Gardimax medica strawberry flavored

Package leaflet: Information for the patient

Gardimax medica strawberry, 5 mg + 1 mg, lozenges
Chlorhexidini dihydrochloridum + Lidocaini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
advised by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, please contact your pharmacist.

• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

• If there is no improvement after 3–4 days, or if your condition worsens, consult your doctor.

Table of contents

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

1. What Gardimax medica strawberry is and what it is used for

Gardimax medica strawberry contains as active substances lidocaine hydrochloride, which has a local anaesthetic effect, and chlorhexidine dihydrochloride, which has antibacterial properties.
The medicine is intended for symptomatic treatment to relieve pain associated with inflammation or irritation occurring in inflammatory conditions of the mouth and throat.
If there is no improvement after 3–4 days, or if your condition worsens, consult your doctor.

2. Important information before taking Gardimax medica truskawkowy

When not to take Gardimax medica truskawkowy

• if the patient is allergic to the active substances (chlorhexidine dihydrochloride or lidocaine hydrochloride), or to other local anaesthetics of the amide group, or to any of the other ingredients of this medicine (listed in section 6).
• 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 medica truskawkowy, discuss this with your doctor
or pharmacist.

• Use of this product should be limited to cases where relief of existing pain and irritation is absolutely necessary.
• Do not use Gardimax medica truskawkowy for prolonged periods. Do not suck one tablet immediately after another.
• If there is no improvement after 3–4 days, or if the patient feels worse, consult a doctor.
• Avoid use in individuals particularly prone to allergies.
• In case of overdose (more than 20 tablets per day), there is a risk of excessive loss of sensitivity in the glottis area, leading to reduced control of the swallowing reflex and increased risk of choking.
• Due to the presence of menthol, caution is advised when using in children if symptoms preceding seizures occur.
• Since toothpastes may contain anionic surfactants such as sodium lauryl sulfate, which may react with chlorhexidine, it is recommended to leave at least a 30-minute interval between using toothpaste and applying Gardimax medica truskawkowy.

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 truskawkowy and other medicines
Tell 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 this medicine simultaneously with other antiseptic medicines.
Do not use this medicine simultaneously with medicines for mild forms of Alzheimer's disease (cholinesterase inhibitors).
Lidocaine hydrochloride may increase methemoglobin blood levels in patients receiving other medicines affecting its formation, e.g. sulfonamides. Cimetidine, beta-blockers, norepinephrine, and inhalational anaesthetics inhibit lidocaine metabolism, leading to increased drug concentration in serum.
Barbiturates, rifampicin, and phenytoin accelerate lidocaine metabolism.
Lidocaine enhances the effect of skeletal muscle relaxants.
Gardimax medica truskawkowy with food and drink
Avoid eating or drinking immediately after using the medicine. Due to reduced sensitivity to heat, there is an increased risk of thermal injury to the oral cavity and throat from consuming excessively hot food or drinks.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should 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 using machines
No effects of Gardimax medica truskawkowy on the ability to drive and operate machinery have been observed.
Gardimax medica truskawkowy contains:
This medicine contains 1189.9 mg of sorbitol per tablet.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, has been previously diagnosed in the patient, the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Gardimax medica truskawkowy

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in 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.
Children aged 6 years and older: half the adult dose (3 to 5 lozenges per day).
Method of administration
For application to the oral mucosa. The lozenge should be sucked slowly.
Overdose of Gardimax medica truskawkowy
In case of overdose, seek immediate medical advice from a doctor or pharmacist. Symptoms of overdose include: anxiety, yawning, nervousness, tinnitus, nystagmus, muscle tremors, convulsions, depression, respiratory failure, decreased myocardial wall tension, peripheral vasodilation, hypotension, bradycardia (abnormally slow heart rate), cardiac arrhythmias, cardiac arrest.
Missed dose of Gardimax medica truskawkowy
Do not take a double dose to make up for a missed dose.
Stopping Gardimax medica truskawkowy
No special recommendations.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You should stop using the medicine and immediately contact your doctor or go to
the emergency department of the nearest hospital if a severe allergic reaction occurs. Symptoms
of a severe allergic reaction may include fainting, weakness, difficulty swallowing or breathing,
swelling of the lips, face, throat or tongue or other parts of the body, itching, rash.
The following may occur:
Rare (in 1 to 10 patients per 10,000)
allergic reaction of the skin and mucous membranes (rashes, inflammation of the oral mucosa,
desquamation of the oral mucosa and swelling of the salivary glands), severe allergic reaction.
Frequency unknown - cannot be estimated from available data
taste disturbances, burning sensation on the tongue, brownish discolorations on the tongue and teeth
may appear transiently after prolonged use (these discolorations can be removed).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse effects 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: http://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Gardimax medica truskawkowy

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after:
Expiry date (EXP) or on the blister 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. This will help protect the environment.

6. Contents of the package and other information

What Gardimax medica truskawkowy contains

• The active substances are: chlorhexidine dihydrochloride 5 mg, lidocaine hydrochloride monohydrate 1 mg.
• Other ingredients are: levomenthol, citric acid, strawberry flavour 502301TP 0551 (corn maltodextrin, glyceryl triacetate (E1518), natural and artificial flavouring substances), sucralose (E955), magnesium stearate, sorbitol (E420).

What Gardimax medica truskawkowy looks like and contents of the pack
White or almost white, round tablets, slightly mottled, with a strawberry flavour and odour.
Blister packs or single-dose blisters (aluminium/PVC/PCTFE or aluminium/PVC/PE/PVDC), in a cardboard box. The pack contains 12, 24, 36, 48, 12 x 1, 24 x 1, 36 x 1 or 48 x 1 tablets.
Not all pack sizes may be marketed.
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/Qualiphar NV
Rijksweg 9
B-2880 Bornem
Belgium