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BOOTS SORE THROAT AND MOUTH 0.15%W/V OROMUCOSAL SPRAY, BENZYDAMINE HYDROCHLORIDE 0.15%W/V OROMUCOSAL SPRAY, ORAL SOOTHE 0.15%W/V OROMUCOSAL SPRAY - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - BOOTS SORE THROAT AND MOUTH 0.15%W/V OROMUCOSAL SPRAY, BENZYDAMINE HYDROCHLORIDE 0.15%W/V OROMUCOSAL SPRAY, ORAL SOOTHE 0.15%W/V OROMUCOSAL SPRAY

Boots Sore Throat & Mouth

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

  • ■ Keep this leaflet. You may need to read it again

  • ■ Ask your pharmacist if you need more information or advice

  • ■ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

  • ■ You must talk to a doctor if you do not feel better or if you feel worse after 7 days

What is in this leaflet

4. Possible side effects

6. Contents of the pack and other information

The name of your medicine is Benzydamine 0.15%w/v Oromucosal Spray (called Boots Sore Throat & Mouth Spray in this leaflet). Boots Sore Throat & Mouth Spray contains the active substance benzydamine hydrochloride, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs or NSAIDs.

Boots Sore Throat & Mouth Spray works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including:

  • ■ Mouth ulcers

  • ■ Sore throat

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    • ■ Sore mouth or gums


  • ■ if you are allergic (hypersensitive) to benzydamine hydrochloride or any of the other ingredients of Boots Sore Throat & Mouth Spray (listed in Section 6).

Warnings and precautions

Talk to your doctor, dentist or pharmacist before using Boots Sore Throat & Mouth Spray:

  • ■ if you have a history of asthma

  • ■ if you are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

If you are not sure if any of the above applies to you, talk to your doctor, dentist or pharmacist before using Boots Sore Throat & Mouth Spray.



Mouth Spray

Please tell your doctor, dentist or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor, dentist or pharmacist before using any medicine.

This product contains glycerol which may cause headache, stomach upset and diarrhoea.

This product contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

This product contains only a small amount of ethanol (alcohol), less than 100mg per dose.

Always use Boots Sore Throat & Mouth Spray exactly as your doctor, dentist or pharmacist has told you. You should check with your doctor, dentist or pharmacist if you are not sure.

Do not use Boots Sore Throat & Mouth Spray in or near your eyes. If any spray gets into your eyes, wash them immediately with cold water.

Spray directly onto the affected area of the mouth or throat as follows:

  • ■ Adults, the elderly and children over 12 years: 4 to 8 sprays every 1−3 hours

  • ■ Children (6–12 years): 4 sprays every 1−3 hours

  • ■ Children under 6 years: 1 spray for each 4kg of bodyweight, to a maximum of 4 sprays, every 1−3 hours

Contact your doctor, dentist or pharmacist if your symptoms worsen or they do not improve.

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How to use the spray

  • 1. The product requires the fitting of the extension arm before use.

  • 2. To use the spray, hold the bottle in an upright position.

  • 3. Remove the protective cap. This will reveal the pump spray. Remove the arm from the carton and apply firmly to the pump spray.

(continued overleaf)

  • Figure 2 4. The first time you

use the spray, z-7-\ point the spray

/, a - arm away from you and anyone else. Then press – / ~X) the white plunger down firmly / Vy s several times until a fine spray

ZZy/ appears out of the end of the spray arm, as shown in figure 2. Your ' spray is now ready to use.

  • 5. Point the spray arm at the sore part of your throat or mouth and press the white plunger down firmly. One press releases one spray of medicine.

  • 6. Apply the correct number of sprays according to the instruction above. Then wipe the end of the spray arm with a clean tissue. This helps to prevent your spray blocking.

  • 7. If your spray blocks or stops working properly, return it to your pharmacist. Do not push anything into the end of the spray arm to try to clear a blockage. No additional cleaning is required in use of the product.

If you use too much or you accidentally swallow large quantities of Boots Sore Throat & Mouth Spray, contact your doctor, dentist or pharmacist for advice.

Do not use a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any further questions about the use of this medicine, ask your doctor, dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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Some side effects could be serious. If you have any of the following side effects listed below, seek immediate medical help:

  • ■ Serious allergic reaction which may include difficulty in breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, and which may be potentially life-threatening

Other side effects include the following, if they get serious, tell your doctor: Uncommon (affects 1 in 1,000 people):

  • ■ Numbness and/or stinging in the mouth and/or throat

Very rare (affects less than 1 in 10,000 people):

  • ■ Difficulty in breathing and wheezing

  • ■ Itching

  • ■ Skin rash

  • ■ Your skin becoming more sensitive to sunlight than normal causing an itchy, red, scaly rash, sometimes with blisters

Not known (frequency cannot be estimated from the available data):

  • ■ Skin redness or swelling

  • ■ Allergic reaction (hypersensitivity)

6. contents of the pack and other information

The active ingredient is benzydamine hydrochloride at a concentration of 0.15%w/v.

Each spray contains 225 micrograms of benzydamine hydrochloride.

The other ingredients are glycerol, ethanol, methyl parahydroxybenzoate (E218), saccharin sodium (E954), sodium hydrogen carbonate, polysorbate 20, mint flavour and purified water.

Boots Sore Throat & Mouth Spray is an oromucosal spray. It is a clear, colourless liquid, available in a bottle fitted with a metering pump and protective cap. This means it provides a measured amount of spray each time it is used. Each bottle contains 15ml or 30ml of liquid. Not all pack sizes may be marketed.

MA Holder and Manufacturer

Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.

This leaflet was last revised in April 2020

WIP URN: 140420-XXXX-PIL-01

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A01 STOMATOLOGICAL PREPARATIONS

A01A STOMATOLOGICAL PREPARATIONS

A01AD Other agents for local oral treatment in ATC

A01AD02 benzydamine

Frequently Asked Questions

What is Boots Sore Throat and Mouth Spray used for?

Boots Sore Throat and Mouth Spray is used to temporarily relieve pain and discomfort in the throat and mouth caused by conditions like sore throat, toothache, or oral lesions.

How does benzydamine hydrochloride work in this spray?

Benzydamine hydrochloride works as a non-steroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation in the throat and mouth area.

Is Boots Oral Soothe Spray safe for children?

Boots Oral Soothe Spray is generally not recommended for children under 12 years old. Always consult a healthcare professional before use.

Can I use this spray if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, it's important to consult your doctor before using this spray to ensure it’s safe for you.

How often can I use Boots Sore Throat and Mouth Spray?

You can use the spray every 1.5 to 3 hours as needed, but do not exceed the recommended dose. Check the instructions for more details.

What should I do if I forget to use the spray?

If you forget to use the spray, simply take it as soon as you remember. If it’s close to the time for your next dose, skip the missed dose and continue with your regular schedule.

Are there any side effects of using benzydamine oromucosal spray?

Side effects may include a temporary stinging sensation, dryness of the mouth, or allergic reactions. If you experience severe side effects, seek medical attention immediately.

Can I use other throat remedies while using this spray?

While it's generally safe, check with your healthcare provider before combining this spray with other throat remedies to avoid potential interactions.

How should I store Boots Sore Throat and Mouth Spray?

Store the spray at room temperature away from direct sunlight and out of reach of children. Do not freeze it.

What happens if I accidentally swallow a large amount of the spray?

If a large amount is swallowed, seek medical advice immediately or contact your local poison control center.

Can older adults safely use this throat spray?

Yes, older adults can typically use this spray safely; however, they should consult their healthcare provider if they have underlying health issues.

Does this oromucosal spray have an effect on my ability to drive or operate machinery?

No significant effects on driving or operating machinery have been reported. However, if you feel dizzy or unwell after using it, do not drive until you feel better.

What is the active ingredient in this oral soothe product?

The active ingredient in Boots Oral Soothe Spray is benzydamine hydrochloride at a concentration of 0.15% w/v.

Is there any alcohol in Boots Sore Throat Spray?

No, Boots Sore Throat and Mouth Spray does not contain alcohol in its formulation.

How long can I use this product continuously?

You should not use this product continuously for more than 7 days without consulting a healthcare professional.

Can I use Boots Sore Throat Spray alongside other medications such as antibiotics?

Yes, but it’s best to speak with your doctor or pharmacist to ensure there are no interactions with other medications you're taking.

Will using this spray stain my teeth or tongue?

No, there are no known issues regarding staining teeth or tongue when using Boots Sore Throat and Mouth Spray as directed.

Is there any flavor in the oral soothe formulation?

Boots Sore Throat Spray may have a mild flavor to make it more palatable; however, specific flavoring details can vary by product line.

Can I take pain relief pills along with using this throat spray?|

Yes, you can generally take oral pain relief medications alongside using the throat spray but consult your doctor for specific advice based on your health condition.