Inaldin throat max

Patient Information Leaflet

INALDIN Throat MAX, 3 mg/ml, oral spray, solution
Benzydamini hydrochloridum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if the patient feels worse, consult a doctor.

Table of Contents

1. What INALDIN Throat MAX is and what it is 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 pack and other information

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

INALDIN Throat MAX contains benzydamine, which belongs to a group of non-steroidal anti-inflammatory drugs. It acts to relieve pain and reduce swelling (inflammation). INALDIN Throat MAX is used in adults for the short-term treatment of symptoms associated with inflammatory conditions of the mouth and throat (pain, redness, swelling) or irritation of the mucous membranes of the mouth or throat.
If there is no improvement after 3 days of treatment, or if the patient feels worse, consult a doctor.

2. Important information before using the medicine INALDIN Gardło MAX

When not to use INALDIN Gardło MAX

• 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 to use INALDIN Gardło MAX, discuss this with your doctor or
pharmacist:

• if the patient is allergic to acetylsalicylic acid or other antipyretic, analgesic and anti-inflammatory medicines (known as NSAIDs), because there may be an increased risk of developing an allergy to benzidamine,
• if the patient has or has had bronchial asthma or allergic diseases in the past, because in such cases the risk of bronchospasm or allergic reactions is increased.

The duration of treatment should not exceed 7 days. If symptoms do not improve or the patient feels
worse after 3 days, or if fever or other symptoms occur, consult a doctor.
If an allergic reaction occurs, stop using the medicine and contact a doctor or
emergency department.
Avoid contact of the medicine with the eyes.
INALDIN Gardło MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
To date, no interactions have been observed where other medicines affect the action of INALDIN Gardło MAX, or where INALDIN Gardło MAX alters the effects of other medicines.
INALDIN Gardło MAX with food and drink
Immediately after application, a sensation of numbness in the mouth or throat may occur.
Avoid eating and drinking until the numbness subsides.
The medicine should be used after eating and drinking.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine.
Do not use INALDIN Gardło MAX during pregnancy unless absolutely
necessary and recommended by a doctor. If use is necessary, the lowest possible dose for the shortest possible duration should be used.
Do not use INALDIN Gardło MAX during breastfeeding.
Driving and operating machinery
INALDIN Gardło MAX has no effect or has a negligible effect on the ability to drive
and operate machinery.
INALDIN Gardło MAX contains ethanol
This medicine contains 81.40 mg of alcohol (ethanol) in each millilitre, equivalent to 13.84 mg in 0.17 ml
(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 Gardło MAX contains methyl parahydroxybenzoate (E 218)
The medicine may cause allergic reactions (including delayed-type reactions).
INALDIN Gardło MAX contains polysorbate 80
Polysorbates may cause allergic reactions.
INALDIN Gardło MAX contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per single dose (0.17 ml), meaning the medicine is considered "sodium-free".

3. How to use INALDIN Gardło MAX

This medicine should always be used 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:
This medicine is intended for use in adults.
The recommended dose is 2 to 4 sprays (actuations) of the aerosol at a time, administered 2 to 6 times daily, no more frequently than every 1.5 to 3 hours. One press of the metering pump (measuring device) delivers one dose of the aerosol.
Do not exceed the recommended dose.
The duration of treatment should not exceed 7 days unless otherwise decided by a doctor. If symptoms do not improve or the patient feels worse after 3 days, or if fever or other symptoms occur, consult a 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

• Position the spray nozzle horizontally (Fig. 1).
• If the medicine is used for the first time, hold the bottle in an upright position and press the spray pump firmly with the thumb or index finger. Repeat this step 5 times to ensure proper spray function. If the medicine has been used before, press the pump twice.
• Then insert the spray nozzle into the mouth and press the pump (Fig. 2).
• The patient should hold their breath during spraying.

Use of more than the recommended dose of INALDIN Gardło MAX
In case of overdose or accidental ingestion of a larger amount of the medicine, contact a doctor or pharmacist immediately.
Missed dose of INALDIN Gardło MAX
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed one.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using
this medicine immediately and contact your doctor or the nearest emergency department:

• swelling of the face, hands and feet, eyes, lips and (or) tongue, which may cause difficulty
  in breathing or swallowing (angioedema) – a very rare adverse reaction,

• allergic reaction (hypersensitivity). A severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, severe skin itching or raised skin rashes, swelling of the face, lips, tongue and (or) throat, which may be potentially life-threatening (this is an adverse reaction whose frequency is unknown – cannot be estimated based on available data).

Shortly after taking the medicine, a sensation of numbness or tingling in the mouth or
throat may occur. This reaction is related to the normal action of the medicine and subsides after a short time. In isolated cases, nausea or vomiting may occur, caused by a reflex irritation of the throat associated with taking the medicine. These symptoms resolve spontaneously after discontinuation of the medicine.
In patients using benzydamine in aerosol form, the following adverse reactions have also been reported, with the following frequencies:

• uncommon adverse reactions (may occur in fewer than 1 in 100 patients) – photosensitivity,
• rare adverse reactions (may occur in fewer than 1 in 1,000 patients) – burning sensation and dryness in the mouth,
• very rare adverse reactions (may occur in fewer than 1 in 10,000 patients) – difficulty in breathing or swallowing (laryngospasm or bronchospasm).

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 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What INALDIN Throat MAX contains

• The active substance is benzidamine hydrochloride. One millilitre of INALDIN Throat MAX oral spray solution contains 3 mg of benzidamine hydrochloride, equivalent to 2.68 mg of benzidamine. One spray (one dose) of aerosol (0.17 ml) contains 510 micrograms of benzidamine hydrochloride, equivalent to 456 micrograms of benzidamine.
• Other ingredients are: methyl 4-hydroxybenzoate (E 218), sodium cyclamate (E 952), glycerol (E 422), sodium hydrogen carbonate, polysorbate 80, 96% ethanol, peppermint flavour [containing peppermint oil, ethanol, menthol], concentrated phosphoric acid (for pH adjustment), purified water.

What INALDIN Throat MAX looks like and contents of the pack
A clear, colourless solution with a characteristic peppermint odour in a white bottle (HDPE)
with a volume of 15 ml or 30 ml, equipped with a white dosing pump (LDPE/HDPE) and a white applicator for the dosing pump (PP), packed in a cardboard box.
Package sizes: 75 doses (15 ml) or 150 doses (30 ml).
Not all package sizes may be marketed.
Pack:
1 bottle.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-105 Rzeszów
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Bertolix
Finland: Bertolix 3 mg/ml sumute suuonteloon, liuos
Norway: Bertolix
Poland: INALDIN Throat MAX
Slovakia: Garganta Forte 3 mg/ml orálna roztoková aerodisperzia
Sweden: Bertolix 3 mg/ml munhålespray, lösning