Bucopro 8.75 mg lozenges honey and lemon flavour
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Bucopro 8.75 mg lozenges with honey and lemon flavour
flurbiprofen
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow the instructions for use of this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days of treatment.
Contents of this leaflet
- What Bucopro is and what it is used for
- What you need to know before taking Bucopro
- How to take Bucopro
- Possible side effects
- How to store Bucopro
- Contents of the pack and other information
1. What Bucopro is and what it is used for
Bucopro contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by modifying the body's response to pain, inflammation, and fever.
Bucopro is used for the short-term relief of sore throat symptoms such as irritation, pain, inflammation, and difficulty swallowing in adults and children over 12 years of age.
You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.
2. What you need to know before taking Bucopro
Do not take Bucopro if you:
- are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6)
- after taking acetylsalicylic acid (Aspirin) or any other NSAID have ever experienced asthma, sudden wheezing or difficulty breathing, nasal discharge, swelling of the face, or itchy rash (urticaria)
- currently have or have ever had a peptic ulcer (two or more episodes of gastric or intestinal ulcer)
- after taking any other NSAID have experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders
- are in the last three months of pregnancy
- currently have or have ever had severe heart, kidney, or liver failure
Warnings and precautions
Talk to your doctor or pharmacist before taking Bucopro if you:
- have ever had asthma or suffer from allergies
- have tonsillitis (inflamed tonsils) or suspect you may have a bacterial throat infection (as you may need antibiotics)
- have heart, kidney, or liver problems
- have had a stroke
- have a history of intestinal disease (ulcerative colitis, Crohn’s disease)
- have high blood pressure
- suffer from a chronic autoimmune disease (such as systemic lupus erythematosus or connective tissue disease)
- are elderly, as you are more likely to experience the adverse reactions described in this leaflet
- are in the first 6 months of pregnancy or are breastfeeding
- have medication-overuse headache
- have an infection – see the section “Infections” below
Avoid concomitant use of two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac, or prednisolone), as this may increase the risk of adverse effects, particularly gastrointestinal adverse events such as ulcers and bleeding (see section “Other medicines and Bucopro” below).
While taking Bucopro
- At the first sign of a skin reaction (rash, peeling) or any other sign of an allergic reaction, stop taking this medicine and consult a doctor immediately.
- Inform your doctor of any unusual abdominal symptoms you may experience (especially bleeding). Consult your doctor if your symptoms do not improve, worsen, or if new symptoms appear.
- The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days).
Children
This medicine must not be used in children under 12 years of age.
Other medicines and Bucopro
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. In particular, if you are taking:
- acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day)
- medicines for high blood pressure or heart problems (antihypertensives, cardiac glycosides)
- diuretics (including potassium-sparing diuretics)
- medicines to thin the blood (anticoagulants, antiplatelet agents)
- medicines for gout (probenecid, sulfinpyrazone)
- other NSAIDs, including selective cyclooxygenase-2 inhibitors or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac, or prednisolone)
- mifepristone (a medicine used for abortion)
- quinolone antibiotics (such as ciprofloxacin)
- cyclosporine or tacrolimus (medicines used to suppress the immune system)
- phenytoin (a medicine for treating epilepsy)
- methotrexate (a medicine for treating autoimmune diseases or cancer)
- lithium or selective serotonin reuptake inhibitors (medicines for depression)
- oral antidiabetics (medicines for treating diabetes)
- zidovudine (a medicine for treating HIV)
Taking Bucopro with food, drinks, and alcohol
Alcohol consumption should be avoided during treatment with Bucopro, as it may increase the risk of stomach or intestinal bleeding.
Pregnancy, breastfeeding, and fertility
Oral forms (e.g., tablets) of flurbiprofen may cause adverse effects in unborn babies. It is not known whether the same risk applies with Bucopro.
Do not take this medicine if you are in the last three months of pregnancy. If you are in the first 6 months of pregnancy or are breastfeeding, consult your doctor before taking this medicine. If treatment is needed during this period, the lowest possible dose for the shortest possible time should be used.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible when the medicine is discontinued. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant; however, inform your doctor before taking this medicine if you have difficulty conceiving.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted. However, if adverse reactions such as dizziness and/or visual disturbances occur, do not drive or operate machinery.
Bucopro contains isomalt, maltitol, and fragrances containing allergens.
This medicine contains isomalt and maltitol. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. It may produce a mild laxative effect. Energy value: 2.3 kcal/g of maltitol/isomalt.
This medicine contains fragrances with d-limonene and geraniol.
D-limonene and geraniol may cause allergic reactions.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This could delay the start of appropriate treatment for the infection, potentially increasing the risk of complications. If you take this medicine while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.
3. How to take Bucopro.
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose: Adults and adolescents over 12 years of age:
Take 1 tablet every 3–6 hours as needed.
Do not take more than 5 tablets in 24 hours.
- Place a tablet in the mouth and suck it slowly. Do not swallow or chew the tablet.
- Move the tablet around in the mouth while sucking.
Use in children:
Children under 12 years of age must not take this medicine.
These tablets are intended for short-term treatment only.
Take the lowest number of tablets needed for the shortest possible time required to relieve your symptoms. The lowest effective dose should be used for the shortest duration necessary to control symptoms. If you have an infection, consult a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
Do not take Bucopro for more than 3 days, unless advised otherwise by your doctor. If your condition does not improve, worsens, or new symptoms appear, consult your doctor or pharmacist.
If you take more Bucopro than you should
In case of overdose or accidental ingestion, consult a doctor or pharmacist or go to the nearest hospital. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. Symptoms of overdose may include nausea or vomiting, stomach pain, or more rarely, diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
STOP TAKING this medicine and consult your doctor immediately if you develop:
- allergic reactions such as asthma, wheezing or shortness of breath, itching, runny nose, skin rashes, etc.
- swelling of the face, tongue or throat causing difficulty breathing, palpitations, drop in blood pressure leading to shock (these effects may occur even when the medicine is used for the first time).
- severe skin reactions such as peeling, blisters or skin shedding.
Inform your doctor or pharmacist if you notice any of the following effects or any effect not described in this leaflet:
The following adverse effects may occur:
Frequent (may affect up to 1 in 10 people)
- dizziness, headache
- throat irritation
- mouth ulcers or mouth pain
- sore throat
- mouth discomfort (sensation of heat, burning, itching, tingling, etc.)
- nausea and diarrhea
- itching and pruritus of the skin
Uncommon (may affect up to 1 in 100 people)
- numbness
- drowsiness or difficulty sleeping
- worsening of asthma, wheezing, breathing difficulty
- blisters in the mouth or throat, throat numbness
- dry mouth
- burning sensation in the mouth, altered taste sensation
- abdominal distension, abdominal pain, flatulence, constipation, indigestion, vomiting
- reduced throat sensitivity
- fever, pain
- skin rashes, skin itching
Rare (may affect up to 1 in 1,000 people)
- anaphylactic reaction
Frequency not known (cannot be estimated from the available data)
- anemia, thrombocytopenia (low platelet count in the blood which may lead to bruising and bleeding)
- swelling (edema), high blood pressure, heart failure or heart attack
- severe forms of skin reaction such as blistering reactions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis
- hepatitis (inflammation of the liver)
- hypersensitivity
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bucopro
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.
Do not store above 30 °C.
6. Contents of the pack and other information
Composition of Bucopro
The active substance is flurbiprofen. One tablet contains 8.75 mg of flurbiprofen.
The other components are:
Isomalt (E-953)
Maltitol (E-965)
Peppermint oil (contains d-limonene)
Lemon flavour (contains d-limonene and geraniol)
Honey flavour
Nature and contents of the container
Round tablets, pale to yellowish in colour, with a diameter of 19±1 mm.
The tablets are available in PVC-PVDC/Aluminium blisters.
Pack sizes: 8, 12, 16, 20, 24 lozenges
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Lozy’s Pharmaceuticals, S.L.
Campus Empresarial s/n
31795 Lekaroz, Navarra
Spain
or
Przedsiebiorstwo Produkcyjno - Handlowe “EWA” S.A.
ul.Zamkowy Folwark 9
63-700 Krotoszyn
Poland
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria: ratioDolor Flurbiprofen 8.75 mg Lutschtabletten mit Zitronengeschmack
Spain: Bucopro 8.75 pastillas para chupar sabor miel y limón
Portugal: Macifen Mel e Limão
Hungary: Dolioflen 8.75 mg szopogató tabletta
Germany: Flurbiprofen-ratiopharm mit Honig- und Zitronengeschmack
Finland: Flusils hunaja-sitruuna 8.75 mg, imeskelytabletti
Luxembourg: Flurbiprofen-ratiopharm mit Honig-Zitrone-Geschmack
Bulgaria: Efisol Intense 8.75 mg lozenges
You can access up-to-date, detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging.
You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81912/P_81912.html
Date of the most recent review of this leaflet: July 2022