Bucopro Spray 8.75 mg/dose solution for oral spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bucopro spray 8.75 mg/dose solution for oral spray

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

Follow exactly the instructions for administration of this medicine provided in this leaflet or as directed 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, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

Contents of the leaflet

1. What Bucopro spray is and what it is used for
2. What you need to know before using Bucopro spray
3. How to use Bucopro spray
4. Possible adverse effects
5. How to store Bucopro spray
6. Contents of the pack and other information

1. What Bucopro spray is and what it is used for

The active substance is flurbiprofen. Bucopro spray belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which work by modifying the body's response to pain, inflammation, and fever.

Bucopro spray is used for the short-term relief of sore throat symptoms such as irritation, pain, difficulty swallowing, and inflammation, in adults over 18 years of age.

2. What you need to know before using Bucopro spray

Do not use Bucopro spray

• if you are allergic to flurbiprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid, e.g., asthma, wheezing, itching, nasal discharge, rash, swelling.
• if you currently have or have previously had two or more episodes of stomach ulcers or gastrointestinal bleeding or intestinal ulcers.
• if you have had severe colitis (intestinal inflammation).
• if you have ever had blood clotting disorders or bleeding problems after taking NSAIDs.
• if you are in the last trimester of pregnancy.
• if you have severe heart, kidney, or liver failure.
• if you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Bucopro spray if:

• You are already taking another non-steroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid.
• You have tonsillitis (inflamed tonsils) or suspect you may have a bacterial throat infection (as you may need antibiotics).
• You are an elderly patient (as you may be more likely to experience adverse effects).
• You have or have had asthma or allergies.
• You have a skin disease called systemic lupus erythematosus or mixed connective tissue disease.
• You have high blood pressure (hypertension).
• You have had an intestinal disease (ulcerative colitis, Crohn's disease).
• You have heart, kidney, or liver problems.
• You have had a stroke.
• You are in the first 6 months of pregnancy or are breastfeeding.
• You have an infection – see the section "Infections" below.

While using Bucopro spray:

• At the first sign of a skin reaction (rash, peeling, blistering) 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 experience (especially bleeding).
• If your symptoms do not improve, worsen, or new symptoms appear, consult your doctor.
• Medicines such as flurbiprofen may be associated with a slight increase in the risk of myocardial infarction or stroke. The risk is greater when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment (see section 3).

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 by children or adolescents under 18 years of age.

Using Bucopro spray with other medicines

Tell 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. Specifically:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors for pain and inflammation, as these may increase the risk of gastrointestinal bleeding.
• Warfarin, acetylsalicylic acid, and other anticoagulant medicines.
• ACE inhibitors, angiotensin-II antagonists (medicines that lower blood pressure).
• Diuretics, including potassium-sparing diuretics.
• Selective serotonin reuptake inhibitors (SSRIs) for depression.
• Digitalis agents (for heart problems) such as digoxin.
• Cyclosporine (to prevent organ rejection after transplantation).
• Corticosteroids (to reduce inflammation).
• Lithium (for mood disorders).
• Methotrexate (for psoriasis, arthritis, and cancer).
• Mifepristone (used to induce abortion); NSAIDs should not be used within 8–12 days after taking mifepristone, as they may reduce its effect.
• Oral antidiabetic agents.
• Phenytoin (for epilepsy).
• Probenecid and sulfinpyrazone (for gout and arthritis).
• Quinolone antibiotics (for bacterial infections) such as ciprofloxacin or levofloxacin.
• Tacrolimus (an immunosuppressant used after organ transplantation).
• Zidovudine (for HIV infection).

Using Bucopro spray with food and drinks

Do not consume alcohol 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 not known whether the same risk applies with Bucopro spray.

Pregnancy

Do not use this medicine if you are in the last trimester of pregnancy.

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

Breastfeeding

Do not use this medicine if you are breastfeeding.

Fertility

Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible upon discontinuation of the medicine. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant; however, inform your doctor before using 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, dizziness, drowsiness, and visual disturbances are possible adverse effects of NSAIDs. If you experience these effects, do not drive or operate machinery.

Bucopro spray contains ethanol

This medicine contains a small amount of ethanol (alcohol), less than 100 mg per dose (3 sprays).

3. How to use Bucopro spray

Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

The recommended dose is:

Adults from 18 years of age: apply a dose of 3 sprays administered to the back of the throat every 3–6 hours as needed, up to a maximum of 5 doses within a 24-hour period.

One dose (3 sprays) contains 8.75 mg of flurbiprofen.

Use in children and adolescents

This medicine must not be administered to children and adolescents under 18 years of age.

For oral use only.

• Spray only at the back of the throat.
• Do not inhale during spraying.
• Do not apply more than 5 doses (15 sprays) in 24 hours.

Bucopro spray is intended for short-term use only.

The lowest effective dose should be used for the shortest duration 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). In case of oral irritation, treatment with flurbiprofen should be discontinued.

Do not use this medicine for more than 3 days unless otherwise directed by your doctor.

If symptoms do not improve, worsen, or new symptoms appear, consult your doctor or pharmacist.

Preparation of the spray pump

When using the spray pump for the first time (or after storing the medicine for a long time), shake the container and prime the spray pump.

Point the nozzle away from you and spray at least 4 times until a fine, uniform mist is produced. The spray pump is now primed and ready for use. If the medicine has not been used for some time, point the nozzle away from you and spray at least once to ensure a fine, uniform mist is produced. Before administering the medicine, always ensure that a fine, uniform spray is generated.

How to administer the spray

Hold the bottle in an upright position with the nozzle directed towards the back of the throat.

Press the spray pump 3 times, with a quick and continuous motion, making sure to press it fully down with each spray, and remove your finger from the top of the pump between each spray.

Do not inhale during spraying.

If you use more Bucopro spray than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include: nausea, vomiting, stomach pain, or more rarely, diarrhea. You may also experience tinnitus (ringing in the ears), headache, and gastrointestinal bleeding.

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 USING this medicine and consult a doctor immediately if you experience:

• Signs of an allergic reaction, such as asthma, wheezing or unexplained difficulty breathing, itching, runny nose or rash.
• Swelling of the face, tongue or throat causing difficulty breathing, palpitations and drop in blood pressure leading to circulatory shock (all of these effects may occur even with the first use of this medicine).
• Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, flaking or ulcers on the skin and mucous membranes.

Other adverse effects may also occur:

Tell your doctor or pharmacist if you notice any of the following adverse effects, or any effect not described in this leaflet:

Frequent (may affect up to 1 in 10 people)

• dizziness, headache
• sore throat
• mouth ulcers, pain or numbness in the mouth
• sore throat
• discomfort (sensation of heat, burning or tingling) in the mouth
• nausea and diarrhoea
• skin prickling and itching

Uncommon (may affect up to 1 in 100 people)

• somnolence
• blistering in the mouth or throat, throat numbness
• abdominal swelling and pain, gas, constipation, indigestion, vomiting
• dry mouth
• burning sensation in the mouth and altered taste sensation
• skin rashes and itching
• fever, pain
• sensation of numbness or difficulty falling asleep
• worsening of asthma, wheezing, difficulty breathing
• reduced throat sensitivity

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

• anaphylactic reaction

Frequency not known (cannot be estimated from the 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 myocardial infarction
• severe forms of skin reactions, including blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (rare diseases due to serious adverse reactions to medicines or infections, in which a severe reaction of the skin or mucous membranes occurs)
• hepatitis (inflammation of the liver)

Reporting of adverse effects

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

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

Do not use this medicine after the expiry date stated on the bottle and blister pack. The expiry date (EXP) refers to the last day of the month indicated.

Do not refrigerate or freeze.

Do not use this medicine for more than 1 month after first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bucopro spray:

The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen. One spray contains 2.91 mg of flurbiprofen. One millilitre of oral spray solution contains 17.16 mg of flurbiprofen.

The other components are:

Betadex (E459)

Hydroxypropyl betadex

Disodium phosphate dodecahydrate

Citric acid

Sodium hydroxide

Cherry flavour

Sodium saccharin (E954)

Purified water

Qualitative composition of cherry flavour:

Flavouring substance(s)

Flavouring preparation(s)

Ethanol

Glycerol triacetate (E1518)

Propylene glycol (E1520)

Ascorbic acid (E300)

DL-α-tocopherol (E307)

Water

Appearance of the product and contents of the container

Bucopro spray 8.75 mg oral spray solution is a clear, colourless solution with cherry flavour and odour.

This medicine is presented in a plastic bottle containing the solution, fitted with a dispenser equipped with a mechanical pump spray.

Each bottle contains 15 ml of solution, providing 88 sprays.

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorium Sanitatis

P.T. Alava

Calle Leonardo Da Vinci, 11

01510 Miñano (Álava)

Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

This medicinal product is authorised in the EEA Member States under the following names:

Portugal: Mentocaína Spray

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