Nitroglycerin Eg Stada

Package leaflet: Information for the user

NITROGLICERINA EG STADA 5 mg transdermal patch, 10 mg transdermal patch, 15 mg transdermal patch

Nitroglycerin
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NITROGLICERINA EG STADA is and what it is used for
2. What you need to know before you use NITROGLICERINA EG STADA
3. How to use NITROGLICERINA EG STADA
4. Possible side effects
5. How to store NITROGLICERINA EG STADA
6. Contents of the pack and other information.

1. What NITROGLICERINA EG STADA is and what it is used for

NITROGLICERINA EG STADA is an adhesive patch containing the active substance
nitroglycerin, which is released into the body through the skin. Nitroglycerin belongs to a
group of medicines called nitrates that dilate blood vessels and make blood flow easier.
NITROGLICERINA EG STADA is used for the treatment of angina pectoris, a
painful tightness in the chest that occurs when the heart muscles do not receive enough
blood and oxygen.
NITROGLICERINA EG STADA may be used for the treatment of angina pectoris alone or
in combination with other medicines belonging to the class of beta-blockers and/or calcium antagonists.

2. What you need to know before using NITROGLICERIN EG STADA

Do not use NITROGLICERIN EG STADA

• if you are allergic to nitroglycerin, to any organic nitrate, or to any of the other ingredients of this medicine (listed in section 6)

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• if you have a severe form of circulatory failure associated with severe drop in blood pressure (shock)
• if you have a condition associated with: o increased pressure inside the head o cerebral haemorrhage o head trauma o increased pressure inside the eye (closed-angle glaucoma)
• if you have severe anaemia
• if you have heart failure due to: o narrowing (stenosis) of the mitral valve o inflammation of the heart lining (constrictive pericarditis) o obstruction to blood leaving the heart, such as narrowing (stenosis) of the aortic valve o heart muscle thickening disease (hypertrophic cardiomyopathy) o fluid accumulation around the heart (pericardial tamponade)
• if you are taking medicines for erectile dysfunction (phosphodiesterase-5 inhibitors) such as sildenafil, since a severe drop in blood pressure may occur
• if you suffer from very low blood pressure (systolic pressure below 90 mmHg)
• if you have low circulating blood volume (severe hypovolemia)
• if you are taking a medicine containing the active substance riociguat, used to treat high blood pressure in the lungs.

Warnings and precautions
Talk to your doctor or pharmacist before using NITROGLICERIN EG STADA if any
of the following conditions apply to you:

• if you suffer from hypoxaemia (reduced oxygen content in arterial blood) due to severe anaemia
• if you suffer from hypoxaemia due to lung disease or severe heart disease (ischaemic heart failure)
• if you have thickening of the heart muscle (hypertrophic cardiomyopathy)
• if you have recently had a heart attack or suffer from acute heart failure.

Take particular care:

• and inform your doctor that you are using NITROGLICERIN EG STADA if you are undergoing procedures involving electric fields such as cardioversion or defibrillation (an electric shock used to restore the heart to its normal rhythm), because the patch must be removed before these procedures
• if you are using the therapy intermittently, because during periods when the transdermal patch is not applied, the frequency of angina attacks may increase. In such cases, your doctor will assess whether to prescribe another medicine
• a loss of response (tolerance) to nitroglycerin patches may occur; if this happens, the effect of sublingual nitroglycerin may also be reduced
• if your blood pressure becomes very low, contact your doctor, who will advise whether to continue using NITROGLICERIN EG STADA or to remove the patch. 2/8

Children and adolescents
NITROGLICERIN EG STADA must not be used in paediatric patients.
Other medicines and NITROGLICERIN EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Do not use NITROGLICERIN EG STADA together with:

• medicines for erectile dysfunction (phosphodiesterase-5 inhibitors) such as sildenafil, since, if taken together with NITROGLICERIN EG STADA, they may cause a severe drop in blood pressure
• medicines containing the active substance riociguat, used to treat high blood pressure in the lungs.

Inform your doctor if you are taking:

• calcium antagonists, ACE inhibitors, beta-blockers, diuretic antihypertensives (medicines used to lower blood pressure, for fluid retention, or for heart problems)
• tricyclic antidepressants and major tranquillisers (medicines used to treat anxiety or depression)
• dihydroergotamine, used for example for migraine
• amifostine (a medicine used to reduce side effects of certain cancer treatments or radiotherapy)
• acetylsalicylic acid
• non-steroidal anti-inflammatory drugs, NSAIDs (used to treat pain and inflammation). Concomitant administration of phenobarbital (an anticonvulsant) may increase liver metabolism, reducing blood levels.

NITROGLICERIN EG STADA and alcohol
Do not drink alcohol when using NITROGLICERIN EG STADA, as alcohol may enhance
the drop in blood pressure that may occur when using the patch.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, your doctor will assess whether the benefits to you clearly outweigh the risks to the foetus
before prescribing NITROGLICERIN EG STADA, especially during the first three months of
pregnancy.
Breastfeeding
There is insufficient information on the passage of nitroglycerin into breast milk. Your doctor
will decide whether to discontinue breastfeeding or to discontinue therapy with NITROGLICERIN EG
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STADA, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
There are no available data regarding the effect of NITROGLICERIN EG STADA on male fertility.
There are no data supporting special recommendations for women of childbearing age.
Driving and using machines
NITROGLICERIN EG STADA may affect your reactions or may rarely cause dizziness or
low blood pressure when standing up, particularly at the beginning of treatment or when the dose is changed. If these symptoms occur, do not drive and do not operate machinery.

3. How to use NITROGLICERINA EG STADA

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The response to NITROGLICERINA EG STADA varies from patient to patient; therefore, you should
use the dose prescribed by your doctor.
Treatment of angina pectoris
NITROGLICERINA EG STADA is used to prevent angina and not to treat an acute attack.
In case of an acute angina attack, you must use another medicine prescribed by your doctor.
The recommended initial dose is normally one NITROGLICERINA EG STADA 5 mg/day patch per day.
For maintenance therapy, your doctor will prescribe either a NITROGLICERINA EG STADA 10 mg/day
patch (usual maintenance dose) or a NITROGLICERINA EG STADA 15 mg/day patch.
Prolonged or frequent administration of long-acting nitrates, including NITROGLICERINA EG STADA
or other transdermal patches, may lead to loss of response (tolerance) or reduced therapeutic efficacy.
Therapeutic efficacy can be maintained by removing the patch for 8–12 hours each day, usually at night.
Instructions for using NITROGLICERINA EG STADA
The patch should be applied to a clean, healthy skin area with little hair (e.g. the lateral chest area).
To ensure good adhesion, press gently with the palm of your hand for a few seconds.
Active blood levels are achieved approximately 30 minutes after patch application.
The daily duration of application should be determined by your doctor. It may be continuous for 24 hours
or interrupted for several hours (e.g. during the night), in order to prevent the development of drug tolerance.
After the prescribed use, remove the patch and dispose of it properly. Apply the new patch to a different skin area.
To avoid local irritation, wait several days before reapplying a patch to the same skin site.
If the patch detaches spontaneously, apply a new patch to another site.
Apply the patch according to the following instructions:

• remove the patch from the sachet;
• grasp one tab and carefully peel it off;
• apply the adhesive side, freed from the tab, to the selected site;
• grasp the remaining tab and carefully peel it off;
• press gently for about 10 seconds to ensure complete adhesion.

Use in elderly patients
Dose adjustment is normally not required; your doctor will prescribe the most appropriate dose for you.
If you use more NITROGLICERINA EG STADA than you should
If you accidentally apply too many patches, remove them immediately and contact your doctor or go to the nearest hospital without delay.
While waiting for medical help, elevate your legs to counteract low blood pressure, or wrap your legs to apply mild pressure.
High doses of nitroglycerin may cause:

• low blood pressure
• increased heart rate
• collapse
• fainting

If you forget to use NITROGLICERINA EG STADA
If you forget to change the NITROGLICERINA EG STADA patch at the scheduled time, change it as soon as you remember, and apply the new patch as described above.
If you forget to apply the patch one day, do not apply two or more patches simultaneously to make up for the missed dose.
If you stop using NITROGLICERINA EG STADA
Do not stop treatment abruptly.
When switching from chronic therapy to another type of treatment, nitroglycerin should be discontinued gradually (over 4–6 weeks), while initiating the new treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• Nausea, vomiting.

Common side effects (may affect up to 1 in 10 people)

• Headache. Headache often improves after a few days, without the need to stop treatment. If you experience headache also during intermittent treatment, you may use mild analgesics. If headache does not respond to this type of treatment, consult your doctor, who will assess whether it is appropriate to reduce the nitroglycerin dose or discontinue treatment.

Uncommon side effects (may affect up to 1 in 100 people)

• Contact dermatitis (skin inflammation with symptoms such as redness, itching, and skin peeling)
• Skin rash at the patch application site, with itching, redness, burning sensation, and skin irritation. Mild skin redness usually disappears within a few hours after removing the patch. Regularly change the patch application site to prevent local irritation.

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

• Increased heart rate
• Tachycardia
• Sudden drop in blood pressure, especially when standing up
• Flushing.

Very rare side effects (may affect up to 1 in 10,000 people)

• Dizziness.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Palpitations
• Skin rash affecting large areas of skin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NITROGLICERIN EUROGENERICI

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 25°C.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month. Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NITROGLICERIN EG STADA contains

• The active substance is nitroglycerin.
• The other components are: acrylic copolymer, sorbitan monooleate. Patch composition: silicone-coated polyester, low-density polyethylene.

NITROGLICERIN EG STADA 5 mg transdermal patch
A transdermal patch with a surface area of 7 cm² that releases 5 mg of nitroglycerin in vivo over 24 hours contains: nitroglycerin 22.4 mg.
NITROGLICERIN EG STADA 10 mg transdermal patch
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A transdermal patch with a surface area of 14 cm² that releases 10 mg of nitroglycerin in vivo over 24 hours contains: nitroglycerin 44.8 mg.
NITROGLICERIN EG STADA 15 mg transdermal patch
A transdermal patch with a surface area of 21 cm² that releases 15 mg of nitroglycerin in vivo over 24 hours contains: nitroglycerin 67.2 mg.

Description of the appearance of NITROGLICERIN EG STADA and contents of the package
NITROGLICERIN EG STADA 5 mg: box containing 15 or 30 transdermal patches
NITROGLICERIN EG STADA 10 mg: box containing 15 or 30 transdermal patches
NITROGLICERIN EG STADA 15 mg: box containing 15 or 30 transdermal patches

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Lavipharm S.A.
Agias Marinas street, GR-190 02 Peania, Attica, Greece
Distribution Licensee
EG S.p.A.
Via Pavia, 6
20136 Milan
Italy
Manufacturer
Lavipharm S.A.
Agias Marinas street, GR-190 02 Peania, Attica, Greece
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