Rinaadvance

Patient Information Leaflet

RinaAdvance 1 mg/ml nasal drops, solution, 1 mg/ml nasal spray, solution

xylometazoline hydrochloride
Please read this leaflet carefully before 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.
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 RinaAdvance is and what it is used for
2. What you need to know before using RinaAdvance
3. How to use RinaAdvance
4. Possible side effects
5. How to store RinaAdvance
6. Package contents and other information

1. What RinaAdvance is and what it is used for

RinaAdvance contains the active substance xylometazoline hydrochloride, which belongs to the class of nasal decongestant medicines. It works by constricting blood vessels in the nasal mucosa, thereby reducing swelling (edema) that makes breathing difficult.
RinaAdvance is used in cases of nasal mucosal congestion due to colds, hay fever or other allergic rhinitis, and sinusitis.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using RinaAdvance

Do not use RinaAdvance

• if you are allergic to xylometazoline or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-term nasal irritation (chronic rhinitis), with little or no nasal discharge (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you have increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery, such as surgical removal of the gland called pituitary (transsphenoidal hypophysectomy), or other major cranial surgeries;
• if you are under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using RinaAdvance.
Consult your doctor before using RinaAdvance if:

• you have previously experienced a severe reaction to other medicines containing sympathomimetic agents, such as those contained in other nasal decongestants, resulting in symptoms such as insomnia, dizziness, tremor, irregular heartbeat, or high blood pressure;
• you have recently undergone nasal surgery;
• you have or have had a benign adrenal gland tumor (pheochromocytoma);
• you have or have had high blood pressure;
• you have or have had heart or vascular problems (e.g., long QT syndrome);
• you have a thyroid disease (hyperthyroidism);
• you have diabetes;
• you have an enlarged prostate (prostatic hypertrophy);
• you are taking or have taken within the last two weeks antidepressant medicines (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) (see “Other medicines and RinaAdvance”).

Do not exceed the recommended doses and do not use RinaAdvance for more than 7 consecutive days: prolonged or excessive use may cause recurrence of nasal congestion and may alter the normal function of the nasal mucosa, leading to reduced effectiveness of the medicine, thinning of the nasal mucosa, and reduction in number and size of mucus-producing glands.

Children and adolescents
This medicine must not be used in children under 12 years of age (see “Do not use RinaAdvance”).

Elderly
Elderly patients are more susceptible to adverse effects associated with RinaAdvance; inform your doctor if you experience unusual symptoms.

Other medicines and RinaAdvance
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Concomitant use of RinaAdvance is not recommended if you are taking or have taken within the last two weeks antidepressant medicines (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants).

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

Pregnancy
RinaAdvance must not be used during pregnancy or if you suspect or are planning a pregnancy.

Breastfeeding
RinaAdvance may be used during breastfeeding only under medical advice.

Driving and using machines
RinaAdvance does not affect or affects negligibly the ability to drive and use machines.
However, RinaAdvance may cause visual disturbances, dizziness, vertigo, or other central nervous system disturbances. If you experience such symptoms, do not drive or operate machinery.

RinaAdvance contains benzalkonium chloride
RinaAdvance spray contains 0.014 mg of benzalkonium chloride (BAC) per spray as a preservative, equivalent to 0.10 mg/ml of solution.
RinaAdvance drops contain 0.0025 mg of benzalkonium chloride (BAC) per drop as a preservative, equivalent to 0.10 mg/ml of solution.
Benzalkonium chloride, especially if used for prolonged periods, may cause irritation and swelling inside the nose. If such a reaction is suspected (persistent nasal congestion), a nasal medicine without benzalkonium chloride should be used, if possible. If nasal medicines without benzalkonium chloride are not available, another pharmaceutical form should be considered.
It may cause bronchospasm.

Attention 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 RinaAdvance

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Nasal drops, solution
Instill 2–3 drops of the solution into each nostril 1–3 times a day, as needed.
Do not exceed 3 applications per nostril per day.
Follow these instructions:

1. Blow your nose thoroughly.
2. Tilt your head backward into a comfortable position, or if lying in bed, tilt your head to one side.
3. Instill the drops into each nostril and keep your head tilted backward for a while to allow the drops to spread inside the nose.
4. Immediately after use, clean and dry the dropper before returning it to the bottle.

Nasal spray, solution
Administer 1 spray into each nostril 1–3 times daily, as needed.
Do not exceed 3 sprays per nostril per day.

1. Do not cut the nozzle. The spray is ready to use.

2. Blow your nose thoroughly.
3. Remove the protective cap.

4. At first use, prime the pump by pressing it 4 times; this will ensure the pump remains primed throughout the daily treatment period. If no spray is released when fully pressing the nozzle, or if the product has not been used for more than 7 days, re-prime the pump by pressing it 4 times.

Be careful not to spray into the eyes or mouth.

5. Hold the bottle upright with your thumb underneath the base and the nozzle between two fingers.
6. Lean slightly forward and insert the nozzle into one nostril.
7. Spray while gently inhaling through the nose.
8. Repeat the same procedure in the other nostril.
9. Immediately after use, clean and dry the spray nozzle before replacing the cap.

To prevent possible spread of infection, the medicine package must be used by only one person.
Within a few minutes, you will experience the local effect of the medicine, which lasts up to 10 hours and gradually wears off.

If you use more RinaAdvance than you should
If you accidentally swallow the medicine or use an excessive dose, contact your doctor immediately or go to the nearest hospital.
If the medicine is accidentally ingested or used excessively over a long period, the following symptoms may occur:

• increased blood pressure
• rapid heartbeat
• excessive sensitivity to light
• severe headache
• chest tightness

In children, the following may occur:

• drop in body temperature
• severe depression of the central nervous system with strong sedation
• rapid and irregular pulse
• high blood pressure
• sometimes confusion (clouding of consciousness)

If you forget to use RinaAdvance
Do not use a double dose to make up for the missed dose.

If you stop using RinaAdvance
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can be minimized by using the lowest effective dose for the shortest necessary duration of treatment.
Contact your doctor immediately and stop taking this medicine if you experience the following symptoms:

• severe allergic reactions, including: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, nasal congestion and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in red areas, skin eruptions with blisters or peeling skin, giant wheals (swollen skin accompanied by itching and burning). These conditions may also affect the lips, eyes, nose and genitals.

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

• headache
• dryness or discomfort in the nose
• nausea
• nasal burning.

Uncommon side effects (may affect up to 1 in 100 people)

• nosebleeds (epistaxis).

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

• transient visual disturbances
• irregular heartbeat and increased heart rate.

Other side effects

• increased blood pressure
• slowed heartbeat
• urinary problems
• insomnia
• restlessness.

Reporting of side effects
If you get 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 national reporting system at 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 RinaAdvance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Nasal spray, solution: after first opening, the medicine can be used until the expiry date indicated on the packaging.
Store below 30°C. Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What RinaAdvance contains
Nasal drops, solution
The active substance is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline hydrochloride. Each drop delivers 0.025 mg of xylometazoline hydrochloride.
The other components are: sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, sodium edetate, benzalkonium chloride, sorbitol 70%, hypromellose, sodium chloride, purified water.

Nasal spray, solution
The active substance is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline hydrochloride. Each spray actuation delivers 0.14 mg of xylometazoline hydrochloride.
The other components are: sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, sodium edetate, benzalkonium chloride, sorbitol 70%, hypromellose, sodium chloride, purified water.

Description of the appearance of RinaAdvance and contents of the pack
Nasal drops, 0.1% solution. The bottle contains 10 ml of a clear, colourless and almost odourless solution.
Nasal spray, 0.1% solution. The bottle contains 10 ml of a clear, colourless and almost odourless solution.

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

Manufacturer
Haleon Germany GmbH, Barthstraße 4, 80339 Munich, Germany

Patient information leaflet

RinaAdvance 1 mg/ml nasal spray, solution

xylometazoline hydrochloride
Please read this leaflet carefully before 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.
Keep this leaflet. You may need to read it again.
If you need more advice or information, 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 RinaAdvance is and what it is used for
2. What you need to know before using RinaAdvance
3. How to use RinaAdvance
4. Possible side effects
5. How to store RinaAdvance
6. Contents of the pack and other information

1. What Rinadvance is and what it is used for

Rinadvance contains the active substance xylometazoline hydrochloride, which belongs to the class of medicines known as nasal decongestants. It works by constricting blood vessels in the nasal mucosa, thereby reducing swelling (edema) that makes breathing difficult.
Rinadvance is used to treat nasal mucosal congestion due to colds, hay fever or other allergic rhinitis, and sinusitis.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using RinaAdvance

Do not use RinaAdvance

• if you are allergic to xylometazoline or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-term nasal irritation (chronic rhinitis), with little or no nasal discharge (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you have increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery, such as surgical removal of the gland called the pituitary (transsphenoidal hypophysectomy), or other major cranial surgeries;
• if you are under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using RinaAdvance.
Consult your doctor before using RinaAdvance if:

• you have previously experienced a strong reaction to other medicines containing sympathomimetic substances, such as those contained in other nasal decongestants, resulting in symptoms such as insomnia, dizziness, tremor, irregular or rapid heartbeat, or high blood pressure;
• you have recently undergone nasal surgery;
• you suffer or have suffered from a benign adrenal gland tumor (pheochromocytoma);
• you suffer or have suffered from high blood pressure;
• you have heart or vascular problems (e.g., long QT syndrome);
• you have a thyroid disease (hyperthyroidism);
• you have diabetes;
• you have an enlarged prostate (prostatic hypertrophy);
• you are taking, or have taken within the last two weeks, medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) (see “Other medicines and RinaAdvance”).

Do not exceed the recommended doses and do not use RinaAdvance for more than 7 consecutive days: prolonged or excessive use may cause recurrence of nasal congestion and may alter the normal function of the nasal mucosa, leading to reduced effectiveness of the medicine, thinning of the nasal mucosa, and reduction in number and size of mucus-producing glands.

Children and adolescents
This medicine must not be used in children under 12 years of age (see “Do not use RinaAdvance”).

Elderly
Elderly patients are more susceptible to adverse effects associated with RinaAdvance. Inform your doctor if you experience unusual symptoms.

Other medicines and RinaAdvance
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of RinaAdvance is not recommended if you are taking or have taken within the last two weeks medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants).

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

Pregnancy
RinaAdvance must not be used during pregnancy or if you suspect or are planning a pregnancy.

Breastfeeding
RinaAdvance may be used during breastfeeding only under medical advice.

Driving and using machines
RinaAdvance does not affect or affects negligibly the ability to drive and use machinery.
However, RinaAdvance may cause visual disturbances, dizziness, vertigo, or other central nervous system disturbances. If you experience such symptoms, do not drive or operate machinery.

RinaAdvance contains benzalkonium chloride
RinaAdvance spray contains 0.014 mg of benzalkonium chloride (BAC) per spray as a preservative, equivalent to 0.10 mg/mL of solution.
Benzalkonium chloride, especially if used for prolonged periods, may cause irritation and swelling inside the nose. If such a reaction is suspected (persistent nasal congestion), a nasal medicine without benzalkonium chloride should be used, if possible. If nasal medicines without benzalkonium chloride are not available, another pharmaceutical form should be considered.
It may cause bronchospasm.

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 RinaAdvance

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Nasal spray, solution with side-button activated nebulization
Administer 1 spray into each nostril 1–3 times daily, depending on need.
Do not exceed 3 sprays per day in each nostril.
The dose-measuring spray activated by a side button ensures accurate dosing and guarantees that the solution is evenly distributed over the nasal mucosal surface by finely nebulizing the spray. It is easy to use.
Each pre-dosed spray of RinaAdvance 0.1% delivers 0.14 ml of solution (0.14 mg of xylometazoline hydrochloride).
At first use, press the side button 5 times without inserting into the nostrils. Once activated, the device will remain primed for the entire regular treatment period. The device must be re-primed by pressing the button 2 times if, after the initial priming, no spray is released or if the product has not been used for more than 7 days.
Be careful not to spray into the eyes.
Remove the protective cap.

1. Blow your nose.
2. Hold the bottle in an upright position 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 and at the same time gently inhale through the nose.
   Repeat in the other nostril (steps 1 to 4).
5. After each use, clean and dry the nozzle.
6. Replace the protective cap until you hear a "click".

To avoid possible spread of infection, the medicine package should be used by only one person.
Within a few minutes, you will experience the local effect of the medicine, which lasts up to 10 hours and gradually subsides.
If you use more RinaAdvance than you should
In case of accidental ingestion or overdose of RinaAdvance, contact your doctor immediately or go to the nearest hospital.
If the medicine is accidentally swallowed or used excessively over a prolonged period, the following symptoms may occur:

• increased blood pressure
• rapid heartbeat
• increased sensitivity to light
• severe headache
• chest tightness

In children, the following may occur:

• lowered body temperature
• severe depression of the central nervous system with strong sedation
• rapid and irregular pulse
• elevated blood pressure
• sometimes confusion (obnubilation of consciousness)

If you forget to use RinaAdvance
Do not use a double dose to make up for a forgotten dose.
If you stop using RinaAdvance
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary for treatment.
Immediately contact your doctor and stop taking this medicine if you experience the following symptoms:

• severe allergic reactions, including: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, runny nose and skin rash;
• severe skin rashes, itching, hives, bruising, pain in red areas, rashes with blisters or peeling skin, giant hives (swollen skin accompanied by itching and burning). These conditions may also affect the lips, eyes, nose and genitals.

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

• headache
• dryness or nasal discomfort
• nausea
• nasal burning.

Uncommon side effects (may affect up to 1 in 100 people)

• nosebleeds (epistaxis)

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

• transient visual disturbances
• irregular heartbeat and increased heart rate.

Other side effects

• increased blood pressure
• slowed heart rate
• urinary disorders
• insomnia
• restlessness.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 RinaAdvance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
After first opening, the medicine can be used until the expiry date indicated on the
packaging.
Store below 30°C. Keep in the original packaging.
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 RinaAdvance contains
The active substance is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline hydrochloride. Each metered spray delivers 0.14 ml of solution (0.14 mg of xylometazoline hydrochloride).
The other components are: sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, edetate sodium, benzalkonium chloride, sorbitol 70%, hypromellose, sodium chloride, purified water.

Description of the appearance of RinaAdvance and contents of the pack
Nasal spray, 0.1% solution. The bottle contains 10 ml of a clear, colourless and almost odourless solution.

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

Manufacturer
Haleon Germany GmbH, Barthstraße 4, 80339 Munich, Germany

Patient information leaflet: information for the patient

RinaAdvance 1 mg/ml nasal spray, solution, menthol flavour

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

Contents of this leaflet:

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

1. What RinaAdvance is and what it is used for

RinaAdvance contains the active substance xylometazoline hydrochloride, which belongs to the class of medicines known as nasal decongestants. It works by constricting blood vessels in the nasal mucosa, thereby reducing swelling (edema) that makes breathing difficult.
RinaAdvance is used for nasal mucosal congestion due to colds, hay fever or other allergic rhinitis, and sinusitis.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using RinaAdvance

Do not use RinaAdvance

• if you are allergic to xylometazoline or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-term nasal irritation (chronic rhinitis), with little or no nasal discharge (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you have increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery, such as surgical removal of the gland called pituitary (transsphenoidal hypophysectomy), or other major cranial surgeries;
• if you are under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using RinaAdvance.
Before using RinaAdvance, consult your doctor if:

• you have previously experienced a strong reaction to other medicines containing adrenergic substances, such as those contained in other nasal decongestants, resulting in symptoms such as insomnia, dizziness, tremor, irregular heartbeat, or high blood pressure;
• you have recently undergone nasal surgery;
• you suffer or have suffered from a benign tumor of the adrenal gland (pheochromocytoma);
• you suffer or have suffered from high blood pressure;
• you have heart or vascular problems (e.g., long QT syndrome);
• you have a thyroid disease (hyperthyroidism);
• you have diabetes;
• you have an enlarged prostate (prostatic hypertrophy);
• you are taking, or have taken within the last two weeks, medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) (see “Other medicines and RinaAdvance”).

Do not exceed the recommended doses and do not use RinaAdvance for more than 7 consecutive days: prolonged or excessive use may cause recurrence of nasal congestion and may alter the normal function of the nasal mucosa, leading to reduced effectiveness of the medicine, thinning of the nasal mucosa, and reduction in the number and size of glands producing mucus.

Children and adolescents
This medicine must not be used in children under 12 years of age (see “Do not use RinaAdvance”).

Elderly
Elderly patients are more likely to experience adverse effects associated with RinaAdvance. Inform your doctor if you experience unusual symptoms.

Other medicines and RinaAdvance
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Concomitant use of RinaAdvance is not recommended if you are taking or have taken within the last two weeks medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
RinaAdvance must not be used during pregnancy, nor if you suspect you may be pregnant or are planning a pregnancy.

Breastfeeding
RinaAdvance may be used during breastfeeding only under medical advice.

Driving and using machines
RinaAdvance does not affect or affects only slightly the ability to drive and use machines.
However, RinaAdvance may cause visual disturbances, dizziness, vertigo, or other central nervous system disorders. If you experience such symptoms, do not drive or operate machinery.

Important information about some excipients:
RinaAdvance contains macrogol hydroxystearate, which may cause localized skin reactions.
RinaAdvance contains cineole flavor, which in turn contains limonene. Limonene may cause allergic reactions.

Caution for athletes:
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 RinaAdvance

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Administer 1 spray into each nostril 1 to 3 times daily, depending on need.
Do not exceed 3 sprays per day in each nostril.
Follow these instructions carefully, taking care not to spray the product into the eyes:

1. At first use, remove the protective cap and prime the pump by pressing down 4 times; this will ensure the pump is ready for use throughout the daily treatment period. If no spray comes out when you fully press the nozzle, or if the product has not been used for more than 6 days, re-prime the pump by pressing 4 times.
2. Do not cut the nozzle. The spray is now ready for use.

3. Blow your nose thoroughly.
4. Hold the bottle upright, with your thumb underneath the base and the nozzle between two fingers.
5. Tilt your head slightly forward and insert the nozzle into one nostril.
6. Spray while gently inhaling through your nose.
7. Clean and dry the nozzle before replacing the cap after use.

To avoid the possible spread of infection, the spray must be used by only one person.
Within a few minutes, you will obtain the local effect of the medicine, which lasts up to 10 hours and gradually diminishes.
If you use more RinaAdvance than you should
In case of accidental ingestion or overdose of RinaAdvance, contact your doctor immediately or go to the nearest hospital.
If the medicine is accidentally swallowed or used excessively over a prolonged period, the following symptoms may occur:

• increased blood pressure
• rapid heartbeat
• excessive sensitivity to light
• severe headache
• chest tightness.

In children, the following may occur:

• lowered body temperature
• severe depression of the central nervous system with strong sedation
• rapid and irregular pulse
• elevated blood pressure
• sometimes confusion (impaired consciousness).

If you forget to use RinaAdvance
Do not use a double dose to make up for a missed dose.
If you stop using RinaAdvance
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions can be minimized by using the lowest effective dose for the shortest necessary duration of treatment.
Contact your doctor immediately and stop taking the medicine if you experience any of the following symptoms:

• severe allergic reactions, including: swelling of the face, throat or tongue, breathing difficulties, shortness of breath, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in red areas, blistering rashes or peeling skin, giant wheals (swollen skin accompanied by itching and burning). These conditions may also affect the lips, eyes, nose and genitals.

Common adverse reactions (may affect up to 1 in 10 people)

• headache
• dryness or discomfort in the nose
• nausea
• nasal burning.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• nosebleeds (epistaxis).

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

• transient visual disturbances
• irregular heartbeat and increased heart rate.

Other adverse reactions

• increased blood pressure
• slowed heartbeat
• urinary disorders
• insomnia
• restlessness.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store RinaAdvance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The medicine, once opened, may be used until the expiry date indicated on the packaging.
The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging.
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 RinaAdvance contains
The active substance is xylometazoline hydrochloride. Each ml of solution contains 1 mg of
xylometazoline hydrochloride. Each spray delivers 0.14 mg of xylometazoline hydrochloride.
The other ingredients are: monosodium phosphate monohydrate, disodium phosphate dodecahydrate,
sodium chloride, sodium edetate, levomenthol, cineole (containing limonene), sorbitol,
macrogol glycerol hydroxystearate, purified water.
Description of the appearance of RinaAdvance and contents of the pack
RinaAdvance is available as a nasal spray, 0.1% solution. The bottle contains 10 ml
of a white, opalescent solution with a menthol and eucalyptol (cineole) odour.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy
Manufacturer
Haleon Germany GmbH, Barthstraße 4, 80339 Munich, Germany

Patient Information Leaflet

RinaAdvance 1 mg/ml nasal spray, solution with menthol aroma

xylometazoline hydrochloride
Please read this leaflet carefully before 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.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the 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 any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What RinaAdvance is and what it is used for

RinaAdvance contains the active substance xylometazoline hydrochloride, which belongs to a class of medicines called
nasal mucosal decongestants. It works by constricting blood vessels in the nasal mucosa, thereby reducing swelling (edema) that makes breathing difficult.
RinaAdvance is used for nasal mucosal congestion due to colds, hay fever or other allergic rhinitis, and sinusitis.
Consult your doctor if you do not feel better or feel worse after 7 days.

2. What you need to know before using RinaAdvance

Do not use RinaAdvance

• if you are allergic to xylometazoline or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-term nasal irritation (chronic rhinitis), with little or no discharge (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you have increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery, such as surgical removal of the gland called the pituitary (transsphenoidal hypophysectomy) or other major cranial surgeries;
• if you are under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using RinaAdvance
Consult your doctor before using RinaAdvance if:

• You have previously experienced a strong reaction to other medicines containing adrenergic substances, such as those found in other nasal decongestants, resulting in symptoms such as insomnia, dizziness, tremor, irregular or fast heartbeat, or high blood pressure;
• You have recently undergone nasal surgery;
• You suffer or have suffered from a benign adrenal gland tumor (pheochromocytoma);
• You suffer or have suffered from high blood pressure;
• You have heart or vascular problems (e.g., long QT syndrome);
• You have a thyroid disorder (hyperthyroidism);
• You have diabetes;
• You have an enlarged prostate (prostatic hypertrophy);
• You are taking or have taken within the last two weeks medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) (see “Other medicines and RinaAdvance”).

Do not exceed the recommended doses and do not use RinaAdvance for more than 7 consecutive days: prolonged or excessive use may cause recurrence of nasal congestion and may alter the normal function of the nasal mucosa, leading to reduced effectiveness of the medicine, thinning of the nasal mucosa, and reduction in number and size of mucus-producing glands.

Children and adolescents
This medicine must not be used in children under 12 years of age (see “Do not use RinaAdvance”).

Elderly
Elderly patients are more likely to experience adverse effects associated with RinaAdvance. Inform your doctor if you experience unusual symptoms.

Other medicines and RinaAdvance
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Concomitant use of RinaAdvance is not recommended if you are taking or have taken within the last two weeks medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants).

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

Pregnancy
RinaAdvance must not be used during pregnancy, nor if you suspect you may be pregnant or are planning a pregnancy.

Breastfeeding
RinaAdvance may be used during breastfeeding only under medical advice.

Driving and using machines
RinaAdvance does not affect or has a negligible effect on the ability to drive or operate machinery.
However, RinaAdvance may cause visual disturbances, dizziness, vertigo, or other central nervous system effects. If you experience such symptoms, do not drive or operate machinery.

Important information about certain excipients:
RinaAdvance contains macrogol glycerol hydroxystearate, which may cause localized skin reactions.
RinaAdvance contains cineole flavor, which in turn contains limonene. Limonene may cause allergic reactions.

Attention for those engaged in sports activities:
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 RinaAdvance

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Administer 1 spray into each nostril 1 to 3 times daily, depending on need.
Do not exceed 3 sprays per day in each nostril.
The dosing spray with side button ensures accurate dosing and evenly distributes the solution over the nasal mucosa by finely nebulizing the spray. It is easy to use.

At first use
Press the side button 5 times without inserting into the nostrils. Once activated, the device will remain primed for the entire regular treatment period. The device must be re-primed by pressing the button twice if, after the initial priming, the spray does not come out or if the product has not been used for more than 7 days.

Instructions for use
Remove the protective cap.
Be careful not to spray into the eyes.

1. Blow your nose.
2. Hold the bottle upright with your thumb on the side button.
3. Insert the nozzle into the nostril while keeping the bottle upright to prevent the spray from dripping down the throat.
4. Press the side button to spray and simultaneously inhale gently 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".

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.
Within a few minutes, you will obtain the local effect of the medicine, which lasts up to 10 hours and gradually diminishes.

If you use more RinaAdvance than you should
In case of accidental ingestion or overdose of RinaAdvance, contact your doctor immediately or go to the nearest hospital.
If the medicine is accidentally ingested or used excessively over a long period, the following symptoms may occur:

• increased blood pressure
• rapid heartbeat
• increased sensitivity to light
• severe headache
• chest tightness

In children, the following may occur:

• lowered body temperature
• severe depression of the central nervous system with strong sedation
• rapid and irregular pulse
• elevated blood pressure
• sometimes confusion (impaired consciousness).

If you forget to use RinaAdvance
Do not use a double dose to make up for the forgotten dose.

If you stop using RinaAdvance
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects can be minimised by using the lowest effective dose for the shortest necessary duration of treatment.
Immediately contact your doctor and stop taking the medicine if you experience the following symptoms:

• severe allergic reactions, including: swelling of the face, throat or tongue, breathing difficulties, shortness of breath, nasal inflammation (rinite), and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in red or inflamed areas, skin eruptions with blisters or peeling skin, giant wheals (swollen skin accompanied by itching and burning). These conditions may also affect the lips, eyes, nose, and genitals.

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

• headache
• dryness or discomfort in the nose
• nausea
• nasal burning.

Uncommon side effects (may affect up to 1 in 100 people)

• nosebleeds (epistaxis).

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

• transient visual disturbances
• irregular heartbeat and increased heart rate.

Other side effects

• increased blood pressure
• slowed heart rate
• urinary problems
• insomnia
• restlessness.

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 national reporting system at 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 RinaAdvance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
After opening, the medicine can be used until the expiry date indicated on the packaging.
The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging.
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 RinaAdvance contains
The active substance is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline hydrochloride. Each metered spray delivers 0.14 ml of solution (0.14 mg of xylometazoline hydrochloride).
The other components are: monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium chloride, sodium edetate, levomenthol, cineole (containing limonene), sorbitol, macrogol glycerol hydroxystearate, purified water.
Description of the appearance of RinaAdvance and contents of the pack
RinaAdvance is a nasal spray, 0.1% solution. The bottle contains 10 ml of white, opalescent solution with a menthol and eucalyptol (cineole) odour.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan
Manufacturer
Haleon Germany GmbH, Barthstraße 4, 80339, Munich (Germany)