Medicinal Products

EPINITRIL 5 mg / 24 hours

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Trinitrin
laboratory: Bouchara-Recordati

Transdermal patch
Case of 30
All forms

Indication

Preventive treatment of the angina attack, used alone or in combination with other anti-anginal treatments.

Dosage EPINITRIL 5 mg / 24 hours transdermal device Case of 30

Different dosages of EPINITRIL are available.

The treatment is usually initiated with an EPINITRIL 5 mg / 24 h device applied to the skin once a day. EPINITRIL 5 mg / 24 h delivers 0.2 mg / hour of trinitrin.

The dose should be individually adjusted during treatment to achieve an optimal therapeutic effect.

The maximum daily dose should not exceed 15 mg trinitrin.

EPINITRIL is administered discontinuously, with a daily free interval without trinitrin to avoid the development of tolerance to nitrates. This free interval must correspond to a period during which the patient does not have a seizure. The schedule for the associated anti-anginal treatment (beta-blocker and / or calcium channel blocker) should be chosen to ensure therapeutic coverage during this free interval.

The duration of the interval must be at least 8 hours.

In the preventive treatment of the angina attack, the development of tolerance to nitrates is a well-established phenomenon. A suitable prescription respecting a free interval ensures the therapeutic efficacy of nitrates.

Patients suffering from nocturnal angina will benefit from overnight treatment followed by a free interval during the day. In these patients, an associated anti-anginal treatment may be necessary during the day.

Patients with severe angina may also require associated anti-anginal therapy during the free interval.

It is recommended that the EPINITRIL transdermal patch be applied to the chest skin or the upper arm on the outer side, in a place free of redness or irritation, and to alternate areas of application. If necessary, the shaving of the application area can be achieved. Application areas forming folds or susceptible to friction during movement should be avoided.

In the elderly

No dose adjustment is recommended in the elderly, as no studies have been performed in this population.

In patients with renal and / or hepatic insufficiency

Since no studies have been performed in patients with impaired renal and / or hepatic function, no dose recommendation can be made.

In children and teenagers

EPINITRIL is not recommended for children and adolescents under 18 years of age.

Against indications

· Known hypersensitivity to trinitrin and nitrates or to any of the excipients of EPINITRIL,

· Acute circulatory insufficiency associated with significant hypotension (shock),

· Conditions of intracranial hypertension, including head trauma,

Obstructive heart failure (for example, in the presence of mitral or aortic stenosis or constrictive pericarditis),

· Combination with Phosphodiesterase 5 (PDE5) inhibitors, such as sildenafil, is contraindicated because PDE5 inhibitors increase the vasodilator action of EPINITRIL, causing severe hypotension,

Severe hypotension (systolic blood pressure less than 90 mm Hg),

· Severe hypovolemia,

· Severe anemia,

· Toxic pulmonary edema.

Epinitril side effects

Adverse drug reactions are listed by MedDRA System Organ Class (SOC) classes. For each class, the adverse effects of the drug are ranked according to their frequency, with the most common occurring first. In addition, within each frequency group, the adverse effects of the drug are ranked in order of decreasing severity. Finally, the frequency of adverse effects is also given according to the CIOMS III classification: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000), including isolated notifications.

Class organ system

Very common (≥ 1/10)

Frequent

( 1/100 to <1/10)

Rare

( 1/1000 to <1/100)

Rare ( 1/10 000 to <1/1000)

Very rare

(<1 / 10, 000)

Central nervous system disorders

- Headache 1

- Feeling light

- Dizziness

- Syncope

Heart conditions

- Tachycardia 2

Vascular disorders

- Orthostatic hypotension

- puffs

vasomotor 2

Gastrointestinal disorders

- Nausea

- Vomiting

Skin and subcutaneous tissue disorders

- Eczema of contact

General disorders and administration site conditions

- Erythema at the application site

- Pruritus

- Burn

- Irritation 3

investigations

- Increase

the frequency

cardiac

1 Like all other nitrates, EPINITRIL frequently causes dose-dependent headaches due to cerebral vasodilation. These headaches often regress after a few days despite the maintenance of treatment. If the headache persists during intermittent treatment, it should be treated with mild analgesics. In the case of headaches not responding to analgesic treatment, the dosage of trinitrine should be reduced or treatment discontinued.

2 A slight reflex increase in heart rate can be controlled, if necessary, by combining a beta-blocker.

3 When removing the patch, the slight redness of the skin usually disappears within a few hours. The application site should be changed regularly to avoid local irritation.

The following adverse reactions have been reported during the post-marketing authorization experience and come from spontaneous reports and published cases. Since these effects were voluntarily reported by a population whose size is not precisely defined, their frequency can not be reliably estimated, hence their classification in the category "Frequency not known". Within each class of organ systems, the adverse effects of the drug are presented in order of decreasing severity.

· Heart diseases: palpitations.

· Skin and subcutaneous tissue disorders: generalized rash.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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