Inaldin Gardvo

Package Leaflet: Information for the User

INALDIN Throat, 3 mg, lozenges

Benzydamine hydrochloride

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

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

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

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

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

INALDIN Throat is indicated for use in adults, adolescents, and children over 6 years of age.

2. Important information before taking INALDIN Throat

When not to take INALDIN Throat

• -if the patient is allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has phenylketonuria (a disease characterized by the inability to metabolize the amino acid phenylalanine, which can have a harmful effect on the body).

Warnings and precautions

Before taking INALDIN Throat, the patient should discuss it with their doctor or pharmacist:

• if the patient is allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), as there is an increased risk of allergy to benzydamine;
• if the patient has or has had asthma or an allergic disease, as the risk of bronchospasm or allergy is increased.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor, as in rare cases, cheek or throat ulcers may be caused by an underlying serious disease.

INALDIN Throat should not be used for more than 7 days without consulting a doctor, as prolonged use may cause an allergic reaction. If an allergic reaction occurs, the patient should immediately talk to their doctor or pharmacist and stop taking the medicine.

Children and adolescents

INALDIN Throat is not recommended for use in children under 6 years of age.

INALDIN Throat and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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

Soon after taking the medicine, a feeling of numbness may occur in the mouth or throat. The patient should avoid eating and drinking until the numbness has passed.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking 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 aspartame (E 951)

This medicine contains 7 mg of aspartame in each lozenge.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates due to its improper removal from the body.

3. How to take INALDIN Throat

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose:

Adults and the elderly: 1 lozenge 3 times a day.

Children over 6 years of age: the same dosage as for adults.

INALDIN Throat is not recommended for use in children under 6 years of age.

INALDIN Throat should not be used for more than 7 days without a doctor's recommendation.

Instructions for use

The lozenges should be sucked. They should not be chewed or swallowed.

Overdose of INALDIN Throat

Overdose of INALDIN Throat is unlikely. No symptoms of toxicity should occur, even if the medicine is accidentally swallowed in larger quantities than the recommended dose. However, if the patient takes a larger dose of the medicine than recommended and experiences symptoms such as excitement, convulsions, sweating, balance and coordination disorders (e.g., uncoordinated movements), tremors, or vomiting, they should consult their doctor or pharmacist.

Missed dose of INALDIN Throat

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose. They should not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

In patients taking benzydamine, the following side effects have been reported with the following frequency:

• uncommon side effects (may occur in less than 1 in 100 patients) - hypersensitivity to light;
• rare side effects (may occur in less than 1 in 1,000 patients) - burning and dryness in the mouth;
• very rare side effects (may occur in less than 1 in 10,000 patients) - laryngeal spasm, facial, hand, and foot edema, eye, lip, and (or) tongue edema, which can cause difficulty breathing or swallowing (angioedema);
• frequency not known (frequency cannot be estimated from the available data) - 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, facial, lip, tongue, and (or) throat edema, which can be life-threatening.

Soon after taking the medicine, a feeling of numbness or burning may occur in the mouth or throat. 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.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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

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

Do not store above 30°C.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What INALDIN Throat contains

• The active substance is benzydamine hydrochloride. Each lozenge contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: mannitol (E 421), citric acid, hypromellose, peppermint flavor [containing natural peppermint flavor, corn maltodextrin, modified corn starch E 1450], aspartame (E 951), patent blue V (E 131), quinoline yellow (E 104), magnesium stearate.

What INALDIN Throat looks like and contents of the pack

Round, biconvex, green lozenges with a marbled surface, packaged in PVC/PE/PVDC/Aluminum blisters (10 lozenges per blister).

Pack sizes:

10 or 20 lozenges (1 or 2 blisters of 10 each).

Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

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 3 mg

Date of last revision of the leaflet:December 2021