Efrinol 1%

Package Leaflet: Information for the User

EFRINOL 1%, 10 mg/g, Nasal Drops, Solution

Ephedrine Hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor. See section 4.

Table of Contents of the Leaflet

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

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

Efrinol 1% is a solution. Efrinol 1% contains the active substance ephedrine hydrochloride, which, when applied locally to the nasal mucosa, causes vasoconstriction and reduces swelling of the nasal mucosa.
Indications for use of Efrinol 1%:

• in acute inflammatory conditions of the nasal mucosa and paranasal sinuses;
• in allergic inflammatory conditions of the nasal mucosa.

2. Important information before using Efrinol 1%

When not to use Efrinol 1%:

• 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 hypertension, coronary heart disease, heart rhythm disorders (especially paroxysmal tachycardia),
• in acute coronary insufficiency,
• in hyperthyroidism,
• in glaucoma with closed-angle filtration,
• in the case of general anesthesia with cyclopropane or halothane.

Warnings and precautions

In the following cases, before starting to use Efrinol 1%, you should always consult a doctor:

• if the patient has diabetes, prostatic hyperplasia, cardiovascular disease, or angina pectoris.

Long-term use of the medicine should be avoided in patients who are overexcited.
Tachyphylaxis (rapid decrease in response to repeated administration at short intervals
of time) may occur within a few days of starting to use the medicine.
After long-term use of the medicine, tolerance and dependence have been observed.

Efrinol 1% and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Ephedrine may interact with other medicines, especially if they are:

• monoamine oxidase inhibitors (nialamide, selegiline, furazolidone) that inhibit the breakdown of noradrenaline, increasing the effect of ephedrine, which can lead to a significant increase in blood pressure.
• salbutamol and other medicines that stimulate the sympathetic nervous system, increasing the undesirable effects of ephedrine on the cardiovascular system, and should not be used at the same time. It is permissible to use ephedrine with small doses of salbutamol and medicines that stimulate the sympathetic nervous system, which are found in inhalation products.
• methyldopa, which reduces the effect of ephedrine.
• reserpine, which inhibits the storage of noradrenaline, reducing the effect of ephedrine, and accelerates its elimination, a similar effect can be caused by acidification of the urine.
• acetazolamide and other substances that alkalize the urine, which can increase the toxic effect of ephedrine, as they lead to an increase in its concentration in the blood.
• ephedrine acts against medicines that lower blood pressure.
• ephedrine, when administered simultaneously with theophylline, increases the central nervous system side effects of theophylline (nausea, vomiting, increased excitability).
• guanethidine, which inhibits the release of noradrenaline, can cause swelling of the nasal mucosa, making it difficult to absorb ephedrine. Ephedrine may reduce the blood pressure-lowering 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 fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Before using any medicine, consult your doctor.
Ephedrine easily crosses the placental barrier. It causes heart rhythm disorders in both the mother and the child. Ephedrine passes into breast milk. In infants breastfed by mothers using ephedrine, symptoms of excitement and sleep disorders occur.
Do not use Efrinol 1% during pregnancy and breastfeeding.

Driving and using machines

So far, the effect of the medicine on the ability to drive vehicles and operate machinery is not known.

3. How to use Efrinol 1%

This medicine should always be used as directed by your doctor. In case of doubts, consult your doctor.
The medicine is used intranasally.
Use the following dosing schedule: instill 1-3 drops into each nostril 2 to 5 times a day.
Do not use the medicine for more than 5 days.
If you feel that the effect of Efrinol 1% is too strong or too weak, consult your doctor.

Using a higher dose of Efrinol 1% than recommended

After doses significantly higher than recommended or in people who are particularly sensitive, Efrinol 1% may cause excessive nervous excitability, as well as an increase in blood pressure, heart rate, anxiety, and insomnia, convulsions, urinary retention, dizziness.
Long-term intranasal use of the medicine may cause chronic congestion of the nasal mucosa.
In case of taking a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Efrinol 1%

Continue using the medicine without increasing the next dose.
Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During use of Efrinol 1%, the following may occur:
rapid heartbeat, increased blood pressure, palpitations, tachycardia, and other heart rhythm disorders, increased excitability, anxiety, restlessness, tremors, headaches, difficulty falling asleep, nausea, vomiting, dryness of the nasal and throat mucosa. After long-term use, dependence may develop, which is associated with an increase in aggressive behavior of a psychotic nature. Difficulty urinating, especially in patients with prostatic hyperplasia, and rare cases of skin allergy in the form of a rash.
In some people, during use of Efrinol 1%, other side effects may occur. If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor.
Reporting side effects
If you get any side effects, talk to your 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:
Jerozolimskie Avenue 181 C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Efrinol 1%

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date stated on the packaging is the last day of the specified month.
The abbreviation "EXP" on the carton indicates the expiry date.
The abbreviation "Lot" on the carton indicates the batch number.
Store in a temperature below 25°C, in a closed packaging.
Medicines should 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 pack and other information

What Efrinol 1% contains

• The active substance of the medicine is ephedrine hydrochloride. 1 g of solution contains 10 mg of ephedrine hydrochloride. 1 drop of solution contains 0.5 mg of ephedrine hydrochloride.
• The other ingredients are: sodium chloride, chlorobutanol, methylcellulose, purified water.

What Efrinol 1% looks like and contents of the pack

Efrinol 1% is a colorless, clear solution.

Pack sizes

Polyethylene container PE in a cardboard box, containing 10 g of solution.

Marketing authorization 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

Date of last revision of the leaflet: