Orofar ultra spray

Package leaflet: Information for the user

Orofar Ultra Spray, 8.75 mg/dose, oral spray, solution
Flurbiprofenum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

1. What Orofar Ultra Spray is and what it is used for
2. What you need to know before using Orofar Ultra Spray
3. How to use Orofar Ultra Spray
4. Possible side effects
5. How to store Orofar Ultra Spray
6. Contents of the pack and other information

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

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and fever.
Orofar Ultra Spray is used for the short-term relief of symptoms of inflammatory sore throat, such as irritation, sore throat, swelling of the throat, and difficulty swallowing in adults aged 18 years and older.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

2. Important Information Before Using Orofar Ultra Spray

When not to use Orofar Ultra Spray:

• if the patient is allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid), such as asthma, wheezing, itching, rhinitis, skin rash, or swelling;
• if the patient has or has had two or more episodes of stomach ulcers or bleeding, or intestinal ulcers;
• if the patient has ever had severe colitis (inflammation of the large intestine);
• if the patient has ever had blood clotting disorders or bleeding after taking NSAIDs;
• if the patient is in the last three months of pregnancy;
• if the patient has severe heart, kidney, or liver failure.

Warnings and precautions
Before starting treatment with Orofar Ultra Spray, consult a doctor or pharmacist:

• if the patient is already taking any other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• if the patient has tonsillitis or suspects a bacterial throat infection (which may require antibiotics);
• if the patient is elderly (may be more susceptible to adverse effects);
• if the patient has or has ever had asthma or allergies;
• if the patient has a skin condition called systemic lupus erythematosus or mixed connective tissue disease;
• if the patient has been diagnosed with high blood pressure (hypertension);
• if the patient has previously had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient has or has ever had heart, kidney, or liver disease;
• if the patient has had a stroke;
• if the patient is in the first six months of pregnancy or is breastfeeding;
• if the patient suffers from medication-overuse headaches;
• if the patient has diabetes;
• if the patient develops an infection – see section "Infections" below.

While using Orofar Ultra Spray

• At the first signs of any hypersensitivity reaction (rash, peeling, blisters) or other symptoms of an allergic reaction, stop using the spray immediately and consult a doctor.
• Report any unusual abdominal symptoms (especially bleeding) to a doctor.
• If the patient's condition does not improve, worsens, or new symptoms appear, consult a doctor.
• Medicines such as flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses or long-term use. Do not exceed the recommended dose or duration of treatment (see section 3).

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 the patient takes this medicine during an ongoing infection and symptoms persist or worsen, seek immediate advice from a doctor or pharmacist.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.

Orofar Ultra Spray and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines. In particular:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors used for pain or inflammation, as they may increase the risk of gastrointestinal bleeding;
• warfarin, acetylsalicylic acid, and other anticoagulant and antiplatelet medicines;
• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines used to lower blood pressure);
• diuretics (water tablets), including potassium-sparing diuretics;
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression;
• cardiac glycosides (used in heart conditions) such as digoxin;
• cyclosporine (used to prevent organ rejection after transplantation);
• corticosteroids (reduce inflammation);
• lithium (used to treat mood disorders);
• methotrexate (used in the treatment of psoriasis, arthritis, and cancer);
• mifepristone (used to terminate pregnancy); NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone;
• oral antidiabetic medicines;
• phenytoin (used to treat epilepsy);
• probenecid, sulfinpyrazone (used to treat gout and arthritis);
• quinolone antibiotics (used to treat bacterial infections), such as ciprofloxacin, levofloxacin;
• tacrolimus (an immunosuppressant used after organ transplantation);
• zidovudine (used in HIV infection);
• fluconazole (an antifungal medicine used to treat various fungal infections);
• acetazolamide (used to treat glaucoma or fluid retention).

Orofar Ultra Spray with food, drink, and alcohol
Avoid alcohol while using this medicine, as it may increase the risk of gastrointestinal bleeding.
Taking this medicine with food may delay the onset of its effect.

Pregnancy, breastfeeding, and fertility

Pregnancy
Oral forms (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Orofar Ultra Spray.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. Orofar Ultra Spray must not be used during the last three months of pregnancy. Orofar Ultra Spray should not be used during the first six months of pregnancy unless clearly necessary and specifically recommended by a doctor. If treatment is necessary during this period, the lowest effective dose should be used for the shortest possible time.

Breastfeeding
Use of this medicine during breastfeeding is not recommended.

Effect on fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
This medicine is unlikely to affect the ability to drive or operate machinery. However, dizziness and visual disturbances may occur after taking NSAIDs. In such cases, do not drive or operate machinery.

Orofar Ultra Spray contains sodium, ethanol, and aromatic substances containing d-limonene, citral, and eugenol
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is considered "sodium-free".
This medicine contains 0.14 mg of alcohol (ethanol) per dose. The amount of alcohol in each dose is equivalent to less than 0.0035 mL of beer or 0.0014 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains aromatic substances containing d-limonene, citral, and eugenol, which may cause allergic reactions.

3. How to use Orofar Ultra Spray

This medicine should always be used exactly as described in this patient information leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults aged 18 years and over
One dose (3 sprays of aerosol) to the back of the throat every 3–6 hours, as needed. Do not exceed
5 doses (15 sprays) within 24 hours.
One dose (3 sprays of aerosol) contains 8.75 mg of flurbiprofen.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age.
For oral use only.

• Spray the aerosol only onto the back wall of the throat.
• Do not inhale during aerosol spraying.
• Do not exceed 5 doses (15 sprays of aerosol) within 24 hours.

Orofar Ultra Spray is intended for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has
an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
If irritation of the oral cavity occurs, discontinue use of flurbiprofen.
Do not use the medicine for longer than 3 days unless otherwise advised by a doctor.
If there is no improvement, if symptoms worsen, or if new symptoms appear, consult a doctor or pharmacist.
Priming the pump
At first use of the pump (or after prolonged storage), shake the applicator and prime the pump.
Point the nozzle away from you and spray the aerosol at least four times until a fine, uniform mist is obtained. The pump is now ready for use. If the product has not been used for some time, point the nozzle away from you and spray at least once to obtain a fine, uniform mist.
Before each administration, always ensure that a fine, uniform mist is produced.
Using the aerosol
Direct the nozzle towards the back of the throat.

With a quick, smooth motion, press the pump three times, ensuring that the pump is fully depressed with each spray, and remove your finger from the top of the pump between each spray.

Do not inhale during aerosol spraying.
Overdose of Orofar Ultra Spray
Consult a doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose may include: nausea or vomiting, abdominal pain, or less commonly diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur.
Missed dose of Orofar Ultra Spray
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• Severe skin reactions, e.g. blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare conditions caused by serious adverse drug reactions or infections, in which there is a severe reaction affecting the skin and mucous membranes). Frequency: not known (frequency cannot be estimated from available data);
• Symptoms of anaphylactic shock characterized by swelling of the face, tongue or throat, causing difficulty in breathing, palpitations, drop in blood pressure leading to shock (may occur even with the first use of the medicine). Frequency: rare (may affect up to 1 in 1,000 people);
• Symptoms of hypersensitivity and skin reactions such as redness, swelling, peeling, formation of blisters or ulceration of the skin and mucous membranes. Frequency: uncommon (may affect up to 1 in 100 people);
• Symptoms of allergic reactions, e.g. asthma, unexplained wheezing or shortness of breath, itching, rhinitis or skin rash. Frequency: uncommon (may affect up to 1 in 100 people);
• Swelling of various body parts (angioedema). Frequency: very rare (may affect up to 1 in 10,000 people).

IF ANY OF THE FOLLOWING SYMPTOMS OR UNLISTED ADVERSE REACTIONS OCCUR,
CONSULT A DOCTOR OR PHARMACIST:
Very common (may affect more than 1 in 10 people)

• Inflammation of the oral mucosa (stomatitis)

Common (may affect up to 1 in 10 people)

• Dizziness, headache
• Throat irritation
• Oral ulceration, pain and numbness in the mouth
• Sore throat
• Discomfort (sensation of warmth, burning or tingling) in the mouth
• Nausea and diarrhoea
• Skin tingling and itching

Uncommon (may affect up to 1 in 100 people)

• Blisters in the mouth or throat, sensation of throat numbness
• Abdominal distension, abdominal pain, flatulence, constipation, dyspepsia, vomiting
• Dry mouth
• Burning sensation in the mouth, taste disturbances
• Fever, pain
• Drowsiness or difficulty sleeping
• Decreased sensation in the throat

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

• Anaphylactic reaction
• Jaundice

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

• Gastrointestinal bleeding (black, hard stools accompanied by abdominal pain, possible appearance of blood in stools or vomiting blood)

Frequency unknown (frequency cannot be estimated from available data)

• Anaemia, thrombocytopenia (low platelet count, which may cause bruising and bleeding)
• Oedema, high blood pressure, heart failure or heart attack
• Hepatitis

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

5. How to store Orofar Ultra Spray

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the stated month.
Do not use the medicine for longer than 1 month after first use.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Orofar Ultra Spray contains
The active substance is flurbiprofen. One dose (3 sprays of aerosol) contains 8.75 mg
of flurbiprofen. One spray of aerosol contains 2.92 mg of flurbiprofen. 1 mL of oral aerosol contains 16.2 mg of flurbiprofen.
The other ingredients are: betadex (E 459), hydroxypropylbetadex, disodium phosphate dodecahydrate, citric acid (E 330), sodium hydroxide, sodium saccharin (E 954), purified water, cherry flavour (containing natural flavouring substances: d-limonene, citral, eugenol, ethanol, glyceryl triacetate (E 1518), water, propylene glycol (E 1520), ascorbic acid (E 300), alpha-tocopherol (E 307), citric acid (E 330)), mint flavour (containing natural flavouring substances: d-limonene, propylene glycol (E 1520), glyceryl triacetate (E 1518), alpha-tocopherol (E 307), ethanol, pulegone, menthofuran).

What Orofar Ultra Spray looks like and contents of the pack
Orofar Ultra Spray, 8.75 mg/dose, oral spray solution, is a clear solution with a mint-cherry taste, packed in HDPE bottles with a metering pump spray in a cardboard box.
Each bottle contains 15 mL of oral aerosol solution, sufficient for 84 sprays.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information, contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel.: +48 22 737 79 20

Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Infarmade Sl.
C/ Torre de los Herberos, 35,
P.I. Carretera de la Isla, Dos Hermanas,
41703 Sevilla
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Belgium Flurbiprofen EG Spray Kers en Munt 8,75mg/dose spray for oromucosal use, solution
Cyprus OROPFEN
Denmark Flurbiprofen Stada
Finland Flurbiprofen STADA 16,2 mg/ml sumute suuonteloon, liuos
Greece OROPFEN
Luxembourg Flurbiprofen EG Spray Cerise et Menthe 8.75mg/dose solution for buccal spray
Germany Flurbiprofen STADA 8.75 mg/Dosis Spray zur Anwendung in der Mundhöhle, Lösung
Norway Flurbiprofen Stada
Poland Orofar Ultra Spray
Slovakia Flurbiprofen STADA
Sweden Flurbiprofen STADA 16,2 mg/ml munhålespray, lösning
Italy Lisomucil GOLAmed