Septolete extra 3mg/1mg sucking tablets lemon elderflavoured 16x

Septolete extra lemon-elderberry 3 mg/1 mg lozenge benzidamine hydrochloride/cetylpyridinium chloride Before you start taking this medicine, read this leaflet carefully 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. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1. What Septolete extra lemon-elderberry 3 mg/1 mg lozenge (hereinafter: Septolete extra lemon-elderberry) is and what it is used for 2. What you need to know before you take Septolete extra lemon-elderberry 3. How to take Septolete extra lemon-elderberry 4. Possible side effects 5. How to store Septolete extra lemon-elderberry 6. Contents of the pack and other information

1. What Septolete extra lemon-elderberry is and what it is used for

Septolete extra lemon-elderberry contains the active substances benzidamine hydrochloride and cetylpyridinium chloride. Septolete extra lemon-elderberry lozenge is an anti-inflammatory, analgesic and antiseptic (disinfectant) medicine for local use. Septolete extra lemon-elderberry disinfects the oral cavity and pharynx, relieves symptoms of pharyngitis, such as pain, redness, swelling, burning sensation and difficulty swallowing. Septolete extra lemon-elderberry is used to treat symptoms of pharyngitis associated with mild infections of the oral cavity and pharynx (including gingivitis and pharyngitis). 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 you take Septolete extra lemon-elderberry

Do not take Septolete extra lemon-elderberry: - 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Septolete extra lemon-elderberry. Do not use Septolete extra lemon-elderberry for more than 7 days. If symptoms worsen or do not improve within 3 days, or if other symptoms (e.g. fever) occur, consult a doctor. Local use preparations – especially if used for a long time – may cause an allergic reaction, in which case treatment must be discontinued. Septolete extra lemon-elderberry should not be used together with anionic compounds (such as those found in toothpastes), therefore it is not recommended to use the product immediately before or after brushing your teeth. Special caution is required: - if you are allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other anti-inflammatory painkillers, the so-called non-steroidal anti-inflammatory drugs (NSAIDs). Use of the medicine is not recommended. - if you currently have or have previously suffered from asthma. In this case, caution is required.

Children and adolescents

Septolete extra lemon-elderberry must not be used in children under 6 years of age.

Other medicines and Septolete extra lemon-elderberry

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take. Do not use any other disinfectant preparation during the use of Septolete extra lemon-elderberry.

Septolete extra lemon-elderberry taken with food, drink and alcohol

Septolete extra lemon-elderberry should not be taken with milk, as milk reduces the effect of the lozenges. Do not take Septolete extra lemon-elderberry before or during meals or with drinks! Do not eat or drink for at least one hour after taking Septolete extra lemon-elderberry!

Pregnancy and breast-feeding

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. Septolete extra lemon-elderberry is not recommended during pregnancy. During breast-feeding, talk to your doctor, who will decide whether you should stop breast-feeding or Septolete extra lemon-elderberry treatment.

Effects of the medicine on the ability to drive and use machines

Septolete extra does not affect the ability to drive and use machines.

Septolete extra lemon-elderberry contains isomalt (E953), butylhydroxyanisole (E320), sodium benzoate (E211) and propylene glycol (E1520)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Butylhydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Sodium benzoate may cause mild irritation to the skin, eyes and mucous membranes. Propylene glycol may cause skin irritation.

3. How to take Septolete extra lemon-elderberry

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure about the dose. Adults The recommended dose is 3-4 lozenges per day. One lozenge should be allowed to dissolve slowly in the oral cavity every 3-6 hours. Children aged 12 years and over The recommended dose is 3-4 lozenges per day. One lozenge should be allowed to dissolve slowly in the oral cavity every 3-6 hours. Children aged 6-12 years The recommended dose is 3 lozenges per day. One lozenge should be allowed to dissolve slowly in the oral cavity every 3-6 hours. Children under 6 years of age: Septolete extra lemon-elderberry must not be used in children under 6 years of age. Do not exceed the stated dose. Do not take the lozenge immediately before or during meals or with drinks! Do not eat or drink for at least one hour after taking the medicine! For optimal effect, it is not recommended to use the preparation 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 within 3 days, or if other symptoms (e.g. fever) occur, consult a doctor. Ask your doctor for advice if your illness returns or if you notice a change in its characteristics. If you take more Septolete extra lemon-elderberry than you should If you accidentally swallow too much of the medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take Septolete extra lemon-elderberry

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask 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): - hypersensitivity reaction, - urticaria (hives), increased skin reaction to sunlight (photosensitivity), - sudden, uncontrolled narrowing of the airways (bronchospasm).

Very rare (may affect up to 1 in 10,000 people): - local irritation, mild burning sensation in the oral cavity.

Not known (frequency cannot be estimated from the available data): - burning sensation of the oral mucosa, loss of sensation in the oral mucosa (anaesthesia). These side effects are usually transient. However, if they do occur, it is recommended that you talk to your doctor or pharmacist. By following the instructions in the patient information leaflet, you reduce the risk of side effects. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the authority, through the contact details listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Septolete extra lemon-elderberry

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 carton after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. This medicinal product does not require any special storage conditions. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Septolete extra lemon-elderberry contains - The active substances are benzidamine hydrochloride and cetylpyridinium chloride. One lozenge contains 3 mg benzidamine hydrochloride and 1 mg cetylpyridinium chloride. - The other ingredients are: peppermint oil, levomenthol, sucralose (E955), anhydrous citric acid (E330), isomalt (E953), citrus flavour (contains butylhydroxyanisole (E320)), elderberry flavour (contains propylene glycol (E1520)), curcumin (E100) (contains sodium benzoate (E211)), chlorophyll-copper complexes (E141) (contains propylene glycol (E1520)). See section 2 “Septolete extra lemon-elderberry contains isomalt (E953), butylhydroxyanisole (E320), sodium benzoate (E211) and propylene glycol (E1520)”. What Septolete extra lemon-elderberry looks like and contents of the pack Round, pale green-green, rough-surfaced, bevelled-edge lozenge. White spots, uneven colour, air bubbles in the “hard candy” mass and slightly uneven edges may be present on the lozenge. Diameter of the lozenge: 18.0-19.0 mm, height: 7.0-8.0 mm. Septolete extra lemon-elderberry is available in blister packs and boxes containing 8, 16, 24, 32 or 40 lozenges. Not all pack sizes may be marketed. Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Manufacturers: 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 EEA under the following names: Czech Republic Septabene citron a bezový květ Bulgaria Септолете тотал лимон и цвят от бъз 3 mg/1 mg таблетки за смучене Estonia Septolete omni lemon & elderflower Finland Septabene sitruuna & seljankukka 3 mg/1 mg imeskelytabletti Croatia Septolete duo limun i bazga 3 mg/ 1 mg pastile Latvia Septabene ar citronu un plūškoku 3 mg / 1 mg sūkājamās tablets Poland Septolete ultra o smaku cytryny i czarnego bzu Lithuania Septabene 3 mg/1 mg kietosios pastilės Hungary Septolete extra citrom-bodza 3 mg/1 mg szopogató tabletta Italy Septolete Portugal Septolete Duo limão e flor de sabugueiro Romania Septolete omni lămâie şi soc 3 mg/1 mg pastile Slovakia Septolete extra s príchuťou citrónu a bazového kvetu 3 mg/1 mg tvrdé pastilky Slovenia Septabene z okusom limone in bezga 3 mg / 1 mg pastile OGYI-T-22871/12 8× OGYI-T-22871/13 16× OGYI-T-22871/14 24× OGYI-T-22871/15 32× OGYI-T-22871/16 40× Date of last revision of the leaflet: September 2017