Septolet 3 mg/1 mg lozenges for sucking, honey and lemon flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Septolete 3 mg/1 mg lozenges with honey and lemon flavour
bendizamidine hydrochloride/cetylpyridinium chloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet
- What Septolete is and what it is used for
- What you need to know before taking Septolete
- How to take Septolete
- Possible side effects
- How to store Septolete
- Contents of the pack and other information
1. What Septolete is and what it is used for
This medicine contains the active substances bencidamine hydrochloride and cetylpyridinium chloride.
This medicine is an anti-inflammatory, analgesic, and antiseptic for local oral use. It disinfects the mouth and throat and reduces signs of throat inflammation such as pain, redness, swelling, heat, and impaired function.
This medicine is used in adults, adolescents, and children over 6 years of age for short-term local anti-inflammatory, analgesic, and antiseptic treatment of irritation of the throat, mouth, and gums.
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 starting to take Septolete
Do not take Septolete
- if you are allergic to benzidamine 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 this medicine:
- If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other anti-inflammatory painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), you should not use this medicine, as benzidamine hydrochloride also belongs to the class of non-steroidal anti-inflammatory drugs.
- If you have or have had bronchial asthma. Caution is advised in this case.
- If you have open wounds or ulcers in the mouth or throat.
Do not take this medicine for longer than 7 days. If symptoms do not improve or worsen after 3 days, or if new symptoms such as fever appear, consult a doctor.
The use of topical preparations, especially over a long period of time, may lead to sensitization; in such a case, treatment should be discontinued and a doctor should be consulted to establish appropriate therapy.
This medicine should not be used in combination with anionic compounds, such as those present in toothpastes; therefore, it is not recommended to use the product immediately before or after tooth brushing.
Children and adolescents
This medicine should not be given to children under 6 years of age, as the pharmaceutical form is not suitable for this age group.
Other medicines and Septolete
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take any other type of antiseptic while taking this medicine.
Taking Septolete with food, drink and alcohol
Do not take this medicine with milk, as milk may reduce its effectiveness.
Do not take this medicine with meals or drinks. Do not eat or drink at least one hour before taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
This medicine is not recommended during pregnancy.
You should discuss breastfeeding with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.
Driving and using machines
This medicine has not been shown to affect the ability to drive or operate machinery.
This medicine contains isomalt (E953), sodium benzoate (E211) and sodium
This medicine contains isomalt. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains up to 0.0009 mg of sodium benzoate in each lozenge. Sodium benzoate may cause local irritation.
This medicine contains less than 1 mmol (23 mg of sodium) per lozenge, which is essentially "sodium-free".
3. How to take Septolete
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist again.
Adults
The recommended dose is 3 to 4 lozenges per day. One lozenge should be slowly dissolved in the mouth every 3 to 6 hours.
Adolescents over 12 years of age
The recommended dose is 3 to 4 lozenges per day. One lozenge should be slowly dissolved in the mouth every 3 to 6 hours.
Children from 6 to 12 years of age
The recommended dose is 3 lozenges per day. One lozenge should be slowly dissolved in the mouth every 3 to 6 hours. An adult should supervise the administration of the lozenges in children aged 6 to 12 years.
Children under 6 years of age
This medicine must not be used in children under 6 years of age.
Do not exceed the recommended dose.
Do not take this medicine immediately before or during meals or drinks.
Do not eat or drink for at least one hour after taking the medicine.
It is not recommended to use the medicine immediately before or after tooth brushing.
Duration of treatment
Do not take this medicine for longer than 7 days. If symptoms do not improve or worsen after 3 days, or if other symptoms appear, such as fever, consult a doctor.
Consult your doctor if the condition is recurrent or if you notice any recent changes in its characteristics.
If you take more Septolete than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.
If you forget to take Septolete
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following serious adverse effects, stop taking this medicine and contact a doctor immediately:
- allergic reaction (hypersensitivity).
- severe allergic reaction (anaphylactic shock), which may include signs such as difficulty breathing, pain or tightness in the chest and/or dizziness/fainting, intense itching of the skin or skin lumps (hives), swelling of the face, lips, tongue and/or throat, which may potentially be life-threatening.
The frequency of these adverse effects is unknown.
Rare (may affect more than 1 in 1,000 patients):
-
hives (urticaria), increased skin sensitivity to sunlight (photosensitivity),
-
sudden and uncontrolled narrowing of the airways in the lungs (bronchospasm).
Very rare (may affect more than 1 in 10,000 patients):
- local irritation in the mouth, burning sensation in the mouth.
Frequency not known (frequency cannot be estimated from available data):
- burning of the oral mucosa, loss of sensation (anaesthesia) of the oral mucosa.
Generally, these side effects are transient. However, if they occur, it is recommended to speak with your doctor or pharmacist.
If you follow the instructions in the patient information leaflet, you will reduce the risk of side effects.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Septolete
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 the month indicated.
Store in the original packaging to protect from light.
This medicine does not require any special storage temperature.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Septolete
- The active substances are bencidamine hydrochloride and cetylpyridinium chloride. Each pastille contains 3 mg of bencidamine hydrochloride and 1 mg of cetylpyridinium chloride.
- The other components are peppermint oil, levomenthol, sucralose (E955), citric acid (E330), isomalt (E953), lemon flavour, honey flavour, curcumin (E100) (containing sodium benzoate (E211)).
See section 2 “Septolete contains isomalt (E953), sodium benzoate (E211) and sodium”.
Appearance of the product and contents of the pack
Yellowish-white to yellow, round pastilles with bevelled edges and a rough surface. White specks, uneven colouring, presence of air bubbles in the "hard candy" mass, and small irregular edges may be present. Diameter of the pastille: 18 mm – 19 mm, thickness: 7 mm – 8 mm.
Septolete pastilles are available in boxes containing 8, 16, 24, 32 and 40 pastilles in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
KRKA, d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
Manufacturer
TAD Pharma GmbH
Heinz-Lohmann-Strasse 5
27472 Cuxhaven,
Germany
Or
KRKA, d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder:
KRKA Farmacéutica, S.L.,
C/Anabel Segura 10,
28108 Alcobendas, Madrid
Spain
This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Member State | Name of the medicinal product |
Czech Republic | Benzydamin/cetylpyridinium chlorid KRKA d.d. |
Denmark | Septabene lemon and honey 3 mg/1 mg lozenges |
Iceland | Septabene lemon and honey 3 mg/1 mg oral tablets |
Spain | Septolete 3 mg/1 mg honey and lemon flavored lozenges |
Date of the last revision of this leaflet: May 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).