Gardimax Medica Sprai

Package Leaflet: Information for the Patient

GARDIMAX MEDICA SPRAY, (20 mg + 5 mg)/10 ml, Oral Spray

Chlorhexidine Digluconate Solution + Lidocaine Hydrochloride

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3-4 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet:

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

1. WHAT IS GARDIMAX MEDICA SPRAY AND WHAT IS IT USED FOR

This medication is used for symptomatic relief of painful conditions associated with inflammation or irritation in the mouth and throat. If after 3-4 days there is no improvement or you feel worse, consult a doctor.

2. IMPORTANT INFORMATION BEFORE TAKING GARDIMAX MEDICA SPRAY

When not to use Gardimax Medica Spray:

• if you are allergic to chlorhexidine digluconate or lidocaine hydrochloride or any of the other ingredients of this medication (listed in section 6);
• hypersensitivity to other local anesthetics of the amide type;
• in children under 2.5 years (30 months) of age.

Consult a doctor if any of the above contraindications apply to you, or have applied in the past.

Warnings and precautions

Before starting to use Gardimax Medica Spray, discuss it with your doctor or pharmacist.

• Gardimax Medica Spray should not be used for a long time. Do not use one dose after another.
• The use of this medication should be limited to cases where relief of the existing pain and irritation is absolutely necessary.
• Avoid contact with the eyes and ears. If the spray gets into the eyes, rinse them immediately with plenty of water.
• In case of taking too much of the medication (more than 1 bottle per day), there is a risk of excessive loss of sensitivity in the laryngeal area, leading to decreased control of the swallowing reflex and increased risk of choking.
• Avoid using the medication in people who are particularly prone to allergies.
• Due to the presence of menthol, caution should be exercised when using in children if symptoms preceding seizures have occurred.

Gardimax Medica Spray contains alcohol. Also, read the section titled "Gardimax Medica Spray contains alcohol (ethanol) and menthol".

Children and adolescents

Do not use in children under 30 months of age.

Gardimax Medica Spray and other medications

Tell your doctor or pharmacist about all medications you are taking, or have recently taken, and about any medications you plan to take. Do not use this medication at the same time as medications for mild forms of Alzheimer's disease (cholinesterase inhibitors). Do not use this medication at the same time as other disinfectant medications. Lidocaine hydrochloride may increase methemoglobin levels in the blood in patients receiving other medications that affect its production, such as sulfonamides. Cimetidine, beta-adrenergic blockers, norepinephrine, inhalation anesthetics slow down the metabolism of lidocaine, leading to increased levels of the medication in the serum. Barbiturates, rifampicin, phenytoin accelerate the metabolism of lidocaine. Lidocaine enhances the effect of muscle relaxants.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication. This medication should not be used during pregnancy unless your doctor considers it absolutely necessary. Your doctor will decide whether you should stop breastfeeding or continue using Gardimax Medica Spray, considering the benefits of breastfeeding to the baby and the benefits of using the medication to the mother.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Gardimax Medica Spray contains alcohol (ethanol) and menthol

• Gardimax Medica Spray contains alcohol (42.5% v/v ethanol), i.e., up to 168 mg in 5 doses, which is equivalent to 0.85 ml of beer or 0.35 ml of wine per dose. This is harmful to individuals dependent on alcohol. This should also be taken into account in pregnant women, breastfeeding women, children, and patients at high risk, such as those with liver disease or epilepsy.
• Gardimax Medica Spray contains menthol: caution should be exercised when using in children who have had seizures in the past.

Gardimax Medica Spray does not contain sugar and can be used in diabetic patients.

3. HOW TO USE GARDIMAX MEDICA SPRAY

This medication should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist. This medication is for short-term use: 3 to 4 days. If after this period there is no improvement or you feel worse, or if new symptoms or general symptoms such as fever appear during use, consult a doctor.

Route of administration

On the mucous membrane of the mouth and throat.

Recommended dose

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

Instructions for using Gardimax Medica Spray with a dosing pump and foldable dosing tip.

Direct the dosing tip towards the throat and press the pump. It is recommended to clean the dosing tip daily as follows:

• 1. Invert the bottle and press the dosing pump until the liquid remaining in the dosing tip is emptied (to prevent the solution from spraying 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, twisting it downwards until it blocks the pump.

Overdose of Gardimax Medica Spray

In case of overdose, contact a doctor or pharmacist immediately. Symptoms of overdose: anxiety, tinnitus, nystagmus, respiratory failure, hypotension, bradycardia, cardiac arrest, arrhythmia, difficulty swallowing, yawning, nervousness, muscle tremors, seizures, depression.

Missed dose of Gardimax Medica Spray

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

Stopping the use of Gardimax Medica Spray

No special precautions. If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medications, this medication 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 long-term use, brown discoloration of the tongue and teeth may occur (these discolorations can be removed).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medication. Side effects can also be reported to the marketing authorization holder.

5. HOW TO STORE GARDIMAX MEDICA SPRAY

Keep this medication out of the sight and reach of children. There are no special precautions for storage. Shelf life after first opening: 3 months. Do not use this medication after the expiry date stated on the packaging after: Expiry Date (EXP) or on the label after: EXP. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gardimax Medica Spray contains

The active substances are: chlorhexidine digluconate solution 20 mg/10 ml, lidocaine hydrochloride 5 mg/10 ml. One dose contains 0.180 mg of chlorhexidine digluconate solution and 0.045 mg of lidocaine hydrochloride. The other ingredients are: ethanol 96%, glycerol, levomenthol, cineole, sodium saccharin, citric acid monohydrate, purified water.

What Gardimax Medica Spray looks like and contents of the pack

Bottle containing 30 ml of solution in orange glass with a dosing pump made of PP/stainless steel/acetale resin, with a foldable dosing tip made of PE.

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: