Gardimax Medica

Leaflet attached to the packaging: patient information

GARDIMAX medica, 5 mg + 1 mg, lozenges

Chlorhexidine dihydrochloride + Lidocaine hydrochloride
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
This medicine should be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
You should keep this leaflet, so you can read it again if you need to.
You should consult a pharmacist if you need advice or additional information.

• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
• If after 3-4 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. WHAT IS GARDIMAX MEDICA AND WHAT IS IT USED FOR

This medicine is used for symptomatic treatment to relieve painful conditions associated with inflammation or irritation in the course of inflammatory conditions of the oral cavity and throat.

2. IMPORTANT INFORMATION BEFORE TAKING GARDIMAX MEDICA

When not to take Gardimax medica

• If the patient is allergic to the active substances (chlorhexidine dihydrochloride or lidocaine hydrochloride) or any of the other ingredients of this medicine (listed in section 6).
• Due to the presence of menthol, caution should be exercised when using in children if symptoms preceding seizures occur.
• In children under 6 years of age.

You should consult a doctor if any of the above contraindications apply to the patient or have applied in the past.

Warnings and precautions

Before taking Gardimax medica, you should consult a pharmacist.
Gardimax medica should not be used for a long time. You should not suck one lozenge immediately after another.
You should avoid using the product in people who are particularly prone to allergies.
In the event of taking too high a dose (more than 20 lozenges per day), there is a risk of excessive loss of sensitivity in the laryngeal area, leading to reduced control of the swallowing reflex and increased risk of choking.
Due to the presence of menthol, caution should be exercised when using in children if symptoms preceding seizures occur.
You should consult a doctor if any of the above warnings apply to the patient or have applied in the past.

Children and adolescents

This medicine should not be used in children under 6 years of age.

Gardimax medica and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This medicine should not be used at the same time as medicines for mild forms of Alzheimer's disease (cholinesterase inhibitors).
This medicine should not be used at the same time as other disinfectant medicines.

Gardimax medica with food and drink

You should avoid taking food and drink immediately after using the medicine. Due to reduced sensitivity to heat, there is an increased risk of burns to the oral cavity and throat caused by taking too hot drinks and food.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you suspect you are pregnant or plan to become pregnant, you should consult a doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, this medicine should only be used if necessary, after consulting a doctor.

Driving and using machines

No effects of Gardimax medica on the ability to drive and use machines have been found.

Gardimax medica contains sorbitol

This medicine contains sorbitol. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
Gardimax medica does not contain sugar and can be used by diabetics.

3. HOW TO TAKE GARDIMAX MEDICA

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
This medicine is for short-term symptomatic use: 3 to 4 days. If after this period there is no improvement or new symptoms and/or general symptoms, such as fever, occur during use, you should contact your doctor.

Recommended dose

Adults: 6 to 10 lozenges per day, suck one lozenge slowly.
Children from 6 years of age: half the adult dose (3 to 5 lozenges per day).

Taking a higher dose of Gardimax medica than recommended

If you take more of this medicine than recommended, you should immediately contact your doctor or pharmacist. Symptoms of overdose: anxiety, tinnitus, respiratory failure, arrhythmia, swallowing difficulties.

Missing a dose of Gardimax medica

You should not take a double dose to make up for a missed dose.

Stopping treatment with Gardimax medica

No special precautions are necessary.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases:

• allergic skin and mucous membrane reactions (rash, oral mucosa inflammation)
• possibility of taste disturbance, burning sensation on the tongue, and acute allergic reactions (anaphylactic reactions).
• after long-term and constant use of chlorhexidine, transient brown discoloration of the teeth may occur. These discolorations can be removed.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. HOW TO STORE GARDIMAX MEDICA

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton after: EXP (Expiry Date). The first two digits indicate the month, the next two or four digits indicate the year. The expiry date indicates the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Gardimax medica contains

• The active substances of the medicine are: chlorhexidine dihydrochloride 5 mg, lidocaine hydrochloride 1 mg.
• The other ingredients are: sorbitol (E420), magnesium stearate, anhydrous citric acid, levomenthol.

What Gardimax medica looks like and what the pack contains

Gardimax medica lozenges are available in packs containing 12, 24, 36 lozenges in perforated blisters divided into single doses.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

TACTICA Pharmaceuticals Sp z.o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
phone: +48 889 388 538
Logo of the marketing authorization holder

Manufacturer

Laboratoria QUALIPHAR N.V./S.A
Rijksweg 9
B 2880 Bornem
Belgium
Authorization number: 19926
Available without prescription.
Other medicines with the same range of action:
Gardimax medica spray, (20 mg + 5 mg)/10 ml, oral spray.
Antiseptic and local analgesic for use in cases of oral cavity and throat pain.
Date of leaflet approval