Effortil

Package Leaflet: Information for the Patient

EFFORTIL 7.5 mg/g Oral Drops

Etilefrine Hydrochloride

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

• 1. What is Effortil and what is it 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 is Effortil and what is it used for

Etilefrine, the active substance of the medication, 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, feeling of weakness.

2. Important information before taking Effortil

When not to take Effortil

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 medications"),
• hyperthyroidism.

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

Effortil and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
Concomitant use of guanethidine, mineralocorticoids, reserpine (a medication that lowers blood pressure), thyroid hormones, adrenergic agonists (medications used, e.g., in the treatment of asthma, chronic obstructive pulmonary disease, upper respiratory tract infections, circulatory disorders, including hypotension) or medications with sympathomimetic activity [such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) (antidepressants and medications that increase blood pressure)] may enhance the effect of the medication.
Halogenated hydrocarbon anesthetics and cardiac glycosides in higher doses may increase the effect of Effortil on the heart, leading to arrhythmias.
Dihydroergotamine (an anti-migraine medication) increases the intestinal absorption of Effortil, thereby enhancing its effect.
Atropine [a medication used in spastic conditions of the gastrointestinal tract, urinary tract, and asthma, in the treatment of bradycardia (slow heart rate), a medication that dilates the pupils] may enhance the effect of Effortil and accelerate heart rate.
Medications that block adrenergic receptors (alpha- and beta-adrenergic blockers used, e.g., 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 (abnormally slow heart rate).
The effect of antidiabetic medications that lower blood sugar levels may be weakened.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Due to insufficient human data and the teratogenic effect observed in animal studies, the medication should not be used during the first trimester of pregnancy (see "When not to take Effortil").
In the second and third trimesters of pregnancy, the medication may be used only after careful consideration of the risk and benefit.
The medication may disrupt blood circulation in the uterus and placenta and cause uterine relaxation.
The medication should not be used during breastfeeding, as it cannot be excluded that the medication 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 medication 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 methylparaben and propylparaben

Sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.
Methylparaben and propylparaben may cause allergic reactions (possible late reactions).
1 ml of the solution (approximately 15 drops) contains 0.24 mg of sodium.
Therefore, the medication contains less than 1 mmol (23 mg) of sodium per dose, which means the medication is considered "sodium-free".

3. How to take Effortil

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose is:
Adults and children over 6 years: 10-20 drops three times a day.
Children between 2 and 6 years: 5-10 drops three times a day.
Children under 2 years: 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 medication is administered before meals.
Hold the inverted bottle in a vertical position. To start the drop flow, tap the bottom of the bottle lightly.
Tap here on the bottom of the bottle

What to do if you take more Effortil than you should

If you take more Effortil than you should, contact your doctor or pharmacist immediately.
Symptoms of overdose
Acute overdose exacerbates the side effects described below. In infants and small children, overdose may lead to respiratory depression and coma.

4. Possible side effects

Like all medications, Effortil 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 you experience any of these symptoms, contact your doctor immediately.
• 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Effortil

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C. Do not freeze.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Effortil contains

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

What Effortil looks like and contents of the pack

Effortil is oral drops.
Pack size: one bottle of 15 g.

Marketing authorization holder

SERB SA
Avenue Louise 480
1050 Brussels
Belgium

Manufacturer

Istituto de Angeli S.r.l.
Localita Prulli, 103/C
50066 Reggello (FI)
Italy
For more information, please contact:
Tel.: +48 22 307 03 61

Date of last revision of the leaflet: