BECLOMETHASONE DIPROPIONATE BECLONASAL AQUA

Package leaflet: Information for the user

Beclonasal Aqua, 50 micrograms/dose, nasal aerosol, suspension
beclometasoni dipropionas
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Beclonasal Aqua is and what it is used for
2. Important information before using Beclonasal Aqua
3. How to use Beclonasal Aqua
4. Possible side effects
5. How to store Beclonasal Aqua
6. Contents of the pack and other information

1. What Beclonasal Aqua is and what it is used for

The active substance in Beclonasal Aqua is beclometasone dipropionate. Beclometasone
dipropionate belongs to a group of medicines called corticosteroids. When administered locally to the
nasal mucosa, it reduces inflammation and swelling.
This medicine is used for the prevention and treatment of seasonal and perennial allergic rhinitis,
including hay fever, and vasomotor rhinitis (inflammation of the nasal mucosa caused by dilation of
blood vessels in the nasal mucosa).

2. Important information before using Beclonasal Aqua
When not to use Beclonasal Aqua:

• if you are allergic to beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Beclonasal Aqua, discuss with your doctor or pharmacist if:

• you have an infection or ulceration inside the nose,
• you have a tendency to recurrent nosebleeds,
• you have nasal injuries or have undergone nasal surgery,
• you have untreated fungal, bacterial, or systemic viral infections,
• you have asthma treated with steroids,
• you have tuberculosis.

If you experience blurred vision or other visual disturbances, contact your doctor.

Children
Beclonasal Aqua is not recommended for use in children under 6 years of age due to insufficient clinical data.

Beclonasal Aqua and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
Concomitant use of Beclonasal Aqua and corticosteroid-containing medicines taken orally or by inhalation may lead to suppression of adrenal cortex function.
Some medicines may increase the effect of Beclonasal Aqua; therefore, your doctor may recommend close monitoring if you are taking such medicines (including medicines used in HIV infection: ritonavir, cobicistat).

Pregnancy and breastfeeding
The decision to use this medicine in pregnant or breastfeeding women is made by the doctor.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Beclonasal Aqua nasal aerosol contains benzalkonium chloride
This medicine contains 9 micrograms of benzalkonium chloride per single dose (0.09 ml), equivalent to 0.1 mg of benzalkonium chloride per ml of suspension. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Beclonasal Aqua
Always use this medicine exactly as prescribed by your doctor. The appropriate dosage and duration of treatment are determined by your doctor depending on the condition being treated. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults and children over 6 years of age is 1–2 sprays into each nostril twice daily. The total daily dose should not exceed eight single doses (four doses per nostril).
Beclonasal Aqua is not recommended for use in children under 6 years of age.
This medicine is used for the prevention and treatment of allergic and vasomotor rhinitis. It should be used regularly. The medicine does not rapidly reduce swelling of the nasal mucosa or mucus production. The best therapeutic effect occurs after several days of treatment.
For the treatment of seasonal allergic rhinitis, treatment should be started before the pollen season begins.
This medicine does not treat allergic eye symptoms. Your doctor may recommend additional treatment for these symptoms.

Instructions for use
Before use:

1. Shake the bottle well and remove the protective cap.
2. Hold the bottle as shown in Figure 1; place the bottom of the bottle on your thumb and position the pump between your index and middle fingers.
3. Releasing the aerosol dose (spraying): To release a dose, press the pump and the bottom of the bottle with your fingers. Before the first use, spray three to six times into the air until a full dose is obtained. If the medicine has not been used for a prolonged period, ensure a full dose is released by pressing the pump once or twice.

Using the medicine:

1. Blow your nose.

2. Shake the bottle well and remove the protective cap.
3. Hold the bottle as shown in Figure 1; place the bottom of the bottle on your thumb and position the pump between your index and middle fingers. To release the dose, press the pump and the bottom of the bottle with your fingers.

4. Insert the nozzle of the pump into one nostril as shown in Figure 2, and gently close the other nostril with your finger. Tilt your head slightly forward. Release one dose while simultaneously inhaling slowly and deeply through the nose. Figure 2.
5. Remove the pump from the nostril and exhale through the mouth. If the medicine leaks from the nostril, breathe gently through the nose to inhale the medicine.
6. Repeat steps 4 and 5 to administer the medicine into the other nostril.
7. If you are using two doses per nostril, repeat steps 4, 5, and 6.
8. After use, wipe the pump and replace the protective cap.

Cleaning:

1. Detach the pump from the bottle by gently pulling (Figure 3).
2. Rinse the pump and protective cap with warm water.
3. Dry thoroughly.
4. Reassemble the parts. Figure 3.

Using more than the recommended dose of Beclonasal Aqua
It is important to use the medicine exactly as instructed on the packaging or as prescribed by your doctor. Use only the dose recommended by your doctor. Using a higher or lower dose may worsen symptoms.
Long-term use of high doses of beclometasone dipropionate may suppress adrenal function, reducing the body's production of cortisol. Always use the medicine as directed.
If you (or someone else) use more than the recommended dose, contact your doctor immediately.

Missing a dose of Beclonasal Aqua
If you miss a dose of Beclonasal Aqua, take the next dose as scheduled. Do not use a double dose to make up for the missed dose.
Ensure you have an adequate supply of medicine before going on holiday or travelling.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
After using the medicine, mild sneezing and an unpleasant taste or smell may occur.
Rarely (may occur in up to 1 in 1,000 people), the medicine may cause dryness and irritation of the nasal and throat mucosa, ulceration of the nasal mucosa and perforation of the nasal septum (the membrane separating the nostrils), nosebleeds, headache, and increased intraocular pressure (glaucoma).
Very rarely (may occur in up to 1 in 10,000 people), the medicine may cause cataract, allergic reactions including rash, urticaria, itching or redness, and swelling of the face, lips or throat, or shortness of breath and (or) wheezing.
Blurred vision has been reported with unknown frequency (frequency cannot be estimated from the available data).
In very rare cases, treatment with intranasal corticosteroids may affect the normal production of steroids in the body. This is more likely if high doses are used for a prolonged period.
You should inform the doctor if:

• the patient experiences pain in the nose or throat, or nosebleeds occur after using the medicine,
• the patient develops symptoms affecting the eyes that are not typical of hay fever, especially pain and blurred vision.

Additional adverse effects in children
One of the rare symptoms may be slowed growth in children. In children using this medicine for a prolonged period, the doctor will regularly monitor growth.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Beclonasal Aqua

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the bottle
after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Unopened bottle: Store below 30 °C. Do not store in the refrigerator or freeze.
Opened bottle: After first opening, the shelf life is 6 months. Store below 25 °C. Do not store in the refrigerator or freeze.
Medicines should not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Beclonasal Aqua contains

• The active substance is beclometasone dipropionate. Each spray dose contains 50 micrograms of beclometasone dipropionate.
• Other ingredients are: polysorbate 80, glucose, dispersible cellulose (Avicel RC 591), benzalkonium chloride, sodium hydroxide, 1M solution or hydrochloric acid, 1M solution (for pH adjustment), purified water.

What Beclonasal Aqua looks like and contents of the pack
White or almost white suspension. Aerosol: fine mist.
Pack sizes: 10 ml bottle containing 70 doses or 80 doses; 30 ml bottle containing 200 doses.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Volttikatu 8
FI-70700 Kuopio
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]