061S
RINAADVANCE 1 MG/ML NASAL SPRAY MENTHOL SOLUTION 1 10 ML HDPE BOTTLE WITH SIDE-BUTTON ACTIVATED PUMP
RINAADVANCE 1 MG/ML NASAL SPRAY MENTHOL SOLUTION 1 10 ML HDPE BOTTLE WITH SIDE-BUTTON ACTIVATED PUMP
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Description
Description
RinaAdvance 1 mg/ml nasal spray, menthol-flavored solution
Xylometazoline hydrochloride
What is it and what is it for?
RinaAdvance contains the active ingredient xylometazoline hydrochloride, which belongs to the class of nasal mucosal decongestant drugs that work by constricting the vessels in the nasal mucosa, reducing the swelling (edema) that makes breathing difficult.
RinaAdvance is used in case of congestion of the nasal mucosa due to colds, hay fever or other allergic rhinitis and sinusitis.
Contact 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-lasting nasal irritation (chronic rhinitis), with little or no secretion (dry rhinitis) or with crusting (atrophic rhinitis);
• if you suffer from increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain operations such as surgical removal of the pituitary gland (transsphenoidal hypophysectomy) or other major head surgery;
• if you are under 12 years old;
• 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:
• have had a strong reaction to other medicines containing adrenergic substances, such as substances contained in other nasal decongestants, manifested by signs of insomnia, dizziness, tremor, altered heartbeat or high blood pressure;
• has recently had nose surgery;
• suffer or have suffered from a benign tumor of the adrenal gland (pheochromocytoma);
• suffer or have suffered from high blood pressure;
• suffer from heart problems (e.g. long QT syndrome) and vascular problems;
• suffers from thyroid disease (hyperthyroidism);
• suffers from diabetes;
• suffers from an enlarged prostate (prostatic hypertrophy);
• you are taking medicines for depression (monoamine oxidase inhibitors, tetracyclic tricyclic 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 may cause the recurrence of nasal congestion and may 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 should not be used in children under 12 years of age (see "Do not use RinaAdvance" ).
Elderly people
Elderly patients are more prone to side effects associated with RinaAdvance : inform your doctor if you experience any unusual symptoms.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects can be minimized by using the lowest effective dose for the shortest necessary duration of treatment.
Tell your doctor immediately 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, runny nose and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in the red areas, rashes with blisters or peeling skin, giant wheals (swollen skin accompanied by itching and burning). These conditions may also affect the lips, eyes, nose, and genitals.
Common side effects (may affect up to 1 in 10 people):
• heachache;
• dryness or discomfort in the nose;
• nausea;
• burning in the nose.
Uncommon side effects (may affect up to 1 in 100 people):
• nosebleeds (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;
• slow heartbeat;
• urinary difficulties;
• insomnia;
• restlessness.
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.
061S
RINAADVANCE 1 MG/ML NASAL SPRAY MENTHOL SOLUTION 1 10 ML HDPE BOTTLE WITH SIDE-BUTTON ACTIVATED PUMP
RINAADVANCE 1 MG/ML NASAL SPRAY MENTHOL SOLUTION 1 10 ML HDPE BOTTLE WITH SIDE-BUTTON ACTIVATED PUMP
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