Septolete total lozenges a16 lemon and honey

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

Septolete®
total lemon and honey, 1 mg/3 mg, lozenges
INN: cetylpyridinium, benzydamine
Read this leaflet carefully before you start taking this medicine because it contains information
that are important to you.
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
or a pharmacist.
 Save the instructions. You may need to read it again.
 If you have additional questions or need advice, contact your pharmacist.
 If you experience any side effects, contact your doctor or pharmacist. This
includes any side effects not listed in this guide. See section 4.
 If you do not feel better or feel worse after 3 days, you must contact your doctor.
In this guide you will read:
1. What is the medicine Septolete total lemon and honey and what is it intended for
2. What you should know before taking the drug Septolete total lemon and honey
3. How to take the drug Septolete total lemon and honey
4. Possible side effects
5. How to store the drug Septolete total lemon and honey
6. Contents of the package and other information

1. What is the medicine Septolete total lemon and honey and what is it intended for
The drug Septolete total lemon and honey contains the active substances cetylpyridinium chloride and benzydamine hydrochloride.
Cetylpyridinium belongs to the group of antiseptics, while benzydamine acts as an anti-inflammatory (prevents inflammation) and
relieves pain.
Septolete total lemon and honey lozenges are used to relieve symptoms of inflammation and pain:
- for irritation in the throat, mouth and gums,
- in case of inflammation of the gums and pharynx
The drug Septolete total lemon and honey is intended for use in adults, adolescents and children over the age of 6
year.
If you do not get better or your symptoms worsen after 3 days, you must contact your doctor.
2. What you should know before taking the drug Septolete total lemon and honey
You must not take Septolete total lemon and honey:
- if you are allergic (hypersensitive) to cetylpyridinium chloride, benzydamine chloride, or to any auxiliary
the drug substance Septolete total lemon and honey (listed in section 6).
The drug Septolete total lemon and honey must not be used in children under 6 years of age.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist first
before you start taking the medicine Septolete total lemon and honey.
Warnings and precautions
Talk to your doctor or pharmacist before using Septolete total lemon and honey lozenges.
If the condition does not improve or worsens after 3 days, contact your doctor.
Application of topical preparations, especially over a long period of time, can lead to reactions
hypersensitivity. In this case, the treatment must be stopped immediately.
Septolete Total Lemon and Honey must not be used in combination with anionic compounds, such as these
which are found in toothpastes. Therefore, it is not recommended to use this medicine immediately before or after
brushing teeth.
In particular, take care of:
- If you are allergic to salicylates (eg acetylsalicylic acid and salicylic acid) or other medicines
against inflammation and pain called non-steroidal anti-inflammatory drugs (NSAIDs). The use of these
drugs are not advised.
- If you have or have ever had bronchial asthma. In this case, caution is necessary.
Do not use the medicine for more than 7 days.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist first
before you start taking the medicine Septolete total lemon and honey.
Other medicines and medicine Septolete total lemon and honey
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
what other medicines.

Avoid simultaneous application of other antiseptics.
Taking Septolete total lemon and honey with food and drinks
Do not take Septolete total lemon and honey lozenges with milk, as milk reduces their effectiveness.
Do not take Septolete total lemon and honey before or during a meal. Do not eat or drink for at least 1 hour
after taking lozenges.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor or
pharmacist for advice before taking this medicine.
The use of Septolete total lemon and honey is not recommended during pregnancy and breastfeeding.
Driving vehicles and operating machines
Lozenges Septolete total lemon and honey have no or negligible influence on motor control ability
vehicles or operating machinery.
The drug Septolete total lemon and honey contains isomalt (E953) and sodium benzoate (E211).
In case of intolerance to certain sugars, consult your doctor before using this medicine.
Sodium benzoate (E211) is a mild irritant to the skin, eyes and mucous membranes.
3. How to take the drug Septolete total lemon and honey
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
doctor, or pharmacist. If you are not sure, check with your doctor or pharmacist.
Adults and children over 12 years old
The recommended dose is 3-4 lozenges per day. The lozenge should be dissolved slowly in the mouth every 3 to 6 hours.
Children aged 6 to 12 years
The recommended dose is 3 lozenges per day. The lozenge should be dissolved slowly in the mouth every 3 to 6 hours.
Children under 6 years old
The drug Septolete total lemon and honey must not be given to children under 6 years of age.
Do not exceed the recommended dose.
Do not take Septolete total lemon and honey lozenges immediately before a meal.
Do not eat or drink for at least one hour after taking the medicine.
In order to achieve an optimal effect, it is not recommended to use this medicine immediately before or after washing
teeth.
If the condition does not improve or worsens after 3 days, contact your doctor.
Do not use Septolete total lemon and honey for longer than 7 days.
If you have taken more Septolete total lemon and honey than you should
In case of accidental overdose, immediately talk to a doctor or go to the nearest health center
institution.
If you forgot to take the medicine Septolete total lemon and honey

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking 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.
patients taking this medicine.
Adverse effects are classified according to the frequency of occurrence in the following categories:
Rare side effects (may occur in up to 1 in 1000 patients taking the medicine):
- allergic reactions (hypersensitivity reactions),
– hives (urticaria), increased sensitivity of the skin to sunlight caused by the drug (photosensitivity),
- difficulty breathing due to sudden narrowing of the airways in the lungs (bronchospasm).
Very rare side effects (may occur in up to 1 in 10,000 patients taking the drug):
- local irritation of the oral cavity, burning sensation in the oral cavity.
Frequency not known (cannot be estimated from the available data):
- burning sensation on the mucous membrane of the mouth, loss of sensation (anesthesia) on the mucous membrane of the mouth.
These side effects are usually transient. However, if they occur, contact your doctor or
pharmacist.
If you follow the instructions given in the Medication Guide, you will reduce the risk of side effects.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist.
This includes any possible side effects that are not listed in this guide. By signing up
adverse reactions can help evaluate the safety of this medicine. They suspect unwanted reactions
you can report to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store the drug Septolete total lemon and honey
Keep the medicine out of the sight and reach of children.
You must not use the drug Septolete total lemon and honey after the expiration date indicated on the outer label
inner packaging after "Valid until:". The expiration date refers to the last day of the above
of the month.
The drug does not require special temperature storage conditions.
Store in original packaging in order to protect from light.
Unusable medicines are handed over to the pharmacy where the notice that they are to be collected is displayed in that pharmacy
unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with
communal waste. These measures will help protect the environment.

6. Contents of the package and other information
What does Septolete total lemon and honey contain
The active substances are cetylpyridinium chloride and benzydamine hydrochloride.
One lozenge contains 1 mg of cetylpyridinium chloride, anhydrous (as cetylpyridinium chloride,
monohydrate) and 3 mg of benzydamine hydrochloride.
Auxiliary substances are: peppermint essential oil; levomenthol; sucralose (E955); citric acid, anhydrous
(E330); isomalt (type M) (E953); lemon aroma (terpenes, lemon oil, citral); honey aroma (glycerol triacetate
(E1518), ethanol (96%), aromatic substances); color Curcumin (E100) (contains sodium benzoate (E211)).
What the drug Septolete total lemon and honey looks like and the contents of the package
Round lozenges with beveled edges, rough surface, light yellow to yellow color. The presence of white spots is possible,
uneven color, air bubbles in the sweet, hard mass and small sharp edges. Lozenge diameter: 18.0 mm –
19.0 mm, thickness: 7.0 mm – 8.0 mm.
The inner packaging is a blister (PVC/PE/PVDC//Al) with 8 lozenges.
The outer packaging is a collapsible cardboard box containing:
– one blister (8 lozenges in total), or
- two blisters (16 lozenges in total), or
– three blisters (24 lozenges in total), or
- four blisters (32 lozenges in total) and instructions for the medicine.
License holder and manufacturer
License holder:
KRKA-FARMA DOO BELGRADE, Jurija Gagarina 26/V/II, Belgrade
Manufacturer:
KRKA DD, NOVO MESTO, Šmarješka cesta 6, Novo mesto, Slovenia
This instruction was last approved
January 2018
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
Septolete total lemon and honey, blister, 1 x 8 lozenges: 515-01-03117-16-001 from 29.01.2018.
Septolete total lemon and honey, blister, 2 x 8 lozenges: 515-01-03118-16-001 from 29.01.2018.
Septolete total lemon and honey, blister, 3 x 8 lozenges: 515-01-03119-16-001 from 29.01.2018.
Septolete total lemon and honey, blister, 4 x 8 lozenges: 515-01-03120-16-001 from 29.01.2018