Leaflet: information for the user

Beclo-Rino 50 micrograms/dose nasal spray suspension

Beclometasone dipropionate

Read this leaflet carefully before you start using this medicine, because it contains important information for you:

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Beclo-Rino is and what it is used for

2. What you need to know before using Beclo-Rino

3. How to use Beclo-Rino

4. Possible side effects

5. Storage of Beclo-Rino

6. Contents of the pack and additional information

Beclo-Rinois a nasal spray suspension of beclometasone dipropionate.

It is a medication that acts as an anti-allergic.

It is indicated for the temporary relief of symptoms of allergic rhinitis caused by plant pollen (hay fever), domestic animals, dust or other allergens (smoke, pollution), such as nasal discharge, nasal congestion, sneezing and nasal itching.

It is also indicated for nasal polyps.

No use Beclo-Rino:

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Beclo-Rino:

• If you have any nasal or pulmonary tuberculosis infection.
• If you experience pain or bleeding in the nasal passages, discontinue treatment.
• If you are using or have recently used oral or injectable corticosteroids.
• Be especially careful when inserting the applicator into the nose:If you have wounds or ulcers in the nasal passages, or if you have recently undergone nasal surgery.
• If you use this medication for prolonged periods of time, your doctor will periodically review:

· The state of your nasal mucosa

· The state of your adrenal glands

• If Beclo-Rino is administered to children over 6 years old, the doctor must periodically review their growth, as this medication may cause growth retardation.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Beclo-Rino should not be used in children under 6 years old.

Use of Beclo-Rino with other medications:

Inform your doctor if you are taking or have recently taken other medications, including those obtained without a prescription.

Some medications may increase the effects of Beclo-Rino, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery:

This medication has no effect on the ability to drive vehicles or operate machinery.

Use in athletes:

Athletes should be aware that this medication contains beclometasone dipropionate, which may produce a positive result in doping control tests.

Beclo-Rino contains benzalkonium chloride and glucose:

This medication may cause nasal mucosa inflammation, especially with long-term treatments, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medication that does not contain this excipient should be used whenever possible.

This medication contains 5 mg of glucose per application, which should be taken into account by diabetic patients.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Beclo-Rino is a medication administered via the nasal route.

Children from 6 years old:according to medical criteria.

Adults over 18 years old:The recommended dose is 1 or 2 applications (50 micrograms of beclometasone dipropionate per application) in each nasal fossa, as needed, twice a day.

Do not perform more than 4 applications per day (200 micrograms of beclometasone dipropionate) in each nasal fossa.

Do not use for more than 7 consecutive days.

If you estimate that the action of Beclo-Rino is too strong or too weak, inform your doctor or pharmacist.

Guidelines for correct administration:

Verify the expiration date of the product before its use.

Before performing the first application of Beclo-Rino, you must:

• Remove the plastic cap from the nasal applicator.
• Shake the bottle-applicator combination and press several times by pressing down on the applicator, using your index and middle fingers, while holding the base of the container with your thumb. When you have a uniform spray (about 5 presses) the medication will be ready to use. If not used daily, it is necessary to shake the container and perform a press to the air before using it again.

Before each application, you must:

• Blow your nose gently.
• Remove the plastic cap from the nasal applicator.
• Shake the bottle-applicator combination.
• Insert the applicator into one nasal fossa, while covering the other by pressing laterally with your finger.
• Incline your head slightly forward and, while inhaling, press the applicator firmly on the bottom of the bottle. Breathe through your mouth and repeat the process.
• Repeat the same process with the other nasal fossa.

After completing the application, you must put the plastic cap back on the nasal applicator.

Cleaning:

It is recommended to clean the plastic cap and nasal applicator regularly, washing them with warm water. Let dry and put back correctly.

If the nasal applicator becomes clogged, remove the cap, take out the nasal applicator and soak it in warm water for a few minutes. Rinse with cold water, dry and put it back in the bottle.

The nasal applicator is removed by pulling it gently upwards.

If you use more Beclo-Rino than you should:

It is essential that you take your dose as indicated by your doctor. You must use only what your doctor recommends, the use of more or less doses may worsen your symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service 91 562 04 20, indicating the medication and the amount administered.

If you forgot to use Beclo-Rino:

If you forget to apply a dose, apply it as soon as you remember. Do not use a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The adverse effects due to nasal application of Beclo-Rino are generally mild and transient.

The following adverse effects have been reported:

• Very common (may affect more than 1 in 10 people): headache that may be caused by the allergic process or by the administration of the medication.

• Common (may affect up to 1 in 10 people): sore throat, sneezing, tearing, nasal bleeding, cough, dryness, itching and burning in the nose, bad taste and odor in the mouth that may be caused by the allergic process or by the administration of the medication, as well as nasopharyngeal candidiasis (white, cotton-like patches in the nose and throat).

• Very rare (may affect up to 1 in 10,000 people): allergies, which manifest as: rashes, itching, eczema, swelling of eyelids, lips, face, and throat, anaphylactic or anaphylactoid reactions (severe allergic reactions that may impair breathing or alter consciousness) and sudden sensation of choking, as well as increased intraocular pressure, glaucoma, cataracts, and nasal septum perforation.

• Unknown frequency (cannot be estimated from available data): blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above30°C. Store in the original packaging to protect it from light. Do not refrigerate.

Do not useBeclo-Rinoafter the expiration date that appears on the packaging after Cad.:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Beclo-Rino:

• The active ingredient is beclometasone dipropionate.

• The other components (excipients) are: glucose, microcrystalline cellulose, sodium carboxymethylcellulose, polisorbate 80, benzalkonium chloride, phenylethanol, and purified water.

Appearance of the product and contents of the packaging:

Beclo-Rinois a white aqueous suspension and is presented in a container with a dosing pump and nasal applicator.

Each bottle contains 200 applications.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona – SPAIN

Date of the last review of this leaflet:10/2017

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.