Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray

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

• This medicine is available without prescription. However, you still need to use it carefully to get the best results.
• Keep this leaflet. You may need to read it again.
• Ask your doctor or pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• 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.

1. What Benzydamine Hydrochloride is and what it is used for
2. What you need to know before you use Benzydamine Hydrochloride
3. How to use Benzydamine Hydrochloride
4. Possible side effects
5. How to store Benzydamine Hydrochloride
6. Contents of the pack and other information

• allergic to benzydamine hydrochloride
• allergic to any of the other ingredients in Benzydamine Hydrochloride (listed in section 6)

Talk to your doctor, pharmacist or nurse before using Benzydamine Hydrochloride if you:

• have a history of asthma
• are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID) drugs

If any of these apply, talk to your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

Do not take benzydamine hydrochloride if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take benzydamine hydrochloride during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, benzydamine hydrochloride can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Benzydamine Hydrochloride does not affect the ability to drive or to operate machines.

Each puff (0.18 ml) of the spray delivers 0.18 mg of methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Each puff (0.18 ml) of the spray delivers 14.58 mg of ethanol 96%. The amount in one puff of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) in each puff (0.18ml), that is to say essentially ‘sodium-free’.

Always use Benzydamine Hydrochloride exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Do not use Benzydamine Hydrochloride in or near your eyes. If any spray gets in your eyes, wash them immediately with cold water.

• 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.

1. Hold the bottle in an upright position.
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.
3. Aim the spray-tube at the affected area and press down. One press releases one actuation.
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.
5. Do not push anything into the end of spray-tube if it becomes blocked. Return the spray to your pharmacist.

If you take too much or you accidentally swallow large quantities of your medicine, contact immediately your doctor or pharmacist for advice.

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 on the use of this medicine, ask your doctor, pharmacist or nurse.

• 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.

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).

Some people may react after using the product with a severe allergic reaction experiencing symptoms as described above (a so-called anaphylactic reaction) which may be potentially life-threatening. In this case you should seek immediate medical assistance.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is benzydamine 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 purified water.

It is a mouth spray. It is a clear, colourless solution with mint odor 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.