SEPTOLETE 3 mg/1 mg Lozenge

Зміст інструкції

1. Septolete eucalyptus flavour 3 mg/1 mg lozenges
   1. What is Septolete eucalyptus flavour and what is it used for
   2. What you need to know before taking Septolete aroma eucalipto
   3. How to take Septolete aroma eucalipto
   4. Possible side effects
   5. How to store Septolete aroma eucalipto
   6. Contents of the pack and other information
2. Septolete lemon and honey flavour 3 mg/1 mg lozenges
   1. What is Septolete lemon and honey flavour and what is it used for
   2. What you need to know before taking Septolete lemon and honey flavor
   3. How to take Septolete aroma limone e miele
   4. Possible side effects
   5. How to store Septolete aroma limone e miele
   6. Contents of the pack and other information
3. Septolete lemon and elderflower flavour 3 mg/1 mg lozenges
   1. What Septolete lemon and elderflower flavour is and what it is used for
   2. What you need to know before taking Septolete aroma limone e fiori di sambuco
   3. How to take Septolete aroma limone e fiori di sambuco
   4. Possible side effects
   5. How to store Septolete aroma limone e fiori di sambuco
   6. Package Contents and Other Information

Septolete eucalyptus flavour 3 mg/1 mg lozenges

benzidamine hydrochloride/cetylpyridinium chloride

Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What Septolete eucalyptus flavour is and what it is used for
• 2. What you need to know before you take Septolete eucalyptus flavour
• 3. How to take Septolete eucalyptus flavour
• 4. Possible side effects
• 5. How to store Septolete eucalyptus flavour
• 6. Contents of the pack and other information

1. What is Septolete eucalyptus flavour and what is it used for

Septolete eucalyptus flavour lozenges is an anti-inflammatory, analgesic and antiseptic medicine for
local oral use. Septolete eucalyptus flavour disinfects the mouth and throat and reduces the signs of
throat inflammation such as pain, redness, swelling, burning and impaired function.
Septolete eucalyptus flavour is used in the anti-inflammatory, analgesic and antiseptic treatment of:

• irritations of the throat, mouth and gums
• gingivitis and pharyngitis. You should consult a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Septolete aroma eucalipto

Do not take Septolete aroma eucalipto

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Septolete aroma eucalipto.
Septolete aroma eucalipto should not be used for more than 7 days. If symptoms worsen or do not
improve after 3 days, or if other symptoms appear, such as fever, consult your doctor.

The use, especially if prolonged, of topical preparations may lead to sensitization phenomena, in
which case you should stop treatment.
Septolete aroma eucalipto should not be used together with anionic compounds, such as those present
for example in toothpastes, therefore it is recommended not to use the product immediately before or
after brushing your teeth.

Children and adolescents
Septolete aroma eucalipto should not be used in children under 6 years of age as the
lozenges are not suitable for this age group.

Other medicines and Septolete aroma eucalipto
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not use other antiseptics when taking Septolete aroma eucalipto.

Septolete aroma eucaliptowith food, drinks and alcohol
Do not take Septolete aroma eucalipto with milk as milk reduces its effectiveness.
Do not take Septolete aroma eucalipto before or during meals. Do not eat or drink for at least one hour
after taking Septolete aroma eucalipto.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Septolete aroma eucalipto is not recommended during pregnancy.
You should discuss breastfeeding with your doctor, and he/she will decide whether to stop
breastfeeding or stop therapy with Septolete aroma eucalipto.

Driving and operating machinery
Septolete aroma eucalipto does not affect the ability to drive or operate machinery.

Septolete aroma eucaliptocontains isomalto (E953)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Septolete aroma eucalipto

Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. If you have doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 3-4 lozenges per day. The lozenge should be dissolved slowly in the mouth
every 3-6 hours.

Adolescents over 12 years of age
The recommended dose is 3-4 lozenges per day. The lozenge should be dissolved slowly in the mouth
every 3-6 hours.

Children from 6 to 12 years of age
The recommended dose is 3 lozenges per day. The lozenge should be dissolved slowly in the mouth
every 3-6 hours. Septolete aroma eucalipto can only be used in this age group on medical advice.
medical advice.

Children under 6 years
Septolete aroma eucalipto is contraindicated in children under 6 years of age.

Do not exceed the recommended doses.
Do not take Septolete aroma eucalipto immediately before or during meals.
Do not eat or drink for at least one hour after taking Septolete aroma eucalipto.
For optimal effect, it is recommended not to use the product immediately before or after
brushing your teeth.

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 occur, such as fever, consult your doctor.
Consult your doctor if the condition is recurrent or if you notice any recent changes in its
characteristics.

If you take more Septolete aroma eucaliptothan you should
In case of accidental ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Septolete aroma eucalipto
Do not take a double dose to make up for a 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 side effects (may affect up to 1 in 1,000 people):

• urticaria, increased skin reactivity to sunlight (photosensitivity),
• sudden and uncontrolled narrowing of the airways to the lungs (bronchospasm) Very rare side effects (may affect up to 1 in 10,000 people):
• local irritation in the oral cavity, burning sensation in the oral cavity

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

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), signs that may include difficulty breathing, chest pain or tightness and/or dizziness/fainting, severe itching of the skin or raised bumps on the skin, swelling of the face, lips, tongue and/or throat and which can be potentially life-threatening,
• burning of the oral mucosa, loss of sensation (anaesthesia) of the oral mucosa.

These side effects are usually transient. However, if they occur, it is recommended to
talk to your doctor or pharmacist.
By following the instructions in the package leaflet, you will reduce the risk of side effects.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store Septolete aroma eucalipto

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 packaging after Scad. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in 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 Septolete eucalyptus flavour contains

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: eucalyptus oil, levomenthol, citric acid (E330), sucralose (E955), isomalt (E953), brilliant blue FCF (E133). See section 2 “Septolete eucalyptus flavour contains isomalt (E953)”.

Description of the appearance of Septolete eucalyptus flavourand contents of the pack
Round lozenges, from blue-white to blue, with bevelled edges. Some small
scratches may be present. Lozenge diameter: 18.0 mm – 19.0 mm, thickness: 7.0 mm – 8.0 mm.
Septolete eucalyptus flavour is available in boxes of 8, 16, 24, 32 or 40 lozenges, in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

Septolete lemon and honey flavour 3 mg/1 mg lozenges

benzidamine hydrochloride/cetylpyridinium chloride

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What Septolete lemon and honey flavour is and what it is used for
• 2. What you need to know before you take Septolete lemon and honey flavour
• 3. How to take Septolete lemon and honey flavour
• 4. Possible side effects
• 5. How to store Septolete lemon and honey flavour
• 6. Contents of the pack and other information

1. What is Septolete lemon and honey flavour and what is it used for

Septolete lemon and honey flavour contains the active substances benzydamine hydrochloride and cetylpyridinium chloride.
Septolete lemon and honey flavour lozenge is a non-steroidal anti-inflammatory, analgesic and antiseptic
medicinal product for local oral use. Septolete lemon and honey flavour disinfects the mouth and throat and reduces the signs of
throat inflammation such as pain, redness, swelling, heat and altered function.
Septolete lemon and honey flavour is used for the treatment of symptoms of sore throat associated with
mild infections of the mouth and throat (including gingivitis and pharyngitis).
You should consult a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Septolete lemon and honey flavor

Do not take Septolete lemon and honey flavor

• if you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).
• this medicine should not be used in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Septolete lemon and honey flavor.
Do not use Septolete lemon and honey flavor for more than 7 days. If symptoms worsen or do not improve
after 3 days, or if other symptoms appear, such as fever, consult your doctor.

The use, especially of topical preparations, particularly for a long period of time, can lead to
sensitization phenomena, in which case you should stop treatment and consult your
doctor to establish appropriate therapy.
Septolete lemon and honey flavor should not be used together with anionic compounds, such as those
present for example in toothpastes, therefore it is recommended not to use the product immediately
before or after brushing your teeth.
Take special care:

• if you are allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or to any other pain reliever and anti-inflammatory drug called non-steroidal anti-inflammatory drugs (NSAIDs). The use of this product is not recommended.
• if you have or have ever had bronchial asthma. In this case, caution should be exercised.

Children and adolescents
Septolete lemon and honey flavor should not be used in children under 6 years of age.

Other medicines and Septolete lemon and honey flavor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not use other antiseptics when taking Septolete lemon and honey flavor.

Septolete lemon and honey flavor with food, drinks and alcohol
Do not take Septolete lemon and honey flavor with milk as milk reduces its effectiveness.
Do not take Septolete lemon and honey flavor before or during meals and while drinking. Do not eat or drink
for at least one hour after taking Septolete lemon and honey flavor.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Septolete lemon and honey flavor is not recommended during pregnancy.
You should discuss breastfeeding with your doctor, and he/she will decide whether to stop
breastfeeding or stop therapy with Septolete lemon and honey flavor.

Driving and using machines
Septolete lemon and honey flavor does not or negligibly alters the ability to drive or
use machines.

Septolete lemon and honey flavor contains isomalt (E 953) and sodium benzoate (E 211) and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
This medicine contains 0.0009 mg of sodium benzoate in each lozenge and may cause local irritation.
This medicine contains less than 1 mmol (23 mg) of sodium per lozenge, i.e. essentially
‘sodium-free’.

3. How to take Septolete aroma limone e miele

Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. If you have doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 3-4 lozenges per day. The lozenge must be dissolved slowly in the mouth
every 3-6 hours.

Adolescents over 12 years of age

The recommended dose is 3-4 lozenges per day. The lozenge must be dissolved slowly in the mouth
every 3-6 hours.

Children from 6 to 12 years of age
The recommended dose is 3 lozenges per day. The lozenge must be dissolved slowly in the mouth
every 3-6 hours. Septolete aroma limone e miele can only be used in this age group on medical advice.

Children under 6 years of age
Septolete aroma limone e miele should not be used in children under 6 years of age.

Do not exceed the recommended doses.
Do not take Septolete aroma limone e miele immediately before or during meals and while drinking.
Do not eat or drink for at least one hour after taking this medicine.
It is not recommended to use this medicine immediately before or after brushing your teeth.

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

If you take more Septolete aroma limone e miele than you should
In case of accidental ingestion of an excessive dose of this medicine, inform your doctor immediately
or go to the nearest hospital.

If you forget to take Septolete aroma limone e miele
Do not take a double dose to make up for a 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):

• skin rash (urticaria), increased reactivity of the skin to sunlight (photosensitivity),
• sudden and uncontrolled narrowing of the airways of the lungs (bronchospasm).

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

• local irritation of the oral cavity, burning sensation in the oral cavity.

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

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), signs that may include difficulty breathing, chest pain or tightness and/or feeling dizzy/faint, severe itching of the skin or raised bumps on the skin, swelling of the face, lips, tongue and/or throat and which may be potentially life-threatening,
• burning of the oral mucosa, loss of sensitivity of the oral mucosa (anaesthesia).

Normally these undesirable events are transient. However, if they occur, it is recommended

to talk to your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through
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 Septolete aroma limone e miele

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 package and on the blister after
Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
This medicine does not require particular storage conditions of
temperature.
Do not dispose of any medicine in 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 Septolete lemon and honey flavour contains

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: peppermint oil, levomenthol, sucralose (E 955), citric acid (E 330), isomalt (E 953), lemon flavour, honey flavour, curcumin (E 100) (containing sodium benzoate (E 211)). See section 2 “Septolete lemon and honey flavour contains isomalt (E 953), sodium benzoate (E 211) and sodium”.

Description of the appearance of Septolete lemon and honey flavour and contents of the pack
Round lozenges with bevelled edges and rough surfaces ranging from light yellow to yellow. Spots may be
present, irregular colouring, air bubbles in the "hard candy" and small jagged
edges. Lozenge diameter: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm.
Septolete lemon and honey flavour is available in boxes containing 8, 16, 24, 32 or 40 lozenges, in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the

following denominations:

Septolete lemon and elderflower flavour 3 mg/1 mg lozenges

benzydamine hydrochloride/cetylpyridinium chloride

Read this leaflet carefully before you start to take this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 7. What Septolete lemon and elderflower flavour is and what it is used for
• 8. What you need to know before you take Septolete lemon and elderflower flavour
• 9. How to take Septolete lemon and elderflower flavour
• 10. Possible side effects
• 11. How to store Septolete lemon and elderflower flavour
• 12. Contents of the pack and other information

1. What Septolete lemon and elderflower flavour is and what it is used for

Septolete lemon and elderflower flavour contains the active substance benzydamine hydrochloride and cetylpyridinium chloride.
Septolete lemon and elderflower flavour lozenge is a non-steroidal anti-inflammatory, analgesic and
antiseptic medicine for local oral use. Septolete lemon and elderflower flavour disinfects the mouth and throat
and reduces the signs of inflammation of the throat such as pain, redness, swelling, heat and altered function.
Septolete lemon and elderflower flavour is used for the treatment of symptoms of sore throat
associated with mild infections of the mouth and throat (including gingivitis and pharyngitis).
You should consult a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Septolete aroma limone e fiori di sambuco

Do not take Septolete aroma limone e fiori di sambuco:

• if you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).
• this medicine should not be used in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Septolete aroma limone e fiori di sambuco.
Do not use Septolete aroma limone e fiori di sambuco for more than 7 days. If symptoms worsen or do not
improve after 3 days, or if other symptoms appear, such as fever, consult your doctor.
The use, especially of topical preparations, particularly for a long period of time, can lead
to sensitization reactions, in which case you should stop treatment and consult your

doctor to establish appropriate therapy.
Septolete aroma limone e fiori di sambuco should not be used together with anionic compounds,
such as those found for example in toothpastes, therefore it is recommended not to use the product
immediately before or after brushing your teeth.
Take special care:

• if you are allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or to any other pain reliever and anti-inflammatory drug called non-steroidal anti-inflammatory drugs (NSAIDs). The use of this product is not recommended.
• if you have or have ever had bronchial asthma. In this case, caution should be exercised.

Children and adolescents
Septolete aroma limone e fiori di sambuco should not be used in children under 6 years of age.

Other medicines and Septolete aroma limone e fiori di sambuco
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not use other antiseptics when taking Septolete aroma limone e fiori di sambuco.

Septolete aroma limone e fiori di sambuco with food, beverages and alcohol
Do not take Septolete aroma limone e fiori di sambuco with milk as milk reduces its
effectiveness.
Do not take Septolete aroma limone e fiori di sambuco before or during meals and drinks. Do not eat or
drink for at least one hour after taking Septolete aroma limone e fiori di sambuco.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Septolete aroma limone e fiori di sambuco is not recommended during pregnancy.
You should discuss breastfeeding with your doctor, and he/she will decide whether to discontinue
breastfeeding or discontinue therapy with Septolete aroma limone e fiori di sambuco.

Driving and using machines
Septolete aroma limone e fiori di sambuco does not alter or alters negligibly the ability to
drive or operate machinery.

Septolete aroma limone e fiori di sambuco contains isomalto (E 953), butylated hydroxyanisole (E

• 320) and sodium benzoate (E 211) and sodiumIf you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes. This medicine contains 0.00075 mg of sodium benzoate in each tablet and may cause local irritation. This medicine contains less than 1 mmol (23 mg) of sodium, i.e. essentially ‘sodium-free’.

3. How to take Septolete aroma limone e fiori di sambuco

Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. If you have doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 3 – 4 lozenges per day. The lozenge must be dissolved slowly in the mouth

every 3-6 hours.

Adolescents over 12 years of age
The recommended dose is 3-4 lozenges per day. The lozenge must be dissolved slowly in the mouth
every 3-6 hours.

Children from 6 to 12 years of age
The recommended dose is 3 lozenges per day. The lozenge must be dissolved slowly in the mouth
every 3-6 hours. Septolete aroma limone e fiori di sambuco can only be used in this age group on
medical advice.

Children under 6 years
Septolete aroma limone e fiori di sambuco should not be used in children under 6 years of age.

Do not exceed the recommended doses.
Do not take Septolete aroma limone e fiori di sambuco immediately before or during meals and
while drinking.
Do not eat or drink for at least one hour after taking this medicine.
It is not recommended to use this medicine immediately before or after brushing your teeth.

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

If you take more Septolete aroma limone e fiori di sambuco than you should
In case of accidental ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Septolete aroma limone e fiori di sambuco
Do not take a double dose to make up for a 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):

• skin rash (urticaria), increased reactivity of the skin to sunlight (photosensitivity),
• sudden and uncontrolled narrowing of the airways of the lungs (bronchospasm).

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

• local irritation of the oral cavity, burning sensation in the oral cavity.

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

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), signs that may include difficulty breathing, chest pain or chest tightness and/or feeling dizzy/faint, severe itching of the skin or raised bumps on the skin, swelling of the face, lips, tongue and/or throat and

which can be potentially life-threatening,

• burning of the oral mucosa, loss of sensitivity of the oral mucosa (anesthesia). Normally these undesirable events are transient. However, if they occur, it is recommended to talk to your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 Septolete aroma limone e fiori di sambuco

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 package and blister after Scad.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
This medicine does not require any particular storage conditions of
temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Septolete lemon and elderflower flavour contains

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: peppermint oil, levomenthol, sucralose (E 955), citric acid (E 330), isomalt (E 953), lemon flavour (containing butylated hydroxyanisole (E 320)), elderflower flavour, curcumin (E 100) (containing sodium benzoate (E 211)), chlorophyll complexes (E 141) (containing sodium). See section 2 “Septolete lemon and elderflower flavour contains isomalt (E 953), butylated hydroxyanisole (E 320), sodium benzoate (E 211) and sodium”.

Description of the appearance of Septolete lemon and elderflower flavour and package contents
Round lozenges with bevelled edges and rough surfaces ranging from light green to green. White spots, irregular colouring, air bubbles in the "hard candy" and small jagged edges may be present.
Lozenges diameter: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm.
Septolete lemon and elderflower flavour is available in boxes containing 8, 16, 24, 32 or 40
lozenges, in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy

KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following names: