FORTEX PHARYNGOSEPT 8.75mg x 20 tabl
PHARYNGOSEPT
8.75 mg lozenges, compressed
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.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
- What FARINGOSEPT is and what it is used for
- What you need to know before you take FARINGOSEPT
- How to take FARINGOSEPT
- Possible side effects
- How to store FARINGOSEPT
- Package contents and additional information
What FARINGOSEPT is and what it is used for
PHARYNGOSEPT:
- contains flurbiprofen. It belongs to the group of non-steroidal anti-inflammatory drugs
- drugs (NSAIDs) that reduce inflammation and relieve pain
- provides relief of the symptoms characteristic of a red and painful sore throat;
- provides a measurable soothing and covering effect in the second minute. Half an hour after taking the tablet, relief of pain and reduction of irritation in the throat is observed. The action lasts up to 4 hours after taking the lozenge.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What you need to know before you take FARINGOSEPT
Do not take FARINGOSEPT if:
- you are allergic to flurbiprofen or to 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, hives or itching;
- an allergic runny nose 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 prolonged blood clotting time;
- you are elderly, as side effects are more likely to occur;
- 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 suffered from gastrointestinal diseases (ulcerative colitis, Crohn's disease).
Children and adolescents
FARINGOSEPT is not for use in 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 that relieve pain or are used for colds, others containing acetylsalicylic acid, ibuprofen, flurbiprofen or from the group of NSAIDs;
- medicines that facilitate the excretion of fluids (diuretics) containing furosemide;
- medicines for high blood pressure (beta blockers);
- medicines to prevent blood clotting (anticoagulants), eg warfarin;
- quinolone antibacterial drugs such as ciprofloxacin or nalidixic acid;
- lithium or selective serotonin reuptake inhibitors (to treat depression);
- mifepristone (medicine to terminate pregnancy);
- cardiac glycosides;
- cyclosporine;
- corticosteroids;
- methotrexate (to treat autoimmune diseases or cancer);
- tacrolimus;
- zidovudine (to treat HIV).
PHARYNGOSEPT with food, drink and alcohol
The use of alcohol should be avoided during treatment with FARINGOSEPT, as it may increase the risk of side effects, in particular bleeding in the stomach or intestines.
Pregnancy, lactation and fertility
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 using this medicine.
If you are in the first 6 months of pregnancy or breast-feeding, ask your doctor or pharmacist before taking this medicine. During the last 3 months of pregnancy, the use of flurbiprofen is contraindicated.
Flurbiprofen may impair the ability of women to conceive. This effect is reversible after discontinuation of treatment.
Driving and using machines
When taking flurbiprofen, side effects such as dizziness and visual disturbances are possible. If these symptoms occur, do not drive or operate machinery.
PHARYNGOSEPT contains:
- sodium. This medicine contains less than 1 mmol sodium (23 mg) per lozenge, i.e. it can be said to be practically sodium-free.
How to take FARINGOSEPT
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
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, consult your doctor or pharmacist.
Application method
For oromucous application. To suck slowly, moving in the mouth.
Like all other lozenges, to avoid local irritation, FARINGOSEPT lozenges should be moved in the mouth while being sucked. If oral irritation occurs, treatment with flurbiprofen should be discontinued.
Use in children and adolescents
PHARYNGOSEPT should not be used in children under 12 years of age.
The score line is not intended to break the tablet.
If you have taken more than the required dose of FARINGOSEPT
You may feel sleepy 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 missed dose.
If you have stopped taking FARINGOSEPT
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and consult a doctor immediately if:
- signs of allergic reactions, such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, skin rashes, etc.;
- swelling of the face, tongue or throat, which causes difficulty breathing, palpitations, a drop in blood pressure leading to shock (this can happen even when taking the drug for the first time);
- 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;
- mouth ulcers or pain, discomfort or unusual sensations in the mouth (such as heat, burning, tingling, stinging, etc.);
- nausea or diarrhea;
- tingling or itching of the skin.
Uncommon (may affect up to 1 in 100 people):
- drowsiness;
- blistering of the mouth or throat, a tingling sensation in the throat;
- bloating, abdominal pain, gas, constipation, indigestion, vomiting;
- dry mouth, burning sensation in the mouth, change in taste;
- skin rashes, 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 patients):
- anaphylactic reactions.
Not known (frequency cannot be estimated from the available data):
- anemia, thrombocytopenia (a reduced number of platelets in the blood, which can lead to a tendency to bruise or bleed easily);
- swelling (edema), high blood pressure, heart failure, or heart attack;
- severe forms of skin reactions, such as bullous reactions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis;
- hepatitis (inflammation of the liver).
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Executive Medicines Agency, 8 Damyan Gruev St., 1303 Sofia, phone: +359 28903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
How to store FARINGOSEPT
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date corresponds to the last day of the specified month.
Do not use this medicine if you notice visible signs of product deterioration.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
What FARINGOSEPT looks like and contents of the pack
Blister of white, opaque PVC/PVDC/Alu foil with 10 lozenges, pressed.
Each box contains 20 compressed lozenges (2 blisters) and a patient leaflet.
Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd
10 Prohladen kat St.,
Sofia 1362, Bulgaria
Date of last revision of leaflet
January 2020
