EFFORTIL Solution for injection Ref.[51028] Active ingredients: Etafedrine

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 (α-blockers and β-blockers) may partially or completely abolish the effects of etilefrine. Treatment with β-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 (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of EFFORTIL is important. It allows continued monitoring of the benefit/risk balance of EFFORTIL. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8, or to the Pharmacovigilance Unit at PHARMACO at 011 784 0077 (Tel).

EFFORTIL should not be mixed with levulose solutions or hydroxyethyl starch (HES/HAES) solution due to incompatibilities.

This medicine must not be mixed with other medicines except those mentioned in section 6.6.