Gardimax medica
Poland
Table of Contents
Package leaflet: information for the patient
GARDIMAX medica, 5 mg + 1 mg, lozenges
Chlorhexidini dihydrochloridum + Lidocaini hydrochloridum
Please read carefully all the information in this 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 the doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
Please consult your pharmacist if you need advice or further information.
- If the patient experiences any adverse reactions, including any possible symptoms not listed in this leaflet, inform a doctor or pharmacist.
- If there is no improvement after 3–4 days, or if the patient feels worse, contact a doctor.
Contents of the leaflet
- What Gardimax medica is and what it is used for
- Important information before taking Gardimax medica
- How to use Gardimax medica
- Possible side effects
- How to store Gardimax medica
- Contents of the pack and other information
1. WHAT GARDIMAX MEDICA IS AND WHAT IT IS USED FOR
A medicinal product for symptomatic use in relieving pain associated with inflammation or irritation occurring in inflammatory conditions of the mouth and throat.
2. IMPORTANT INFORMATION BEFORE TAKING GARDIMAX MEDICA
When not to take Gardimax Medica
- If the patient is allergic to the active substances (dichlorohydrogen chloride chlorhexidine or lidocaine hydrochloride) or to 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.
Consult a doctor if any of the above contraindications apply to the patient or have applied in the past.
Warnings and precautions
Before starting to take Gardimax, consult a pharmacist.
Do not use Gardimax Medica for prolonged periods. Do not suck one tablet immediately after another.
Avoid using the product in individuals particularly prone to allergies.
If an excessive dose is taken (more than 20 tablets per day), there is a risk of excessive loss of sensitivity in the laryngeal area, leading to reduced control of the swallowing reflex and an increased risk of choking.
Due to the presence of menthol, caution should be exercised when using in children if symptoms preceding seizures occur.
Consult a doctor if any of the above warnings apply to the patient or have applied in the past.
Children and adolescents
Do not use in children under 6 years of age.
Gardimax Medica with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Do not use this medicine simultaneously with drugs for mild forms of Alzheimer's disease (cholinesterase inhibitors).
Do not use this medicine simultaneously with other antiseptic medicines.
Gardimax Medica with food and drink
Avoid consuming food and beverages immediately after using the medicine. Due to reduced sensitivity to heat, there is an increased risk of burns to the oral cavity and throat from consuming excessively hot drinks or food.
Pregnancy, breastfeeding and fertility
During pregnancy and breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use only if clearly necessary and after consultation with a doctor.
Driving and operating machinery
No influence of Gardimax Medica on the ability to drive motor vehicles or operate mechanical equipment has been observed.
Gardimax Medica contains sorbitol
This medicine contains sorbitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Gardimax Medica does not contain sugar and may be used by diabetics.
3. HOW TO USE GARDIMAX MEDICA
This medicine should always be used exactly as described in the patient leaflet or as recommended by the physician or pharmacist. In case of doubt, consult a doctor or pharmacist.
This medicine is intended for short-term symptomatic use: 3 to 4 days. If there is no improvement after this period, or if new symptoms and/or general symptoms such as fever appear during treatment, the patient should contact a doctor.
Recommended dose
Adults: 6 to 10 lozenges per day, slowly suck one lozenge.
Children from 6 years of age: half the adult dose (3 to 5 lozenges per day).
.
Accidental overdose of Gardimax Medica
In case of taking more than the recommended dose, contact a doctor or pharmacist immediately. Symptoms of overdose: restlessness, tinnitus, respiratory failure, cardiac arrhythmia, difficulty swallowing.
Missed dose of Gardimax Medica
Do not take a double dose to make up for a missed dose.
Stopping Gardimax Medica
No special recommendations.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
In rare cases:
- allergic reaction of the skin and mucous membranes (rash, inflammation of the oral mucosa)
- possibility of taste disturbances, burning sensation on the tongue, and severe allergic reactions (anaphylactic reactions)
- prolonged and continuous use of chlorhexidine may lead to transient brownish discoloration of teeth. These discolorations can be removed.
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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 helps to provide more information on the safety of the medicine.
5. HOW TO STORE GARDIMAX MEDICA
Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP (Expiry date). The first two digits indicate the month, and the following two or four digits indicate the year. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Gardimax medica contains
- The active substances are: dichlorohydrochloride of chlorhexidine 5 mg, hydrochloride of lidocaine 1 mg.
- Other ingredients: sorbitol (E420), magnesium stearate, anhydrous citric acid, levomenthol.
What Gardimax medica looks like and contents of the pack
Gardimax medica lozenges are available in packages containing 12, 24, 36 lozenges in perforated blisters divided into single doses.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Królowej Jadwigi Street 148a/1a
30-212 Kraków
Poland
Tel.: +48 889 388 538
Logo of the marketing authorisation holder
Manufacturer
Laboratoria QUALIPHAR N.V./S.A
Rijksweg 9
B 2880 Bornem
Belgium
Marketing Authorisation Number: 19926
Available without prescription.
Other medicines with the same therapeutic action:
Gardimax medica spray, (20 mg + 5 mg)/10 ml, oral aerosol.
An antiseptic and local analgesic agent used in cases of oral and throat pain.