Septolette

Package leaflet: Information for the user

Septolete soft core ginger flavour 3 mg/1 mg tablets

benzalkonium chloride/cetilpiridinium chloride
Please read all of 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 instructed you to do.

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

Contents of this leaflet:

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

1. What Septolete soft core ginger flavour is and what it is used for

Septolete soft core ginger flavour contains the active substances benzalkonium chloride and cetilpiridinium chloride.
Septolete soft core ginger flavour tablets are a locally acting oromucosal anti-inflammatory, analgesic (relieves pain), and antiseptic (prevents the spread of pathogens) medicine. Septolete soft core ginger flavour disinfects the mouth and throat and reduces signs of throat inflammation such as pain, redness, swelling, heat, and impaired function.
Septolete soft core ginger flavour is used for short-term local anti-inflammatory, analgesic, and antiseptic treatment of irritations in the throat, mouth, and gums (including gingivitis and pharyngitis) in adults, adolescents, and children aged 6 years and over.
You should consult a doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before taking Septolete soft core ginger flavour

Do not take Septolete soft core ginger flavour

• if you are allergic to benzydamine 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Septolete soft core ginger flavour.

• if you are allergic to salicylates (e.g. acetylsalicylic acid, salicylic acid) or to any other anti-inflammatory painkiller belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Use of this product is not recommended.
• if you have or have ever had bronchial asthma. In this case, caution is required.
• if you have open wounds or ulcerations in the mouth or throat (e.g. following dental extractions).

Do not use Septolete soft core ginger flavour for more than 7 days. If symptoms worsen or do not improve after 3 days, or if additional symptoms occur (e.g. fever), consult your doctor.
The use of topical preparations, especially over prolonged periods, may lead to sensitization reactions; if this occurs, treatment must be discontinued and a doctor should be consulted to establish appropriate therapy.
Septolete soft core ginger flavour 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 tooth brushing.
Children and adolescents
Septolete soft core ginger flavour must not be used in children under 6 years of age.
Other medicines and Septolete soft core ginger flavour
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use other antiseptics while taking Septolete soft core ginger flavour.
Septolete soft core ginger flavour with food, drinks and alcohol
Do not take Septolete soft core ginger flavour with milk, as milk reduces its effectiveness.
Do not take Septolete soft core ginger flavour before or during meals or while drinking. Do not eat or drink for at least one hour after taking Septolete soft core ginger flavour.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Septolete soft core ginger flavour is not recommended during pregnancy.
You should discuss breastfeeding with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with Septolete soft core ginger flavour.
Driving and using machines
Septolete soft core ginger flavour does not affect or affects negligibly the ability to drive or use machinery.
Septolete soft core ginger flavour contains isomalt (E 953), sodium benzoate (E 211), benzyl alcohol (E 1519), sodium and limonene
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains up to 0.0015 mg of sodium benzoate per tablet and may cause local irritation.
This medicine contains 0.63 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you suffer from liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause side effects (called "metabolic acidosis").
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
This medicine contains limonene fragrance (contained in peppermint oil). Limonene may cause allergic reactions.

3. How to take Septolete soft core ginger flavour

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 3–4 tablets per day. The tablet should be slowly dissolved in the mouth every 3–6 hours.
Adolescents above 12 years of age
The recommended dose is 3–4 tablets per day. The tablet should be slowly dissolved in the mouth every 3–6 hours.
Children from 6 to 12 years of age
The recommended dose is 3 tablets per day. The tablet should be slowly dissolved in the mouth every 3–6 hours. Septolete soft core ginger flavour may be used in this age group only on medical advice.
Children under 6 years of age
Septolete soft core ginger flavour must not be used in children under 6 years of age.
Do not exceed the recommended doses.
Do not take Septolete soft core ginger flavour immediately before or during meals or 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 teeth.
Duration of treatment
Do not use this medicine for longer than 7 days. If symptoms worsen or do not improve after 3 days, or if new 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 soft core ginger flavour than you should
In case of accidental overdose, inform your doctor immediately or go to the nearest hospital.
If you forget to take Septolete soft core ginger flavour
Do not take a double dose to make up for the forgotten 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 sensitivity of the skin 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 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 which may include difficulty breathing, chest pain or tightness in the chest and/or dizziness/fainting, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, which may potentially be life-threatening,
• burning of the oral mucosa, loss of sensitivity of the oral mucosa (anaesthesia).

These side effects are usually temporary. However, if any of these occur, it is recommended to speak to 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 Septolete soft core ginger aroma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp/EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Septolete soft core ginger flavour contains

• The active substances are benzalkonium chloride and cetylpyridinium chloride. Each tablet contains 3 mg of benzalkonium chloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: citric acid (E 330), sucralose (E 955), levomenthol, peppermint oil (containing limonene), natural honey flavour, natural lemon flavour, curcumin colouring (containing sodium benzoate (E 211)), liquid maltitol and isomalt (E 953) in the outer part of the tablet; and liquid maltitol, citric acid (E 330), sucralose (E 955), natural lemon flavour and ginger flavour (containing benzyl alcohol (E 1519)) in the soft core. See section 2 “Septolete soft core ginger flavour contains isomalt (E 953), sodium benzoate (E 211), benzyl alcohol (E 1519), sodium and limonene”.

Description of the appearance of Septolete soft core ginger flavour and package contents
Oval-shaped tablets, light yellow to yellow, with bevelled edges and a rough surface. White spots, uneven colouring, air bubbles within the tablet and small irregular edges may be present. Inside the tablet there is a colourless soft core. Tablet dimensions: approximately 20 × 15 mm in length and width, thickness between 10.0 and 11.7 mm.
Septolete soft core ginger flavour is available in packs containing 8, 16, 24, 32 or 40 tablets 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 European Economic Area Member States under the following names: