MINITRAN - PACKAGE LEAFLET - LEAFLETS

Home / leaflets / 2021

Minitran - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Nitroglycerin

MINITRAN 5 mg / 24 h transdermal patch
MINITRAN 10 mg / 24 h transdermal patch
MINITRAN 15 mg / 24 h transdermal patch

Indications Why is Minitran used? What is it for?

Minitran patches contain the active ingredient nitroglycerin, a vasodilator used for heart conditions that belongs to a group of medicines called organic nitrates.

Minitran is indicated for the prevention and treatment of angina attacks occurring both at rest and after exertion in adults.

Angina usually presents with chest pain or tightness that can spread to the neck or arm. Pain occurs when the heart is not sufficiently oxygenated. Minitran is not indicated for the treatment of acute episodes of angina .

Minitran patches are for external use only.

Talk to your doctor if you don't feel better or if you feel worse.

Contraindications When Minitran should not be used

Do not use Minitran:

if you are allergic to nitroglycerin or similar molecules (organic nitrates related to nitroglycerin) or to any of the other ingredients of this medicine;
if you suffer from severe anemia;
if you suffer from increased intraocular pressure;
if you suffer from increased intracranial pressure;
if you are currently or have recently suffered a collapse (acute circulatory failure associated with marked hypotension);
if you are pregnant and breastfeeding (see section "Fertility, pregnancy and breastfeeding");
if you are "under 18 years of age (see section" Children and adolescents ");
if you suffer from an inability of the heart to pump enough blood to meet the body's needs (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 (stenosis aortic or mitral stenosis, respectively), or a thickening of the thin, sac-like membrane surrounding the heart (constrictive pericarditis);
if you are taking medicines to treat erectile dysfunction (e.g. sildenalfil or other PDE-5 inhibitors). Patients undergoing nitrate therapy should not take sildenafil or other medicines for the treatment of erectile dysfunction. Combining a nitrate with sildenafil or other PDE-5 inhibitors can cause a sudden and sharp drop in blood pressure, which can lead to fainting, unconsciousness or even heart attack (see section "Other medicines and Minitran");
if you suffer from a disease that causes your blood pressure to drop sharply (maximum blood pressure below 90 mm Hg);
if you suffer from a severe decrease in the volume of blood in your body due to blood loss or loss of body fluids (severe hypovolaemia);
if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section "Other medicines and Minitran").

Precautions for use What you need to know before taking Minitran

Talk to your doctor or pharmacist before using Minitran:
if the level of oxygenation of the blood is insufficient (hypoxemia) due to severe anemia, or lung disease, or a reduced blood supply to the heart (ischemic heart failure);
if angina is caused by thickening of the heart (hypertrophic cardiomyopathy). Nitrates can make this type of angina worse;
if you experience an increase in the frequency of anginal attacks during patch-free periods (intermittent therapy). Your doctor may wish to re-evaluate your coronary artery disease and consider adjusting your treatment by administering an antianginal drug at the same time (see section "How to use Minitran");
if you are taking other nitrates (e.g. sublingual nitroglycerin), as your body may generate resistance to the effects of these substances upon repeated exposure. This can be prevented with intermittent therapy (see section "How to use Minitran");
if you stop treatment or if you need to switch to another treatment. Discontinuation of treatment with Minitran should be done gradually and under close medical supervision;
if you have or have recently had a heart attack (myocardial infarction) or acute heart failure. Treatment should be done with caution and under close medical supervision;
if you need to have electrical stimulation of the heart to restore normal heart rhythm (defibrillation or cardioversion) or procedures that use magnetic fields (magnetic resonance imaging). You must remove the Minitran patch before undergoing any of the above treatments or procedures;
if your blood pressure is below normal (hypotension) and if you collapse while being treated with Minitran. In these cases, the removal of the patch should be considered;
in case you have to undergo a laboratory test for catecholamines, you must be careful as nitroglycerin could alter the test result (higher than real values or false positivity).

During treatment with Minitran, avoid changing positions too quickly: it is possible that Minitran, especially in elderly patients, may cause an excessive reduction in pressure during the abrupt transition from lying to standing (orthostatic hypotension).

Children and adolescents

Minitran should not be used in children and adolescents below 18 years of age as safety and efficacy have not been established.

Interactions Which drugs or foods may change the effect of Minitran

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid concomitant administration of medicines to treat erectile dysfunction (eg sildenafil or other PDE-5 inhibitors) as they may potentiate the blood pressure lowering effect of nitrates (see also section "Do not use Minitran") .

The use of Minitran with riociguat, a soluble guanylate cyclase stimulator, is contraindicated as concomitant use may cause hypotension (see section "Do not use Minitran").

You may have a "further decrease in blood pressure if you are taking medicines at the same time as they are indicated for:

the treatment of high blood pressure (such as calcium channel blockers, beta blockers, ACE inhibitors, diuretics),
for the treatment of mental illnesses (neuroleptics, major tranquilizers),
for the treatment of depression (tricyclic antidepressants)

The effect of nitroglycerin may be reduced if you take dihydroergotamine (a drug used to treat headaches) at the same time, resulting in narrowing of the heart vessels.

If you take non-steroidal anti-inflammatory drugs at the same time, with the exception of acetylsalicylic acid, you may have a reduction in the therapeutic response of Minitran.

You may have a further decrease in blood pressure if you are taking acetylsalicylic acid and amifostine at the same time.

Minitran with alcohol

If you drink alcohol the blood pressure lowering effect of Minitran may increase.

Warnings It is important to know that:

Fertility, pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Fertility: There are no data on the effect of Minitran on human fertility.

Pregnancy: You should not take Minitran during pregnancy, especially in the first three months. If during regular use of Minitran you become pregnant, immediately inform your doctor who will decide if and how to continue the therapy.

Breastfeeding: There is insufficient information on the passage of nitroglycerin into breast milk. A risk to the newborns / infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Minitran therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for her.

Driving and using machines

Minitran, especially at the start of treatment or when making dose adjustments, may alter your reactions or may rarely cause orthostatic hypotension and dizziness (as well as exceptionally fainting from overdosing). If these effects occur, you should refrain from driving or driving. "use of machinery.

Dosage and method of use How to use Minitran: Dosage

Always use this medicine exactly as your doctor or pharmacist has told you.

If in doubt, consult your doctor or pharmacist. The recommended dose is the application of one transdermal patch per day. Your doctor will determine the duration of the daily application; your doctor will tell you whether to apply the transdermal patch continuously for all 24 hours or to suspend the application for a few hours. (for example during the night), in order to avoid the onset of tolerance towards the drug (intermittent therapy).

Intermittent therapy applies especially if you are taking other nitrates (eg sublingual nitroglycerin); it is recommended to apply Minitran daily with a free interval of 8-12 hours.

Duration of treatment with Minitran

Treatment with Minitran can continue for several years; however, your doctor will want to see you regularly to decide whether to continue the treatment or to change the treatment regimen.

How to apply the patch

You should apply the patch to clean, dry skin and not to wounds, spots or moles or to an area to which you have just applied a cream, moisturizing lotion or talc. Apply the Minitran transdermal patches to the skin of the chest or area outer and upper arm (see Figure 2), free from redness or irritation and to vary patch application sites. You can shave the application area if necessary. You should avoid areas that form folds or that are subject to rubbing during movement.

Do not apply two patches consecutively to the same area.

Follow the instructions below for applying the Minitran patch to the skin as soon as you remove it from its sachet:

Open the sachet by tearing it from the marked notch and take the patch out of the sachet. Do not use scissors.
Fold the patch along the pre-marked line on the back of the patch, grab one of the two protective tabs and carefully pull one out. Discard the tab. Do not touch the sticky side of the patch or it will not adhere properly.
Apply the adhesive part released by the tongue to the selected area of the skin.
Grab the remaining tab and pull carefully to prevent the patch from coming off.
Press the patch firmly with the palm of your hand.

Wash your hands before and after applying Minitran. To remove the patch, simply lift a flap and pull gently.

Overdose What to do if you have taken too much Minitran

In case of accidental intake of an excessive dose of Minitran you should notify your doctor immediately or go to the nearest hospital. The risk of overdose is very low thanks to the controlled release of nitroglycerin.

Symptoms

If you take high doses of nitroglycerin, you may experience severe drop in blood pressure, increased heart rate or collapse and fainting, bluish discoloration of the skin and mucous membranes (cyanosis), coma and seizures. Alteration of hemoglobin (methemoglobinemia) has also been reported following accidental overdose.

Treatment

In case of accidental overdose, the effect of nitroglycerin can be quickly stopped by removing the patch from the skin. Hypotension, or collapse, can be treated by elevating the patient's lower limbs to a lying position or, if necessary, bandaging the themselves; if necessary, this first intervention can be followed by adequate therapy in accordance with the judgment of the treating physician. In case of methemoglobinemia, the treating doctor will provide you with adequate therapy.

If you stop taking Minitran

When you stop taking Minitran, you may have a recurrence of anginal attacks.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Minitran

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

Undesirable effects are classified in order of decreasing frequency:

Very Common (may affect more than 1 in 10 patients):

stomach upset (nausea and vomiting).

Common (may affect up to 1 in 10 patients):

headache (headache) Uncommon (may affect up to 1 in 100 people):
inflammation of the skin (dermatitis) from contact
redness of the skin (erythema) at the patch application site
itching, burning and irritation

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

increased heart rate (tachycardia) which could also alter any diagnostic tests
abrupt drop in blood pressure following a sudden transition from sitting or lying to standing (orthostatic hypotension), hot flashes

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

dizziness

Not known (frequency cannot be estimated from the available data):

syncope

Like all nitrate-based preparations, Minitran commonly causes headaches, which vary according to the dose, due to dilation of the cerebral vessels: they generally occur at the beginning of treatment and disappear after a few days without interrupting the therapy. headache persists even during intermittent therapy, mild analgesics can be used.If the headache does not respond to this type of treatment, it is advisable to reduce the dosage of nitroglycerin, or to interrupt the treatment.

A slight increase in heart rate can be avoided by resorting, if necessary, to combined treatment with a beta blocker.

After removing the transdermal patch, any slight redness of the skin usually disappears after a few hours. Application site should be changed regularly to prevent local irritation.

With regard to the possible undesirable effects affecting the heart and the circulatory system, orthostatic hypotension, tachycardia, palpitations, hot flashes and dizziness, are undesirable effects which occur mainly at the beginning of the treatment.

The use, especially if prolonged, of products for local application can give rise to sensitization phenomena; in such cases it is necessary to interrupt the treatment and adopt suitable therapeutic measures.

The following adverse reactions are derived from post-marketing experience with Minitran through spontaneous reports and case reports. As these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore classified as not Note:

effects affecting the heart: palpitations
effects affecting the skin: redness of the skin not limited to the application site.

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 via the national reporting system at www.agenziafarmaco.it/it/responsabili.

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children both before and after use.

Do not store above 25 ° C. Minitran must be kept in its unopened sachet.

Do not use this medicine after the expiry date which is stated on the carton and sachets after EXP. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other Information

What Minitran contains

The active ingredient is nitroglycerin
The other components are: copolymer derived from acrylic acid, ethyl oleate, glyceryl monolaurate, low density polyethylene, polyester.

Description of what Minitran looks like and contents of the pack

Minitran 5 mg / day transdermal patch is a clear oval-shaped patch with the inscription Minitran 5

It is available in packs of 15 and 30 transdermal systems. Minitran 10 mg / day transdermal patch is a clear oval-shaped patch with the inscription Minitran 10

It is available in packs of 15 and 30 transdermal systems.

Minitran 15 mg / day transdermal patch is a clear oval-shaped patch with the inscription Minitran 15.

It is available in packs of 15 and 30 trans dermal systems.

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Minitran can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

MINITRAN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

MINITRAN 5 mg / 24 hours transdermal patches

A 6.7 cm2 surface patch contains:

Active principle nitroglycerin 18 mg.

(The average amount of nitroglycerin released in 24 hours is 5 mg)

MINITRAN 10 mg / 24 hours transdermal patches

A patch of 13.3 cm2 surface area contains:

Active principle nitroglycerin 36 mg.

(The average amount of nitroglycerin released in 24 hours is 10 mg)

MINITRAN 15 mg / 24 hours transdermal patches

A patch of surface of 20 cm2 contains:

Active principle nitroglycerin 54 mg.

(The average amount of nitroglycerin released in 24 hours is 15 mg)

03.0 PHARMACEUTICAL FORM

Transdermal patches.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Prophylaxis and treatment of angina pectoris both from exertion and at rest, associated or consequent to coronary insufficiency.

04.2 Posology and method of administration

The response to nitrates varies from subject to subject and in any case the minimum effective dose must be prescribed.

It is recommended to start treatment with one patch of Minitran 5 mg per day, with subsequent dose increase: Minitran 10 mg or possibly Minitran 15 mg, if needed.

The application can be either continuous for a period of 24 hours, or intermittent, with free interval (usually at night).

Attenuation of the effect has occurred in some patients treated with slow-release nitrate preparations. In these cases, based on recent clinical studies, it is recommended to apply Minitran daily with a free interval of 8-12 hours.

Use in the elderly: There is no special information on use in the elderly, however there is no evidence to suggest the need for dose adjustments.

Use in children: The safety and efficacy of Minitran in children has not yet been established.

The patch consists of a thin transparent film of low density polyethylene permeable to oxygen and vapors, but not to liquids, covered with an acrylic adhesive matrix in which nitroglycerin is dispersed. The three-dimensional matrix regulates the rate of release of the principle active evenly.

Each Minitran patch is contained in a sealed sachet. The adhesive layer is covered with a protective polyester membrane which is removed and eliminated before use.

The patch should be applied to a clean, dry and healthy area of the skin on the chest or arms, without hair or ointment residue.

Subsequent patches can only be applied to the same area several days after the previous application. Minitran adheres easily to the skin and remains perfectly adherent during bathing or sports exercises.

04.3 Contraindications

- Known hypersensitivity to nitroglycerin and related organic nitrates, or to any of the excipients of Minitran;

- severe anemia;

- increased intraocular pressure;

- conditions associated with elevated intracranial pressure;

- acute circulatory failure associated with marked hypotension (shock);

- heart failure due to obstruction, such as in case of aortic or mitral valve stenosis or in constrictive pericarditis;

- generally contraindicated in pregnancy and lactation (see section 4.6);

- generally contraindicated in pediatric age;

- concomitant use of Minitran and phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil (Viagra), is contraindicated as PDE5 inhibitors may amplify the vasodilatory effects of Minitran causing severe hypotension (see section 4.5);

- Severe hypotension (systolic blood pressure below 90 mmHg);

- Severe hypovolemia;

- During therapy with nitrates or nitric oxide donors, the soluble guanylate cyclase stimulator riociguat should not be used (see section 4.5).

04.4 Special warnings and appropriate precautions for use

Warnings

Minitran is not indicated in cases of acute angina attacks that require rapid resolution.

As with other nitrate preparations, when a patient on long-term therapy switches to other forms of treatment, the nitroglycerin therapy should be gradually discontinued and the new therapy should be introduced simultaneously during the tapering of Minitran.

In the event of discontinuation of treatment, in patients with angina, the dose and frequency of applications of Minitran should be gradually reduced to prevent withdrawal reactions characteristic of vasodilators of this class.

In case of recent myocardial infarction or acute heart failure, treatment with Minitran should be carried out with caution under close medical supervision and / or with haemodynamic monitoring.

The use, especially if prolonged, of products for topical application, can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and adopt suitable therapeutic measures.

The Minitran patch must be removed before applying magnetic or electric fields to the body during procedures such as MRI (Magnetic Resonance Imaging), cardioversion or DC defibrillation, or diathermic treatment.

Since the product can cause orthostatic hypotension, especially in elderly patients, patients should be advised of this possibility in order to avoid abrupt changes in position at the start of treatment.

If significant hypotension occurs, removal of the patch should be an integral part of patient management.

The onset of habituation (ie decrease or disappearance of efficacy) to the product and cross habituation with other nitro derivatives may occur with repeated or continuous administration of long-acting nitrates, including Minitran or other transdermal patches. This can be prevented by maintaining low plasma levels of nitroglycerin for a certain period of the dose interval and for this reason intermittent therapy is preferable (see section 4.2).

Nitroglycerin can interfere with the dosage of catecholamines or vanyl-mandelic acid in the urine, increasing the excretion of these substances.

Precautions

Hypoxemia

Caution should be exercised in patients with arterial hypoxemia caused by severe anemia (including the deficient induced forms of G6PD), as the biotransformation of nitroglycerin is reduced in such patients. Similarly, Minitran should be used with caution in patients with hypoxemia or changes in the ventilation / perfusion ratio due to pulmonary disease or ischemic heart failure. In patients with alveolar hypoventilation, vasoconstriction occurs within the lung to shift perfusion from areas of alveolar hypoxia to better ventilated regions of the lung (Euler-Liljestrand mechanism).Patients with angina pectoris, myocardial infarction or cerebral ischaemia frequently suffer from small airway abnormalities (especially alveolar hypoxia). The potent vasodilator activity of nitroglycerin could reverse this protective vasoconstriction and thus lead to an increase in perfusion in areas where ventilation is poor, a worsening of the ventilation / perfusion imbalance, and a further reduction in arterial partial pressure of oxygen.

Hypertrophic cardiomyopathy

Nitrate therapy can worsen angina caused by hypertrophic cardiomyopathy.

Increased episodes of angina

It is possible that the frequency of anginal attacks may increase during the periods when the patch is not applied; in these cases the use of additional anti-anginal therapy is advisable.

Tolerance to sublingual nitroglycerin.

If tolerance to nitroglycerin patches develops, the effect of sublingual nitroglycerin on exercise tolerance may be partially diminished.

04.5 Interactions with other medicinal products and other forms of interaction

Interactions that determine contraindication to concomitant use

The concomitant use of Minitran and other vasodilators, (eg. PDE5 inhibitors such as sildenafil [Viagra]), potentiates the hypotensive effects of Minitran and, therefore, it is contraindicated (see paragraph 4.3).

The use of Minitran with riociguat, a soluble guanylate cyclase stimulator, is contraindicated as concomitant use may cause hypotension (see section 4.3).

Interactions to consider

Calcium antagonists, beta blockers, ACE inhibitors, neuroleptics, diuretics, antihypertensives, tricyclic antidepressants and major tranquilizers, as well as alcohol consumption, may increase the hypotensive effect of Minitran.

Co-administration of Minitran with dihydroergotamine may increase the bioavailability of the latter. This requires particular attention in patients with coronary artery disease, because dihydroergotamine antagonizes the effect of nitroglycerin and can induce vasoconstriction in the coronary arteries.

Non-steroidal anti-inflammatory drugs, with the exception of acetylsalicylic acid, may decrease the therapeutic response to Minitran.

Co-administration of Minitran with amifostine and acetylsalicylic acid may potentiate the hypotensive effect of Minitran.

04.6 Pregnancy and breastfeeding

Fertility

There are no data available on the effect of Minitran on human fertility.

Pregnancy

Minitran, like all other medicines, should not be given in pregnancy, especially during the first trimester, unless there are important reasons for doing so.

If you become pregnant during regular use of Minitran, you should immediately notify your doctor.

Feeding time

Little information is available on the excretion of the active substance in human or animal milk. It cannot be excluded that there is a risk to the suckling child.

04.7 Effects on ability to drive and use machines

Minitran, especially at the start of treatment or after dose changes, may impair the ability to react, as well as rarely cause orthostatic hypotension and dizziness (as well as, exceptionally, overdose syncope). Patients experiencing these effects should not drive or use machinery.

04.8 Undesirable effects

Adverse reactions are listed below by system classification and organs according to MedDRA. Within each class, adverse reactions are ranked in order of frequency, with the most frequent first. Within each frequency group, adverse reactions are listed in order of decreasing severity. Furthermore, the corresponding frequency category is indicated using the following convention (CIOMS III): very common (≥1 / 10), common (≥1 / 100,

Table 1 Adverse drug reactions

Nervous system: Common: headache 1 Very rare: dizziness Not known: syncope Cardiac disorders: Rare: tachycardia 2 Vascular disorders: Rare: orthostatic hypotension, flushing 2 Gastrointestinal disorders: Very common: nausea, vomiting Skin and subcutaneous tissue disorders: Uncommon: contact dermatitis General disorders and administration site conditions Uncommon: application site erythema, pruritus, burning, irritation 3 Diagnostic tests Rare: increased heart rate

1 Like other nitrate preparations, Minitran commonly causes dose-dependent headache, due to cerebral vasodilation, which often disappears after a few days despite continued therapy. If headache persists during intermittent therapy, it should be treated with mild analgesics. If the headache is refractory to treatment it is necessary to decrease the dose of nitroglycerin or discontinue the treatment.

2 A modest reflex increase in heart rate can be avoided by combining a beta blocker if necessary.

3 After removing the patch, the effects of slight skin redness generally disappear within a few hours. The site of application must be changed regularly to avoid local irritation phenomena.

With regard to the undesirable effects affecting the cardio-vascular system, hypotension (especially orthostatic), tachycardia, lipothymias, palpitations, hot flashes and dizziness are undesirable effects that occur especially at the beginning of the treatment.

• Cardiac disorders: palpitations.

• Skin and subcutaneous tissue disorders: generalized rash.

04.9 Overdose

In view of the slow-release formulation of Minitran, an overdose is rare.

Symptoms

High doses of nitroglycerin can cause severe hypotension and reflex tachycardia or collapse and syncope, cyanosis, coma and seizures.

Cases of methaemoglobinaemia have also been reported following accidental overdose.

Treatment

The nitrate effect of Minitran can be quickly stopped by simply removing the patch.

Hypotension or collapse can be treated by elevating the patient's legs or, where necessary, using bandages that compress them.

Severe methemoglobinemia can be treated with an injection of methylthionine or tolonium.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Nitroglycerin directly causes dilation of the veins and a reduction in resistance in the venous system (venous pooling). In this way the venous reflux to the heart is reduced, the final diastolic ventricular filling is decreased and the end-diastolic pressure is lowered.

Nitroglycerin also causes a slight lowering of peripheral and coronary arteriolar resistance.

Based on these effects on the cardio-circulatory system, a saving of cardiac work and a decrease in oxygen consumption by the myocardium are obtained.

The lowering of the parietal pressure improves the perfusion of the sub-endocardial region of the myocardium.

The effect on the coronary district is also exerted on the vasospastic forms.

05.2 Pharmacokinetic properties

The three-dimensional matrix of the patch, in which nitroglycerin is dispersed, regulates the rate of release of the active ingredient in a uniform way: respectively 0.2 mg, 0.4 mg and 0.6 mg per hour for the three different packs available ( 5mg, 10mg and 15mg).

On the basis of pharmacokinetic studies conducted with Minitran alone and / or in comparison with similar preparations, the nitroglycerin released by the patch was well absorbed: it is detectable in the plasma as early as 30 minutes after application and the peak concentration is reached after. 2 hours.

The average release rate of nitroglycerin from the patch is such as to allow plasma concentrations constant over 24 hours and always proportional to the dose.

05.3 Preclinical safety data

Absence of significant elements.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Copolymer derived from acrylic acid, ethyl oleate, glyceryl monolaurate, low density polyethylene, polyester.

06.2 Incompatibility

Not known.

06.3 Period of validity

24 months.

06.4 Special precautions for storage

Store at a temperature not exceeding 25 ° C.

06.5 Nature of the immediate packaging and contents of the package

MINITRAN 5 mg / 24 hours transdermal patches: lithographed cardboard box containing 15 or 30 transdermal patches, which release 5 mg of nitroglycerin in 24 hours, contained in paper / aluminum / polyethylene sachets.

Public sale price:

MINITRAN 10 mg / 24 hours transdermal patches: lithographed cardboard box containing 15 or 30 transdermal patches, which release 10 mg of nitroglycerin in 24 hours, contained in paper / aluminum / polyethylene sachets.

Public sale price:

MINITRAN 15 mg / 24 hours transdermal patches: lithographed cardboard box containing 15 or 30 transdermal patches, which release 15 mg of nitroglycerin in 24 hours, contained in paper / aluminum / polyethylene sachets.

06.6 Instructions for use and handling

Remove the patch from the package. Remove the adhesive protection, taking care not to touch the release surface with your hands, apply the patch in the desired area, after having thoroughly cleaned it.