SEPTOLETE PLUS AER 10MG/2MG/ML 30ML MŪTES

ATC code: R02AA06 

Active substances: Cetylpyridinii Chloridum

Vendor, principal: Krka. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

SEPTOLETE PLUS 2MG/+10MG/1ML 30ML

Package leaflet: Information for the user

Septolete plus 10 mg/2 mg/mL oromucosal spray, solution

benzocaine/cetylpyridinium chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

1. What Septolete plus is and what it is used for

Septolete plus oromucosal spray contains two active substances, cetylpyridinium chloride and benzocaine.
Cetylpyridinium chloride is a mild antiseptic that destroys bacteria and inhibits growth of certain fungi and viruses. It reduces inflammation in the oral cavity and the pharynx and primarily prevents the development of more severe bacterial infections.
Benzocaine belongs to a group of medicines called topical analgesics (painkillers). It alleviates painful swallowing that frequently accompanies infections and inflammations of the oral cavity and the pharynx.
Septolete plus oromucosal spray has topical analgesic and antimicrobial effect. It disinfects the oral cavity and the pharynx and alleviate topical pain.
Septolete plus oromucosal spray is used as analgesic and disinfectant in inflammations of the oral cavity and the pharynx.

2. What you need to know before you use Septolete plus Do not take Septolete plus:

-   if you are allergic to benzocaine, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).
-   if you are allergic (hypersensitive) to other topical analgesics.
-   if you have alcohol dependency.
-   if you suffer from methemoglobinemia (a rare blood disease that causes reduced oxygencarrying capacity of the blood).

Warnings and precautions

Talk to your doctor or pharmacist before using Septolete plus.
-   if you have any difficulties breathing,
-   if you are older than 65 years,
-   if you smoke,
-   if you have a heart disease.
In all of the above cases you may be at risk of methemoglobinemia (blood disease), which is a severe side effect (see Section 4: Possible side effects).

Important

-   Do not use Septolete plus if you have open wounds in the mouth, because cetylpyridinium chloride slows down healing of the wounds.
-   If you have a severe infection involving high fever, headache and vomiting; contact your doctor, especially if your condition does not improve within 3 days.
-   Do not spray Septolete plus near the eyes and do not inhale it.
-   After using Septolete plus, you may experience temporary burning sensation, numbness (insensitivity) of mouth and throat or difficulty swallowing. Patients may find it difficult to eat or drink and these patients are more likely to bite their lip and/or tongue, and thus they should avoid eating, drinking, chewing or brushing teeth for at least one hour after using the medicine.
Septolete plus must not be used for prolonged periods or too frequently, because exceeding the prescribed doses increases the risk of side effects.
Septolete plus does not contain sucrose and can thus be used by patients with diabetes.

Children and adolescents

Septolete plus is not recommended for children under 6 years of age.

Other medicines and Septolete plus

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Septolete plus has no known effect on other medicines.

Septolete plus with food and drink

Do not take Septolete plus together with milk because milk reduces Septolete plus efficacy.
Do not eat or drink for at least one hour after taking Septolete plus.

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.
Due to limited data on the safety of using the medicine in pregnant and breast-feeding women, it is not recommended to use Septolete plus during pregnancy and breast-feeding.

Driving and using machines

Septolete plus does not affect the ability to drive and use machines.
Septolete plus contains small amount of ethanol (alcohol), less than 100 mg per dose.

3. How to use Septolete plus

Always use Septolete plus exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents aged 12 and older
Press the spray twice to administer a single dose. You may repeat it in every 2-3 hours, up to 8 times a day.
Children aged 6 to 12 years
Press the spray twice to administer a single dose. You may repeat it in every 2-3 hours, up to 8 times a day. Children must use the spray under adult supervision.
Due to limited data on safety, Septolete plus is not recommended for children aged under 6 years. Elderly patients
Recommended dose for the elderly is the same as for the adults. If you are older than 65 years, if you take other medicines and you have other diseases, you are at higher risk of developing methemoglobinemia.
Do not use Septolete plus for more than seven consecutive days.

Instructions for use

Before using the medicine, remove the plastic cap.
Open your mouth, direct the spray nozzle towards throat and press the spray head. Hold your breath while spraying.
Always recap the bottle after using the spray.
One bottle of Septolete plus can be used by one patient.
When pressing the spray once, it releases 0.15 mL of solution containing 1.5 mg of benzocaine and 0.3mg of cetylpyridinium chloride.

If you take more Septolete plus than you should

The possibility of overdose is minimal considering the amount of active substance in a single dose. Using higher doses may cause gastrointestinal disorders, nausea, vomiting and diarrhoea.
Prolonged use of higher than recommended doses or too frequent use over a short period may lead to development of methemoglobinemia (inability of blood to carry oxygen). If you notice symptoms such as headache, fatigue, dizziness and difficulty breathing, notify your doctor immediately and stop using the medicine.

If you forget to take Septolete plus

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. Uncommon (may affect up to 1 in 100 people):
-   Hypersensitivity reaction (allergy). If you notice symptoms such as rash, itching, swelling of skin (angioedema) and difficulty breathing, contact your doctor immediately. If you are hypersensitive benzocaine (also known by its chemical name 4-amino benzoic acid ester), it is possible that you are also hypersensitive to other topical anaesthetics of the same class such as procaine and tetracaine.
Rare (may affect up to 1 in 1,000 people):
-   Gastrointestinal disorders such as nausea, vomiting and diarrhoea, especially when using higher than recommended doses
-   Blood disorders (methemoglobinemia - blood disease involving inability of blood to carry oxygen). If you notice symptoms such as headache, fatigue, dizziness and difficulty breathing, notify your doctor immediately and stop using the medicine.

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 via www.ravimiamet.ee. By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Septolete plus

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.
This medicine does not require any special storage conditions.
Do not throw away 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 plus contains

-   The active substances are benzocaine and cetylpyridinium chloride. One mL of oromucosal spray contains 10 mg of benzocaine and 2 mg of cetylpyridinium chloride.
-   The excipients are ethanol (96%), glycerol (E422), sodium sucrose (E954), peppermint oil and purified water.

What Septolete plus looks like and contents of the pack

Oromucosal spray is clear, colourless to yellowish solution.
Plastic bottle with spray pump and plastic cap contains 30 mL of oromucosal spray and is packaged in a carton.

Marketing Authorisation Holder and Manufacturer

KRKA, d. d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA, d.d., Novo Mesto Eesti Pärnu mnt 141 11314 Tallinn
Phone: +372 6671658
This leaflet was last revised in July 2015.