Orofar Ultra

Package Leaflet: Information for the User

Orofar Ultra, 8.75 mg, Hard Lozenges

Flurbiprofen

Read the leaflet carefully 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 directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those 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, contact your doctor.

Table of Contents of the Leaflet

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

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

Orofar Ultra contains flurbiprofen. Flurbiprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory properties.

Orofar Ultra is used for the short-term relief of symptoms of throat inflammation, such as irritation, pain, and swelling, as well as 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 Orofar Ultra

When not to take Orofar Ultra

• 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, runny nose, facial swelling, or skin rash, as in the case of hives (urticaria) after taking acetylsalicylic acid or other NSAIDs.
• if you have had stomach ulcers (two or more episodes of stomach or duodenal ulcers) or gastrointestinal bleeding or perforation.
• if you have had severe heart, liver, or kidney failure.
• if you are in the last three months of pregnancy.

Warnings and precautions

Before taking Orofar Ultra, discuss with your doctor or pharmacist:

• if you have ever had asthma or allergies.
• if you have tonsillitis (tonsil swelling) or think 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 there is a greater risk of side effects listed in this leaflet.
• if you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby.
• if you have medication-overuse headache.
• if you have diabetes.
• if you have an infection - see "Infections" below.

During treatment with Orofar Ultra

• In case of the first signs of skin reaction (rash, peeling) or other signs of allergic reaction, discontinue the medicine and consult your doctor immediately.
• Report any unusual abdominal symptoms to your doctor (especially bleeding). If your condition does not improve, worsens, or other symptoms occur, talk to your doctor.
• Taking flurbiprofen-containing medicines may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk increases with high doses and long-term treatment. Do not take higher doses than recommended and do not prolong treatment (3 days).

Infections

Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection, such as fever and pain.

This may delay appropriate treatment of the infection, leading to increased risk of complications. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, consult your doctor or pharmacist immediately.

Children

Do not give this medicine to children under 12 years of age.

Orofar Ultra and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

In particular, inform your doctor about taking the following medicines:

• acetylsalicylic acid in low doses (up to 75 mg per day)
• blood pressure-lowering medicines or those used in 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, diclofenac sodium, prednisolone)
• mifepristone (a medicine used to terminate pregnancy)
• quinolone antibiotics (e.g., ciprofloxacin)
• cyclosporine or tacrolimus (immunosuppressive medicines)
• phenytoin (a medicine used to treat epilepsy)
• methotrexate (a medicine 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)
• zydovudine (a medicine used to treat HIV infection)
• fluconazole (an antifungal medicine used to treat various fungal infections)
• medicines that reduce stomach acid (used to treat stomach hyperacidity)
• acetazolamide (used to treat glaucoma or fluid retention)

Orofar Ultra with food, drink, and alcohol

Avoid drinking alcohol while taking Orofar Ultra, as it may increase the risk of stomach or intestinal bleeding. Taking with food may delay the onset of action.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your 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 Orofar Ultra.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. Do not take Orofar Ultra during the last 3 months of pregnancy. Do not take Orofar Ultra during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.

If treatment is necessary during this period, use the smallest effective 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 lozenges will affect the chances of getting pregnant when taken occasionally; however, tell your doctor before taking this medicine if you have difficulty getting pregnant.

Driving and using machines

Orofar Ultra should not affect your ability to drive or use machines. However, dizziness and vision disturbances are possible side effects of NSAIDs. If you experience these, do not drive or use machines. Drowsiness is also a possible side effect and may affect your ability to drive or use machines.

Orofar Ultra contains isomalt (E953) and maltitol (E965)

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

Orofar Ultra contains a flavoring substance with citral, citronellol, geraniol, and linalool, which may cause allergic reactions.

3. How to take Orofar Ultra

Always take Orofar Ultra exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents over 12 years of age:

1 lozenge every 3 to 6 hours as needed.

Do not take more than 5 lozenges per day.

Take 1 lozenge and slowly dissolve it in your mouth. While dissolving, always move the lozenge around your mouth.

Use in children

Do not give these lozenges to children under 12 years of age.

Hard lozenges are intended for short-term use only.Use the smallest effective dose for the shortest possible time to relieve symptoms.

If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

If you experience mouth irritation, discontinue flurbiprofen treatment.

Do not take Orofar Ultra for more than 3 days.If there is no improvement or if you feel worse, contact your doctor.

Overdose of Orofar Ultra

Immediately consult your doctor or pharmacist or go to the nearest hospital.

Overdose symptoms may include: nausea, vomiting, abdominal pain, and less frequently, diarrhea.

It is also possible to experience ringing in the ears, headache, and gastrointestinal bleeding.

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

4. Possible side effects

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

STOP TAKINGthis medicine and contact your doctor immediately if you experience:

• symptoms of allergic reactions, such as asthma, unexpected wheezing, shortness of breath, itching, runny nose, skin rash, etc.
• facial swelling, tongue, or throat swelling causing difficulty breathing, rapid heartbeat, and blood pressure drop leading to shock (which can occur even after the first dose).
• severe skin reactions such as peeling, blistering, or skin shedding.

If you experience any of the following symptoms or any other symptoms not listed in this leaflet, tell your doctor or pharmacist.

Other side effects that may occur:

Very common(may affect more than 1 in 10 people)

• mouth inflammation (stomatitis)

Common(may affect up to 1 in 10 people)

• dizziness, headache, tingling, or itching sensation on the skin (paresthesia)
• throat irritation
• mouth ulcers or mouth pain
• throat pain
• discomfort or unusual sensation in the mouth (e.g., burning or warmth in the mouth, tingling, pricking, etc.)
• nausea and diarrhea
• abdominal pain

Uncommon(may affect up to 1 in 100 people)

• drowsiness or difficulty sleeping
• worsening of asthma and bronchospasm, shortness of breath, wheezing
• blistering in the mouth and throat, numbness of the throat
• dry mouth
• pain or sensation of heat, burning sensation in the mouth, change in taste, bloating, gas, constipation, indigestion, vomiting
• reduced sensation in the throat
• fever, pain
• skin rash, itching

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

• anaphylactic reaction
• jaundice and decreased platelet count (thrombocytopenia), which usually resolve after stopping the medicine

Very rare(may affect up to 1 in 10,000 people)

• gastrointestinal bleeding (black, tarry stools with abdominal pain, possibly blood in stools or vomiting blood)
• swelling of various body parts (angioedema)

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

• anemia
• edema (swelling), high blood pressure, heart failure, or heart attack
• severe skin reactions such as blistering, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis
• hepatitis
• sinusitis

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, 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

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 Orofar Ultra

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after:

EXP. The expiry date refers to the last day of the month stated.

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.

6. Package contents and other information

What Orofar Ultra contains

The active substance is flurbiprofen. One hard lozenge contains 8.75 mg of flurbiprofen.

The other ingredients are:

Isomalt (E953)

Maltitol liquid (E965)

Acesulfame potassium (E950)

Macrogol 400

Levomenthol

Orange flavor (contains triacetin (E1518), flavoring preparations, natural flavoring substances, including citral, citronellol, geraniol, and linalool).

What Orofar Ultra looks like and contents of the pack

Orofar Ultra, 8.75 mg, hard lozenges, are white to light yellow, round, flat lozenges with an orange flavor, 7.0 to 8.0 mm thick and 18.0 to 19.0 mm in diameter.

The lozenges are available in PVC/PVDC/Aluminum blisters.

Package sizes: 8, 16, or 24 hard lozenges.

Marketing authorization holder and importer

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer / Importer

Infarmade S.L.

Calle De La Torre De Los Herberos 35

Polígono Industrial Carretera De La Isla

Dos Hermanas

41703 Sevilla

Spain

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Orofar Ultra

Czech Republic: Orodon

Romania: Orofar Intensiv Portocale fără zahăr 8,75 mg pastile

Hungary: Meboflur cukormentes narancsízű 8,75 mg szopogató tabletta

Slovakia: Oroflurb pastilky s pomarančovou príchuťou

For more information, contact the representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Tel.: +48 22 737 79 20

Date of last revision of the leaflet:03/2025