Gardlox Med smak pomaranihovo-miodovi

Package Leaflet: Information for the Patient

Gardlox Med Orange-Honey Flavor,

3 mg, hard tablets
Benzydamine Hydrochloride

Read the package 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 package leaflet or as directed by your doctor, pharmacist, or nurse.

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

Table of Contents of the Leaflet:

• 1. What is Gardlox Med Orange-Honey Flavor and what is it used for
• 2. Important information before taking Gardlox Med Orange-Honey Flavor
• 3. How to take Gardlox Med Orange-Honey Flavor
• 4. Possible side effects
• 5. How to store Gardlox Med Orange-Honey Flavor
• 6. Package contents and other information

1. What is Gardlox Med Orange-Honey Flavor and what is it used for

Gardlox Med contains benzydamine hydrochloride as the active substance.
The active substance is the component of the tablets that produces the therapeutic effect needed by the patient.
The medicine is indicated for the symptomatic local treatment of acute sore throat in adults and children over 6 years of age.
If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Gardlox Med Orange-Honey Flavor

When not to take Gardlox Med Orange-Honey Flavor

• if the patient is allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Gardlox Med, the patient should discuss it with their doctor or pharmacist:

• if the patient has been diagnosed with phenylketonuria,
• if the patient has or has had asthma,
• if the patient is allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if after taking the tablets the sore throat worsens or does not improve within 3 days, or if fever, severe sore throat, or other symptoms occur, the patient should consult their doctor.

Children and adolescents

Due to the pharmaceutical form of Gardlox Med, hard tablets, it should not be given to children under 6 years of age.
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Taking Gardlox Med with food and drink

Food and drink do not affect the treatment with this medicine.

Gardlox Med Orange-Honey Flavor and other medicines

The patient should inform their doctor or pharmacist about all medicines they are taking or have recently taken, including those available without a prescription.

Pregnancy, breastfeeding

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.
Gardlox Med is not recommended during pregnancy or breastfeeding.

Driving and using machines

There is no available data on the effect of Gardlox Med on the ability to drive and use machines.

This medicine contains aspartame

The medicine contains 3.4 mg of aspartame in each tablet. 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 impaired elimination.

This medicine contains isomalt.

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains cochineal red (E 124), a colorant that may cause allergic reactions.

3. How to take Gardlox Med Orange-Honey Flavor

This medicine should always be taken exactly as described in the package leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Adults and children over 6 years: suck 1 tablet 3 times a day to relieve pain.
Do not take more than 3 tablets per day.

Benzydamine hydrochloride tablets should not be taken for more than 7 days.

If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.
Children from 6 to 11 years:this medicine should be given under adult supervision.

Sublingual administration.

Suck 1 tablet slowly until it dissolves in the mouth. The tablets should not be swallowed.
The tablets should not be chewed.

Taking a higher dose of Gardlox Med Orange-Honey Flavor than recommended

In case of taking too many tablets, the patient should immediately contact a pharmacist, doctor, or the nearest emergency department. The patient should always take the medicine packaging with them, regardless of whether there are any tablets left.
Very rarely, symptoms of overdose have been reported in children, including excitement, convulsions, sweating, ataxia, tremors, and vomiting after oral administration of benzydamine in a dose about 100 times higher than that contained in a tablet.
If the patient has further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur:
Very common: may affect more than 1 in 10 people
Common: may affect less than 1 in 10 people
Uncommon: may affect less than 1 in 100 people
Rare: may affect less than 1 in 1000 people
Very rare: may affect less than 1 in 10,000 people
Frequency not known: cannot be estimated from the available data
Uncommon:

• phototoxic reactions (causing rash and sunburn).

Rare:

• burning or dryness in the mouth. If this occurs, the patient can drink a glass of water to alleviate the sensation.

Very rare:

• sudden swelling in the mouth/throat and mucous membranes (angioedema (difficulty breathing or swallowing, rash, itching, hives, or swelling of the face, hands, and feet, eyes, lips, and (or) tongue, dizziness)),
• difficulty breathing (laryngospasm or bronchospasm).

Frequency not known:

• severe allergic reactions (anaphylactic reactions),
• allergic reactions, rash, or itching, especially if it affects the whole body (hypersensitivity reactions),
• local numbness of the oral mucosa (hypoaesthesia).

Reporting side effects

If the patient experiences any side effects, including any possible side effects 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Gardlox Med Orange-Honey Flavor

Store the medicine in a place out of sight and reach of children.
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Do not use this medicine after the expiry date stated on the carton and blister after the EXP mark. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 Gardlox Med Orange-Honey Flavor contains

The active substance of the medicine is benzydamine hydrochloride. One hard tablet contains 3 mg of benzydamine hydrochloride (which corresponds to 2.68 mg of benzydamine).
The other ingredients of the medicine are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), honey flavor, orange flavor, peppermint essential oil, cochineal red (E 124).

What Gardlox Med Orange-Honey Flavor looks like and what the package contains

Gardlox Med Orange-Honey Flavor is a round, hard tablet, orange in color, with a diameter of 19 mm and an orange-honey flavor.
The hard tablets are packaged in PVC/PVDC/Aluminum blisters.
The package contains 8, 12, 16, or 24 hard tablets.

Marketing authorization holder:

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków

Manufacturer:

KYMOS PHARMA SERVICES, S.L,
Ronda de Can Fatjó, 7B (Parque Technológico del Valles)
Cerdanyola del Valles
08290, Barcelona, Spain
LOZY’S PHARMACEUTICALS S.L.,
Campus Empresarial s/n

• 31795- Lekaroz Navarra, Spain

For more information, please contact:

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków

Date of last revision of the leaflet: 04/2022

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