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Experience with the use of Nitroderm TTS in pregnant women is limited. Inform your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss with you the potential risk of using Nitroderm TTS during pregnancy.

It is not known whether nitroglycerin passes into breast milk. You should inform your doctor if you are breastfeeding.

Driving and using machines

Nitroderm TTS may produce hypotension and dizziness, especially at the start of treatment or when changing doses. If you notice any of these effects, avoid driving vehicles or using machines.

3. How to use NITRODERM TTS 10 transdermal patches

Follow your doctor's instructions for administering Nitroderm TTS exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate which dose of Nitroderm TTS is best for you (Nitroderm TTS 5, 10, or 15) and how many patches you should use based on your individual needs.

In addition, they will indicate when and how often you should change the patch and the duration of treatment. Follow your doctor's instructions carefully and do not exceed the recommended dose.

How many Nitroderm TTS 10 patches to use

Generally, treatment is started with the smallest patch size (Nitroderm TTS 5) and gradually increased. For most patients, one Nitroderm TTS 10 patch is sufficient. Do not use more than two Nitroderm TTS 10 patches at the same time or one Nitroderm TTS 15 patch combined with one Nitroderm TTS 5 patch. Normally, you should apply a new patch once a day, preferably in the morning. Your doctor may indicate that you should remove the patch for 8-12 hours a day, usually at night. If you think the effect of Nitroderm TTS is too strong or too weak, tell your doctor.

According to the response to treatment, your doctor may increase or decrease your dose.

How and when to use Nitroderm TTS 10

Choose any area of skin on the torso or upper arm, without hair. The skin should not be inflamed, cracked, or irritated. For the patch to adhere well, the skin should be clean, dry, and free of creams, lotions, oils, or powders. You should choose a different area of skin each day. Wait several days before choosing the same area of skin again.

Each Nitroderm TTS patch is individually packaged in a heat-sealed bag. Open the bag at the notch without using scissors and remove the patch. The patch (pink in color) has a sticky surface covered with a white plastic protective film.

Tear the bag at the notch and remove the patch. Hold the patch carefully so that the white protective film is facing you.

Fold the tab firmly forward with your thumb. Remove the white protective film from the patch, starting from the tab, and discard it. Do not touch the adhesive.

Press the sticky part of the patch firmly onto the chosen area of the body (the torso or upper arm) using the palm of your hand. Hold it in place for 10-20 seconds. Make sure it is well adhered, especially at the edges. But do not try to ensure it is adhered by peeling it off once it is stuck to the skin.

Nitroderm TTS should be removed when your doctor indicates. When you change the patch, fold it in half, pressing the ends together and joining the sticky part before disposing of it properly, as it still contains nitroglycerin. Never cut or tear the patch. Any remaining adhesive that may be left on your skin can be easily removed with alcohol. To apply the next patch, you should choose a different area of skin.

Nitroderm TTS adheres well to the skin and its action is not affected by bathing, showering, or physical activity, if it is correctly placed. If the patch comes off despite this, it should be discarded and a new one applied to a different area of skin. If you forget to remove the patch at the right time, remove it as soon as possible and apply the next one without altering the established schedule.

If you use more Nitroderm TTS 10 than you should

If you have accidentally used more patches than your doctor has indicated, contact your doctor immediately. You may need medical attention.

High doses of nitroglycerin can cause a rapid drop in blood pressure. The effect of Nitroderm TTS can be quickly eliminated by removing the patch.

The drop in blood pressure can be treated by elevating the legs and, if necessary, bandaging them.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91.562.04.20.

If you forget to use Nitroderm TTS 10

If you forget to change the Nitroderm TTS patch at the right time, do not worry. Change it as soon as you remember, apply a new patch, and continue with the established schedule. Do not use a double dose to make up for forgotten doses.

If you interrupt treatment with Nitroderm TTS 10

If you have been using Nitroderm TTS regularly for weeks, do not stop treatment abruptly, as it may cause angina attacks to appear. Your doctor will indicate the best way to do it.

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

4. Possible side effects

Like all medicines, Nitroderm TTS can cause side effects, although not everybody gets them. The following side effects may appear and disappear during treatment. They usually do not require medical attention, but consult your doctor if they last or are severe.

Very common (may affect more than 1 in 10 people):

• Nausea.
• Vomiting.

Common (may affect up to 1 in 10 people):

• Headache, which can be treated with mild painkillers.

Uncommon (may affect up to 1 in 100 people):

• Skin irritation: a slight redness and itching may occur under the patch. This will disappear within a day after removing the patch. Change the patch application site regularly to avoid local irritation.
• Skin allergies: the skin under the patch becomes very red, swollen, or forms blisters. If you experience a widespread rash, covering a large area of skin, tell your doctor.

Rare (may affect up to 1 in 1,000 people):

• Redness of the face
• Dizziness, especially when standing up quickly, due to a decrease in blood pressure, so it is recommended to do it slowly and, if you feel dizzy, sit or lie down
• Acceleration of heart rhythms

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 the heart rhythm. Inform your doctor if you have a very marked sensation.
• Widespread rash across the skin

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of NITRODERM TTS 10 transdermal patches

Keep out of the reach and sight of children.

Nitroderm TTS should be stored in the original packaging in a dry and cool place. Do not store above 25°C.

Do not use Nitroderm TTS after the expiration date stated on the packaging or on the blister. The expiration 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 medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Nitroderm TTS 10

The active substance is nitroglycerin. Each 20 cm2 patch contains 50 mg of nitroglycerin, releasing approximately 10 mg of nitroglycerin every 24 hours.

The other components are: lactose, dimeticone, ethylene-vinyl acetate copolymer, medical adhesive CH 15, and aluminum foil.

Nitroderm TTS 10 is available in packs of 7 and 30 patches.

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

or

Novartis Pharma GmbH,

Roonstrasse 25,

90429 Nürnberg,

Germany

or

LTS Lohmann Therapie-Systeme AG,

Lohmannstr.2

56626 Andernach

Germany

Date of last revision of this leaflet:October 2013

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