DELTARINDEK DEC*SPRAY NASAL 10ML

Deltarindek decongestant 1 mg/mL nasal spray, solution
Xylometazoline hydrochloride

What it is and what it is used for
Deltarindek decongestant contains the active ingredient xylometazoline hydrochloride, which belongs to the class of nasal mucosa decongestant medicines that act by constricting blood vessels in the nasal mucosa, reducing the swelling (edema) that makes breathing difficult.
Deltarindek decongestant is used for the temporary symptomatic treatment of nasal congestion due to colds, hay fever or other allergic rhinitis and sinusitis in adults and adolescents (aged between 12 and 18 years).

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 Deltarindek decongestant:
- if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in paragraph 6);
- if you suffer from long-term nasal irritation (chronic rhinitis), with scanty or absent secretion (rhinitis sicca) or with crust formation (atrophic rhinitis);
- if you suffer from increased pressure inside the eye (angle-closure glaucoma);
- if you have undergone brain surgery such as surgical removal of the gland called the pituitary gland (transsphenoidal hypophysectomy) or other major skull surgeries;
- in children under 12 years of age;
- if you are pregnant (see the Pregnancy and breastfeeding section).

Warnings and precautions
Consult your doctor or pharmacist before using Deltarindek decongestant.

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

Do not exceed the indicated doses and do not use Deltarindek decongestant for more than 7 consecutive days: prolonged or excessive use can cause a 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.

The detachable part of the device may pose a choking hazard for children. Keep this product out of sight and reach of children.

Elderly
Elderly subjects are more susceptible to undesirable effects associated with Deltarindek decongestant: inform your doctor in case of unusual symptoms.

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

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;
• nasal dryness or discomfort in the nose;
• nausea;
• burning sensation in the nose.

Uncommon side effect (may affect up to 1 in 100 people):
• nosebleeds.

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

Side effects with unknown frequency (frequency cannot be estimated from the available data):
• increased blood pressure;
• slowed heartbeat;
• urinary problems;
• insomnia.

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.