Effortil

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

EFFORTIL

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

Etilefrine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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. Contents of the packaging and other information

1. What is Effortil and what is it used for

Etilefrine, the active substance of the medicine, is an adrenergic agonist with high affinity for both alpha-1, beta-1, and beta-2 receptors. Effortil is indicated for the treatment of symptomatic or orthostatic hypotension (position-dependent), generally associated with symptoms such as dizziness, unexplained fatigue, blurred vision or loss of vision, and a feeling of weakness.

2. Important information before using Effortil

When not to use Effortil:

• if the patient is allergic to the active substance or 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 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:

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

The patient should inform their doctor if they have any of the above conditions. The use of etilefrine during sports competitions may result in a positive doping test.

Effortil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Concomitant use of guanethidine, mineralocorticoids, reserpine (a medicine that lowers blood pressure), thyroid hormones, adrenergic agonists (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 activity [such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs)] may enhance the effect of Effortil. Halogenated hydrocarbon anesthetics and cardiac glycosides in higher doses may increase the effect of Effortil on the heart, leading to arrhythmias. Dihydroergotamine (a medicine used to treat migraines) 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), and as a mydriatic] may enhance the effect of Effortil and accelerate heart rate. Adrenergic receptor blockers (alpha- and beta-adrenergic blockers used, for example, in the treatment of hypertension, vascular diseases of the central nervous system, and certain heart diseases) may completely or partially abolish the effect of Effortil. Treatment with beta-adrenergic blockers may cause reflex bradycardia (abnormally slow heart rate). The effect of antidiabetic medicines may be weakened.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 during 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. The medicine may disrupt blood circulation in the uterus and placenta and cause uterine relaxation. The medicine should not be used during breastfeeding, as it cannot be excluded that the medicine may pass 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. During treatment with Effortil, side effects such as dizziness may occur. Therefore, caution should be exercised when driving and operating machinery.

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 (possible late reactions). 1 ml of the solution (approximately 15 drops) contains 0.24 mg of sodium. Therefore, 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 doubts, the patient should consult their doctor. 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. The oral drops of Effortil should be taken with a liquid. A faster 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 patient should gently tap 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 patient should immediately consult their doctor or pharmacist. Symptoms of overdose: Acute overdose enhances the described side effects below. In infants and small children, overdose may lead to respiratory depression and coma.

4. Possible side effects

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

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: 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. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Store in the original packaging to protect from light. After opening the bottle, use within 6 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Effortil contains

• The active substance of the medicine is etilefrine hydrochloride. 1 g of the solution (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 contents of the packaging

Effortil is oral drops. The pack size is one bottle of 15 g. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

SERB SA
Avenue Louise 480
1050 Brussels
Belgium

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:9106
Parallel import authorization number:241/14

Date of approval of the leaflet: 28.06.2024

[Information about the trademark]