Orofar Max

Package Leaflet: Information for the User

Orofar MAX, 2 mg + 1 mg, Hard Lozenges

Cetylpyridinium chloride + Lidocaine hydrochloride

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet:

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

1. What is Orofar MAX and what is it used for

Orofar MAX contains two active substances:

• cetylpyridinium chloride - an antiseptic substance (disinfectant) with bactericidal, antifungal, and antiviral properties.
• lidocaine hydrochloride - a substance with anesthetic properties, relieving pain.

Orofar MAX is used for the local treatment of sore throat and inflammation of the mouth.
The medicine has antiseptic properties, relieves pain and irritations associated with the above-mentioned ailments.
Pain relief in the throat starts within two minutes of taking the Orofar Max medicine.

2. Important information before using Orofar MAX

When not to use Orofar MAX

• if the patient is allergic to cetylpyridinium chloride, lidocaine hydrochloride, other local anesthetics from the amide group, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Orofar MAX, consult a doctor or pharmacist if:

• the sore throat persists for several days and the patient has a fever
• the sore throat persists after 5 days of using the medicine or is accompanied by a high fever, dizziness, or vomiting.

Local anesthetics may cause temporary swallowing disorders and increase the risk of choking.
Use the lowest effective dose for the shortest possible time.
Do not exceed the recommended dose or frequency of administration.
Do not use with other antiseptic agents.
Orofar MAX is intended for short-term use, for a maximum of 5 consecutive days.
Be cautious and consult a doctor or pharmacist if the patient has injuries in the mouth and throat, such as cuts, wounds, or actively bleeding wounds.
Keep the medicine out of the sight and reach of children.

Children

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

Orofar MAX and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.

Orofar MAX with food, drink, and alcohol

Orofar Max should not be taken during or immediately before eating or drinking. The medicine may cause temporary swallowing disorders and increase the risk of choking. Avoid eating or drinking until the numbness has passed.
Avoid consuming alcohol at the same time, as it increases the absorption of cetylpyridinium chloride, which may lead to an overdose.
Some substances in toothpastes may reduce the effect of cetylpyridinium chloride. Therefore, do not use this medicine immediately before or after brushing teeth.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.
During pregnancy, Orofar MAX should only be used on the advice of a doctor.
Orofar MAX is not recommended during breastfeeding.

Driving and using machines

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

Orofar MAX contains sorbitol

The medicine contains 1.107 g of sorbitol in each hard lozenge.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.

Orofar MAX contains peppermint oil

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

3. How to use Orofar MAX

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you have any doubts about using Orofar MAX, consult a doctor or pharmacist.

Children from 6 to 12 years old:

1 lozenge every 3 to 4 hours, depending on the severity of the pain, do not use more than 3 lozenges per day.

Adults and children over 12 years old:

Acute inflammation of the mouth and throat: 1 lozenge every 1 or 2 hours, depending on the severity of the pain.
Milder inflammation of the mouth and throat: 1 lozenge every 2 to 3 hours, depending on the severity of the pain.
Do not use more than 6 lozenges per day.
Use the lowest effective dose for the shortest possible time.
Do not exceed the recommended dose or frequency of administration.
Orofar MAX is intended for short-term use.
If symptoms persist for more than 5 days or are accompanied by a high fever, dizziness, or vomiting, consult a doctor.

Children under 6 years old:

Orofar MAX should not be used in children under 6 years old.

Method of administration

Suck the lozenge slowly in the mouth. Do not chew or swallow it.
Orofar Max should not be taken during or immediately before eating or drinking.

Overdose of Orofar MAX

In case of using more lozenges than recommended, consult a doctor or pharmacist immediately.
Due to the low concentration of lidocaine hydrochloride in the Orofar Max product, poisoning after oral administration can only occur if large amounts of the product are taken.
Accidental ingestion of a large amount of Orofar MAX may cause nausea and vomiting, shortness of breath, cyanosis, asphyxia (lack of oxygen) resulting from paralysis of the respiratory muscles, central nervous system depression, hypotension, and coma.
In case of accidental or intentional ingestion of a large amount of Orofar Max, seek medical help immediately.
Treatment should be symptomatic and supportive. Further action should be in accordance with clinical guidelines or the recommendations of the poison treatment center.

Missed dose of Orofar MAX

Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and consult a doctor immediately if you experience:

• allergic reactions, including skin rash or hives (itchy, raised rash), swelling of the tongue, lips, mouth. The following side effects may occur when using this medicine:

Rare(may affect up to 1 in 1000 people):

• nausea
• irritation of the mouth
• irritation of the throat
• allergic reactions, including skin rash or hives (itchy, raised rash), swelling of the tongue, lips, mouth.

Reporting side effects

If you experience any side effects, including any side effects not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 this medicine.

5. How to store Orofar MAX

Keep the medicine out of the sight and reach of children.
Do not use Orofar MAX after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store in a temperature below 30°C, in the original packaging.
Medicines should not be disposed of via wastewater 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 Orofar MAX contains

• The active substances of the medicine are cetylpyridinium chloride and lidocaine hydrochloride. One Orofar MAX lozenge contains 2 mg of cetylpyridinium chloride and 1 mg of lidocaine hydrochloride.
• The other ingredients of the medicine are: peppermint oil from peppermint leaves, Schimmel's peppermint oil (containing limonene, among others), levomenthol, acesulfame potassium, corn starch, citric acid monohydrate, macrogol 6000, microcrystalline cellulose, magnesium stearate, sorbitol.

What Orofar MAX looks like and contents of the pack

Orofar MAX is available in the form of lozenges (white, rectangular lozenges) in a blister pack made of three-layer foil consisting of Polyvinyl Chloride (PVC)/Polyethylene (PE)/Polyvinylidene.
The blister is placed in a cardboard box.
Available packs:10, 20, or 30 hard lozenges.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
Estrada Consiglieri Pedroso 69-B, Queluz de Baixo
2730-055 Barcarena
Portugal

Date of last revision of the package leaflet: