TURBINAL 50 MCG Nasal spray, suspension

Зміст інструкції

1. Turbinal 50 micrograms/spray nasal spray, suspension
   1. What Turbinal is and what it is used for
   2. What you need to know before using Turbinal
   3. How to use Turbinal
   4. Possible side effects
   5. Content of the pack and other information

Turbinal 50 micrograms/spray nasal spray, suspension

beclometasone dipropionate
Generic medicine

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Turbinal is and what it is used for

The active ingredient of Turbinal is beclometasone dipropionate, a substance that belongs to
a group of medicines called corticosteroids. Turbinal is a medicine for topical
(local) nasal use, which acts against inflammation by reducing or eliminating the swelling of the
nasal mucosa.
This medicine is used for the prevention and treatment of inflammation of the
nasal mucosa (rhinitis) allergic, seasonal and chronic, including hay fever.
Turbinal is also indicated in the course of rhinitis of other nature and forms of hypertrophy of the
nasal mucosa (increase in the volume of cells that make up a tissue or organ)
for the resolution of abundant mucus secretions.
The effect, unlike that of vasoconstrictors (medicines used to raise blood
pressure), is not immediate, so regular administration for more
days is necessary.

2. What you need to know before using Turbinal

Do not use Turbinal

• if you are allergic to beclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6);
• if you have a viral or fungal infection;
• if you have tuberculosis;
• if you are pregnant or breastfeeding;
• if your child is under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Turbinal.

Contact your doctor if you experience blurred vision or other visual disturbances
Take special care with Turbinal:

• if you have an infection of the nasal passages, as imbalances in the bacterial flora (bacterial or fungal dysbiosis) may occur; in case of local infections, your doctor may prescribe covering antibiotic therapy.

Talk to your doctor or pharmacist if, after prolonged use and at high doses of
intranasal corticosteroids, you experience the following conditions:

• Cushing's syndrome (excess hormones in the bloodstream),
• cushingoid appearance (swelling of the face or trunk),
• adrenal suppression (suppression of the function of the gland that regulates the stress response),
• delayed growth in children and adolescents, reduced bone mineral density,
• cataract (loss of visual clarity) and glaucoma (damage to the optic nerve),
• psychological and behavioral changes including psychomotor hyperactivity (mania), sleep disturbances, anxiety, depression or aggression (particularly in children).

Talk to your doctor or pharmacist also if you should experience phenomena of
skin sensitization.
doctor. Using doses higher than those recommended can worsen
symptoms.

Other medicines and Turbinal
Tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines can increase the effects of Turbinal and your doctor may want to
monitor you closely if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.
Turbinal is not recommended during the first three months of pregnancy.
In the subsequent period, use this medicine only if absolutely necessary and under the
direct control of your doctor.

Driving and using machines
No effects on the ability to drive or operate machinery have been reported.

Turbinal contains benzalkonium chloride and propylene glycol
This medicine contains 0.025 mg of benzalkonium chloride per dose (spray).
Benzalkonium chloride can 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 BAC should be used, if possible. If such nasal medicines without BAC are not available, another pharmaceutical form should be considered.
BAC can cause bronchospasm.
This medicine contains 5 mg of propylene glycol per dose (spray).

3. How to use Turbinal

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:

Adults:1 self-dosing spray per nostril, two to four times a day.

Children over 6 years of age:1 self-dosing spray per nostril, one or two times a day.

Instructions for use
When the spray is used for the first time, it is advisable to precede the administration with 4 empty sprays.

• 1. Shake.
• 2. Remove the safety clip.
• 3. Remove the protective cap.
• 4. Press firmly and decisively from top to bottom with your index and middle fingers.
• 5. Replace the cap.
• 6. Reapply the safety clip.

If the nasal applicator becomes blocked, wash it with lukewarm water.

If you use more Turbinal than you should
In case of ingestion or accidental intake of an excessive dose of Turbinal, immediately notify your doctor or go to the nearest hospital.

If you forget to use Turbinal
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Possible side effects that may occur with Turbinal are:

Common side effects

• Unpleasant changes in smell and taste.
• Dryness and irritation of the nose and throat.
• Nosebleeds.

Very rare side effects

• Hypersensitivity reactions of the skin, redness, urticaria, itching, erythema, swelling, allergic reactions, bronchospasm.
• Increased eye pressure (glaucoma).
• Decreased vision or blurred vision (cataract).
• Perforation of the nasal septum.

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

• Blurred vision
• Irritation of the mucous membranes.
• Hypersensitization phenomena.
• Impaired adrenal function.
• Growth retardation in children and adolescents.

If you experience irritative or hypersensitivity symptoms, discontinue treatment and
consult your doctor to establish appropriate therapy.
The same applies in case of impaired adrenal function, even if, due to the minimal doses
used and very low absorption, Turbinal is normally devoid of general effects.
Effects on the body (systemic) can occur with intranasal corticosteroids
(a class of medicines to which Turbinal belongs), particularly if prescribed at high
doses for prolonged periods. These may include growth retardation in children and
adolescents.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
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 Turbinal
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 packaging after
“Expires on”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging,
correctly stored.
Do not store the medicine at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Turbinal contains

• The active ingredient is beclometasone dipropionate. One bottle contains 10 mg of beclometasone dipropionate. Each spray delivers 50 micrograms of beclometasone dipropionate.
• The other ingredients are: glycerol, propylene glycol, MCCS (a mixture of microcrystalline cellulose and sodium carboxymethylcellulose), polysorbate 60, benzalkonium chloride and purified water.

Description of the appearance of Turbinal and content of the pack
Turbinal is presented as a nasal spray, suspension.
Bottle equipped with a dosing nebulizing pump for 200 sprays.

Marketing authorization holder and manufacturer
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano
…….