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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 3 days or your condition worsens, you should seek medical attention.
What this leaflet contains
- What is PHARYNGOSEPT and what is it used for?
- What you need to know before taking FARINGOSEPT
- How to take PHARYNGOSEPT
- Possible side effects
- How to store PHARYNGOSEPT
- Package contents and additional information
What is PHARYNGOSEPT and what is it used for?
PHARYNGOSEPTUS:
- contains flurbiprofen. It belongs to the group of non-steroidal anti-inflammatory drugs
- drugs (NSAIDs) that reduce inflammation and relieve pain
- provides relief from 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, pain relief and reduced throat irritation are observed. The effect lasts up to 4 hours after taking the lozenge.
If you do not feel better after 3 days or your condition worsens, you should seek medical attention.
What you need to know before taking 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, hives 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 PHARYNGOSEPT 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;
- 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 suffered from gastrointestinal diseases (ulcerative colitis, Crohn's disease).
Children and adolescents
PHARYNGOSEPT is not used in children under 12 years of age.
Other medicines and PHARYNGOSEPT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are regularly taking:
- pain relievers or cold medicines, others containing acetylsalicylic acid, ibuprofen, flurbiprofen or from the NSAID group;
- medicines that facilitate the excretion of fluids (diuretics) containing furosemide;
- high blood pressure medications (beta blockers);
- medicines to prevent blood clotting (anticoagulants), such as warfarin;
- quinolone antibacterial drugs such as ciprofloxacin or nalidixic acid;
- lithium or selective serotonin reuptake inhibitors (for the treatment of depression);
- mifepristone (a medicine for terminating pregnancy);
- cardiac glycosides;
- cyclosporine;
- corticosteroids;
- methotrexate (to treat autoimmune diseases or cancer);
- tacrolimus;
- zidovudine (for the treatment of HIV).
PHARYNGOSEPT with food, drinks and alcohol
Alcohol consumption 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, breastfeeding 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 for advice before taking this medicine. During the last 3 months of pregnancy, the use of flurbiprofen is contraindicated.
Flurbiprofen may impair the ability to conceive in women. This effect is reversible upon discontinuation of treatment.
Driving and using machines
When taking flurbiprofen, side effects such as dizziness and visual disturbances may occur. 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. essentially ‘sodium-free’.
How to take PHARYNGOSEPT
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 of age: 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.
Method of administration
For oromucosal use. Suck slowly, moving in the mouth.
As with all lozenges, to avoid local irritation, FARINGOSEPT lozenges should be moved around in the mouth while being sucked. If irritation occurs in the mouth, treatment with flurbiprofen should be discontinued.
Use in children and adolescents
FARINGOSEPT should not be used in children under 12 years of age.
The score line is not intended to break the tablet.
If you take more than the required dose of FARINGOSEPT
You may feel sleepy or nauseous. In case of overdose, seek medical attention immediately, even if you feel well.
If you forget to take PHARYNGOSEPT
Do not take a double dose to make up for a missed dose.
If you stop taking FARINGOSEPT
If you have any further questions on 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 in case of:
- 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, low blood pressure leading to shock (this can happen even when you first take the medicine);
- severe skin reactions such as peeling, blistering or flaking 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 warmth, burning, tingling, prickling, 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, numbness of the throat;
- stomach bloating, abdominal pain, gas, constipation, indigestion, vomiting;
- dry mouth, burning sensation in the mouth, change in taste;
- skin rashes, itching of the 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 (frequency cannot be estimated from the available data):
- anemia, thrombocytopenia (reduced number of platelets in the blood, which may lead to easy bruising or bleeding);
- 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 side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, tel.: +359 28903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on the safety of this medicine.
How to store PHARYNGOSEPT
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 expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of product deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
What does FARINGOSEPT look like and what the pack contains?
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 the leaflet was last revised
January 2020
