ADESITRIN 5 mg /24 H Transdermal Patch

Зміст інструкції

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

Adesitrin 5 mg/24 h transdermal patches, 10 mg/24 h transdermal patches, 15 mg/24 h transdermal patches

nitroglycerin

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 they have the same symptoms as you, as it may 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 Adesitrin is and what it is used for
• 2. What you need to know before you use Adesitrin
• 3. How to use Adesitrin
• 4. Possible side effects
• 5. How to store Adesitrin
• 6. Contents of the pack and other information

1. What is Adesitrin and what is it used for

Adesitrin contains the active substance nitroglycerin and belongs to a group of drugs called organic nitrates.
Organic nitrates work by dilating both venous and peripheral arteries, making the heart's work less
demanding. They also work by dilating the blood vessels of the heart, allowing for an
increase in blood supply to the area that needs it.
Adesitrin is used to prevent and treat angina pectoris at rest and on exertion, as monotherapy or in
combination with other drugs, such as beta-blockers, calcium antagonists, etc., both in a stable phase and in
instability following or concurrent with coronary insufficiency, coronary artery disease, sub-occlusion
coronary artery, subacute myocardial infarction.
Angina usually manifests as oppressive and constricting pain in the chest, neck and/or left arm
caused by a reduction in blood flow to the heart walls.

2. What you need to know before using Adesitrin

Do not use Adesitrin

• If you are allergic to nitroglycerin, to other nitrates or to any of the other ingredients of this medicine (listed in section 6).
• If you have a disease that severely compromises the heart's ability to pump blood into the vessels adequately, such as cardiogenic shock (severe impairment of heart function), narrowing of the heart valves (aortic or mitral stenosis), obstructive hypertrophic cardiomyopathy (increase in the volume of the heart walls leading to a reduction in its ability to contract and pump blood into the vessels), constrictive pericarditis (inflammation of the pericardium, the envelope surrounding the heart) or pericardial tamponade (accumulation of fluid in the pericardium that prevents the heart from functioning).
• If you have any condition in which blood pressure is very low (systolic < 90 mmHg).
• Acute circulatory failure associated with very low blood pressure (shock, collapse).
• If you have conditions associated with increased pressure in the head (increased intracranial pressure), have suffered a brain hemorrhage (cerebral hemorrhage), another type of head injury or trauma (craniotrauma) or if you suffer from increased pressure inside the eye (closed-angle glaucoma).
• If you suffer from severe anemia (reduction of red blood cells in the blood).
• If you have a reduced blood volume (hypovolemia).
• If you are taking any other medicine used for erectile dysfunction (phosphodiesterase inhibitors such as sildenafil (Viagra), tadalafil, vardenafil) see section “Warnings and precautions” and “Other medicines and Adesitrin”.
• If you are taking medicines used for pulmonary hypertension (such as riociguat, soluble guanylate cyclase stimulator) see section “Other medicines and Adesitrin”.
• If you have an acute attack of angina.

Warnings and precautions
Talk to your doctor or pharmacist before using Adesitrin.
Particular caution should be exercised in the following conditions:

• If you have a heart problem with severe impairment of the heart's pumping function (myocardial infarction with left ventricular failure).
• If you have recently had a heart attack (myocardial infarction) or in case of heart failure.
• If you suffer from anemia (reduction of red blood cells in the blood).
• If you suffer from a dysfunction where blood pressure drops when you stand up (orthostatic dysfunction).
• If you suffer from arterial hypoxemia and ventilation/perfusion imbalance due to lung disease or ischemic heart failure. Tell your doctor if you are using products containing phosphodiesterase inhibitors (e.g. sildenafil, tadalafil, vardenafil). The Adesitrin patch does not contain aluminum or other metals, so it is not necessary to remove it if you undergo magnetic resonance imaging. Children and adolescentsThe safety and efficacy of Adesitrin in children have not yet been established.

Other medicines and Adesitrin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not use Adesitrin with:

• Phosphodiesterase inhibitors such as sildenafil, vardenafil and tadalafil, used for erectile dysfunction. The use of Adesitrin with these medicines may cause a dangerous drop in blood pressure. Do not stop or interrupt taking Adesitrin to take phosphodiesterase inhibitors as this will increase the likelihood of having an angina attack.
• Soluble guanylate cyclase stimulators such as riociguat, used for pulmonary hypertension. The use of Adesitrin with this medicine may cause a drop in blood pressure. Tell your doctor if you are taking:
• Medicines used to lower blood pressure (e.g. beta-blockers, calcium antagonists, ACE inhibitors, monoamine oxidase inhibitors, diuretics) because they can cause a further drop in blood pressure.
• Medicines used to treat depression (tricyclic antidepressants) or other mental illnesses (such as neuroleptics and major tranquilizers). These medicines can also cause a further drop in blood pressure.
• Medicines used to treat migraine (dihydroergotamine). If taken together, a dangerous increase in blood pressure may occur.
• Aspirin because it can cause a further drop in blood pressure.
• Anti-inflammatory medicines (excluding aspirin) which may reduce the effectiveness of Adesitrin.
• Medicines used for example to reduce the side effects of some cancer treatments or radiotherapy (amifostine).
• Medicines containing sapropterin (used for example for the treatment of a disease called phenylketonuria).

Adesitrin with food, drinks and alcohol
Alcohol can enhance the blood pressure lowering effect. Do not drink alcohol during
treatment with Adesitrin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Adesitrin should be used in pregnancy only if strictly necessary and under medical prescription and continuous
medical supervision.
Breastfeeding
Since the active ingredient of Adesitrin is excreted in breast milk and can cause problems for the newborn,
tell your doctor if you are breastfeeding.
Fertility
There are no data available on the effect of Adesitrin on fertility in men.

Driving and using machines
Adesitrin may affect your ability to react or may rarely cause a drop in
blood pressure (orthostatic hypotension), nausea, dizziness and lightheadedness, to the point of impairing your
ability to drive vehicles or operate machinery. This effect is enhanced by alcohol (see
section “Adesitrin with food, drinks and alcohol”). Do not drive and do not use machines until you have verified if
this medicine affects your ability to perform these activities.

3. How to use Adesitrin

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts
consult your doctor or pharmacist.
Normally, therapy will be started with a low dose which will be adjusted, if necessary, by the doctor, until the
appropriate dose is reached.
You must change the Adesitrin patch once a day. To achieve the necessary dose, different Adesitrin patches are
available, each of which releases a different amount of active substance
per day: 5 mg/24 h, 10 mg/24 h and 15 mg/24 h.

Adults
The recommended initial dose is one 5 mg patch per day. If necessary, at the doctor's discretion, the dose may be increased in the following days. Two patches may be used
simultaneously. The maximum recommended daily dose is 15 mg. For the management of any
angina attacks, concomitant administration of fast-acting nitroglycerin is recommended.

Elderly
There is no evidence to suggest the need for dosage adjustment in elderly patients.

Use in children
This medicine is not suitable for children. If you have further questions about the use of this medicine, please
consult your doctor.

To use Adesitrin, follow these instructions:
The Adesitrin patch is effective wherever it is applied, provided it is not applied to a very thick area of skin (for example the feet) and with poor circulation. To avoid skin irritation, the patch
must be applied every day to a different area. An application site must not be
reused for at least 2-3 days. The best areas to apply the patch are those that are easily
accessible, i.e. relatively static areas on the front or side of the chest. However, the patch can also
be applied to the upper arm, thigh, abdomen or shoulder. ( Figure 1)

Figure 1

Skin at the application site
The skin at the application site must be healthy, intact and relatively wrinkle-free and hairless.

• The patch should not be applied to damaged or diseased skin.
• The patch will adhere better if applied to a region of skin that is not subject to significant movement when the patient moves.
• The patch should not be applied to very hairy skin. It is not recommended to shave the area or cut the hair with scissors, as the hair when it grows back can lift the patch from the skin. The application site must be cleaned and dried before applying the patch.
• Before applying the patch, the skin must be washed with soap in a normal way. It is not necessary to use strong detergents such as alcohol.
• The patch should not be applied after showering or bathing, before the body has returned to a normal temperature and before it is dry. If the patch was already applied before showering, bathing or going to the pool, it generally adheres firmly to the skin and continues to work. In any case, to be sure, you should not stay in the water for too long. Skin care products should not be used before applying the patch
• Products containing oils, creams or lotions should not be used at the application site before using the patch, as the patch does not adhere well to oily skin. The imperceptible layer of fat that protects the skin does not affect the adhesion of the patch. Applying the Adesitrin patch:Each patch is packaged in a separate sachet and should be left in this until use. The sealed sachet can be easily opened via one of the cuts on the edge of the sachet itself. ( Figure 2)

Figure 2
Remove the patch from the sachet and hold it with both hands with the protective layer facing up.
Fold the patch so that the central S-shaped opening line opens. ( Figure 3)

Figure 3
Remove one half of the protective layer and do not touch the adhesive surface with your fingers.
Apply the patch to the prepared skin area and remove the other half of the protective layer. ( Figure 4)

Figure 4
Press the patch firmly with the palm of your hand to ensure that the entire adhesive surface of the
patch is firmly adhered to the skin. ( Figure 5)

Figure 5
Do not cut the patch into pieces.
To avoid the development of tolerance, the patch must remain on the skin for only about 10-14 hours to
ensure a nitrate-free interval of 10-12 hours. During the nitrate-free period, your doctor may prescribe you additional antianginal therapy with medications not containing nitroderivatives.

If you use more Adesitrin than you should
The possible symptoms of an Adesitrin overdose are: drastic lowering of blood pressure, paleness,
sweating, weak pulse, rapid heartbeat, collapse, fainting (syncope), dizziness when
standing up, headache, weakness, dizziness, nausea, vomiting and diarrhea.
An increase in pressure in the head (intracranial pressure) with resulting
brain suffering symptoms can also occur.
Cases of hemoglobin alteration (metahemoglobinemia) with resulting
bluish discoloration of the lips, nails and skin (cyanosis), increased respiratory rate
(tachypnea), anxiety, loss of consciousness and cardiac arrest have also been described.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
However, in case of low blood pressure, it is important that you lie down, with your head slightly
lowered and your legs slightly raised.

If you forget to replace the patch at the usual time
If you forget to replace the patch at the usual time, remove the old patch and inform your doctor.

If you stop treatment with Adesitrin
Do not suddenly stop using Adesitrin even if you feel better. If you stop using the
medicine, your condition may worsen. Continue to use Adesitrin until your doctor tells you to stop. If the doctor believes that you should stop treatment with Adesitrin, your
dose will be gradually reduced.

4. Possible side effects

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

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

• Headache (especially at the beginning of treatment)
• Nausea
• Vomiting Common(may affect up to 1 in 10 people)
• Dizziness (including postural dizziness)
• Drowsiness
• Increased heart rate (tachycardia)
• Sudden drop in blood pressure when moving from a sitting or lying position to standing (orthostatic hypotension)
• Feeling weak (asthenia) Uncommon(may affect up to 1 in 100 people)
• Increased angina symptoms (e.g. chest pain)
• Circulatory collapse sometimes with slowing of the heartbeat and fainting (syncope)
• Allergic skin reactions (e.g. rash)
• At the application site: redness, itching, burning, irritation. After removal of the transdermal patch, any mild skin redness, itching or burning usually disappears after a few hours. The application site should be changed regularly to prevent local irritation. Rare(may affect up to 1 in 1000)
• Redness
• Increased heart rate Very rare(may affect up to 1 in 10000)
• Heartburn (pyrosis) Not known(frequency cannot be estimated based on available data)
• Palpitations
• Decreased blood pressure (hypotension)
• Thickening of the skin surface with scaling (exfoliative dermatitis) During treatment with Adesitrin, a decrease in blood oxygen content (hypoxia) may occur. Like other nitrate-based preparations, ADESITRIN commonly causes dose-dependent headaches which usually disappear after a few days without interrupting treatment Reporting of side effectsIf 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 https://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 Adesitrin

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 pack after: Exp.
The expiry date refers to the last day of that month.

Do not store at a temperature above 25°C. Store in the 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. Contents of the pack and other information

What Adesitrin contains

• The active ingredient is nitroglycerin. Each Adesitrin 5 mg/24 h patch releases 5 mg of nitroglycerin in 24 hours. Each 9 cm patch contains 18.7 mg of nitroglycerin. Each Adesitrin 10 mg/24 h patch releases 10 mg of nitroglycerin in 24 hours. Each 18 cm patch contains 37.4 mg of nitroglycerin. Each Adesitrin 15 mg/24 h patch releases 15 mg of nitroglycerin in 24 hours. Each 27 cm patch contains 56.2 mg of nitroglycerin.
• The other ingredients are: acrylic-vinyl acetate copolymer (adhesive matrix). Support layer: BOPP film (biaxially oriented polypropylene). Description of the appearance of Adesitrin and contents of the packAdesitrin is a transdermal patch. The patches, individually packaged in sachets, are placed in cardboard boxes containing: 5 mg/24 h: 15 patches 10 mg/24 h: 15 patches 15 mg/24 h: 15 patches Marketing Authorisation HolderMERUS LABS LUXCO II S.A.R.L, 26-28 Rue Edward Steichen, L2540 Luxembourg (Luxembourg)

Manufacturer
Aesica Pharmaceuticals GmbH, Alfred-Nobel-Strasse 10, Monheim, Germany