Beclo-Rino 50 micrograms application suspension for nasal spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Beclo-Rino 50 micrograms/dose nasal spray suspension
Beclometasone dipropionate
Read all of 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Beclo-Rino is and what it is used for
- What you need to know before using Beclo-Rino
- How to use Beclo-Rino
- Possible adverse effects
- How to store Beclo-Rino
- Contents of the pack and other information
1. What Beclo-Rino is and what it is used for
Beclo-Rino is an aqueous suspension of beclometasone dipropionate for nasal spray.
It is a medication that acts as an antiallergic.
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 in nasal polyposis.
2. What you need to know before using Beclo-Rino
Do not use Beclo-Rino:
- If you are allergic to beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
Consult your doctor or pharmacist before starting to use Beclo-Rino:
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If you have any infection in the nasal passages or pulmonary tuberculosis.
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If you experience pain or bleeding in the nasal cavities, you must stop treatment.
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If you are currently using or have recently used oral or injectable corticosteroid medicines.
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Take special care when inserting the applicator into the nose: if you have wounds or ulcers in the nasal cavities, or if you have recently undergone nasal surgery.
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If you use this medicine for prolonged periods, your doctor will periodically check:
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The condition of your nasal mucosa
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The function of your adrenal glands
- If Beclo-Rino is administered to children over 6 years of age, the doctor must periodically monitor their growth, as this medicine may cause growth delay.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Beclo-Rino must not be used in children under 6 years of age.
Use of Beclo-Rino with other medicines:
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Beclo-Rino, so your doctor will closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines:
This medicine has no effect on the ability to drive or operate machinery.
Use in athletes:
Athletes should be aware that this medicine contains beclometasone dipropionate, which may result in a positive doping test.
Beclo-Rino contains benzalkonium chloride and glucose:
This medicine may cause inflammation of the nasal mucosa, especially with long-term treatment, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medicine not containing this excipient should be used whenever possible.
This medicine contains 5 mg of glucose per spray, which should be taken into account by diabetic patients.
3. How to use Beclo-Rino
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Beclo-Rino is a medicine administered via the nasal route.
Children from 6 years of age: as directed by a physician.
Adults over 18 years: the recommended dose is 1 or 2 sprays (50 micrograms of beclometasone dipropionate per spray) in each nostril, as needed, twice daily.
Do not exceed 4 sprays per day (200 micrograms of beclometasone dipropionate) in each nostril.
Do not use for more than 7 consecutive days.
If you feel that the effect of Beclo-Rino is too strong or too weak, inform your doctor or pharmacist.
Instructions for correct administration:
Check the product's expiry date before use.
Before administering the first dose of Beclo-Rino, you must:
- Remove the plastic cap from the nasal applicator.
- Shake the bottle-applicator assembly and prime by pressing down several times on the applicator using the index and middle fingers, while holding the base of the container with the thumb. When a uniform spray is obtained (approximately 5 sprays), the medicine will be ready for use. If not used daily, it is necessary to shake the container and spray once into the air before using it again.
Before each administration, you must:
- Gently blow your nose.
- Remove the plastic cap from the nasal applicator.
- Shake the bottle-applicator assembly.
- Insert the applicator into one nostril, while closing the other nostril by pressing the side with a finger.
- Tilt your head slightly forward and, while inhaling, press down firmly on the applicator towards the bottom of the bottle. Breathe through your mouth and repeat the process.
- Repeat the same procedure with the other nostril.
After completing the administration, replace the plastic cap on the nasal applicator.
Cleaning:
It is advisable to clean the plastic cap and nasal applicator regularly by washing them with lukewarm water. Allow to dry and then replace correctly.
If the nasal applicator becomes blocked, remove the cap, take out the nasal applicator, and soak it in lukewarm water for a few minutes. Rinse with cold water, dry, and reinsert into the bottle.
The nasal applicator is removed by gently pulling it upwards.
If you use more Beclo-Rino than you should:
It is important that you take your dose exactly as prescribed by your doctor. You should only use the amount recommended by your doctor; using more or less than prescribed may worsen your symptoms.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount administered.
If you forget to use Beclo-Rino:
If you forget to administer a dose, use it as soon as you remember. Do not use a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The adverse effects due to nasal administration of Beclo-Rino are generally mild and transient.
The following adverse effects have been reported:
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Very common (may affect more than 1 in 10 people): headache, which may be caused by the allergic process or by administration of the medicine.
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Common (may affect up to 1 in 10 people): sore throat, sneezing, tearing, nasal bleeding, cough, dryness, itching and burning in the nose, unpleasant taste and smell, which may be caused by the allergic process or by administration of the medicine, as well as nasopharyngeal candidiasis (white, cotton-like patches in the nose and throat).
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Very rare (may affect up to 1 in 10,000 people): allergic reactions manifesting as rashes, itching, eczema, swelling of the eyelids, lips, face and throat, anaphylactic or anaphylactoid reactions (severe allergic reactions that may cause breathing difficulties or altered consciousness), sudden sensation of suffocation, as well as increased intraocular pressure, glaucoma, cataracts, and nasal septum perforation.
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Frequency not known (cannot be estimated from the available data): blurred vision.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Beclo-Rino
Keep this medicine out of sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from light. Do not refrigerate.
Do not use Beclo-Rino after the expiry date stated on the packaging after Exp.:. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Beclo-Rino:
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The active substance is beclometasone dipropionate.
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The other components (excipients) are: glucose, microcrystalline cellulose, sodium carboxymethylcellulose, polysorbate 80, benzalkonium chloride, phenylethanol and purified water.
Appearance of the medicine and contents of the pack:
Beclo-Rino is a white aqueous suspension and is supplied in a container with a metering pump and nasal applicator.
Each bottle contains 200 doses.
Marketing Authorization Holder and Manufacturer:
Laboratorio ALDO-UNIÓN, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat
Barcelona – SPAIN
Date of the most recent revision of this leaflet: 10/2017
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.