Rhinovin Duo is a combination of 2 active ingredients: ipratropium, which reduces nasal discharge, and xylometazoline, which has a decongestant effect.

Rhinovín Duo is used to treat congestion and runny nose (rhinorrhea) related to the common cold.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days of treatment.

Do not use Rhinovin Duo:

• In children under 18 years of age, since adequate information is not available
• If you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to atropine or similar substances, eg hyoscyamine and scopolamine.
• If, through a surgical operation, through the nose, the pituitary gland has been removed.
• If you have had brain surgery through the nose or mouth.
• If you suffer from glaucoma (high intraocular pressure).
• If you suffer from severe nasal dryness (inflammatory nasal dryness, dry rhinitis).

Warnings and cautions

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

- Some cardiovascular disease (for example, long QT syndrome)

- High blood pressure

- Diabetes

- Hyperthyroidism (elevated thyroid hormone release).

- Difficulty urinating and / or prostatic hypertrophy

- Narrow-angle glaucoma.

- Predisposition to nasal bleeding

- Intestinal obstruction

- Cystic fibrosis.

- Benign tumor of the adrenal gland that produces large amounts of adrenaline and norepinephrine (pheochromocytoma) or exceptional sensitivity to adrenaline and norepinephrine that manifests with dizziness, tremor, tachycardia, increased blood pressure and insomnia.

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

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

Avoid spraying Rhinovin Duo around the eyes. If Rhinovin Duo comes into contact with them, it can temporarily cause blurred vision, irritation and pain in the eyes. Narrow-angle glaucoma can also get worse. Rinse your eyes with water and see your doctor if your eyes are hurt or your vision is blurred.

Children and adolescents

The use of Rhinovín Duo in children and adolescents under 18 years of age is not recommended as there is no adequate information on safety and efficacy.

Using Rhinovín Duo with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might take any other medicine. Rhinovin Duo can influence or be influenced by:

• Monoamine oxidase inhibitors, used to treat depression. If you are taking or have taken this type of medicine in the last two weeks, a dangerous increase in blood pressure can occur.
• Tricyclic and tetracyclic antidepressants (if you are taking or have taken these types of medicines in the last two weeks)
• Medicines used to reduce motion sickness in transport (medicines containing anticholinergic substances).
• Medicines used to treat intestinal disorders (particularly those used in the treatment of impaired intestinal motility) (medicines containing substances with anticholinergic effect).

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

Pregnancy and breastfeeding

Rhinovin Duo should not be used during pregnancy unless your doctor has prescribed it. You should not use Rhinovín Duo during breast-feeding unless your doctor decides that the benefits outweigh the possible risks to the child.

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

With the administration of Rhinovín Duo visual disturbances (including blurred vision and mydriasis), dizziness and fatigue have been reported. Patients should be warned that if they are affected by these symptoms, do not drive, use machines, or take part in certain activities as they may put themselves and others at risk.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

It is recommended to stop 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 you think that the effect of Rhinovín Duo is too strong or too weak, check with your doctor or pharmacist.

Instructions for use:

• Always blow your nose before using a nasal spray
• Remove the protector
• Do not cut the end of the valve. The dosing valve is ready to be actuated before use

• Before the first application, charge the pump by actuating it 4 times. Once charged, the pump remains charged through normal daily use throughout the treatment period. If the spray is not ejected during the actuation, or if the medicine has not been used for more than 6 days, the pump must be reloaded by activating it 4 times as before the first application.

• Keep the boat straight
• Move head forward slightly
• Close one of the nostrils by placing a finger against the side of your nose and insert the tip of the spray into the other nostril. Press the sprayer quickly while taking a deep breath of the product
• Repeat in the other pit

The effect appears after 5-15 minutes.

Avoid spraying Rhinovín Duo around the eyes.

If you use more Rhinovin Duo than you should If you, or someone close to you, take more medicine than you should, contact your doctor, hospital or emergency department to request a risk assessment. This is especially important in the case of children as they are more susceptible to adverse effects than adults.

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

Overdose symptoms are: severe dizziness, sweating, sudden drop in body temperature, headache, slow heartbeat, fast heartbeat, shortness of breath, coma, seizures, hypertension (high blood pressure) which may be followed by hypotension (low blood pressure).

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

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

Stop taking Rhinovín Duo and see your doctor immediately if you experience any of the following:

• Palpitations or increased heart rate (affects less 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 itching of the skin, with red rash or hives (frequency cannot be determined from the available data).
• Vision disturbances (including blurred vision, worsening glaucoma or increased pressure in the eye), rainbow colored halos / circles around bright lights, and / or eye pain (frequency cannot be determined from the available data).

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

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

• Nasal bleeding and nasal dryness.

Common (affects 1 in 10 people):

• Nose discomfort, nasal congestion, dry and sore throat, sore nose
• Dry mouth
• Altered taste sensation and headache.

Uncommon (affects 1 in 100 patients):

• Nasal ulcer, sneezing, sore throat, cough, hoarseness, upset stomach, nausea
• Altered olfactory sensation, dizziness, agitation
• Malaise, tiredness
• Insomnia
• Eye irritation, dry eyes

Rare (affects 1 in 1,000 people):

• Runny nose

Unknown frequency (cannot be calculated from the available data):

• Rash, hives
• Discomfort around the nose
• Chest discomfort, thirst
• Sudden spasm of the throat muscles
• Irregular pulse
• Eye focus problems, pupil dilation
• Itching
• Difficulty urinating

In order to minimize the risk of adverse reactions such as nasal bleeding or other effects on the nose, it is recommended to stop treatment with Rhinovin Duo when symptoms improve, even before reaching the maximum 7 days of treatment. .

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es .

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

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

Do not use this medicine after the expiry date which is stated on the carton and the label after "Expiry". The expiration date is 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. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of unneeded medicine and containers. This way you will help to protect the environment.

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.

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

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

What the product looks like and contents of the pack

Rhinovin Duo is a clear solution.

The 10 ml multi-dose bottle with metering pump contains approximately 70 sprays.

HOLDER AND RESPONSIBLE FOR MANUFACTURING:
GLAXOSMITHKLINE CONSUMER HEALTHCARE SA
Madrid Technology Park, Calle de Severo Ochoa, 2
28760 Tres Cantos, Madrid - Spain

Responsible for manufacturing

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG

Barthstraße 4 - 80339 Munich - Germany

OR

GlaxoSmithKline Consumer Healthcare A / S

Nykær 68 - 2605 Brøndby - Denmark                                            

OR

GlaxoSmithKline Consumer Healthcare SA

Site Apollo - Avenue Pascal 2-4-6

1300 Wavre

Belgium

OR

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road

Brentford, Middlesex

TW8 9GS

UK

OR

GSK -Gebro Consumer Healthcare GmbH

Bahnhofbichl, 13

6391 Fieberbrunn

Austria

OR

GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z OO

Gnatowice Stare 30

05-085 Kampinos, Poland

OR

GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z OO

ul. Rzymowskiego 53

02-697 Warszawa, Poland

This medicine has been 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 neusspray oplossing

Bulgaria               Otrivin Complex 0.5 mg / ml + 0.6 mg / ml nasal spray, solution

Cyprus               Otrivin Advance

Czech Republic               Otrivin Rhinostop

Germany               Otriven Duo mit Xylometazolin und Ipratropium

Denmark               Otrivin Comp naesespray, oplosning

Estonia               Otrivin Total

Greece               Otrivin Advance

Spain                            Rhinovín Duo 0.5 mg / ml + 0.6 mg / ml nasal spray solution

Finland               Otrivin Comp 0.5mg / ml + 0.6mg / ml nenäsumute, liuos

Hungary               Otrivin Komplex 0.5mg / ml + 0.6mg / ml oldata 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 nefuoi lausn

Italy               Rinazine Doppia Azione 0.5mg / ml + 0.6mg / ml nasal spray,               solution

Lithuania               OtriDuo 0.5 mg / 0.6 mg / ml nosies purškalas, tirpalas

Luxembourg               Otrivine Duo

Latvia               Otrivin Total 0.5 mg / ml + 0.6mg / ml deguna pilieni skidums

malt               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, opplosning

Poland               Otrivin Ipra MAX

Portugal               Vibrocil ActilongDuo 0.5mg / ml + 0.6mg / ml solution for               pulverizaçao

Romania               Vibrocil Duo 0.5mg / ml + 0.6mg / ml nazal spray,               solutie

Sweden               Otrivin Comp 0.5mg / ml + 0.6mg / ml nässpray lösning

Slovenia               Otrivin Duo 0.5 mg / 0.6 mg v 1 ml pršilo za nos, raztopine

Slovakia               Otrivin Complete

UK               Otrivine Extra Dual Relief 0.5 mg / ml, 0.6 mg / ml Nasal Spray

This leaflet was approved in January 2019

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