RINAADVANCE 1 mg /Ml Krople Do Nosa, Roztwór

Treść ulotki

1. RinaAdvance 1 mg/ml nasal drops, solution, 1 mg/ml nasal spray, solution
   1. What is RinaAdvance and what is it used for
   2. What you need to know before using RinaAdvance
   3. Possible side effects
   4. How to store RinaAdvance
   5. Contents of the pack and other information
2. RinaAdvance 1 mg/ml nasal spray, solution
   1. What is RinaAdvance and what is it 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
3. RinaAdvance 1 mg/ml nasal spray, menthol aroma solution
   1. What is RinaAdvance and what is it 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
4. RinaAdvance 1 mg/ml nasal spray, menthol aroma solution
   1. What is RinaAdvance and what is it 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

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

xilometazoline hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
pharmacist has told you to do.
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 effects not listed in this leaflet, contact
your doctor or pharmacist. See section 4.
Contact your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 1. What RinaAdvanceis 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 is RinaAdvance and what is it used for

RinaAdvancecontains the active ingredient xylometazoline hydrochloride, which belongs to the class of drugs
that are nasal mucosa decongestants, acting by constricting blood vessels in the nasal mucosa, reducing
swelling (edema) that makes breathing difficult.

RinaAdvanceis used in cases of congestion of the nasal mucosa 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 any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-lasting nasal irritation (chronic rhinitis), with little or no secretion (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you suffer from increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery such as surgical removal of the pituitary gland (transsphenoidal hypophysectomy) or other major surgery to the skull;
• 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 RinaAdvanceconsult your doctor if:

• you have had a severe reaction to other medicines containing adrenergic substances, such as those contained in other nasal decongestants, which manifests with signs of insomnia, dizziness, tremor, altered heartbeat or high blood pressure;
• you have recently had nasal surgery;
• you suffer from or have suffered from a benign tumor of the adrenal gland (pheochromocytoma);
• you suffer from or have suffered from high blood pressure;
• you suffer from heart problems (e.g., long QT syndrome) and vascular problems;
• you suffer from a thyroid disease (hyperthyroidism);
• you suffer from diabetes;
• you suffer from an enlarged prostate (prostatic hypertrophy); you are taking medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) or have taken them in the last two weeks (see “Other medicines and RinaAdvance”Do not exceed the indicated doses and do not use RinaAdvancefor more than 7 consecutive days: prolonged or excessive use can cause the congestion to return and can alter the normal function of the nasal mucosa causing a reduction in the effectiveness of the medicine and thinning of the nasal mucosa and reduction in the number and size of the glands that produce mucus.

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

Elderly
Elderly patients are more prone to 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 taking, have recently taken or might take any other
medicine.
If you are taking or have taken medicines for the treatment of depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) in the last two weeks, the concomitant use of RinaAdvanceis not
recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

RinaAdvanceshould not be used during pregnancy or if you suspect or are planning a
pregnancy.
Breastfeeding

RinaAdvancecan be used during breastfeeding only under medical advice.

Driving and operating machinery
RinaAdvancedoes not alter or negligibly alters the ability to drive vehicles and operate machinery.
However, RinaAdvancemay cause visual disturbances, dizziness, vertigo, or other central nervous system disorders. If you experience these disorders, do not drive vehicles and do not operate machinery.

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

Attention for athletes:
The product contains substances prohibited for doping. Taking it in a manner different from the dosage regimen and route of administration as reported is prohibited.

• 3.How to use RinaAdvanceUse this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, ask your doctor or pharmacist.

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

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

Nasal spray, solution
Spray 1 spray into each nostril 1-3 times a day, as needed.
Do not exceed 3 sprays per day in each nostril.

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

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

• 4. For the first use, actuate the pump by pressing 4 times, in this way the pump will remain charged for the entire daily treatment period. If, by fully pressing the nozzle, the spray does not come out, or if the product has not been used for more than 7 days, the pump must be recharged by pressing 4 times.

Be careful not to spray the spray into your eyes or mouth.

• 5. Hold the bottle upright with your thumb under the base and the nozzle between two fingers.
• 6. Lean slightly forward and insert the nozzle into one nostril.
• 7. Spray and simultaneously breathe gently through your nose.
• 8. Repeat the same operation in the other nostril
• 9. Immediately after use, clean and dry the applicator before replacing the cap.

To avoid the possible spread of infection, the package of the medicine should be used by one
person only.
Within a few minutes you will obtain the effect of the drug at the local level which lasts up to 10 hours and gradually subsides.

If you take too much RinaAdvance
In case of accidental ingestion or overdose of RinaAdvance, immediately inform
your doctor or go to the nearest hospital.
If you accidentally ingest the medicine or use it for a long period at excessive doses, the following symptoms may occur:

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

In children, it may occur:

• lowering of body temperature
• severe depression of the central nervous system with strong sedation
• acceleration and irregularity of the pulse
• elevated blood pressure
• sometimes a state of confusion (clouding of 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration necessary of treatment.

Immediately inform your doctor and stop taking the medicine if you experience the following
symptoms:

• severe allergic reactions, including: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in the reddened areas, blistering rashes or skin peeling, large blisters (skin swelling 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
• burning in the nose.

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
• urination disorders
• insomnia
• restlessness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 that is 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 at a temperature below 30°C. Store in the original packaging.
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 RinaAdvance contains
Nasal drops, solution
The active ingredient is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline
hydrochloride. Each drop delivers 0.025 mg of xylometazoline hydrochloride.
The other ingredients are: disodium phosphate dihydrate, disodium phosphate dodecahydrate,
sodium edetate, benzalkonium chloride, sorbitol 70%, hypromellose, sodium chloride, purified water.
Nasal spray, solution
The active ingredient 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: disodium phosphate dihydrate, disodium 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 content of the bottle is 10 ml of clear, colorless and
practically odorless solution.
Nasal spray, 0.1% solution. The content of the bottle is 10 ml of clear, colorless and
practically odorless solution.

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

Manufacturer
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstraße 4, 80339, Munich (Germany)
Or
Haleon Germany GmbH, Barthstraße 4, 80339, Munich (Germany)

RinaAdvance 1 mg/ml nasal spray, solution

xilometazoline hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
pharmacist told you to do.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any of the side effects occur, including effects not listed in this leaflet, contact
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 RinaAdvanceis 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 is RinaAdvance and what is it used for

Rinadvance contains the active ingredient xylometazoline hydrochloride, which belongs to the class of nasal mucosa decongestant drugs that works by constricting blood vessels at the level of the nasal mucosa, reducing the swelling (edema) that makes breathing difficult.
RinaAdvance is used in cases of nasal mucosa congestion due to colds, hay fever or other allergic rhinitis and sinusitis.
See a 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 any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-lasting nasal irritation (chronic rhinitis), with little or no secretion (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you suffer from increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone operations on the brain such as surgical removal of the pituitary gland (transsphenoidal hypophysectomy) or other major surgeries on the skull;
• if you are under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using RinaAdvance
Before using RinaAdvance, consult your doctor if:

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

Do not exceed the indicated doses and do not use RinaAdvancefor 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 causing reduced efficacy of the medicine and thinning of the nasal mucosa and reduction in the
number and size of the glands that produce mucus.

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

Elderly
Elderly patients are more prone to side effects associated with RinaAdvance: inform your doctor if
you experience unusual symptoms.

Other medicines and RinaAdvanceTell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
If you are taking or have taken medicines for the treatment of depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) in the last two weeks, the concomitant use of RinaAdvance is not
recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

RinaAdvanceshould not be used during pregnancy and even if you suspect or are planning a
pregnancy.
Breastfeeding

RinaAdvancecan be used during breastfeeding only under medical advice.

Driving and operating machinery
RinaAdvance does not alter or negligibly alters the ability to drive vehicles and operate machinery.
However, RinaAdvance may cause visual disturbances, dizziness, vertigo, or other central nervous system disorders. If you experience these disorders, do not drive vehicles and do not operate machinery.

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

Attention for athletes:
The product contains substances prohibited for doping. Taking it in a manner different from the dosage regimen and route of administration as indicated is prohibited.

3. How to use RinaAdvance

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Nasal spray, solution with spray activated by a side button
Administer 1 spray in each nostril 1-3 times a day, as needed.
Do not exceed 3 administrations per day in each nostril.
The metered-dose spray activated with a side button allows for dosage accuracy and ensures that the solution is
well distributed on the surface of the nasal mucosa by finely misting the spray. It is easy to use.
Each pre-dosed spray of RinaAdvance0.1% delivers 0.14 ml of solution (0.14 mg of xylometazoline
hydrochloride).
For first use, press the side button 5 times, without inserting into the nostrils. Once activated, the
device will remain charged for the entire regular treatment period. The device will need to be recharged
by pressing 2 times if, at the end of the activation phase, the spray does not come out 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) 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 1 to 4).
• 5) After each use, clean and dry the nozzle
• 6) Reposition the protective cap until you hear a "click".

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

If you take more RinaAdvance than you should
In case of accidental ingestion or use of an excessive dose of RinaAdvance, immediately inform your
doctor or go to the nearest hospital.
If you accidentally ingest the medicine or if you use it for a long period at excessive doses, the following symptoms may occur:

• increased blood pressure
• accelerated heartbeat
• excessive sensitivity to light
• intense headache
• chest tightness.

In children, it may occur:

• lowering of body temperature
• severe depression of the central nervous system with strong sedation
• acceleration and irregularity of the pulse
• elevated blood pressure
• sometimes a confused state (clouding of 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration necessary of treatment.

Immediately inform your doctor and stop taking the medicine if you experience the following
symptoms:

• severe allergic reactions, which include: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in the reddened areas, rashes with blisters or skin that is peeling, large blisters (skin swelling 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
• burning in the nose.

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
• urination disorders
• insomnia
• restlessness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 that is stated on the packaging after Expiry.
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 at a temperature below 30°C. Store in the original packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RinaAdvance contains
The active ingredient is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline
hydrochloride. Each pre-dosed spray delivers 0.14 ml of solution (0.14 mg of xylometazoline
hydrochloride).
The other ingredients are: monobasic sodium phosphate dihydrate, disodium 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 spray, 0.1% solution. The contents of the bottle are 10 ml of clear, colorless and
practically odorless solution.

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

Manufacturer
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstraße 4, 80339, Munich (Germany)
Or
Haleon Germany GmbH, Barthstraße 4, 80339, Munich (Germany)

RinaAdvance 1 mg/ml nasal spray, menthol aroma solution

xylometazoline hydrochloride

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
pharmacist told you to do.
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 effects not listed in this leaflet, tell your
doctor or pharmacist. See section 4.
Talk to your doctor if you do not feel better 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 you use 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 is RinaAdvance and what is it used for

RinaAdvance contains the active ingredient xylometazoline hydrochloride, which belongs to the class of
nasal mucosa decongestant drugs that works by constricting blood vessels at the level of the nasal mucosa, reducing
swelling (edema) that makes breathing difficult.
RinaAdvance is used in cases of nasal mucosa congestion due to colds, hay fever or
other allergic rhinitis and sinusitis.
See a 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 any of the other ingredients of this medicine (listed in section 6).
• if you suffer from long-lasting nasal irritation (chronic rhinitis), with little or no secretion (dry rhinitis) or with crust formation (atrophic rhinitis);
• if you suffer from increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery such as surgical removal of the pituitary gland (transsphenoidal hypophysectomy) or other major surgery to the skull;
• if you are under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using RinaAdvance.
Before using RinaAdvanceconsult your doctor if:

• you have had a severe reaction to other medicines containing adrenergic substances, such as those contained in other nasal decongestants, which manifests with signs of insomnia, dizziness, tremor, altered 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 suffer from heart (e.g., long QT syndrome) and vascular problems
• You suffer from a thyroid disease (hyperthyroidism)
• You suffer from diabetes
• You suffer from an enlarged prostate (prostatic hypertrophy)
• You are taking medications for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) or have taken them in the last two weeks (see “Other medicines and RinaAdvance)

Do not exceed the indicated doses and do not use RinaAdvance for more than 7 consecutive days: prolonged or
excessive use may cause the recurrence of nasal congestion and may alter the normal function of the
nasal mucosa causing a reduction in the effectiveness of the medicine and thinning of the nasal mucosa and
reduction in the number and size of the glands that produce mucus.

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

Elderly
Elderly patients are more prone to side effects associated with RinaAdvance: inform your doctor if
you experience unusual symptoms.

Other medicines and RinaAdvance
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are taking or have taken medicines for the treatment of depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) in the last two weeks, the concomitant use of RinaAdvanceis not
recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

RinaAdvanceshould not be used during pregnancy or if you suspect or are planning a
pregnancy.
Breastfeeding

RinaAdvancecan be used during breastfeeding only under medical advice.

Driving and using machines
RinaAdvancedoes not alter or negligibly alters the ability to drive vehicles and use machines.
However, RinaAdvancemay cause visual disturbances, dizziness, vertigo, or other central nervous system disorders. If you experience these disorders, do not drive vehicles and do not use machinery.

Important information about some excipients:
RinaAdvancecontains macrogol hydroxystearate which may cause localized skin reactions.

RinaAdvancecontains the aroma cineole, which in turn contains limonene. Limonene may cause allergic
reactions.

Warning for athletes:
The product contains substances prohibited for doping. Taking it in a manner different from the dosage regimen and route of administration as reported is prohibited.

3. How to use RinaAdvance

Use this medicine following 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 in each nostril 1-3 times a day, as needed.
Do not exceed 3 administrations per day in each nostril.

Follow these instructions, being careful not to spray the spray into your eyes:

• 1. For the first use, remove the protective cap and activate the pump by pressing 4 times, this will keep it charged for the entire daily treatment period. If the spray does not come out when the nozzle is fully pressed, or if the product has not been used for more than 6 days, the pump will need to be recharged by pressing 4 times.
• 2. Do not cut the nozzle. The spray is ready for use.

• 3. Blow your nose carefully.
• 4. Hold the bottle in a vertical position with your thumb under the base and the nozzle between two fingers.
• 5. Lean slightly forward and insert the nozzle into one nostril.
• 6. Spray and simultaneously breathe gently through your nose.
• 7. Clean and dry the applicator before replacing the cap after use.

To avoid the possible spread of infection, the spray must be used by one person only
Within a few minutes you will obtain the effect of the drug locally 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, immediately inform your doctor or go to the nearest hospital.
If you accidentally ingest the medicine or use it for a long period at excessive doses, the following symptoms may occur:

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

In children, it may occur:

• lowering of temperature
• severe depression of the central nervous system with strong sedation
• acceleration and irregularity of the pulse
• elevated blood pressure
• sometimes confusion (clouding of 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• severe allergic reactions, including: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in reddened areas, blistering rashes or skin peeling, large blisters (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
• burning in the nose.

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
• urination disorders
• insomnia
• restlessness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 that is reported on the packaging after Scad.
The medicine, once opened, can be used until the expiry date reported on the packaging.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Store in the original packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RinaAdvance contains
The active ingredient 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: monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate,
sodium chloride, sodium edetate, levomenthol, cineole(containing limonene), sorbitol,

macrogolglycerol hydroxystearate, purified water.

Description of the appearance of RinaAdvance and contents of the pack
RinaAdvanceis presented in the form of a nasal spray, 0.1% solution. The content of the bottle is 10 ml
of white, opalescent solution, with a menthol and eucalyptus (cineole) aroma.

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

Manufacturer
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstraße 4, 80339 Munich (Germany)
Or
Haleon Germany GmbH, Barthstraße 4, 80339, Munich (Germany)

RinaAdvance 1 mg/ml nasal spray, menthol aroma solution

xylometazoline hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
pharmacist told you to do.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any of the undesirable effects occur, including effects not listed in this leaflet, contact
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 RinaAdvanceis 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 is RinaAdvance and what is it used for

RinaAdvancecontains the active ingredient xylometazoline hydrochloride, which belongs to the class of nasal mucosa decongestant drugs that works by constricting blood vessels in the nasal mucosa, reducing
swelling (edema) that makes breathing difficult.

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

Warnings and precautions
Consult your doctor or pharmacist before using RinaAdvance
Before using RinaAdvanceconsult your doctor if:

• You have had a severe reaction to other medicines containing adrenergic substances, such as those contained in other nasal decongestants, which manifests with signs of insomnia, dizziness, tremor, altered heartbeat or high blood pressure;
• You have recently undergone nasal surgery;
• You suffer from or have suffered from a benign tumor of the adrenal gland (pheochromocytoma);
• You suffer from or have suffered from high blood pressure.
• You suffer from heart (e.g. long QT syndrome) and vascular problems
• You suffer from a thyroid disease (hyperthyroidism)
• You suffer from diabetes
• You suffer from an enlarged prostate (prostatic hypertrophy)
• You are taking medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) or have taken them in the last two weeks (see “Other medicines and RinaAdvance)Do not exceed the indicated doses and do not use RinaAdvancefor more than 7 consecutive days: prolonged or excessive use can cause the recurrence of nasal congestion and can alter the normal function of the nasal mucosa causing a reduction in the effectiveness of the medicine and thinning of the nasal mucosa and reduction in the number and size of the glands that produce mucus.

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

Elderly
Elderly patients are more prone to side effects associated with RinaAdvance: inform your doctor in case
of unusual symptoms.

Other medicines and RinaAdvance
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
If you are taking or have taken medicines for the treatment of depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) in the last two weeks, the concomitant use of RinaAdvanceis not
recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

RinaAdvanceshould not be used during pregnancy or if you suspect you are pregnant or are planning a
pregnancy.
Breastfeeding

RinaAdvancecan be used during breastfeeding only under medical advice.

Driving and using machines
RinaAdvancedoes not alter or negligibly alters the ability to drive vehicles and use machines.
However RinaAdvancemay cause visual disturbances, dizziness, vertigo, or other central nervous system disorders. If you experience these disorders, do not drive vehicles and do not use machinery.

Important information about some excipients:
RinaAdvancecontains macrogolglycerol hydroxystearate which may cause localized skin reactions.

RinaAdvancecontains the aroma cineole, which in turn contains limonene. Limonene may cause allergic
reactions.

Attention for those who play sports:
The product contains substances prohibited for doping. Taking it differently than the dosage regimen and route of administration specified is prohibited.

3. How to use RinaAdvance

Use this medicine following 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 1-3 times a day, as needed.
Do not exceed 3 administrations per day in each nostril.
The metered-dose spray activated with a side button allows for dosage accuracy and ensures that the solution is
well distributed on the surface of the nasal mucosa by finely nebulizing the spray. It is easy to use.

For first use
Press the side button 5 times without inserting it into the nostrils. Once activated, the device will remain charged
for the entire regular treatment period. The device will need to be recharged by pressing it 2 times if, at the end
of the activation phase, 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 your eyes.

• 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 complete spray is not administered, the dose should not be repeated.
To avoid the possible spread of infections, the spray should be used by only one person.
Within a few minutes you will obtain the effect of the drug locally which lasts up to 10 hours and gradually subsides.

If you take more RinaAdvance than you should
In case of accidental ingestion or use of an excessive dose of RinaAdvance, immediately inform your
doctor or go to the nearest hospital.
If you accidentally ingest the medicine or if you use it for a long period at excessive doses, the following symptoms may occur:

• increased blood pressure
• accelerated heartbeat
• excessive sensitivity to light
• intense headache
• chest tightness.

In children, it may occur:

• lowering of body temperature
• severe depression of the central nervous system with strong sedation
• acceleration and irregularity of the pulse
• elevated blood pressure
• sometimes confusion (clouding of 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• severe allergic reactions, which include: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in the reddened areas, blistering rashes or skin peeling, large blisters (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
• burning in the nose.

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
• urination disorders
• insomnia
• restlessness.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 that is stated on the packaging after Scad.
The medicine, once opened, can be used until the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Store in the original packaging.
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 RinaAdvance contains
The active ingredient is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline
hydrochloride. Each pre-dosed spray delivers 0.14 ml of solution (0.14 mg of xylometazoline
hydrochloride).
The other ingredients are: monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate,
sodium chloride, sodium edetate, levomenthol, cineole (containing limonene), sorbitol,
macrogolglycerol hydroxystearate, purified water.

Description of the appearance of RinaAdvance and contents of the pack
RinaAdvanceis presented in the form of a nasal spray, 0.1% solution. The content of the bottle is 10 ml
of white, opalescent solution, with a menthol and eucalyptus (cineole) aroma.

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

Manufacturer
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstraße 4, 80339 Munich (Germany)
Or
Haleon Germany GmbH, Barthstraße 4, 80339, Munich (Germany)