Gardimax medica lemon

Leaflet attached to the packaging: patient information

Gardimax medica lemon, 5 mg + 1 mg, lozenges

Chlorhexidine dihydrochloride+ Lidocaine hydrochloride

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 as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 4 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

Gardimax medica lemon contains the active substances: lidocaine hydrochloride with a local anesthetic effect and chlorhexidine dihydrochloride with an antibacterial effect.
Gardimax medica lemon is indicated for symptomatic use to relieve painful conditions associated with inflammation or irritation in the course of inflammatory conditions of the mouth and throat.
If there is no improvement after 3 to 4 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Gardimax medica lemon

When not to take Gardimax medica lemon

• if the patient is allergic to the active substances (chlorhexidine dihydrochloride or lidocaine hydrochloride) or other local anesthetics of the amide group, or any of the other ingredients of this medicine (listed in section 6).
• in children under 6 years of age.

A doctor should be consulted if any of the above contraindications apply to the patient or have applied in the past.

Warnings and precautions

Before taking Gardimax medica lemon, the patient should discuss it with their doctor or pharmacist.

• Gardimax medica lemon should not be used for a long time. One lozenge should not be sucked immediately after another.
• The medicine should be avoided in people who are particularly prone to allergies.
• In case 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.
• A doctor should be consulted if any of the above warnings apply to the patient or have applied in the past.

or have applied in the past.

• Due to the fact that toothpastes may contain anionic surfactants, such as sodium lauryl sulfate, which may react with the active substance chlorhexidine, it is recommended to ensure a break of at least 30 minutes between brushing teeth and taking the medicine.

Children and adolescents

Not to be used in children under 6 years of age.

Gardimax medica lemon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The medicine should not be taken at the same time as other disinfectant medicines.
The medicine should not be taken at the same time as medicines for mild forms of Alzheimer's disease (cholinesterase inhibitors).
Lidocaine hydrochloride may increase methemoglobin levels in patients taking other medicines that affect its formation, e.g. sulfonamides. Cimetidine, beta-adrenergic blockers, norepinephrine, inhalation anesthetics inhibit lidocaine metabolism, leading to increased drug levels in serum.
Barbiturates, rifampicin, phenytoin accelerate lidocaine metabolism. Lidocaine enhances the effect of muscle relaxants.

Gardimax medica lemon with food and drink

Food and drink should be avoided immediately after taking the medicine. Due to reduced sensitivity to heat, there is an increased risk of burns to the mouth and throat, caused by consuming too hot drinks and food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
During pregnancy and breastfeeding, the medicine should only be used if necessary, after consulting a doctor.

Driving and using machines

No effect of Gardimax medica lemon on the ability to drive and use machines has been observed.

Gardimax medica lemon contains sorbitol and aspartame

Gardimax Medica lemon contains 1208.95 mg of sorbitol (E 420) in each lozenge. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Gardimax medica lemon contains 5.5 mg of aspartame (E 951) in each lozenge.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Gardimax medica lemon

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is for short-term use: 3 to 4 days. If there is no improvement after this period or new symptoms and/or general symptoms, e.g. fever, appear during use, the patient should contact their doctor.

Recommended dose

Adults: 6 to 10 lozenges per day, suck slowly.
Children from 6 years of age: half the adult dose (3 to 5 lozenges per day).
Administration route
On the mucous membrane of the mouth.
Suck the lozenge slowly. Do not suck one lozenge immediately after another (see section 2 "Gardimax medica lemon with food and drink").

Taking a higher dose of Gardimax medica lemon than recommended

In case of taking a higher dose of Gardimax medica lemon than recommended, the patient should immediately contact their doctor. Symptoms of overdose are: restlessness, yawning, nervousness, tinnitus, nystagmus, muscle tremors, convulsions, depression, respiratory failure, decreased cardiac muscle tone, peripheral vasodilation, hypotension, bradycardia (too slow heart rate), arrhythmia, cardiac arrest.

Missing a dose of Gardimax medica lemon

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Gardimax medica lemon

No special precautions are necessary.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gardimax medica lemon can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and immediately consult their doctor or contact 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 out of 10,000)
allergic reactions affecting the skin and mucous membranes (rash, oral mucositis, desquamation of the oral mucosa, and swelling of the salivary glands), severe allergic reactions.
Frequency not known (cannot be estimated from available data)
taste disorders, burning sensation on the tongue, after prolonged use, brown discoloration of the tongue, teeth (these discolorations can be removed).

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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 the medicine.

5. How to store Gardimax medica lemon

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Do not take this medicine after the expiry date stated on the carton after: Expiry Date (EXP) and on the blister after: EXP. The expiry date refers to the last day of the given month.
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 Gardimax medica lemon contains

The active substances of the medicine are: chlorhexidine dihydrochloride 5 mg and lidocaine hydrochloride 1 mg.
The other ingredients are: sorbitol (E 420), magnesium stearate, aspartame (E 951), lemon flavor 501050 AP0551, acesulfame potassium (E 950).

What Gardimax medica lemon looks like and what the pack contains

White or almost white, round, lemon-flavored lozenges.
Single-dose blisters (aluminum/PVC/PCTFE or aluminum/PVC/PE/PVDC), in a cardboard box. The pack contains 12, 24, or 36 lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Laboratoria Qualiphar N.V./S.A Rijksweg 9
B-2880 Bornem Belgium
Date of last revision of the leaflet:05/2025