VICKS 0.05% Nasal spray, solution

Зміст інструкції

1. Vicks Sinex Aloe 0.05% spray solution
   1. What is Vicks Sinex Aloe and what is it 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
2. Vicks Sinex 0.05% Nasal Spray Solution
   1. What is Vicks Sinex and what is it 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

Vicks Sinex Aloe 0.05% spray solution

oxymetazoline hydrochloride

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

Contents of this leaflet:

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

Vicks Sinex Aloe contains oxymetazoline hydrochloridewhich has decongestant properties and is
indicated for the treatment of the common cold.
See 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 ingredients 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 a serious heart condition;
• if you suffer from high blood pressure (severe arterial hypertension);
• if you suffer from a disease characterized by high pressure inside the eye ( closed-angle glaucoma);
• if your thyroid gland is overactive ( hyperthyroidism);
• during and for two weeks after therapy with certain drugs used against depression called monoamine oxidase inhibitors ( MAOIs);
• if you have inflammation or the presence of crusts on the skin around the nostrils or inside the nose (dry rhinitis);
• if the child to be treated is less than 12 years old;

Warnings and precautions
Consult your doctor or pharmacist before using Vicks Sinex Aloe.
Pay particular attention and ask your doctor for advice before using Vicks Sinex Aloe:

• during pregnancy;
• if you are elderly, as you may experience problems with urination ( urinary retention);
• if you suffer from a disease that causes chest pain ( angina);
• if you suffer from diabetes.
• If you have a tumor of the adrenal gland called pheochromocytoma

In addition, consult your doctor if you experience swelling of the nasal mucosa
(persistent nasal congestion), as this may be a reaction due to a
preservative present in the medicine, benzalkonium chloride, especially if it is used for
a prolonged period.
Treatment, in any case, should not be prolonged for more than 4 days as
symptoms may reappear for which you started taking Vicks Sinex Aloe (rebound effects), inflammation or irritation of the nasal mucosa (rhinitis) may occur, and
the effectiveness of the product may be reduced.
Accidental ingestion can cause serious sedative effects.
Accidental ingestion and prolonged use at excessive doses can cause
toxicity.
Prolonged use can cause sensitization and effects due to discontinuation
of the medicine (congestion of the mucous membranes as a "rebound" effect).
DO NOT use the medicine orally and avoid getting the liquid in contact with your eyes.

Children and adolescents
Vicks Sinex Aloe should 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 in the two weeks preceding
drugs used against depression belonging to the class of monoamine oxidase

inhibitors(see also “Do not use Vicks Sinex Aloe”).
Also, pay particular attention and inform your doctor if you are taking:

• medicines used for high blood pressure (antihypertensives) such as beta-blockers, methyldopa orothers;
• certain medicines used against depression ( tricyclic antidepressants);
• certain medicines used in the treatment of Parkinson's disease (for example bromocriptine).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
Use this medicine with caution and only under the control of a doctor during the first months of
pregnancy.
Breastfeeding
Use this medicine with caution and only under the control of a doctor during breastfeeding
with breast milk.

Driving and using machines
No effects on the ability to drive vehicles 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 can cause irritation and swelling of the nose, 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 can cause allergic reactions. Benzyl alcohol can cause mild local irritation.

3. How to use Vicks Sinex Aloe

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.
The recommended dose is 1 - 2 sprays per nostril every 8 - 12 hours, unless otherwise indicated by your doctor.
Instructions for use
Remove the protective cap. Hold the bottle in a vertical position, keeping your thumb at the base and the applicator between your index and middle fingers. Insert the tip into the nostril and press the sprayer quickly and firmly, without tilting your head. After application, then inhale deeply keeping your mouth closed. Do not use the product while lying down.
Do not exceed the recommended doses and the 4 days of treatment. If after this period of time you do not obtain appreciable results, consult your doctor.

If you use more Vicks Sinex Aloe than you should
In case of ingestion/accidental intake or incorrect use of the medicine, contact your doctor or the nearest hospital immediately. Overdosage may occur after nasal administration or accidental oral administration.
If you use an excessive dose of Vicks Sinex Aloe, symptoms such as increased blood pressure (hypertension), increased heart rate (tachycardia), accentuated perception of the heartbeat (palpitations), irregular heartbeat (cardiac arrhythmias), cessation of heart activity, heart failure, sweating, agitation, increased pupil diameter (mydriasis), nausea, vomiting, bluish-purple discoloration of skin and mucous membranes (cyanosis), fever, spasms, severe decrease in blood pressure (circulatory collapse), fluid accumulation around the lungs (pulmonary edema), difficulty breathing, psychiatric disorders, drowsiness, pallor, miosis, decreased body temperature, slowed heartbeat (bradycardia), reduced blood pressure (hypotension) as a result of shock, apnea, loss of consciousness, convulsions and coma may occur. And, in children, severe depression of the central nervous system which manifests with symptoms such as decreased body temperature, decreased heart rate (bradycardia), decreased blood pressure (hypotension), apnea and loss of consciousness.
The doctor will assess the most appropriate treatment based on the severity of the situation.
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.
In general, no severe side effects have been observed.
The side effects may be:

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

• irritation, discomfort or redness of the eyes;
• discomfort or irritation of the mouth or throat;
• sneezing.

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

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

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

• Nasal dryness;
• Nosebleed (epistaxis);
• Inflammation of the nasal mucosa that makes breathing difficult (nasal congestion)
• Hypersensitivity reactions (swelling, rash, itching).

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
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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
“Expiry”. The expiry date refers to the last day of that month.
Once the spray bottle is opened, use within 3 months.
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 Vicks Sinex Aloe contains

• The active substanceis oxymetazoline hydrochloride. 1 ml of product contains 0.5 mg of oxymetazoline hydrochloride (for a total of 7.5 mg per 15 ml bottle). 1 spray (approximately 0.05 ml) contains approximately 25 micrograms of oxymetazoline hydrochloride.
• The other ingredients are: levomenthol, sodium citrate, anhydrous citric acid, benzalkonium chloride solution, disodium edetate, eucalyptus oil (cineole), non-crystallizing liquid sorbitol, aloe vera, acesulfame potassium, 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 is presented in a 15 ml spray bottle, equipped with a cap. The bottle
contains a minimum of 265 sprays.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Procter & Gamble S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Roma

Manufacturer
Procter & Gamble Manufacturing GmbH, Procter-&-Gamble Strasse 1, 64521 Gross-Gerau,
Germany

Vicks Sinex 0.05% Nasal Spray Solution

oxymetazoline hydrochloride

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you.

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

Vicks Sinex 0.05% Nasal Spray solution, from now on will be referred to as Vicks Sinex in

Contents of this leaflet:

• 1. What Vicks Sinex is and what it is used for
• 2. What you need to know before you use 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 is Vicks Sinex and what is it used for

Vicks Sinex contains oxymetazoline hydrochloridewhich has decongestant properties and is indicated
for the treatment of the common cold.
See 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

Do not use Vicks Sinex

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems urinating due to an enlarged prostate ( prostatic hypertrophy);
• if you suffer from a serious heart condition;
• if you suffer from high blood pressure (severe arterial hypertension);
• if you suffer from a disease characterized by high pressure inside the eye ( glaucoma);
• if your thyroid gland is overactive ( hyperthyroidism);
• during and for two weeks following therapy with certain drugs used against depression called monoamine oxidase inhibitors (MAOIs);
• if you have inflammation or crusting on the skin around your nostrils or inside your nose (dry rhinitis);
• if the child to be treated is less than 12 years old.

Warnings and precautions
Consult your doctor or pharmacist before using Vicks Sinex.
Pay particular attention and ask your doctor for advice before using Vicks Sinex:

• during the first months of pregnancy;
• if you are elderly, as you may experience problems urinating ( urinary retention);
• if you suffer from a disease that causes chest pain ( angina);
• if you suffer from diabetes;
• if you have a tumor of the adrenal gland called pheochromocytoma;

Prolonged use of vasoconstrictors may alter the normal function of the nasal
mucosa and paranasal sinuses, and may also induce habituation.
Treatment, in any case, should not be prolonged for more than 4 days as
symptoms may reappear for which you started taking Vicks Sinex (rebound effects), or inflammation or irritation of the nasal mucosa (rhinitis) may occur.
Accidental ingestion can cause serious sedative effects.
Accidental ingestion and prolonged use at excessive doses can cause toxicity.
Frequent, prolonged, or abusive use can cause sensitization and effects
due to discontinuation of the medicine (congestion of the mucous membranes as a “rebound”
effect) or their worsening.
DO NOT use the medicine orally and avoid getting the liquid in contact with your eyes.

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

Other medicines and Vicks Sinex
Tell 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 taking or have taken in the two weeks preceding
medicines used against depression belonging to the class of monoamine oxidase

inhibitors(see also “Do not use Vicks Sinex”).
Also, pay particular attention and tell your doctor if you are taking:

• medicines used for high blood pressure (antihypertensives) such as beta-blockers, methyldopaor others;
• certain medicines used against depression ( tricyclic antidepressants);
• certain medicines used in the treatment of Parkinson's disease (for example bromocriptine).

Pregnancy, breastfeeding and fertility
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 taking
this medicine.
Pregnancy
Use this medicine with caution and only under the control of a doctor during pregnancy.
Breastfeeding
Use this medicine with caution and only under the control of a doctor during breastfeeding
with breast milk.

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

3. How to use Vicks Sinex

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.
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;
• For first use, before inserting the spray nozzle into the nostril, hold the nozzle of the bottle upwards away from your face and press the nozzle 7 times until a uniform spray is formed. 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 in a supine position. After a period of disuse of at least 4
weeks and before use, activate the dispenser 2 times until a uniform spray is obtained, then proceed according to the instructions for use
Do not exceed the recommended doses and the 4 days of treatment. If after this period of time you do not
obtain appreciable results, consult your doctor.

If you use more Vicks Sinex than you should
In case of ingestion/accidental intake, incorrect use of the medicine or overdose, immediately contact your doctor or the nearest hospital.
If you use an excessive dose of Vicks Sinex, symptoms such as increased
pupil diameter (mydriasis), nausea, bluish-purple discoloration of the lips and skin (cyanosis), fever,
increased heart rate (tachycardia), heart rhythm disturbances
(arrhythmias), increased blood pressure (hypertension), difficulty breathing (dyspnea),
heart failure, cessation of heart activity, sweating, agitation, convulsions,
vomiting, spasms, severe decrease in blood pressure (circulatory collapse), fluid accumulation
around the lungs (pulmonary edema), psychiatric disorders, drowsiness, pallor,
reduction in pupil diameter (miosis), sensitivity to light (photophobia), headache
(cephalalgia), intense feeling of tightness in the chest, convulsions and coma and, in
children, severe depression of the central nervous system which manifests with symptoms such as
decreased body temperature, decreased heart rate
(bradycardia), lowering of pressure (hypotension), apnea and loss of consciousness.
The doctor will assess the most appropriate treatment based on the severity of the situation.
If you have any doubts about the use of this medicine, contact 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.
Side effects may include:

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

• irritation, discomfort or redness of the eyes;
• discomfort or irritation of the nose, mouth or throat;
• 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;
• nausea;
• problems with urination (urinary disorders).

Not known:

• Nasal dryness;
• Inflammation of the nasal mucosa that makes breathing difficult and increases nasal secretions (nasal congestion);
• Nosebleed (epistaxis);
• Hypersensitivity reactions (swelling, rash, itching).

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 Vicks Sinex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after
“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 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 Vicks Sinex contains

• The active ingredient is oxymetazoline hydrochloride. 1 ml of product contains 0.5 mg of oxymetazoline hydrochloride (for a total of 5.0 mg per 10 ml bottle). 1 spray of 45 microliters of solution contains 22.5 micrograms of oxymetazoline hydrochloride. The bottle contains a minimum of 143 sprays.
• The other ingredients 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 presented as a clear and colorless aqueous solution in a 10 ml bottle with a
metered-dose pump, equipped with a cap

Marketing authorization holder and manufacturer

Marketing authorization holder
Procter & Gamble S.r.l. - Via Giorgio Ribotta, 11 - 00144 Roma

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