Effortil 10 Mg/1 Ml Injection

To correct hypotension in:

• circulatory failure
• during anaesthesia
• post-operatively

Posology

EFFORTIL can be administered as intravenous injection or drip infusion, subcutaneously and intramuscularly. The recommended doses are as follows:

• Children under 1 year - u00bd to 1 ampoule (10 mg) daily
• 4 years - up to 1u00bd ampoules daily
• 8 years - 1 to 2 ampoules daily
• 13 years - 1u00bd to 3 ampoules daily
• Adults - 3 to 6 ampoules daily

For infusion physiological saline solution, lactated Ringeru2019s solution, 5 % glucose solution or 10 % xylitol solution without any further additives should be used.

• Hypersensitivity to the active substance (etilefrine) or to any of the excipients listed in section 6.1.
• Thyrotoxicosis
• Phaeochromocytoma
• Narrow-angle glaucoma
• Prostatic hypertrophy or prostatic adenoma with urinary retention
• Hypertension
• Coronary heart failure
• Hypertrophic obstructive cardiomyopathy
• Hypotensive dysregulation (produce for a patient a hypertensive reaction upon standing)
• The first trimester of pregnancy (see section 4.6)
• Lactation (see section 4.6)
• Decompensated heart failure
• Stenosis of the heart valves or central arteries

Stenosis of the heart valves or central arteries must be ruled out as a cause of hypotension before starting treatment with EFFORTIL. Caution should be exercised in patients with tachycardia, cardiac arrhythmias or severe cardiovascular disorders, diabetes (see section 4.5) or hyperthyroidism. The product can cause positive results in athlete doping tests.

• The effects of EFFORTIL may be enhanced by concomitant use of guanethidine, mineralocorticoids, reserpine, thyroid hormones, other sympathomimetics or any substance with sympathomimetic activity such as tricyclic antidepressants, MAO inhibitors, antihistamines.
• Halogenated aliphatic hydrocarbons in inhalational anaesthetics and cardiac glycosides in higher doses may enhance the effects of sympathomimetic agents on the heart and thus lead to the development of cardiac arrhythmias.
• Dihydroergotamine increases the enteral absorption of EFFORTIL and thereby enhances its action.
• Atropine may lead to an enhanced effect of EFFORTIL and to an increased heart rate.
• Adrenergic blocking agents (u03b1-blockers and u03b2-blockers) may partially or completely abolish the effects of etilefrine. Treatment with u03b2-blockers can induce reflex bradycardia.
• The blood sugar lowering effect of antidiabetic medication may be decreased (see section 4.4).

Pregnancy

EFFORTIL is contraindicated during the first trimester of pregnancy (see section 4.3). Safety of its use during the second and third trimesters has not yet been established. EFFORTIL may impair uteroplacental perfusion and cause uterine relaxation.

Breastfeeding

Entering of the drug into breast milk cannot be excluded, therefore EFFORTIL should not be administered during lactation (see section 4.3).

Fertility

No studies on the effects on human fertility have been conducted.

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness during treatment. Therefore, caution should be recommended when driving or operating machinery. If patients experience the above-mentioned side effects, they should avoid potentially hazardous tasks such as driving or operating machinery.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: Very common (u2265 1/10); common (u2265 1/100 to < 1/10); uncommon (u2265 1/1 000 to < 1/100); rare (u2265 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Immune system disorders

• Not known: Hypersensitivity (allergic reaction)

Psychiatric disorders

• Uncommon: Anxiety, insomnia

Nervous system disorders

• Common: Headache, a sensation of pressure in the head
• Uncommon: Restlessness, dizziness, tremor

Cardiac disorders

• Uncommon: Tachycardia, palpitations, cardiac arrhythmia
• Not known: anginal pain (angina pectoris), unwanted increase in blood pressure

Gastrointestinal disorders

• Uncommon: Nausea

General disorders and administration site conditions

• Not known: Sweating (hyperhidrosis)

The dose of EFFORTIL should be reduced in patients experiencing these symptoms.

Symptoms

Acute overdosage or excessively rapid intravenous injection intensifies the adverse effects previously described. In addition, agitation and vomiting may occur. In babies and small children, overdosage may cause central respiratory paralysis and coma.

Treatment

Symptomatic and supportive treatment should be given as appropriate. Intensive care measures should be taken in cases of severe overdosage. Symptoms which are due to u03b21-sympathomimetic activity may be treated with u03b2-blockers administered in accordance with the usual therapeutic guidelines for this class of medicines.