Orofar ultra

Package leaflet: Information for the user

Orofar Ultra, 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 directed by a doctor 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 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, consult your doctor.

Leaflet contents

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

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

Orofar Ultra 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.
Orofar Ultra is used for the short-term relief of symptoms of inflammatory sore throat, such as irritation, 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 Orofar Ultra

When not to use 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, nasal congestion, facial swelling, or skin rash (such as itching or hives) after taking acetylsalicylic acid or other NSAIDs.
• if you have or have had a peptic ulcer (two or more episodes of stomach or duodenal ulcers).
• 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 Orofar Ultra, discuss with your doctor or pharmacist if:

• you have ever had asthma or allergies.
• you have tonsillitis (swollen tonsils) or suspect you may have a bacterial throat infection (as antibiotic treatment may be necessary).
• you have cardiovascular, liver, or kidney problems.
• you have had a stroke.
• you have a history of intestinal diseases (ulcerative colitis, Crohn's disease).
• you have high blood pressure or heart failure.
• you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
• you are elderly, as there is a higher likelihood of experiencing the adverse effects listed in this leaflet.
• you are in the first six months of pregnancy or are breastfeeding.
• you have medication-overuse headache.
• you have diabetes.
• you have an infection – see section "Infections" below.

While using Orofar Ultra

• 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.
• Report any unusual abdominal symptoms to your doctor (especially bleeding). If your condition does not improve, worsens, or new symptoms appear, consult 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 beyond 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 are taking 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.

Orofar Ultra and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.

In particular, inform your doctor if you are taking any of the following medicines:

• acetylsalicylic acid in low doses (up to 75 mg per day)
• medicines to lower blood pressure or 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, 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) (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-neutralizing medicines (used to treat stomach acidity)
• 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 the medicine with food may delay the onset of action.

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 Orofar Ultra.
Do not use Orofar Ultra during the last three months of pregnancy. Do not use Orofar Ultra 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 effective dose for the shortest possible duration.
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 operating machinery
Orofar Ultra is not expected to affect the ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects of NSAIDs. If these occur, patients should not drive or operate machinery. Drowsiness is also a possible side effect and may affect driving ability.

Orofar Ultra contains isomalt (E953) and maltitol (E965)
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Orofar Ultra contains a flavouring substance containing citral, citronellol, geraniol, and linalool, which may cause allergic reactions.

3. How to use Orofar Ultra

Orofar Ultra must 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 allow it to dissolve slowly 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. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

In case of infection, consult a doctor or pharmacist promptly 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 Orofar Ultra for longer than 3 days. If there is no improvement or if symptoms worsen, or if new symptoms appear, consult a doctor.

Taking more than the recommended dose of Orofar Ultra
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest hospital.
Symptoms of overdose may include nausea, vomiting, abdominal pain, and less commonly diarrhea.
Tinnitus, headache, and gastrointestinal bleeding are also possible.

If you have any further doubts about using this medicine, consult 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 DISCONTINUE USE of this medicine and contact your doctor immediately if any of the following symptoms occur:

• Symptoms of allergic reactions such as asthma, unexpected wheezing or shortness of breath, itching, rhinitis, 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 skin detachment.

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 reactions include:
Very common (may occur in more than 1 in 10 people)

• Inflammation of the oral mucosa (stomatitis)

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

• Dizziness, headache, tingling and itching of the skin (paraesthesia)
• Throat irritation
• Oral 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
• Blister formation 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
• Oedema (swelling), high blood pressure, heart failure or heart attack
• Severe forms of skin reactions such as blistering eruptions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis
• Hepatitis
• Sinus pain

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Orofar Ultra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister foil 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 you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Orofar Ultra contains
The active substance is flurbiprofen. One hard tablet contains 8.75 mg of flurbiprofen.
The other ingredients are:
Isomalt (E953)
Maltitol liquid (E965)
Potassium acesulfame (E950)
Macrogol 400
Levomenthol
Orange flavour (contains triacetin (E1518), flavouring preparations, natural flavouring substances, including citral, citronellol, geraniol and linalool).

What Orofar Ultra looks like and contents of the pack
Orofar Ultra 8.75 mg, hard tablets, are white to pale yellow, round, flat-faced tablets with an orange flavour, with a thickness of 7.0 to 8.0 mm and a diameter of 18.0 to 19.00 mm.
The tablets are available in PVC/PVDC/Aluminium blisters.
Pack sizes: 8, 16 or 24 hard tablets.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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 further information, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel.: +48 22 737 79 20