Gardlox med lemon flavor

Package leaflet: Information for the patient

Gardlox Med lemon flavour,
3 mg, hard pastilles
Benzydamine hydrochloride
Please read the entire 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 patient leaflet or as directed by
a doctor, pharmacist, or nurse.

• 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult a doctor.

Table of contents:

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

1. What Gardlox Med lemon flavour is and what it is used for

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

2. Important information before using Gardlox Med lemon flavour

When not to take Gardlox Med lemon 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, discuss with 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 from the group of so-called non-steroidal anti-inflammatory drugs (NSAIDs),
• if after using the pastilles 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 pastilles, the medicine should not be given to
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children under 6 years of age.
Taking Gardlox Med with food and drink
Food and drink do not affect treatment with this medicine.
Gardlox Med lemon flavour and other medicines
Tell 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 become pregnant, 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 influence of Gardlox Med on the ability to drive or operate machinery.
This medicine contains aspartame
The medicine contains 3.4 mg of aspartame in each pastille. 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 improper excretion.
This medicine contains isomalt.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Gardlox Med lemon flavour

This medicine should always be taken exactly as described in this patient information 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 three times daily to relieve pain.
Do not exceed 3 tablets per day.
Benzydamine hydrochloride tablets should not be used 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 administered under adult supervision.
Oropharyngeal administration.
Slowly suck 1 tablet until it dissolves in the mouth. Tablets must not be swallowed.
Do not chew the tablets.
Overdose of Gardlox Med lemon flavour
In case of taking more tablets than recommended, contact a pharmacist, doctor, or the nearest hospital emergency department immediately. Always bring the medicine packaging with you, 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 following oral administration of benzydamine at a dose approximately 100 times higher than that contained in one tablet.
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If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse 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 1,000 people
Very rare: may affect less than 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 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)),
• 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gardlox Med lemon 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 conditions are required for this medicine.
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 Gardlox Med lemon flavour contains
The active substance is benzidamine hydrochloride. One hard tablet contains 3 mg of benzidamine hydrochloride (equivalent to 2.68 mg of benzidamine).
Other ingredients of the medicine are: isomalt (E 953), monohydrate citric acid, aspartame (E 951), quinoline yellow (E 104), lemon flavour, peppermint essential oil.

What Gardlox Med lemon flavour looks like and contents of the pack
Gardlox Med lemon flavour is in the form of yellow, round hard tablets, 19 mm in diameter, with a lemon flavour.
The hard tablets are packed in blisters made of PVC/PVDC/Aluminium foil.
The packaging contains 8, 12, 16 or 24 hard tablets.

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

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