Doppelsept throat

Package leaflet: Information for the user

DoppelSept Gardło, 5 mg + 5 mg, lozenges
Benzocainum + Chlorhexidini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your 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 5 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

1. What DoppelSept Gardło is and what it is used for
2. Important information before taking DoppelSept Gardło
3. How to take DoppelSept Gardło
4. Possible side effects
5. How to store DoppelSept Gardło
6. Contents of the pack and other information

1. What DoppelSept Gardło is and what it is used for

DoppelSept Gardło contains two active substances:

• benzocaine – a substance with anaesthetic and analgesic properties.
• chlorhexidine dihydrochloride – a substance with antibacterial properties.

DoppelSept Gardło is used for local, short-term, symptomatic treatment of mild infections of the throat and oral cavity occurring without fever, accompanied by sore throat, throat irritation, or hoarseness.
DoppelSept Gardło is also used for local, short-term, symptomatic treatment of inflammatory conditions of the oral cavity, such as minor mucosal ulcers (aphthae).
If there is no improvement after 5 days, or if your condition worsens, consult your doctor.
DoppelSept Gardło is indicated for use in adults and children over 12 years of age.

2. Important information before using DoppelSept Gardło

When not to use DoppelSept Gardło

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• in patients suffering from methemoglobinemia (a blood disorder involving the formation of abnormal hemoglobin, unable to bind and transport oxygen). The most common symptom is cyanosis, resulting from tissue hypoxia.

Warnings and precautions
Before starting treatment with DoppelSept Gardło, consult a doctor or pharmacist:

• If the patient has intolerance to ester-type local anesthetics (especially para-aminobenzoic acid [PABA] derivatives), parabens, or p-phenylenediamine, as they may exhibit hypersensitivity to benzocaine.
• If the patient has severe or extensive injuries of the oral mucosa.
• If the patient has periodontitis (gum disease), chlorhexidine may cause increased supragingival calculus formation.

Maintaining adequate oral hygiene is recommended to reduce the accumulation of dental calculus and tooth staining, which may be caused by chlorhexidine.
DoppelSept Gardło should not be used immediately before or during eating or drinking due to the risk of choking. The benzocaine contained in the product may cause transient numbness in the mouth and throat and may impair swallowing. It is best to use the product one hour before or after a meal.
Adults over 65 years of age
Elderly and debilitated individuals may be more sensitive to benzocaine; therefore, a lower dose may be necessary in these patients.
Children and adolescents
Children, similarly to elderly or debilitated individuals, may be more sensitive to benzocaine.
Do not use in children under 12 years of age, as local anesthetics may cause transient swallowing disturbances and increase the risk of choking.
DoppelSept Gardło and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use other antiseptic-containing products simultaneously without consulting a doctor.
Do not use DoppelSept Gardło together with:

• sulfonamides (bactericidal drugs)
• cholinesterase inhibitors (drugs used, among others, in Alzheimer's disease).

Some ingredients in toothpastes may reduce the effectiveness of chlorhexidine; therefore, rinse the mouth thoroughly after using toothpaste.
Effect on diagnostic test results
The use of benzocaine affects the results of pancreatic function tests using bentiromide. Treatment should be discontinued at least three days before the test, and the doctor should be informed.
DoppelSept Gardło, food, drink, and alcohol
DoppelSept Gardło should not be used immediately before or during eating or drinking.
The benzocaine contained in the product may cause transient numbness in the mouth and throat and may impair swallowing. It is best to use the product one hour before or after a meal.
Pregnancy and breastfeeding
The use of this medicinal product is not recommended during pregnancy. The use of this medicinal product is not recommended during breastfeeding.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
DoppelSept Gardło contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, meaning the medicine is considered "sodium-free".

3. How to use DoppelSept Gardło

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and children over 12 years of age: 1 lozenge every 2 hours. Do not use more than 8 lozenges per day.
Always use the lowest effective dose.
If symptoms persist for more than 5 days, or if they are accompanied by high fever, dizziness or vomiting, consult a doctor.
Do not use DoppelSept Gardło immediately before or during eating or drinking.
Use in children and adolescents:
Do not use in children under 12 years of age.
Method of administration:
This medicine is intended for oral use. The lozenge should be slowly sucked in the mouth. Do not chew or swallow it.
Overdose of DoppelSept Gardło
In case of overdose, consult a doctor or pharmacist immediately and inform them of the number of lozenges taken.
Symptoms of overdose include slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, restlessness or convulsions, tinnitus, and increased sweating.
Low blood pressure may also occur.
Missed dose of DoppelSept Gardło
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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.
Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients):

• irritation of the tip of the tongue and oral mucosa.

Adverse reaction for which the frequency cannot be determined based on available data:

• methemoglobinemia (a blood disorder associated with the presence of abnormal hemoglobin);
• allergic reactions affecting the skin and mucous membranes;
• loss of appetite;
• taste disturbances (rarely permanent);
• breathing difficulties, nasal mucosa congestion, throat irritation;
• brown discoloration of teeth, tongue, nausea, dyspepsia, abdominal pain, diarrhea, dry mouth, burning sensation of the tongue, tingling of the tongue, increased dental calculus formation;
• rash, urticaria, contact dermatitis, allergic dermatitis;
• brown discoloration of dental fillings, dental prostheses and other oral appliances.

Brown discolorations may be more pronounced in patients with dental calculus and usually appear within a week after starting treatment. Discoloration of the tongue is not dangerous and usually resolves spontaneously. Tooth discoloration is not permanent and can be removed during oral hygiene procedures. Discoloration of dental fillings may be permanent.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 .
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store DoppelSept Gardło

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
Do not use this medicine after the expiry date stated on the carton after: EXP. 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 DoppelSept Throat contains

• The active substances are benzocaine and chlorhexidine dihydrochloride.
• The other ingredients are: mannitol, microcrystalline cellulose, povidone K29/32, magnesium stearate, sodium cyclamate (E 952), sodium saccharin (E 954), menthol flavour PHS-003268, orange flavour PHS-003270.

What DoppelSept Throat looks like and contents of the pack
DoppelSept Throat lozenges are round, white-yellow in colour, with a score line on one side.
Packaged in blisters made of PVC/PE/PVDC – Aluminium, contained in a cardboard box.
The pack contains 20 lozenges.
Marketing Authorisation Holder
Doppelherz Pharma GmbH
Schleswiger Strasse 74
24941 Flensburg
Germany
Manufacturer
Laboratorios ALCALA FARMA S.L.
Avenida de Madrid 82
Alcalá de Henares
28802 – Madrid
Spain
For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Queisser Pharma Poland Sp. z o.o.
ul. Domaniewska 39
02-672 Warsaw
Poland