Effortil

Patient Information Leaflet

Warning! Please keep the leaflet. The packaging information in a foreign language.
Effortil
7.5 mg/g (7.5 mg/mL), oral drops
Etilephrine hydrochloride
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Effortil is and what it is used for
2. Important information before taking Effortil
3. How to take Effortil
4. Possible side effects
5. How to store Effortil
6. Contents of the pack and other information

1. What Effortil is and what it is used for

Etilephrine, the active substance in Effortil, is a sympathomimetic agent with high affinity for both alpha-1, beta-1, and beta-2 receptors.
Effortil is indicated in the treatment of symptomatic or orthostatic hypotension (related to body position), commonly associated with symptoms such as dizziness, unexplained fatigue, blurred or loss of vision, and feeling of weakness.

2. Important information before using Effortil

When not to use Effortil:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has arterial hypertension,
• if the patient has hyperthyroidism,
• if the patient has a chromaffin cell tumour of the adrenal gland (pheochromocytoma),
• if the patient has narrow-angle glaucoma,
• if the patient has prostatic hypertrophy with urinary retention,
• if the patient has coronary artery disease,
• if the patient has decompensated heart failure,
• if the patient has hypertrophic cardiomyopathy with left ventricular outflow tract obstruction,
• if the patient has valvular heart disease or stenosis of major arteries,
• if the patient is in the first trimester of pregnancy or during breastfeeding (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Caution is advised when using Effortil in patients with:

• increased heart rate (tachycardia),
• cardiac arrhythmias,
• severe cardiovascular disorders,
• diabetes (see "Effortil with other medicines"),
• hyperthyroidism.

Inform the doctor if any of the above conditions apply to the patient.
Use of etilefrine during sports competitions may lead to a positive result in out-of-competition drug testing (i.e. anti-doping tests).

Effortil with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of guanethidine, mineralocorticoids, reserpine (an antihypertensive agent), thyroid hormones, adrenomimetics (medicines used, for example, in the treatment of bronchial asthma and chronic obstructive pulmonary disease, upper respiratory tract infections, circulatory disorders including hypotension), or other medicines with sympathomimetic activity [such as tricyclic antidepressants (antidepressant drugs), monoamine oxidase inhibitors (MAO inhibitors) (antidepressant drugs and drugs that increase arterial blood pressure)] may enhance the effect of Effortil.
Halogenated aliphatic hydrocarbon derivatives (inhalational general anaesthetics) and cardiac glycosides at higher doses may increase the effect of Effortil on the heart, leading to cardiac arrhythmias.
Dihydroergotamine (an antimigraine drug) increases intestinal absorption of Effortil and thereby enhances its effect.
Atropine [a drug used in spastic conditions of the gastrointestinal tract, urinary tract, and bronchial asthma, in the treatment of bradycardia (slow heart rate), and as a pupil-dilating agent] may enhance the effect of Effortil and increase heart rate.
Adrenergic receptor blockers (alpha- and beta-adrenergic blocking agents used, for example, in the treatment of hypertension, central nervous system vascular disorders, and certain heart diseases) may completely or partially counteract the effect of Effortil. Treatment with beta-adrenergic blocking agents may induce reflex bradycardia (abnormally slow heart rate).
The blood glucose-lowering effect of antidiabetic medicines may be reduced.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient human data and teratogenic effects observed in animal studies, the medicine must not be used during the first trimester of pregnancy (see "When not to use Effortil").
During the second and third trimesters of pregnancy, the medicine may be used only after careful consideration of the risks and benefits.
The medicine may impair uterine and placental blood flow and cause uterine muscle relaxation.
The medicine should not be used during breastfeeding, as passage into breast milk cannot be excluded.
Non-clinical and human studies on the effect of etilefrine on fertility have not been conducted.

Driving and operating machinery
No studies on the effect of the medicine on the ability to drive vehicles or operate machinery have been conducted. During treatment with Effortil, adverse effects such as dizziness may occur. Therefore, caution should be exercised when driving or operating machinery.

Effortil contains sodium metabisulfite (E 223), methyl parahydroxybenzoate (E 218), and
propyl parahydroxybenzoate (E 216)
Sodium metabisulfite (E 223) may rarely cause severe hypersensitivity reactions and bronchospasm.
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (including delayed-type reactions).

Effortil contains sodium
Effortil contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Effortil

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor.
Recommended dose:
Adults and children over 6 years of age: 10–20 drops three times daily.
Children between 2 and 6 years of age: 5–10 drops three times daily.
Children under 2 years of age: 2–5 drops three times daily (see "Warnings and precautions").
10 drops correspond to approximately 5 mg of ethylnoradrenaline hydrochloride.
Effortil should be taken with liquid. A particularly rapid effect can be achieved if the medicine is administered before meals.
Hold the inverted bottle in an upright position. To initiate drop release, tap lightly at the bottom of the bottle.
Tap here at the bottom of the bottle

Use of Effortil in higher than recommended doses
If more Effortil than recommended has been taken, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose
Acute overdose intensifies the undesirable effects described below. In infants and young children, overdose may lead to respiratory centre depression and coma.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them:

• hypersensitivity (allergic reactions), which may manifest as raised, itchy rash (urticaria) or swelling of the face, eyelids, lips, mouth, or difficulty breathing. If any of these symptoms occur in a patient, immediate medical attention must be sought;
• angina (chest pain), cardiac arrhythmias, tachycardia (rapid heartbeat), increased blood pressure, palpitations;
• anxiety, insomnia;
• tremors, motor restlessness, headache;
• dizziness;
• nausea;
• excessive sweating.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Effortil medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
After first opening, do not use beyond 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Effortil contains

• The active substance is ethylnoradrenaline hydrochloride. 1 ml of the medicine (approximately 15 drops) contains 7.5 mg of ethylnoradrenaline hydrochloride.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium metabisulfite (E 223), purified water.

What Effortil looks like and contents of the pack
Effortil is a clear, colourless oral solution.
Pack size: one 15 g bottle.
For further information, please contact the responsible party or parallel importer:
Marketing Authorisation Holder in Austria, country of export:
SERB SA
Avenue Louise 480
1050 Brussels, Belgium
Manufacturer:
Istituto De Angeli S.R.L.
Reggello (Florence)
Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Austria, country of export: 9106
Parallel import licence number: 528/15