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

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.

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.

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