Septafar

Package leaflet: information for the user

Septafar 1.5 mg/ml + 5.0 mg/ml oral mucosa spray, solution

benzidamine hydrochloride/cetylpyridinium chloride
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your condition worsens after 3 days.

Contents of this leaflet:

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

1. What Septafar is and what it is used for

Septafar oral mucosa spray, solution, is an anti-inflammatory, analgesic and antiseptic medicinal product for local oral use. The oral mucosa spray disinfects the mouth and throat and reduces signs of throat inflammation such as pain, redness, swelling, burning sensation and impaired function.

Septafar is used for anti-inflammatory, analgesic and antiseptic treatment of:

• irritations of the throat, mouth and gums
• gingivitis and pharyngitis
• before and after tooth extractions.

It is necessary to speak with a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using Septafar

Do not use Septafar

• if you are allergic to benzidamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6).
• this medicine must not be used in children under 6 years of age, as this pharmaceutical form is not suitable for this age group.

Warnings and precautions
Talk to your doctor or pharmacist before using Septafar.
Septafar must not be used for longer than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms appear, such as fever, consult your doctor.
Prolonged use, especially, of topical preparations may lead to sensitization reactions.

in which case treatment must be discontinued.
Septafar must not be used together with anionic compounds, such as those present in toothpastes;
therefore, it is recommended not to use the product immediately before or after brushing teeth.
Avoid direct contact of Septafar oral mucosal spray, solution with the eyes.
The product must not be inhaled.
Children and adolescents
Septafar must not be used in children under 6 years of age, as the oral mucosal spray is not suitable for this age group.
Other medicines and Septafar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use other antiseptics while using Septafar.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Septafar is not recommended during pregnancy.
Breastfeeding should be discussed with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with Septafar.
Driving and using machines
Septafar does not affect the ability to drive or operate machinery.
Septafar contains ethanol, hydrogenated polyoxyl castor oil, and sodium
This medicine contains 267.60 mg of alcohol (ethanol) per 1 ml of oral mucosal spray, solution.
The amount in 1 ml of this medicine is equivalent to less than 7 ml of beer or 3 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
Hydrogenated polyoxyl castor oil may cause gastrointestinal disturbances and diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may lead to a positive result in doping tests according to the blood alcohol concentration limits indicated by certain sports federations.

3. How to use Septafar

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
For a single dose, press the dispenser one or two times. You may repeat this every 2 hours,
3–5 times a day.
Use in children and adolescents
Adolescents above 12 years of age
For a single dose, press the dispenser one or two times. You may repeat this every 2 hours,
3–5 times a day.

Children aged 6 to 12 years
Septafar should be used in this age group only on medical advice.
For a single dose, press the dispenser once. This may be repeated every 2 hours, 3–5 times a day.
Do not use Septafar in children under 6 years of age.
Do not exceed the recommended doses.
For optimal effect, it is recommended not to use the product immediately before or after brushing teeth.

Method of administration
Before first use of Septafar oral mucosa spray, to ensure proper dispensing, press the spray several times. If the spray has not been used for a long time (at least one week), press the dispenser once to ensure regular spray delivery.

Remove the plastic cap before use.

Open the mouth widely, direct the spray nozzle towards the throat, and press the dispenser 1–2 times. Hold your breath during administration.
Each time the dispenser is pressed once, 0.1 ml of oral mucosa spray solution is released, containing 0.15 mg of benzidamine hydrochloride and 0.5 mg of cetylpyridinium chloride.

Duration of treatment
Do not use this medicine for more than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms appear (e.g. fever), consult your doctor. Consult your doctor if the condition is recurrent or if you notice any recent changes in its characteristics.

If you use more Septafar than you should
If you take an excessive amount of this medicine or accidentally ingest large quantities, consult your doctor or pharmacist immediately.

If you forget to use Septafar
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):

• urticaria, increased skin sensitivity to sunlight (photosensitivity),
• sudden and involuntary narrowing of the airways in the lungs (bronchospasm).

Very rare (may affect up to 1 in 10,000 people):

• local irritation in the mouth, burning sensation in the mouth.

Not known (frequency cannot be estimated from the available data):

• allergic reaction (hypersensitivity), severe allergic reaction (anaphylactic shock), the signs of which may include breathing difficulties, chest pain or tightness and/or dizziness/weakness, intense skin itching or appearance of swellings on the skin, swelling of the face, lips, tongue and/or throat, which could potentially put the patient's life at risk.
• burning of the oral mucosa, loss of sensation (anaesthesia) of the oral mucosa.

These side effects are usually temporary. However, if any of these occur, it is recommended to speak with your doctor or pharmacist.
By following the instructions in this leaflet, you will reduce the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Septafar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening the container, the product must be used within 12 months when stored below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Septafar contains

• The active substances are benzalkonium chloride and cetylpyridinium chloride. Each ml of oral mucosal spray, solution contains 1.5 mg of benzalkonium chloride and 5 mg of cetylpyridinium chloride. One spray delivery contains 0.1 ml of oral mucosal spray, solution, which corresponds to 0.15 mg of benzalkonium chloride and 0.5 mg of cetylpyridinium chloride.
• The other components are: ethanol (96 percent), glycerol (E422), macrogol glyceryl hydroxystearate, sodium saccharin (E954), peppermint oil, purified water. See section 2 “Septafar contains ethanol, hydrogenated castor oil polyoxyl and sodium”.

Description of the appearance of Septafar and contents of the pack
The oral mucosal spray, solution (oral spray) is a clear, colourless to slightly yellow liquid.
Septafar is available in 30 ml bottles of oral mucosal spray, solution, supplied with a spray pump dispenser and cap. 30 ml of oral mucosal spray, solution provides approximately 250 spray doses.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Responsible Pharmacist for Batch Release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the European Economic Area Member States under the following names: