Gardlox med orange-honey flavor

Package leaflet: Information for the patient

Gardlox Med orange-honey flavour,
3 mg, hard pastilles
Benzydamine hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If advice or additional information is needed, consult the pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, contact the doctor.

Contents of the leaflet:

1. What Gardlox Med orange-honey flavour is and what it is used for
2. Important information before using Gardlox Med orange-honey flavour
3. How to use Gardlox Med orange-honey flavour
4. Possible side effects
5. How to store Gardlox Med orange-honey flavour
6. Contents of the pack and other information

1. What Gardlox Med orange-honey flavour is and what it is used for

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

2. Important information before using Gardlox Med orange-honey flavour

When not to take Gardlox Med orange-honey flavour

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

Warnings and precautions
Before starting treatment with Gardlox Med, consult a doctor or pharmacist:

• if the patient has been diagnosed with phenylketonuria,
• if the patient has asthma or has had asthma in the past,
• if the patient is allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or to any other medicine in the group of non-steroidal anti-inflammatory drugs (NSAIDs),
• if after using the lozenges the sore throat worsens or does not improve within 3 days, or if fever, severe sore throat or other symptoms occur, medical advice should be sought.

Children and adolescents
Due to the pharmaceutical form of Gardlox Med hard lozenges, 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 treatment with this medicine.
Gardlox Med orange-honey flavour and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, including medicines available without prescription.
Pregnancy, breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Use of Gardlox Med during pregnancy or breastfeeding is not recommended.
Driving and operating machinery
There are no available data on the effect of Gardlox Med on the ability to drive or operate machinery.
This medicine contains aspartame
The medicine contains 3.4 mg of aspartame per lozenge. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
This medicine contains isomalt.
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains cochineal red (E 124), a dye which may cause allergic reactions.

3. How to use Gardlox Med orange-honey flavour

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and children over 6 years: suck 1 tablet 3 times daily to relieve pain.
Do not exceed 3 tablets per day.
Do not use tablets containing benzylamine hydrochloride for longer than 7 days.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Children aged 6 to 11 years: this medicine should be given under adult supervision.
Oromucosal administration.
Slowly suck 1 tablet until it dissolves in the mouth. Do not swallow the tablets whole.
Do not chew the tablets.
Accidental overdose of Gardlox Med orange-honey flavour
If too many tablets have been taken, contact a pharmacist, doctor, or the nearest hospital emergency department immediately. Always bring the medicine packaging, regardless of whether any tablets remain.
Very rarely, symptoms of overdose such as excitation, convulsions, sweating, ataxia, tremor, and vomiting have been reported in children after oral administration of benzylamine at a dose approximately 100 times higher than that contained in one tablet.
For any further questions about the use of this medicine, consult a doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions that may occur:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated based on available data

Uncommon:

• Phototoxic reactions (causing rash and sunburn).

Rare:

• Burning or dryness in the mouth. If this occurs, you may drink a glass of water to relieve this sensation.

Very rare:

• Sudden swelling of 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)),
• Breathing difficulties (laryngeal or bronchial spasm).

Frequency not known:

• Severe allergic reactions (anaphylactic reactions),
• Allergic reactions, rash or itching, especially if affecting the whole body (hypersensitivity reactions),
• Localized loss of sensitivity of the oral mucosa (numbness).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Gardlox Med orange-honey flavour

Keep this medicine 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 EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Gardlox Med orange-honey flavour contains
The active substance is benzylamine hydrochloride. Each hard pastille contains 3 mg of
benzylamine hydrochloride (equivalent to 2.68 mg of benzylamine).
Other ingredients of the medicine are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), honey flavour, orange flavour, peppermint essential oil, carmine red (E 124).

What Gardlox Med orange-honey flavour looks like and contents of the pack
Gardlox Med orange-honey flavour is in the form of round, hard pastilles of orange colour, 19 mm in diameter, with an orange-honey flavour.
The hard pastilles are packed in blisters made of PVC/PVDC/Aluminium.
The pack contains 8, 12, 16 or 24 hard pastilles.

Marketing Authorisation 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 Tecnológico del Vallès)
Cerdanyola del Vallès
08290, Barcelona, Spain
LOZY’S PHARMACEUTICALS S.L.,
Campus Empresarial s/n
31795- Lekaroz Navarra, Spain

For more detailed information, please contact:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
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