RINAADVANCE*GTT RINOL 10ML

RinaAdvance 1 mg/ml nasal drops, solution
RinaAdvance 1 mg/ml nasal spray, solution
Xylometazoline hydrochloride

What it is and what it is used for
RinaAdvance contains the active ingredient xylometazoline hydrochloride, which belongs to the class of nasal decongestant medicines that works by constricting blood vessels in the nasal mucosa, reducing swelling (edema) that makes breathing difficult.
RinaAdvance is used for nasal congestion due to colds, hay fever or other allergic rhinitis and sinusitis.

Consult your doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before taking the medicine
Do not use RinaAdvance
• if you are allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-term nasal irritation (chronic rhinitis), with scanty or absent discharge (rhinitis sicca) or with crust formation (atrophic rhinitis);
• if you suffer from increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery such as surgical removal of the pituitary gland (transsphenoidal hypophysectomy) or other major skull surgeries;
• if you are under 12 years of age;
• if you are pregnant (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before using RinaAdvance.

Before using RinaAdvance, consult your doctor if:
• you have had a strong reaction to other medicines containing adrenergic substances, such as those contained in other nasal decongestants, which manifests with signs of insomnia, dizziness, tremor, altered heartbeat or high blood pressure;
• you have recently had nose surgery;
• you suffer or have suffered from a benign adrenal tumor (pheochromocytoma);
• you suffer or have suffered from high blood pressure;
• you suffer from heart problems (for example, long QT syndrome) and vascular problems;
• you suffer from a thyroid disease (hyperthyroidism);
• you suffer from diabetes;
• you suffer from an enlarged prostate (prostatic hypertrophy);
• you are taking medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) or have taken them in the last two weeks (see Other medicines and RinaAdvance).

Do not exceed the indicated doses and do not use RinaAdvance for more than 7 consecutive days: prolonged or excessive use can cause the recurrence of nasal congestion and can alter the normal function of the nasal mucosa, causing a reduction in the effectiveness of the medicine and thinning of the nasal mucosa and a reduction in the number and size of the glands that produce mucus.

Children and adolescents The medicine must not be used in children under 12 years of age (see Do not use RinaAdvance).

Elderly
Elderly patients are more susceptible to side effects associated with RinaAdvance: inform your doctor if you experience unusual symptoms.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by using the lowest effective dose for the shortest necessary duration of treatment.

Immediately inform your doctor and stop taking the medicine if you experience the following symptoms:
• severe allergic reactions, including: swelling of the face, throat or tongue, difficulty breathing, wheezing, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruises, pain in reddened areas, rashes with blisters or peeling skin, giant wheals (swollen skin accompanied by itching and burning). These conditions can also affect the lips, eyes, nose and genitals.

Common side effects (may affect up to 1 in 10 people)
• headache
• dryness or discomfort in the nose
• nausea
• burning in the nose

Uncommon side effects (may affect up to 1 in 100 people)
• nosebleed (epistaxis)

Very rare side effects (may affect up to 1 in 10,000 people)
• transient vision disturbances
• irregular heartbeat and increased heart rate

Other side effects
• increased blood pressure
• slowed heartbeat
• urination problems
• insomnia
• restlessness

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.