Inaldin Gardvo Max

Leaflet attached to the packaging: information for the user

INALDIN Throat MAX, 3 mg/ml, spray for oral use, solution

Benzydamine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your 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 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is INALDIN Throat MAX and what is it used for
• 2. Important information before using INALDIN Throat MAX
• 3. How to use INALDIN Throat MAX
• 4. Possible side effects
• 5. How to store INALDIN Throat MAX
• 6. Contents of the packaging and other information

1. What is INALDIN Throat MAX and what is it used for

INALDIN Throat MAX contains benzydamine, which belongs to a group of non-steroidal anti-inflammatory drugs. It acts as a pain reliever and reduces swelling (inflammation). INALDIN Throat MAX is used in adults for short-term treatment of symptoms associated with inflammatory conditions of the mouth and throat (pain, redness, swelling) or irritation of the mucous membrane of the mouth or throat.
If after 3 days there is no improvement or you feel worse, contact your doctor.

2. Important information before using INALDIN Throat MAX

When not to use INALDIN Throat MAX

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

Warnings and precautions

Before starting to use INALDIN Throat MAX, discuss it with your doctor or pharmacist:

• if you are allergic to acetylsalicylic acid or other anti-fever, pain-relieving, and anti-inflammatory medicines (called NSAIDs), as you may have an increased risk of developing an allergy to benzydamine,
• if you have or have had asthma or allergic diseases, as the risk of bronchospasm or allergic reactions is increased.

Treatment should not last longer than 7 days. If symptoms do not improve or you feel worse after 3 days, if a fever or other symptoms occur, contact your doctor.
If an allergic reaction occurs, stop using the medicine and contact your doctor or emergency department.
Avoid contact of the medicine with the eyes.

INALDIN Throat MAX and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
So far, it has not been found that other medicines affect the action of INALDIN Throat MAX, or that INALDIN Throat MAX changes the action of other medicines.

INALDIN Throat MAX with food and drink

Immediately after using the medicine, a feeling of numbness or burning in the mouth or throat may occur.
Avoid eating and drinking until the numbness has passed.
The medicine should be used after eating and drinking.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
INALDIN Throat MAX should not be used during pregnancy and breastfeeding.

Driving and using machines

INALDIN Throat MAX has no influence or negligible influence on the ability to drive and use machines.

INALDIN Throat MAX contains ethanol

This medicine contains 81.40 mg of alcohol (ethanol) per milliliter, which corresponds to 13.84 mg in 0.17 ml (in one dose). The amount of alcohol in one dose (0.17 ml) of this medicine is equivalent to less than 0.4 ml of beer or 0.2 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

INALDIN Throat MAX contains methyl parahydroxybenzoate (E 218)

The medicine may cause allergic reactions (possible late reactions).

INALDIN Throat MAX contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose (0.17 ml), i.e., the medicine is considered "sodium-free".

3. How to use INALDIN Throat MAX

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Adults:
The medicine is intended for use in adults.
The recommended dose is 2 to 4 doses (sprays) of the spray, 2 to 6 times a day, not more often than every 1.5 to 3 hours. One press of the dosing pump (measuring device) delivers one dose of the spray.
Do not exceed the recommended dose.
Treatment should not last longer than 7 days, unless your doctor decides otherwise. If symptoms do not improve or you feel worse after 3 days, if a fever or other symptoms occur, contact your doctor.
Children and adolescents:
This medicine is not intended for use in children and adolescents (under 18 years of age).

Instructions for use:

Fig. 1
Fig. 2

• Set the tip of the dosing device to the horizontal position (Fig. 1).
• If the medicine is used for the first time, holding the bottle in a vertical position, press the dosing device firmly with your thumb or index finger. Repeat this action 5 times to achieve proper spraying. If the medicine is used again, press the dosing device 2 times.
• Then direct the tip of the dosing device to the mouth and press the dosing device (Fig. 2).
• While spraying, the patient should hold their breath.

Using a higher dose of INALDIN Throat MAX than recommended

In case of taking a higher dose than recommended or accidental ingestion of a larger amount of the medicine, contact your doctor or pharmacist immediately.

Missing a dose of INALDIN Throat MAX

If you miss a dose, use it as soon as possible. However, if it is close to the time of the next dose, do not use the missed dose. Do not use a double dose to make up for the missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using this medicine and contact your doctor or the nearest emergency department immediately:

• swelling of the face, hands, and feet, eyes, lips, and (or) tongue, which may cause difficulty breathing or swallowing (angioedema) - a very rare side effect,
• allergic reaction (hypersensitivity). Severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, chest pain or tightness, and (or) dizziness/fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, which may be life-threatening (this is a side effect whose frequency is unknown - it cannot be determined from available data).

Immediately after taking the medicine, a feeling of numbness or burning in the mouth or throat may occur. This reaction is related to the normal action of the medicine and passes after a short time. In individual cases, nausea or vomiting may occur, which are caused by the reflex irritation of the throat associated with taking the medicine. These symptoms pass on their own after stopping the medicine.
In patients using benzydamine in spray, the following side effects have also been reported, with the following frequencies:

• uncommon side effects (may occur less often than in 1 in 100 patients) - hypersensitivity to light,
• rare side effects (may occur less often than in 1 in 1000 patients) - burning and dryness in the mouth
• very rare side effects (may occur less often than in 1 in 10,000 patients) - difficulty breathing or swallowing (laryngospasm or bronchospasm).

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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store INALDIN Throat MAX

Do not store above 30°C.
Shelf life after first use: 160 days.
Keep the medicine out of the sight and reach of children.
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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What INALDIN Throat MAX contains

• The active substance is benzydamine hydrochloride. One milliliter of INALDIN Throat MAX spray for oral use, solution contains 3 mg of benzydamine hydrochloride, which corresponds to 2.68 mg of benzydamine. One spray (one dose) of the spray (0.17 ml) contains 510 micrograms of benzydamine hydrochloride, which corresponds to 456 micrograms of benzydamine.
• The other ingredients are: methyl parahydroxybenzoate (E 218), sodium cyclamate (E 952), glycerol (E 422), sodium bicarbonate, polysorbate 80, ethanol 96%, peppermint flavor [containing peppermint oil, ethanol, menthol], phosphoric acid concentrated (to adjust pH), purified water.

What INALDIN Throat MAX looks like and what the pack contains

Clear, colorless solution with a characteristic peppermint smell in a white bottle (HDPE) with a capacity of 15 ml or 30 ml, with a white dosing pump (LDPE/HDPE) and a white applicator for the dosing pump (PP), in a cardboard box.
Pack sizes: 75 doses (15 ml) or 150 doses (30 ml).
Not all pack sizes may be marketed.
Packaging:
1 bottle.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Bertolix
Finland:
Bertolix 3 mg/ml suuonteloon, liuos
Norway:
Bertolix
Poland:
INALDIN Throat MAX
Slovakia:
Garganta Forte 3 mg/ml orálna roztoková aerodisperzia
Sweden:
Bertolix 3 mg/ml munhålespray, lösning
Date of last revision of the leaflet:August 2024