INOVOX 8.75 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. INOVOX Ultra mint flavor,
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is INOVOX Ultra mint flavor and what is it used for
4. Important information before taking INOVOX Ultra mint flavor
   1. When not to take INOVOX Ultra mint flavor:
   2. Warnings and precautions
   3. During treatment with INOVOX Ultra mint flavor
   4. Children and adolescents
   5. INOVOX Ultra mint flavor and other medicines
   6. Taking INOVOX Ultra mint flavor with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. INOVOX Ultra mint flavor contains sucrose and glucose
5. How to take INOVOX Ultra mint flavor
   1. Recommended dose
   2. Use in children
   3. This medicine is intended for short-term treatment only.
   4. Taking a higher dose of INOVOX Ultra mint flavor than recommended
6. Possible side effects
   1. THE PATIENT SHOULD STOP TAKING THE MEDICINE AND CONTACT THEIR DOCTOR IMMEDIATELY IF THEY EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS:
   2. Side effects that may occur:
   3. Reporting side effects
7. How to store INOVOX Ultra mint flavor
8. Package contents and other information
   1. What INOVOX Ultra mint flavor contains
   2. What INOVOX Ultra mint flavor looks like and what the package contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. For more information, please contact:
   6. Date of last revision of the leaflet: June 2025

Leaflet attached to the packaging: patient information

INOVOX Ultra mint flavor,

8.75 mg, hard lozenges
Flurbiprofen

You should carefully read the contents of the leaflet before taking 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 advised by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is INOVOX Ultra mint flavor and what is it used for
• 2. Important information before taking INOVOX Ultra mint flavor
• 3. How to take INOVOX Ultra mint flavor
• 4. Possible side effects
• 5. How to store INOVOX Ultra mint flavor
• 6. Package contents and other information

1. What is INOVOX Ultra mint flavor and what is it used for

INOVOX Ultra mint flavor contains the active substance flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties.
INOVOX Ultra mint flavor is used for short-term relief of symptoms of throat inflammation, such as pain, swelling, and difficulty swallowing, in adults and adolescents over 12 years of age.
If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking INOVOX Ultra mint flavor

When not to take INOVOX Ultra mint flavor:

• if the patient is allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has asthma, has had wheezing, shortness of breath, nasal congestion, facial swelling, or skin rash (hives) after taking acetylsalicylic acid or any other NSAID;
• if the patient currently has or has had stomach or intestinal ulcers (two or more episodes of stomach or duodenal ulcers);
• if the patient has had bleeding or perforation of the gastrointestinal tract, severe colitis, or blood disorders after taking another NSAID;
• if the patient is in the last three months of pregnancy;
• if the patient has severe heart, liver, or kidney failure.

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Warnings and precautions

Before starting treatment with INOVOX Ultra, the patient should discuss it with their doctor or pharmacist:

• if the patient has ever had asthma or allergies,
• if the patient has had tonsillitis (tonsil swelling) or if there is a suspicion of bacterial infection (as the patient may need to take an antibiotic),
• if the patient has cardiovascular, liver, or kidney disease,
• if the patient has had a stroke,
• if the patient has intestinal diseases (ulcerative colitis, Crohn's disease),
• if the patient has high blood pressure,
• if the patient has a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease),
• if the patient is elderly, as they are more likely to experience side effects listed in this leaflet,
• if the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child,
• if the patient has an infection - see "Infections" below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain.
This may delay appropriate treatment of infections, which can lead to increased risk of complications.
If the patient is taking this medicine during an ongoing infection and their symptoms persist or worsen, they should consult their doctor or pharmacist immediately.

During treatment with INOVOX Ultra mint flavor

• After the first signs of skin reaction (rash, peeling) or other signs of allergic reaction, the patient should stop taking this medicine and consult their doctor immediately.
• The patient should report any unusual symptoms related to the abdominal cavity (especially bleeding) to their doctor. The patient should consult their doctor if their condition does not improve, worsens, or new symptoms develop.
• Taking medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher with high doses and long-term use of the medicine. The patient should not exceed the recommended dose and duration of treatment (3 days).
• In the case of long-term use of painkillers or use not in accordance with the recommendations, headaches may occur, which should not be treated with increased doses of the medicine.

Children and adolescents

This medicine should not be given to children under 12 years of age.

INOVOX Ultra mint flavor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription. In particular, they should mention:

• low-dose acetylsalicylic acid (up to 75 mg per day),
• medicines used in hypertension or heart failure (antihypertensives, cardiac glycosides),
• medicines that affect water balance (diuretics, including those that spare potassium),
• blood-thinning medicines (anticoagulants, antiplatelets),
• medicines for gout (probenecid, sulfinpyrazone),
• other NSAIDs or corticosteroids (e.g., celecoxib, ibuprofen, sodium diclofenac, or prednisolone),
• mifepristone (a medicine used to terminate pregnancy),

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• quinolone antibiotics (e.g., ciprofloxacin),
• cyclosporine or tacrolimus (medicines used to suppress the immune system),
• phenytoin (a medicine used to treat epilepsy),
• methotrexate (a medicine used to treat autoimmune diseases or cancer),
• lithium or selective serotonin reuptake inhibitors (medicines used to treat depression),
• oral antidiabetic medicines (used to treat diabetes),
• zidovudine (used to treat HIV infection).

Taking INOVOX Ultra mint flavor with food, drink, and alcohol

During treatment with INOVOX Ultra mint flavor, the patient should avoid drinking alcohol, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
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 mint flavor.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine. The patient should not take INOVOX Ultra mint flavor in the last 3 months of pregnancy. The patient should not take INOVOX Ultra mint flavor during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the patient should take the smallest dose for the shortest time.
Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible after stopping the medicine. It is unlikely that these lozenges will affect the ability to become pregnant when taken occasionally; however, the patient should consult their doctor before taking this medicine if they have had problems becoming pregnant.

Driving and using machines

No studies have been conducted on the effect of this medicine on the ability to drive and use machines. However, after taking NSAIDs, dizziness or vision disturbances may occur. If these symptoms occur, the patient should not drive or operate machines.

INOVOX Ultra mint flavor contains sucrose and glucose

The medicine contains 1.351 g of sucrose and 1.128 g of glucose per lozenge. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take INOVOX Ultra mint flavor

The patient should always take INOVOX Ultra mint flavor exactly as described in this leaflet or as advised by their doctor or pharmacist. If they are unsure, they should consult their doctor or pharmacist.
The patient should take the smallest effective dose for the shortest duration necessary to relieve symptoms.
If the patient has an infection, they should consult their doctor or pharmacist immediately if their symptoms (such as fever and pain) persist or worsen (see section 2).

Recommended dose

Adults and adolescents over 12 years of age: 1 lozenge as needed every 3 to 6 hours.
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The patient should not take more than 5 lozenges per day.

• The patient should slowly suck 1 lozenge until it dissolves in the mouth.
• The patient should always move the lozenge around the mouth until it dissolves.

Use in children

This medicine should not be given to children under 12 years of age.

This medicine is intended for short-term treatment only.

The patient should take the smallest number of lozenges for the shortest time necessary to relieve symptoms. If irritation of the mouth occurs, treatment with flurbiprofen should be discontinued.
The patient should not take INOVOX Ultra mint flavor for more than 3 days, unless their doctor recommends otherwise. The patient should consult their doctor if their condition does not improve, worsens, or new symptoms develop.

Taking a higher dose of INOVOX Ultra mint flavor than recommended

The patient should tell their doctor or pharmacist or go to the nearest hospital immediately.
Symptoms of overdose may include: nausea or vomiting, stomach pain, or diarrhea.
It is also possible to experience ringing in the ears, headache, or gastrointestinal bleeding.
If the patient has any further questions about the use of this product, they should ask their doctor or pharmacist.

4. Possible side effects

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

THE PATIENT SHOULD STOP TAKING THE MEDICINE AND CONTACT THEIR DOCTOR IMMEDIATELY IF THEY EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS:

• symptoms of allergic reactions, such as asthma, unexplained wheezing or shortness of breath, itching, rhinitis, skin rash, and others,
• swelling of the face, tongue, or throat causing difficulty breathing, palpitations, low blood pressure leading to shock (may occur even with the first use of the medicine),
• severe skin reactions, such as peeling, blistering.

If the patient experiences any of the following symptoms or side effects not listed in the leaflet, they should consult their doctor or pharmacist.

Side effects that may occur:

Frequently(may affect less than 1 in 10 people)

• dizziness, headache,
• throat irritation,
• mouth ulcers and mouth pain,
• throat pain,
• discomfort or unusual sensations in the mouth (such as a feeling of heat, burning, tingling, numbness, etc.),
• nausea and diarrhea.

Less frequently(may affect less than 1 in 100 people)

• drowsiness,
• feeling of sleepiness or difficulty falling asleep,
• worsening of asthma and bronchospasm, shortness of breath, wheezing,

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• blisters in the mouth and throat, feeling of numbness in the throat,
• dry mouth,
• feeling of burning in the mouth, taste disturbances, abdominal bloating, stomach pain, gas, constipation, indigestion, vomiting,
• decreased sensation in the throat,
• fever, pain,
• skin rash, itching.

Rarely(may affect less than 1 in 1,000 people)

• anaphylactic reaction.

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

• anemia, thrombocytopenia (low platelet count, which can cause bruising and bleeding),
• edema (swelling), high blood pressure, heart failure, or heart attack,
• severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis,
• hepatitis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, it is possible to gather more information on the safety of the medicine.

5. How to store INOVOX Ultra mint flavor

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What INOVOX Ultra mint flavor contains

The active substance of the medicine is flurbiprofen. One hard lozenge contains 8.75 mg of flurbiprofen.
The other ingredients of the medicine are: sucrose, liquid glucose, macrogol 300 (E-1521), peppermint oil, levomenthol, potassium hydroxide.
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What INOVOX Ultra mint flavor looks like and what the package contains

INOVOX Ultra mint flavor is a hard lozenge, white to yellowish in color, with a diameter of 19±1 mm.
The hard lozenges are packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
The package contains 8, 12, 16, 20, 24, or 36 hard lozenges.

Marketing authorization holder:

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

Manufacturer:

LOZY'S PHARMACEUTICALS S.L.
Campus Empresarial s/n,
31795 Lekaroz Navarra, Spain

For more information, please contact:

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

Date of last revision of the leaflet: June 2025

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