TRACHISAN 8 mg Lozenges

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. WHAT IS TRACHISAN 8 MG AND WHAT IS IT USED FOR
3. IMPORTANT INFORMATION BEFORE TAKING TRACHISAN 8 MG
4. HOW TO TAKE TRACHISAN 8 MG
5. POSSIBLE SIDE EFFECTS
6. HOW TO STORE TRACHISAN 8 MG
7. OTHER INFORMATION
   1. and eating hot foods. Due to reduced sensitivity to heat, there is an increased risk of burning the mucous membrane of the mouth and throat. Repeated use of the medicine may cause numbness of the throat and difficulty swallowing.
   2. Dosage
8. HOW TO TAKE TRACHISAN 8 MG
9. POSSIBLE SIDE EFFECTS
   1. Very rare:
10. HOW TO STORE TRACHISAN 8 MG
11. OTHER INFORMATION
    1. Cyprus:
    2. Czech Republic:
    3. Estonia:
    4. Greece:
    5. Poland:
    6. Latvia:
    7. Lithuania:
    8. Slovenia:
    9. Netherlands:

PATIENT INFORMATION LEAFLET: USER INFORMATION

Read the entire leaflet carefully, as it contains important information for the patient. This medicine is available without a prescription, so that some conditions can be treated without the help of a doctor. However, to achieve good treatment results, the Trachisan 8 mg medicine should be used cautiously.
Keep this leaflet, so that you can read it again if necessary. Consult a doctor or pharmacist if advice or additional information is needed.
If symptoms worsen or do not improve after 3 days, consult a doctor. If symptoms not listed in the leaflet occur, inform a doctor or pharmacist.

1. Table of contents of the leaflet:
2. What is Trachisan 8 mg and what is it used for
3. Important information before taking Trachisan 8 mg
4. How to take Trachisan 8 mg
5. Possible side effects
6. How to store Trachisan 8 mg
7. Other information

1. WHAT IS TRACHISAN 8 MG AND WHAT IS IT USED FOR

These lozenges are a group of medicines used to reduce throat pain (local anesthetics). The use of local anesthetics reduces throat discomfort.
Trachisan 8 mg is used for short-term local treatment of pain associated with non-purulent throat infections.

2. IMPORTANT INFORMATION BEFORE TAKING TRACHISAN 8 MG

When not to use Trachisan 8 mg:

Trachisan 8 mg should not be used in children under 12 years of age.
When to exercise special caution when using Trachisan 8 mg:
Cautious use is advised in patients with impaired liver function, as this may lead to increased lidocaine blood levels and the occurrence of toxic symptoms. If toxic symptoms occur, the use of the medicine should be discontinued and a doctor consulted.

3. HOW TO TAKE TRACHISAN 8 MG

• Adults and children over 12 years: 1 lozenge every 2-3 hours.
• Do not take more than 8 lozenges per day.

The lozenge should be slowly dissolved in the mouth.
Do not exceed the recommended dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Trachisan 8 mg can cause side effects, although not everybody gets them.
Possible side effects:

• Rarely: allergic reactions (e.g., rash, itching, swelling), dizziness, drowsiness.
• Very rarely: heart rhythm disturbances, decreased blood pressure.

If any side effects occur, discontinue use and consult a doctor.

5. HOW TO STORE TRACHISAN 8 MG

Store at room temperature, in a dry place, out of reach of children.

6. OTHER INFORMATION

The above information has been approved by the Office for Registration of Medicinal Products, Medical Devices, and Biocides.

and eating hot foods. Due to reduced sensitivity to heat, there is an increased risk of burning the mucous membrane of the mouth and throat. Repeated use of the medicine may cause numbness of the throat and difficulty swallowing.

in patients with severe damage and/or inflammation of the mucous membrane of the mouth and throat, as the absorption of the active substance may be increased. This applies especially to patients with cardiovascular diseases or those prone to seizures.
in patients with impaired liver and/or kidney function, as these conditions may cause an increase in the level of the active substance.Children and adolescents
Trachisan 8 mg should not be used in children under 12 years of age (see above).
There is no sufficient information on the use of Trachisan 8 mg in children and adolescents if and immediately after taking Trachisan 8 mg, to prevent choking or injury caused by biting (see above).
Taking Trachisan 8 mg with other medicines
Inform your doctor about all medicines taken recently, including those available without a prescription.
Taking Trachisan 8 mg with food and drink
Do not eat and drink immediately after taking Trachisan 8 mg, to prevent choking or injury caused by biting (see above).
Be cautious when drinking hot beverages and eating hot foods. Due to reduced sensitivity to heat, there is an increased risk of burning the mouth and throat.
Pregnancy
Trachisan 8 mg should not be used during pregnancy, unless the doctor considers it absolutely necessary.
Before using the medicine during breastfeeding, consult a doctor.
Breastfeeding
Before using Trachisan 8 mg during breastfeeding, consult a doctor, as lidocaine may pass into breast milk.
Driving and operating machinery
Trachisan 8 mg has no effect on the ability to drive and operate machinery.

Dosage

Adults and children over 12 years:

• Usually 1 Trachisan 8 mg tablet every 2-3 hours.
• Maximum daily dose: 8 Trachisan 8 mg tablets.

Do not use Trachisan 8 mg for more than 5 days without consulting a doctor.
Method of administration
The tablet should be slowly dissolved in the mouth until completely dissolved. Do not chew or swallow the tablet.
If side effects occur, discontinue use and consult a doctor.
If symptoms persist or worsen, consult a doctor.
Overdose
In case of overdose, seek medical attention immediately.
Overdose symptoms may include: seizures, heart rhythm disturbances, decreased blood pressure, respiratory depression, and coma.
2

3. HOW TO TAKE TRACHISAN 8 MG

Trachisan 8 mg should always be taken according to the recommendations in this leaflet. In case of doubt, consult a doctor or pharmacist.
Unless the doctor recommends otherwise, the usual dose of the medicine is:
Adults - 1 lozenge to be sucked at intervals of at least 2 hours. Do not take more than 6 lozenges per day. Trachisan 8 mg should be slowly dissolved in the mouth.
How long to take Trachisan 8 mg?
Without consulting a doctor, do not take Trachisan 8 mg for more than 3 days.
If you feel that the effect of Trachisan 8 mg is too strong or too weak, consult a doctor or pharmacist.
Taking a higher dose of Trachisan 8 mg than recommended
Consult a doctor or pharmacist immediately.
If a patient takes a very large number of tablets or Trachisan 8 mg, lidocaine overdose and symptoms such as: yawning, excitement, dizziness, nausea, dysarthria (speech disorders caused by certain nervous system disorders), hearing and vision disturbances, as well as coordination disorders may occur.
Missing a dose of Trachisan 8 mg
Do not take a double dose to make up for a missed lozenge.
Continue taking the lozenges as recommended above (do not take more than 1 lozenge every 2 hours and no more than 6 lozenges per day).
Stopping Trachisan 8 mg treatment
The effect is currently unknown.
In case of doubt, always consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Trachisan 8 mg can cause side effects, although not everybody gets them.
Frequent (may occur in up to 1 in 10 patients):

• Irritation of the oral mucosa.

Rare (may occur in up to 1 in 1000 patients):

• Allergic reactions, such as: rash, itching, angioedema (swelling of the face, tongue, throat, which can cause difficulty breathing and swallowing).

If an allergic reaction occurs, discontinue use and consult a doctor immediately.
Very rare (may occur in up to 1 in 10,000 patients):

• Visual disturbances, dizziness, drowsiness, nausea, vomiting, diarrhea, constipation.

Reporting side effects
If any side effects occur, report them to a doctor or pharmacist, or directly to the Office for Registration of Medicinal Products, Medical Devices, and Biocides.

Very rare:

Sorbitol contained in this medicine may have a laxative effect.
If any of the side effects worsen or any side effects not listed in the leaflet occur, inform a doctor or pharmacist.

5. HOW TO STORE TRACHISAN 8 MG

Store in a place inaccessible and out of sight of children.
Do not use Trachisan 8 mg after the expiry date stated on the immediate packaging (blister) and the carton after the "Expiry date" label.
The expiry date stated is the last day of the given month.
Do not store above 25°C.
Do not store in the refrigerator or freeze.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. OTHER INFORMATION

What Trachisan 8 mg contains

• The active substance of the medicine is lidocaine hydrochloride.
• One lozenge contains 8 mg of lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate).
• Other ingredients of the medicine are sorbitol, peppermint oil, magnesium stearate.

What Trachisan 8 mg looks like and what the pack contains
The lozenges are white and round.
Trachisan 8 mg is available in packs containing 20 lozenges (2 blisters of 10 each).
Marketing authorization holder:
YES Pharmaceutical Development Services GmbH
Bahnstrasse 42 – 46
61381 Friedrichsdorf
Germany
Manufacturer:
Engelhard Arzneimittel GmbH & Co KG
Herbergerstrasse 3,
61138 Niederoderlen
Germany
Email: [email protected]

Cyprus:

Lidocaine YES 8 mg

Czech Republic:

name to be provided later

Estonia:

name to be provided later

Greece:

Lidocaine YES 8 mg

Poland:

Trachisan 8 mg

Latvia:

Lidocaine YES 8 mg

Lithuania:

Lidocaine YES 8 mg

Slovenia:

Trachisan 8 mg

Netherlands:

Trachisan 8 mg
Date of leaflet approval:
For more detailed information, please contact the representative of the marketing authorization holder: YES Pharmaceutical Development Services GmbH, Bahnstrasse 42 – 46
61381 Friedrichsdorf, Germany.
This medicine is authorized in the Member States of the European Economic Area under the following names: