Orofar Intensive Orange, 8.75 mg, 16 pills, Stada [4011548049310] Indications: Orofar Intensiv Orange Sugar-Free contains flurbiprofen. Flurbiprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties. Orofar Intensive Orange Sugar-Free is used for the short-term relief of symptoms of throat conditions, such as irritation, pain and swelling of the throat and difficulty swallowing, in adults and adolescents over 12 years of age. Contraindications: Do not take Orofar Intensive Orange without sugar: - if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6) - if you have had bronchial asthma, unexpected sounds during breathing or difficulty breathing, - you have had a runny nose, swollen face or itchy skin rash (hives) after taking acetylsalicylic acid or any other NSAID medicine. - if you have or have had an ulcer (two or more episodes of gastric ulcer or duodenal ulcer) in the stomach or intestine. - if you have had gastrointestinal bleeding or perforation, severe colitis or blood disorders after using another NSAID. - if you are in the last 3 months of pregnancy - if you have or have had severe heart, liver or kidney failure. Precautions: Before taking Orofar Intensive Orange without sugar, talk to your doctor or pharmacist. - if you have ever had bronchial asthma or suffer from allergies - if you have tonsillitis (swollen tonsils) or think you may have a bacterial throat infection (as you may need antibiotic medication) - if you have heart, liver or kidney problems - if you have had a stroke - if you have a history of intestinal diseases (ulcerative colitis, Crohns 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 older, you are more likely to experience the side effects listed in this leaflet. - if you are in the first 6 months of pregnancy or breastfeeding. - if you have headaches induced by painkillers - if you have diabetes - if you have an infection. While using Orofar Intensive Oranges without sugar - At the first sign of a skin reaction (rash, peeling) or other signs of an allergic reaction, stop taking this medicine and consult a doctor immediately. - Report any unusual abdominal symptoms (especially bleeding) to your doctor. If you do not feel better, feel worse, or develop new symptoms, contact your doctor. - The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack or stroke. This risk is more likely at high doses and with long-term treatment. Do not exceed the recommended dose or duration of treatment (3 days). Infections: Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection, such as fever and pain. This may delay proper treatment of the infection, which may increase the risk of complications. If you are taking this medication while you have an infection and the symptoms of the infection do not go away or get worse, talk to a doctor or pharmacist immediately. Children and adolescents: This medicine is not indicated in children under 12 years of age. Orofar Intensive Oranges without sugar with other medicines Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking: - low doses of acetylsalicylic acid (up to 75 mg daily) - medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides) - tablets to alter fluid balance (diuretics, including potassium-sparing medicines) - blood thinning medications (anticoagulants, antiplatelet agents) - medicines for the treatment of gout (probenecid, sulfinpyrazone) - other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium or prednisolone) - mifepristone (a medicine used to terminate pregnancy) - quinolone antibiotics (such as ciprofloxacin) - ciclosporin or tacrolimus (medicines used to reduce the activity of the immune system) - phenytoin (medicine for the treatment of epilepsy) - methotrexate (medicine for the treatment of autoimmune diseases or cancer) - lithium or selective serotonin reuptake inhibitors (medicines for depression) - oral antidiabetics (for the treatment of diabetes) - zidovudine (for the treatment of HIV infection). - fluconazole (an antifungal medicine used for a number of fungal infections) - antacids (for the treatment of stomach acidity) - acetazolamide (for the treatment of glaucoma or fluid retention) Orofar Intensive Oranges without sugar with food, drinks and alcohol: Alcohol should be avoided during treatment with Orofar Intensiv Orange Sugar-Free as it may increase the risk of bleeding in the stomach or intestine. Taking it with food may delay the onset of effectiveness. Pregnancy and breastfeeding Oral forms of flurbiprofen (e.g. tablets) may cause adverse reactions in the fetus. It is not known whether the same risk applies to Orofar Intensiv Orange Sugar-Free. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not use Orofar Intensiv Orange Sugar-Free if you are in the last 3 months of pregnancy. You should not use Orofar Intensiv Orange Sugar-Free during the first 6 months of pregnancy unless absolutely necessary and recommended by your doctor. If you need to be treated during this period, the lowest dose should be used and for the shortest possible duration. Flurbiprofen belongs to a class of drugs that can affect fertility in women. This effect is reversible when you stop taking this drug. These pills are unlikely to affect your chances of getting pregnant when taken occasionally, however tell your doctor if you have difficulty getting pregnant before taking this drug. Driving and using machines: Orofar Intensiv Orange Sugar-Free should not affect your ability to drive or use machines. However, dizziness and visual disturbances are possible side effects after using NSAIDs. If you are affected, do not drive or use machines. Drowsiness is also a possible side effect and may affect your ability to drive. Orofar Intensive Orange Sugar-Free contains isomalt (E953) and maltitol (E965) If you have been told by your doctor that you have an intolerance to some carbohydrates, contact your doctor before taking this medicine. Orofar Intensive Orange Sugar-Free contains flavors with citral, citronellol, geraniol and linalool which may cause allergic reactions. These lozenges are for short-term treatment only. The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, seek medical advice immediately if symptoms (such as fever and pain) do not go away or get worse (see section 2). If mouth irritation occurs, treatment with flurbiprofen should be stopped Do not take Orofar Intensiv Orange without sugar for more than 3 days. If you do not feel better, feel worse, or if new symptoms appear, consult a doctor. Possible side effects: Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP TAKING this medicine and see a doctor immediately if you experience: - signs of an allergic reaction, such as asthma, unexpected wheezing or difficulty breathing, itching, runny nose, skin rash, etc. - swelling of the face, tongue or throat, which causes difficulty breathing, rapid heartbeat and low blood pressure which can lead to shock (These may occur even from the first use of the medicine). - severe skin reactions such as peeling, blistering or peeling of the skin. Tell your doctor or pharmacist if you experience any of the following reactions or any other reaction not listed: Other side effects that may occur: Very common (may affect more than 1 in 10 people) - inflammation of the mucous membrane of the oral cavity (stomatitis). Common (may affect up to 1 in 10 people) − dizziness, headache, paresthesia − throat irritation − mouth ulcers or pain in the mouth − sore throat − discomfort or unusual sensation in the mouth (such as a feeling of warmth, burning, tingling, prickling, etc.) − nausea and diarrhea − abdominal pain Uncommon (may affect up to 1 in 100 people): − feeling sleepy or having difficulty falling asleep − worsening of bronchial asthma and bronchospasm, dyspnea, wheezing, blisters in the mouth or throat, numbness in the throat. − dry mouth − pain or burning sensation, burning in the mouth or oral cavity, change in taste, bloating, gas, constipation, indigestion, vomiting − reduced sensitivity in the neck − fever, pain − skin rash, itching of the skin Rare (may affect up to 1 in 1,000 people) − anaphylactic reaction − jaundice and decreased platelet count (thrombocytopenia), but this usually disappears after stopping the medicine; Very rare (may affect up to 1 in 10,000 people) - bleeding in the digestive tract (hard, black stools, accompanied by abdominal pain, possibly with blood in the stool or vomiting blood); - swelling of various parts of the body (angioedema); Not known (frequency cannot be estimated from the available data) − anemia, − swelling (edema), high blood pressure, heart failure or heart attack − severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, Lyell syndrome and toxic epidermal necrolysis − hepatitis (inflammation of the liver) − pain. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Method of administration: Always take Orofar Intensiv Orange without sugar exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure. The recommended dose is: Adults and adolescents over 12 years of age: 1 tablet every 3-6 hours, as needed. Do not take more than 5 pills within 24 hours. Take 1 tablet and slowly dissolve it in your mouth. Always move the tablet around in your mouth as it dissolves. Use in children: The pills are not intended for children under 12 years of age. Composition: The active substance is flurbiprofen. One tablet contains 8.75 mg flurbiprofen. The other ingredients are: isomalt (E953), liquid maltitol (E965), acesulfame potassium (E950), macrogol 400, levomenthol, orange flavour (contains triacetin (E1518), flavouring preparations, nature-identical flavouring substances and natural flavouring substances including citral, citronellol, geraniol and linaliol). Presentation: 16 pills