VICKS SINEX ALOE*NASAL SPRAY 15ML0.05%

Vicks Sinex Aloe 0.05% spray solution
Oxymetazoline hydrochloride

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

Consult 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 ingredients or to any of the other components of this medicine (listed in section 6);
- if you have an enlarged prostate (prostatic hypertrophy);
- if you suffer from a severe heart condition;
- 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 overactive (hyperthyroidism);
- during and within two weeks after therapy with certain medicines used to treat depression called monoamine oxidase inhibitors (MAOIs);
- if you have inflammation or crusts on the skin around the nostrils or inside the nose (rhinitis sicca);
- if the child to be treated is under 12 years of age.

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 tumour of the adrenal gland called phaeochromocytoma.

Furthermore, consult your doctor if you experience swelling of the nasal mucosa (persistent nasal congestion), as this could be a reaction due to a preservative present in the medicine, benzalkonium chloride, especially if used for a prolonged period.
In any case, treatment MUST NOT be prolonged for more than 4 days as the symptoms for which you started taking Vicks Sinex Aloe may reappear (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 severe sedative effects.

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

Prolonged use can cause sensitisation phenomena and effects due to the discontinuation of the medicine (mucosal congestion as a rebound effect).

DO NOT use the medicine orally and avoid getting the liquid in contact with the eyes.

Children and adolescents
Vicks Sinex Aloe must 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.

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 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;
- decreased heart rate (reflex bradycardia);
- insomnia;
- nervousness;
- tremors;
- anxiety;
- restlessness;
- irritability;
- headache;
- nausea;
- problems with urination (urinary disorders).

Not known (frequency cannot be estimated from the 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, 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.