DERMATRANS 5 mg /24 H Трансдермальный Пластырь

Содержание инструкции

1. DERMATRANS 5 mg/24 hours transdermal patch, 10 mg/24 hours transdermal patch, 15 mg/24 hours transdermal patch
   1. What DERMATRANS is and what it is used for
   2. What you need to know before using DERMATRANS
   3. How to use DERMATRANS
   4. Possible side effects
   5. How to store DERMATRANS
   6. Contents of the pack and other information

DERMATRANS 5 mg/24 hours transdermal patch, 10 mg/24 hours transdermal patch, 15 mg/24 hours transdermal patch

Glyceril trinitrate
Read this leaflet carefully before you start to take 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DERMATRANS is and what it is used for

DERMATRANS transdermal patches contain the active substance glyceryl trinitrate, a
vasodilator used in heart disease, which belongs to a group of drugs called
organic nitrates.
DERMATRANS patches are applied to the skin and the active substance, passing through the
skin, penetrates into the body.
DERMATRANS is indicated in the prevention of angina attacks, taken as monotherapy or in
association with other anti-anginal therapy.
Angina usually manifests with chest pain or a feeling of oppression that may
spread to the neck or arm. The pain occurs when the heart is not sufficiently
oxygenated. DERMATRANS is not indicated for the treatment of acute angina episodes. In this
case, the usual sublingual tablet or spray should be used for the treatment of acute attacks.
DERMATRANS patches are for external use only.

2. What you need to know before using DERMATRANS

Do not use DERMATRANS

• if you are allergic (hypersensitive) to glyceryl trinitrate, related organic nitrates or to any of the other ingredients of this medicine (listed in section 6);
• if you are experiencing or have recently experienced shock associated with very low blood pressure;
• if you have medical conditions such as headache, vomiting or convulsions associated with an increase in intracranial pressure, including that caused by head trauma;
• if you suffer from heart failure due to obstruction such as, for example, in the presence of a narrowing of the aortic orifice or the atrioventricular orifice of the heart (aortic stenosis or mitral stenosis, respectively), or a fibrous thickening of the thin sac-like membrane surrounding the heart (constrictive pericarditis);
• if you are taking medicines for the treatment of erectile dysfunction (e.g. sildenafil or other PDE-5 inhibitors). Nitrates must not be administered to patients treated with sildenafil or with any other medicine used to treat erectile dysfunction. Patients undergoing nitrate therapy must not take sildenafil or any other medicine for the treatment of erectile dysfunction. The combination of a nitrate with sildenafil or with any other PDE-5 inhibitor may cause a sudden and severe drop in blood pressure, which may lead to fainting, loss of consciousness or even heart attack (see also section “ Other medicines and DERMATRANS”);
• if you are taking medicines with riociguat, a soluble guanylate cyclase stimulator;
• if you suffer from severe hypotension (systolic blood pressure below 90 mm Hg);
• if you suffer from a severe decrease in blood volume in the body due to blood loss or loss of body fluids (severe hypovolemia);
• if you suffer from severe anemia;
• if you suffer from toxic fluid retention in the lungs (toxic pulmonary edema).

Warnings and precautions
Talk to your doctor or pharmacist before using DERMATRANS:

• if you stop the treatment. Stopping treatment with DERMATRANS must be done gradually, replacing the patch with decreasing doses of long-acting nitrates orally;
• in case you need to undergo magnetic resonance imaging, electrical stimulation of the heart to restore normal heart rhythm (defibrillation or cardioversion), and before thermal therapy (diathermy). You must remove the DERMATRANS patch before undergoing the aforementioned treatments;
• if you have, or have recently had a heart attack (myocardial infarction) or if you develop rapidly symptoms of heart failure (acute heart failure) such as shortness of breath, severe fatigue, swelling of the legs. Your doctor may ask you to undergo laboratory tests on your cardiovascular functions;
• if you suffer from severe hypotension during treatment with DERMATRANS, it may be necessary to remove the patch. If you experience collapse or shock, the DERMATRANS patch must be removed;
• in case of chest pain (acute angina attacks), or if the heart does not receive enough blood and oxygen (unstable angina) or in case of a heart attack (myocardial infarction). DERMATRANS should not be used as immediate treatment for these conditions;
• if you experience severe headache or if blood pressure values are lower than normal (hypotension). This may occur in the case of a dose that is too high initially. It is advisable to increase the dose gradually until the optimal effect is achieved;
• if you are taking other nitrates or sublingual glyceryl trinitrate, as your body may develop resistance to the effects of these substances after repeated exposure (cross-tolerance);
• if you report or have reported blood pressure values lower than normal induced by glyceryl trinitrate. In this case, a slowing of the heartbeat (paradoxical bradycardia) and increased angina may occur;
• if you suffer from a pathology of the optic nerve (closed-angle glaucoma);
• if the oxygenation of the blood is insufficient (hypoxemia) due to severe anemia, or a lung disease, or reduced blood supply to the heart (ischemic heart failure). Patients with these medical conditions frequently suffer from an imbalance in the ventilation/perfusion ratio which is an index of respiratory function. In these patients, glyceryl trinitrate may worsen the ventilation/perfusion imbalance and cause a further decrease in blood oxygenation;
• if the angina is caused by thickening of the heart (hypertrophic cardiomyopathy). Nitrates may worsen this type of angina;
• if you experience an increase in the frequency of angina attacks during periods without a patch. Your doctor may assess the suitability of additional antianginal therapy;
• if you experience skin sensitization phenomena (itching, burning, inflammation), stop the treatment and consult your doctor.

Other medicines and DERMATRANS
The concomitant administration of medicines for the treatment of erectile dysfunction (e.g. sildenafil or other PDE-5 inhibitors) potentiates the hypotensive effects of nitrates and therefore must be avoided (see also section “ Do not use DERMATRANS”).
Concomitant treatment with riociguat, a soluble guanylate cyclase stimulator must be avoided as concomitant use may cause hypotension (see also section “ Do not use DERMATRANS”).
Concomitant treatment with

• medicines used to lower high blood pressure, such as calcium antagonists, ACE inhibitors (for the treatment of congestive heart failure), beta-blockers (used to manage heart arrhythmias), diuretics (to increase the elimination of water from the body) and other antihypertensives,
• tricyclic antidepressants (medicines for the treatment of depressive disorders),
• neuroleptics (medicines used to manage psychoses) and
• major tranquilizers (sedatives),
• as well as alcohol consumption and with the association of amifostine (cytoprotective medicine in chemo and radiotherapy) and
• acetylsalicylic acid (an NSAID), may potentiate the blood pressure lowering effects (hypotensive effects) of DERMATRANS. Concomitant treatment with dihydroergotamine may reduce the effect of DERMATRANS.

Non-steroidal anti-inflammatory drugs, except acetylsalicylic acid, may decrease the therapeutic response to DERMATRANS.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
DERMATRANS should not be used during pregnancy, especially in the first three months, unless your doctor has told you to.
Due to limited information on the presence of glyceryl trinitrate in human breast milk, a risk to the infant cannot be excluded. Your doctor will assess whether to discontinue breastfeeding or the use of DERMATRANS.
No data are available on the effect of DERMATRANS on fertility in men.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Especially at the beginning of treatment or in case of dose adjustments, DERMATRANS may affect your ability to drive or use machines, as it may alter your reactions or may rarely cause a lowering of blood pressure in an upright position and dizziness, as well as, in exceptional cases, fainting following an overdose.
If you experience these effects, you should avoid driving or using machines.

3. How to use DERMATRANS

Use DERMATRANS always exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one DERMATRANS 5 mg/24 hour patch applied to the skin once a
day. Your doctor will tell you to remove the patch after a period of less than 24 hours and will advise
you not to apply a new patch for a period of at least 8 hours a day. You must replace the
DERMATRANS patch according to the instructions provided by your doctor. Your doctor may prescribe
a maximum daily dose of 15 mg of glyceryl trinitrate, which is one DERMATRANS 15
mg/24 hour patch once a day.

Use in children and adolescents
DERMATRANS must not be used in children and adolescents under 18 years of age.

Duration of treatment with DERMATRANS
Treatment with DERMATRANS can continue for several years, however your doctor will want to see you
regularly to decide whether to continue treatment or to modify the therapeutic regimen.

How to apply the patch
The patch must be applied to clean and dry skin, not on wounds, spots or imperfections or
on an area to which cream, lotion or talcum powder has just been applied. It is recommended to
apply the transdermal patches of DERMATRANS to the skin of the chest (see Figure 1), or to the
outermost upper part of the arm, free of redness or irritation, and to vary the patch application sites.
The application area can be shaved if necessary. Areas that
form folds or are subject to friction during movement should be avoided.

Figure 1
Do not apply two patches consecutively to the same area.
The DERMATRANS patch should be applied to the skin immediately after it is removed from
its sachet, as follows:

• (1) Open the sachet by tearing it along the marked notch (do not use scissors) (see Figure 2)

Figure 2

• (2) Hold the patch between your thumb and index finger on the smallest part of the protective sheet delimited by a notch (see Figure 3).

Figure 3

• (3) Peel off the protective sheet with the other hand and discard it (see Figure 4). Do not touch the adhesive side of the patch otherwise it will not adhere properly to the skin.

Figure 4

• (4) Apply the patch to the skin and remove the remaining part of the protective sheet. Press firmly for about 10 seconds over the entire surface of the patch. Run a finger along the edges to ensure good adhesion.

Your hands must be washed before and after applying DERMATRANS.
To remove the patch, simply lift one edge and pull it off gently.
After use, fold the patch in half, with the adhesive sides facing inwards and discard it in a bin
out of the reach of children.

What to do if the patch comes off
If DERMATRANS is applied correctly, it is unlikely to come off. However, if the patch
should come off, it must be replaced with a new one and, subsequently, the initial treatment schedule must be restored.

If you use more DERMATRANS than you should
If you take high doses of glyceryl trinitrate, you may experience a severe drop in
blood pressure, increased heart rate or collapse and fainting, as well as alteration
of haemoglobin (metahemoglobinemia).
If you or someone else applies too many patches at the same time, they should be carefully removed
and the underlying skin should be washed thoroughly to reduce absorption. If you experience
hypotension or collapse, it is recommended to raise the legs or, if necessary, apply compressive bandages
to the legs.

If you forget to change the patch
If you forget to change the patch when you should, replace it as soon
as possible, then follow the normal dosage schedule for applying the next patch.

If you stop using DERMATRANS
When you stop treatment with DERMATRANS you may recurrently experience angina attacks.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause some side effects, although not everyone will experience them.
The following side effects have been reported:

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

• nausea;
• vomiting.

Common side effects (affect more than 1 in 100 and less than 1 in 10 people):

• headache.

Uncommon side effects (affect more than 1 in 1,000 and less than 1 in 100 people):

• contact dermatitis (inflammatory skin reaction);
• redness and irritation of the skin at the patch application site;
• itching;
• burning sensation.

Rare side effects (affect more than 1 in 10,000 and less than 1 in 1,000 people):

• fast heartbeat (tachycardia);
• low blood pressure when standing up (orthostatic hypotension), which may be described as transient episodes of confusion;
• hot flushes;
• increased heart rate in diagnostic tests.

Very rare side effects (affect less than 1 in 10,000 people):

• dizziness;
• fainting (syncope).

Side effects with unknown frequency:

• irregular heartbeat (palpitations);
• generalized skin rash (generalized rash).

If any of these side effects get worse or become troublesome, please tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: ww.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DERMATRANS

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C. DERMATRANS must be stored in
its intact sachet.
Do not use this medicine after the expiry date which is stated on the carton and on the sachets. The
expiry date refers to the last day of that month.
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. Contents of the pack and other information

What DERMATRANS contains
The DERMATRANS patches contain the active ingredient glyceryl trinitrate and are available in three
formats:
DERMATRANS 5 mg/24 hours contains 15.70 mg of active ingredient glyceryl trinitrate and
releases approximately 5 mg of glyceryl trinitrate per day (0.2 mg/hour);
the release area of the patch is 6.38 cm². The identification code
printed on the backing film is NR5.
DERMATRANS 10 mg/24 hours contains 31.37 mg of active ingredient glyceryl trinitrate and
releases approximately 10 mg of glyceryl trinitrate per day (0.4 mg/hour);
the release area of the patch is 12.75 cm². The identification code
printed on the backing film is NR10.
DERMATRANS 15 mg/24 hours contains 47.04 mg of active ingredient glyceryl trinitrate and
releases approximately 15 mg of glyceryl trinitrate per day (0.6 mg/hour);
the release area of the patch is 19.12 cm². The identification code
printed on the backing film is NR15.
The other components are an adhesive substance (acrylate-vinyl acetate), a tackifier (hydroabietyl
phthalate) and a crosslinking agent (polybutyl titanate), which, combined with the active ingredient, are spread on a
backing film (lacquered propylene sheet). The adhesive layer is then covered by a
protective aluminum foil, siliconized on both sides, which is removed before use
of the patch.

Description of the appearance of DERMATRANS and contents of the pack
DERMATRANS consists of transdermal adhesive patches. Each patch is individually sealed in
a protective sachet.
Pack sizes: 15 or 30 patches. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and Manufacturer
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Ireland Dermatrans
Italy Dermatrans
Portugal Dermatrans
Spain Dermatrans