Name
Fexallegra nasal 1 mg/ml + 3.55 mg/ml nasal spray, solution
Tramazoline + Chlorpheniramine


What it is and what it is used for
Fexallegra nasal is a nasal spray that contains tramazoline and chlorpheniramine. Fexallegra nasal is used in adults and adolescents aged 12 years and above to treat the symptoms of allergic rhinitis (e.g. “hay fever”).
Allergic rhinitis causes runny nose and sneezing and swelling of the nasal mucosa causing a feeling of obstruction. Fexallegra nasal reduces swelling and irritation of the nose and relieves sneezing, itching, stuffy nose and runny nose conditions.

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 Fexallegra nasal
- if you are allergic to tramazoline, chlorpheniramine, benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from inflammation of the nasal passages with little or no nasal secretion (dry rhinitis);
- if you suffer from heart disease and very high blood pressure (severe arterial hypertension);
- if you suffer from a disease characterized by an increase in the pressure of the fluid inside the eye (acute angle glaucoma);
- if you suffer from a disease in which there is an increased production of hormones by the thyroid (hyperthyroidism);
- if you suffer from a disease characterized by an increase in the volume of the prostate (prostatic hypertrophy);
- if you have had head surgery performed through the nose;
- if under 12 years of age;
- if you are pregnant or breast-feeding (see section “Fertility, pregnancy and breast-feeding”).


Warnings and precautions
Use Fexallegra nasal only after consulting your doctor:
- if you are elderly (you may have an increased risk of experiencing side effects, in particular, dizziness, sedation, confusion, low blood pressure and dry mouth; especially male patients may also have an increased risk of experiencing urinary retention);
- if you suffer from diabetes mellitus;
- if you suffer from pheochromocytoma (a tumor of the adrenal glands);
- if you suffer from porphyria (a disease that interferes with the production of haemoglobin, the substance that allows red blood cells to carry oxygen in the blood);
- if you suffer from mild or moderate increase in blood pressure (mild-moderate arterial hypertension). Consult your doctor even if such disorders have occurred in the past.

Prolonged use of products to be administered locally may cause irritation and inflammation of the nasal mucosa and paranasal sinuses. Prolonged use may also cause habituation to the medicine (addiction). When the effect of the medicine ceases, swelling of the nasal mucosa (nasal edema) may occur.

Do not use Fexallegra nasal by mouth because it can be toxic.
Avoid contact of the liquid with the eyes to avoid irritation.

Children
Do not give this medicine to children under 12 years of age.

Attention for those who practice sports: the product contains substances prohibited for doping. It is forbidden to take it differently, for dosage scheme and administration route, from those reported.


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

If irritation, inflammation and reduction in the thickness of the nasal mucosa occur during treatment, discontinue treatment and consult your doctor to establish appropriate therapy.

The following side effects may occur following the use of Fexallegra nasal: the frequency of these side effects is not known.

Immune system disorders:
- allergy (swelling of the skin and mucous membranes).

Psychiatric disorders:
- perception of things that do not exist in reality (hallucinations);
- insomnia;
- restlessness.

Nervous system disorders:
- drowsiness;
- sedation;
- heachache;
- dizziness;
- alteration of taste (dysgeusia).

Heart disease:
- alterations in heart rhythm (arrhythmias);
- increased heart rate (tachycardia);
- heightened perception of heartbeats (palpitations).

Respiratory and chest disorders:
- nosebleeds (epistaxis);
- swelling of the nasal mucosa (nasal edema);
- burning nose;
- dryness of the nasal mucosa;
- runny nose (rhinorrhea);
- sneezing.

Gastrointestinal disorders:
- nausea.

Skin and subcutaneous tissue disorders:
- skin rash;
- itching.

Systemic disorders and conditions related to the administration site:
- fatigue.

Diagnostic tests alteration:
- increased blood pressure.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.