3 mg / ml oral spray, solution 
benzydamine hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

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

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse within 3 days.

This leaflet contains information about: 
1. What Bertolix is ​​and what it is used for 
2. What you need to know before using Bertolix 
3. How to use Bertolix 
4. Possible side effects 
5. How to store Bertolix 
6. Contents of the packaging and other information 

1. What Bertolix is ​​and what it is used for

Bertolix contains benzydamine which belongs to a group of medicines called non-steroidal inflammatory medicines. It works by relieving pain and swelling ( inflammation ).

Bertolix is ​​used in adults for short-term treatment of symptoms of inflammation of the oral cavity and throat (pain, redness, swelling) or irritation of the mucous membranes of the mouth or throat.

Benzydamine hydrochloride contained in Bertolix may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using Bertolix

Do not use Bertolix

  • if you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Bertolix:

  • If you are hypersensitive to acetylsalicylic acid or other medicines for fever, pain, and inflammation (so-called NSAIDs )
  • If you have or have ever had asthma or allergies in the trachea because then you suffer a greater risk of developing cramps or allergies in the trachea.

The treatment should not exceed 7 days. If your symptoms do not get better or if you feel worse after 3 days, if you get a fever or other symptoms, you should contact a doctor.

If you get an allergic reaction, stop treatment, and contact a doctor or emergency room.

Avoid contact with eyes.

Other medicines and Bertolix

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

It has not been established that other medicines affect the effect of Bertolix or that Bertolix affects the effect of other medicines when used at the same time.

Bertolix with food and drink

Numbness in the oral cavity or throat can occur immediately after application of the spray. Food and drink should therefore be avoided until the numbness has passed. Use after meal and drink.

Pregnancy and breastfeeding

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.

Bertolix should not be used during pregnancy and lactation.

Driving and using machines

Bertolix does not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bertolix contains methyl parahydroxybenzoate (E 218), 96% ethanol, and sodium

Bertolix contains methyl parahydroxybenzoate (E 218) which may cause an allergic reaction (possibly delayed).

Bertolix contains 96% ethanol

This medicine contains 81.40 mg of alcohol ( ethanol ) per ml corresponding to 13.84 mg / 0.17 ml (one puff spray). The amount of ethanol in a puff (0.17 ml) of this medicine corresponds to less than 0.4 ml of beer or 0.2 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects. 

Bertolix contains  sodium

This medicine contains less than 1 mmol (23 mg) sodium per spray dose (0.17 ml), ie essentially ‘sodium-free’.

3. How to use Bertolix

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults:

This medicine is for use in adults.

The recommended dose is 2-4 puffs each time 2-6 times daily, no more often than every 1.5-3 hours. Pressure on the pump gives a puff spray.

Do not exceed the recommended dose.

The treatment should not exceed 7 days unless you have a prescription from a doctor. If your symptoms do not improve or if you feel worse after 3 days, if you get a fever or other symptoms, contact your doctor.

Children and adolescents:

This medicine is not for use in children or adolescents (under 18 years of age).

How to use the spray:

  • Put the nozzle in a horizontal position (fig. 1)
  • If the product is used for the first time, hold the spray bottle in an upright position and press firmly with your thumb or forefinger on the spray bottle. To get an even spray, repeat this 5 times. When using the product next time, press the spray bottle twice.
  • Then place the nozzle in the oral cavity and press the spray bottle (fig. 2).
  • When spraying the product, hold your breath.

If you forget to take Bertolix

If you miss a dose, take it as soon as possible. However, if it is time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you get any of the following side effects, stop using the medicine, and contact your doctor immediately or go to the nearest emergency room:

  • swelling of the face, hands and feet, eyes, lips and/or tongue, which may cause difficulty in breathing or swallowing ( angioedema ) – very rare side effect
  • allergic reaction (hypersensitivity)
  • severe allergic reaction (anaphylactic shock ) with signs such as difficulty breathing, chest pain or tightness in the chest and/or dizziness / feeling faint, severe itching or increased rash on the skin, swelling of the face, lips, tongue, and/or throat. This can be life-threatening (this is a side effect that has been reported and occurs in an unknown number of users).

Immediately after use, numbness or tingling may occur in the oral cavity or throat. This reaction occurs due to the normal action of the drug and disappears after a short time. In rare cases, nausea or vomiting may occur which is caused by irritation of the throat after using the medicine. These symptoms go away on their own when you stop using the medicine.

The following side effects have also been reported with the use of benzydamine spray at the following frequencies:

  • Uncommon (may affect up to 1 in 100 people) – increased sensitivity to sunlight ( photosensitivity )
  • Rare (may affect up to 1 in 1,000 people) – burning sensation and dry mouth
  • Very rare (may affect up to 1 in 10,000 people) – difficulty breathing or swallowing (cramps in the larynx or trachea)

Reporting of side effects

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bertolix

Do not store above 30 ° C. Opened packaging is durable for 160 days.

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 label and carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is benzydamine hydrochloride1 milliliter Bertolix oral spray solution contains 3 mg benzydamine hydrochloride equivalent to 2.68 mg benzydamine. One puff (0.17 ml) of the spray contains 510 micrograms of benzydamine hydrochloride equivalent to 456 micrograms of benzydamine.
  • The other ingredients are methyl (E 218), sodium cyclamate (E 952), glycerol(E422), natriumvätebikarbonat, polysorbate 80, ethanol 96%, peppermint flavor (containing peppermint oil, ethanol, menthol), concentrated phosphoric acid ( pH-reglerande), purified water.

What the medicine looks like and the contents of the pack

A clear, colorless liquid with a characteristic peppermint scent in a white HDPE plastic bottle 15 ml or 30 ml, with a white LDPE / HDPE nozzle and a white PP adapter for the pump, in a cardboard box.

Pack size: 75 sprays (15ml) and 150 sprays (30ml)

Pack size:

1 bottle

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

PharmaSwiss Ceska Republika sro 
Jankovcova 1569/2 c 
170 00 Prague 7

Czech Republic

Manufacturer

ICN Polfa Rzeszów SA

ul. Przemysłowa 2

35-959 Rzeszów

Poland

Muhammad Nadeem

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