VICKS SINEX ALOE ALOE 0.05% SOLUTION FOR NEBULIZER 15 ML NEBULIZER BOTTLE

Name
Vicks Sinex Aloe 0.05% nebulizer solution
Oxymetazoline hydrochloride


What is it and what is it for?
Vicks Sinex Aloe contains oxymetazoline hydrochloride which has decongestant properties and is indicated for the treatment of colds.

Contact your doctor if you do not feel better or if you feel worse after 4 days.


What you need to know before taking the medicine
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 a serious heart disease;
- if you suffer from high blood pressure (severe arterial hypertension ); - if you suffer from a disease characterised by high pressure inside the eye ( closed-angle glaucoma );
- if your thyroid is working more than normal ( hyperthyroidism );
- during and in the two weeks following therapy with some drugs used against depression called monoamine oxidase inhibitors (MAOIs);
- if you have inflammation or crusting of the skin around your nostrils or inside your nose (dry rhinitis);
- if the child to be treated is under 12 years old.


Warnings and precautions
Talk to your doctor or pharmacist before using Vicks Sinex Aloe.

Take special care and ask your doctor for advice before using Vicks Sinex Aloe :
- during pregnancy;
- if you are elderly, as you may experience problems urinating (urinary retention);
- if you suffer from a disease that causes heart pain (angina);
- if you suffer from diabetes;
- if you have an adrenal tumor called pheochromocytoma.

Also, contact your doctor if you experience swelling of the nasal mucosa (persistent nasal congestion), as this could be a reaction to a preservative in the medicine, benzalkonium chloride , especially if it is used for a prolonged period.
In any case, treatment should NOT be prolonged for more than 4 days since the symptoms for which you started taking Vicks Sinex Aloe may recur (rebound effects), inflammation or irritation of the nasal mucosa (rhinitis) may occur, and the effectiveness of the product may be reduced.

Accidental ingestion may cause serious sedative effects.

Accidental ingestion and prolonged use in excessive doses can cause toxicity phenomena.

Prolonged use may cause sensitization phenomena and effects due to the withdrawal of the drug (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.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Overall, no serious adverse effects were observed.

Side effects may include:

Rare (may affect up to 1 in 1,000 people)
- irritation, discomfort or redness in 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);
- perception of heartbeat (palpitations);
- increased blood pressure;
- decrease in the number of heartbeats (reflex bradycardia);
- insomnia;
- nervousness;
- tremors;
- anxiety;
- agitation;
- irritability;
- headache (cephalalgia);
- nausea;
- problems urinating (micturition disorders).

Not known (frequency cannot be estimated from the available data):
- Nasal dryness;
- Nosebleed (epistaxis);
- Inflammation of the nasal mucosa which makes breathing difficult (nasal congestion);
- Hypersensitivity reactions (swelling, rash, itching).

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.