Deltarindek decongestant

Patient Information Leaflet: Information for the User

DELTARINDEK DECONGESTANT 1 mg/mL nasal spray, solution

Xylometazoline hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What DELTARINDEK DECONGESTANT is and what it is used for
2. What you need to know before using DELTARINDEK DECONGESTANT
3. How to use DELTARINDEK DECONGESTANT
4. Possible side effects
5. How to store DELTARINDEK DECONGESTANT
6. Contents of the pack and other information

1. What DELTARINDEK DECONGESTIONANTE is and what it is used for

DELTARINDEK DECONGESTIONANTE contains the active substance xylometazoline hydrochloride, which
belongs to the class of nasal mucosal decongestant medicines that work by constricting blood vessels in the nasal mucosa, thereby reducing swelling (edema) that makes breathing difficult.
DELTARINDEK DECONGESTIONANTE 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.

2. What you need to know before using DELTARINDEK DECONGESTANT

Do not use DELTARINDEK DECONGESTANT

• if you are allergic to xylometazoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from long-term nasal irritation (chronic rhinitis), with little or no nasal discharge (dry rhinitis) or with formation of crusts (atrophic rhinitis);
• if you have increased pressure inside the eye (closed-angle glaucoma);
• if you have undergone brain surgery, such as surgical removal of the gland called the pituitary (transsphenoidal hypophysectomy), or other major cranial surgery;
• in children 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 DELTARINDEK DECONGESTANT.
Consult your doctor before using DELTARINDEK DECONGESTANT if:

• you have previously experienced a strong reaction to other medicines containing adrenergic substances, such as those found in other nasal decongestants, resulting in symptoms such as insomnia, dizziness, tremor, irregular or rapid heartbeat, or high blood pressure;
• you have recently undergone nasal surgery;
• you suffer or have suffered from a benign tumour of the adrenal gland (pheochromocytoma);
• you suffer or have suffered from high blood pressure;
• you have heart problems (e.g. long QT syndrome) or cardiovascular disorders;
• you have a thyroid disease (hyperthyroidism);
• you have diabetes;
• you have porphyria;
• you have an enlarged prostate (prostatic hypertrophy);
• you are taking, or have taken within the last two weeks, medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants) (see “Other medicines and DELTARINDEK DECONGESTANT”).

Do not exceed the recommended doses and do not use DELTARINDEK DECONGESTANT for more than 7 consecutive days: prolonged or excessive use may cause nasal congestion to return and may alter the normal function of the nasal mucosa, leading to reduced effectiveness of the medicine, thinning of the nasal mucosa, and a reduction in the number and size of mucus-producing glands.
The detachable part of the device may pose a choking hazard for children. Keep this product out of sight and reach of children.

Elderly patients
Elderly individuals may be more susceptible to adverse effects associated with DELTARINDEK DECONGESTANT: inform your doctor if you experience unusual symptoms.

Children and adolescents
This medicine must not be used in children under 12 years of age (see “Do not use DELTARINDEK DECONGESTANT”).

Other medicines and DELTARINDEK DECONGESTANT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking, or have taken within the last two weeks, medicines for depression (monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants), concomitant use of DELTARINDEK DECONGESTANT is not recommended.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
DELTARINDEK DECONGESTANT must not be used during pregnancy.

Breastfeeding
DELTARINDEK DECONGESTANT must not be used during breastfeeding.

Driving and using machines
DELTARINDEK DECONGESTANT does not affect, or affects only slightly, the ability to drive or operate machinery. However, DELTARINDEK DECONGESTANT may cause visual disturbances, drowsiness, dizziness, or other central nervous system effects. If you experience any of these symptoms, do not drive or operate machinery.

DELTARINDEK DECONGESTANT contains benzalkonium chloride 50% solution
This medicine contains 0.014 mg of benzalkonium chloride per spray (delivered dose), equivalent to 0.1 mg per mL of solution.
Benzalkonium chloride may cause nasal irritation and swelling, especially if used for prolonged periods.
If such a reaction is suspected (persistent nasal congestion), a nasal medicine without benzalkonium chloride should be used, if possible. If nasal medicines without benzalkonium chloride are not available, another pharmaceutical form should be considered.
Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), particularly if you have asthma.

3. How to use DELTARINDEK DECONGESTANT

Use this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Administer 1 spray into each nostril 1-3 times daily, as needed.
Do not exceed 3 sprays per day in each nostril.
Do not use DELTARINDEK DECONGESTANT for more than 7 consecutive days (see section
Warnings and precautions).
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.
Follow these instructions carefully, taking care not to spray the product into your eyes or mouth.

1. Check the integrity of the product before use.
2. Blow your nose thoroughly.
3. Remove the protective cap.

4. Prime the pump by releasing 3 sprays into the air before the first use, until a uniform mist is obtained. For subsequent uses, the metering pump will be ready for immediate use. If no spray is released during priming, or if the product has not been used for more than 7 days, re-prime the pump by pressing it twice.

5. Hold the bottle in an upright position with your thumb under the base and the nozzle between two fingers.
6. Lean slightly forward and insert the nozzle into one nostril.
7. Spray and at the same time breathe gently through your nose.

8. Repeat the same procedure in the other nostril.
9. Wipe the applicator clean immediately after use before replacing the protective cap.
   To avoid the possible spread of infection, this container must be used by only one person.
   Within a few minutes, you will obtain a local effect of the medicine lasting up to 10 hours, gradually diminishing.
   If you use more DELTARINDEK DECONGESTANT than you should
   In case of accidental ingestion or overdose with DELTARINDEK DECONGESTANT, contact your doctor immediately or go to the nearest hospital.
   If the medicine is accidentally ingested or used excessively over a long period, the following symptoms may occur:

• dizziness
• sweating
• lowering of body temperature (hypothermia)
• slow or irregular heartbeat (bradycardia)
• increase in blood pressure (hypertension)
• rapid heartbeat (tachycardia)
• excessive sensitivity to light (photophobia)
• severe headache
• chest tightness
• coma
• seizures

In children, the following may occur:

• lowering of body temperature (hypothermia)
• severe depression of the central nervous system with intense sedation

If you forget to use DELTARINDEK DECONGESTANT
Do not use a double dose to make up for the forgotten dose.
If you stop using DELTARINDEK DECONGESTANT
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects can be minimized by using the lowest effective dose for the shortest necessary duration of treatment.
Contact 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, shortness of breath, nasal congestion and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in red areas, rashes with blisters or peeling skin, giant hives (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)

• headache
• 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DELTARINDEK DECONGESTANT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
After first opening, the medicine should be used within 6 months.
Store below 25 °C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DELTARINDEK DECONGESTIONANT contains

• The active substance is xylometazoline hydrochloride. Each mL of solution contains 1 mg of xylometazoline hydrochloride. Each spray delivers 0.14 mg of xylometazoline hydrochloride.
• The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, edetate sodium, benzalkonium chloride 50% solution ( excipient with known effect), sorbitol liquid (non-crystallizable), hypromellose, sodium chloride, purified water.

Description of the appearance of DELTARINDEK DECONGESTIONANT and contents of the pack
Amber glass bottle with micro-dosing pump and spray applicator with protective closure cap.
The bottle contains 10 mL of a clear, colourless, slightly viscous liquid.

Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto, Pisa
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy – DELTARINDEK DECONGESTIONANT 1 mg/mL nasal spray, solution
Germany – Televitica 1 mg/mL Nasenspray, Lösung