Orofar Iunior

Package Leaflet: Information for the Patient

Orofar Junior, 1 mg + 1 mg, Sucking Tablets

Benzoxonium Chloride + Lidocaine Hydrochloride

Read the Leaflet Carefully Before Using the Medicinal Product

This medicinal product must be used exactly as described in this leaflet for the patient or as directed by the doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further 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, consult a doctor.

Table of Contents of the Leaflet

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

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

Orofar Junior has antibacterial, antifungal, antiviral, and analgesic effects. It contains an antiseptic active substance - benzoxonium chloride and a local anesthetic (a topical pain-relieving substance). Orofar Junior combats bacteria, viruses, and fungi that cause throat and mouth infections. Orofar Junior soothes a sore throat.

• in throat infections;
• in mouth infections (gum inflammation, mouth ulcers, and mucous membrane infections - aphthae).

The medicinal product soothes throat pain accompanying colds, sore throats, and laryngitis. It can also be used as an auxiliary treatment for tonsillitis (angina). Orofar Junior is indicated for use in adults, adolescents, and children over 6 years of age.

2. Important information before using Orofar Junior

When not to use Orofar Junior

Orofar Junior must not be used if the patient is allergic to:

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

Warnings and precautions

Consult a doctor or pharmacist before using Orofar Junior if:

• the sore throat is accompanied by a high fever or there are serious swallowing difficulties;
• the 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 use in people with a tendency to choke, especially in people over 60 years of age. When using Orofar Junior, be cautious in the presence of wounds or changes in the mouth and throat mucosa. Do not exceed the recommended dose or frequency of administration. Use the lowest effective dose for the shortest possible duration. Do not use Orofar Junior during or immediately before eating and drinking. The medicinal product may cause temporary numbness in the mouth and throat, making swallowing difficult. Avoid eating and drinking until the numbness has passed. Do not use with other antiseptic agents. This medicinal product must always be used as described in the leaflet or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist. Orofar Junior must not be used with anionic agents, such as toothpaste. Anionic agents may reduce the effect of benzoxonium chloride. Therefore, do not use this medicinal product immediately before or after brushing teeth. Keep the medicinal product out of the sight and reach of children.

Children and adolescents

Orofar Junior must not be used in children under 6 years of age.

Orofar Junior and other medicinal products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

Orofar Junior with food, drink, and alcohol

Do not use Orofar Junior immediately before or during eating and drinking: 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 has passed.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Orofar Junior has no influence or negligible influence on the ability to drive and use machines.
Orofar Junior contains sorbitol, sodium, citral, citronellol, geraniol, limonene, and linalool
Sorbitol: The medicinal product contains 1 g of sorbitol per sucking tablet. Sorbitol is a source of fructose. If you have been diagnosed with an intolerance to some sugars or have a rare genetic disorder, hereditary fructose intolerance, where your body does not break down fructose, consult your doctor before taking the medicinal product or giving it to your child. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect. Sodium: The medicinal product contains less than 1 mmol (23 mg) of sodium per sucking tablet, which means it is essentially sodium-free. Orange flavor: The medicinal product contains a flavoring substance with citral, citronellol, geraniol, limonene, and linalool, which may cause allergic reactions.

3. How to use Orofar Junior

This medicinal product must always be used exactly as described in this leaflet for the patient or as directed by the doctor and pharmacist. If in doubt, consult a doctor or pharmacist.

Adults and adolescents over 12 years of age

Suck one tablet slowly every 2-3 hours. In case of severe infection, the dose can be increased to one tablet every 1-2 hours. Do not use more than 10 tablets in 24 hours. When treating mouth ulcers, let the tablet dissolve slowly near the affected area.

Use in children over 6 years of age

Suck one tablet slowly every 2-3 hours. Children over 6 years of age should not take more than 6 tablets in 24 hours. Do not use Orofar Junior in children under 6 years of age, as local anesthetics may cause temporary swallowing difficulties and increase the risk of choking. Do not use Orofar Junior immediately before or during eating and drinking. Do not chew or swallow the tablets. Do not exceed the recommended dose or frequency of administration. Do not use for more than 7 days without consulting a doctor.

Overdose of Orofar Junior

In case of using more tablets than recommended, contact a doctor or pharmacist immediately. If in doubt about the use of Orofar Junior, consult a doctor or pharmacist.

Missed dose of Orofar Junior

Do not take a double dose to make up for a missed dose. If you have any further doubts about the use of this medicinal product, consult a doctor or pharmacist.

4. Possible side effects

Like all medicinal products, Orofar Junior can cause side effects, although not everybody gets them. STOP USINGOrofar Junior and seek medical help immediately if you experience any of the following side effects, which may be signs 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 Junior 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 Post-Marketing Surveillance 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. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Orofar Junior

Keep the medicinal product out of the sight and reach of children. Do not use this medicinal product 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. Protect from moisture. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Orofar Junior contains

• The active substances are benzoxonium chloride and lidocaine hydrochloride. One sucking tablet of Orofar Junior contains 1 mg of benzoxonium chloride + 1 mg of lidocaine hydrochloride.
• The other ingredients are: sorbitol, microcrystalline cellulose, macrogol 6000, corn starch, sodium saccharin, sodium chloride, citric acid monohydrate, orange flavor 55607 TP.05.51 (contains corn maltodextrin, flavors (natural flavor complexes, synthetic flavor substances, natural flavor substances) including citral, citronellol, geraniol, limonene, and linalool), magnesium stearate.

What Orofar Junior looks like and contents of the pack

Orofar Junior is available in the form of orange-flavored sucking tablets.
Packaging of the medicinal product:24 tablets (3 blisters of 8 tablets each), 16 tablets (2 blisters of 8 tablets each), or 8 tablets (1 blister of 8 tablets). Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

Recipharm Uppsala AB
Björkgatan 30
SE-751 82 Uppsala
Sweden
To obtain more detailed information, contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Date of last revision of the leaflet: