Orofar Total Action

Package Leaflet: Information for the Patient

Orofar Total Action, (2 mg + 1.5 mg)/ml, Oral Spray

Benzoxonium Chloride + Lidocaine Hydrochloride

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

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

Table of Contents of the Leaflet

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

1. What is Orofar Total Action and what is it used for

Orofar Total Action contains an antiseptic active substance - benzoxonium chloride and a local anesthetic (a topical pain-relieving substance). Orofar Total Action combats bacteria, viruses, and fungi that cause throat and mouth infections. Orofar Total Action soothes throat pain.

Orofar Total Action is used:

• for throat infections
• for mouth infections (gum inflammation, mouth infections, and mouth ulcers - aphthae).

The medication soothes throat pain accompanying colds, sore throats, and laryngitis.

It can be used as an auxiliary treatment for tonsillitis (angina).

Orofar Total Action is indicated for use in adults and children over 6 years of age.

2. Important information before using Orofar Total Action

When not to use Orofar Total Action

Orofar Total Action should not be used if the patient is allergic to:

• Benzoxonium chloride or other quaternary ammonium salts,
• Any of the other ingredients of this medication (listed in section 6),
• Lidocaine hydrochloride or other local anesthetic amide medications.

Warnings and precautions

Consult a doctor or pharmacist before using Orofar Total Action if:

• Throat pain is accompanied by high fever or severe swallowing difficulties,
• Symptoms do not improve or persist for more than 3 days.

Do not use for more than 7 days without consulting a doctor.

Do not spray near the eyes or inhale (hold your breath while spraying).

Do not use in people with a tendency to choke, especially in people over 60 years of age.

When using Orofar Total Action, be cautious in the presence of wounds or changes in the mouth and throat mucosa.

Do not exceed the recommended dose or frequency of dosing.

Use the lowest effective dose for the shortest possible time.

Do not use Orofar Total Action during or immediately before eating and drinking. The medication may cause temporary numbness in the mouth and throat, making swallowing difficult. Avoid eating and drinking until the numbness subsides.

Do not use with other antiseptic agents.

This medication should always be used as described in the leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Orofar Total Action should not be used with anionic agents, such as toothpaste.

Anionic agents may reduce the effect of benzoxonium chloride. Therefore, do not use this medication immediately before or after brushing your teeth.

Store the medication out of sight and reach of children.

Children

Orofar Total Action should not be used in children under 6 years of age.

Orofar Total Action and other medications

Tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take.

Orofar Total Action with food, drink, and alcohol

Do not use Orofar Total Action immediately before or during eating and drinking, as the local anesthetic effect of lidocaine may cause temporary numbness in the mouth and throat, making swallowing difficult. Avoid eating and drinking until the numbness subsides.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medication.

Driving and using machines

Orofar Total Action has no or negligible influence on the ability to drive and use machines.

Orofar Total Action contains ethanol.

This medication contains up to 17.5 mg of alcohol (96% ethanol) per spray.

The amount of alcohol in one spray of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication will not have noticeable effects.

It may cause a burning sensation on damaged skin.

Orofar Total Action contains peppermint oil

The medication contains a fragrant substance (peppermint oil) with limonene, which may cause allergic reactions.

3. How to use Orofar Total Action

This medication should always be used exactly as described in this patient leaflet or as directed by a doctor and pharmacist.

Children over 6 years of age:

The recommended dose is 2-3 sprays of the oral spray in the mouth or on the back of the throat where it hurts. If necessary, the dose can be repeated 3 to 6 times a day, with 2-3 hour intervals between applications.

Children should use the medication under adult supervision. Do not use in children who cannot hold their breath during administration.

Adults

The recommended dose is 2-4 sprays of the oral spray in the mouth or on the back of the throat where it hurts.

Hold the container upright and spray 2 to 4 times at each use. If necessary, the dose can be repeated 3 to 6 times a day, with 2-3 hour intervals between applications.

Do not exceed the recommended dose or frequency of dosing.

Do not use for more than 7 days without consulting a doctor.

Method of administration:

• Remove the protective cap from the container,
• Gently press the dispenser tip onto the container,
• Before the first use, press the pump several times to achieve the correct spray, holding the container away from your face, press the pump until one dose of the medication is sprayed into the air,
• Hold the container upright and spray the solution into the mouth or on the back of the throat. Hold your breath while spraying,
• After each use, clean and dry the dispenser tip (using a tissue moistened with a small amount of Orofar Total Action solution),
• After use, remove the dispenser tip and store it with the medication in the outer packaging,
• To avoid spreading infection, the dispenser tip should only be used by one person,
• Do not use the medication if the dispenser tip is damaged.

Use in children

Do not use in children under 6 years of age.

Using more than the recommended dose of Orofar Total Action

In case of using more than the recommended dose of Orofar Total Action, consult a doctor or pharmacist immediately. If in doubt about the use of Orofar Total Action, consult a doctor or pharmacist.

Missing a dose of Orofar Total Action

Do not use a double dose to make up for a missed dose.

If you have any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Orofar Total Action can cause side effects, although not everybody gets them.

Stop using Orofar Total Action and seek medical help immediately if you experience any of the following side effects, which may be symptoms of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue, or throat
• Severe itching of the skin with red rash and blisters. These side effects are very rare (may occur in less than 1 in 10,000 people).

Some side effects are common(may occur in less than 1 in 10 people)

• Irritation or tingling in the mouth or throat.

All patients who have accidentally or intentionally taken large amounts of Orofar Total Action should seek medical help immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 gather more information on the safety of this medication.

5. How to store Orofar Total Action

Store the medication out of sight and reach of children.

Store in a temperature below 30°C.

Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Orofar Total Action contains

• The active substances of the medication are benzoxonium chloride and lidocaine hydrochloride. One ml of the solution contains 2 mg of benzoxonium chloride and 1.5 mg of lidocaine hydrochloride. One dose contains 0.2798 mg of benzoxonium chloride and 0.2098 mg of lidocaine hydrochloride.
• The other ingredients of the medication are: ethanol 96% v/v, glycerol, peppermint oil, menthol, hydrochloric acid 0.1 N, purified water.

What Orofar Total Action looks like and contents of the pack

Orofar Total Action is available as an oral spray.

Available packs:30 ml bottle

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer

Doppel Farmaceutici S.R.L.

Via Martiri Delle Foibe, 1

29016 Cortemaggiore (PC)

Italy

Date of last revision of the leaflet: