Effortil

ENCLOSED WITH THE PACKAGE: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Effortil

7.5 mg/g (7.5 mg/ml), oral drops

Etilefrine hydrochloride

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Effortil and what is it used for
• 2. Important information before using Effortil
• 3. How to use Effortil
• 4. Possible side effects
• 5. How to store Effortil
• 6. Package contents and other information

1. What is Effortil and what is it used for

Etilefrine, the active substance of the medicine, is an adrenergic agent with high affinity for both alpha-1, beta-1, and beta-2 receptors.
Effortil is indicated for the treatment of symptomatic or orthostatic hypotension (dependent on body position), generally associated with symptoms such as dizziness,
unexplained feeling of fatigue, blurred vision or loss of vision, 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 pheochromocytoma (a tumor of the adrenal gland)
• if the patient has narrow-angle glaucoma
• if the patient has prostatic hyperplasia 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 or major vascular stenosis
• if the patient is in the first trimester of pregnancy and during breastfeeding (see "Pregnancy, breastfeeding, and fertility")

Warnings and precautions

Caution should be exercised when using Effortil in patients with:

• increased heart rate (tachycardia),
• arrhythmias,
• severe cardiovascular diseases,
• diabetes (see "Effortil and other medicines"),
• hyperthyroidism.

The doctor should be informed if the patient has any of the above-mentioned conditions.
Using etilefrine during sports competitions may result in a positive doping test.

Effortil and other medicines

The doctor or pharmacist should be told 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 (a medicine that lowers blood pressure), thyroid hormones, adrenergic agents (medicines used, for example, in the treatment of asthma, chronic obstructive pulmonary disease, upper respiratory tract infections, circulatory disorders, including hypotension) or medicines with sympathomimetic action [such as tricyclic antidepressants (antidepressants), monoamine oxidase inhibitors (MAOIs) (antidepressants and medicines that increase blood pressure)] may enhance the effect of the medicine.
Halogenated hydrocarbon anesthetics and cardiac glycosides in higher doses may increase the effect of Effortil on the heart, leading to arrhythmias.
Dihydroergotamine (a medicine for migraine) increases the intestinal absorption of Effortil, thereby enhancing its effect.
Atropine [a medicine used in spastic conditions of the gastrointestinal tract, urinary tract, and asthma, in the treatment of bradycardia (slow heart rate), a medicine that dilates the pupils] may enhance the effect of Effortil and accelerate heart rate.
Medicines that block adrenergic receptors (alpha- and beta-adrenergic blockers used, for example, in the treatment of hypertension, vascular diseases of the central nervous system, certain heart diseases) may completely or partially eliminate the effect of Effortil. Treatment with beta-adrenergic blockers may cause reflex bradycardia (too slow heart rate).
The effect of antidiabetic medicines that lower blood sugar levels may be weakened.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient human data and the teratogenic effect observed in animal studies, the medicine should not be used in the first trimester of pregnancy (see "When not to use Effortil").
In the second and third trimesters of pregnancy, the medicine may be used only after careful consideration of the risk and benefit of use.
The medicine may disrupt blood circulation in the uterus and placenta and cause uterine muscle relaxation.
The medicine should not be used during breastfeeding, as it cannot be excluded that the medicine passes into breast milk.
No non-clinical or human studies have been conducted on the effect of etilefrine on fertility.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. When using Effortil, side effects such as dizziness may occur. Therefore, caution should be exercised when driving and operating equipment.

Effortil contains sodium metabisulfite and methyl parahydroxybenzoate and propyl parahydroxybenzoate.

Sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions.
1 ml of the solution (approximately 15 drops) contains 0.24 mg of sodium.
Thus, the medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Effortil

This medicine should always be used as directed by the doctor. In case of doubt, the doctor should be consulted.
The recommended dose is:
Adults and children over 6 years of age: 10-20 drops three times a day.
Children between 2 and 6 years of age: 5-10 drops three times a day.
Children under 2 years of age: 2-5 drops three times a day (see "Warnings and precautions").
10 drops correspond to approximately 5 mg of etilefrine hydrochloride.
Effortil oral drops should be taken with a liquid. A particularly rapid effect can be achieved if the medicine is administered before meals.
The inverted bottle should be held in a vertical position. To start the release of drops, the base of the bottle should be tapped lightly.
Tap here on the base of the bottle

Using a higher dose of Effortil than recommended

In case of taking a higher dose of Effortil than recommended, the doctor or pharmacist should be consulted immediately.
Symptoms of overdose
Acute overdose exacerbates the described side effects below. In infants and small children, overdose may lead to inhibition of respiratory center activity and coma.

4. Possible side effects

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

• hypersensitivity (allergic reactions), which may manifest as a rash or itching or swelling of the face, eyelids, lips, mouth, or difficulty breathing. If the patient experiences any of these symptoms, they should immediatelyconsult a doctor
• angina pectoris (chest pain), arrhythmias, tachycardia (fast heart rate), increased blood pressure, palpitations
• anxiety, insomnia
• tremors, restlessness, headache, dizziness
• nausea
• excessive sweating.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Effortil

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.
After opening the package, the medicine remains valid for 6 months.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Effortil contains

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

What Effortil looks like and what the package contains

Effortil is oral drops.
Package size: one bottle of 15 g (15 ml).
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Austria, the country of export:

SERB SA
Avenue Louise 480
1050 Brussels
Belgium

Manufacturer:

Istituto De Angeli S.R.L
Reggello (Florence)
Italy

Parallel importer:

Pharmapoint SA
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o. o.
Jagiellońska 76 Street
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Austria, the country of export: 9106
Parallel import authorization number: 67/20
Date of leaflet approval: 14.02.2022
[Information about the trademark]