PATIENT INFORMATION LEAFLET:INFORMATION FOR THE USER

Nitroderm® TTS 10transdermal patches

Nitroglycerin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Nitroderm TTS 10contains nitroglycerin as the active ingredient, which belongs to a group of medications called nitrates.

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

Nitroderm TTS 10is used to prevent or reduce the frequency of angina attacks (chest pain or discomfort). Nitroderm TTS dilates blood vessels, thus facilitating the heart's work.

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

Follow carefully the instructions of your doctor. They may be different from the general information given in this prospectus.

Do not use Nitroderm TTS 10

• If you are allergic (hypersensitive) to nitroglycerin, nitrates, or nitrites, or to 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 high intracranial pressure (a situation that your doctor will know and have told you about).
• If you have a heart valve disease or an inflammatory heart disease.
• If you are currently taking any medication to treat erectile dysfunction 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

Inform 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 vascular disorder other than angina.
• If you have recently had a heart attack or an embolism.

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

Nitroderm may cause orthostatic hypotension, dizziness when standing up, so it is recommended to avoid changes in posture.

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

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

It may be necessary to change your dose or, in some cases, discontinue the use of one of the medications. It is especially important to inform your doctor if you are taking or plan to take any of the following medications:

• to treat high 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).
• to treat inflammation, pain, and fever (non-steroidal anti-inflammatory drugs)
• to protect against the effects of a carcinogenic treatment (amifostine)
• to treat erectile dysfunction or pulmonary hypertension (phosphodiesterase type 5 inhibitors, such as sildenafil, vardenafil, or tadalafil). If you are taking Nitroderm TTS, you should never take these medications, even if you have removed the patch.

Use of Nitroderm TTS with food and beverages:

Be careful when consuming 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 adults (65 years or older)may be more sensitive to the effects of nitrates. Your doctor will inform you about this.

Pregnancy and lactation

Consult your doctor or pharmacist about using any medication.

The experience with the use ofNitroderm TTSin pregnant womenis limited. Inform your doctor if you are pregnant or plan to become pregnant.Your doctor will discuss with you the potential risk ofusing Nitroderm TTSduring pregnancy.

It is unknown whether nitroglycerin passes into breast milk. Inform your doctor if you are breastfeeding.

Driving and operating machinery

Nitroderm TTS may cause hypotension and dizziness, especially at the beginning of treatment or when changing doses. If you experience any of these effects, avoid driving vehicles or operating machinery.

Follow exactly the administration instructions for Nitroderm TTS as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Additionally, they will tell you when and how often to 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 should be used

Generally, treatment starts with the smallest patch size (Nitroderm TTS 5) and is gradually increased. For most patients, a Nitroderm TTS 10 patch is sufficient. Do not use more than two Nitroderm TTS 10 patches at the same time or a Nitroderm TTS 15 patch combined with a Nitroderm TTS 5 patch. You should put a new patch on once a day, preferably in the morning. Your doctor may tell you to remove the patch for 8-12 hours a day, usually at night. If you consider the action of Nitroderm TTS to be too strong or too weak, inform your doctor.

Your doctor may increase or decrease your dose based on your response to treatment.

How and when to use Nitroderm TTS 10

Choose any area of the 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. Choose a different area of the skin each day. Wait several days before choosing the same area again.

Each Nitroderm TTS patch is individually packaged in a thermosealed pouch. Open the pouch by the notch without using scissors and remove the patch.The patch (pink in color) has an adhesive surface covered with a white plastic protective film.

Open the pouch by the notch and remove the patch. Hold the patch carefully so that the white plastic protective film is facing you.

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

Press the adhesive surface of the patch firmly onto the chosen area of the body (torso or upper arm) using the palm of your hand. Hold it in place for 10-20 seconds. Make sure it is well attached, especially around the edges. However, do not try to secure it by removing it once it is attached to the skin.

Nitroderm TTS should be removed when your doctor tells you to. When changing the patch, fold it in half, pressing the ends together and joining the adhesive surface before discarding it as it still contains nitroglycerin. Never cut or tear the patch. Any remaining adhesive on the skin can be easily removed with alcohol. To apply the next patch, choose a different area of the skin.

Nitroderm TTS adheres well to the skin and its action is not affected by bathing, showering, or physical activity if it is properly placed. If the patch does come off, discard it and apply a new one to a different area of the 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 accidentally use more patches than your doctor has indicated, contact your doctor immediately. You may require 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 your 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 follow the established schedule. Do not use a double dose to compensate for the missed 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. Your doctor will tell you the best way to do it.

If you have any other doubts about using this product, ask your doctor or pharmacist.

Like all medications, Nitroderm TTS may produce adverse effects, although not everyone will experience them. The following adverse effects may appear and disappear during treatment. Normally, they do not require medical attention, but consult your doctor if they persist 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 may be treated with mild analgesics.

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

• Skin irritation: a mild redness and itching sensation 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 the skin, inform your doctor.

Rare (may affect up to 1 in 1000 people):

• Face redness
• Dizziness, especially when standing up quickly, due to a decrease in blood pressure, so it is recommended to do so 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 heart rhythm sensation. Inform your doctor if you experience a strong sensation.
• Generalized skin rash

Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this prospectus.

Keepoutof the reach and sight of children.

Nitroderm TTS should be stored in the original packaging in a dry and cool place. Do not store at a temperature above25°C.

Do not use Nitroderm TTS after the expiration date that appears on the packaging or on the overwrap. 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 packaging and unused medicines at the Pharmacy Take-BackPoint. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment

Composition of Nitroderm TTS 10

The active ingredient is nitroglycerin. Each patch of 20 cm2contains 50 mg of nitroglycerin, releasing approximately 10 mg of nitroglycerin every 24 hours.

The other components are: lactose, dimethicone, 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

Responsible for Manufacturing

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

Last review date of this leaflet:October2013

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/