Bucopro 8.75 mg orange-flavored lozenges

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bucopro 8.75 mg orange-flavoured lozenges

Flurbiprofen

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, 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 does not improve after 3 days.

Contents of the leaflet

1. What Bucopro is and what it is used for
2. What you need to know before using Bucopro
3. How to use Bucopro
4. Possible adverse effects
5. How to store Bucopro
6. 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), which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by modifying the body's response to pain, inflammation, and fever.

Bucopro is used for the short-term relief of symptoms of sore throat, such as irritation, pain and inflammation, and difficulty swallowing, in adults and children over 12 years of age.

You should consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before using Bucopro

Do not use Bucopro:

• If you are allergic to flurbiprofen or to any of the other ingredients (listed in section 6).
• If after taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid you have experienced asthma, sudden wheezing or difficulty breathing, nasal discharge, facial swelling, or itchy rash (urticaria).
• If you currently have or have previously had a stomach or intestinal ulcer (two or more episodes of gastric or duodenal ulcer).
• If you have ever experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders after taking NSAIDs.
• If you currently have or have previously had severe heart, kidney, or liver failure.
  • If you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine:

• If you have ever had asthma or suffer from allergies.
• If you have tonsillitis (inflammation of the tonsils) or suspect you may have a bacterial throat infection (as you may need antibiotics).
• If you have heart, kidney, or liver problems.
• If you have had a stroke.
• If you have a history of intestinal disease (ulcerative colitis, Crohn's disease).
• If you have high blood pressure (hypertension).
• If you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
• If you are elderly, as you are more likely to experience the adverse effects described in this leaflet.
• If you are in the first 6 months of pregnancy or are breastfeeding.
• If you have analgesic-induced headache.
  • If you have an infection – see the section "Infections" below.

Avoid using two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac, or prednisolone) simultaneously, as this may increase the risk of adverse effects, particularly gastrointestinal effects such as ulcers and bleeding (see section "Use of Bucopro with other medicines").

While using this medicine

• At the first sign of a skin reaction (rash, peeling), or any other sign of an allergic reaction, stop using 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 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 the duration of treatment stated in this leaflet (3 days).

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.

Children and adolescents

This medicine must not be used in children or adolescents under 12 years of age.

Use of Bucopro with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. In particular, if you are taking:

• Acetylsalicylic acid at low doses (up to 75 mg per day).
• Medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medicines to thin the blood (anticoagulants, antiplatelet agents).
• Medicines for gout (probenecid, sulfinpyrazone).
• Other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac, or prednisolone) (see section "Warnings and precautions").
• Mifepristone (a medicine used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Cyclosporine or tacrolimus (to suppress the immune system).
• Phenytoin (for treating epilepsy).
• Methotrexate (for treating autoimmune diseases or cancer).
• Lithium or selective serotonin reuptake inhibitors (for depression).
  • Oral antidiabetic medicines (for treating diabetes).
  • Zidovudine (for treating HIV).

Taking Bucopro with food, drinks, and alcohol

Alcohol intake should be avoided during treatment with this medicine, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Oral forms (e.g., tablets) of flurbiprofen may cause adverse effects in unborn babies. It is unknown whether the same risk exists with Bucopro.

Do not take this medicine if you are in the last trimester of pregnancy. If you are in the first six months of pregnancy or are breastfeeding, consult your doctor before taking this medicine.

You should not take Bucopro during the first six months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.

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 becoming pregnant.

Driving and using machines

This medicine should not affect your ability to drive or operate machinery. However, if adverse reactions such as dizziness and/or visual disturbances occur, do not drive or use machines.

Bucopro contains maltitol and isomalt

This medicine contains maltitol and isomalt. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may produce a mild laxative effect because it contains 2.03 g of isomalt and 0.43 g of maltitol per lozenge.

Calorific value: 2.3 kcal/g maltitol/isomaltose

Bucopro contains sunset yellow FCF (E-110) and cochineal red A (E-124)

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110) and cochineal red A (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to use Bucopro

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest time necessary to relieve 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).

Recommended dose:

Adults and children over 12 years of age:

• Take one tablet every 3 to 6 hours as needed.
• Do not take more than 5 tablets in 24 hours.

Method of administration:

Oral use

Allow the tablet to dissolve slowly in the mouth; do not swallow or chew it.

Move the tablet around in the mouth while it dissolves.

Use in children

Do not use this medicine in children under 12 years of age.

Do not take this medicine for more than 3 days. If symptoms do not improve, worsen, or new symptoms appear, consult your doctor or pharmacist.

If you take more Bucopro than you should

Contact your doctor or pharmacist or go to the nearest hospital as soon as possible. Symptoms of overdose may include: nausea or vomiting, stomach pain, or more rarely, diarrhea. Tinnitus (ringing in the ears), headache, and gastrointestinal bleeding may also occur.

If you have taken more Bucopro than you should, contact your doctor, pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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 a doctor immediately if you notice:

• Signs of an allergic reaction such as asthma, shortness of breath or unexplained wheezing, itching, runny nose, skin rash, etc.
• Swelling of the face, tongue or throat causing difficulty breathing, palpitations, drop in blood pressure causing shock (all of 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 experience any of the following effects or any effects not described in this leaflet:

Other adverse effects may also occur:

Frequent (may affect up to 1 in 10 people)

• Dizziness, headache.
• Throat irritation.
• Mouth ulcers, mouth pain.
• Sore throat.
• Discomfort or unusual sensation in the mouth (burning sensation, tingling, itching, prickling, 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, shortness of breath.
• 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 rash, skin 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 platelet count in the blood which may lead to 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, Lyell's syndrome and toxic epidermal necrolysis.
• Hepatitis (inflammation of the liver).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bucopro

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused or expired medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bucopro

The active substance is flurbiprofen. Each pastille contains 8.75 mg of flurbiprofen.

The other components (excipients) are:

Isomalt (E953)

Liquid maltitol (E965)

Carmine red (E 124)

Orange yellow (E 110)

Acesulfame potassium

Potassium hydroxide

Orange flavour (Limonene (50.0%-100%), decanal (0.0%-10%), citral, citronellol (0.1%-1.0%))

Levomenthol

Nature of the product and contents of the pack

Bucopro 8.75 mg pastilles are orange, round pastilles with an approximate diameter of 19±1 mm and an orange flavour.

The pastilles are presented in PVC-PVDC/Aluminium blisters in cardboard boxes or in child-resistant PVC-PVDC/Aluminium blisters in cardboard boxes.

Pack sizes: 8, 12, 16, 20 and 24 pastilles.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

Manufacturer

Lozy´s Pharmaceuticals S.L.
Campus Empresarial Lekaroz nº1
31795 Lekaroz (Navarra), Spain

Dexcel Pharma GmbH
Carl-Zeiss-Str. 2
63755 Alzenau
Germany

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Przedsiebiorstwo Produkcyjno – Handlowe “EWA” S.A.
ul.Zamkowy Folwark 9
63-700 Krotoszyn
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

ES: Bucopro 8.75 mg pastillas para chupar sabor naranja
CZ: Flurbiprofen Galenika
SK: Flurbiprofen Galenika
PL: POLOPIRYNA GARDŁO
PT: Geilozen 8.75 mg pastilhas
RO: Septazulen Portocale 8.75 mg pastile
DE: Flurbiprofen Dexcel 8.75 mg Lutschtabletten
LV: Tonzirin 8,75 mg sukajamas tabletes
BG: Septazulen Orange 8.75 mg lozenges

Date of the most recent revision of this leaflet: November 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es