RINOCALYPTOL*NASAL SPRAY FL 15ML

Rino Calyptol 0.5 mg/ml nasal spray, solution
Oxymetazoline hydrochloride

What it is and what it is used for
Rino Calyptol contains oxymetazoline hydrochloride, a nasal decongestant, a substance that helps constrict the blood vessels in the nose, reducing oedema of the nasal mucosa (the inner lining of the nose) and facilitating breathing.
Rino Calyptol is used for the short-term treatment of "blocked nose" symptoms (nasal mucosal congestion), especially in cases of colds.

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 Rino Calyptol:
- if you are allergic to oxymetazoline or any of the other ingredients of this medicine (listed in section 6);
- if you have an enlarged prostate (prostatic hypertrophy);
- if you have heart disease;
- if you have very high blood pressure (severe arterial hypertension);
- if you have high eye pressure (glaucoma);
- if your thyroid is overactive (hyperthyroidism);
- if you are taking or have taken antidepressants in the previous two weeks.

This spray should not be used in children under 12 years of age.

Warnings and precautions
Consult your doctor before using Rino Calyptol:
• if you have high blood pressure or a heart or circulatory disease because your doctor will need to assess if you can take this medicine;
• if you are elderly because this medicine can cause difficulty urinating (urinary retention).

The use of this medicine can cause difficulty breathing (bronchospasm).
Do not use Rino Calyptol for prolonged treatments; after a few days of treatment without appreciable results, consult your doctor. This medicine should not be used for more than 4 days.
Continuous use of the spray can alter the normal functioning of the nose and lead to habituation (the need to use increasingly larger doses of medicine). Use, especially if prolonged, can give rise to sensitisation phenomena (excessive reaction of the body to foreign substances with which it has come into contact). In this case, stop the treatment and consult your doctor to start an appropriate therapy.
The product is for external use only and should not be ingested.
Accidental ingestion or use of excessive amounts for long periods of time can have toxic effects (see paragraph 3 "If you use more Rino Calyptol than you should").
Avoid contact with eyes.

Children
This medicine should not be used in children under 12 years of age. Accidental ingestion by children can cause an excessive state of "calm" (severe sedation), (see paragraph 3 "If you use more Rino Calyptol than you should").

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

With this medicine, local sensitisation phenomena (excessive reaction of the body to foreign substances with which it has come into contact) and excessive swelling and redness of the nasal mucous membranes (nasal congestion) may occur after discontinuing use of the product.
Non-local effects may also occur, such as:
- increased blood pressure (arterial hypertension);
- reduced heart rate (reflex bradycardia);
- headache (cephalea);
- urination disorders (micturition disorders).

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.