NIREDIL 5 mg /24 Hours Трансдермальный Пластырь

Содержание инструкции

1. NIREDIL 5 mg/24 hour transdermal patches, 10 mg/24 hour transdermal patches, 15 mg/24 hour transdermal patches
   1. What is NIREDIL and what is it used for
   2. What you need to know before using NIREDIL
   3. How to use NIREDIL
   4. Possible side effects
   5. How to store NIREDIL
   6. Package Contents and Other Information

NIREDIL 5 mg/24 hour transdermal patches, 10 mg/24 hour transdermal patches, 15 mg/24 hour transdermal patches

Nitroglycerin
Equivalent medicinal product

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is NIREDIL and what is it used for

The NIREDIL transdermal patch contains the active ingredient nitroglycerin, which belongs to the
group of vasodilator drugs, used in the treatment of some heart diseases. This
medicinal product works by dilating blood vessels and improving blood circulation and oxygen supply to the
heart.
The transdermal patch is applied to the skin and the active ingredient, passing through the
skin, penetrates the body.
NIREDIL alone or in combination with other medicines is indicated for the prevention and
treatment of chest pain that occurs in case of insufficient oxygen supply to the
heart (angina pectoris).

2. What you need to know before using NIREDIL

Do not use NIREDIL

• if you are allergic to nitroglycerin or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines similar to nitroglycerin (organic nitrates);
• if you have low levels of red blood cells in your blood (anemia);
• if you have high pressure inside your eye (glaucoma) or skull, or in case of head trauma or cerebral hemorrhage;
• if you have an acute circulatory problem with a severe drop in blood pressure (shock);
• if you suffer from heart problems such as heart failure due to obstruction, such as in the case of narrowing (stenosis) of the aortic or mitral valve, or if you suffer from an inflammatory disease involving thickening of the membrane surrounding the heart (constrictive pericarditis) or a heart disease that causes a marked increase in the thickness of the heart walls and alters normal blood flow (obstructive hypertrophic cardiomyopathy) or in case of accumulation of fluid or blood in the area of the heart (cardiac tamponade);
• if you are pregnant or if you are breastfeeding (see section Pregnancy and breastfeeding);
• if the person who needs to use this medicine is a child;
• if you are taking medicines for erectile dysfunction, sometimes called impotence (see section Other medicines and NIREDIL);
• if you have very low blood pressure (severe hypotension);
• if you have a severe decrease in blood volume (severe hypovolemia);
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section Other medicines and NIREDIL).

Warnings and precautions
Talk to your doctor or pharmacist before using NIREDIL.
This medicine is not indicated for acute angina attacks that require rapid
intervention.
Use this medicine with caution and under the direct supervision of your doctor in the following situations:

• if you have recently suffered from heart problems such as heart attack or acute heart failure;
• if you have low levels of oxygen in your blood (hypoxia) due to a reduction in red blood cells (anemia), lung problems (hypoventilation) or heart problems (ischemic heart failure);
• if you suffer from chest pain (angina) caused by an enlarged heart (hypertrophic cardiomyopathy), because nitroglycerin may worsen these conditions.

Prolonged use of this medicine may cause allergic reactions, which can be resolved
by removing the patch, or a decrease/loss of the effectiveness of nitroglycerin itself or
similar medicines (tolerance and cross-tolerance), which can be resolved by applying the patch in a
intermittent manner (see section How to take NIREDIL). The patch must be removed if
you experience an excessive drop in blood pressure (severe hypotension) or if you must
undergo medical procedures such as Magnetic Resonance Imaging, cardioversion, defibrillation or
diathermy treatment.
If you temporarily stop treatment with this medicine, your doctor will advise you
to follow other therapies to avoid an increase in the frequency with which chest pain caused by
heart problems (angina pectoris) occurs.
If you are elderly, avoid sudden changes in position, as this medicine may
cause a feeling of dizziness when getting up due to a
rapid drop in pressure (orthostatic hypotension).
This medicine can increase the levels of certain substances present in the urine such as
catecholamines and vanillyl-mandelic acid, altering the results of control tests of the same.

Other medicines and NIREDIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not use NIREDIL together with medicines used to facilitate erection, such as sildenafil (Viagra®), in
because these increase the effect of reducing blood pressure.
Do not use NIREDIL with riociguat, a medicine used to treat pulmonary
hypertension, as concomitant use may increase the effect of reducing blood
pressure (see section Do not use NIREDIL).
Use caution if you are taking the following medicines because they may increase the effect of
reducing blood pressure due to the use of NIREDIL:

• medicines used to regulate blood pressure or heart activity, such as calcium antagonists, beta-blockers, ACE inhibitors and other antihypertensives;
• medicines used to increase urine elimination (diuretics);
• medicines used in central nervous system diseases such as neuroleptics, antidepressants and major tranquilizers;
• a medicine called amifostine, used in certain types of cancer;
• a medicine called acetylsalicylic acid used to relieve inflammation and pain.

Use caution if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), with the exception
of acetylsalicylic acid, as they may decrease the effectiveness of nitroglycerin.
Use caution and tell your doctor if you are using a medicine for headache called
dihydroergotamine, because nitroglycerin can increase its amount in the blood.

NIREDIL and alcohol
Avoid drinking alcohol during treatment with NIREDIL, as a
excessive drop in blood pressure may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine if you are pregnant, especially during the first trimester, or if you are breastfeeding
breastfeeding, unless absolutely necessary and in any case after the doctor has
evaluated the risks and benefits for you and the fetus or newborn.

Driving and operating machinery
Avoid driving your car or using machinery if you experience the following symptoms:
decreased ability to react to stimuli, dizziness, feeling of dizziness
when getting up due to a rapid drop in pressure (orthostatic hypotension), which
may occur especially at the beginning of treatment or after changes in dose.

NIREDIL contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

3. How to use NIREDIL

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The recommended initial dose is 5 mg (one NIREDIL 5 mg/24 hour patch) per day, with
subsequent increase to 10 mg (one NIREDIL 10 mg/24 hour patch) per day or, if necessary, to 15
mg (one NIREDIL 15 mg/24 hour patch) per day.
Your doctor will tell you whether the patch should be applied continuously for 24 hours, or intermittently,
removing it for a few hours, usually during sleep.
If you experience a decrease in the effectiveness of the medicine, your doctor will recommend that you
respect periods of patch removal of 8-12 hours per day.
Apply the patch after washing your hands and on a clean, dry, undamaged area of
skin on the chest or arms, free of hair or residues of ointments or creams.
It is advisable to vary the area of patch application every day.
Do not remove the patch during bathing or sports exercises, as it remains perfectly
adhered to the skin.
Apply the patch following these instructions:

• Open the sachet by tearing it along the marked notch (do not use scissors to avoid damaging the patch) and remove the patch (Fig. 1)
• Hold the patch between your thumb and index finger. Peel off the protective sheet with your other hand and discard it (Fig. 1)
• Avoid touching the adhesive side of the patch, and apply it to the skin while holding between your thumb and index finger the part still covered by the protective sheet
• Peel off the remaining part of the protective sheet and press firmly for about 10 seconds over the entire surface of the patch (Fig. 2)
• Press along the edges with a finger to ensure good adhesion (Fig. 2)
• Wash your hands after applying the patch
• After use, the patch must be folded with the adhesive side inwards and discarded.

Use in children
This medicine should not be used in children.

If you use more NIREDIL than you should
Being a slow-release formulation, the risk of overdose is rare.
However, if you experience the following symptoms, remove the patch and immediately inform your doctor or
go to the nearest hospital:

• severe lowering of blood pressure with consequent acceleration of the heartbeat (hypotension with reflex tachycardia);
• loss of consciousness (collapse or syncope);
• bluish discoloration of the skin (cyanosis);
• coma, convulsions;
• alteration of the structure of hemoglobin (methemoglobinemia). Treatment includes, in addition to immediate removal of the patch, raising the patient's legs, kept in a horizontal position, or bandaging to compress them, to increase

blood pressure and promote recovery of consciousness and, in case of methemoglobinemia, the
administration by vein of medicines such as methylene blue or toluidine blue.

If you stop using NIREDIL
Discontinuation of treatment with this medicine must be carried out gradually,
especially if it is necessary to start a new therapy with other medicines.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

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

• nausea and vomiting.

Common(may affect up to 1 in 10 people)

• temporary headache, which can be resolved by taking pain relievers (mild analgesics), reducing the dose of nitroglycerin or stopping treatment.

Uncommon(may affect up to 1 in 100 people)

• itching, burning, irritation and skin problems such as contact dermatitis and erythema, which can be resolved by changing the patch application site or removing it.

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

• increased heart rate (tachycardia), which can be resolved by taking medicines that regulate heart activity such as beta-blockers;
• low blood pressure after changes in position (orthostatic hypotension);
• hot flushes;
• increased heart rate during specific diagnostic tests.

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

• dizziness.

Not known(frequency cannot be estimated from available data)

• severe loss of consciousness (syncope)
• increased awareness of heartbeat (palpitations);
• skin problems such as skin rashes.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NIREDIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
“Expiry”.
The expiry date refers to the last day of that month.
Keep this medicine in its original packaging.
Do not dispose of any medicine in 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 NIREDIL contains
NIREDIL 5 mg/24 hour transdermal patches

• The active ingredient is nitroglycerin. Each patch contains 26.60 mg of nitroglycerin, releasing 5 mg over 24 hours at a rate of 0.2 mg/hour.
• The other ingredients are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

NIREDIL 10 mg/24 hour transdermal patches

• The active ingredient is nitroglycerin. Each patch contains 53.00 mg of nitroglycerin, releasing 10 mg over 24 hours at a rate of 0.4 mg/hour.
• The other ingredients are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

NIREDIL 15 mg/24 hour transdermal patches

• The active ingredient is nitroglycerin. Each patch contains 80.00 mg of nitroglycerin, releasing 15 mg over 24 hours at a rate of 0.6 mg/hour.
• The other ingredients are: acrylic acid copolymer (durotak 87-2852), sorbitan oleate, propylene glycol, low-density polyethylene, polyester.

Description of the appearance of NIREDIL and package contents
Pack of 15 transdermal patches.
Each patch is sealed in a sachet.
The adhesive side of the patch is covered by a protective sheet that must be removed before
use.

Marketing Authorisation Holder
SPA – Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 Milan
Italy

Manufacturer
SPA ITALIANA LABORATORI BOUTY
S.S. n. 11, Padana Superiore Km 160
20060 Cassina de' Pecchi (MI)
Italy
ALTERGON ITALIA S.R.L.
Industrial Area
83040 Morra De Sanctis (AV)
Italy