EFRINOL 2%

Patient Information Leaflet

EFRINOL 2%, 20 mg/g, nasal drops, solution
Ephedrini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because
it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

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

1. What Efrinol 2% is and what it is used for

Efrinol 2% is a solution. Efrinol 2% contains the active substance ephedrine hydrochloride, which, when applied locally to the nasal mucosa, causes constriction of blood vessels and reduces swelling of the nasal mucosa.

Indications for Efrinol 2%:

• Acute inflammatory conditions of the nasal mucosa and paranasal sinuses;
• Allergic inflammatory conditions of the nasal mucosa.

2. Important information before using Efrinol 2%

When not to use Efrinol 2%:

• if the patient is allergic to ephedrine, other sympathomimetic amines, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has arterial hypertension, ischemic heart disease, cardiac arrhythmias (especially paroxysmal tachycardia),
• in acute coronary insufficiency,
• in hyperthyroidism,
• in closed-angle glaucoma,
• during general anesthesia with cyclopropane or halothane.

Warnings and precautions
Before starting treatment with Efrinol 2%, always consult a doctor in the following cases:

• if the patient has diabetes, prostate hyperplasia, circulatory system disorders, or angina pectoris. Prolonged use of the medicine should be avoided in hyperexcitable patients. Tachyphylaxis (rapidly decreasing response to repeated doses administered at short intervals) may occur within a few days of starting treatment. Tolerance and dependence have been observed after long-term use of the medicine.

Efrinol 2% and other medicines
Tell your doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Ephedrine may interact with other medicines, particularly:

• monoamine oxidase inhibitors (nialamide, selegiline, furazolidone) – by inhibiting the breakdown of noradrenaline, they enhance the effect of ephedrine, which may lead to a significant increase in blood pressure.
• salbutamol and other sympathomimetic agents – they intensify the undesirable cardiovascular effects of ephedrine and should not be used concomitantly. Cautious use of ephedrine with low doses of salbutamol and sympathomimetic agents present in inhaled products may be permitted.
• methyldopa – reduces the effect of ephedrine.
• reserpine – by inhibiting the storage of noradrenaline, it reduces the effect of ephedrine and accelerates its elimination; a similar effect may be caused by acidification of urine.
• acetazolamide and other urinary alkalinizing agents – may intensify the toxic effects of ephedrine by increasing its blood concentration.
• ephedrine acts antagonistically to antihypertensive medicines.
• ephedrine administered concomitantly with theophylline intensifies the central adverse effects of theophylline (nausea, vomiting, increased excitability).
• guanethidine – by inhibiting the release of noradrenaline, may cause nasal mucosal edema, which impairs ephedrine absorption. Ephedrine may reduce the antihypertensive effect of guanethidine.
• concomitant use of ephedrine with cardiac glycosides (e.g. digoxin) or medicines used in general anesthesia may increase the risk of cardiac arrhythmias.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
A doctor should be consulted before using any medicine.
Ephedrine readily crosses the placental barrier. It may cause cardiac arrhythmias in both the mother and the fetus. Ephedrine passes into breast milk. Infants breastfed by mothers using ephedrine may experience symptoms of excitation and sleep disturbances.
Efrinol 2% should not be used during pregnancy and breastfeeding.

Driving and operating machinery
The effect of the medicine on the ability to drive and operate mechanical equipment is currently unknown.

3. How to use Efrinol 2%

This medicine should always be used according to the doctor's instructions. If in doubt, consult your doctor.
The medicine is administered intranasally.
The following dosing regimen should be used: instill 1–2 drops into each nostril 2 to 5 times daily.
Do not use the medicine for longer than 5 days.
If you feel that the effect of Efrinol 2% is too strong or too weak, consult your doctor.

Taking a higher than recommended dose of Efrinol 2%
After doses significantly higher than recommended, or in particularly sensitive individuals, Efrinol 2% may cause excessive nervous system stimulation, increased arterial blood pressure, accelerated heart function, anxiety, insomnia, convulsions, urinary retention, and dizziness.
Prolonged intranasal use of the medicine may lead to chronic congestion of the nasal mucosa.
In case of accidental overdose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Efrinol 2%
Continue using the medicine as prescribed without increasing the next dose.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not everyone will experience them.
When using Efrinol 2%, the following may occur:
increased heart rate, elevated blood pressure, palpitations, tachycardia and other cardiac arrhythmias, increased excitability, anxiety, restlessness, tremors, headaches, difficulty sleeping, nausea, vomiting, dryness of the nasal and pharyngeal mucosa. With prolonged use, dependence may develop, associated with increased aggressiveness with psychotic features. Urinary difficulties, especially in patients with benign prostatic hyperplasia, and rare cases of skin allergy such as rash.
In some individuals, other adverse reactions may occur during treatment with Efrinol 2%. If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your 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 181 C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather further information on the safety of the medicine.

5. How to store Efrinol 2%

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.
The abbreviation "EXP" on the carton indicates the expiry date.
The abbreviation "Lot" on the carton indicates the batch number.
Store below 25°C, in the closed original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Efrinol 2% contains

• The active substance is ephedrine hydrochloride. 1 g of the solution contains 20 mg of ephedrine hydrochloride. 1 drop of the solution contains 1.0 mg of ephedrine hydrochloride.
• Other components are: sodium chloride, chlorobutanol, methylcellulose, purified water.

What Efrinol 2% looks like and contents of the pack
Efrinol 2% is a colourless, transparent solution.
Pack size available
Polyethylene container (PE) in a cardboard box containing 10 g of solution.
Marketing Authorisation Holder
Poland
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
Towarowa 47-51, 61-896 Poznań
tel. +48 61 886 18 00, fax +48 61 853 60 58
Manufacturer
Przedsiębiorstwo Farmaceutyczne „PROLAB” Sp. z o.o.
Paterek, Przemysłowa 3, 89-100 Nakło nad Notecią
tel. 52 386 73 10, fax 52 386 73 23