Inovox ultra sugar-free orange flavor

Package leaflet: Information for the user

Inovox Ultra sugar-free orange flavour, 8.75 mg, hard pastilles
Flurbiprofen
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised.

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

Contents of the leaflet

1. What Inovox Ultra sugar-free orange flavour is and what it is used for
2. Important information before taking Inovox Ultra sugar-free orange flavour
3. How to take Inovox Ultra sugar-free orange flavour
4. Possible side effects
5. How to store Inovox Ultra sugar-free orange flavour
6. Contents of the pack and other information

1. What Inovox Ultra sugar-free orange flavour is and what it is used for

Inovox Ultra sugar-free orange flavour contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have pain-relieving, antipyretic and anti-inflammatory properties.
Inovox Ultra sugar-free orange flavour is used for short-term local relief of inflammatory symptoms of the throat, such as irritation, sore throat, swelling and difficulty swallowing, in adults and adolescents aged 12 years and older.
If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

2. Important information before taking Inovox Ultra sugar-free orange flavour
When not to take Inovox Ultra sugar-free orange flavour

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have asthma, unexpected breathing sounds or difficulty breathing, nasal congestion, facial swelling or skin rash such as itching (urticaria) after taking acetylsalicylic acid or other NSAIDs.
• if you have or have had a peptic ulcer (two or more episodes of gastric or duodenal ulcers) in the stomach or intestines.
• if you have experienced gastrointestinal bleeding or perforation, severe colitis or blood disorders associated with previous treatment with NSAIDs.
• if you are in the last three months of pregnancy.
• if you have or have had severe heart, liver or kidney failure.

Warnings and precautions
Before starting to take Inovox Ultra sugar-free orange flavour, discuss this with your doctor or pharmacist:

• if you have ever had asthma or allergies.
• if you have tonsillitis (swollen tonsils) or suspect you may have a bacterial throat infection (as antibiotic treatment may be necessary).
• if you have cardiovascular, liver or kidney disorders.
• if you have had a stroke.
• if you have a history of intestinal diseases (ulcerative colitis, Crohn's disease).
• if you have high blood pressure or heart failure.
• if you have a chronic autoimmune disease (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 six months of pregnancy or are breastfeeding.
• if you have medication-overuse headache.
• if you have diabetes.
• if you have an infection – see section "Infections" below.

While using Inovox Ultra sugar-free orange flavour

• If you experience the first signs of a skin reaction (rash, peeling) or other symptoms of an allergic reaction, stop taking the medicine and consult your doctor immediately.
• Inform your doctor of any unusual abdominal symptoms (especially bleeding). If your condition does not improve, worsens or new symptoms appear, talk to your doctor.
• Use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or extend the treatment period (3 days).

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as fever and pain.
This may delay appropriate treatment of the infection, potentially increasing the risk of complications. If you take this medicine during an infection and symptoms persist or worsen, consult your doctor or pharmacist immediately.
Children
Do not use this medicine in children under 12 years of age.
Inovox Ultra sugar-free orange flavour and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
In particular, inform your doctor if you are taking the following medicines:

• acetylsalicylic acid in low doses (up to 75 mg per day)
• medicines used to lower blood pressure or treat heart failure (antihypertensives, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• blood-thinning medicines (anticoagulants, antiplatelet agents)
• medicines used to treat gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, prednisolone)
• mifepristone (used to terminate pregnancy)
• quinolone antibiotics (e.g. ciprofloxacin)
• cyclosporine or tacrolimus (immunosuppressive medicines)
• phenytoin (used to treat epilepsy)
• methotrexate (used to treat autoimmune diseases or cancer)
• lithium or selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression)
• oral antidiabetic medicines (used to treat diabetes)
• zidovudine (used to treat HIV infection)
• fluconazole (an antifungal medicine used for various fungal infections)
• acid-reducing medicines (used to treat gastric hyperacidity)
• acetazolamide (used to treat glaucoma or fluid retention)

Inovox Ultra sugar-free orange flavour with food, drink and alcohol
Avoid drinking alcohol while taking Inovox Ultra sugar-free orange flavour, as it may increase the risk of gastrointestinal bleeding. Taking the medicine with food may delay the onset of action.
Pregnancy, breastfeeding and fertility
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 sugar-free orange flavour.
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. Do not use Inovox Ultra sugar-free orange flavour during the last three months of pregnancy.
Do not use Inovox Ultra sugar-free orange flavour during the first six months of pregnancy unless clearly necessary and recommended by your 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 the chances of becoming pregnant when used occasionally, but you should inform your doctor before using this medicine if you have difficulty becoming pregnant.
Driving and using machines
Inovox Ultra sugar-free orange flavour is not expected to affect the ability to drive or use machines. However, dizziness and visual disturbances are possible side effects of NSAIDs. If these occur, do not drive or operate machinery. Drowsiness is also a possible side effect and may affect your ability to drive.
Inovox Ultra sugar-free orange flavour contains isomalt (E953) and maltitol (E965)
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Inovox Ultra sugar-free orange flavour may have a mild laxative effect. The caloric value of maltitol and isomalt is 2.3 kcal/g.
Inovox Ultra sugar-free orange flavour contains a flavouring substance containing citral, citronellol, geraniol and linalool, which may cause allergic reactions.

3. How to use Inovox Ultra without sugar orange flavour

Inovox Ultra without sugar orange flavour should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:
Adults and adolescents over 12 years of age:
1 tablet every 3 to 6 hours, as needed.
Do not use more than 5 tablets per day.
Take 1 tablet and slowly dissolve it in the mouth. The tablet should always be moved around in the mouth during dissolution.

Use in children
Do not give these tablets to children under 12 years of age.

Hard tablets are intended for short-term use only. Use the lowest effective dose for the shortest necessary duration to relieve symptoms.
In case of infection, consult a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If irritation of the mouth occurs, discontinue treatment with flurbiprofen.

Do not use Inovox Ultra without sugar orange flavour for longer than 3 days. If there is no improvement, if symptoms worsen, or if new symptoms appear, consult a doctor.

Taking more Inovox Ultra without sugar orange flavour than recommended
Contact a doctor or pharmacist immediately or go to the nearest hospital.
Symptoms of overdose may include: nausea or vomiting, stomach pain or, less commonly, diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible.

If you miss a dose of Inovox Ultra without sugar orange flavour
Do not take a double dose to make up for the missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
YOU MUST STOP USING this medicine and contact your doctor immediately if
any of the following symptoms occur:

• Signs of allergic reactions, such as asthma, unexpected wheezing or shortness of breath, itching, runny nose, skin rash, etc.
• Swelling of the face, tongue or throat causing difficulty in breathing, rapid heartbeat and drop in blood pressure leading to shock (these may occur even during the first use of the medicine).
• Severe skin reactions such as peeling, blistering or shedding of the skin.

If any of the following symptoms occur, or if any symptoms not listed in this leaflet appear, inform your doctor or pharmacist.
Other possible adverse effects:
Very common (may occur in more than 1 in 10 people)

• Oral mucosal inflammation (inflammation of the mouth)

Common (may occur in less than 1 in 10 people)

• Dizziness, headache, tingling and itching of the skin (paresthesia)
• Sore throat
• Mouth ulcers or mouth pain
• Sore throat
• Discomfort or unusual sensation in the mouth (e.g. burning or warmth in the mouth, tingling, pricking, etc.)
• Nausea and diarrhoea
• Abdominal pain

Uncommon (may occur in less than 1 in 100 people)

• Drowsiness or difficulty sleeping
• Worsening of asthma and bronchospasm, shortness of breath, wheezing
• Blistering in the mouth and throat, throat numbness
• Dryness in the mouth
• Pain or sensation of heat, burning sensation in the mouth, taste alteration, bloating, flatulence, constipation, indigestion, vomiting
• Reduced throat sensation
• Fever, pain
• Skin rash, skin itching

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

• Anaphylactic reaction
• Jaundice and reduced platelet count (thrombocytopenia), which usually resolve after discontinuation of the medicine

Very rare (may occur in less than 1 in 10,000 people)

• Gastrointestinal bleeding (black hard stools with abdominal pain, possibly blood in stool or vomiting blood)
• Swelling of various body parts (angioedema)

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

• Anaemia
• Edema (swelling), high blood pressure, heart failure or heart attack
• Severe forms of skin reactions such as blistering skin reactions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis
• Hepatitis
• Sinus pain

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Inovox Ultra without sugar orange flavour

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and foil blister after:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Inovox Ultra sugar-free orange flavoured contains
The active substance is flurbiprofen. One hard pastille contains 8.75 mg of flurbiprofen.
The other ingredients are: isomalt (E953), maltitol liquid (E965), potassium acesulfame (E950), macrogol 400, levomenthol, orange juice flavour (containing triacetin (E1518), flavouring agents and natural flavouring substances, including citral, citronellol, geraniol and linalool).

What Inovox Ultra sugar-free orange flavoured looks like and contents of the pack
Inovox Ultra sugar-free orange flavoured 8.75 mg hard pastilles are white to light yellow, round, flat-faced pastilles with an orange flavour, 7 to 8 mm thick and 18 to 19 mm in diameter.
The pastilles are available in white opaque PVC/PVDC/Aluminium blisters, placed in printed cardboard boxes.
Pack sizes: 8, 16 or 24 hard pastilles.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
{marketing authorisation holder's logo}

Importer
Infarmade S.L.
C/ Torre de los Herberos, 35
P.I. Carretera de la Isla
41703 Dos Hermanas, Sevilla
Spain

For further information about this medicine, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Poland: Inovox Ultra bez cukru smak pomarańczowy
Slovakia: Inovox 8,75 mg tvrdé pastilky