Septanazal for adults

Package leaflet: Information for the user

Septanazal dla dorosłych, (1 mg + 50 mg)/1 ml, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
Please read 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 so that you can read it again if necessary.
• If you need advice or further information, please contact your 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 of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Septanazal dla dorosłych is and what it is used for

Septanazal dla dorosłych nasal spray contains the active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride constricts blood vessels in the nasal mucosa, thereby reducing swelling of the nasal mucosa and decreasing nasal discharge. This helps relieve nasal congestion. Dexpanthenol is a derivative of vitamin pantothenic acid, which has properties supporting wound healing and protecting the nasal mucosal epithelium.

Septanazal dla dorosłych is indicated:

• for reducing swelling of the nasal mucosa in nasal mucosal inflammation and as supportive treatment in nasal mucosal damage,
• in the treatment of non-allergic rhinitis (vasomotor rhinitis),
• in the treatment of nasal passage obstruction following nasal surgery.

Septanazal dla dorosłych is indicated for adults, adolescents, and children aged 6 years and older.

2. Information before using Septanazal for adults

When not to use Septanazal for adults:

• if the patient is allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has dry inflammation of the nasal mucosa with formation of crusts ( rhinitis sicca ),
• if the patient has undergone surgical removal of the pituitary gland or other operations involving exposure of the meninges (the membranes covering the brain). This medicine is contraindicated in children under 6 years of age.

Warnings and precautions
Before starting to use Septanazal for adults, discuss with your doctor or
pharmacist:

• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) or other medicines that may increase blood pressure,
• if the patient has increased intraocular pressure (glaucoma), particularly narrow-angle glaucoma,
• if the patient has severe cardiovascular disease (e.g. ischemic heart disease, hypertension, long QT syndrome),
• if the patient has a pheochromocytoma,
• if the patient has a metabolic disorder (e.g. hyperthyroidism presenting with excessive sweating, increased body temperature, and rapid heartbeat, or diabetes),
• if the patient has a metabolic disorder called porphyria,
• if the patient has prostate enlargement.

Due to the risk of nasal mucosa atrophy, this medicine should be used during chronic rhinitis only under medical supervision.
Improper use or excessive use of the spray may cause systemic adverse effects, particularly in children (see section 4).
Prolonged use of the medicine or use in doses higher than recommended may lead to chronic swelling, and sometimes thinning (damage) of the nasal mucosa.
Do not use Septanazal for adults while using:

• other medicines for treating flu,
• other cough and cold medicines containing sympathomimetics (medicines used to treat nasal mucosal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane). Concurrent use of these medicines with Septanazal for adults may increase the risk of cardiovascular and central nervous system adverse effects.

Avoid direct contact of the medicine with the eyes.
Children
Do not exceed the dose recommended by the doctor. Consult a doctor regarding the duration and frequency of treatment in children.
Septanazal for adults is intended for use in adolescents and children aged 6 years and older. For children under 6 years of age, Septanazal for children nasal spray, containing a lower dose of active substances, is available.
The use of this medicine should be supervised in children under 12 years of age.
If a child's symptoms worsen or do not improve after 3 days of treatment, consult a doctor.
Septanazal for adults and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Avoid concomitant use of Septanazal for adults with medicines used to lower blood pressure (e.g. methyldopa) due to the possible effect of xylometazoline on blood pressure.
Concurrent use of Septanazal for adults with certain antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants), as well as with medicines that increase blood pressure, may lead to elevated blood pressure.
Concurrent use of Septanazal for adults with medicines used to treat flu and with cough and cold medicines containing sympathomimetics (medicines used to treat nasal mucosal congestion, e.g. pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may intensify adverse effects on the cardiovascular and central nervous systems.
Consult a doctor before using Septanazal for adults if taking any of the above-mentioned medicines.
Septanazal for adults with food and drink
This medicine can be used regardless of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy due to lack of safety data in pregnant women.
This medicine should not be used during breastfeeding, as it is unknown whether xylometazoline hydrochloride passes into human milk.
Driving and operating machinery
This medicine is not expected to affect the ability to drive or operate machinery when used according to recommendations.
Septanazal for adults contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use the medicine Septanazal dla dorosłych

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose for adults, adolescents, and children aged 6 years and older is one spray into each nostril up to three times daily, as needed. Dosage depends on individual patient sensitivity and clinical response.
Duration of treatment
Do not use this medicine for longer than 7 days. Repeated use is possible only after a several-day break.
The duration of use in children should always be discussed with a doctor.
Method of administration
Remove the protective cap from the spray nozzle.
Before first use or if the spray has not been used for a prolonged period, press the pump several times until a uniform mist appears.

Position the dispenser tip vertically into the nostril, if possible, and press the pump once. During administration, gently inhale through the nose. If necessary, repeat the procedure in the other nostril.
After each use, wipe the dispenser tip with a tissue and replace the protective cap.

Patients with increased intraocular pressure (glaucoma), particularly narrow-angle glaucoma, should consult a doctor before using this medicine.
Use of a higher than recommended dose of Septanazal dla dorosłych
If a higher than recommended dose is used or if large amounts of the medicine are accidentally swallowed, the following adverse effects may occur: constriction of the pupils, dilation of the pupils, fever, sweating, pallor, bluish discoloration of the lips (cyanosis), nausea, convulsions, cardiovascular disorders (increased heart rate, decreased heart rate, cardiac arrhythmias, circulatory failure, cardiac arrest, high blood pressure [hypertension]), respiratory disorders (pulmonary edema, breathing difficulties), and psychiatric disturbances.
Drowsiness, decreased body temperature, slowed heart rate, low blood pressure, respiratory arrest, and coma may also occur.
If any of these symptoms occur, contact a doctor immediately.
Missed dose of Septanazal dla dorosłych
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding 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.

Not common: may occur in fewer than 1 in 100 people:

• hypersensitivity reactions such as skin and mucous membrane swelling, skin rash, itching.

Rare: may occur in fewer than 1 in 1,000 people:

• palpitations (awareness of heartbeat), tachycardia (increased heart rate), arterial hypertension (high blood pressure).

Very rare: may occur in fewer than 1 in 10,000 people:

• anxiety, insomnia, hallucinations (mainly in children),
• fatigue (drowsiness, sedation), headache,
• cardiac arrhythmias,
• nasal mucosal swelling (after discontinuation of treatment), nosebleeds,
• seizures (convulsions, particularly in children).

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

• burning sensation and dryness of the nasal mucosa, sneezing.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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 181C, 02-222 Warsaw
Tel.: +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 contributes to further information on the safety of the medicine.

5. How to store the medicine Septanazal dla dorosłych

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
The shelf life of the medicine after first opening the container is 12 months.
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 pack and other information

What Septanazal dla dorosłych contains

• The active substances are xylometazoline hydrochloride and dexpanthenol. Each ml of nasal spray solution contains 1 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol. One dose of nasal spray (0.1 ml of solution) contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• Other ingredients are: potassium dihydrogen phosphate, disodium phosphate dodecahydrate, purified water. See section 2 "Septanazal dla dorosłych contains sodium".

What Septanazal dla dorosłych looks like and contents of the pack
Nasal spray, solution (nasal aerosol) is a clear, colourless solution.
Septanazal dla dorosłych is supplied in an HDPE container with a spray pump and a transparent nasal applicator, packed in a cardboard box. 10 ml of solution provides 90 doses.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
This medicinal product is authorised in the European Economic Area under the following names:

For more detailed information, please contact the local representative of the responsible entity:
Krka - Polska Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
telephone: +48 22 573 75 00