Rinazina double action

Package leaflet: Information for the user

RINAZINA DUAL ACTION 0.5 mg/ml + 0.6 mg/ml nasal spray, solution

Xylometazoline hydrochloride/Ipratropium bromide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What RINAZINA DOPPIA AZIONE is and what it is used for

RINAZINA DOPPIA AZIONE is a combination medicine containing two different substances.
One of the active substances helps relieve runny nose, the other has a decongestant effect.
RINAZINA DOPPIA AZIONE is used for the treatment of nasal congestion with runny nose (rhinorrhea) associated with common colds.

2. What you should know before using RINAZINA DOPPIA AZIONE

Do not use RINAZINA DOPPIA AZIONE:

• in children under 18 years of age, as adequate information on safety and efficacy is not available
• if you are allergic to xylometazoline hydrochloride or ipratropium bromide or to any of the excipients of this medicine (listed in section 6)
• if you are allergic to atropine or substances similar to atropine, such as hyosciamine and scopolamine
• if your pituitary gland has been surgically removed through the nose
• if you have undergone brain surgery performed through the nose or mouth
• if you suffer from glaucoma (increased pressure in the eyes)
• if you have a very dry nose (inflammatory nasal dryness, dry rhinitis or atrophic rhinitis).

Warnings and precautions
RINAZINA DOPPIA AZIONE may cause sleep disturbances, dizziness, tremor, irregular heartbeat or high blood pressure if you are sensitive to medicines used to relieve nasal congestion.
Consult your doctor if these symptoms occur and are bothersome.
Contact your doctor or pharmacist before using RINAZINA DOPPIA AZIONE if you have:

• heart conditions (e.g., long QT syndrome)
• high blood pressure
• diabetes
• overactive thyroid gland (hyperthyroidism)
• difficulty urinating and/or enlarged prostate
• closed-angle glaucoma
• tendency to nosebleeds
• intestinal obstruction (paralytic ileus)
• cystic fibrosis
• a benign tumour of the adrenal gland producing high levels of adrenaline and noradrenaline (pheochromocytoma) or particular sensitivity to adrenaline and noradrenaline.

Immediate hypersensitivity (allergic reaction) may occur. This may present as an itchy red rash with raised inflamed skin (urticaria), difficulty breathing or speaking, or difficulty swallowing due to swelling of the lips, face or throat. These symptoms may appear individually or together as a severe allergic reaction. In such a case, stop using RINAZINA DOPPIA AZIONE immediately (see section 4).
RINAZINA DOPPIA AZIONE must not be used for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged or excessive use may cause recurrence or worsening of nasal congestion and swelling of the nasal mucosa.
Avoid spraying RINAZINA DOPPIA AZIONE into or around the eyes. If this occurs, rinse eyes thoroughly with cold water. Your vision may become temporarily blurred and your eyes may become irritated, painful and red. If this happens, consult your doctor for advice.
Worsening of closed-angle glaucoma may also occur.
Children and adolescents
The use of RINAZINA DOPPIA AZIONE is not recommended in children and adolescents under 18 years of age, as adequate information on safety and efficacy is not available.
Other medicines and RINAZINA DOPPIA AZIONE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that you mention the following:

• Monoamine oxidase inhibitors (used to treat depression). If you are taking or have taken these medicines within the last two weeks, dangerous increases in blood pressure may occur;
• Tricyclic and tetracyclic antidepressants. If you are taking or have taken these medicines within the last two weeks, dangerous increases in blood pressure may occur;
• Medicines used for travel sickness (medicines containing anticholinergic substances);
• Medicines used for intestinal disorders (particularly those for altered motility) (medicines containing anticholinergic substances);
• 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 closed-angle glaucoma.

If you are taking any of the medicines listed above, consult your doctor before using RINAZINA DOPPIA AZIONE.
Pregnancy and breastfeeding
RINAZINA DOPPIA AZIONE must not be used during pregnancy unless recommended by your doctor. During breastfeeding, RINAZINA DOPPIA AZIONE must not be used unless your doctor decides that the benefits outweigh the potential risks to the newborn. If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
With RINAZINA DOPPIA AZIONE, visual disturbances (including blurred vision and dilated pupils), dizziness and fatigue have been reported. If affected, you should avoid driving, using machinery or engaging in activities where these symptoms could put you or others at risk.
Caution for those engaged in sports:
This product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.

3. How to use RINAZINA DOPPIA AZIONE

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: one spray into each nostril as needed, up to 3 times a day for a maximum of 7 days. Allow at least 6 hours between doses. Do not exceed 3 applications per day in each nostril.
Do not exceed the stated 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 more than 7 days.
It is recommended to stop treatment with RINAZINA DOPPIA AZIONE once symptoms have improved, even if this is before the 7-day period, 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 that the effect of RINAZINA DOPPIA AZIONE is too strong or too weak, consult your doctor or pharmacist.

Instructions for use

• Remove the protective cap.
• Do not cut the nozzle. The spray is ready to be primed before first use.

• For first use, press the pump 4 times to prime it. Once primed, the pump will normally remain charged throughout the period of continuous daily treatment. If no spray is released during full activation, or if the product has not been used for more than 6 days, the pump will need to be re-primed by pressing 4 times as initially performed.
  1. Blow your nose.
  2. Hold the bottle upright with your thumb under the base and the nozzle between two fingers.
  3. Lean slightly forward and insert the nozzle into one nostril.
  4. Press the pump to spray while gently inhaling through the nose at the same time.
  5. Repeat this procedure (steps 1 to 4) in the other nostril.
  6. Immediately after use, clean and dry the nozzle before replacing the cap.

If no spray is released during full actuation, or if the product has not been used for more than 7 days, the pump must be re-primed by pressing twice. If a full spray 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 RINAZINA DOPPIA AZIONE into or around the eyes.
The effect begins within 5–15 minutes.

If you use more RINAZINA DOPPIA AZIONE than you should
If you or someone else has used more medicine than recommended, contact your doctor, hospital, or emergency department for risk assessment. It is advisable to bring this leaflet, the bottle, or the carton with you. This is particularly important for children, as they are more likely to experience adverse effects than adults.
Severe symptoms of overdose include dizziness, sweating, severely lowered body temperature, headache, slowed heart rate, rapid heartbeat, 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, and hallucinations.

If you forget to use RINAZINA DOPPIA AZIONE
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using RINAZINA DOPPIA AZIONE and seek immediate medical help if you experience any of the following symptoms:

• Palpitations and increased heart rate (affects less than 1 in 100 people).
• 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 lumps (frequency not known, cannot be estimated from available data).
• Vision disturbances (including blurred vision, worsening of glaucoma or increased eye pressure), coloured halos or rainbows around bright lights and/or eye pain (frequency not known, cannot be estimated from available data).

The most common side effects are nosebleeds and nasal dryness. Many of the reported side effects are also symptoms of the common cold.
Very common side effects (may affect more than 1 in 10 people):

• Nosebleed (epistaxis)

Common side effects (may affect up to 1 in 10 people):

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

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

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

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

• Runny nose

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

• Reaction to the medicine such as swelling, skin rash, itching
• Visual disturbances

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

• Urticaria
• Irritation around the nose
• Difficulty swallowing
• Chest discomfort, thirst
• Sudden spasm of the throat, throat swelling
• Irregular heartbeat
• Difficulty focusing eyes, dilated pupils, seeing flashes of light, increased eye pressure, glaucoma, blurred vision, halos around bright lights and eye pain
• Difficulty emptying the bladder.
  To minimize the risk of side effects, it is recommended to stop treatment with RINAZINA DOPPIA AZIONE as soon as your symptoms improve.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RINAZINA DUAL ACTION

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after Exp. The expiry date refers to the last day of the month. This date applies even after opening the package.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What RINAZINA DOPPIA AZIONE Contains
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 excipients are disodium edetate, glycerol (85%), purified water, sodium hydroxide and hydrochloric acid.

Description of the Appearance of RINAZINA DOPPIA AZIONE and Contents of the Package
RINAZINA DOPPIA AZIONE is a clear solution.
The bottle contains approximately 70 sprays.
RINAZINA DOPPIA AZIONE is available as a 10 ml nasal spray with a pump activated vertically.

Marketing Authorization Holder and Manufacturer:
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy

Manufacturers:
Haleon Belgium NV, Da Vincilaan 5, 1930 Zaventem, Belgium.
Haleon-Gebro Consumer Healthcare GmbH, Bahnhofbichl 13, 6391 Fieberbrunn, Austria
Haleon Denmark ApS, Delta Park 37, 2665 Vallensbæk Strand, Denmark
Haleon Germany GmbH, Barthstraße 4, 80339 Munich, Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
AT Otrivin Duo 0.5 mg/ml + 0.6 mg/ml Nasenspray, Lösung
BE Otrivine Duo 0.5mg/ml + 0.6mg/ml solution pour pulvérisation nasale
CY Otrivin Advance (0.5mg/ml + 0.6mg/ml) nasal spray solution
CZ Otrivin Duo
DK Otrivin Comp næsespray, opløsning
EE Otrivin Total
EL Otrivin Advance 0.5mg/ml + 0.6mg/ml Ρινικό εκνέφωμα, διάλυμα
ES Rhinovin Duo 0.5mg/ml + 0.6mg/ml solución para pulverización nasal
FI Otrivin Comp 0.5mg/ml + 0.6mg/ml nenäsumute, liuos
HU Otrivin Komplex 0.5mg/ml + 0.6mg/ml oldatos orrspray
IE Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray, Solution
IS Otrivin Comp 0.5mg/ml + 0.6mg/ml nefúði lausn
IT RINAZINA DOPPIA AZIONE 0.5mg/ml + 0.6mg/ml nasal spray, solution
LT OtriDuo 0.5 mg/0.6 mg/ml nosies purškalas, tirpalas
LU Otrivine Duo 0.5mg/ml + 0.6mg/ml solution pour pulvérisation nasale
LV Otrivin Total 0.5 mg/ml + 0.6mg/ml deguna aerosols, šķīdums
MT Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray
Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6
NL
mg/ml, neusspray, oplossing
NO Otrivin Comp 0.5mg/ml + 0.6mg/ml nesespray, oppløsning
PL Otrivin Ipra MAX
PT Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml soluçao para pulverizaçao nasal
RO Vibrocil Duo 0.5mg/ml + 0.6mg/ml spray nazal, solutie
SE Otrivin Comp 0.5mg/ml + 0.6 mg/ml nässpray lösning
SI Otrivin Duo 0.5 mg/0.6 mg per 1 ml nasal spray, solution
SK Otrivin Duo
UK (NI) Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray

Package leaflet: Information for the user

RINAZINA DOPPIA AZIONE 0.5 mg/ml + 0.6 mg/ml nasal spray, solution

Xylometazoline hydrochloride/Ipratropium bromide
Read this entire leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

2. What RINAZINA DOPPIA AZIONE is and what it is used for

RINAZINA DOPPIA AZIONE is a combination medicine containing two different substances.
One of the active substances helps relieve runny nose, the other has a decongestant effect.
RINAZINA DOPPIA AZIONE is used for the treatment of nasal congestion with runny nose (rhinorrhoea) associated with the common cold.

3. What you need to know before using RINAZINA DOPPIA AZIONE

Do not use RINAZINA DOPPIA AZIONE:

• in children under 18 years of age, as adequate information on safety and efficacy is not available
• if you are allergic to xylometazoline hydrochloride or ipratropium bromide or to any of the excipients of this medicine (listed in section 6)
• if you are allergic to atropine or substances similar to atropine, such as hyoscine and scopolamine
• if your pituitary gland has been surgically removed via the nose
• if you have undergone brain surgery performed through the nose or mouth
• if you have glaucoma (increased pressure in the eyes)
• if you have a very dry nose (inflammatory nasal dryness, dry rhinitis or atrophic rhinitis).

Warnings and precautions
RINAZINA DOPPIA AZIONE may cause sleep disturbances, dizziness, tremor, irregular heartbeat or high blood pressure if you are sensitive to medicines used for nasal congestion relief.
Consult your doctor if these symptoms occur and are bothersome.
Contact your doctor or pharmacist before using RINAZINA DOPPIA AZIONE if you have:

• heart conditions (e.g., long QT syndrome)
• high blood pressure
• diabetes
• overactive thyroid gland (hyperthyroidism)
• difficulty urinating and/or enlarged prostate
• closed-angle glaucoma
• tendency to nosebleeds
• intestinal obstruction (paralytic ileus)
• cystic fibrosis
• a benign tumour of the adrenal gland producing high levels of adrenaline and noradrenaline (pheochromocytoma) or a particular sensitivity to adrenaline and noradrenaline.

Immediate hypersensitivity (allergic reaction) may occur. This may present as itchy red rash with inflamed raised skin (urticaria), difficulty breathing or speaking, or difficulty swallowing due to swelling of the lips, face or throat. These symptoms may appear individually or together as a severe allergic reaction. In such case, stop using RINAZINA DOPPIA AZIONE immediately (see section 4).
RINAZINA DOPPIA AZIONE must not be used for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged or excessive use may cause recurrence or worsening of nasal congestion and swelling of the nasal mucosa.
Avoid spraying RINAZINA DOPPIA AZIONE into or around the eyes. If this occurs, rinse the eyes thoroughly with cold water. Your vision may become temporarily blurred and the eye may become irritated, painful and red. If this happens, consult your doctor for advice.
Worsening of closed-angle glaucoma may also occur.
Children and adolescents
The use of RINAZINA DOPPIA AZIONE is not recommended in children and adolescents under 18 years of age, as adequate information on safety and efficacy is not available.
Other medicines and RINAZINA DOPPIA AZIONE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that you mention the following:

• Monoamine oxidase inhibitors (used to treat depression). If you are taking or have taken these medicines within the last two weeks, dangerous increases in blood pressure may occur;
• Tricyclic and tetracyclic antidepressants. If you are taking or have taken these medicines within the last two weeks, dangerous increases in blood pressure may occur;
• Medicines used for travel sickness (medicines containing anticholinergic substances);
• Medicines used for intestinal disorders (particularly those for altered motility) (medicines containing anticholinergic substances);
• 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 closed-angle glaucoma.

If you are taking any of the medicines listed above, consult your doctor before using RINAZINA DOPPIA AZIONE.
Pregnancy and breastfeeding
RINAZINA DOPPIA AZIONE must not be used during pregnancy unless recommended by your doctor. During breastfeeding, RINAZINA DOPPIA AZIONE must not be used unless your doctor decides that the benefits outweigh the potential risks to the newborn. If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Visual disturbances (including blurred vision and pupil dilation), dizziness and fatigue have been reported with RINAZINA DOPPIA AZIONE. If affected, you should avoid driving, operating machinery or engaging in activities where these symptoms could put you or others at risk.
Caution for athletes:
The product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.

3. How to use RINAZINA DOPPIA AZIONE

Use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has instructed you. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults: one spray into each nostril as needed, up to 3 times a day for a maximum of 7 days. Allow at least 6 hours between doses. Do not exceed 3 applications per day in each nostril.
Do not exceed the stated dose. Use the lowest effective 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 more than 7 days.
It is recommended to stop treatment with RINAZINA DOPPIA AZIONE once symptoms have improved, even if earlier than 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 that the effect of RINAZINA DOPPIA AZIONE is too strong or too weak, consult your doctor or pharmacist.

Instructions for use
Remove the cap.
For first use
Press the side button 5 times. Once activated, the device will remain primed for the entire regular treatment period.

1. Blow your nose.
2. Hold the bottle upright with your thumb on the side button.
3. Insert the nozzle into one nostril, keeping the bottle upright to prevent the spray from dripping down the throat.
4. Press the side button to spray while gently inhaling through the nose.
   Repeat in the other nostril (steps 2 to 4).
5. After each use, clean and dry the nozzle.
6. Replace the protective cap until you hear a "click".

1. Clean nose 2. Place thumb 3. Insert into 4. Press side 5. Clean and 6. Replace
   on side button nose button dry nozzle cap

If no spray is released during full actuation, or if the product has not been used for more than 7 days, re-prime the pump by pressing twice. If a full spray 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 RINAZINA DOPPIA AZIONE into or around the eyes.
The effect occurs within 5–15 minutes.

If you use more RINAZINA DOPPIA AZIONE than you should
If you or someone else has used more of this medicine than recommended, contact your doctor, hospital, or emergency department for risk assessment. It is advisable to bring this leaflet, the bottle, or the package with you. This is particularly important for children, as they are more likely to experience adverse effects than adults.
Serious overdose symptoms include dizziness, sweating, severely lowered body temperature, headache, slowed heartbeat, rapid heartbeat, breathing difficulties, coma, seizures, hypertension (high blood pressure), which may be followed by hypotension (low blood pressure).
Other symptoms may include dry mouth, blurred vision, and hallucinations.

If you forget to use RINAZINA DOPPIA AZIONE
Do not take a double dose to make up for a missed one.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop using RINAZINA DOPPIA AZIONE and seek immediate medical help if you experience any of the following symptoms:

• Palpitations and increased heart rate (affects less than 1 in 100 people).
• 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 swellings (frequency not known, cannot be estimated from available data).
• Vision disturbances (including blurred vision, worsening of glaucoma or increased eye pressure), coloured halos or rainbows around bright lights and/or eye pain (frequency not known, cannot be estimated from available data).

The most common side effects are nosebleeds and nasal dryness. Many of the reported side effects are also symptoms of the common cold.
Very common side effects (may affect more than 1 in 10 people):

• Nosebleeds (epistaxis).

Common side effects (may affect up to 1 in 10 people):

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

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

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

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

• Runny nose.

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

• Reaction to the medicine such as swelling, skin rash, itching
• Impaired vision.

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

• Urticaria (hives)
• Irritation around the nose
• Difficulty swallowing
• Chest discomfort, thirst
• Sudden spasm of the throat, throat swelling
• Irregular heartbeat
• Difficulty focusing the eyes, pupil dilation, seeing flashes of light, increased eye pressure, glaucoma, blurred vision, halos around bright lights, and eye pain
• Difficulty emptying the bladder.

To minimize the risk of side effects, it is recommended to stop treatment with RINAZINA DOPPIA AZIONE as soon as your symptoms improve.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RINAZINA DOPPIA AZIONE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after Exp..
The expiry date refers to the last day of the month. This date applies even after opening the package.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RINAZINA DOPPIA AZIONE contains
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 excipients are disodium edetate, glycerol (85%), purified water, sodium hydroxide and hydrochloric
acid.

Description of the appearance of RINAZINA DOPPIA AZIONE and contents of the pack
RINAZINA DOPPIA AZIONE is a clear solution.
The bottle contains approximately 70 sprays.
RINAZINA DOPPIA AZIONE is available as a 10 ml nasal spray with a thumb-activated pump, pre-metered sprays and a protective cap.

Marketing Authorization Holder and Manufacturer:
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy

Manufacturers
Haleon Belgium NV, Da Vincilaan 5, 1930 Zaventem, Belgium.
Haleon-Gebro Consumer Healthcare GmbH, Bahnhofbichl 13, 6391 Fieberbrunn, Austria
Haleon Denmark ApS, Delta Park 37, 2665 Vallensbæk Strand, Denmark
Haleon Germany GmbH, Barthstraße 4, 80339 Munich, Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
AT Otrivin Duo 0.5 mg/ml + 0.6 mg/ml Nasenspray, Lösung
BE Otrivine Duo 0.5 mg/ml + 0.6 mg/ml solution pour pulvérisation nasale
CY Otrivin Advance (0.5 mg/ml + 0.6 mg/ml) nasal spray solution
CZ Otrivin Duo
DK Otrivin Comp næsespray, opløsning
EE Otrivin Total
EL Otrivin Advance 0.5 mg/ml + 0.6 mg/ml Ρινικό εκνέφωμα, διάλυμα
ES Rhinovin Duo 0.5 mg/ml + 0.6 mg/ml solución para pulverización nasal
FI Otrivin Comp 0.5 mg/ml + 0.6 mg/ml nenäsumute, liuos
HU Otrivin Komplex 0.5 mg/ml + 0.6 mg/ml oldatos orrspray
IE Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml Nasal Spray, Solution
IS Otrivin Comp 0.5 mg/ml + 0.6 mg/ml nefúði lausn
IT RINAZINA DOPPIA AZIONE 0.5 mg/ml + 0.6 mg/ml spray nasale, soluzione
LT OtriDuo 0.5 mg/0.6 mg/ml nosies purškalas, tirpalas
LU Otrivine Duo 0.5 mg/ml + 0.6 mg/ml solution pour pulvérisation nasale
LV Otrivin Total 0.5 mg/ml + 0.6 mg/ml deguna aerosols, šķīdums
MT Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml Nasal Spray
Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6
NL
mg/ml, neusspray, oplossing
NO Otrivin Comp 0.5 mg/ml + 0.6 mg/ml nesespray, oppløsning
PL Otrivin Ipra MAX
PT Vibrocil ActilongDuo 0.5 mg/ml + 0.6 mg/ml soluçao para pulverizaçao nasal
RO Vibrocil Duo 0.5 mg/ml + 0.6 mg/ml spray nazal, solutie
SE Otrivin Comp 0.5 mg/ml + 0.6 mg/ml nässpray lösning
SI Otrivin Duo 0.5 mg/0.6 mg v 1 ml pršilo za nos, raztopina
SK Otrivin Duo
UK (NI) Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml Nasal Spray