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FAQS - BECODEFENCE

WHO DO I CONTACT IF I HAVE QUESTIONS ABOUT BECODEFENCE?

You can contact us at 02035989601 or by email: UKLOcustomerservice@perrigo.com

CAN I USE MORE OF THE PRODUCTS IN BECODEFENCE RANGE AT ONCE?

No, please do not use more than one BecoDefence product at the same time.

WHY WAS THERE A CHANGE TO THE BECODEFENCE FORMULATION?

The new formulation has lower percentages of the preservatives and should therefore lead to lower number of stinging complaints.

These are set to be released for the Hayfever season in 2018.

WHAT WAS THE FORMULATION UPDATE FOR BECODEFENCE AND BECODEFENCE KIDS?

BecoDefence Allergy and BecoDefence Allergy Kids have had a formulation update. The product now contains preservatives.

HOW LONG AFTER OPENING BECODEFENCE CAN IT BE USED FOR?

The product should be used within 90 days after opening.

ARE THERE ANY SIDE EFFECTS?

Very rare cases of allergic reactions have been reported, with symptoms such as blocked or running nose, localized soreness, dryness, itching, swelling, watery eyes or rashes. In such cases the use of product should be discontinued immediately and if symptoms persist medical treatment should be sought.

CAN BECODEFENCE ALLERGY BE TAKEN WITH OTHER MEDICATION?

BECODEFENCE™ ALLERGY is not known to interact with other medicines or with other forms of allergy treatment.

WHERE CAN I FIND OUT MORE INFORMATION RELATED TO BECODEFENCE?

For more information regarding Becodefence you can refer to the website at: http://www.prevalin.com/uk/. Alternatively you can contact us at 02035989601 or by email: UKLOcustomerservice@perrigo.com

WHAT IS BECODEFENCE?

Becodefence is clinically proven to reduce allergic rhinitis symptoms, as it blocks allergens that cause the allergic reaction. Becodefence nasal spray works directly where the allergic reaction starts, on the respiratory mucosa of the nose. Becodefence’s patented Nasya™ technology uses a combination of oils and emulsifiers, which give unique transformation properties from gel to liquid for easy dispersion. Upon settling on the nasal mucosa, Becodefence reverts to its original gel-like consistency to form an allergen-impermeable micro-gel barrier. As most airborne allergens come in through the nose, Becodefence is an ideal solution for hay fever and allergic rhinitis.

WHERE CAN I BUY BECODEFENCE?

Most major pharmacies and supermarkets.

IS BECODEFENCE SAFE TO USE?

Becodefence is considered safe for use when used in line with the instructions for use.

DO I NEED A PRESCRIPTION?

Becodefence is available without a prescription.

HAS THERE BEEN AN ARTWORK UPDATE?

Yes, Becodefence was previous known as Prevalin. The name and artwork have both been updated.

WHAT IS THE DIFFERENCE BETWEEN BECODEFENCE ADULTS AND KIDS?

It contains the same Becodefence formula, only the dispensing tip is smaller so the amount sprayed into the nostril is especially adapted to the size of a child’s nostril.

WHAT IS THE ‘TRIPLE ACTION’ OF BECODEFENCE?

It ‘defuses’ pollen already inside the nose. Its free fatty acids in the formula are known for reducing the allergenic potential of pollen, i.e. they inhibit the release of allergens from pollen onto the mucosa. As such, they ‘defuse’ the pollen by reducing the allergenic activity.

Becodefence’s fine mist resettles as a barrier on the nasal mucosa, preventing pollen that will be inhaled from contacting the nasal mucosa and subsequently attaching to mast cells and triggering an allergic reaction.

The sesame oil in Becodefence stimulates the clearance of the pollen out of the nose, i.e. the mucociliary process.

DOES IT WORK IMMEDIATELY?

Becodefence does not need prior resorption into the cell, which is required to exert activity in the case of any drug / drug like substances (i.e. corticosteroids or decongestants). The gel-barrier will form immediately, and prevent further pollens inhaled from getting in contact with the nasal mucosa and subsequently attach to mast cells. This will ensure immediate action against further pollen exposure.

HOW DOES BECODEFENCE ‘DEFUSE’ POLLEN?

Its formula contains free fatty acids, which are known for decreasing the pollens’ allergic potential and hence ‘defusing’ them from triggering the allergic reaction.

IS BECODEFENCE JUST A BARRIER?

No. When sprayed into the nose, it does 3 things:

  1. It defuses the pollen already inside the nose and decreases their allergenic potential

  2. It forms a stable, impermeable, long-lasting gel-barrier on the nasal mucosa so future inhaled pollen will not be able to penetrate the mucosa and cause symptoms

  3. It stimulates the clearance of allergens in the nose

WHY DO WE CLAIM 4 – 6 HOURS OF PROTECTION?

The mucociliary clearance takes place approximately every 6 hours. This is a normal mechanism of the body to get rid of foreign particles in the nose. The Becodefence micro-gel on the nasal lining will thus be discarded over time. Therefore, re-application is recommended after 4-6 hours

DOES BECODEFENCE ONLY TREAT AND PROTECT AGAINST POLLEN (HAY FEVER) OR ALSO AGAINST OTHER ALLERGENS SUCH AS DUST MITE, ANIMAL HAIR, ETC?

Becodefence’s formula resettles as an impermeable, non-porous barrier on the nasal mucosa. Theoretically, based on comparing the size of pollen versus other allergens, Becodefence should also be effective for other allergens as pollen are the smallest ones.

DOES BECODEFENCE ONLY TREAT THE NASAL SYMPTOMS OR ALSO THE ITCHY AND RUNNY EYES?

The majority of secondary eye symptoms can be traced back to the aggression of the nasal mucosa:

  • Mast cells (containing histamine) are predominantly present in areas with good blood flow (i.e. nasal mucosa), once in contact with pollen the histamine is released and causes the allergic reaction. The histamine is distributed by the blood flow to neighbouring areas (i.e. eyes), and cause symptoms there as well. In the eye itself only the conjunctiva contains mast cells, but much fewer than in the nasal mucosa, and the surface area is also considerably smaller.

  • The conjunctiva will not be exposed to allergens directly, so the symptoms that origin from the conjunctiva’s mast cells will be less severe than the ones caused in the nasal mucosa. The mast cells are also present in the conjunctiva underneath the eyelids. Although the conjunctiva is not exposed directly to allergens in the air, allergens touching the exposed cornea may be trapped by tears and could be distributed to the conjunctiva.

  • As there are fewer mast cells in the conjunctiva than in the nasal mucosa, there will be less symptoms, even if challenged with same quantum of pollen. Furthermore, the eyes are constantly moistened/ washed by the tears. As such, most of the allergens are being washed down before they can reach the conjunctiva.

WHAT ABOUT POLLEN THAT ENTER THROUGH THE MOUTH?

If inhaled, pollen will rarely reach the deeper bronchi, as they get trapped in the upper respiratory tract and transported out

DOES BECODEFENCE COVER THE COMPLETE SENSITIVE AREA IN THE NOSE?
  1. Becodefence has patented thixotropic properties, which when shaken turns the original gel-like consistency into a fine fluid that can be sprayed easily up in the nose and reaches a broad inner surface of the nasal cavity, where it immediately resettles as a stable, impermeable barrier.

  2. Research shows that even very crude application methods such as ointments or creams, which achieve less coverage of the nasal mucosa cause significant improvement of symptoms.

  3. Mast cells have been shown to migrate to the nasal epithelium during the pollen season, which is predominantly exposed to pollen. This indicates that only the areas that are reached by Becodefence fine spray need to be covered, as the inhaled pollen will basically reach out to the same areas.

  4. Recent study also show that pollen are affecting the frontal regions of the nose, where even nasal sprays with a particle size of 50μm reach a perfect coverage. As Becodefence has a spray particle size of <100μm, so its particles are distributed to cover the frontal area of the nose with some portion that may reach deeper to cover the upper half of the nasal cavity.

CAN BECODEFENCE BE USED TOGETHER WITH NASAL CORTICOSTEROIDS OR ANTIHISTAMINES?

Becodefence is drug-free and contains mainly natural ingredients. It is inert and non-toxic. Becodefence is not known to interact with other medicines or with other forms of allergy treatment. The application of Becodefence should not affect the efficacy of anti-histamine tablets. If other nasal spray is needed, Becodefence should be applied after any other nasal spray in order not to disturb the formation of the impermeable barrier

WHAT HAPPENS IF BECODEFENCE IS NOT SHAKEN BEFORE DISPENSED?

Becodefence is made with unique Nasya™ technology, its thixotropic properties allow transformation from gel to liquid state merely by shaking. Therefore, it is very important to shake well before spraying. There is a possibility to spray without shaking the bottle, but the spraying pattern would not be even and hence cannot form a proper layer of protection on the nasal mucosa. Without proper shaking, Becodefence fluid will not be dispensed as fine sprayed particles (spray droplet).

WHERE DOES BECODEFENCE GO A FEW HOURS AFTER THE APPLICATION

Becodefence gel is naturally dislodged and is then blown out as a natural reaction or is sneezed out. A small amount will drip down the back of the nose into the throat and is naturally spat out or swallowed. This is a normal mechanism by which our body gets rid of particulate matter in the nose. No unwanted side effect is expected as the product is made of food grade ingredients. Furthermore, the quantity involved is negligible.

WHAT WOULD HAPPEN IF BECODEFENCE REACHES THE SINUSES?

Becodefence gel can get into the sinuses. It would be cleared through normal muco-ciliary clearance.

DOES BECODEFENCE AFFECT THE SENSE OF SMELL?

No. The application of Becodefence should not affect the ability to smell.

CAN BECODEFENCE BE USED LONG TERM?

The long term usage was not studied. However, Becodefence is made of natural, gras & food grade ingredients and the ingredients used are chemically inert & non-invasive. We recommend to use as per directions.

WHAT HAPPENS TO THE PROTECTIVE MICRO-GEL BARRIER WHEN THE NOSE IS BLOWN?

Becodefence is expelled from the nose when blown. The Becodefence gel is naturally dislodged and is then blown out as a natural reaction or is sneezed out. A small amount will drip down the back of the nose into the throat and is naturally spat out or swallowed. This is a normal and natural mechanism by which our body gets rid of particulate matter in the nose.

To maintain the protective barrier on nasal cavity, we suggest the application of Becodefence at 2-3 times a day (every 6 hours) and to blow the nose to clear off the disrupted Becodefence gel before every application. Since every application of Becodefence will be discarded over time, it will not remain in the nasal cavity.

BECODEFENCE CONTAINS THE INGREDIENT SESAME OIL. IS THIS DANGEROUS FOR PEOPLE WHO ARE ALLERGIC TO SESAME?

As per the product information, do not use this product if you are sensitive to sesame seed oil

BECODEFENCE CONTAINS THE INGREDIENT SPEARMINT OIL. IS THIS DANGEROUS FOR PEOPLE WHO ARE ALLERGIC TO MINT?

As per the product information do not use this product if you are sensitive to any of the ingredients in Becodefence.

CAN ATHLETES AND PROFESSIONAL SPORTSPEOPLE USE BECODEFENCE?

Yes. Becodefence is not a drug and it is non-systemic. It is non-sedating and does not contain ingredients forbidden by the international sports organizations.

CAN PEOPLE WITH PEANUT/NUT ALLERGIES TAKE BECODEFENCE?

Sesame seeds do not fall into the same category as peanuts or tree nuts. We do not have any peanuts based ingredient in our formula.

DO YOU KNOW IF BECODEFENCE CAN BE USED SAFELY BY SOMEONE WITH NASAL POLYPS?

We recommend patients with nasal polyps to seek medical advice from their healthcare professional before using Becodefence.

CAN PEOPLE WITH EPILEPSY TAKE BECODEFENCE?

We have to exercise caution with these patients as their trigger could be anything. The management of epilepsy is a joint management of HCPs. Therefore, usage of any medications/products MUST be discussed with the respective HCPs to avoid a relapse. On the basis Becodefence is a medical device exerting its action via a physical barrier in the nose, Becodefence should be safe to be used in patients with epilepsy. Unless, the patient is allergic to components of Becodefence or his/her seizures are triggered by strong smells.

CAN YOU RECOMMEND IT WITH AN ANTIHISTAMINE?

Becodefence is drug-free and contains mainly natural ingredients. It is inert and non-toxic. Becodefence is not known to interact with other medicines or with other forms of allergy treatment. The application of Becodefence should not affect the efficacy of anti-histamine tablets. If other nasal spray is needed, Becodefence should be applied after any other nasal spray in order not to disturb the formation of the impermeable barrier.

CAN ASTHMATICS TAKE BECODEFENCE?

Becodefence is a Medical Device that is intended for the management of allergic rhinitis, acting principally through the formation of a physical barrier that protects the nasal mucosa. The use of Becodefence in patients suffering from asthma has not been studied in a clinical trial specifically. As such there are no efficacy and safety data available. As a general precaution, we recommend asthmatic users to seek advice from their healthcare professional before using Becodefence.

CAN PEOPLE ON WARFARIN TAKE BECODEFENCE?

Warfarin is an oral anticoagulant that is prescribed to people who are diagnosed with blood coagulation/ thrombosis or atrial fibrillation (AF). These people normally require warfarin to prevent recurrence of blood clotting or other complications. They are considered the high-risk group. Physicians or doctors normally treat this group of patients with extra caution. Even though Becodefence is a certified medical device that does not cause any pharmacological, immunological or metabolic effects, and is administered via nasal route, it is still strongly recommended that this group of patients seek further advise from their physician before taking Becodefence.

DOES BECODEFENCE CONTAIN ANY CARBOHYDRATES?

Carbohydrates are one of the main types of nutrients. The most common and abundant forms are sugars, dietary fibers and starches.

We can confirm that Becodefence Plus and Becodefence do not contain carbohydrates.

IS THE BECODEFENCE RANGE SUITABLE FOR DIABETICS?

Becodefence is a drug free medical device suitable for adults and children 12+. Its ingredients are non-toxic and are commonly used in food and preparations. As such we don’t expect any reaction when used by diabetic end-users. We encourage diabetic end-users to seek advices from their HCP so that their glycaemic level a properly controlled.

WHAT IS THE DIFFERENCE BETWEEN BECODEFENCE AND BECODEFENCE PLUS SPRAYS?

Becodefence is clinically proven to reduce allergic rhinitis symptoms, as it blocks allergens that cause the allergic reaction. Becodefence nasal spray works directly where the allergic reaction starts, on the respiratory mucosa of the nose. Becodefence’s patented Nasya™ technology uses a combination of oils and emulsifiers, which give unique transformation properties from gel to liquid for easy dispersion. Upon settling on the nasal mucosa, Becodefence reverts to its original gel-like consistency to form an allergen-impermeable micro-gel barrier. As most airborne allergens come in through the nose, Becodefence is an ideal solution for hay fever and allergic rhinitis.

Becodefence Plus is a drug-free nasal spray with a double protection action to provide fast relief and extra protection against hay fever, dust mite and pet allergies. This product contains a patented combination of oil and emulsifiers, Nasya™ Technology with clinically proven efficacy, which gives unique transformation properties from gel to liquid for easy dispersion. Upon settling on the nasal mucosa, Becodefence Plus reverts to its original gel-like consistency to form an impermeable micro-gel barrier, hence blocking the body’s allergic responses. If the allergic reaction has been triggered, the therapeutic oil in Nasya™ will act as a mast cell stabiliser, thus reducing sensitivity to allergens. Symptoms such as sneezing, blocked/runny nose or itchy/watery eyes will be relieved.

The main difference between the products as highlighted by the writing in bold, is that Allergy Plus gives extra protection against nasal allergens.

ARE BECODEFENCE PRODUCTS TESTED ON ANIMALS?

The product is tested on animals in order to collect necessary data on safety following mandatory legislation and standard.

HOW DO I USE BECODEFENCE?

Apply 1 to 2 sprays into each nostril, 2 to 3 times a day (works up to 6 hours). Children of 12 years and below should use Becodefence Kids and only under adult supervision. Always blow nose thoroughly before each application.

During the first hour of use, you may experience a slight blocked nose sensation. This is a transient sensation that will subside quickly and will gradually disappear with subsequent use. If you experience any serious discomfort after the application, discontinue using the product or consult your physician. If concurrent use of another nasal spray is required, Becodefence should be applied afterwards in order not to disturb the formation of the impermeable barrier.

HOW DOES BECODEFENCE WORK?

Becodefence works directly where allergens trigger an allergic reaction, on the respiratory mucosa of the nose.

HOW LONG CAN I TAKE BECODEFENCE FOR?

Becodefence should not be used for more than 30 days.

WHAT IS THE SHELF LIFE FOR BECODEFENCE?

The shelf life for Becodefence Allergy is 30 months. The product should be used within 90 days after opening.

WHAT IS THE AGE RANGE FOR BECODEFENCE?

12+

WHAT IS BECODEFENCE CLASSIFICATION?

Medical device.

WHO SHOULD NOT USE BECODEFENCE?

Do not use this product in case you are hypersensitive to sesame seed oil or any other ingredients contained in Becodefence.

IS BECODEFENCE SUITABLE FOR VEGETARIANS / VEGANS?

Becodefence does not contain any ingredient of animal origin and is therefore it is suitable for vegetarians and vegans.

IS BECODEFENCE SAFE TO USE WHILE PREGNANT OR BREAST-FEEDING?

Yes. Pregnant women can use Becodefence. We have obtained an official expert opinion for this statement “The product can be used safely by pregnant and breastfeeding women” from Dr Lautenbacher.

IS IT OK TO USE BECODEFENCE IF YOU SUFFER FROM GLAUCOMA?

We generally do not give medical advice to our customer but ask them to check any treatment with their doctor.

Becodefence is not known to increase the pressure in the eyes and is therefore not contra indicated with Glaucom.

An increase of the pressure in the eyes is not expected from the mode of action of Becodefence nor from the ingredients that are contained.

DOES IT CONTAIN ANY INGREDIENTS DERIVED FROM GRAIN?

We confirm that none of the ingredients used in Becodefence are derived from any kind of grain, including corn or their derivatives. Also the Xanthan gum contained is derived by bio fermentation of a sugar source, which is not from grains, corn or their derivatives. However, an individual with known allergy might also be allergy to other plant base materials, hence you should consult your healthcare professional to assess need for an allergy test before start using Becodefence.

WHY IS THERE SESAME SEED OIL IN THIS PRODUCT?

The packaging of this product states that one of the ingredients is sesame oil.

The sesame oil in BecoDefence™ stimulates the clearance of the pollen out of the nose, i.e. the mucociliary process.

Sesamum indicum (sesame) seed oil is widely used for food, an edible oil or pharmaceutical products (intramuscular, subcutaneous or topical). It is generally regarded as non-toxic and non-irritant material.

 

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(2) Schran HF, Petryk L, Chang CT, O’Connor R, Gelbert MB. The pharmacokinetics and bioavailability of clemastine and phenylpropanolamine in single-component and combination formulations. J Clin Pharmacol 1996;36:911-922.

(3) Simons FE, Simons KJ. Clinical pharmacology of new histamine H1 receptor antagonists. Clin Pharmacokinet 1999;36(5):329-52.

(4) Georgitis JW, Meltzer EO, Kaliner M, Weiler J, Berkowitz R. Onset-of-action for antihistamine and decongestant combinations during an outdoor challenge. Ann Allergy Asthma Immunol 2000;84(4):451-459.

Beconase Hay fever and Beconase Hay fever Relief for Adults 0.05% Nasal Spray contains beclometasone dipropionate. For the treatment of hay fever in adults aged 18 and over. Becodefence, Becodefence Kids and Becodefence Plus are medical devices. Always read the leaflet.