Patient leaflet - BENZYDAMINE HYDROCHLORIDE 0.15 % W/V OROMUCOSAL SPRAY
1. what benzydamine hydrochloride 0.15% w/v oromucosal spray is and what it is used for
Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray contains the active substance benzydamine hydrochloride, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS.
Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including:
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– Mouth ulcers
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– Sore throat
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– Sore tongue or gums
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– Discomfort associated with dentures or dental work.
2. what you need to know before you take benzydamine hydrochloride 0.15% w/v oromucosal spray
Do not use Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray if:
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– You are allergic to benzydamine hydrochloride
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– You are allergic to any of the other ingredients in Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Benzydamine Hydrochloride
- 0.15% w/v Oromucosal Spray: If you have a history of asthma
- If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory antiinflammatory (NSAID) drugs
If any of these apply, talk to your doctor or pharmacist.
Other medicines and Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray does not affect the ability to drive or to operate machines.
Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray Contains:
This medicine contains glycerol which may cause headache, stomach upset and diarrhoea.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Each puff (0.18 ml) of the spray delivers 0.18 milligrams of methyl parahydroxybenzoate and 14.58 milligrams of ethanol 96%.
3. how to use benzydamine hydrochloride 0.15% w/v oromucosal spray
Important:
Always use Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray exactly as your pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Do not use Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray in or near your eyes. If any spray gets in your eyes, wash them immediately with cold water.
Do not use Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray for more than 7 days except under medical supervision.
- How much Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray to use Adults adolescents and elderly – spray 4 – 8 puffs to the sore area every 1.5 – 3 hours.
- Children 6 to 12 years of age – spray 4 puffs to the sore area every 1.5 – 3 hours.
- Children less than 6 years of age -spray 1 puff for every 4 kilograms of body weight, up to a maximum of 4 puffs, to the sore area every 1.5 – 3 hours.
Contact your doctor if your symptoms worsen or they do not improve.
How to use the spray
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1. Hold the bottle in an upright position.
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2. You need to prime the spray the first time you use it (max. 5 sprays). Point the spray-tube away from your face. Press down firmly until a fine spray appears from the end of the spray-tube.
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3. Aim the spray-tube at the affected area and press down. One press releases one actuation.
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4. After spraying the desired number of actuations, wipe the end of the spray-tube with a tissue. This prevents the spray-tube becoming blocked.
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5. Do not push anything into the end of spray-tube if it becomes blocked. Return the spray to your pharmacist.
If you use more Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray than you should
If you take too much or you accidentally swallow large quantities of your medicine, contact immediately your doctor or pharmacist for advice.
If you forget to use Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you have any further questions about theuse of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray can cause side effects, although not everybody gets them.
Some side effects could be serious. If you have any of the side effects listed below, seek immediate medical help: – severe allergic reaction (anaphylaxis) seen as swelling of throat and mouth, difficulty in swallowing or speaking, alterations in heart rate, severe asthma, collapse and unconsciousness
Other side effects include the following, if they get serious, please 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 breathing and wheezing
- Itching
- Skin rash
- Not known (frequency cannot be estimated from the available data): Skin redness or swelling
- Allergic reaction (Hypersensitivity) Serious allergic reaction (anaphylactic shock), signs of which may include difficulty 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.
5. how to store benzydamine hydrochloride 0.15% w/v oromucosal spray
Do not use this medicine after the expiry date on the bottle. The expiry date refers to the last day of that month.
This medical product does not require any special storage condition. Do not freeze. Store in an upright position.
Keep this medicine out of the sight and reach of children.
Once opened use within 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray contains
The active substance is benzyamine hydrochloride at a concentration of 0.15% w/v.
Each metered dose pump spray delivers Benzydamine hydrochloride 0.15 % w/v, approximately 180 microlitres per puff.
The other excipients are sodium bicarbonate, polysorbate 20, ethanol 96%, glycerol, saccharin sodium, Methyl parahydroxybenzoate (E218), peppermint oil and water, purified.
What Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray looks like and contents of the pack
It is a mouth spray. It is a clear, colourless solution that comes in an amber glass bottle fitted with a metered dose pump and a stopper-lid on the neck of sprayer. This means it provides a measured amount of spray each time it is used. Each bottle contains 30 ml of liquid and comes in a carton.
Marketing Authorisation Holder
ABDI FARMA, Unipessoal Lda Quinta da Fonte, Rua dos Malhoes, Edificio D. Pedro I 2770–071 Pa?o de Arcos, Portugal
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray
Manufacturer HBM Pharma s.r.o.
Sklabinska 30, 036 80 Martin Slovakia
Interpharma Services Ltd.
43A Cherni Vrach Bvld. Sofia 1407 Bulgaria
This leaflet was last revised in 02/2020