Otrivin regeneracja

Package leaflet: Information for the user

Otrivin Regeneration, (1 mg + 50 mg)/ml, nasal spray, solution
Xylometazolinum hydrochloridum + Dexpanthenolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Leaflet contents:

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

1. What Otrivin Regeneration is and what it is used for
Otrivin Regeneration is a nasal spray.
Otrivin Regeneration contains the active substance xylometazolinum hydrochloridum, which has vasoconstrictive properties and reduces swelling of the nasal mucosa.
Otrivin Regeneration also contains the active substance dexpanthenolum, a derivative of vitamin – pantothenic acid. It supports wound healing and protects the nasal mucosa.
Otrivin Regeneration is intended for use in adults and adolescents aged 12 years and older:

• to reduce swelling of the nasal mucosa in rhinitis, as well as supportive treatment for healing of skin and mucous membrane injuries, for alleviating vasomotor rhinitis and treating impaired nasal breathing following nasal surgery,
• to reduce swelling of the nasal mucosa in rhinitis associated with acute sinusitis (rhinosinusitis).

2. Important information before using Otrivin Regeneration

When not to use Otrivin Regeneration

• if you are allergic to xylometazolinum hydrochloridum or dexpanthenolum, or to any of the other ingredients of this medicine (listed in section 6),
• if you have dry rhinitis, including crusting (dry or atrophic rhinitis),
• if you have undergone nasal surgery, e.g. pituitary gland removal or any other nasal surgery involving exposure of the meninges,
• if you have increased intraocular pressure, particularly narrow-angle glaucoma,
• in infants and children under 12 years of age.

Warnings and precautions
Before starting to use Otrivin Regeneration, discuss this with your doctor or pharmacist:

• if you are being treated with monoamine oxidase inhibitors (MAOIs) or have received such medicines within the last two weeks, or if you are taking other medicines that may increase blood pressure,
• in patients using tricyclic and tetracyclic antidepressants,
• if you have severe cardiovascular disease (e.g. coronary heart disease, long QT syndrome) or high blood pressure (hypertension),
• if you have a tumour of the adrenal gland (pheochromocytoma),
• if you have metabolic disorders such as hyperthyroidism or diabetes,
• if you have a metabolic disease (porphyria),
• if you have benign prostatic hyperplasia (enlarged prostate).

To avoid spreading infection, one package should be used by only one patient, and the nozzle should be rinsed after use.
In very rare cases, xylometazoline may cause insomnia. In such cases, avoid using the medicine late in the evening or at night.
Elderly patients
Elderly patients may be more susceptible to adverse effects of this medicine.
During prolonged colds, this medicine should be used only under medical supervision due to the risk of thinning of the nasal mucosa.
Children and adolescents
Avoid prolonged use (longer than ten consecutive days) and use of higher than recommended doses, especially in children, as this may lead to nasal mucosal hyperaemia and consequently to airway constriction. Continued use may result in secondary drug-induced swelling and atrophy of the nasal mucosa.
The concentration of active substances in Otrivin Regeneration has been formulated for use in adults and adolescents aged 12 years and older; therefore, this medicine should not be used in infants or children under 12 years of age.
For children aged 1 to 11 years, appropriate nasal spray products containing a lower dose of the active substance reducing nasal mucosal swelling – xylometazolinum hydrochloridum – are available.
Otrivin Regeneration and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of Otrivin Regeneration with mood-enhancing medicines (monoamine oxidase inhibitors or tricyclic and tetracyclic antidepressants), as well as with other medicines increasing blood pressure, may lead to elevated blood pressure due to the effects of these substances on the cardiovascular system.
Pregnancy, breastfeeding and fertility
Pregnancy
There are insufficient data on the use of xylometazolinum hydrochloridum and dexpanthenolum in pregnant women; therefore, Otrivin Regeneration should not be used during pregnancy.
Breastfeeding
It is not known whether xylometazoline and dexpanthenolum pass into human milk; therefore, Otrivin Regeneration should not be used during breastfeeding.
Fertility
There is insufficient data on the effect of xylometazolinum hydrochloridum and dexpanthenolum on human fertility.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Adverse effects should not occur when this medicine is used at recommended doses.
However, if you experience drowsiness or somnolence, you should not drive or operate machinery.
Otrivin Regeneration contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per spray dose, equivalent to 0.2 mg of benzalkonium chloride per 1 ml of solution.
This substance may cause irritation or swelling of the nasal mucosa, particularly with prolonged use.
If you experience any discomfort during use of Otrivin Regeneration, inform your doctor or pharmacist.

3. How to use Otrivin Regeneracja

This medicine should always be used exactly as described in the patient leaflet. If in
doubt, consult a doctor or pharmacist.
Instructions for use
Otrivin Regeneracja is intended for nasal use.

1. Remove the protective cap from the applicator tip.

2. Before first use, press the pump several times until a fine mist of the medicine is released into the air.

This step does not need to be repeated with subsequent doses.
The pump will remain ready for further use throughout the recommended treatment period.
However, if no medicine is released after pressing the pump, or if the product has not been used for several days, prime the pump again by pressing it twice.

Take care not to spray the medicine into the eyes.

3. Clean the nose.
4. Hold the bottle upright, supporting the bottom with your thumb, and hold the tip between two fingers.
5. Tilt the head slightly forward and insert the tip into one nostril.
6. Press the pump while gently inhaling through the nose. Repeat the procedure when administering the medicine into the other nostril.
7. Wipe the applicator tip immediately after use and replace the protective cap.
8. To avoid spreading infection, the aerosol container should be used by only one person.

Dosage
In adults and adolescents, unless otherwise directed by a physician, one dose of Otrivin Regeneracja aerosol should be administered into each nostril, up to 3 times daily, as needed. Dosage depends on individual sensitivity and clinical response. Do not exceed 3 doses per day per nostril.
Duration of treatment
Otrivin Regeneracja should not be used for longer than 7 days, unless a doctor specifically advises longer use.
Prolonged use of this medicine may lead to chronic swelling and, ultimately, damage to the nasal mucosa.
Use in children
Otrivin Regeneracja should not be used in children under 12 years of age. See section 2 When
not to use Otrivin Regeneracja.
Use of more than the recommended dose of Otrivin Regeneracja
In case of overdose or accidental ingestion, the following symptoms may occur:
pupil constriction, pupil dilation, fever, sweating, pallor, blue lips (cyanosis), nausea, seizures, cardiovascular disturbances such as heart rhythm disorders (tachycardia, bradycardia, other arrhythmias), circulatory collapse, cardiac arrest, high blood pressure (arterial hypertension), pulmonary complications (pulmonary edema, breathing difficulties), and psychiatric disturbances.
Drowsiness, lowered body temperature, reduced heart rate, low blood pressure resembling shock, respiratory failure, and loss of consciousness (coma) may also occur. If overdose is suspected, seek immediate medical attention. Appropriate measures may be taken as needed.
Missed dose of Otrivin Regeneracja
Do not use a double dose to make up for a missed dose. Continue treatment according to the recommended dosage.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Uncommon adverse effects (occur in no more than 1 in 100 people)

• allergic reactions (rash, itching, swelling of the skin and mucous membranes)
• nosebleeds

Rare adverse effects (occur in no more than 1 in 1,000 people)

• palpitations
• rapid heartbeat (tachycardia)
• high blood pressure (arterial hypertension)

Very rare adverse effects (occur in no more than 1 in 10,000 people)

• excitation
• insomnia
• fatigue (drowsiness, sedation)
• headache
• hallucinations (especially in children)
• irregular heartbeat (cardiac arrhythmia)
• increased swelling of the mucous membrane due to reduced effectiveness of the medicine
• spasms (especially in children)

Frequency not known (frequency cannot be estimated from available data)

• burning or dryness of the nasal mucous membrane
• sneezing

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Otrivin Regeneration
Keep the 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 expiry date applies even if the packaging has been opened.
Do not store above 25°C.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Otrivin Regeneracja contains

• The active substances in this medicine are xylometazoline hydrochloride and dexpanthenol. One 0.1 ml dose of spray solution contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• Other components of the medicine are: benzalkonium chloride (solution), potassium dihydrogen phosphate, disodium phosphate dodecahydrate, purified water.

What Otrivin Regeneracja looks like and contents of the pack
Otrivin Regeneracja is a colourless, clear solution.
The packaging consists of a 15 ml plastic bottle with a dispenser and applicator with a protective cap, in a carton box.
Each bottle contains 10 ml of solution.

Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer
Zakłady Farmaceutyczne Polpharma S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10
98-200 Sieradz, Poland
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

This medicine has been authorised in the European Union member states under the following trade names:
Austria Otrivin plus Dexpanthenol 1 mg/ml + 50 mg/ml Nasenspray, Lösung
Bulgaria Отривин Плюс 1 mg/ml + 50 mg/ml спрей за нос, разтвор
Estonia Otrinazil
Germany Otriven Protect 1 mg/ml + 50 mg/ml Nasenspray, Lösung
Greece Xylometazoline + Dexpanthenol / GSK 1mg/ml+50mg/ml ρινικό εκνέφωμα, διάλυμα
Hungary Otrivin Extra 1 mg/ml + 50 mg/ml adagoló oldatos orrspray
Latvia Otrinazil 1 mg/50 mg/ml deguna aerosols, šķīdums
Lithuania Otrinazil 1 mg/50 mg/ml nosies purškalas (tirpalas)
Poland Otrivin Regeneracja
Portugal Vibrocil ActilongProtect
Romania Vibrocil Actilong Plus 1mg/ml + 50mg/ml spray nazal soluţie
Slovakia Otrivin Plus 1 mg/ml + 50 mg/ml
Spain Rhinovín Cuidado Activo 1mg/ml + 50mg/ml Solución para pulverización nasal

Further information
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov.pl/pl

Additional information for the user
The healthy nose functions to warm, humidify and filter inhaled air. This protects the bronchi from cold outside air and prevents the nose from drying out. The inside of the nose is lined with a well-vascularised mucous membrane.

The mucous membrane may become damaged due to various factors such as colds or surgical procedures. This leads to swelling of the nasal mucous membrane, which in turn makes nasal breathing difficult and causes the sensation of a "blocked nose".

Otrivin Regeneracja nasal spray, containing xylometazoline hydrochloride and dexpanthenol as active substances, is applied directly to the nasal mucous membrane to counteract swelling caused by colds or nasal surgery.

Xylometazoline hydrochloride, within a few minutes of administration, produces a long-lasting reduction in nasal mucosal swelling, thereby facilitating nasal breathing.

This effect is further enhanced by combination with dexpanthenol. Dexpanthenol is a derivative of pantothenic acid – a vitamin required in all human body tissues and present in the daily diet.