Package leaflet: Information for the patient

Faringo SEPT, 10 mg, lozenges
Ambazone monohydrate
Please read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, even if their symptoms appear identical.
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 3–4 days, or if you feel worse, contact your doctor.

Table of contents of the leaflet:

What Faringo SEPT is and what it is used for
Important information before using Faringo SEPT
How to use Faringo SEPT
Possible side effects
How to store Faringo SEPT
Contents of the pack and other information

1. What Faringo SEPT is and what it is used for

Faringo SEPT is an antiseptic medicine used in infections of the oral cavity and throat. It exhibits bacteriostatic activity (inhibits bacterial growth) against certain types of bacteria such as streptococci (haemolytic, viridans) and pneumococci, which are common causes of oral and throat infections. It has moderate activity against staphylococci. Faringo SEPT does not disturb the physiological intestinal flora.
Faringo SEPT is used as an adjunctive treatment in acute infections of the oral cavity and throat, such as tonsillitis, gingivitis, stomatitis, as well as after tonsillectomy and tooth extraction.

2. Important information before using Faringo SEPT

When not to use Faringo SEPT:
if the patient is allergic to the active substance or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
The medicine contains lactose and sucrose (further information: see below).

Faringo SEPT and other medicines
No interactions between Faringo SEPT and other medicines have been reported. However, if a doctor prescribes other medications, inform him about the use of Faringo SEPT.

Pregnancy and breastfeeding
Faringo SEPT may be used during pregnancy and breastfeeding; however, consult a doctor before using the medicine.

Driving and operating machinery
Faringo SEPT has no influence on the ability to drive or operate machinery.

Faringo SEPT contains sucrose and lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Faringo SEPT

Slowly suck 3 to 5 tablets per day for 3 to 4 days. Do not swallow the tablets, but allow them to dissolve slowly in the oral cavity.
Administer shortly after eating (15–30 minutes), and avoid eating or drinking for 2–3 hours after taking the medication.
Do not exceed the recommended dosage. If symptoms persist, consult a physician.

Overdose of Faringo SEPT
In case of ingestion exceeding the recommended dose, consult a doctor or pharmacist.
There have been no reports of overdose to date. There is no specific antidote for ambazone. In the event of significant overdose, induce vomiting or perform gastric lavage.

Missed dose of Faringo SEPT
If a dose is missed, take the next dose as scheduled. Do not use a double dose to make up for the missed dose.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not everybody experiences them.
No adverse reactions have been reported to date.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 enables continued monitoring of the safety of the medicine.

5. How to store Faringo SEPT

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Faringo SEPT contains

The active substance is ambazone (in the form of ambazone monohydrate).
The other ingredients are: sucrose, lactose, cocoa, povidone K30, stearic acid, vanillin.

The pack contains 10 or 20 lozenges.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Manufacturer:
Terapia S.A.
Fabricii Street No. 124, 400632 Cluj-Napoca
Romania