Buscoactfokus

Package leaflet: Information for the user

BUSCOACTFOKUS 400 mg + 100 mg film-coated tablets

Ibuprofen + Caffeine
For use in adults
Please read all of this leaflet carefully before you take this medicine because 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 to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet

1. What BUSCOACTFOKUS is and what it is used for
2. What you need to know before taking BUSCOACTFOKUS
3. How to take BUSCOACTFOKUS
4. Possible side effects
5. How to store BUSCOACTFOKUS
6. Contents of the pack and other information

1. What BUSCOACTFOKUS is and what it is used for

BUSCOACTFOKUS contains two active substances: ibuprofen and caffeine.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs provide relief by altering the body's response to pain.
Caffeine belongs to a group of medicines called stimulants.
BUSCOACTFOKUS is used for the short-term symptomatic treatment of moderate acute pain, such as toothache or headache.
BUSCOACTFOKUS is indicated only for use in adults.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking BUSCOACTFOKUS

Do not take BUSCOACTFOKUS:
• if you are allergic to ibuprofen, caffeine, or any of the other ingredients of this
medicinal product (listed in section 6)
• if you have ever experienced breathlessness, asthma, runny nose, swelling, or hives after taking acetylsalicylic acid (e.g. Aspirin) or other similar painkillers (NSAIDs)
• if you have (or have had two or more episodes of) stomach ulcer, duodenal ulcer, or gastrointestinal bleeding
• if you have had stomach or intestinal bleeding related to previous treatment with NSAIDs
• if you suffer from severe liver or kidney failure
• if you suffer from severe heart failure
• if you have a brain hemorrhage (cerebrovascular hemorrhage) or any other active bleeding
• if you have blood formation disorders of unknown origin
• if you are severely dehydrated (caused by vomiting, diarrhea, or insufficient fluid intake)
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking BUSCOACTFOKUS:
• if used for types of pain other than toothache or headache, the effect of BUSCOACTFOKUS may vary depending on the type of pain (e.g. benefit has not been established for back pain or neck pain)
• if you suffer or have suffered from asthma or an allergic disease, as breathlessness may occur
• if you have hay fever, nasal polyps, or chronic obstructive respiratory diseases, as you may be at higher risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's edema (angioedema), or hives
• if you have liver problems
• if you have reduced kidney function
• if you are taking medicines that interact with BUSCOACTFOKUS, such as corticosteroids, blood thinners (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression), or antiplatelet agents (such as acetylsalicylic acid (e.g. Aspirin)) (see section “Other medicines and BUSCOACTFOKUS”)
• if you suffer or have suffered from intestinal diseases (ulcerative colitis or Crohn's disease)
• if you have heart problems including heart failure, angina (chest pain), or a history of heart attack, bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack, "TIA")
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker
• if you have ever had high blood pressure and/or heart failure
• close medical monitoring is required if you have undergone major surgery
• if you suffer from coagulation disorders
• if you suffer from an inherited blood formation disorder (e.g. acute intermittent porphyria)
• if you suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease)
• if you have chickenpox, it is advisable to avoid using BUSCOACTFOKUS
• if you suffer from hyperthyroidism (the risk of caffeine side effects may be increased)
• if you have been taking medicines containing ibuprofen for a long time (regular monitoring of liver values, kidney function, and blood counts may be necessary)
• if you have an infection – see section “Infections” below
• if you develop a skin rash or skin symptoms, stop taking ibuprofen immediately, consult a doctor immediately, and inform the doctor that you are taking this medicine
• if you develop symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including skin rash, fever, swollen lymph nodes, and increased levels of a type of white blood cell (eosinophilia).

Skin reactions
Serious skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and generalized pustular eruption (AGEP).
Stop using BUSCOACTFOKUS and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Isolated round or oval red patches and swelling of the skin, possibly accompanied by itching (fixed drug eruption), or widespread skin involvement that may progress to blistering (generalized bullous fixed drug eruption), have also been reported with ibuprofen treatment.
Stop using BUSCOACTFOKUS and consult your doctor immediately if you notice any of these symptoms.

Infections
BUSCOACTFOKUS may mask symptoms of infections such as fever and pain. Therefore, BUSCOACTFOKUS could delay appropriate treatment of an infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Contact your doctor immediately if you experience:
• bright red stools (faeces), black tarry stools, vomiting blood or dark particles resembling coffee grounds
• severe pain in the upper part of the stomach

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms. Elderly patients are at higher risk of experiencing adverse effects.

Concomitant use of NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, increases the risk of adverse reactions (see section “Other medicines and BUSCOACTFOKUS”) and should be avoided.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment (3 days). While taking BUSCOACTFOKUS, you must consult/inform your doctor or dentist before undergoing any surgical procedure.

Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking BUSCOACTFOKUS immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Generally, habitual use of painkillers, especially combinations of different analgesic active substances, may lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy). This risk may increase during physical exertion associated with loss of salts and dehydration. Therefore, such use should be avoided.

Prolonged use of any type of painkiller for headache may worsen it. If this occurs or is suspected, you must consult a doctor and stop treatment.

Patients who experience eye disorders during treatment with ibuprofen must stop therapy and undergo ophthalmological examinations.

Other medicines and BUSCOACTFOKUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

BUSCOACTFOKUS may affect or be affected by other medicines. For example:
• anticoagulant medicines (i.e. those that thin the blood/prevent clotting, e.g. acetylsalicylic acid (e.g. Aspirin), warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan)

Some other medicines may also affect or be affected by treatment with BUSCOACTFOKUS. Therefore, always consult your doctor or pharmacist before using BUSCOACTFOKUS with other medicines.

In particular, inform your doctor or pharmacist if you are taking:

BUSCOACTFOKUS with food, drinks and alcohol
Some side effects, such as those affecting the gastrointestinal system and the central nervous system, may be more likely if alcohol is consumed together with BUSCOACTFOKUS. You should avoid consuming large amounts of products containing caffeine (e.g. coffee, tea, food, other medicines and beverages) together with BUSCOACTFOKUS.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Inform your doctor if you become pregnant while taking BUSCOACTFOKUS.
Do not take BUSCOACTFOKUS during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect your own and your baby's tendency to bleed and delay or prolong labour more than expected. You must not take BUSCOACTFOKUS during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, BUSCOACTFOKUS may cause kidney problems in the unborn baby, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is necessary, your doctor may recommend additional monitoring.
The active substances, ibuprofen and caffeine, pass into breast milk. Irritability and sleep disturbances have been reported in breastfed infants. BUSCOACTFOKUS should only be used by breastfeeding mothers if clearly necessary.
This medicine belongs to a group of medicines (NSAIDs) that may have negative effects on female fertility. This effect is reversible after stopping treatment.
Driving and using machines
For short-term treatment at the normal dosage, this medicine has little or no influence on the ability to drive and use machines. However, patients who experience dizziness, fatigue or visual disturbances should avoid driving vehicles or operating machinery. This is particularly important when combined with alcohol.
BUSCOACTFOKUS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take BUSCOACTFOKUS

Take this medicine exactly as stated 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:
Initial dose: Take 1 film-coated tablet (400 mg of ibuprofen and 100 mg of caffeine). If necessary, take an additional dose (1 film-coated tablet), but do not exceed a total of 3 film-coated tablets (1200 mg of ibuprofen and 300 mg of caffeine) within 24 hours. The dosing interval must not be less than 6 hours. If you feel that the effect of this medicine is stronger or weaker than expected, consult your doctor or pharmacist.
BUSCOACTFOKUS is not recommended for mild pain or if treatment exceeds 3 days.
This medicine is not intended for use in children and adolescents under 18 years of age, as data are not available.
Oral use.
Swallow the film-coated tablet whole with a glass of water.
It is advisable to take BUSCOACTFOKUS during meals, especially for individuals with a sensitive stomach.
For short-term use only.
Do not take for more than 3 days.
Consult your doctor if symptoms worsen or if you still have pain after 3 days.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
If you take more BUSCOACTFOKUS than you should
If you have taken more BUSCOACTFOKUS than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and what actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), gastrointestinal bleeding, increased heart rate, headache, tinnitus, tremor, restlessness, confusion, uncontrolled eye movements, or more rarely, diarrhoea. Additionally, at high doses, dizziness, blurred vision, low blood pressure, agitation, coma, increased blood potassium levels, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthmatic patients have been reported, as well as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties.
If you forget to take BUSCOACTFOKUS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You may experience one of the known side effects of NSAIDs (see below). If this happens, or if you have
any concerns, stop taking this medicine and contact your doctor as soon as possible. Elderly patients
taking this medicine are at higher risk of developing problems related to side effects.
With regard to the following side effects, it is important to note that they largely depend on the dose and
may vary from patient to patient.
STOP TAKING BUSCOACTFOKUS IMMEDIATELY and consult a doctor if any of the following
conditions occur, which may be possible signs of serious adverse events:

• severe stomach upset

• vomiting blood or dark particles resembling coffee grounds

• black, tarry stools or blood in the urine

• allergic reactions such as skin rashes, itching

• difficulty breathing and/or swelling of the face or throat

• fatigue accompanied by loss of appetite

• unusual tiredness together with reduced urine output

• swelling of the face, feet or legs

• chest pain

• visual disturbances

• red, flat, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome)

• widespread, red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis)

Other side effects
Common (may affect up to 1 in 10 people)

• heartburn, abdominal pain, malaise and indigestion, nausea, vomiting, intestinal gas (flatulence), diarrhoea, constipation and minor gastrointestinal bleeding which may exceptionally lead to anaemia
• dizziness, insomnia, headache

Uncommon (may affect up to 1 in 100 people)

• gastric or intestinal ulcers, sometimes with bleeding and perforation, particularly in elderly patients, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), black tarry stools, vomiting with dark particles resembling coffee grounds, worsening of colitis and Crohn’s disease. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
• restlessness, awareness of heartbeat, irritability or fatigue
• visual disturbances, psychotic reactions
• allergic reactions such as skin rashes, itching and asthma attacks. You must stop taking BUSCOACTFOKUS and inform your doctor immediately

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

• tinnitus (ringing in the ears), hearing loss
• kidney damage (papillary necrosis), increased blood levels of uric acid, increased blood urea levels

Very rare (may affect up to 1 in 10,000 people)

• swelling (oedema), high blood pressure (hypertension) and heart failure have been reported during treatment with NSAIDs

• inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestine (diaphragm-like intestinal stenosis)

• reduced urine output and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which may lead to acute kidney failure. If you experience any of these symptoms or feel generally unwell, stop taking BUSCOACTFOKUS and consult your doctor immediately, as these may be early signs of kidney damage or kidney failure

• blood cell formation disorders – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, stop treatment immediately and consult your doctor. Do not treat these symptoms with painkillers or fever-reducing medicines (antipyretics)

• depression

• worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been reported with the use of some painkillers (NSAIDs). If signs of infection appear or worsen during use of BUSCOACTFOKUS, contact your doctor immediately to determine whether anti-infective/antibiotic treatment is needed

• high blood pressure, heart failure, heart attack, vasculitis

• liver dysfunction (early signs may include skin discolouration), liver damage, especially with long-term treatment, liver failure, acute inflammation of the liver (acute hepatitis)

• symptoms of aseptic meningitis such as neck stiffness, headache, malaise, nausea, fever or confusion have been observed during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur

• severe skin reactions such as skin rashes with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia), severe skin infections and soft tissue complications during chickenpox infection

• severe generalized hypersensitivity reactions (signs may include a severe allergic reaction causing swelling of the face or throat, difficulty breathing, rapid heartbeat, drop in blood pressure, anaphylactic shock (a severe allergic reaction causing breathing difficulties or dizziness))

Not known (frequency cannot be estimated from available data)

• restlessness
• rapid heartbeat
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
• a widespread, red, scaly rash with pustule formation under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• Stop using BUSCOACTFOKUS if you develop these symptoms and contact your doctor immediately. See also section 2.
• skin becomes sensitive to light.
• isolated round or oval red patches and swelling of the skin, possibly associated with itching (fixed drug eruption), or covering a large area of the body, which may progress to blistering (generalized bullous fixed drug eruption).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines such as BUSCOACTFOKUS may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
In a study on dental extractions, some patients (2.8%) developed inflammation of the tooth extraction socket and some patients (1.4%) developed gingival inflammation after the surgical procedure.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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.

5. How to store BUSCOACTFOKUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BUSCOACTFOKUS contains
The active substances are ibuprofen and caffeine.
Each film-coated tablet contains 400 mg of ibuprofen and 100 mg of caffeine.
The other components are:
Tablet core:
Microcrystalline cellulose
Sodium croscarmellose
Anhydrous colloidal silica
Magnesium stearate
Film coating:
Hydroxypropyl methylcellulose
Hydroxypropyl cellulose
Macrogol 6000
Talc
Titanium dioxide (E171)
Description of the appearance of BUSCOACTFOKUS and pack sizes
BUSCOACTFOKUS is a white, oblong, film-coated tablet, 17.8 mm x 8.6 mm in size.
BUSCOACTFOKUS is available in blisters.
Pack sizes: 6, 10, 12, 15, 18, 20 and 24 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale Luigi Bodio 37/b
20158 Milan
Italy
Manufacturer
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Ibuprofen / Coffein Sanofi 400 mg/100 mg Filmtabletten
Bulgaria: Nospalgin 400 mg/100 mg film-coated tablets (Ношпалгин 400 mg/100 mg филмирани таблетки)
Hungary: Algoflex Duo 400 mg/100 mg filmtabletta
Italy: BUSCOACTFOKUS 400 mg + 100 mg film-coated tablets
Poland: IBU-SPA 400 mg + 100 mg tabletki powlekane
Portugal: Ibuprofeno + Cafeína Aspegic
Slovakia: Ibalgin PLUS 400 mg/100 mg filmom obalené tablet
Greece: Buscofem Extra 400 mg/100 mg επικαλυμμένα με λεπτό υμένιο δισκία