Inovox Ultra

Leaflet accompanying the packaging: patient information

Inovox Ultra 2.5 mg/mL, throat/mouthwash solution

Flurbiprofen

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

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 Inovox Ultra and what is it used for
• 2. Important information before using Inovox Ultra
• 3. How to use Inovox Ultra
• 4. Possible side effects
• 5. How to store Inovox Ultra
• 6. Contents of the packaging and other information

1. What is Inovox Ultra and what is it used for

Inovox Ultra contains flurbiprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and swelling associated with inflammation.
Flurbiprofen is used to treat irritations, pain, and inflammation of the mouth and throat in adults associated with:

• gingivitis;
• stomatitis;
• pharyngitis;
• dental procedures (dental treatment).

If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before using Inovox Ultra

When not to use Inovox Ultra

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had asthma, hives, or other allergic reactions after taking flurbiprofen or acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs);

Warnings and precautions

Before starting to use Inovox Ultra, discuss it with your doctor or pharmacist:

• if you are elderly, as you are more likely to experience side effects;
• if you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant;
• if you have liver or kidney problems;
• if you have heart or circulatory problems, as taking medicines like Inovox Ultra may be associated with a moderate increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with increasing doses and longer treatment duration. Do not exceed the maximum dose of the medicine and do not take it for a long time. Inform your doctor if you have heart problems, have had a stroke, or are at risk of such conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker);
• if you have had stomach or intestinal ulcers or other stomach or intestinal diseases;
• if you have asthma;
• if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases affecting connective tissue, causing joint pain or muscle pain, skin changes, or impaired function of other organs;
• if you are dehydrated, as you are more likely to experience kidney problems;
• if you have an infection - see "Infections" below.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of an infection, such as fever and pain. This may delay proper treatment of infections, which can lead to increased risk of complications. If you are taking this medicine during an ongoing infection and its symptoms persist or worsen, consult your doctor or pharmacist immediately.
NOTE, when taking all NSAID medicines, the following may occur:

• unusual abdominal symptoms, with or without warning signs, even in patients who have not previously had serious gastrointestinal disorders (gastrointestinal tract), such as bleeding, ulcers, or perforation of the stomach or intestines, which can be fatal.
• very rare, severe skin reactions, characterized by redness, blisters, and peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can lead to death. It seems that patients are more likely to experience this type of reaction at the early stages of treatment. Such reactions occur in most cases within the first month of treatment.

Stop taking the medicine and consult a doctor immediately if:

• gastrointestinal symptoms occur, especially if there is bleeding;
• a skin rash, mucosal lesions, or any other symptoms of an allergic reaction (e.g., redness, itching, swelling) occur in the face and throat, sudden drop in blood pressure. The above conditions have occurred mainly after taking flurbiprofen in systemic forms.

Inovox Ultra and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Some medicines may interfere with the action of Inovox Ultra or increase the risk of serious side effects.
In particular, consult your doctor if you are taking:

• diuretics (medicines that increase urine production, e.g., furosemide and spironolactone);
• cardiac glycosides (medicines used in heart diseases, such as digoxin);
• angiotensin-converting enzyme (ACE) inhibitors (e.g., captopril) or angiotensin II receptor antagonists (e.g., losartan), medicines used to treat high blood pressure (hypertension);
• anticoagulant medicines (e.g., warfarin) used to prevent blood clots;
• medicines that prevent platelet aggregation, used to thin the blood;
• lithium, used to treat depression;
• zydovudine, an antiviral medicine;
• methotrexate, used to treat certain cancers and certain types of immune system diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, immunosuppressive medicines used to reduce the immune response;
• medicines known as corticosteroids, used to treat inflammatory diseases (e.g., prednisone, dexamethasone, hydrocortisone);
• antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) (e.g., paroxetine, fluoxetine);
• antibiotics called quinolones (e.g., ciprofloxacin);
• mifepristone, a medicine used to induce abortion (taken currently or within the last 12 days);
• any other anti-inflammatory medicine (NSAID), including acetylsalicylic acid known as aspirin and medicines belonging to COX-2 inhibitors (e.g., celecoxib).

The above interactions have been reported particularly in the case of taking flurbiprofen in systemic forms.
No interactions have been reported with the recommended doses.

Pregnancy, breastfeeding, and fertility

Oral forms (e.g., tablets) of flurbiprofen may cause side effects in the unborn child. It is not known if the same risk applies to Inovox Ultra 2.5 mg/mL.
If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult a doctor or pharmacist before using this medicine. Do not use Inovox Ultra 2.5 mg/mL in the last 3 months of pregnancy. Do not use Inovox Ultra 2.5 mg/mL during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period, use the smallest dose for the shortest time possible.
Avoid using the medicine during breastfeeding.
If you want to become pregnant or have fertility problems, consult a doctor, as this medicine may cause fertility problems.

Driving and using machines

The medicine may cause drowsiness, vision disturbances, dizziness, and fatigue. You should be sure that you do not experience such side effects before driving a vehicle or operating machines.

Inovox Ultra contains sorbitol (E 420), ethanol, macrogol glycerol hydroxystearate, patent blue (E 131), sodium.

The medicine contains 70 mg of sorbitol (E 420) per 1 mL. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, consult a doctor before using the medicine.
This medicine contains ethanol (alcohol), up to 1.0 g per dose, which corresponds to 24 mL of beer, 10 mL of wine per dose.
A small amount of alcohol in this medicine will not have noticeable effects.
Do not swallow the medicine.
The medicine may cause skin reactions.
The medicine may cause allergic reactions.
The medicine contains less than 1 mmol of sodium (23 mg) per 1 mL, which means the medicine is considered "sodium-free".

3. How to use Inovox Ultra

Always take this medicine exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist immediately if your symptoms (such as fever and pain) persist or worsen (see section 2).
Adults
Rinse your mouth and throat 2 to 3 times a day with 10 mL of the solution. The solution can be diluted in a small amount of water. Do not swallow the solution.
Do not use this medicine for more than 3 days.
Do not use this medicine for a longer period and do not exceed the recommended dose.
If after 3 days there is no improvement or you feel worse, consult a doctor.
Children and adolescents
Due to the lack of data, it is not recommended to use Inovox Ultra in children and adolescents.
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Method of administration

Inovox Ultra can be used at any time of day.
To measure the dose of the medicine, use the measuring cup provided with the packaging. Do not swallow the medicine, but accidental swallowing of the solution is not associated with a particular risk, as the dose of flurbiprofen used is much lower than the dose usually taken orally. After finishing rinsing your throat and/or mouth with the solution, remove the solution from your mouth.

Taking a higher dose of Inovox Ultra than recommended

In case of accidental swallowing of a larger amount of Inovox Ultra, immediately inform a doctor or go to the nearest hospital. Take the packaging of Inovox Ultra with you.

4. Possible side effects

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

STOP TAKING the medicine and consult a doctor immediately if you experience any of the following symptoms:

• severe burning or abdominal pain due to stomach and duodenal ulcers (uncommon side effects);
• sudden, severe abdominal pain (perforation, ulcer) (uncommon side effects);
• bleeding from the stomach or intestines (common side effects);
• excessive fatigue, shortness of breath, swelling, symptoms of heart failure (common side effects)
• decreased urine output (common side effects);
• symptoms of allergic reactions, such as asthma, shortness of breath, bronchospasm, unexplained wheezing or shortness of breath, itching, rhinitis, skin rash, and other (uncommon side effects);
• swelling of the face, tongue, or throat causing difficulty breathing, palpitations, drop in blood pressure leading to shock (rare side effects; may occur even with the first use of the medicine);
• severe skin reactions, such as peeling, blistering, severe skin reactions (e.g., erythema multiforme, blistering reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare side effects);
• pancreatitis (very rare side effects);
• cerebrovascular incident (frequency not known);
• aseptic meningitis (very rare side effects).

Side effects that may occur:

Common(may occur in up to 1 in 10 people)

• dizziness, headache;
• fatigue, malaise, swelling;
• abnormal liver function test results, prolonged bleeding time;
• nausea, diarrhea, nausea, vomiting, abdominal pain, bloating, constipation.

Uncommon(may occur in up to 1 in 100 people)

• anemia;
• paresthesia;
• vision disturbances;

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• tinnitus, dizziness;
• gastritis, oral ulcers;
• skin rash, urticaria, itching, lichen planus, photosensitivity reaction;
• hypertension.

Rare(may occur in up to 1 in 1,000 people)

• depression, confusion;
• drowsiness, insomnia;
• nephrotoxicity in various forms, including tubulointerstitial nephritis, nephrotic syndrome, renal failure, and acute renal failure. Very rare(may occur in up to 1 in 10,000 people)
• blood and lymphatic system disorders (leukopenia, agranulocytosis, aplastic anemia, neutropenia, thrombocytopenia, hemolytic anemia);
• hallucinations;
• jaundice, cholestatic jaundice, liver function disorders.

Frequency not known(frequency cannot be estimated from the available data)

• optic neuritis;
• ulcerative colitis and Crohn's disease;
• hepatitis;
• glomerulonephritis.

Reporting side effects

If you experience any side effects, including those not listed in this 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
Phone: +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 medicine.

5. How to store Inovox Ultra

Keep the medicine out of sight and reach of children.
No special precautions for storage temperature are required.
After opening the packaging: do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
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.
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6. Contents of the packaging and other information

What Inovox Ultra contains

The active substance of the medicine is flurbiprofen. 1 mL of the solution contains 2.5 mg of flurbiprofen.
The other ingredients of the medicine are: glycerol 85%, ethanol 96%, sorbitol (E 420), macrogol glycerol hydroxystearate, sodium saccharin (E 954), peppermint oil, patent blue (E 131), potassium hydrocarbonate, sodium hydroxide (to adjust pH), concentrated hydrochloric acid (to adjust pH), purified water.

What Inovox Ultra looks like and what the packaging contains

A clear, blue solution with a minty smell and taste and a pH of 6.5-9.5.
An orange glass bottle (type III) with a PP/HDPE child-resistant cap and a measuring cup made of polypropylene with a 10 mL graduation, in a cardboard box.
1 bottle - 150 mL solution.

Marketing authorization holder:

US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław

Manufacturer:

UAB "Valentis"
Taikos pr. 102, LT-51195, Kaunas, Lithuania

For more information on this medicine, contact:

USP Zdrowie Sp. z o.o.
Poleczki 35, 02-822 Warsaw
Phone: +48 (22) 543 60 00

Date of last revision of the leaflet:

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