Gardimax medica truskavkovi

Leaflet attached to the packaging: patient information

Gardimax medica strawberry, 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 directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3-4 days, they should contact their doctor.

Table of contents of the leaflet

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

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

Gardimax medica strawberry contains the active substances lidocaine hydrochloride, which has a local anesthetic effect, and chlorhexidine dihydrochloride, which has an antibacterial effect. The medicine is used to relieve painful symptoms associated with inflammation or irritation in the mouth and throat. If there is no improvement or the patient feels worse after 3-4 days, they should consult their doctor.

2. Important information before taking Gardimax medica strawberry

When not to take Gardimax medica strawberry

• 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.

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 strawberry, discuss it with a doctor or pharmacist.

• The use of this product should be limited to cases where relief of pain and irritation is absolutely necessary.
• Gardimax medica strawberry should not be used for a long time. Do not suck one lozenge immediately after another.
• If there is no improvement or the patient feels worse after 3-4 days, they should contact their doctor.
• Avoid using the medicine in people who are particularly prone to allergies.
• In case of taking an overdose (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.
• Since toothpastes may contain anionic surfactants, such as sodium lauryl sulfate, which can react with chlorhexidine, it is recommended to ensure at least a 30-minute time interval between using toothpaste and taking Gardimax medica strawberry.

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 strawberry and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Do not use with other disinfectant medicines. Do not use with medicines for mild forms of Alzheimer's disease (cholinesterase inhibitors). Lidocaine hydrochloride may increase methemoglobin levels in patients taking other medicines that affect its production, such as sulfonamides. Cimetidine, beta-adrenergic blockers, norepinephrine, and inhalation anesthetics inhibit lidocaine metabolism, leading to increased drug levels in serum. Barbiturates, rifampicin, and phenytoin accelerate lidocaine metabolism. Lidocaine enhances the effect of muscle relaxants.

Gardimax medica strawberry with food and drink

Avoid taking food and drink immediately after taking the medicine. Due to reduced sensitivity to heat, there is an increased risk of oral and throat burns caused by consuming hot drinks and food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Gardimax medica strawberry contains:

The medicine contains 1189.9 mg of sorbitol in each lozenge. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, they should consult their doctor before taking the medicine. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect. The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, which means it is considered "sodium-free".

3. How to take Gardimax medica strawberry

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

Recommended dose

Adults: 6 to 10 lozenges per day. Children from 6 years of age: half the adult dose (3 to 5 lozenges per day). Administration: on the oral mucosa. Suck the lozenge slowly.

Taking a higher dose of Gardimax medica strawberry than recommended

In case of taking a higher dose than recommended, consult a doctor or pharmacist immediately. Overdose symptoms: restlessness, yawning, nervousness, tinnitus, nystagmus, muscle tremors, seizures, depression, respiratory failure, decreased cardiac wall tension, peripheral vasodilation, hypotension, bradycardia (slow heart rate), arrhythmias, cardiac arrest.

Missing a dose of Gardimax medica strawberry

Do not take a double dose to make up for a missed dose.

Stopping treatment with Gardimax medica strawberry

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

4. Possible side effects

Like all medicines, Gardimax medica strawberry can cause side effects, although not everybody gets them. Stop taking the medicine and consult a doctor or contact the emergency department of the nearest hospital immediately 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 side effects may occur: Rare (in 1 to 10 patients out of 10,000)allergic skin and mucous membrane reactions (rash, oral mucositis, desquamation of the oral mucosa, and swelling of the salivary glands), severe allergic reaction. Frequency not known - cannot be estimated from available datataste disorders, burning sensation on the tongue, after prolonged use, transient brown discoloration of the tongue and teeth (these discolorations can be removed).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your 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, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: http://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gardimax medica strawberry

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store 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 specified month. Medicines should 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. Package contents and other information

What Gardimax medica strawberry contains

• The active substances are: chlorhexidine dihydrochloride 5 mg, lidocaine hydrochloride monohydrate 1 mg.
• The other ingredients are: levomenthol, citric acid, strawberry flavor 502301TP 0551 (corn maltodextrin, trioctan glycerol (E1518), natural and artificial flavor and aroma enhancers), sucralose (E955), magnesium stearate, sorbitol (E420).

What Gardimax medica strawberry looks like and contents of the pack

White or almost white, slightly speckled, round lozenges with a strawberry flavor and aroma. Blister packs or single-dose blisters (aluminum/PVC/PCTFE or aluminum/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 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/Qualiphar NV, Rijksweg 9, B-2880 Bornem, Belgium, Date of last revision of the leaflet:05/2025