ASPIGOLADOL 8.75 mg Pastylka
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Jak stosować ASPIGOLADOL
Treść ulotki
- What is Aspigoladol and what is it used for
- What you need to know before taking Aspigoladol
- How to take Aspigoladol
- Possible side effects
- How to store Aspigoladol
- Contents of the pack and other information
Aspigoladol 8.75 mg orange flavored lozenges
flurbiprofen
Read this leaflet carefully before taking this medicine as 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 want more information or advice, ask your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 3 days.
Contents of this leaflet
- 1. What Aspigoladol is and what it is used for
- 2. What you need to know before you take Aspigoladol
- 3. How to take Aspigoladol
- 4. Possible side effects
- 5. How to store Aspigoladol
- 6. Contents of the pack and other information
1. What is Aspigoladol and what is it used for
Aspigoladol contains the active ingredient flurbiprofen. Flurbiprofen belongs to a group of medicines
called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) which have analgesic and anti-inflammatory properties
in the treatment of sore throat. These medicines work by changing the way the body responds to
pain, swelling and high temperatures.
Aspigoladol is used for the short-term treatment of symptoms of pain and inflammation of the throat such as
sore throat, pain and swelling, and difficulty swallowing, in adults and adolescents over 12 years of age.
See a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before taking Aspigoladol
Do not takeAspigoladol
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
- if you have had asthma, wheezing or difficulty breathing, runny nose, facial swelling or skin rash accompanied by itching (urticaria) after taking acetylsalicylic acid or similar substances used to treat pain, inflammation or rheumatism, called non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have or have had two or more episodes of gastric or intestinal ulcers;
- if you have or have had bleeding or perforation of the stomach or intestines, severe colitis (inflammation of the intestine) or blood disorders after using another NSAID;
- if you suffer from heart, liver or kidney failure;
- if you are in the last trimester of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aspigoladol if:
- you are using other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac or prednisolone) to treat pain, inflammation or rheumatism, as this may increase the risk of adverse events, particularly adverse events affecting the stomach and intestines such as ulcers and bleeding;
- you have or have had asthma or suffer from allergies;
- you have heart, liver or kidney problems;
- you have had a stroke;
- you have a history of gastric or intestinal diseases (ulcerative colitis, Crohn's disease);
- you suffer from high blood pressure;
- you have tonsillitis (swollen tonsils) or think you have a bacterial throat infection (because you may need antibiotics);
- you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
Elderly
Elderly people are more likely to experience the undesirable effects listed in this leaflet.
Children
Do not give this medicine to children under 12 years of age.
Other medicines and Aspigoladol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, especially if you are using medicines that contain:
- other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium or prednisolone) to treat pain, inflammation or rheumatism;
- limited doses of acetylsalicylic acid (up to 100 mg per day);
- substances that inhibit blood clotting or dissolve blood clots;
- medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides);
- methotrexate (a medicine for treating autoimmune diseases or cancer);
- mifepristone (a medicine used for medical abortion);
- oral antidiabetics (to treat diabetes);
- phenytoin (a medicine for treating epilepsy);
- agents to increase water elimination through the kidneys (diuretics, including potassium-sparing agents);
- agents against gout (probenecid, sulfinpyrazone);
- quinolone antibiotics (such as ciprofloxacin);
- lithium or selective serotonin reuptake inhibitors (medicines for treating depression);
- cyclosporine or tacrolimus (medicines used to suppress the immune system after an organ transplant);
- zidovudine (to treat HIV infection).
Aspigoladol with food, drinks and alcohol
Avoid drinking alcohol while being treated with Aspigoladol, as it may increase the risk of
gastric or intestinal bleeding.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are in the last trimester of pregnancy. If you are in the first 6 months of
pregnancy or if you are breastfeeding, talk to your doctor before taking this medicine.
Flurbiprofen belongs to a group of drugs that can affect fertility in women. This effect
is reversible by stopping the medicine. Occasional use of this
medicine is unlikely to affect your ability to get pregnant, however, talk to your doctor before taking
this medicine if you have problems getting pregnant.
Driving and using machines
Aspigoladol is not known to affect the ability to drive vehicles and use machines. However,
dizziness and visual disturbances are possible side effects after taking NSAIDs. If these effects occur,
do not drive and do not use machines.
Aspigoladol contains isomalt and maltitol.
If you have been diagnosed with an intolerance to certain sugars, talk to your doctor before taking this
medicine.
Aspigoladol contains ponceau 4R and yellow orange S.
May cause allergic reactions.
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3. How to take Aspigoladol
Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over the age of 12 years:
1 lozenge every 3-6 hours, if necessary.
Do not exceed the maximum daily dose of 5 lozenges.
Method of use:
For oral mucosal use.
- Dissolve the lozenge slowly in your mouth, do not swallow and do not chew the lozenge.
- Move the lozenge continuously in your mouth while it dissolves.
Duration of treatment
Do not take Aspigoladol for more than 3 days without consulting your doctor.
If irritation of the mouth occurs, treatment with Aspigoladol must be discontinued.
If you take more Aspigoladol than you should
Talk to your doctor or pharmacist or go immediately to the nearest hospital if you suspect an overdose.
Symptoms of overdose may include: nausea or vomiting, stomach pain or, more rarely, diarrhea.
Tinnitus, headache and gastrointestinal bleeding are also possible.
If you have any doubts about 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 seek medical attention immediately or go to the nearest hospital if you develop:
- signs of allergic reactions such as asthma, sudden wheezing or difficulty breathing, itching, runny nose, skin rashes;
- swelling of the face, tongue or throat causing difficulty breathing, rapid heartbeat and a drop in blood pressure leading to shock (these events can also occur upon first use of the medicine);
- severe skin reactions such as redness, swelling, peeling, blistering, flaking of the skin or ulceration of the skin and mucous membranes.
Talk to your doctor or pharmacist if you experience any of the following effects or any other effects not
described:
Common(may affect up to 1 in 10 people)
- dizziness, headache
- sore throat
- mouth ulcers or mouth pain
- throat pain
- uncomfortable or unusual sensation in the mouth (such as warmth, burning, tingling, prickling)
- nausea and diarrhoea
- tingling and itching of the skin
Uncommon(may affect up to 1 in 100 people)
- drowsiness
- feeling sleepy or having difficulty falling asleep
- worsening of asthma, wheezing, difficulty breathing
- blisters in the mouth or throat, numbness in the throat
- dry mouth
- burning sensation in the mouth, altered sense of taste
- abdominal pain, bloated stomach, flatulence, constipation, indigestion, vomiting
- reduced sensitivity of the throat
- fever, pain
- skin rashes, itching Rare(may affect up to 1 in 1,000 people)
- anaphylactic reaction
Frequency not known (cannot be estimated from available data)
- anaemia, thrombocytopenia (low number of platelets in the blood which can cause bruising and bleeding)
- swelling (oedema), high blood pressure, heart failure or heart attack
- severe forms of skin reactions such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
- hepatitis (inflammation of the liver)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system
at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help
provide more information on the safety of this medicine.
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5. How to store Aspigoladol
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 package and on the aluminium blister
foil after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage precautions.
Do not dispose of any medicine in waste water 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 pack and other information
What Aspigoladol contains
The active ingredient is flurbiprofen. One lozenge contains 8.75 mg of flurbiprofen.
The other ingredients are:
Isomalt
Maltitol, liquid
Acesulfame potassium
Macrogol 300
Potassium hydroxide
Ponceau 4R (E-124)
Yellow Orange S (E-110)
Natural orange flavour
Levomenthol
Description of the appearance of Aspigoladol and contents of the pack
Aspigoladol lozenges are presented as round lozenges of orange colour, with a diameter of 19±1
mm, with an orange flavour.
The lozenges are available in PVC-PVDC/aluminium blisters in a printed cardboard box.
Pack size: 8, 12, 16 or 24 lozenges.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bayer S.p.A. Viale Certosa 130, 20156 Milan
Manufacturer
Lozy's Pharmaceuticals S.L.
Campus Empresarial Lekaroz
Navarra 31795, Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
| Germany: | Flurbiprofen Bayer Vital mit Orangengeschmack 8,75 mg Lutschtabletten |
| Italy: | Aspigoladol |
[To be completed at national level]
- Kraj rejestracji
- Postać farmaceutycznaLozenge, 8.75 mg
- Kod ATCA01AD11
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ASPIGOLADOLPostać farmaceutyczna: Mouthwash, 0.25 %Substancja czynna: variousProducent: BAYER S.P.A.Bez receptyPostać farmaceutyczna: Mouthwash, 2,5 MG/MLSubstancja czynna: variousProducent: RECKITT BENCKISER HEALTHCARE (ITALIA) S.P.A.Bez receptyPostać farmaceutyczna: Mouthwash, 2,5 MG/MLSubstancja czynna: variousProducent: PERRIGO ITALIA S.R.L.Bez recepty
Odpowiedniki ASPIGOLADOL w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
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ASPIGOLADOL nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ASPIGOLADOL jest various. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ASPIGOLADOL jest produkowany przez BAYER S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie ASPIGOLADOL jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić ASPIGOLADOL w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (various) to m.in. ASPI GOLA, BENAKTIV GOLA, BRONKENOLO GOLA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
