Inaldin Gardvo

Package Leaflet: Information for the User

INALDIN Throat, 1.5 mg/ml, oral spray, solution
Benzydamine hydrochloride

Read the package leaflet carefully before using 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 or pharmacist.

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

Table of Contents of the Package Leaflet

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

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

INALDIN Throat contains benzydamine, which belongs to a group of non-steroidal anti-inflammatory drugs. It has local anti-inflammatory and analgesic effects and acts locally as an anesthetic on the mucous membrane of the oral cavity. INALDIN Throat in the form of an oral spray, solution, is used to treat symptoms (pain, redness, swelling) associated with inflammatory conditions of the oral cavity and throat.

2. Important information before using INALDIN Throat

When not to use INALDIN Throat

• 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, you should discuss it with your doctor or pharmacist:

• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as there is an increased risk of an allergic reaction to benzydamine,
• if you have or have had asthma or allergic diseases, as the risk of bronchospasm or allergic reaction is increased.

If after 3 days there is no improvement or you feel worse, you should consult your doctor, as in rare cases, ulcers of the cheeks or throat may be caused by a serious underlying disease.
Do not use INALDIN Throat for more than 7 days without consulting your doctor, as prolonged use may cause an allergic reaction. If an allergic reaction occurs, you should stop using the medicine immediately and consult your doctor or pharmacist.
Avoid contact of the medicine with the eyes.

INALDIN Throat 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, or that INALDIN Throat changes the action of other medicines.

INALDIN Throat with food and drink

Immediately after taking the medicine, a feeling of numbness or burning in the oral cavity or throat may occur. You should avoid eating and drinking until the feeling of numbness has passed.
The medicine should be used after eating and drinking.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

INALDIN Throat contains ethanol

This medicine contains 81.40 mg of alcohol (ethanol) per milliliter, which corresponds to 13.84 mg / 0.17 ml (in one dose). The amount of ethanol 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 contains methyl parahydroxybenzoate (E 218)

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

INALDIN Throat contains sodium

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

3. How to use INALDIN Throat

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Recommended dose:
Adults, adolescents, and children over 12 years: 4 to 8 doses (sprays) of the spray 2 to 6 times a day; no more often than every 1.5 to 3 hours.
Children from 6 to 12 years: 4 doses (sprays) of the spray 2 to 6 times a day, no more often than every 1.5 to 3 hours.
Children under 6 years: 1 dose (spray) per 4 kg of body weight 2 to 6 times a day, no more often than every 1.5 to 3 hours. Regardless of body weight, no more than 4 doses of the spray should be used at a time.
Do not use in children who cannot hold their breath during application.
Elderly patients: no dose adjustment is necessary.
Do not use INALDIN Throat for more than 7 days without consulting your doctor.

Instructions for use:

Fig. 1
Fig. 2

• Set the nozzle of the spray in a horizontal position (Fig. 1).
• If the medicine is used for the first time, holding the bottle in a vertical position, press the nozzle firmly with your thumb or index finger. Repeat this action 5 times to achieve proper spraying. If the medicine is used again, press the nozzle 2 times.
• Then direct the nozzle of the spray to the oral cavity and press the nozzle (Fig. 2).

Using a higher dose of INALDIN Throat than recommended

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

Missing a dose of INALDIN Throat

In case of missing 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, INALDIN Throat can cause side effects, although not everybody gets them.

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

• swelling of the face, hands, and feet, eyes, lips, and (or) tongue, which can 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 can be life-threatening (this is a side effect whose frequency is unknown - it cannot be determined based on available data).

Immediately after taking the medicine, a feeling of numbness or burning in the oral cavity 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 a 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 a spray, the following side effects were 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 oral cavity
• 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 any not listed in this package leaflet, tell your 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,
Aleje 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, you can help provide more information on the safety of this medicine.

5. How to store INALDIN Throat

Store in a temperature below 25°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 package and other information

What INALDIN Throat contains

• The active substance of the medicine is benzydamine hydrochloride. One milliliter of INALDIN Throat, oral spray, solution, contains 1.5 mg of benzydamine hydrochloride, which corresponds to 1.34 mg of benzydamine.

One spray (one dose) of the spray (0.17 ml) contains 255 micrograms of benzydamine hydrochloride, which corresponds to 228 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 looks like and what the package contains

Clear, colorless solution with a characteristic peppermint smell in a white HDPE bottle with a white polyethylene pump dispenser 0.17 ml VP6/33 and a white polypropylene applicator for the pump dispenser 0.17 ml, in a cardboard box.
Number of doses: 150.
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.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

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

Poland:
INALDIN Throat
Slovakia:
Garganta 1.5 mg/ml
Date of last revision of the package leaflet:September 2024