OROFAR JUNIOR

Package leaflet: Information for the user

Orofar Junior, 1 mg + 1 mg, lozenges
Benzoxonii chloridum + Lidocaini hydrochloridum
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 so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Contents of the leaflet

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

Orofar Junior has antibacterial, antifungal, antiviral, and analgesic properties. It contains an antiseptic substance – benzalkonium chloride and an anesthetic component (a locally acting analgesic substance). Orofar Junior combats bacteria, viruses, and fungi causing throat and oral cavity infections. Orofar Junior relieves sore throat pain.

Orofar Junior is indicated for:

• throat infections;
• oral cavity infections (inflammatory conditions of the gums, infections and ulcerations 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 Junior is indicated for use in adults, adolescents, and children aged 6 years and older.

2. Important information before using Orofar Junior

When not to use Orofar Junior
Do not use Orofar Junior if the patient is allergic to:

• Benzoxonium 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 Junior if:

• Sore throat is accompanied by high fever or if there are serious difficulties with 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 use in patients with a tendency for choking, especially in patients over 60 years of age.
Use with caution if there are wounds or lesions present in the oral cavity or pharyngeal mucosa.
Do not exceed the recommended dose or frequency of dosing.
Use the lowest effective dose for the shortest possible duration.
Do not use Orofar Junior immediately before or during 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 together 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 Junior with anionic agents, for example, toothpastes.
Anionic agents may reduce the activity of benzoxonium chloride. Therefore, do not use this medicine immediately before or after brushing teeth.
Keep the medicine out of sight and reach of children.

Children and adolescents
Do not use Orofar Junior in children under 6 years of age.

Orofar Junior and other medicines
Inform your doctor or pharmacist about any medicines currently or recently taken, or those planned to be taken.

Orofar Junior with food, drink and alcohol
Do not use Orofar Junior 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 and drinking until the numbness has resolved.

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

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

Orofar Junior contains sorbitol, sodium, citral, citronellol, geraniol, limonene and linalool
Sorbitol: The medicine contains 1 g of sorbitol per lozenge. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolize fructose, the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Sodium: The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, i.e. the medicine is considered "sodium-free".
Orange flavour: The medicine contains flavouring substances including citral, citronellol, geraniol, limonene and linalool, which may cause allergic reactions.

3. How to use Orofar Junior

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents aged over 12 years
Slowly suck one tablet every two to three hours. In case of severe infection, the dose may be
increased to one tablet every one or two hours.
Do not exceed ten tablets in 24 hours.
When treating aphthae (mouth ulcers), allow the tablet to dissolve slowly near the affected area.
Use in children aged over 6 years
Slowly suck one tablet every two to three hours. Children aged over 6 years should not take more
than six tablets in 24 hours.
Do not use Orofar Junior in children under 6 years of age, as locally acting anaesthetics may cause
transient swallowing disturbances and increase the risk of aspiration.
Do not use Orofar Junior immediately before or during eating or drinking.
Do not chew or swallow the tablets.
Do not exceed the stated dose or recommended dosing frequency.
Do not use for longer than 7 days without consulting a doctor.
Use of a higher than recommended dose of Orofar Junior
If more tablets than recommended have been taken, 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 questions about the use of this medicine, consult a 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 Junior 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 occur frequently (may occur in fewer than 1 in 10 people):

• Irritation or tingling in the mouth or throat.

All patients who have accidentally or intentionally ingested large amounts of Orofar Junior
should immediately go to a doctor or hospital.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
you should inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
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.
Adverse reactions can also be reported to the Marketing Authorisation Holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Orofar Junior

Keep this medicine out of sight and reach of children.
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.
Store below 30°C. Protect from moisture.
Medicines must 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 Junior contains

• The active substances are benzoxonium chloride and lidocaine hydrochloride. One Orofar Junior tablet contains 1 mg benzoxonium chloride + 1 mg lidocaine hydrochloride.
• The other ingredients are: sorbitol, microcrystalline cellulose, macrogol 6000, maize starch, sodium saccharin, sodium chloride, citric acid monohydrate, orange flavour 55607 TP.05.51 (containing maize maltodextrin, flavourings (natural flavour complexes, synthetic flavouring substances, natural flavouring substances) containing, among others, citral, citronellol, geraniol, limonene and linalool), magnesium stearate.

What Orofar Junior looks like and contents of the pack
Orofar Junior is available as orange-flavoured lozenges.
Pack sizes: 24 tablets (3 blisters of 8), 16 tablets (2 blisters of 8) or 8 tablets (1 blister of 8).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Recipharm Uppsala AB
Björkgatan 30
SE-751 82 Uppsala
Sweden
For further information, please contact the marketing authorisation holder's representative:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20