Gardimax medica lemon spray

Patient Information Leaflet

Gardimax medica lemon spray, (2 mg + 0.5 mg)/ml, oral spray, solution
Chlorhexidini digluconatis solutio + Lidocaini hydrochloridum
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 4 days, or if your condition worsens, consult your doctor.

Table of Contents:

1. What Gardimax medica lemon spray is and what it is used for
2. Important information before using 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. Contents of the pack and other information

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

This medicine is intended for symptomatic use to relieve pain associated with inflammation or irritation in inflammatory conditions of the throat and oral cavity.

2. Information before using Gardimax medica lemon spray

When not to use Gardimax medica lemon spray:

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

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 use Gardimax medica lemon spray, consult a pharmacist.

• Do not use Gardimax medica lemon spray for prolonged periods. Do not use one dose immediately after another.
• The use of this medicine should be limited to cases where relief of existing pain and irritation is absolutely necessary.
• Avoid using the medicine in individuals particularly prone to allergies.
• Avoid contact of the medicine with eyes and ears. If the spray gets into the eyes, rinse immediately with plenty of water.
• In case of overdose (more than 1 bottle per day), there is a risk of reduced swallowing reflex control and increased risk of choking.

Children and adolescents
Do not use in children under 30 months of age.
Gardimax medica lemon spray 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, including those
available without a prescription.
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 agents.
Lidocaine hydrochloride may increase methemoglobin blood levels in patients receiving
concomitant medications affecting its formation, e.g. sulfonamides, and may enhance the effect of
skeletal muscle relaxants.
Cimetidine, beta-blockers, norepinephrine, and inhaled anesthetics inhibit lidocaine metabolism,
leading to increased drug concentration in serum.
Barbiturates, rifampicin, and phenytoin accelerate lidocaine metabolism.
Pregnancy and breastfeeding
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.
This medicine should not be used during pregnancy unless, in the opinion of the doctor, it is absolutely necessary.
The doctor will decide whether the patient should discontinue breastfeeding or continue using
Gardimax medica lemon spray, taking into account the benefits of breastfeeding for the child and
the benefits of the medicine for the woman.
Driving and operating machinery
No effects of Gardimax medica lemon spray on the ability to drive and operate machinery have been observed.
Gardimax medica lemon spray contains alcohol (ethanol), propylene glycol, citral, geraniol, linalool,
citronellol, butylhydroxyanisole (E 320), and butylhydroxytoluene (BHT, E 321)
This medicine contains 21.4 mg of alcohol (ethanol) per single dose. The amount of alcohol in a single dose of this
medicine corresponds to less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not cause 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 fragrance substances including citral, geraniol, linalool, and 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 patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult your physician or pharmacist.
This medicine is intended for short-term symptomatic use only: 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, consult a
physician.
Route of administration
Oral mucosa, oropharyngeal (directed towards the throat).
Recommended dosage:
Adults and adolescents aged 12 years and older: 3 to 5 sprays per dose, 6 to 10 times daily.
Children above the age of 2.5 years (30 months): 2 to 3 sprays per dose, 3 to 5 times daily.
Instructions for use of Gardimax medica lemon spray with a dosing pump and foldable dosing nozzle
Direct the dosing nozzle towards the throat and press the pump.
Daily cleaning of the dosing nozzle is recommended as follows:

1. Turn the bottle upside down and press the dosing pump until the liquid remaining in the nozzle is expelled (to prevent solution from spraying out of the bottle).
2. Remove the nozzle from the dosing pump and place it in a container with hot water for several minutes.
3. Remove the dosing nozzle from the water and allow it to dry.
4. Reattach the dry dosing nozzle to the dosing pump, twisting it downward until it locks the pump in place.

Overdose of Gardimax medica lemon spray
In case of accidental overdose of Gardimax medica lemon spray, seek immediate medical advice from a physician or pharmacist. Symptoms of overdose include: anxiety, tinnitus, nystagmus, respiratory failure, hypotension, bradycardia, cardiac arrhythmia, difficulty swallowing, yawning, nervousness, muscle tremors, convulsions, depression.
Missed dose of Gardimax medica lemon spray
Do not take a double dose to make up for a missed dose.
Stopping Gardimax medica lemon spray
No special recommendations apply.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
Rare (less than 1 in 1,000 patients):
allergic reaction affecting the skin and mucous membranes (rash, inflammation of the oral mucosa,
desquamation of the oral mucosa, salivary gland swelling), severe allergic reactions (anaphylactic
reactions).
Frequency unknown (frequency cannot be determined from available data):
taste disturbances, burning sensation on the tongue, brown discoloration of the tongue and teeth after
prolonged use (these discolorations can be removed).
Gardimax medica lemon spray contains butylated hydroxyanisole (BHA) (E 320) and butylated hydroxytoluene (BHT) (E 321). These may cause local skin reactions (e.g. contact dermatitis) or irritation of mucous membranes.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Gardimax medica lemon spray

Keep the medicine out of the sight and reach of children.
Store at a temperature below 25°C.
The shelf life of the medicine after first opening the container: 6 months.
Do not use this medicine after the expiry date stated on the label and carton. 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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Gardimax medica lemon spray contains

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

What Gardimax medica lemon spray looks like and contents of the pack
A bottle containing 30 ml of solution, made of amber glass type III with a metered pump dispenser composed of PE/stainless steel/acetal resin, with a folding dosing nozzle made of PP/PE and a cap with a tamper-evident seal, packed in a cardboard box.
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 NV
Rijksweg 9
2880 Bornem
Belgium