Vicks Sinex

Package leaflet: Information for the patient

Vicks Sinex Aloe 0.05% spray solution

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

• 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 any improvement or if your symptoms worsen after 4 days.

Contents of this leaflet:

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

1. What Vicks Sinex Aloe is and what it is used for

Vicks Sinex Aloe contains oxymetazoline hydrochloride, which has decongestant properties and is indicated for the treatment of colds.
Consult a doctor if you do not feel better or if you feel worse after 4 days.

2. What you need to know before using Vicks Sinex Aloe

Do not use Vicks Sinex Aloe

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have an enlarged prostate ( prostatic hypertrophy );
• if you suffer from severe heart disease;
• if you suffer from high blood pressure (severe arterial hypertension );
• if you suffer from a condition characterized by increased pressure inside the eye ( closed-angle glaucoma );
• if your thyroid gland is overactive ( hyperthyroidism );
• during and within two weeks after treatment with certain antidepressant medicines called monoamine oxidase inhibitors ( MAOIs );
• if you have inflammation or crusts on the skin around the nostrils or inside the nose (dry rhinitis);
• if the child to be treated is under 12 years of age;

Warnings and precautions
Talk to your doctor or pharmacist before using Vicks Sinex Aloe.
Take particular care and consult your doctor before using Vicks Sinex Aloe:

• during pregnancy;
• if you are elderly, as you may experience difficulty urinating ( urinary retention );
• if you suffer from a condition causing chest pain ( angina );
• if you have diabetes;
• if you have a tumour of the adrenal gland called phaeochromocytoma.

Additionally, consult your doctor if you develop swelling of the nasal mucosa (persistent nasal congestion), as this could be a reaction to a preservative in the medicine, benzalkonium chloride, especially if used for prolonged periods.

In any case, treatment should NOT last longer than 4 days, as symptoms for which you started using Vicks Sinex Aloe may return (rebound effects), inflammation or irritation of the nasal mucosa (rhinitis) may occur, and the effectiveness of the product may decrease.

Accidental ingestion may cause severe sedative effects.
Accidental ingestion and prolonged use at excessive doses may cause toxic effects.
Prolonged use may lead to sensitization and withdrawal effects (mucosal congestion such as "rebound effect").
DO NOT take this medicine orally and avoid contact of the liquid with the eyes.

Children and adolescents
Vicks Sinex Aloe must not be used in children under 12 years of age.

Other medicines and Vicks Sinex Aloe
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Vicks Sinex Aloe if you are taking or have taken within the previous two weeks antidepressant medicines belonging to the class of monoamine oxidase inhibitors (see also "Do not use Vicks Sinex Aloe").
Also, take particular care and inform your doctor if you are taking:

• medicines used for high blood pressure (antihypertensives) such as beta-blockers, methyldopa or others;
• certain antidepressant medicines ( tricyclic antidepressants );
• certain medicines used in the treatment of Parkinson's disease (e.g. bromocriptine ).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Use this medicine with caution and only under medical supervision during the first months of pregnancy.

Breastfeeding
Use this medicine with caution and only under medical supervision during breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

Vicks Sinex Aloe contains

• Benzalkonium chloride: may cause bronchospasm. This medicine contains 0.01 mg of benzalkonium chloride per dose (1 spray), equivalent to 0.2 mg/ml. Benzalkonium chloride may cause nasal irritation and swelling, especially if used for long periods.
• Benzyl alcohol: this medicine contains 0.1 mg of benzyl alcohol per dose (1 spray), equivalent to 2 mg/ml. Benzyl alcohol may cause allergic reactions and may cause mild local irritation.

3. How to use Vicks Sinex Aloe

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.
The recommended dose is 1 - 2 sprays per nostril every 8 - 12 hours, unless otherwise directed by a physician.

Instructions for use
Remove the protective cap. Hold the bottle in an upright position, placing your thumb at the base and the spray nozzle between your index and middle fingers. Insert the tip into the nostril and press the spray pump quickly and firmly, without tilting your head. After application, inhale deeply through the nose while keeping your mouth closed. Do not use the product while lying down.

Do not exceed the recommended doses or use for longer than 4 days. If you do not experience noticeable improvement after this period, consult your doctor.

If you use more Vicks Sinex Aloe than you should
In case of accidental ingestion or misuse of the medicine, seek immediate medical attention at the nearest hospital or contact your doctor. Overdose may occur following nasal administration or accidental oral intake.

Symptoms of overdose may include increased blood pressure (hypertension), increased heart rate (tachycardia), awareness of heartbeats (palpitations), irregular heart rhythms (cardiac arrhythmias), cardiac arrest, heart failure, sweating, agitation, pupil dilation (mydriasis), nausea, vomiting, bluish-purple discoloration of the skin and mucous membranes (cyanosis), fever, spasms, severe drop in blood pressure (circulatory collapse), fluid accumulation around the lungs (pulmonary edema), breathing difficulties, psychiatric disturbances, drowsiness, pallor, miosis, decreased body temperature, slowed heart rate (bradycardia), low blood pressure (hypotension) due to shock, apnea, loss of consciousness, seizures, and coma. In children, severe central nervous system depression may occur, characterized by symptoms such as decreased body temperature, reduced heart rate (bradycardia), low blood pressure (hypotension), apnea, and loss of consciousness.

The doctor will assess and provide the most appropriate treatment depending on the severity of the condition.

If you have any doubts about how to use 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.
In general, no severe side effects have been observed.
Possible side effects include:

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

• eye irritation, discomfort or redness;
• mouth or throat discomfort or irritation;
• sneezing.

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

• increased heart rate (tachycardia);
• awareness of heart beat (palpitations);
• increased blood pressure;
• decreased heart rate (reflex bradycardia);
• insomnia;
• nervousness;
• tremors;
• anxiety;
• agitation;
• irritability;
• headache (cephalalgia);
• nausea;
• difficulty urinating (urinary disorders).

Not known (frequency cannot be estimated from the available data):

• Nasal dryness;
• Nosebleeds (epistaxis);
• Inflammation of the nasal mucosa causing breathing difficulty (nasal congestion);
• Hypersensitivity reactions (swelling, skin rash, itching).

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
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 Vicks Sinex Aloe

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 opening the spray bottle, use within 3 months.
Do not dispose of medicines via 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 package and other information

What Vicks Sinex Aloe contains

• The active substance is oxymetazoline hydrochloride. 1 ml of product contains 0.5 mg of oxymetazoline hydrochloride (for a total of 7.5 mg in a 15 ml bottle). One spray (approximately 0.05 ml) contains about 25 micrograms of oxymetazoline hydrochloride.
• The other components are: levomenthol, sodium citrate, anhydrous citric acid, benzalkonium chloride solution, disodium edetate, eucalyptol (cineole), sorbitol liquid non-crystallizable, aloe vera, potassium acesulfame, L-carvone, polysorbate 80, benzyl alcohol and purified water.

Description of the appearance of Vicks Sinex Aloe and contents of the pack
Vicks Sinex Aloe comes in a 15 ml spray bottle with a cap. The bottle contains a minimum of 265 sprays.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Procter & Gamble S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Rome, Italy
Manufacturer
Procter & Gamble Manufacturing GmbH, Procter-&-Gamble Strasse 1, 64521 Gross-Gerau, Germany

Patient Information Leaflet

Vicks Sinex 0.05% Nasal Spray Solution

Oxymetazoline hydrochloride
Please 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 instructed.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 4 days.

Vicks Sinex 0.05% Nasal Spray Solution, referred to hereinafter as Vicks Sinex in
this package leaflet.
Contents of this leaflet:

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

1. What Vicks Sinex is and what it is used for

Vicks Sinex contains oxymetazoline hydrochloride, which has decongestant properties and is indicated
for the treatment of cold symptoms.
Consult a doctor if you do not feel better or feel worse after 4 days.

2. What you need to know before using Vicks Sinex

Do not use Vicks Sinex

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty urinating due to an enlarged prostate ( prostatic hypertrophy );
• if you suffer from a severe heart condition;
• if you have high blood pressure (severe arterial hypertension );
• if you suffer from a condition characterized by increased pressure inside the eye ( glaucoma );
• if your thyroid gland is overactive ( hyperthyroidism );
• during and within two weeks after treatment with certain antidepressant medicines called monoamine oxidase inhibitors (MAOIs) ;
• if you have inflammation or crusts on the skin around the nostrils or inside the nose (dry rhinitis);
• if the child to be treated is under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Vicks Sinex.
Exercise particular caution and consult your doctor before using Vicks Sinex:

• during the first months of pregnancy;
• if you are elderly, as you may experience difficulty urinating ( urinary retention );
• if you suffer from a condition causing chest pain ( angina );
• if you have diabetes;
• if you have a tumour of the adrenal gland called phaeochromocytoma.

Prolonged use of vasoconstrictors may alter the normal function of the nasal mucosa and paranasal sinuses, and may also lead to drug dependence.
In any case, treatment should NOT last longer than 4 days, as symptoms for which Vicks Sinex was started may return (rebound effects), or inflammation or irritation of the nasal mucosa (rhinitis) may occur.
Accidental ingestion may cause severe sedative effects.
Accidental ingestion and prolonged use at excessive doses may cause toxic effects.
Frequent, prolonged, or excessive use may cause sensitization reactions and withdrawal symptoms (such as mucosal congestion known as "rebound effect") or worsening of symptoms.
DO NOT take this medicine orally and avoid contact of the liquid with the eyes.

Children and adolescents
Vicks Sinex must not be used in children under 12 years of age.

Other medicines and Vicks Sinex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Vicks Sinex if you are currently taking or have taken within the previous two weeks antidepressant medicines belonging to the class of monoamine oxidase inhibitors (MAOIs) (see also "Do not use Vicks Sinex").
Moreover, exercise particular caution and inform your doctor if you are taking:

• medicines used for high blood pressure (antihypertensives) such as beta-blockers, methyldopa or others;
• certain antidepressant medicines ( tricyclic antidepressants );
• certain medicines used in the treatment of Parkinson's disease (e.g. bromocriptines ).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Use this medicine with caution and only under medical supervision during pregnancy.

Breastfeeding
Use this medicine with caution and only under medical supervision during breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

3. How to use Vicks Sinex

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.
The recommended dose is 1 - 2 sprays per nostril every 8 - 12 hours, unless otherwise indicated by your doctor.
Instructions for use
For nasal use.
When used for the first time:

• Remove the protective cap;
• At first use, before inserting the spray nozzle into the nostril, hold the bottle upright with the nozzle pointing away from the face and press the nozzle 7 times until a uniform spray is produced. The spray mechanism works by pressing on the edges of the nozzle;
• Insert the spray nozzle into the nostril and press once. [Figure 1].
• After use, clean the nozzle and replace the protective cap.

Do not use the product while lying on your back. After a period of non-use of at least 4 weeks, and before using, prime the spray pump by pressing it twice until a uniform spray is obtained, then follow the instructions for use.
Do not exceed the recommended doses or use for more than 4 days. If no noticeable improvement occurs after this time, consult your doctor.
If you use more Vicks Sinex than you should
In case of accidental ingestion, incorrect use of the medicine, or overdose, seek immediate medical advice from your doctor or go to the nearest hospital.
If you use an excessive dose of Vicks Sinex, symptoms such as increased pupil diameter (mydriasis), nausea, bluish-purple skin discoloration (cyanosis), fever, increased heart rate (tachycardia), irregular heartbeats (arrhythmias), increased blood pressure (hypertension), difficulty breathing (dyspnea), heart failure, cardiac arrest, sweating, agitation, convulsions, vomiting, spasms, severe drop in blood pressure (circulatory collapse), fluid accumulation around the lungs (pulmonary edema), psychiatric disturbances, drowsiness, pallor, reduced pupil diameter (miosis), light sensitivity (photophobia), headache (cephalalgia), intense chest tightness, seizures and coma may occur. In children, severe depression of the central nervous system may occur, manifesting as decreased body temperature, reduced heart rate (bradycardia), low blood pressure (hypotension), apnea, and loss of consciousness.
The doctor will assess the most appropriate treatment based on the severity of the condition.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
In general, no severe side effects have been observed.
Possible side effects include:
Rare (may affect up to 1 in 1,000 people)

• eye irritation, discomfort or redness;
• nasal, oral or throat discomfort or irritation;
• sneezing.

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

• increased heart rate (tachycardia);
• palpitations;
• increased blood pressure;
• decreased heart rate (reflex bradycardia);
• insomnia;
• nervousness;
• tremors;
• anxiety;
• agitation;
• irritability;
• headache (cephalalgia);
• nausea;
• urinary problems (urinary disorders).

Not known:

• Nasal dryness;
• Inflammation of the nasal mucosa causing breathing difficulties and increased nasal secretions (nasal congestion);
• Nosebleeds (epistaxis);
• Hypersensitivity reactions (swelling, rash, itching).

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack following "Exp.". The expiry date refers to the last day of that month.
Do not use for more than 12 months after opening the bottle.
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 Vicks Sinex contains

• The active substance is oxymetazoline hydrochloride. 1 ml of product contains 0.5 mg of oxymetazoline hydrochloride (for a total of 5.0 mg in a 10 ml bottle). 1 spray of 45 microlitres of solution contains 22.5 micrograms of oxymetazoline hydrochloride. The bottle contains a minimum of 143 sprays.
• The other components are: citric acid monohydrate, sodium citrate, glycerol (85%), purified water. This medicine does not contain preservatives.

Description of the appearance of Vicks Sinex and contents of the pack

Vicks Sinex is a clear, colourless aqueous solution in a 10 ml bottle with a metering pump spray, fitted with a cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Procter & Gamble S.r.l. - Via Giorgio Ribotta, 11 - 00144 Rome, Italy

Manufacturer
Famar Healthcare Services Madrid, S. A. U
Avda. Leganés 62
Alcorcón 28923 (Madrid)
Spain
Sofarimex – Indústria Química e Farmacêutica, S. A.
Av. das Indústrias - Alto do Colaride
2735-213 Cacém
Portugal