TELEVITICA 1 mg /Ml Spray Do Nosa, Roztwór

Treść ulotki

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

DELTARINDEK DECONGESTIONANTE 1 mg/mL nasal spray, solution
Xilometazoline hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is DELTARINDEK DECONGESTIONANTE and what is it for

DELTARINDEK DECONGESTIONANTE contains the active ingredient xylometazoline hydrochloride, which
belongs to the class of nasal mucosa decongestant drugs that works by constricting the vessels at the
level of the nasal mucosa, reducing swelling (edema) that makes breathing difficult.
DELTARINDEK DECONGESTIONANTE is used for the symptomatic temporary treatment of
nasal congestion due to colds, hay fever or other allergic rhinitis and sinusitis in adults and
adolescents (ages 12 to 18 years).
See a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using DELTARINDEK DECONGESTIONANTE

Do not use DELTARINDEK DECONGESTIONANTE

• 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-lasting nasal irritation (chronic rhinitis), with little or no secretion (dry rhinitis) 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 gland called the pituitary gland (transsphenoidal hypophysectomy) or other major surgery on the skull;
• in children under 12 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using DELTARINDEK DECONGESTIONANTE.
Consult your doctor before using DELTARINDEK DECONGESTIONANTE if:

• you have had a severe 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 from or have suffered from a benign tumor of the adrenal gland (pheochromocytoma);
• you suffer from 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 or tetracyclic antidepressants) or have taken them in the last two weeks (see “Other medicines and DELTARINDEK DECONGESTIONANTE”).

Do not exceed the indicated doses and do not use DELTARINDEK DECONGESTIONANTE for more than 7 days
consecutively: 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.
The detachable part of the device may pose a choking hazard to children. Keep this
product out of the sight and reach of children.

Elderly
Elderly subjects are more prone to adverse effects associated with DELTARINDEK
DECONGESTIONANTE: inform your doctor if you experience unusual symptoms.

Children and adolescents
The medicine should not be used in children under 12 years of age (see “Do not use DELTARINDEK
DECONGESTIONANTE”).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
DELTARINDEK DECONGESTIONANTE should not be used during pregnancy.

Breastfeeding
DELTARINDEK DECONGESTIONANTE should not be used during breastfeeding.

Driving and using machines
DELTARINDEK DECONGESTIONANTE does not alter or negligibly alters the ability to
drive vehicles or operate machinery. However, DELTARINDEK DECONGESTIONANTE may
cause visual disturbances, dizziness, vertigo, or other central nervous system disorders. If you
experience these disorders, do not drive vehicles and do not operate machinery.

DELTARINDEK DECONGESTIONANTE contains benzalkonium chloride solution 50%
This medicine contains 0.014 mg of benzalkonium chloride per each spray (released dose),
equivalent to 0.1 mg per mL of solution.
Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for
long periods.
If you suspect such a reaction (persistent nasal congestion), a
medicine for nasal use without benzalkonium chloride should be used, if possible.
If such nasal medicines without benzalkonium chloride are not available, another pharmaceutical form should be considered.
Benzalkonium chloride may cause wheezing and difficulty breathing (bronchospasm), especially
if you suffer from asthma.

3. How to use DELTARINDEK DECONGESTIONANTE

Use this medicine following exactly as described in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Instill 1 spray in each nostril 1-3 times a day, as needed.
Do not exceed 3 administrations per day in each nostril.
Do not use DELTARINDEK DECONGESTIONANTE for more than 7 consecutive days (see section
Warnings and precautions).
See your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.
Follow these instructions, being careful not to spray the spray into your eyes and mouth.

• 1) Check the integrity of the product before use.
• 2) Blow your nose gently.
• 3) Remove the protective closing cap.

• 4) Perform 3 empty sprays as activation before first use until a uniform mist is emitted. For subsequent applications, the dosing pump will be ready for immediate use. If the spray is not delivered during activation, or if the product has not been used for more than 7 days, the dosing pump must be reloaded by pressing it 2 times as re-activation.

• 5) Hold the bottle in a vertical 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 simultaneously breathe gently through your nose.

• 8) Repeat the same operation in the other nostril.
• 9) Immediately after use, dry the applicator before replacing the closing cap.

To avoid the possible spread of infection, this package must be used by one person only.
Within a few minutes you will obtain the effect of the drug locally which lasts up to 10 hours and
gradually fades.

If you use more DELTARINDEK DECONGESTIONANTE than you should
In case of accidental ingestion or use of an excessive dose of DELTARINDEK
DECONGESTIONANTE, immediately inform your doctor or go to the nearest hospital.
If you accidentally ingest the medicine or use it for a long period at excessive doses, the following symptoms may occur:

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

In children, it may occur:

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

If you forget to use DELTARINDEK DECONGESTIONANTE
Do not use a double dose to make up for a missed dose.

If you stop using DELTARINDEK DECONGESTIONANTE
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration of treatment.
Immediately inform your doctor and stop taking the medicine if you experience the following
symptoms:

• severe allergic reactions, which include: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, rhinitis and skin rashes;
• severe skin rashes, itching, hives, bruising, pain in reddened areas, blistering rashes or peeling skin, large blisters (skin swelling 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
• dry nose or nasal discomfort
• 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 vision disturbances
• irregular heartbeat and increased heart rate
• restlessness.

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• increased blood pressure
• slowed heartbeat
• urination disorders
• insomnia

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 DECONGESTIONANTE

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

6. Contents of the pack and other information

What DELTARINDEK DECONGESTIONANTE contains

• The active ingredient 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 disodium phosphate dihydrate, disodium phosphate dodecahydrate, sodium edetate, benzalkonium chloridesolution 50% ( excipient with a known effect),liquid sorbitol (non-crystallizing), hypromellose, sodium chloride, purified water.

Description of the appearance of DELTARINDEK DECONGESTIONANTE and contents of the pack
Amber glass bottle with a micro-dose pump and dispenser with a protective closing cap.
The content of the bottle is 10 mL of clear, colorless and slightly viscous liquid.

Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto, Pisa
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Italy – DELTARINDEK DECONGESTIONANTE 1 mg/mL nasal spray, solution
Germany – Televitica 1 mg/mL Nasenspray, Lösung