Package leaflet: Information for the user

Baxofort
0.74 mg/mL (0.074%), solution for mouth/throat rinsing
Diclofenacum
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 or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

Leaflet contents

What Baxofort is and what it is used for
Important information before using Baxofort
How to use Baxofort
Possible side effects
How to store Baxofort
Contents of the pack and other information

1. What Baxofort is and what it is used for

Baxofort contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
When used locally in inflammatory conditions of the mucous membranes of the mouth and throat, diclofenac exerts analgesic and anti-inflammatory effects.
Baxofort is indicated in adults and adolescents over 14 years of age for the treatment of symptoms of inflammatory conditions of the oral and pharyngeal mucosa (e.g. symptoms of gingivitis, stomatitis, pharyngitis, conditions following dental procedures, symptoms of mechanical irritation).
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using Baxofort

When not to use Baxofort

if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
if during the use of other non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, ketoprofen or acetylsalicylic acid, asthma, skin rash (urticaria) or allergic rhinitis occurred;
in children and adolescents under 14 years of age;
during the last three months of pregnancy.

Warnings and precautions
Before starting to use Baxofort, discuss this with your doctor or pharmacist.

Allergic reactions (hypersensitivity) may occur during topical use of the medicine (especially with prolonged use) – see section 4.
Avoid contact of Baxofort with the eyes.

Children and adolescents
Do not use in children and adolescents under 14 years of age.
Baxofort and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
No interactions of this medicine with other medicines applied topically in the mouth are known.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Baxofort must not be used during the last three months of pregnancy.
During the first six months of pregnancy, Baxofort should not be used unless necessary and recommended by a doctor. If use is necessary, the lowest dose for the shortest possible duration should be administered.
Adverse effects on the unborn child have been reported after oral administration of diclofenac-containing medicines (e.g. tablets).
It is unknown whether similar risks apply when Baxofort is used topically in the mouth.
Breastfeeding
Baxofort must not be used in women who are breastfeeding.
Driving and operating machinery
Baxofort has no effect or negligible effect on the ability to drive and operate machinery.
Baxofort contains sodium, ethanol, sodium benzoate (E 211), carmine red (E 124),
propylene glycol (E 1520), benzyl alcohol, sorbitol liquid non-crystallizing (E 420),
as well as linalool, d-limonene, eugenol and citronellol
Sodium
The medicine contains 35.085 mg of sodium (the main component of table salt) per 15 mL of solution. This corresponds to 1.75% of the maximum recommended daily intake of sodium in the diet for adults.
Ethanol
This medicine contains 9.0 mg of alcohol (ethanol) per dose (15 mL), which is equivalent to 0.06% (w/v). The amount of alcohol in one dose 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.
Sodium benzoate (E 211)
The medicine contains 166.5 mg of sodium benzoate in each 15 mL of solution, which may cause local irritation.
Carmine red (E 124)
The medicine contains 0.78 mg of carmine red in each 15 mL of solution, which may cause allergic reactions.
Propylene glycol (E 1520)
The medicine contains 41.625 mg of propylene glycol in each 15 mL of solution.
Benzyl alcohol
The medicine contains 0.000308745 mg of benzyl alcohol in each 15 mL of solution, which may cause allergic reactions or mild local irritation.
Pregnant women and patients with liver or kidney disease should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Sorbitol, liquid non-crystallizing (E 420)
The medicine contains 2664 mg of liquid non-crystallizing sorbitol in each 15 mL of solution.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child.
Linalool, d-limonene, eugenol and citronellol
The medicine contains linalool, d-limonene, eugenol and citronellol, which may cause allergic reactions.

3. How to use Baxofort

This medicine should always be used exactly as described in this leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults and adolescents over 14 years of age:
Rinse the mouth and throat 2 to 3 times daily, using 15 mL of the solution, undiluted or diluted with
a small amount of water. Rinse for approximately 30-60 seconds.
The solution must not be swallowed – after use, it should be spat out.
A measuring device is provided with the packaging to facilitate dosing.
This medicine may only be used for rinsing by patients who are able to suppress the swallowing
reflex and who are able to spit out the solution after rinsing the mouth or throat.
If symptoms worsen or do not improve within 7 days of using Baxofort, consult your doctor.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use in children and adolescents
Do not use in children and adolescents under 14 years of age.
Patients with kidney or liver function disorders
No dose adjustment is necessary.
Elderly patients (over 65 years of age)
No dose adjustment is necessary.
Use of a higher than recommended dose of Baxofort
Accidental swallowing of a single dose of Baxofort does not pose a health risk.
If more than the recommended dose has been taken, consult your doctor or pharmacist.
Missed dose of Baxofort
Do not use a double dose to make up for a missed dose. Use the next dose at the scheduled time.
If you have any further doubts regarding 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 experiences them.
When the medicine is used locally (especially for prolonged periods), symptoms of irritation of the oral mucosa, cough, or hypersensitivity reactions (allergic reactions) may occur.
In such cases, treatment should be discontinued and the patient should contact their doctor, who will recommend appropriate treatment if necessary.
In case of accidental ingestion or prolonged use of Baxofort, systemic adverse reactions (affecting the whole body) cannot be excluded.

Possible adverse reactions
Frequency unknown (frequency cannot be estimated from the available data):

burning sensation at the site of application;
dry skin.

Reporting of adverse reactions
If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, the doctor or pharmacist should be informed. 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
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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Baxofort

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the specified month.
Store below 25°C. Keep in the original packaging to protect from light.
Shelf life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Baxofort contains

The active substance is diclofenac.
Each mL of oral/pharyngeal rinse solution contains 0.74 mg of diclofenac ( Diclofenacum ) in the form of sodium diclofenac.
The other components are: choline chloride, sorbitol, non-crystallizing liquid (E 420), glycerol (E 422), sodium benzoate (E 211), sodium hydrogen carbonate, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, acesulfame potassium (E 950), peppermint flavour (containing: propylene glycol (E 1520), linalool, d-limonene, benzyl alcohol, citronellol), peach flavour (containing: ethanol 96%, propylene glycol (E 1520), benzyl alcohol, linalool, eugenol), carmine red (E 124), purified water.

What Baxofort looks like and contents of the pack
Baxofort is a red-colored solution for oral/pharyngeal rinsing.
The medicine is packed in: a brown glass type III bottle closed with an aluminium cap with a liner made of LDPE, with a measuring cup made of PP with a capacity of 15 mL, graduated every 2.5 mL, placed in a cardboard box with a leaflet.
The pack contains 200 mL of solution.
Marketing Authorisation Holder:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. +48 42 22-53-100
Manufacturer:
Aflofarm Farmacia Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów