Package Insert: Information for the Patient

Rhinovin Duo 0.5 mg/ml + 0.6 mg/ml Nasal Spray Solution

Xylometazoline Hydrochloride / Ipratropium Bromide

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

1. What is Rhinovin Duo and how is it used

2. What you need to know before starting to use Rhinovin Duo

3. How to use Rhinovin Duo

4. Possible adverse effects

5. Storage of Rhinovin Duo

6. Contents of the package and additional information

Rhinovín Duo is an association of 2 active principles: ipratropium which reduces nasal secretion and xylometazoline which has a decongestant effect.

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

Do not use Rhinovin Duo:

• In children under 18 years, as there is not enough information available
• If you are allergic to xylometazoline hydrochloride or ipratropium bromide or to any of the other components of this medication (listed in section 6)
• If you are allergic to atropine or similar substances, e.g. hyoscyamine and scopolamine
• If you have had a surgical operation, through the nose, to remove the pituitary gland
• If you have undergone surgical intervention of the brain through the nose or mouth
• If you have glaucoma (elevated intraocular pressure)
• If you suffer from severe nasal dryness (inflammatory nasal dryness, dry rhinitis, or atrophic rhinitis)

Warnings and precautions

Rhinovin Duo may cause sleep disturbances, dizziness, tremors, irregular heart rhythm, or increased blood pressure in case of sensitivity to nasal decongestant medications. 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 release)

- Difficulty urinating and/or prostate hypertrophy

- Narrow-angle glaucoma

- Predisposition to nasal bleeding

- Intestinal obstruction (paralytic ileus)

- Cystic fibrosis

- Benign adrenal gland tumor that produces large amounts of adrenaline and noradrenaline (pheochromocytoma) or exceptional sensitivity to adrenaline and noradrenaline

A hypersensitivity reaction may occur, manifesting as a red, itchy rash, elevated skin inflammation (urticaria), difficulty breathing or speaking, difficulty swallowing due to lip, face, or throat inflammation. These symptoms may appear individually or in combination as a severe allergic reaction. If this occurs, discontinue Rhinovín Duo immediately (see section 4).

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

Avoid spraying Rhinovin Duo around the eyes. If this occurs, rinse the eyes with cold water. You may experience temporary blurred vision, irritation, pain, and redness in the eyes. If this occurs, consult your doctor for advice. This may also worsen narrow-angle glaucoma.

Children and adolescents

The use of Rhinovín Duo in children and adolescents under 18 years is not recommended, as there is not enough information available on safety and efficacy.

Use of Rhinovín Duo with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication. Rhinovin Duo may influence or be influenced by:

• Monamine oxidase inhibitors, used for the treatment of depression. If you are taking or have taken this type of medication in the last two weeks, a dangerous increase in blood pressure may occur.
• Tricyclic and tetracyclic antidepressants (if you are taking or have taken this type of medication in the last two weeks, dangerous increases in blood pressure may occur).
• Medications used to reduce motion sickness in transportation (medications containing anticholinergic substances).
• Medications used to treat intestinal disorders (particularly those used to treat altered intestinal motility) (medications containing anticholinergic substances).
• Medications used to treat respiratory disorders (Beta-2-agonists) such as asthma or chronic obstructive pulmonary disease (COPD), as they may worsen your glaucoma if you have a history of narrow-angle glaucoma.

If you are using any of the medications mentioned above, consult your doctor before using Rhinovin Duo.

Pregnancy and lactation

Rhinovin Duo should not be used during pregnancy unless your doctor has prescribed it. During lactation, do not use Rhinovín Duo unless your doctor decides that the benefits outweigh the possible risks for the baby.

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

Driving and operating machinery

Visual disturbances (including blurred vision and mydriasis), dizziness, and fatigue have been reported with the administration of Rhinovín Duo. Warn patients that if they are affected by these symptoms, they should not drive, operate machinery, or participate in certain activities as they may put themselves and others at risk.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: One spray in each nasal passage as needed, up to 3 sprays per day at maximum for 7 days. At least 6 hours should elapse between each dose. No more than 3 applications per day should be made in each nasal passage.

Do not exceed the established dose, use the lowest dose needed to treat your symptoms, and use it for the shortest time necessary to achieve the desired effect.

Treatment duration:

Do not use this medication for more than 7 days.

It is recommended to discontinue treatment with Rhinovín Duo as soon as symptoms have improved, even before 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 with your doctor or pharmacist.

Usage instructions:

Vertical pump action with two fingers:

• Remove the cap
• Do not cut the end of the valve. The dosing valve is prepared to be actuated before use

Before the first application, load the pump by actuating it 4 times. Once loaded, the pump remains loaded through normal daily use during the treatment period. If the spray does not eject during actuation, or if the medication has not been used for more than 6 days, the pump must be reloaded by actuating it 4 times, just like before the first application.

1. Blow your nose.

2. Hold the bottle with the thumb under the base and the nozzle between the two fingers.

3. Lean forward slightly and insert the nozzle into one of the nasal passages.

4. Press the sprayer while breathing in gently through the nose.

5. Repeat this procedure (steps 1 to 4) in the other nasal passage.

6. Clean and dry the nozzle before replacing the cap after use.

Lateral pump action with the thumb:

Remove the cap.

Before using for the first time

Prime the pump by actuating it 5 times. Once primed, the pump will remain loaded normally throughout the daily treatment period.

1. Blow your nose.
2. Hold the bottle vertically with the thumb on the actuation button.
3. To avoid dripping, remain upright and insert the spray nozzle into a nasal passage.
4. Pulse the button to spray and breathe in gently through the nose at the same time.

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

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

If the spray does not eject during actuation, or if the medication has not been used for more than 7 days, the pump will need to be reprimed by actuating it 2 times.

If the full dose is not administered, do not repeat the dose.

To avoid possible infection dissemination, the spray should be used only by one person. Avoid spraying Rhinovin Duo around the eyes.

The effect appears within 5-15 minutes.

If you use more Rhinovin Duo than you should

If you, or someone in your environment, take more medication than you should, contact your doctor, hospital, or emergency service to request an assessment of the risk. It is recommended that you bring the leaflet, the container, or the packaging with you. This is especially important in the case of children, as they are more susceptible to developing adverse effects than adults.

The symptoms of overdose are: severe dizziness, sweating, sudden drop in body temperature, severe headache, slow heart rate, rapid heart rate, difficulty breathing, coma, convulsions, hypertension (high blood pressure) that may be followed by hypotension (low blood pressure).

Other symptoms may be dry mouth, eye focus problems, and hallucinations.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

If you forgot to take Rhinovin Duo

Do not apply a double dose to compensate for a missed dose.

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

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

• Palpitations or increased heart rate (affect less than 1 in 100 patients)
• Allergic reaction symptoms such as difficulty breathing, speaking, or swallowing; facial, lip, tongue, or throat inflammation; severe skin itching, red rash, or hives (frequency cannot be determined with available data)
• Visual disturbances (including blurred vision, worsening of glaucoma, or increased eye pressure), halos/rings with rainbow colors around bright lights, and/or eye pain (frequency cannot be determined with available data)

The most common side effects are nasal bleeding and dryness. Many reported side 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, sore throat, or irritated throat
• Altered sense of taste and headache, dizziness, local burning sensation
• Nausea

Uncommon (affects between 1 in 100 patients):

• Nasal ulcer, sneezing, throat pain, cough, hoarseness, gastrointestinal upset, nausea
• Altered sense of smell, agitation
• Discomfort, fatigue
• Insomnia
• Eye irritation, dry eyes, eye swelling, conjunctival redness
• Palpitations, increased heart rate

Rare (affects 1 in 1,000 patients):

• Nasal discharge

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

• Medication reaction such as swelling, hives, and pruritus
• Visual impairment

Unknown frequency (cannot be calculated from available data):

• Urticaria
• Nasal discomfort
• Difficulty swallowing
• Chest discomfort, thirst
• Sudden spasms of the throat muscles, throat swelling
• Irregular heart rhythm
• Eye focusing problems, dilated pupil, intermittent lights, increased eye 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 Rhinovin Duo when 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and label after “Expiration Date”. The expiration date is the last day of the month indicated.This date applies even if the packaging has been opened.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of Rhinovin Duo

The active ingredients are xylometazoline hydrochloride and ipratropium bromide.

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

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

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

Appearance of the product and contents of the package

Rhinovin Duo is a transparent solution.

The bottle contains approximately 70 sprays.

Rhinovin Duo is available as a 10 ml nasal spray with a two-finger vertical pump and as a 10 ml nasal spray with a lateral pump activated by the thumb (with a protective cap).

Marketing authorization holder and responsible manufacturer
Haleon Spain, S.A.
Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2
28760 Tres Cantos, Madrid – Spain

Responsible manufacturer

Haleon Denmark ApS

Delta Park 37, 2665 Vallensbæk Strand -Denmark

O

Haleon Belgium NV

Da Vincilaan 5,

1930 Zaventem, Belgium

O

Haleon - Gebro Consumer Health GmbH

Bahnhofbichl, 13

6391 Fieberbrunn

Austria

O

Haleon Germany GmbH

Barthstraße 4 – 80339 Munich - Germany

This medicine is authorized in the EEA member states with the following names:

AustriaOtrivin Duo 0.5 mg/ml + 0.6 mg/ml Nasal Spray, Solution

BelgiumOtrivine Duo 0.5mg/ml + 0.6mg/ml solution for nasal spray

CyprusOtrivin Advance (0.5mg/ml + 0.6mg/ml) nasal spray solution

Czech RepublicOtrivin Rhinostop

DenmarkOtrivin Comp nasal spray, solution

EstoniaOtrivin Total

GreeceOtrivin Advance 0.5mg/ml + 0.6mg/ml Ρινικό?κν?φωμα, δι?λυμα

SpainRhinovín Duo 0.5 mg/ml + 0.6 mg/ml solution for nasal spray

FinlandOtrivin Comp 0.5mg/ml + 0.6mg/ml nenäsumute, liuos

HungaryOtrivin Komplex 0.5mg/ml + 0.6mg/ml oldatos orrspray

IrelandOtrivine Extra Dual Relief 0.5 mg/ml, 0.6 mg/ml Nasal Spray

IcelandOtrivin Comp 0.5mg/ml + 0.6mg/ml nefúði lausn

ItalyRinazina Doppia Azione 0.5mg/ml + 0.6mg/ml spray nasale, soluzione

LithuaniaOtriDuo 0.5 mg/0.6 mg/ml nosies purškalas, tirpalas

LuxembourgOtrivine Duo 0.5mg/ml + 0.6mg/ml solution for nasal spray

LatviaOtrivin Total 0.5 mg/ml + 0.6mg/ml deguna pilieni skidums

MaltaOtrivine Extra dual Relief 0.5 mg/ml, 0.6 mg/ml Nasal Spray

NetherlandsOtrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6 mg/ml, neusspray, oplossing

NorwayOtrivin Comp 0.5mg/ml + 0.6mg/ml nesespray, oppløsning

PolandOtrivin Ipra MAX

PortugalVibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml soluçao para pulverizaçao

RomaniaVibrocil Duo 0.5mg/ml + 0.6mg/ml spray nazal, solutie

SwedenOtrivin Comp 0.5mg/ml + 0.6 mg/ml nässpray lösning

SloveniaOtrivin Duo 0.5 mg/0.6 mg v 1 ml pršilo za nos, raztopina

SlovakiaOtrivin Complete

United Kingdom (Northern Ireland)Otrivine Extra Dual Relief 0.5 mg/ml, 0.6 mg/ml Nasal Spray

Last review date of this leaflet:June 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/