Gardimax medica lemon sprai

Package Leaflet: Information for the Patient

Gardimax medica lemon spray, (2 mg + 0.5 mg)/ml, oral spray, solution
Chlorhexidine digluconate solution + Lidocaine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 3 to 4 days or if the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet:

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

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

Medicine for symptomatic use to relieve painful conditions associated with inflammation or irritation in the course of throat and mouth inflammation.

2. Important information before taking Gardimax medica lemon spray

When not to take Gardimax medica lemon spray:

• If the patient is allergic to chlorhexidine digluconate or lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other local anesthetics of the amide group.
• In children under 2.5 years (30 months) 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 spray, a pharmacist should be consulted.

• Gardimax medica lemon spray should not be used for a long time. A single dose should not be followed by another.
• The use of this medicine should be limited to cases where relief of the existing pain and irritation is absolutely necessary.
• Use of the medicine in people who are particularly prone to allergies should be avoided.
• Contact between the medicine and the eyes and ears should be avoided. If the spray gets into the eyes, they should be rinsed immediately with a large amount of water.
• In case of taking too much of the medicine (more than 1 bottle per day), there is a risk of decreased control of the swallowing reflex and increased risk of choking.

Children and adolescents

Not to be used in children under 30 months of age.

Gardimax medica lemon spray and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
The medicine should not be used at the same time as medicines for mild forms of Alzheimer's disease (cholinesterase inhibitors).
The medicine should not be used at the same time as other disinfectants.
Lidocaine hydrochloride may increase the level of methemoglobin in the blood in patients also taking other medicines that affect its formation, such as sulfonamides, and may enhance the effect of muscle relaxants.
Cimetidine, beta-adrenergic blockers, norepinephrine, inhalation anesthetics slow down the metabolism of lidocaine, leading to an increase in the concentration of the medicine in the serum.
Barbiturates, rifampicin, phenytoin accelerate the metabolism of lidocaine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine should not be used during pregnancy unless, in the doctor's opinion, it is absolutely necessary.
The doctor will decide whether the patient should stop breastfeeding or continue using Gardimax medica lemon spray, taking into account the benefits of breastfeeding for the baby and the benefits of using the medicine for the woman.

Driving and using machines

No effect of the medicine on the ability to drive and use machines has been found.
Gardimax medica lemon spray contains alcohol (ethanol), propylene glycol, citral, geraniol, linalool,
citronellol, butylhydroxyanisole (E 320), and butylhydroxytoluene (E 321)
This medicine contains 21.4 mg of alcohol (ethanol) in a single dose. The amount of alcohol in a single dose of this medicine is less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.
Gardimax medica lemon spray contains 90 mg of propylene glycol in 5 doses. Propylene glycol may cause symptoms similar to those after alcohol consumption.
The medicine contains a fragrant substance with citral, geraniol, linalool, citronellol, which may cause an allergic reaction. The medicine contains butylhydroxyanisole (E 320) and butylhydroxytoluene (E 321).
The medicine may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.
Gardimax medica lemon spray does not contain sugar.

3. How to use Gardimax medica lemon spray

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Medicine 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 use, a doctor should be consulted.

Route of administration

On the mucous membrane of the mouth and throat.

Recommended dose:

Adults and adolescents over 12 years of age: 3 to 5 doses at a time, 6 to 10 times a day.
Children over 2.5 years (30 months) of age: 2 to 3 doses at a time, 3 to 5 times a day.

Instructions for using Gardimax medica lemon spray with a dosing pump and folding dosing tip.

Direct the dosing tip towards the throat and press the pump.
It is recommended to clean the dosing tip daily in the following way:

• 1. Turn the bottle upside down and press the dosing pump until it is empty of the liquid remaining in the dosing tip (so that the solution does not splash out of the bottle).
• 2. Remove the dosing tip from the pump and place it in a container of hot water for a few minutes.
• 3. Remove the dosing tip from the water and let it dry.
• 4. Mount the dry dosing tip on the pump, turning it down so that it blocks the pump.

Taking a higher dose of Gardimax medica lemon spray than recommended

In case of taking a higher dose of Gardimax medica lemon spray than recommended, a doctor or pharmacist should be consulted immediately. Symptoms of overdose: anxiety, tinnitus, nystagmus, respiratory failure, hypotension, bradycardia, arrhythmia, difficulty swallowing, yawning, nervousness, muscle tremors, convulsions, depression.

Missing a dose of Gardimax medica lemon spray

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

Stopping the use of Gardimax medica lemon spray

No special precautions.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Rare(less than 1 in 1000 patients):
allergic reactions affecting the skin and mucous membranes (rash, oral mucositis, desquamation of the oral mucosa, swelling of the salivary glands), severe allergic reactions (anaphylactic reactions).
Frequency not known(frequency cannot be estimated from the available data):
taste disorders, burning sensation on the tongue, after prolonged use, brown discoloration may appear on the tongue and teeth (these discolorations can be removed).
Gardimax medica lemon spray contains butylhydroxyanisole (BHA) (E 320) and butylhydroxytoluene (BHT) (E 321). They may cause local skin reactions (e.g., contact dermatitis) or irritation of the mucous membranes.

Reporting side effects

If any side effects occur, including those not listed in the package leaflet, the doctor or pharmacist should be informed. 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
Reporting side effects will allow more information to be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Gardimax medica lemon spray

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Shelf life of the medicine after first opening the package: 6 months.
The medicine should not be used after the expiry date stated on the label and carton. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked 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 spray contains

• The active substances of the medicine are: chlorhexidine digluconate solution 2 mg/ml and lidocaine hydrochloride 0.5 mg/ml. 1 dose contains 0.180 mg of chlorhexidine digluconate solution and 0.045 mg of lidocaine hydrochloride.
• The other ingredients of the medicine are: lemon flavor CRA1585L (containing: ethanol, citral, terpineol, geraniol, linalool, citronellol, synthetic flavoring substances, butylhydroxyanisole (E 320), butylhydroxytoluene (E 321), water), sucralose (E 955), glycerol (E 422), propylene glycol (E 1520), citric acid monohydrate, ethanol 96%, purified water.

What Gardimax medica lemon spray looks like and what the package contains

Bottle containing 30 ml of solution, made of orange glass type III with a dosing pump made of PE/stainless steel/acetate resin, with a folding dosing tip made of PP/PE and a cap containing a guarantee seal, in a cardboard box.

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 NV
Rijksweg 9
2880 Bornem
Belgium

Date of last revision of the package leaflet: