RINOCALYPTOL "0.05% NASAL SPRAY, SOLUTION" 15 ML BOTTLE"

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


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

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 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 pressure in your eyes (glaucoma);
- if your thyroid is too active (hyperthyroidism);
- if you are taking or have taken in the previous two weeks medicines for depression (antidepressants).

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


Warnings and precautions
Talk to 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 whether you can take this medicine;
• if you are elderly because this medicine may cause difficulty urinating (urinary retention).

Using this medicine may cause difficulty breathing (bronchospasm).
Do not use Rino Calyptol for prolonged treatments; after a few days of treatment without noticeable results, consult your doctor. This medicine should not be used for more than 4 days.
Continued use of the spray can alter normal nasal function and lead to habituation (the need to use increasingly larger doses of the medication). Use, especially if prolonged, can cause sensitization (an excessive reaction of the body to foreign substances it has come into contact with). In this case, discontinue use and consult your doctor to initiate appropriate therapy.
The product is for external use only and should not be ingested.
Accidental ingestion or use of excessive quantities for long periods of time may 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 may cause excessive sedation (severe sedation) (see section 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 sensitization phenomena (excessive reaction of the body to foreign substances with which it has come into contact) and excessive swelling and redness of the nasal mucosa (nasal congestion) may occur after stopping use of the product.
Non-local effects may also occur such as:
- increased blood pressure (arterial hypertension);
- reduction in heart rate (reflex bradycardia);
- headache (cephalalgia);
- disorders in urine production (micturition disorders).

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.