Orofar total action

Package leaflet: Information for the user

Orofar Total Action, (2 mg + 1.5 mg)/ml, oral aerosol
Benzoxonium chloride + Lidocaine hydrochloride
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

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

Contents of the leaflet

1. What Orofar Total Action is and what it is used for
2. What you need to know 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 Orofar Total Action is and what it is used for

Orofar Total Action contains an antiseptic substance – benzoxonium chloride – and an anaesthetic component (a locally acting analgesic). Orofar Total Action acts against bacteria, viruses, and fungi causing throat and oral cavity infections. Orofar Total Action relieves sore throat pain.

Orofar Total Action is indicated for:

• throat infections
• oral cavity infections (inflammatory conditions of the gums, infections and ulcers of the oral mucosa – aphthae).

The medicine relieves sore throat associated with colds, pharyngitis, and laryngitis.
It may be used as an adjunct in the treatment of 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
Do not use Orofar Total Action if the patient is allergic to:

• Benzalkonium chloride or other quaternary ammonium salts,
• Any of the other ingredients of this medicine (listed in section 6),
• Lidocaine hydrochloride or other amide-type local anaesthetics.

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

• Sore throat is accompanied by high fever or severe difficulty swallowing,
• Symptoms do not improve or persist for more than 3 days.

Do not use for longer than 7 days without consulting a doctor.
Do not spray near the eyes or inhale (hold breath while spraying).
Do not use in patients with a tendency to choking, especially in patients over 60 years of age.
Use with caution if there are wounds or lesions in the oral cavity or pharyngeal mucosa.
Do not exceed the recommended dose or dosing frequency.
Use the lowest effective dose for the shortest possible duration.
Do not use Orofar Total Action during or immediately before eating or drinking. The medicine may cause temporary numbness in the mouth and throat, making swallowing difficult. Avoid eating or drinking until the numbness has subsided.
Do not use with other antiseptic agents.
This medicine should always be used according to the instructions in the leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use Orofar Total Action with anionic agents, for example toothpastes.
Anionic agents may reduce the activity of benzalkonium chloride. Therefore, do not use this medicine immediately before or after tooth brushing.
Keep this medicine out of sight and reach of children.

Children
Do not use Orofar Total Action in children under 6 years of age.

Orofar Total Action 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 planned for future use.

Orofar Total Action with food, drink and alcohol
Do not use Orofar Total Action immediately before or during eating or drinking: the local anaesthetic effect of lidocaine may cause temporary numbness in the mouth and throat, leading to difficulty in swallowing. Refrain from eating or drinking until the numbness has resolved.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Orofar Total Action has no effect or has a negligible effect on the ability to drive and operate machinery.

Orofar Total Action contains ethanol.
This medicine contains up to 17.5 mg of alcohol (96% ethanol) per spray.
The amount of alcohol in one spray of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
It may cause stinging on damaged skin.

Orofar Total Action contains peppermint oil
This medicine contains a fragrance ingredient (peppermint oil) with limonene, which may cause allergic reactions.

3. How to use Orofar Total Action

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Children over 6 years of age:
The recommended dose is 2–3 sprays of the aerosol into the mouth or onto the back of the throat at the site of pain. If necessary, the dose may be repeated 3 to 6 times daily, with intervals of 2–3 hours between applications.
The medicine should be used in children under adult supervision. Do not use in children who are unable to hold their breath during administration.

Adults
The recommended dose is 2–4 sprays of the aerosol into the mouth or onto the back of the throat at the site of pain. Holding the container vertically, spray 2 to 4 times with each use. If necessary, the dose may be repeated 3 to 6 times daily, with intervals of 2–3 hours between applications.
Do not exceed the stated dose or recommended frequency of administration.
Do not use for longer than 7 days without consulting a doctor.

Instructions for use:

• Remove the protective cap from the container.
• Gently press and attach the spray nozzle onto the container.
• Before first use, prime the pump by pressing it several times to achieve a proper spray. Hold the container away from the face and continue pressing until one dose of the medicine is sprayed into the air.
• Holding the container vertically, spray the solution into the mouth or onto the back of the throat. Hold your breath during spraying.
• After each use, the spray nozzle should be cleaned (using a wipe moistened with a small amount of Orofar Total Action solution) and dried.
• After use, remove the spray nozzle and store it together with the medicine in the outer packaging.
• To prevent the spread of infection, the spray nozzle should be used by only one person.
• Do not use the medicine if the spray nozzle is damaged.

Use in children
Do not use in children under 6 years of age.

Accidental overdose of Orofar Total Action
If more than the recommended dose of Orofar Total Action has been used, consult a doctor or pharmacist immediately. If you have any doubts regarding the use of Orofar Total Action, contact your doctor or pharmacist.

Missed 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 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.
You should stop using Orofar Total Action and seek immediate medical help
if any of the following adverse reactions occur, as they may be symptoms of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue or throat
• Severe skin itching with red rash and blisters

These adverse reactions are very rare (may occur in fewer than 1 in 10,000 people).

Some adverse reactions are common (may occur in fewer 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 immediately go to a doctor or hospital.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Orofar Total Action

Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Orofar Total Action contains

• The active substances in the medicine are benzoxonium chloride and lidocaine hydrochloride. One ml of 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.
• Other ingredients of the medicine 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 aerosol.
Available pack sizes: 30 ml bottle
Marketing Authorisation 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