Septogard plus
Poland
Table of Contents
Package leaflet: information for the user
Septogard Plus, (1.5 mg + 5 mg)/ml, oral aerosol, solution
Benzydamini hydrochloridum + Cetylpyridinii chloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your doctor or pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days, or if you feel worse, consult your doctor.
Table of contents
- What Septogard Plus is and what it is used for
- Important information before using Septogard Plus
- How to use Septogard Plus
- Possible side effects
- How to store Septogard Plus
- Contents of the pack and other information
1. What Septogard Plus is and what it is used for
Septogard Plus is an anti-inflammatory, analgesic and antiseptic medicine intended for local use in the oral cavity. The oral aerosol disinfects the mouth and throat and reduces symptoms of throat inflammation such as pain, redness, swelling, sensation of heat and impaired function.
Septogard Plus is indicated in adults and adolescents over 12 years of age as an anti-inflammatory, analgesic and antiseptic agent for the treatment of:
- irritation of the throat, oral cavity and gums,
- gingivitis and pharyngitis,
- before and after tooth extraction.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.
2. Important information before using Septogard Plus
When not to use Septogard Plus:
- if the patient is allergic (hypersensitive) to benzidamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6);
- in children under 6 years of age, as this pharmaceutical form is not intended for this age group.
Warnings and precautions
Before starting to use Septogard Plus, discuss it with your doctor or pharmacist.
Do not use Septogard Plus for longer than 7 days. If symptoms worsen or do not improve within 3 days, or if other symptoms such as fever occur, contact your doctor.
The use of topically applied medicines, especially over a prolonged period, may lead to irritation. In such a case, treatment should be discontinued.
Do not use Septogard Plus in combination with anionic compounds, such as those found in toothpastes; therefore, it is not recommended to use the medicine immediately before or after brushing teeth.
Avoid direct contact of Septogard Plus with eyes.
This medicine must not be inhaled.
Children and adolescents
Do not use Septogard Plus in children under 6 years of age, as the oral spray is not intended for this age group.
Do not use Septogard Plus in children aged 6 to 12 years unless otherwise advised by a doctor.
Septogard Plus and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not use Septogard Plus simultaneously with other antiseptic products.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Septogard Plus is not recommended during pregnancy.
Before using Septogard Plus while breastfeeding, discuss it with your doctor.
Your doctor will decide whether breastfeeding should be discontinued or whether treatment with Septogard Plus should be stopped.
Driving and operating machinery
Septogard Plus has no effect or has a negligible effect on the ability to drive and operate machinery.
Septogard Plus contains macrogolglycerol hydroxystearate and sodium
Macrogolglycerol hydroxystearate may cause indigestion and diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
3. How to use Septogard Plus
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
To obtain a single dose, press the spray pump head once or twice. The dose may be repeated every 2 hours, 3 to 5 times per day.
Use in children and adolescents
Adolescents over 12 years of age
To obtain a single dose, press the spray pump head once or twice. The dose may be repeated every 2 hours, 3 to 5 times per day.
Do not use Septogard Plus in children under 12 years of age.
Do not exceed the recommended dose.
For optimal effect, it is not recommended to use the medicine immediately before or after tooth brushing.
Method of administration
Before first use of Septogard Plus, press the spray pump head at least 3–4 times until a uniform spray is obtained. If the medicine has not been used for a prolonged period (at least one week), press the spray pump head 1–2 times to ensure a uniform spray.
Open the mouth widely, direct the applicator towards the throat, and press the spray pump head 1–2 times.
Hold your breath while spraying the medicine.
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 other symptoms such as fever occur, consult a doctor.
Consult a doctor if the condition is recurrent or if you notice new changes in its characteristics.
Use of a higher than recommended dose of Septogard Plus
If a dose higher than recommended is used or if a large amount of the medicine is accidentally swallowed, contact a doctor or pharmacist immediately.
Missed dose of Septogard Plus
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (may occur less frequently than in 1 out of 1,000 people):
- urticaria, increased skin sensitivity to sunlight (photosensitivity),
- sudden, uncontrolled constriction of the airways in the lungs (bronchospasm),
- burning sensation in the mouth.
Very rare (may occur less frequently than in 1 out of 10,000 people):
- local irritation of the oral cavity.
Frequency unknown (frequency cannot be estimated from available data):
- allergic reaction (hypersensitivity): severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, intense itching of the skin or raised skin rash (urticaria), swelling of the face, lips, tongue and (or) throat, which may potentially be life-threatening,
- loss of sensation (numbness) of the oral mucosa.
These symptoms are usually transient. However, if they occur, it is recommended to consult a doctor or pharmacist.
Following the instructions provided in the patient information leaflet can reduce the risk of adverse reactions.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.
5. How to store Septogard Plus
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine for more than 6 months after first opening. No special storage conditions are required after first opening.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the pack and other information
What Septogard Plus contains
The active substances in this medicine are: benzylamine hydrochloride and cetylpyridinium chloride.
Each ml of oral cavity aerosol solution contains 1.5 mg of benzylamine hydrochloride and 5 mg of cetylpyridinium chloride in the form of cetylpyridinium chloride monohydrate.
One spray contains 0.1 ml of oral cavity aerosol solution, which includes 0.15 mg of benzylamine hydrochloride and 0.5 mg of cetylpyridinium chloride in the form of cetylpyridinium chloride monohydrate.
Other ingredients are: glycerol (E 422), sodium saccharin, macrogol glycerol hydroxystearate, peppermint flavour (containing: natural essential oil of peppermint, natural peppermint extract, maltodextrins, menthofuran, pulegone, gum arabic (E 414)) and purified water.
What Septogard Plus looks like and contents of the pack
Septogard Plus is a clear, colourless solution.
Polyethylene bottle (HDPE) with a dosing pump (PE/POM/EVA/stainless steel/aluminium/silicone emulsion) and applicator (PP/HDPE): 30 ml of oral cavity aerosol solution in a cardboard box.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the European Economic Area countries under the following names:
Lithuania: Benzydamine hydrochloride/Cetylpyridinium chloride Farmak 1.5 mg/5 mg/ml burnos gleivės purškalas (tirpalas)
Poland: Septogard Plus