Doppelsept Gardvo

Leaflet attached to the packaging: patient information

DoppelSept Throat, 5 mg + 5 mg, lozenges

Benzocaine + Chlorhexidine dihydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is DoppelSept Throat and what is it used for
• 2. Important information before taking DoppelSept Throat
• 3. How to take DoppelSept Throat
• 4. Possible side effects
• 5. How to store DoppelSept Throat
• 6. Package contents and other information

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

DoppelSept Throat contains two active substances:

• benzocaine - a substance with anesthetic and analgesic properties.
• chlorhexidine dihydrochloride - a substance with antibacterial properties.

DoppelSept Throat is used for local, short-term, symptomatic treatment of mild throat and mouth infections without fever, accompanied by sore throat, throat irritation, and loss of voice.

DoppelSept Throat is also used for local, short-term, symptomatic treatment of mouth inflammation, such as minor mouth ulcers (aphthae).

If there is no improvement after 5 days or if the patient feels worse, they should consult their doctor.

DoppelSept Throat is indicated for use in adults and children over 12 years of age.

2. Important information before taking DoppelSept Throat

When not to take DoppelSept Throat

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• in patients with methemoglobinemia (a blood disease related to the formation of abnormal hemoglobin that cannot bind and transport oxygen). The most common symptom is cyanosis, which occurs as a result of tissue hypoxia.

Warnings and precautions

Before starting to take DoppelSept Throat, the patient should discuss it with their doctor or pharmacist:

• if the patient has intolerance to ester-type local anesthetics (especially para-aminobenzoic acid derivatives, PABA), parabens, or p-phenylenediamine, as they may be hypersensitive to benzocaine.
• if the patient has severe or extensive oral mucosa injuries.
• if the patient has gum disease (periodontal disease), as chlorhexidine may cause an increase in dental calculus.

It is recommended to maintain good oral hygiene to reduce the accumulation of dental calculus and tooth discoloration, which may be caused by chlorhexidine.

DoppelSept Throat should not be taken directly before or during eating or drinking, due to the risk of choking.

The benzocaine in the product may cause transient numbness in the mouth and throat, making swallowing difficult.

It is best to take it an hour before a meal or after a meal.

Adults over 65 years of age

Elderly and debilitated patients may be more sensitive to benzocaine, so a lower dose may be necessary for these patients.

Children and adolescents

Children, like elderly or debilitated patients, may be more sensitive to benzocaine.

DoppelSept Throat should not be taken by children under 12 years of age, as local anesthetics may cause transient swallowing disorders and increase the risk of choking.

DoppelSept Throat and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

DoppelSept Throat should not be taken at the same time as other products containing antiseptics without consulting a doctor.

DoppelSept Throat should not be taken with:

• sulfonamides (bactericidal medicines)
• cholinesterase inhibitors (medicines used, among other things, in Alzheimer's disease).

Certain ingredients in toothpastes may reduce the effectiveness of chlorhexidine, so the mouth should be rinsed thoroughly after using toothpaste.

Effect on diagnostic test results

Taking benzocaine may affect the results of tests that assess pancreatic function using bentyromide.

Treatment should be discontinued at least three days before the test and the doctor should be informed.

DoppelSept Throat with food, drink, and alcohol

DoppelSept Throat should not be taken directly before or during eating or drinking.

The benzocaine in the product may cause transient numbness in the mouth and throat, making swallowing difficult.

It is best to take it an hour before a meal or after a meal.

Pregnancy, breastfeeding

The use of the medicinal product is not recommended during pregnancy.

The use of the medicinal product is not recommended during breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive and operate machinery.

DoppelSept Throat contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, which means the medicine is considered "sodium-free".

3. How to take DoppelSept Throat

This medicine should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions.

In case of doubt, the patient should consult their doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years of age:1 lozenge every 2 hours.

Do not take more than 8 lozenges per day.

Always use the smallest effective dose.

If symptoms persist for more than 5 days or are accompanied by high fever, dizziness, or vomiting, the patient should consult their doctor.

DoppelSept Throat should not be taken directly before or during eating or drinking.

Use in children and adolescents

DoppelSept Throat should not be taken by children under 12 years of age.

Method of administration:

The medicine is intended for oral use.

The lozenge should be slowly sucked in the mouth.

Do not chew or swallow it.

Overdose of DoppelSept Throat

In case of overdose, the patient should immediately consult their doctor or pharmacist and inform them of the amount of lozenges taken.

Symptoms of overdose include: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, agitation or convulsions, ringing in the ears, increased sweating.

Low blood pressure may also occur.

Missed dose of DoppelSept Throat

Do not take a double dose to make up for a missed dose.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, DoppelSept Throat can cause side effects, although not everybody gets them.

Uncommon side effects (affecting 1 to 10 in 10,000 patients):

• irritation of the tongue tip and oral mucosa.

Side effects whose frequency cannot be estimated from the available data:

• methemoglobinemia (a blood disease related to the formation of abnormal hemoglobin);
• allergic skin and mucous membrane reactions;
• loss of appetite;
• taste disorders (rarely persistent);
• respiratory disorders, nasal mucosa congestion, throat irritation;
• brown discoloration of teeth, tongue, nausea, indigestion, abdominal pain, diarrhea, dry mouth, burning of the tongue, tingling of the tongue, increased deposition of dental calculus;
• rash, urticaria, contact dermatitis, allergic dermatitis;
• brown discoloration of dental fillings, dental prostheses, and other appliances used in the mouth.

Brown discolorations may be more pronounced in patients with dental calculus and usually appear after one week of treatment.

Discoloration of the tongue is not harmful and usually resolves on its own.

Discoloration of teeth is not permanent and can be removed during oral hygiene.

Discoloration of dental fillings may be permanent.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects can help gather more information on the safety of the medicine.

5. How to store DoppelSept Throat

The medicine should be stored out of sight and reach of children.

Do not store 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 month stated.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Package contents 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 flavor PHS-003268, orange flavor PHS-003270.

What DoppelSept Throat looks like and what the pack contains

DoppelSept Throat lozenges are round with a score line on one side, white-yellow in color.

PVC/PE/PVDC-Aluminum blister pack in a cardboard box.

The pack contains 20 lozenges.

Marketing authorization 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, the patient should contact the local representative of the marketing authorization holder:

Queisser Pharma Poland Sp. z o.o.

ul. Domaniewska 39

02-672 Warsaw

Poland

Date of last revision of the leaflet: