Septanazal dla dorosvih

Package Leaflet: Information for the User

Septanazal for Adults, (1 mg + 50 mg)/1 ml, Nasal Spray, Solution

Xylometazoline Hydrochloride + Dexpanthenol

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 this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Package Leaflet Contents

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

1. What is Septanazal for Adults and what is it used for

Septanazal for Adults nasal spray contains the active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride has a vasoconstrictive effect on the nasal mucosa, reducing swelling of the nasal mucosa and the amount of discharge. This helps to relieve the feeling of a blocked nose. Dexpanthenol is a derivative of pantothenic acid (vitamin B5) with wound-healing and protective properties for the nasal mucosa.
Septanazal for Adults is indicated:

• to reduce swelling of the nasal mucosa in rhinitis and to treat damage to the nasal mucosa,
• for the treatment of non-allergic rhinitis (vasomotor rhinitis),
• for the treatment of nasal congestion after nasal surgery.

Septanazal for Adults is intended for adults, adolescents, and children aged 6 years and older.

2. Important information before using Septanazal for Adults

When not to use Septanazal for Adults:

• if you are allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6),
• if you have atrophic rhinitis (dry rhinitis with crust formation),
• if you have had surgery to remove the pituitary gland or other operations that involve exposure of the meninges (brain lining). This medicine is contraindicated in children under 6 years of age.

Warnings and precautions

Before using Septanazal for Adults, discuss with your doctor or pharmacist:

• if you are taking monoamine oxidase inhibitors (MAOIs) and other medicines that may increase blood pressure,
• if you have increased intraocular pressure (glaucoma), especially with narrow-angle glaucoma,
• if you have severe cardiovascular disease (e.g., coronary heart disease, hypertension, long QT syndrome),
• if you have a pheochromocytoma (a tumor of the adrenal gland),
• if you have a metabolic disorder (e.g., hyperthyroidism, diabetes),
• if you have a metabolic disorder called porphyria,
• if you have an enlarged prostate.

Due to the risk of atrophy of the nasal mucosa, this medicine should only be used in the case of chronic rhinitis under medical supervision.
In case of improper use or excessive use of the spray, the medicine may cause systemic side effects, especially in children (see section 4).
Long-term use of the medicine or use of the medicine in higher doses than recommended may lead to chronic swelling and sometimes thinning (damage) of the nasal mucosa.
You should not use Septanazal for Adults while using:

• other medicines for the treatment of influenza,
• other cough and cold medicines containing sympathomimetics (medicines used to treat nasal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane). Concomitant use of these medicines with Septanazal for Adults may increase the risk of side effects from the cardiovascular and central nervous systems.

Avoid direct contact of the medicine with the eyes.

Children

Do not exceed the dose recommended by your doctor. Consult your doctor regarding the duration of treatment and frequency of use 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, a nasal spray containing a lower dose of active substances, is available.
The use of this medicine in children under 12 years of age should be supervised.
If the child's symptoms worsen or do not improve after 3 days of treatment, consult your doctor.

Septanazal for Adults and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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.
Concomitant use of Septanazal for Adults with certain antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants) and medicines that increase blood pressure may cause an increase in blood pressure.
Concomitant use of Septanazal for Adults with influenza treatments and cough and cold medicines containing sympathomimetics (e.g., pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may lead to increased side effects from the cardiovascular and central nervous systems.
Before using Septanazal for Adults, consult your doctor if you are taking any of the above-mentioned medicines.

Septanazal for Adults with food and drink

The medicine can be used independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine should not be used during pregnancy due to the lack of data on safety in pregnant women.
This medicine should not be used during breastfeeding, as it is not known whether xylometazoline hydrochloride passes into breast milk.

Driving and using machines

It is not expected that this medicine will affect your ability to drive or use machines if used as directed.

Septanazal for Adults contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to use Septanazal for Adults

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose for adults, adolescents, and children aged 6 years and older is one dose of nasal spray into each nostril up to three times a day, as needed. The dosage depends on the individual patient's sensitivity and clinical response.

Duration of treatment

Do not use this medicine for more than 7 days. Repeated use is possible only after a few days' break.
The duration of use in children should always be discussed with your 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 longer period, press the pump several times until a uniform mist appears.

Place the nozzle into the nostril in an upright position, if possible, and press the pump once. During dosing, gently inhale through the nose. If necessary, repeat in the other nostril.
After each use, wipe the nozzle with a tissue and replace the protective cap.

Patient with increased intraocular pressure (glaucoma), especially with narrow-angle glaucoma, should consult their doctor before using this medicine.

Using more than the recommended dose of Septanazal for Adults

In case of using a higher dose of the medicine than recommended or accidental ingestion of large amounts of the medicine, the following side effects may occur: constriction of the pupils, dilation of the pupils, fever, sweating, paleness of the skin, blue discoloration of the lips (cyanosis), nausea, seizures, cardiovascular disorders (increased heart rate, decreased heart rate, arrhythmias, heart failure, cardiac arrest, high blood pressure [hypertension]), respiratory disorders (pulmonary edema, respiratory disorders), and mental disorders.
It may also cause drowsiness, decreased body temperature, slowed heart rate, and decreased blood pressure, respiratory arrest, and coma.
If any of these symptoms occur, seek medical attention immediately.

Missing a dose of Septanazal for Adults

Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon: may affect up to 1 in 100 people:

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

Rare: may affect up to 1 in 1,000 people:

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

Very rare: may affect up to 1 in 10,000 people:

• restlessness, insomnia, hallucinations (mainly in children),
• fatigue (drowsiness, sedation), headache,
• arrhythmias (heart rhythm disorders),
• nasal mucosa swelling (after treatment discontinuation), nasal bleeding,
• seizures (convulsions, especially in children).

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

• burning and dryness of the nasal mucosa, sneezing.

Reporting side effects

If you experience any side effects, including any not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. 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. How to store Septanazal for Adults

Keep this medicine out of the 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 month.
There are no special precautions for storage.
The shelf life of the medicine after first opening the package is 12 months.
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 package and other information

What Septanazal for Adults contains

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

What Septanazal for Adults looks like and contents of the package

The nasal spray solution is a clear, colorless solution.
Septanazal for Adults is supplied in an HDPE container with a spray pump and a transparent protective cap, in a cardboard box. 10 ml of solution is sufficient for 90 doses.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information, please contact your local representative of the marketing authorization holder: Krka - Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, phone: +48 22 573 75 00

Date of last revision of the package leaflet: