Nasivin Vicks Classic

Package Leaflet: Information for the Patient

Nasivin Vicks Classic

0.5 mg/ml, nasal spray, solution

Oxymetazoline hydrochloride

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

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 to 7 days, they should contact their doctor.

Contents of the Package Leaflet:

• 1. What is Nasivin Vicks Classic and what is it used for
• 2. Important information before using Nasivin Vicks Classic
• 3. How to use Nasivin Vicks Classic
• 4. Possible side effects
• 5. How to store Nasivin Vicks Classic
• 6. Package contents and other information

1. What is Nasivin Vicks Classic and what is it used for

Nasivin Vicks Classic contains the active substance oxymetazoline hydrochloride, which narrows blood vessels. Using Nasivin Vicks Classic reduces swelling of the inflamed mucous membrane and inhibits excessive secretion, making it easier to breathe through the nose. Reducing the congestion of the nasal mucosa also opens and widens the paranasal sinuses and unblocks the Eustachian tubes. This facilitates the removal of secretions and the healing of bacterial infections. Compared to a physiological saline solution, Nasivin Vicks Classic shortens the average duration of acute rhinitis (stuffy nose, runny nose, sneezing, malaise) from 6 to 4 days. Nasivin Vicks Classic does not contain preservatives. Nasivin Vicks Classic is used for swelling of the mucous membranes that occurs in acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and middle ear inflammation.

2. Important information before using Nasivin Vicks Classic

When not to use Nasivin Vicks Classic:

• if the patient has dry rhinitis (rhinitis with crust formation);
• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Nasivin Vicks Classic may be used with caution and only after careful consideration by a doctor of the benefits and risks in cases of:

• treatment with monoamine oxidase inhibitors (MAOIs) and other medications that may increase blood pressure;
• increased intraocular pressure, especially in the case of angle-closure glaucoma;
• severe heart and blood vessel diseases (e.g., coronary heart disease, hypertension);
• chromaffin cell tumors of the adrenal gland;
• metabolic disorders (e.g., hyperthyroidism, diabetes).

The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to their prolonged use or overdose. This can lead to the use of increasingly larger doses or more frequent use of the medicine, which in turn can result in permanent use of the medicine. In the case of prolonged use or abuse of the medicine, its use should be stopped immediately. Permanent use of the medicine can lead to a rebound effect and rhinitis medicamentosa (a condition where the nasal mucosa becomes dependent on the decongestant), as well as atrophy of the nasal mucosa or dry rhinitis. The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine. Similarly, abuse of locally applied nasal decongestants can lead to atrophy of the nasal mucosa and rhinitis medicamentosa. It is essential to avoid using the medicine for longer than recommended and to avoid overdose.

Nasivin Vicks Classic and other medicines

Using medicines containing oxymetazoline, such as Nasivin Vicks Classic, at the same time as certain medications used for depression, such as MAOIs of the tranylcypromine type and tricyclic antidepressants, may lead to increased blood pressure.

Pregnancy and breastfeeding

Before using any medicine during pregnancy or breastfeeding, a doctor or pharmacist should be consulted. Caution should be exercised when using the medicine during pregnancy or breastfeeding. The recommended dose should not be exceeded.

Driving and operating machinery

During the use of oxymetazoline, especially for a prolonged period or in doses larger than recommended, systemic effects on the cardiovascular and central nervous systems may occur. In such cases, the ability to drive vehicles or operate machinery may be impaired.

3. How to use Nasivin Vicks Classic

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted. Nasivin Vicks Classic is intended for intranasal use only (also in Eustachian tube inflammation and middle ear inflammation). The packaging of the medicine should only be used by one person. Nasivin Vicks Classic can only be used in adults and children over 6 years of age. The medicine should not be used in infants and children under 6 years of age. Adults and children over 6 years of age: 1 dose of Nasivin Vicks Classic spray into each nostril 2 to 3 times a day. The medicine should not be used for more than 5 to 7 days. Method of administration: The method of administration is shown in the diagram below. Before the first use, the pump should be pressed several times to obtain a full dose.

Using a higher dose of Nasivin Vicks Classic than recommended

In the event of an overdose or accidental ingestion of the medicine, the following symptoms may occur: dilated pupils, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes), fever, muscle spasms, tachycardia (rapid heart rate), arrhythmias, circulatory collapse (sudden decrease in blood circulation), cardiac arrest, increased blood pressure, pulmonary edema (fluid accumulation in the lungs, which can cause shortness of breath), respiratory disorders, and mental disorders. Additionally, the following may occur: central nervous system depression, drowsiness, decreased body temperature, bradycardia (slow heart rate), sudden drop in blood pressure as in shock, apnea, and coma. If a higher dose of the medicine than recommended is used, a doctor should be contacted immediately.

Missing a dose of Nasivin Vicks Classic

A double dose should not be used to make up for a missed dose. In case of any further doubts about the use of the medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Nasivin Vicks Classic can cause side effects, although not everybody gets them. Common side effects (occurring in less than 1 in 10 but more than 1 in 100 patients using the medicine): burning or dryness of the nasal mucosa, sneezing, especially in sensitive patients. Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1,000 patients using the medicine): systemic effects such as palpitations, rapid heart rate, and increased blood pressure, occurring after local (intranasal) use of the medicine. Rare side effects (occurring in less than 1 in 1,000 but more than 1 in 10,000 patients using the medicine): headache, insomnia, or fatigue. In rare cases, after the effect of the medicine has worn off, there may be an increase in nasal congestion (so-called rebound effect). Prolonged or frequent use, as well as the use of higher doses of Nasivin Vicks Classic than recommended, may lead to rebound congestion with rhinitis medicamentosa. This effect may occur after 5-7 days of treatment and, if the medicine is continued, may lead to permanent damage to the nasal mucosa. Long-term use or abuse of oxymetazoline can also lead to a decrease in the effectiveness of the medicine (tachyphylaxis) (frequency not known - cannot be estimated from available data). If any of the side effects worsen or any side effects not listed in the leaflet occur, a doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department for 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting side effects can help gather more information on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Nasivin Vicks Classic

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. The shelf life of Nasivin Vicks Classic after opening the packaging is 12 months. Do not use this medicine after the expiry date stated on the label or carton after: Expiry date. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Nasivin Vicks Classic contains

• The active substance of the medicine is oxymetazoline hydrochloride. 1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride. 1 dose of spray with a volume of 45 microliters contains 22.5 micrograms of oxymetazoline hydrochloride.
• The other ingredients of the medicine are: citric acid monohydrate, sodium citrate, glycerol 85%, purified water.

What Nasivin Vicks Classic looks like and what the package contains

The package contains a polyethylene bottle with a dosing pump in a 3K system containing 10 ml of solution, in a cardboard box. The bottle contains at least 143 doses.

Marketing authorization holder:

Wick Pharma Zweigniederlassung der Procter & Gamble GmbH, Sulzbacher Str. 40, 65824 Schwalbach am Taunus, Germany

Manufacturer:

Famar Health Care Services Madrid, S.A.U., Avda. Leganés, 62, Alcorcón 28923 (Madrid), Spain, Sofarimex - Indústria Química e Farmacêutica, S.A., Av. das Indústrias - Alto do Colaride, 2735 - 213 Cacém, Portugal

Date of last revision of the package leaflet: