Rhinovin Duo 0.5 mg/ml + 0.6 mg/ml nasal spray solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rhinovin Duo 0.5 mg/ml + 0.6 mg/ml nasal spray solution

Xylometazoline Hydrochloride / Ipratropium Bromide

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 further information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You must consult a doctor if your condition worsens or if you do not improve after 7 days of treatment.

Leaflet Contents

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

1. What Rhinovín Duo is and what it is used for

Rhinovín Duo is a combination of two active substances: ipratropium, which reduces nasal secretions, and xylometazoline, which has a decongestant effect.

Rhinovín Duo is used for the treatment of nasal congestion and runny nose (rhinorrhea) associated with the common cold.

2. What you need to know before using Rhinovín Duo

Do not use Rhinovín Duo:

• In children under 18 years of age, as adequate information is not available.
• If you are allergic to xylometazoline hydrochloride or ipratropium bromide, or to any of the other components of this medicine (listed in section 6).
• If you are allergic to atropine or substances similar to it, e.g. hyoscine and scopolamine.
• If you have had surgery through the nose to remove the pituitary gland.
• If you have had brain surgery through the nose or mouth.
• If you have glaucoma (increased intraocular pressure).
• If you suffer from severe nasal dryness (inflammatory nasal dryness, dry rhinitis, or atrophic rhinitis).

Warnings and precautions

Rhinovín Duo may cause sleep disturbances, dizziness, tremors, irregular heartbeat, or increased blood pressure in individuals sensitive to nasal decongestant medicines. Consult your doctor if these symptoms occur and are bothersome.

Consult your doctor or pharmacist before using Rhinovín Duo if you have:

• Any cardiovascular disease (e.g., long QT syndrome)
• High blood pressure
• Diabetes
• Hyperthyroidism (elevated thyroid hormone levels)
• Difficulty urinating and/or prostate enlargement
• Narrow-angle glaucoma
• A tendency for nosebleeds
• Intestinal obstruction (paralytic ileus)
• Cystic fibrosis
• A benign tumor of the adrenal gland that produces large amounts of adrenaline and noradrenaline (pheochromocytoma), or exceptional sensitivity to adrenaline and noradrenaline

An immediate hypersensitivity reaction may occur, manifesting as an itchy red rash, raised skin swelling (urticaria), difficulty breathing or speaking, or difficulty swallowing due to swelling of the lips, face, or throat. These symptoms may appear individually or in combination as a severe allergic reaction. If this occurs, stop treatment with Rhinovín Duo immediately (see section 4).

Rhinovín Duo must not be used for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged use or excessive dosing may lead to nasal congestion as a rebound effect, worsening of this symptom, or inflammation of the nasal mucosa.

Avoid spraying Rhinovín Duo near the eyes. If this happens, rinse the eyes with cold water. Temporary blurred vision, eye irritation, pain, and redness may occur. If this happens, contact your doctor for advice. Narrow-angle glaucoma may also worsen.

Children and adolescents

The use of Rhinovín Duo is not recommended in children and adolescents under 18 years of age due to lack of adequate safety and efficacy data.

Use of Rhinovín Duo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Rhinovín Duo may interact with, or be affected by:

• Monoamine oxidase inhibitors (MAOIs), used to treat depression. If you are taking or have taken these medicines within the last two weeks, a dangerous increase in blood pressure may occur.
• Tricyclic and tetracyclic antidepressants (if taken or used within the last two weeks, dangerous increases in blood pressure may occur).
• Medicines used to prevent motion sickness (medicines containing anticholinergic substances).
• Medicines used to treat intestinal disorders (particularly those used for motility disorders) (medicines containing substances with anticholinergic effects).
• Medicines used to treat respiratory disorders (Beta-2 agonists) such as asthma or chronic obstructive pulmonary disease (COPD), as they may worsen glaucoma if you have a history of narrow-angle glaucoma.

If you are taking any of the medicines listed above, consult your doctor before using Rhinovín Duo.

Pregnancy and breastfeeding

Rhinovín Duo should not be used during pregnancy unless prescribed by your doctor. During breastfeeding, Rhinovín Duo should not be used unless your doctor decides that the benefits outweigh the potential risks to the infant.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Visual disturbances (including blurred vision and mydriasis), dizziness, and fatigue have been reported with the use of Rhinovín Duo. Patients should be advised that if they experience these symptoms, they should not drive, operate machinery, or engage in certain activities, as they may place themselves and others at risk.

3. How to use Rhinovín Duo

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults: One spray into each nostril as needed, up to a maximum of 3 sprays per day for 7 days. There should be at least 6 hours between each dose. Do not exceed more than 3 applications per day in each nostril.

Do not exceed the recommended dose. Use the lowest dose necessary to relieve your symptoms, and use it for the shortest duration needed to achieve the desired effect.

Duration of treatment:

Do not use this medicine for longer than 7 days.

It is recommended to stop treatment with Rhinovín Duo as soon as symptoms have improved, even before reaching the maximum treatment duration of 7 days, in order to minimize the risk of adverse reactions.

If symptoms worsen or do not improve after 7 days, consult your doctor.

If you think the effect of Rhinovín Duo is too strong or too weak, consult your doctor or pharmacist.

Instructions for use:

Vertically operated pump using two fingers:

• Remove the cap.
• Do not cut the end of the valve. The metering valve is ready for use without any preparation.

Before the first use, prime the pump by actuating it 4 times. Once primed, the pump remains ready for use during normal daily use throughout the treatment period. If no spray is expelled when actuated, or if the medicine has not been used for more than 6 days, re-prime the pump by actuating it 4 times, as before the first use.

1. Blow your nose.
2. Hold the bottle upright with your thumb under the base and the nozzle between two fingers.
3. Tilt your head slightly forward and insert the nozzle into one nostril.
4. Press the spray while gently inhaling the product through your nose.
5. Repeat this procedure (steps 1 to 4) in the other nostril.
6. Clean and dry the nozzle before replacing the cap.

Laterally operated pump using the thumb:

Remove the cap.

Before first use:

Prime the pump by actuating it 5 times. Once primed, the pump remains ready for normal daily use throughout the treatment period.

1. Blow your nose.
2. Hold the bottle vertically, placing your thumb on the actuator button.
3. To avoid dripping, remain upright and insert the spray nozzle into one nostril.
4. Press the button to spray and gently inhale through your nose at the same time.

Repeat this process (steps 2 to 4) in the other nostril.

1. After each use, clean and dry the nozzle.
2. Replace the protective cap until you hear a "click".

If no spray is expelled when actuated, or if the medicine has not been used for more than 7 days, re-prime the pump with 2 actuations.

If a full spray dose is not delivered, do not repeat the dose.

To avoid possible spread of infection, the spray should be used by only one person. Avoid spraying Rhinovín Duo near the eyes.

The effect begins within 5–15 minutes.

If you use more Rhinovín Duo than you should

If you or someone else takes more medicine than recommended, contact your doctor, hospital, or emergency services to assess the risk. It is advisable to bring the leaflet, packaging, or carton with you. This is especially important in the case of children, as they are more susceptible to adverse effects than adults.

Symptoms of overdose include: severe dizziness, sweating, sudden drop in body temperature, headache, slow heart rate, rapid heart rate, breathing difficulties, coma, seizures, hypertension (high blood pressure), which may be followed by hypotension (low blood pressure).

Other symptoms may include dry mouth, difficulty focusing the eyes, and hallucinations.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested.

If you forget to take Rhinovín Duo

Do not apply a double dose to make up for a missed application.

4. Possible adverse effects

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

Stop treatment with Rhinovín Duo and consult your doctor immediately if you experience any of the following effects:

• Palpitations or increased heart rate (affects fewer than 1 in 100 patients)
• Signs of an allergic reaction such as difficulty breathing, speaking or swallowing; swelling of the face, lips, tongue or throat; severe skin itching, with red rash or hives (frequency cannot be determined from available data).
• Vision disturbances (including blurred vision, worsening of glaucoma or increased intraocular pressure), halos/colored rings around bright lights and/or eye pain (frequency cannot be determined from available data).

The most common adverse effects are nasal bleeding and nasal dryness. Many of the reported adverse effects are also symptoms of the common cold.

Very common (affects more than 1 in 10 patients):

• Nasal bleeding

Common (affects 1 in 10 patients):

• Nasal discomfort, nasal congestion, dry nose, nasal pain
• Dry mouth, dry or irritated throat
• Altered taste sensation, headache, dizziness, local burning sensation
• Nausea

Uncommon (affects between 1 in 100 patients):

• Nasal ulcer, sneezing, sore throat, cough, hoarseness, stomach discomfort, nausea
• Altered sense of smell, restlessness
• Malaise, fatigue
• Insomnia
• Eye irritation, dry eyes, eye swelling, eye redness
• Palpitations, increased heart rate

Rare (affects 1 in 1,000 patients):

• Runny nose

Very rare (affects 1 in 10,000 patients):

• Drug reaction such as swelling, rash and pruritus
• Visual impairment

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

• Urticaria
• Irritation around the nose
• Difficulty swallowing
• Chest discomfort, thirst
• Sudden spasm of throat muscles, throat swelling
• Irregular heartbeat
• Eye focusing problems, pupil dilation, flickering lights, increased intraocular pressure, glaucoma, blurred vision, halos around bright lights and eye pain
• Difficulty urinating

To minimize the risk of adverse reactions, it is recommended to discontinue treatment with Rhinovín Duo once symptoms improve.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rhinovín Duo

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

Do not use this medicine after the expiry date stated on the carton and label after "Expiry". The expiry date refers to the last day of the month indicated. This date applies even if the container has been opened.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rhinovin Duo

The active substances are xylometazoline hydrochloride and ipratropium bromide.

1 ml contains 0.5 mg of xylometazoline hydrochloride and 0.6 mg of ipratropium bromide.

One spray contains 70 micrograms of xylometazoline hydrochloride and 84 micrograms of ipratropium bromide.

The other components (excipients) are: disodium edetate, glycerol (85%), purified water, sodium hydroxide and hydrochloric acid.

Nature of the product and pack contents

Rhinovin Duo is a clear solution.

The bottle contains approximately 70 sprays.

Rhinovin Duo is available as a 10 ml nasal spray with a vertically operated pump activated by two fingers, and as a 10 ml nasal spray with a laterally operated pump activated by the thumb (with protective cap).

Marketing Authorization Holder and Manufacturer

Haleon Spain, S.A.
Paseo de la Castellana, 259D, planta 32 - 28046 – Madrid – Spain.

Manufacturer

Haleon Denmark ApS
Delta Park 37, 2665 Vallensbæk Strand - Denmark

Or

Haleon Belgium NV
Da Vincilaan 5,
1930 Zaventem - Belgium

Or

Haleon - Gebro Consumer Health GmbH
Bahnhofbichl, 13
6391 Fieberbrunn
Austria

Or

Haleon Germany GmbH
Barthstraße 4 – 80339 Munich - Germany

This medicinal product is authorized in the EEA Member States under the following names:

Austria Otrivin Duo 0.5 mg/ml + 0.6 mg/ml Nasenspray, Lösung
Belgium Otrivine Duo 0.5mg/ml + 0.6mg/ml solution for nasal spray
Cyprus Otrivin Advance (0.5mg/ml + 0.6mg/ml) nasal spray solution
Czech Republic Otrivin Rhinostop
Denmark Otrivin Comp naesespray, oplosning
Estonia Otrivin Total
Greece Otrivin Advance 0.5mg/ml + 0.6mg/ml Ρινικό εκνέφωμα, διάλυμα
Spain Rhinovín Duo 0.5 mg/ml + 0.6 mg/ml solución para pulverización nasal
Finland Otrivin Comp 0.5mg/ml + 0.6mg/ml nenäsumute, liuos
Hungary Otrivin Komplex 0.5mg/ml + 0.6mg/ml oldatos orrspray
Ireland Otrivine Extra Dual Relief 0.5 mg/ml, 0.6 mg/ml Nasal Spray
Iceland Otrivin Comp 0.5mg/ml + 0.6mg/ml nefúði lausn
Italy Rinazina Doppia Azione 0.5mg/ml + 0.6mg/ml spray nasale, soluzione
Lithuania OtriDuo 0.5 mg/0.6 mg/ml nosies purškalas, tirpalas
Luxembourg Otrivine Duo 0.5mg/ml + 0.6mg/ml solution pour pulvérisation nasale
Latvia Otrivin Total 0.5 mg/ml + 0.6mg/ml deguna pilieni skidums
Malta Otrivine Extra Dual Relief 0.5 mg/ml, 0.6 mg/ml Nasal Spray
Netherlands Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6 mg/ml, neusspray, oplossing
Norway Otrivin Comp 0.5mg/ml + 0.6mg/ml nesespray, oppløsning
Poland Otrivin Ipra MAX
Portugal Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml solução para pulverização
Romania Vibrocil Duo 0.5mg/ml + 0.6mg/ml spray nazal, solutie
Sweden Otrivin Comp 0.5mg/ml + 0.6 mg/ml nässpray lösning
Slovenia Otrivin Duo 0.5 mg/0.6 mg v 1 ml pršilo za nos, raztopina
Slovakia Otrivin Complete
United Kingdom (Northern Ireland) Otrivine Extra Dual Relief 0.5 mg/ml, 0.6 mg/ml Nasal Spray

Date of the most recent revision of this leaflet: June 2023

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