Septanasal 1 mg/ml + 50 mg/ml solution for nasal spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

SeptaNasal 1 mg/ml + 50 mg/ml solution for nasal spray

xylometazoline hydrochloride / dexpanthenol

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Contents of the leaflet

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

1. What SeptaNasal is and what it is used for

This medicine contains xylometazoline hydrochloride and dexpanthenol.

Xylometazoline hydrochloride causes rapid constriction of the blood vessels in the nasal mucosa, reducing inflammation of the nasal mucosa and mucous secretion. This helps relieve nasal congestion. Dexpanthenol is a derivative of pantothenic acid vitamin (vitamin B5), which promotes healing and protects the nasal mucosa.

SeptaNasal is used for the local and temporary relief of nasal congestion and nasal mucosal conditions associated with inflammation and/or minor wounds, with or without crust formation, in adults and adolescents over 12 years of age.

2. What you need to know before using SeptaNasal

Do not use SeptaNasal

• if you or your child are allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other components of this medicine (listed in section 6).
• if you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery).
• if you have high ocular pressure, especially if you have narrow-angle glaucoma.
• if you or your child have dry inflammation of the nasal mucosa (dry rhinitis).
• if you are being treated with monoamine oxidase inhibitors (MAOIs), or if you have taken MAOIs within the previous 2 weeks before starting treatment with this medicine.
• if you are particularly prone to inflammation of the blood vessels in your nose.
• if you or your child have undergone surgical removal of the pituitary gland or other surgery exposing the meninges (the lining of the brain).

This medicine must not be used in children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine:

• if you are being treated with antidepressant medicines, monoamine oxidase inhibitors (MAOIs), phenothiazines (tranquilizers), methyldopa (to lower blood pressure), or other medicines that may increase blood pressure.
• if you have elevated intraocular pressure (glaucoma), especially if you have narrow-angle glaucoma.
• if you have a serious cardiovascular or circulatory disorder (e.g. coronary heart disease, arterial hypertension, or long QT syndrome).
• if you have ever experienced insomnia or dizziness while taking other sympathomimetic medicines, such as those used to treat heart conditions, hypotension (low blood pressure), or asthma.
• if you have a metabolic disorder (e.g. diabetes, porphyria, or increased thyroid gland activity associated with increased sweating, body temperature, or heart rate).
• if you have a tumor of the adrenal medulla (pheochromocytoma).
• if you have prostate enlargement.

In any of the above cases, consult your doctor or pharmacist before starting to use this medicine.

In rare cases, xylometazoline may increase nasal congestion rather than relieve it; this is because the effects of xylometazoline are temporary, and prolonged use may lead to rebound congestion with vasodilation, congestion, and rhinitis.

Rarely, insomnia may occur after using the medicine. If this happens, avoid using it late in the afternoon or at night.

To prevent infection, this medicine must not be shared between individuals, and the applicator should always be cleaned after each use with a clean, damp cloth.

Children

The use of SeptaNasal is only indicated in children over 12 years of age.

Use in people aged 65 years or older

Consult your doctor or pharmacist, as elderly individuals may be more sensitive to the effects of this medicine.

Other medicines and SeptaNasal

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Using this medicine together with certain antidepressant medicines (such as MAOIs like tranylcypromine or tricyclic antidepressants), as well as medicines that increase blood pressure, could lead to an increase in blood pressure due to the cardiovascular effects of these substances.

Using this medicine together with other cold, flu, or cough medicines containing sympathomimetics (medicines used to treat nasal congestion such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may increase adverse effects on the cardiovascular and central nervous systems.

Medicines used to lower blood pressure (e.g. methyldopa) should not be used together with xylometazoline due to its hypertensive effect.

Consult a doctor before using this medicine if you or your child are taking any of the above-mentioned medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your 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 is excreted in breast milk.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery when used as recommended. However, if you experience drowsiness or dizziness while using this medicine, do not drive or operate dangerous tools or machinery.

3. How to use SeptaNasal

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

The recommended dose is one spray into each nostril up to 3 times a day if needed.

Do not use this medicine for more than 3 days unless otherwise directed by your doctor.

It may only be used again after a rest period of several days. Do not exceed the recommended dose.

Method of administration

First, remove the protective cap from the spray pump.

Before first use, or if the spray has not been used for a prolonged period, press the spray nozzle 5 times until a fine mist appears.

Insert the spray nozzle as straight as possible into one nostril and press the spray nozzle once. Gently inhale through the nose while spraying the product. If necessary, repeat the procedure for the other nostril. After each use, clean the spray nozzle with a tissue and replace the protective cap on the spray.

Prolonged use or higher doses of this medicine may cause chronic inflammation and also thinning (damage) of the nasal mucosa.

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

Use in children and adolescents

SeptaNasal must not be administered to children under 12 years of age.

If you use more SeptaNasal than you should

• If you use more medicine than you should, or if large amounts are accidentally ingested, the following side effects may occur: pupil constriction (miosis), pupil dilation (mydriasis), fever, sweating, pale skin, bluish discoloration of the lips (cyanosis), nausea, seizures, cardiac and vascular disorders (increased heart rate, slow heart rate, heart rhythm disturbances, circulatory failure, cardiac arrest, high blood pressure (hypertension)), respiratory disorders (pulmonary edema, breathing difficulties), and mental disturbances.

You may also experience drowsiness, decreased body temperature, reduced heart rate and blood pressure, respiratory arrest, and coma.

If you notice any of these symptoms, inform your doctor immediately. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use SeptaNasal

Do not use a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

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

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

• palpitations (awareness of heartbeats), tachycardia (rapid heartbeat), hypertension (high blood pressure).

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

• restlessness, difficulty sleeping, hallucinations (especially in children).
• fatigue (drowsiness, sedation), headache, seizures (convulsions, especially in children).
• heart rhythm disorders (arrhythmias).
• nasal mucosa inflammation (after stopping treatment).

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

• burning and dryness of the nasal mucosa, sneezing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SeptaNasal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

After first opening the container, the product should be used within 12 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE Point. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of SeptaNasal

• 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 spray contains 0.1 ml of nasal spray solution with 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.

• The other components are potassium dihydrogen phosphate, disodium phosphate dodecahydrate and water for injections.

Appearance of the product and contents of the container

The nasal spray solution is liquid, transparent, and colorless.

SeptaNasal is available in 10 ml bottles of nasal spray solution, in a plastic spray container with a pump spray device.

10 ml of nasal spray solution is sufficient for 90 sprays.

Marketing Authorization Holder and Manufacturing Responsible Party

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Date of the most recent review of this leaflet: November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/