Inaldin throat

Patient Information Leaflet

INALDIN Throat, 1.5 mg/ml, oral spray, solution
Benzydamini hydrochloridum
Please read all of this leaflet carefully before using 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
a doctor or pharmacist.

• Keep this leaflet, so that you may read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

INALDIN Throat contains benzydamine, which belongs to a group of non-steroidal anti-inflammatory drugs.
It exerts local anti-inflammatory and analgesic effects and produces local anaesthetic action on the oral mucosa.
INALDIN Throat, in the form of an oral spray solution, is used in the treatment of symptoms (pain, redness, swelling)
associated with inflammatory conditions of the mouth and throat.

2. Important information before using INALDIN Gardło

When not to use INALDIN Gardło

• 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, discuss this with your doctor or
pharmacist:

• if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as in such cases there is an increased risk of developing an allergy to benzidamine,
• if the patient has bronchial asthma or allergic conditions currently or in the past, as in such cases the risk of bronchospasm or allergic reactions is increased.

If there is no improvement after 3 days or if the patient feels worse, consult a doctor, as in rare cases, ulceration of the cheeks or throat may be caused by a serious underlying disease.
Do not use INALDIN Gardło for longer than 7 days without consulting a doctor, as prolonged use may lead to the development of an allergic reaction. If an allergic reaction occurs, discontinue use immediately and consult a doctor or pharmacist.
Avoid contact of the medicine with the eyes.
INALDIN Gardło and other medicines
Inform 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 reported whereby other medicines affect the action of INALDIN Gardło or whereby INALDIN Gardło alters the effect of other medicines.
INALDIN Gardło with food and drink
Numbness in the mouth or throat may occur immediately after taking the medicine. Avoid eating or drinking until the numbness subsides.
The medicine should be used after meals and drinking.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
INALDIN Gardło should not be used during pregnancy and breastfeeding.
Driving and operating machinery
INALDIN Gardło has no effect or has a negligible effect on the ability to drive and operate machinery.
INALDIN Gardło contains ethanol
This medicine contains 81.40 mg of alcohol (ethanol) per millilitre, equivalent 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 Gardło contains methyl parahydroxybenzoate (E 218)
The medicine may cause allergic reactions (including delayed-type reactions).
INALDIN Gardło contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose (0.17 ml), meaning the medicine is considered "sodium-free".

3. How to use INALDIN Throat

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, adolescents and children over 12 years of age: 4 to 8 sprays, 2 to 6 times daily; no more frequently than every 1.5 to 3 hours.
Children aged 6 to 12 years: 4 sprays, 2 to 6 times daily; no more frequently than every 1.5 to 3 hours.
Children under 6 years of age: 1 spray per 4 kg body weight, 2 to 6 times daily; no more frequently than every 1.5 to 3 hours. Regardless of body weight, no more than 4 sprays should be administered at one time.
Do not use in children who are unable to hold their breath during administration of the medicine.
Elderly patients: no dosage adjustment is necessary.
Do not use INALDIN Throat for longer than 7 days without consulting a doctor.

Instructions for use:

Fig. 1 Fig. 2

• Position the spray nozzle horizontally (Fig. 1).
• If the medicine is being used for the first time, hold the bottle in an upright position and press the spray nozzle firmly with the thumb or index finger. Repeat this 5 times to ensure proper spray function. If the medicine has been used before, press the nozzle 2 times.
• Then place the nozzle into the mouth and press the spray nozzle (Fig. 2).

If more medicine is used than recommended
If more than the recommended dose is used or if the medicine is accidentally swallowed, contact a doctor or pharmacist immediately.

If you forget to use the medicine
If a dose is missed, use 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 dose.

If you have any further doubts about the use of this medicine, consult your 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 straight away:

• swelling of the face, hands and feet, eyes, lips and (or) tongue, which may cause difficulty in breathing or swallowing (angioedema) – very rare adverse reaction,
• allergic reaction (hypersensitivity). Severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty in breathing, pain or tightness in the chest, and (or) dizziness/fainting, severe skin itching or raised skin rash, swelling of the face, lips, tongue and (or) throat, which may be potentially life-threatening (this is

an adverse reaction for which the frequency is unknown – cannot be estimated from the available data).
Shortly after taking the medicine, a sensation of numbness or burning 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 been reported with the following frequencies:

• uncommon adverse reactions (may occur in less than 1 in 100 patients) - photosensitivity
• rare adverse reactions (may occur in less than 1 in 1,000 patients) - burning sensation and dryness in the mouth
• very rare adverse reactions (may occur in less 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 the medicine INALDIN Gardło

Store below 25°C.
Shelf life after first use: 90 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 must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What INALDIN Throat contains

• The active substance is benzidamine hydrochloride. One millilitre of INALDIN Throat, oral spray, solution contains 1.5 mg of benzidamine hydrochloride, equivalent to 1.34 mg of benzidamine.

One spray (one dose) of the aerosol (0.17 ml) contains 255 micrograms of benzidamine hydrochloride, equivalent to 228 micrograms of benzidamine.

• Other ingredients are: methyl parahydroxybenzoate (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 looks like and contents of the pack
A clear, colourless solution with a characteristic peppermint odour in a white high-density polyethylene (HDPE) bottle of 30 ml capacity, type “crimp/snap”, with a white polyethylene 0.17 ml VP6/33 “snap” dosing pump and a white polypropylene applicator for the 0.17 ml dosing pump, packed in a cardboard box.
Number of doses: 150.
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 Street
35-959 Rzeszów
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: INALDIN Gardło
Slovakia: Garganta 1.5 mg/ml