RINAZINA <0.5 mg/ml + 0.6 mg/ml Spray do nosa, roztwór

Treść ulotki

1. RINAZINA DOPPIA AZIONE 0.5 mg/ml + 0.6 mg/ml nasal spray, solution
   1. What is RINAZINA DOPPIA AZIONE and what is it 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. RINAZINA DOPPIA AZIONE is available in 10 ml nasal spray with activated pump
3. RINAZINA DOPPIA AZIONE 0.5 mg/ml + 0.6 mg/ml nasal spray, solution
   1. What is RINAZINA DOPPIA AZIONE and what is it 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. Package contents and other information

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

Xilometazoline hydrochloride/Ipratropium bromide
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 1. What is RINAZINA DOPPIA AZIONE and what it is used for
• 2. What you need to know before you use 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

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

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

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

Do not useRINAZINA 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 any of the excipients of this medicine (listed in section 6)
• if you are allergic to atropine or substances similar to atropine, such as hyoscyamine and scopolamine
• if your pituitary gland has been removed by surgery through the nose
• if you have undergone brain surgery where the operation was 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 for nasal congestion.
Consult your doctor if these symptoms occur and are bothersome.
Contact your doctor or pharmacist before using RINAZINA DOPPIA AZIONE if you suffer from:

• heart disease (e.g., long QT syndrome)
• increased blood pressure
• diabetes
• hyperactive thyroid gland (hyperthyroidism)
• difficulty urinating and/or enlarged prostate
• closed-angle glaucoma
• a tendency to have nosebleeds
• intestinal obstruction (paralytic ileus).
• cystic fibrosis
• a benign tumor of the adrenal gland that produces high amounts of adrenaline and noradrenaline (pheochromocytoma) or a particular sensitivity to adrenaline and noradrenaline

Immediate hypersensitivity (allergic reaction) may occur. This can manifest as a red, itchy rash with raised skin inflammation (urticaria), difficulty breathing or
speaking, difficulty swallowing due to swelling of the lips, face or throat. These symptoms
may appear individually or all together as a severe allergic reaction. In this case,
immediately stop using RINAZINA DOPPIA AZIONE (see section 4).
RINAZINA DOPPIA AZIONE should not be used for more than 7 consecutive days. If symptoms
persist, consult a doctor. Prolonged or excessive use may cause a return or worsening
of nasal congestion and swelling of the nasal mucosa.
Avoid spraying RINAZINA DOPPIA AZIONE into or around your eyes. If this happens
rinse your eyes thoroughly with cold water. Your vision may become temporarily
blurred and your eye irritated, painful and red. If this happens, seek advice from your doctor.
A 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 the
age of 18 years as adequate information on safety and efficacy is not available.

Other medicines and RINAZINA DOPPIA AZIONE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
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 in the last two weeks, dangerous increases in blood pressure may occur;
• Tricyclic and tetracyclic antidepressants. If you are taking or have taken these medicines in 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 breathing problems (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 using any of the medicines listed above, consult your doctor before using RINAZINA
DOPPIA AZIONE.

Pregnancy and breastfeeding
RINAZINA DOPPIA AZIONE should not be used during pregnancy unless recommended by
your doctor. During breastfeeding, RINAZINA DOPPIA AZIONE should not be
used unless your doctor decides that the benefits outweigh the potential risks to the newborn. If
you are pregnant or breastfeeding or think you may be pregnant or are planning a pregnancy
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
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 participating in activities where these symptoms may put you and others at risk.

Attention for athletes:
The product contains substances prohibited for doping. Use other than the dosage scheme and route of administration indicated is prohibited.

3. How to use RINAZINA DOPPIA AZIONE

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. If you have doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults: one spray in each nostril as needed up to 3 times a day for a maximum
of 7 days. Allow at least 6 hours between two doses. Do not exceed 3 applications a day in
each nostril.
Do not exceed the indicated dose. Use the lowest dose necessary to treat your symptoms and use it for the
shortest time necessary 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 when symptoms
have improved, even if it is before 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 protective cap.
• Do not cut the applicator. The spray is ready to be activated before use.

• For the first use, press the pump 4 times to activate it. Once activated, the pump will normally remain charged for the entire period of continuous daily treatment. If the spray does not come out during the full activation phase, or if the product has not been used for more than 6 days, the pump will need to be recharged with the 4 presses as performed at the beginning.
• 1. Clean your nose.
• 2. Hold the bottle in a vertical position with your thumb under the base and the applicator between two fingers.
• 3. Lean slightly forward and insert the applicator into one nostril.
• 4. Press the pump to spray and inhale gently through your 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 applicator before replacing the cap.

If the spray does not come out during the complete execution of the spray or if the product
has not been used for more than 7 days, the pump will need to be recharged by pressing twice. If the
full spray is not administered, the dose should not be repeated
To avoid possible spread of infection, the spray must be used by one person only.
Avoid spraying RINAZINA DOPPIA AZIONE into or around your eyes.
The effect occurs within 5-15 minutes.

If you take more RINAZINA DOPPIA AZIONE than you should
If you or someone else has taken more medicine than you should, contact your doctor, hospital or
emergency room for risk assessment. It is advisable to bring this leaflet, the bottle or
the packaging with you. This is particularly important for children as they are more likely to have
undesirable effects compared to adults.
Severe overdose symptoms are dizziness, sweating, severely reduced body temperature,
headache, slowed heartbeat, accelerated heartbeat, altered breathing, coma,
convulsions, 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 take 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 medical help immediately if you have
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 blisters (frequency not known, cannot be estimated from available data).
• Vision disturbances (including blurred vision, worsening of glaucoma or increased pressure in the eye), halos/rings of rainbow colour 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 side effects reported 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
• discomfort, fatigue
• insomnia
• eye irritation, dry eyes, eye swelling, red eyes
• palpitations, increased heart rate

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

• runny nose

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

• reaction to the medicine such as swelling, rash, itching
• impaired vision

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

• urticaria
• discomfort around the nose
• difficulty swallowing
• chest discomfort, thirst
• sudden spasm of the throat, throat swelling
• irregular heartbeat
• difficulty focusing with the eyes, dilated pupils, seeing flashes of light, increased pressure in the eyes, glaucoma, blurred vision, halos around intense lights and eye pain
• difficulty emptying the bladder. In order to minimise 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 reported on the label after Expiry. The
expiry date refers to the last day of the month. This date applies even after the package has been opened.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance ofRINAZINA 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 in 10 ml nasal spray with activated pump

vertically.

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

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AT Otrivin Duo 0.5 mg/ml + 0.6 mg/ml Nasenspray, solution
BE Otrivine Duo 0.5mg/ml + 0.6mg/ml solution for nasal spray
CY Otrivin Advance (0.5mg/ml + 0.6mg/ml) nasal spray solution
CZ Otrivin Rhinostop
DK Otrivin Comp nasal spray, solution
EE Otrivin Total
EL Otrivin Advance 0.5mg/ml + 0.6mg/ml Ρινικό εκνέφωμα, solution
ES Rhinovin Duo 0.5mg/ml + 0.6mg/ml solution for nasal spray
FI Otrivin Comp 0.5mg/ml + 0.6mg/ml nasal spray, solution
HU Otrivin Komplex 0.5mg/ml + 0.6mg/ml aqueous nasal spray
IE Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray, Solution
IS Otrivin Comp 0.5mg/ml + 0.6mg/ml nasal spray solution
IT RINAZINA DOPPIA AZIONE 0.5mg/ml + 0.6mg/ml nasal spray, solution
LT OtriDuo 0.5 mg/0.6 mg/ml nasal spray, solution
LU Otrivine Duo 0.5mg/ml + 0.6mg/ml solution for nasal spray
LV Otrivin Total 0.5 mg/ml + 0.6mg/ml nasal aerosol, solution
MT Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray
NL
Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6
mg/ml, nasal spray, solution
NO Otrivin Comp 0.5mg/ml + 0.6mg/ml nasal spray, solution
PL Otrivin Ipra MAX
PT Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml solution for nasal spray
RO Vibrocil Duo 0.5mg/ml + 0.6mg/ml nasal spray, solution
SE Otrivin Comp 0.5mg/ml + 0.6 mg/ml nasal spray solution
SI Otrivin Duo 0.5 mg/0.6 mg in 1 ml nasal spray, solution
SK Otrivin Complete
UK (NI) Otrivine Extra Dual Relief 0.5mg/ml+ 0.6mg/ml Nasal Spray

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

Xylometazoline hydrochloride/Ipratropium bromide
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you use 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 is RINAZINA DOPPIA AZIONE and what is it used for

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

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

Do not useRINAZINA DOPPIA AZIONE:

• in children under the age of 18, as adequate information on safety and efficacy is not available
• if you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the excipients of this medicine (listed in section 6)
• if you are allergic to atropine or substances similar to atropine, such as hyoscyamine and scopolamine
• if your pituitary gland has been removed by surgery through the nose
• if you have undergone brain surgery where the operation was 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 for nasal congestion.
Consult your doctor if these symptoms occur and are bothersome.
Contact your doctor or pharmacist before using RINAZINA DOPPIA AZIONE if you suffer from:

• heart disease (e.g., long QT syndrome)
• increased blood pressure
• diabetes
• hyperactive thyroid gland (hyperthyroidism)
• difficulty urinating and/or enlarged prostate
• closed-angle glaucoma
• a tendency to have nosebleeds
• intestinal obstruction (paralytic ileus).
• cystic fibrosis
• a benign tumor of the adrenal gland that produces high amounts of adrenaline and noradrenaline (pheochromocytoma) or a particular sensitivity to adrenaline and noradrenaline

Immediate hypersensitivity (allergic reaction) may occur. This can manifest as a red, itchy rash with raised skin inflammation (urticaria), difficulty breathing or
speaking, difficulty swallowing due to swelling of the lips, face or throat. These symptoms
may appear individually or all together as a severe allergic reaction. In this case,
immediately stop using RINAZINA DOPPIA AZIONE (see section 4).
RINAZINA DOPPIA AZIONE should not be used for more than 7 consecutive days. If symptoms
persist, consult a doctor. Prolonged or excessive use may cause a return or worsening
of nasal congestion and swelling of the nasal mucosa.
Avoid spraying RINAZINA DOPPIA AZIONE into or around your eyes. If this happens
rinse your eyes thoroughly with cold water. Your vision may become temporarily
blurred and your eye irritated, painful and red. If this happens, seek advice from your doctor.
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 the age of
18 as adequate information on safety and efficacy is not available.

Other medicines and RINAZINA DOPPIA AZIONE
Tell 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 in the last two weeks, dangerous increases in blood pressure may occur;
• Tricyclic and tetracyclic antidepressants. If you are taking or have taken these medicines in the last two weeks, dangerous increases in blood pressure may occur;
• Medicines used for motion 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 using any of the medicines listed above, consult your doctor before using RINAZINA
DOPPIA AZIONE.

Pregnancy and breastfeeding
RINAZINA DOPPIA AZIONE should not be used during pregnancy unless recommended by
your doctor. During breastfeeding, RINAZINA DOPPIA AZIONE should not be
used unless your doctor decides that the benefits outweigh the potential risks to the newborn. If
you are pregnant or breastfeeding or think you may be pregnant or are planning a pregnancy
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
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 may put you and others at risk.

Attention for athletes:
The product contains substances prohibited for doping. Administration different from the dosage scheme
and route of administration as reported is prohibited.

3. How to use RINAZINA DOPPIA AZIONE

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults: one spray in each nostril as needed, up to 3 times a day for a maximum
of 7 days. Allow at least 6 hours between two doses. Do not exceed 3 applications a day in
each nostril.
Do not exceed the indicated dose. Use the lowest dose necessary to treat your symptoms and use it for the
shortest time necessary 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 when symptoms
have improved, even if it is before 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 charged for the entire regular
treatment period.

• 1) Clean your nose.
• 2) Hold the bottle in a vertical position with your thumb on the side button.
• 3) Insert the nozzle into the nostril while remaining in a vertical position to avoid the spray dripping into your throat.
• 4) Press the side button to spray and simultaneously inhale gently through your nose. Repeat in the other nostril (steps 2 to 4).
• 5) After each use, clean and dry the nozzle
• 6) Reposition the protective cap until you hear a "click".

If the spray does not dispense during the complete spray action or if the product
has not been used for more than 7 days, the pump will need to be primed by pressing twice. If the complete spray is not administered, the dose should not be repeated.
To avoid possible spread of infection, the spray must be used by one person only.
Avoid spraying RINAZINA DOPPIA AZIONE into or around your eyes.
The effect manifests in 5-15 minutes.

If you take more RINAZINA DOPPIA AZIONE than you should
If you or someone else has taken more medicine than you should, contact your doctor, hospital or
emergency room for risk assessment. It is advisable to bring this leaflet, the bottle or
the packaging with you. This is particularly important for children as they are more likely to experience
undesirable effects than adults.
Symptoms of severe overdose are dizziness, sweating, severely reduced body temperature,
headache, slowed heartbeat, accelerated heartbeat, altered breathing, coma,
convulsions, 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 take 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 medical help immediately 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 welts (frequency not known, cannot be estimated from available data).
• Vision disturbances (including blurred vision, worsening of glaucoma or increased pressure in the eye), halos/rings 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 side effects reported 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
• Discomfort, fatigue
• Insomnia
• Eye irritation, dry eyes, swollen eyes, red eyes
• 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, rash, itching
• Impaired vision

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

• Urticaria
• Discomfort around the nose
• Difficulty swallowing
• Chest discomfort, thirst
• Sudden spasm of the throat, throat swelling
• Irregular heartbeat
• Difficulty focusing with the eyes, dilated pupils, seeing flashes of light, increased pressure in the eyes, glaucoma, blurred vision, halos around bright lights and eye pain
• Difficulty emptying the bladder. In order 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through 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 Expiry. The
expiry date refers to the last day of the month. This date applies even after the package has been opened.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in 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 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 excipients are disodium edetate, glycerol (85%), purified water, sodium hydroxide and hydrochloric acid.

Description of the appearance ofRINAZINA 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 in 10 ml nasal spray with a pump activated with the thumb on the side button, with pre-dosed sprays and a protective cap.

Marketing Authorisation Holder and Manufacturer:
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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 Rhinostop
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 spray nasale, soluzione
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
NL
Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6
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 v 1 ml pršilo za nos, raztopina
SK Otrivin Complete
UK (NI) Otrivine Extra Dual Relief 0.5mg/ml+ 0.6mg/ml Nasal Spray