Effortil

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Effortil
7.5 mg/g (7.5 mg/mL), oral drops
Etilefrini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

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

Leaflet 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

Ethylephrine, the active substance in Effortil, is an adrenergic agent with high affinity for both alpha-1, beta-1, and beta-2 receptors.
Effortil is indicated in the treatment of symptomatic or orthostatic (position-dependent) arterial hypotension, generally associated with symptoms such as dizziness, unexplained fatigue, blurred vision or loss of vision, and feelings 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 phaeochromocytoma
• 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 should be exercised when using Effortil in patients with:

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

The doctor should be informed if any of the above conditions apply to the patient.
The use of ethylnorepinephrine during sports competitions leads 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 currently or recently taken, as well as any medicines planned for use.

Concomitant use of guanethidine, mineralocorticoids, reserpine (an antihypertensive agent), thyroid hormones, adrenomimetic agents (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 exhibiting sympathomimetic activity [such as tricyclic antidepressants (antidepressants), monoamine oxidase inhibitors (MAO inhibitors) (antidepressants and agents increasing arterial blood pressure)] may enhance the effect of the medicine.

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 (a medicine used to treat migraine) increases intestinal absorption of Effortil, thereby enhancing its effect.

Atropine [a medicine 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.

Medicines blocking adrenergic receptors (alpha- and beta-adrenolytic 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-adrenolytic 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 her doctor or pharmacist before using this medicine.

Due to insufficient human data and teratogenic effects observed in animal studies, Effortil 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 risk-benefit balance.

The medicine may impair uterine and placental blood flow and cause uterine muscle relaxation.

Effortil should not be used during breastfeeding, as passage into breast milk cannot be excluded.

Non-clinical studies and studies in humans on the effect of ethylnorepinephrine on fertility have not been conducted.

Driving and using machines
Studies on the effect of the medicine on the ability to drive and operate machinery have not 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, 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 medicinal solution (approximately 15 drops) contains 0.24 mg of sodium.
Thus, the medicine 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 recommended by the 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 ethylephrine hydrochloride.
Effortil oral drops 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 start releasing the drops, tap gently at the
bottom of the bottle.
Tap here at the bottom of the bottle

Use of a higher than recommended dose of Effortil
If more Effortil than recommended has been taken, consult a doctor or pharmacist immediately.
Symptoms of overdose
Acute overdose intensifies the adverse reactions 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 experiences 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 the patient, immediate medical attention must be sought
• angina (chest pain), heart rhythm disorders, tachycardia (fast 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 any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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 181 C, 02-222 Warsaw, Tel: + 48 22 49 21 301, Fax: + 48 22 49 21 309, https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Effortil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month. After opening the container, the medicine remains valid for 6 months.
Store in the original packaging in order to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Effortil contains

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

What Effortil looks like and contents of the pack
Effortil is an oral solution (drops).
Pack size: one bottle of 15 g (15 ml).
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 in:
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
Austria Marketing Authorisation Number (country of export): 9106
Parallel Import Authorisation Number: 67/20