Faringosept

• Short description
• How to use

• • for painful sore and red throat
  • with a rapid analgesic effect
  • anti-inflammatory action
  • honey & lemon flavour
  • no sugar

• CONTENT
  What FARINGOSEPT looks like and contents of the pack Blister of white, opaque PVC / PVDC / Alu foil with 10 lozenges, compressed. Each box contains 20 lozenges, compressed (2 blisters) and a patient leaflet.

  Method of use

  Adults and children over 12 years: one lozenge every 3-6 hours. Do not take more than 5 tablets in 24 hours. If your symptoms persist, the pain worsens, or new symptoms appear, talk to your doctor or pharmacist. Method of use: For oromucosal use. Suck slowly, with moving in the mouth. Like all lozenges, to avoid local irritation, FARINGOSEPT lozenges should be moved in the mouth while sucking. If oral irritation occurs, flurbiprofen treatment should be discontinued.

• General information
• Ingredients

• Package leaflet: Information for the patient

  FARINGOSEPT® 8,75 mg compressed lozenges

  Flurbiprofen

   

  Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.  

  - Keep this leaflet. You may need to read it again.  

  - Ask your pharmacist if you need more information or advice.

  - If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  - You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

   

  What is in this leaflet

   1. What FARINGOSEPT is and what it is used for  

  2. What you need to know before you take FARINGOSEPT  

  3. How to take FARINGOSEPT  

  4. Possible side effects  

  5. How to store FARINGOSEPT  

  6. Contents of the pack and other information

   

   1. What FARINGOSEPT is and what it is used for

   FARINGOSEPT:

  - contains flurbiprofen. It belongs to the group of non-steroidal anti-inflammatory drugs

  (NSAIDs) that reduce inflammation and relieve pain;

  - provides relief of symptoms characteristic of red and sore throat;

  - provides a measurable soothing and covering effect in the second minute. Half an hour after taking the tablet, there is relief from pain and reduction of irritation in the throat. The effect lasts up to 4 hours after taking the lozenge.

  You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

  2. What you need to know before you take FARINGOSEPT  

   Do not take FARINGOSEPT, if:

  - you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);

  - you have or have had two or more episodes of stomach ulcer or bleeding, or duodenal ulcer;

  - you have had difficulty breathing, allergic rashes, urticaria or itching;

  - allergic rhinitis occurs after taking flurbiprofen, acetylsalicylic acid (aspirin) or other NSAIDs;

  - you have or have had bleeding or perforation in the gastrointestinal tract, severe colitis or a blood clotting disorder after taking NSAIDs.

   Warnings and precautions  

  Talk to your doctor or pharmacist before taking FARINGOSEPT, if:

  • you have asthma or have had asthma attacks;

  • you have kidney, heart or liver problems;

  • you have high blood pressure;

  • you have a prolonged clotting time;

  • you are elderly, as you are more likely to have side effects;

  • you suffer from a chronic autoimmune disease, such as systemic lupus erythematosus and mixed connective tissue disease;

  • you have already taken some other NSAIDs or acetylsalicylic acid;

  • you have had gastrointestinal problems (ulcerative colitis, Crohn's disease).

   Children and adolescents

  FARINGOSEPT should not be taken from children under 12 years of age.

   Other medicines and FARINGOSEPT

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, report if you regularly take:

  - medicines which relieves pain or are used for colds, others containing acetylsalicylic acid, ibuprofen, flurbiprofen or NSAIDs;

  - medicines that facilitate the excretion of fluids (diuretics) containing furosemide;

  - medicines for high blood pressure (beta blockers);

  - anticoagulants (anticoagulants), such as warfarin;

  - quinolone antibacterial drugs such as ciprofloxacin or nalidixic acid;

  - lithium or selective serotonin reuptake inhibitors (used to treat depression);

  - mifepristone (a medicine to terminate a pregnancy);

  - cardiac glycosides;

  - cyclosporine;

  - corticosteroids;

  - methotrexate (used to treat autoimmune diseases or cancer);

  - tacrolimus;

  - zidovudine (used to treat HIV).

   FARINGOSEPT with food, drink and alcohol

  Alcohol use should be avoided during treatment with FARINGOSEPT, as this may increase the risk of side effects, in particular bleeding in the stomach or intestines.

   Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  If you are in the first 6 months of pregnancy or breast-feeding, talk to your doctor or pharmacist before taking this medicine. In the last 3 months of pregnancy, the use of flurbiprofen is contraindicated.

  Flurbiprofen may impair a woman's ability to conceive. This effect is reversible upon discontinuation of treatment.

   Driving and using machines

  Side effects such as dizziness and visual disturbances may occur with flurbiprofen. If these symptoms occur, do not drive or use machines.

  FARINGOSEPT contains:

  - sodium. This medicine contains less than 1 mmol sodium (23 mg) per lozenge, i.e. it contains practically no sodium.

   3. How to take FARINGOSEPT

   Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.  

   The recommended dose is:

  Adults and children over 12 years: one lozenge every 3-6 hours.

  Do not take more than 5 tablets in 24 hours.

   If your symptoms persist, the pain worsens, or new symptoms appear, talk to your doctor or pharmacist.

   Method of use

  For oromucosal use. Suck slowly, with moving in the mouth.

   Like all lozenges, to avoid local irritation, FARINGOSEPT lozenges should be moved in the mouth while sucking. If oral irritation occurs, flurbiprofen treatment should be discontinued.  

   Use in children and adolescents

  FARINGOSEPT should not be taken from children under 12 years of age.

   If you take more FARINGOSEPT than you should

  You may be drowsy or nauseous. In case of overdose, it is necessary to seek medical help immediately, even if you feel well.

   If you forget to take FARINGOSEPT

  Do not take a double dose to make up for a forgotten dose.

   If you stop taking FARINGOSEPT

  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 taking this medicine and ask your doctor immediately in case of:

  • signs of allergic reactions, such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, skin rash, etc .;

  • swelling of the face, tongue or throat, which causes difficulty breathing, palpitations, lowering of blood pressure, leading to shock (this can happen even with the first dose);

  • severe skin reactions such as peeling, blistering or peeling of the skin.

  Common (may affect up to 1 in 10 people):

  • dizziness, headache;

  • irritation and sore throat;

  • sores or pain in the mouth, discomfort or unusual sensations in the mouth (such as heat, burning, tingling, stabbing, etc.);

  • nausea or diarrhea;

  • tingling or itching of the skin.

  Uncommon (may affect up to 1 in 100 people):

  • drowsiness;

  • blistering in the mouth or throat, tingling in the throat;

  • bloating, abdominal pain, gas, constipation, indigestion, vomiting;

  • dry mouth, burning sensation in the mouth, change in taste;

  • skin rash, itchy skin;

  • fever, pain;

  • drowsiness or difficulty falling asleep;

  • worsening of asthma, wheezing, difficulty breathing;

  • decreased sensitivity in the mouth.

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

  • anaphylactic reactions.

  Not known (cannot be estimated from the available data):

  • anemia, thrombocytopenia (decreased number of platelets in the blood, which may lead to a tendency to easily bruise or bleed);

  • swelling (edema), high blood pressure, heart failure or heart attack;

  • severe skin reactions, such as bullous reactions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis;

  • hepatitis (inflammation of the liver).

   Reporting of side effects

  If you get any side effects, contact your doctor or pharmacist. This includes any possible side effects, not listed in this leaflet. You can also report side effects directly via Bulgarian Drug Agency, Damyan Gruev Str., No 8, 1303 Sofia, tel. +359 2 8903417, website www.bda.bg. By reporting side effects you can help provide more information on the safety of this medicine.

  5. How to store FARINGOSEPT

   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 blister and carton box. The expiry date refers to the last day of that month.

   Do not use this medicine if you notice description of the visible signs of deterioration.

   Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

    6. Contents of the pack and other information

   What FARINGOSEPT contains  

  - The active substance is flurbiprofen 8,75 mg;

  - The other excipient(s) are:  mannitol, magnesium stearate, colloidal anhydrous silica, sodium cyclamate, povidone, honey flavor (flavoring substances, potato maltodextrin), lemon flavoring (flavoring substances, maize maltodextrin, gum arabic, sugar, aromatyl lutyl hydroxy) flavorings, maize maltodextrin).

  What FARINGOSEPT looks like and contents of the pack

  Blister of white, opaque PVC / PVDC / Alu foil with 10 lozenges, compressed.

  Each box contains 20 lozenges, compressed (2 blisters) and a patient leaflet.

   Marketing Authorisation Holder and Manufacturer

  Fortex Nutraceuticals Ltd.,

  10, Prohladen kat street,  

  Sofia 1362, Bulgaria

   

  Date of last revision of the leaflet April 2022

   

• What FARINGOSEPT contains  

  - The active substance is flurbiprofen 8,75 mg;

  - The other excipient(s) are:  mannitol, magnesium stearate, colloidal anhydrous silica, sodium cyclamate, povidone, honey flavor (flavoring substances, potato maltodextrin), lemon flavoring (flavoring substances, maize maltodextrin, gum arabic, sugar, aromatyl lutyl hydroxy) flavorings, maize maltodextrin).

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