BUCOPRO 8.75 mg LOZENGES ORANGE FLAVORED

2. What you need to know before using Bucopro

Do not useBucopro:

• If you are allergic to flurbiprofen or any of the other components (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, swelling of the face, or itchy rash (urticaria).
• If you have or have had stomach or intestinal ulcers (two or more episodes of gastric or duodenal ulcers).
• If you have ever had gastrointestinal bleeding or perforation, severe colitis, or blood disorders after taking NSAIDs.
• If you have or have 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 medication.

• If you have ever had asthma or allergies.
• If you have tonsillitis (inflammation of the tonsils) or think 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 any chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
• If you are an elderly patient, as you are more likely to experience the side effects described in this package leaflet.
• If you are in the first six months of pregnancy or are breastfeeding.
• If you have headache induced by analgesics.
  • If you have an infection - see the "Infections" section below.

Avoid using two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) at the same time, as this may increase the risk of side effects, particularly gastrointestinal ones such as ulcers and bleeding (see the "Using Bucopro with other medications" section).

While using this medication

• At the first sign of a skin reaction (rash, peeling,) or other sign of an allergic reaction, stop using this medication and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms that may occur (especially bleeding). Consult your doctor if they do not improve, worsen, or if new symptoms appear.
• The use of medications containing flurbiprofen may be associated with a small increased risk of suffering a heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or treatment duration indicated in this package leaflet (3 days).

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection, such as fever and pain. This may delay the start of appropriate treatment for the infection, which may lead to a greater risk of complications. If you take this medication while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.

Children and Adolescents

This medication should not be used in children and adolescents under 12 years old.

Using Bucopro with other medications.

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

• Low-dose acetylsalicylic acid (up to 75 mg per day).
• Medications for hypertension or heart failure (antihypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medications to thin the blood (anticoagulants, antiplatelet agents).
• Medications for gout (probenecid, sulfinpyrazone).
• Other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) (see the "Warnings and Precautions" section).
• Mifepristone (a medication used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Cyclosporine or tacrolimus (to suppress the immune system).
• Phenytoin (to treat epilepsy).
• Methotrexate (to treat autoimmune diseases or cancer).
• Lithium or selective serotonin reuptake inhibitors (for depression).
  • Oral antidiabetics (to treat diabetes).
  • Zidovudine (to treat HIV).

Taking Bucopro with food, drinks, and alcohol.

Alcohol consumption should be avoided during treatment with this medication, 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

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

Flurbiprofen belongs to a group of medications that may affect fertility in women. This effect is reversible when the medication is stopped. It is unlikely that occasional use of this medication can affect your chances of becoming pregnant; however, inform your doctor before taking this medication if you have problems becoming pregnant.

Driving and Using Machines

This medication should not affect your ability to drive or use machines. However, if you experience adverse reactions such as dizziness and/or visual disturbances, do not drive or use machines.

Bucoprocontainsmaltitol and isomalt

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

Caloric value: 2.3 kcal/g maltitol/isomaltose

Bucoprocontains orange yellow S (E-110) and cochineal red A (E-124).

This medication may cause allergic reactions because it contains orange yellow S (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 the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use the lowest effective dose for the shortest necessary time 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).

The recommended dose is:

Adults and children over 12 years old:

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

Method of administration:

Oral

Dissolve the lozenge slowly in the mouth, do not swallow it, and do not chew it.

Move the lozenge around in the mouth while it dissolves.

Use in children

Do not use this medication in children under 12 years old.

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

If you take more Bucopro than you should

Consult 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. You may also experience ringing in the ears, headache, and gastrointestinal bleeding.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

STOP TAKING this medication and consult a doctor immediately if you notice:

• Signs of an allergic reaction such as asthma, shortness of breath or wheezing without explanation, itching, nasal discharge, skin rashes, etc.
• Swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, decreased blood pressure that causes shock (all these effects can occur even when using the medication for the first time).
• Severe skin reactions such as peeling, blisters, or skin shedding.

Inform your doctor or pharmacist if you observe any of the following effects or any effect not described in this package leaflet:

Other side effects may also occur:

Frequent(may affect up to 1 in 10 people)

• Dizziness, headache.
• Throat irritation.
• Mouth ulcers, mouth pain.
• Sore throat.
• Unusual sensations in the mouth (feeling 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.
• Somnolence or difficulty falling asleep.
• Worsening of asthma, wheezing, shortness of breath.
• Blisters in the mouth or throat, numbness in the throat.
• Dry mouth.
• Burning sensation in the mouth, altered taste, abdominal distension.
• Abdominal pain, gas, constipation, indigestion, vomiting.
• Reduced sensitivity in the throat.
• Fever, pain.
• Skin rashes, itching of the skin.

Rare(may affect up to 1 in 1,000 people)

• Anaphylactic reaction.

Frequency not known(cannot be estimated from available data)

• Anemia, thrombocytopenia (low platelet count in the blood that can lead to bruising and bleeding).
• Swelling (edema), high blood pressure, heart failure, or heart attack.
• Severe skin reactions such as blistering reactions, including Stevens-Johnson syndrome, Lyell syndrome, and toxic epidermal necrolysis.
• Hepatitis (inflammation of the liver).

Reporting side effects

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

You can also report them directly through the Spanish Medication Surveillance System for Human Use (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bucopro

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Collection Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Bucopro Composition

The active ingredient is flurbiprofen. Each lozenge contains 8.75 mg of flurbiprofen.

The other components (excipients) are:

Isomalt (E953)

Liquid maltitol (E965)

Cochineal red (E 124)

Orange yellow (E 110)

Acesulfame potassium

Potassium hydroxide

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

Levomenthol

Product Appearance and Package Contents

Bucopro 8.75 mg lozenges are orange and round, with a diameter of approximately 19±1 mm and an orange flavor.

The lozenges are presented in PVC-PVDC/Aluminum blisters in cardboard boxes or in child-resistant PVC-PVDC/Aluminum blisters in cardboard boxes.

Package sizes: 8, 12, 16, 20, and 24 lozenges.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 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 medication is authorized in the Member States of the European Economic Area under the following names:

ES: Bucopro 8.75 mg orange-flavored lozenges

CZ: Flurbiprofen Galenika

SK: Flurbiprofen Galenika

PL: POLOPIRYNA GARDLO

PT: Geilozen 8.75 mg lozenges

RO: Septazulen Portocale 8.75 mg lozenges

DE: Flurbiprofen Dexcel 8.75 mg lozenges

LV: Tonzirin 8.75 mg lozenges

BG: Septazulen Orange 8.75 mg lozenges

Date of the last revision of this package leaflet:November 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es