Patient leaflet - BENZYDAMINE HYDROCHLORIDE 0.30 % W/V OROMUCOSAL SPRAY
1. What benzydamine hydrochloride 0.30% w/v oromucosal spray is and what it is used for
Benzydamine hydrochloride 0.30% 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 0.30% w/v
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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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– Sore throat
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– Sore tongue or gums
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– After operations, at Laryngitis and in case of damage after radiotherapy
2. What you need to know before you take benzydamine hydrochloride 0.30% w/v oromucosal spray
Do not use benzydamine hydrochloride 0.30% 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 0.30% w/v Oromucosal Spray (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using benzydamine hydrochloride 0.30% w/v oromucosal spray:
- If you have a history of asthma
- If you are allergic to acetylsalicylic acid or
© ABDIFARMA
BENZYDAMINE HYDROCHLORIDE
0.30%w/v OROMUCOSAL SPRAY
other non-steroidal anti-inflammatory anti- inflammatory (NSAID) drugs
If any of these apply, talk to your doctor or pharmacist.
Other medicines and benzydamine hydrochloride 0.30% 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 0.30% w/v oromucosal spray does not affect the ability to drive or to operate machines.
Benzydamine hydrochloride 0.30% w/v oromucosal spray Contains:
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
This medicinal product contains benzyl alcohol. Benzyl alcohol may cause mild local irritation.
3. How to use benzydamine hydrochloride 0.30% w/v oromucosal spray Important:
Always use benzydamine hydrochloride 0.30% 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 0.30% w/v oromucosal spray in or near your eyes. If any spray gets in your eyes, wash them immediately with cold water.
Recommended treatment period is 5–7 days.
How much benzydamine hydrochloride 0.30% w/v oromucosal spray to use
- Adults adolescents and elderly – spray 2 – 4 puffs to the sore area every 1.5 – 3 hours.
- Children 6 to 12 years of age – spray 2 puffs to the sore area every 1.5 – 3 hours.
- Children less than 6 years of age – spray
1 puff for every 8 kilograms of body weight, up to a maximum of 2 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. Remove the protective cap
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3. 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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4. Aim the spray-tube at the affected area and press down. One press releases one actuation.
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5. 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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6. Replace the protective cap after use. This prevents the actuation being accidentally released.
If you use more benzydamine hydrochloride 0.30% w/v oromucosal spray than you should
It should not cause you any problems if you accidentally take too much or you swallow some of your medicine. If you have any concerns, contact your doctor or pharmacist.
If you forget to use benzydamine hydrochloride 0.30% 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 0.30% 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:
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– 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
5. how to store benzydamine hydrochloride 0.30% w/v oromucosal spray
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle after Exp.
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.
Shelf life after first opening of the medicinal product: 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 0.30% w/v Oromucosal Spray contains
The active substance is benzyamine hydrochloride at a concentration of 0.30% w/v.
Each metered dose pump spray delivers benzydamine hydrochloride 0.30 % w/v, approximately 0.18 ml per puff.
The other excipients are ethanol 96%, glycerol, polysorbate 80, saccharin sodium, methyl parahydroxybenzoate (E218), spearmint flavor ‘containing benzyl alcohol’, sodium hydrogen carbonate and/or hydrochloric acid for pH adjustment and purified water.
What benzydamine hydrochloride 0.30% 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 spray 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 15 ml of liquid and comes in a carton.
Marketing Authorisation Holder
ABDI FARMA, Unipessoal Lda Quinta da Fonte, Rua dos Malhoes, Ediffcio D. Pedro I 2770–071 Pago de Arcos, Portugal
This medicinal product is authorised in the Member States of the EEA under the following names:
UK and Ireland: benzydamine hydrochloride 0.30% 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 20.09.2019