Inovox ultra flavor of mint

Patient Information Leaflet

INOVOX Ultra mint flavour,
8.75 mg, hard pastilles
Flurbiprofen
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by a
doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents:

1. What INOVOX Ultra mint flavour is and what it is used for
2. Important information before taking INOVOX Ultra mint flavour
3. How to use INOVOX Ultra mint flavour
4. Possible side effects
5. How to store INOVOX Ultra mint flavour
6. Contents of the pack and other information

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

INOVOX Ultra mint flavour 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 flavour is used for the 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 there is no improvement after 3 days, or if you feel worse, consult your doctor.
2. Important information before taking INOVOX Ultra mint flavour
When not to take INOVOX Ultra mint flavour:

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from asthma, have experienced wheezing or shortness of breath, nasal congestion, facial swelling, or itchy skin rash (urticaria) after taking acetylsalicylic acid or any other medicine from the group of non-steroidal anti-inflammatory drugs (NSAIDs);
• if you currently have or have previously had a stomach or intestinal ulcer (two or more episodes of gastric or duodenal ulcer);
• if you have experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders after taking another NSAID;
• if you are in the last three months of pregnancy;
• if you have severe heart, liver, or kidney failure.

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Warnings and precautions
Before starting treatment with INOVOX Ultra, discuss with your doctor or pharmacist:

• if you have ever had asthma or allergies,
• if you have tonsillitis (swollen tonsils) or if bacterial infection is suspected (as you may require antibiotics),
• if you have heart, liver, or kidney disease,
• if you have had a stroke,
• if you suffer from intestinal diseases (ulcerative colitis, Crohn's disease),
• if you have high blood pressure,
• if you suffer from chronic autoimmune disorders (including systemic lupus erythematosus or mixed connective tissue disease),
• if you are elderly, as you may be more likely to experience the side effects listed in this leaflet,
• if you are in the first 6 months of pregnancy or if you are breastfeeding,
• if you have an infection – see subsection “Infections” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as fever and pain.
This may delay appropriate treatment of infections, potentially increasing the risk of complications.
If you are taking this medicine during an ongoing infection and your symptoms persist or worsen, consult your doctor or pharmacist immediately.
While using INOVOX Ultra mint flavour

• If you develop the first signs of a skin reaction (rash, peeling) or other symptoms of an allergic reaction, stop using this medicine and consult your doctor immediately.
• Inform your doctor of any unusual abdominal symptoms (especially bleeding). Consult your doctor if your condition does not improve, worsens, or new symptoms develop.
• The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack or stroke. The risk is greater with higher doses and prolonged use. Do not exceed the recommended dose or duration of treatment (3 days).
• Prolonged use of painkillers or use not in accordance with recommendations may lead to headaches, which should not be treated by increasing the dose of the medicine.

Children and adolescents
This medicine should not be given to children under 12 years of age.
INOVOX Ultra mint flavour and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. Especially mention if you are taking:

• low-dose acetylsalicylic acid (up to 75 mg per day),
• medicines used for high blood pressure or heart failure (antihypertensives, cardiac glycosides),
• medicines affecting fluid balance (diuretics, including potassium-sparing diuretics),
• blood-thinning medicines (anticoagulants, antiplatelet agents),
• medicines for gout (probenecid, sulfinpyrazone),
• other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, or prednisolone),
• mifepristone (a medicine used for medical termination of pregnancy),

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• quinolone antibiotics (e.g. ciprofloxacin),
• cyclosporine or tacrolimus (medicines used for immunosuppression),
• 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 flavour with food, drink, and alcohol
During treatment with INOVOX Ultra mint flavour, avoid drinking alcohol, as it may increase the risk of stomach or intestinal bleeding.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to INOVOX Ultra mint flavour.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use INOVOX Ultra mint flavour during the last three months of pregnancy. Do not use INOVOX Ultra mint flavour during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period, use the lowest dose for the shortest possible 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 pastilles will affect fertility when used occasionally, but you should consult your doctor before taking this medicine if you have had difficulties becoming pregnant.
Driving and using machines
Studies on the effect of this medicine on the ability to drive or operate machinery have not been conducted.
However, dizziness or visual disturbances may occur after taking NSAIDs. If such symptoms occur, do not drive or operate machinery.
INOVOX Ultra mint flavour contains sucrose and glucose
This medicine contains 1.351 g of sucrose and 1.128 g of glucose per pastille. This should be taken into account for patients with diabetes. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to use INOVOX Ultra mint flavour
Always take INOVOX Ultra mint flavour exactly as described in this leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If you have an infection, consult your doctor or pharmacist immediately if your symptoms (such as fever and pain) persist or worsen (see section 2).
Recommended dose
Adults and adolescents over 12 years: 1 pastille as needed every 3 to 6 hours.
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Do not take more than 5 pastilles per day.

• Slowly suck 1 pastille until it dissolves in the mouth.
• Always move the pastille around in the mouth until it dissolves completely.

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.
Take the smallest number of pastilles for the shortest time necessary to relieve symptoms. If irritation of the mouth occurs, discontinue treatment with flurbiprofen.
Do not use INOVOX Ultra mint flavour for longer than 3 days unless otherwise advised by a doctor. Consult your doctor if your condition does not improve, worsens, or new symptoms develop.
If you take more INOVOX Ultra mint flavour than recommended
Inform your doctor or pharmacist immediately or go to the nearest hospital without delay.
Symptoms of overdose may include: nausea or vomiting, stomach pain, or less commonly diarrhoea.
Tinnitus, headache, or gastrointestinal bleeding may also occur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
YOU MUST STOP TAKING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF
ANY OF THE FOLLOWING SYMPTOMS OCCUR:

• symptoms of allergic reactions, e.g. asthma, unexplained wheezing or shortness of breath, nasal inflammation, skin rash, and others,
• swelling of the face, tongue or throat causing difficulty in breathing, rapid heartbeat, drop in blood pressure leading to shock (these may occur even after the first use of the medicine),
• severe skin reactions such as peeling, blistering.

If any of the symptoms listed below occur, or any adverse reactions not listed in this leaflet,
you should consult your doctor or pharmacist.
Adverse reactions that may occur:
Common (may affect less than 1 in 10 people)

• dizziness, headache,
• throat irritation,
• mouth ulceration and mouth pain,
• sore throat,
• discomfort or unusual sensations in the mouth (such as warmth, burning, tingling, numbness, etc.),
• nausea and diarrhoea.

Uncommon (may affect less than 1 in 100 people)

• drowsiness,
• feeling sleepy or difficulty sleeping,
• worsening of asthma and bronchospasm, shortness of breath, wheezing,

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• blisters in the mouth and throat, sensation of throat numbness,
• dryness of the mouth,
• burning sensation in the mouth, taste disturbances, bloating, abdominal pain, flatulence, constipation, indigestion, vomiting,
• reduced sensation in the throat,
• fever, pain,
• skin rash, skin itching.

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

• anaphylactic reaction.

Frequency not known (cannot be estimated from available data)

• anaemia, thrombocytopenia (low platelet count, which may lead to bruising and bleeding),
• oedema (swelling), high blood pressure, heart failure or heart attack,
• severe forms of skin reactions, such as blistering reactions, including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis,
• hepatitis.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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, more information on the safety of this medicine can be collected.

5. How to store the medicine INOVOX Ultra smak miętowy

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging following the term "EXP".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What INOVOX Ultra mint flavour contains
The active substance is flurbiprofen. One hard tablet contains 8.75 mg of flurbiprofen.
The other ingredients are: sucrose, liquid glucose, macrogol 300 (E-1521), peppermint essential oil,
levomenthol, potassium hydroxide.
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What INOVOX Ultra mint flavour looks like and contents of the pack
INOVOX Ultra mint flavour is a round, hard tablet, colourless to yellowish, with a diameter of 19±1 mm.
The hard tablets are packed in blisters made of PVC/PVDC/Aluminium, placed in a cardboard box.
The pack contains 8, 12, 16, 20, 24 or 36 hard tablets.

Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław, Poland

Manufacturer:
LOZY’S PHARMACEUTICALS S.L.
Campus Empresarial s/n,
31795 Lekaroz Navarra, Spain

For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35, 02-822 Warsaw, Poland
Tel. +48 (22) 543 60 00
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