Name
Rinogutt 1 mg/ml nasal spray solution with eucalyptol
Tramazoline
What is it and what is it for?
Rinogutt contains tramazolin.
Rinogutt is used in adults and adolescents aged 12 years and over as a nasal decongestant, i.e. to clear a stuffy nose caused by swelling of the nasal mucosa.
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 Rinogutt
- if you are allergic to tramazoline or any of the other ingredients of this medicine, in particular to benzalkonium chloride (listed in section 6);
- if you suffer from dryness of the nasal passages (rhinitis sicca);
- if you suffer from heart disease and severely elevated blood pressure;
- if you suffer from a form of glaucoma, a disease characterized by an increase in the pressure of the fluid inside the eye (acute angle glaucoma);
- if you suffer from a thyroid disease which can cause weight loss, tiredness, weakness (hyperthyroidism);
- if you suffer from an enlarged prostate, the gland that produces seminal fluid in men (prostatic hypertrophy);
- if you have had head surgery performed through the nose;
- if under 12 years of age;
- if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using Rinogutt:
- if you are taking monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (medicines to treat depression);
- if you are taking vasopressor and antihypertensive medicines (medicines to treat heart disease and high blood pressure) (see section “Other medicines and Rinogutt”).
Use Rinogutt only after consulting your doctor:
- if he is elderly;
- if you have pheochromocytoma (a tumor of the adrenal glands that causes high blood pressure);
- if you suffer from porphyria (a disease that affects the production of haemoglobin, the substance that allows red blood cells to carry oxygen in the blood, symptoms of which include excessive sensitivity to light, paralysis and severe stomach pain).
Be very careful if you suffer from heart and circulatory diseases, high blood pressure, diabetes mellitus and enlarged prostate (prostatic hypertrophy) (see section “Do not use Rinogutt”).
Consult your doctor even if these disorders have occurred in the past.
Do not use Rinogutt by mouth.
Avoid contact of the liquid with your eyes to avoid irritation.
Children
Do not give this medicine to children under 12 years of age.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Using Rinogutt for long periods can be harmful. Use of topical products, especially if prolonged, can cause irritation, inflammation, and thinning of the nasal mucosa. If this occurs, discontinue use and consult your doctor to establish appropriate therapy.
Prolonged use can also lead to drug addiction.
When the drug wears off, swelling of the nasal mucosa (nasal edema) may occur.
The following side effects may occur following the use of Rinogutt:
Common (may affect up to 1 in 10 people)
- burning inside the nose.
Uncommon (may affect up to 1 in 100 people):
- restlessness;
- heachache;
- sensation of increased heartbeat (palpitations);
- swelling of the nasal mucosa (nasal edema);
- nasal dryness;
- runny nose (rhinorrhea);
- sneezing;
- nausea.
Rare (may affect up to 1 in 1,000 people):
- dizziness;
- alteration of taste (dysgeusia);
- nosebleeds (epistaxis).
Frequency not known (frequency cannot be estimated from the available data):
- allergy (hypersensitivity);
- perception of things that do not exist in reality (hallucinations);
- insomnia;
- drowsiness;
- physical and mental relaxation (sedation);
- alterations in heart rhythm (arrhythmias);
- increased heart rate (tachycardia);
- skin rash;
- itching;
- swelling of the skin (skin edema*);
- swelling of the mucous membranes (mucosal edema*);
- increased blood pressure;
- fatigue.
* as a symptom of hypersensitivity.
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.