PATIENT LEAFLET: INFORMATION FOR THE USER

BuscofenAct 400 mg soft capsules

For adolescents with body weight > 40 kg (> 12 years of age) and adults.
Ibuprofen
Please read this leaflet carefully before taking 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 instructed you.

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, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms:
after 3 days in adolescents;
after 3 days in case of fever, or after 4 days for pain treatment in adults.

Contents of this leaflet:

What BuscofenAct is and what it is used for
What you need to know before taking BuscofenAct
How to take BuscofenAct
Possible side effects
How to store BuscofenAct
Contents of the pack and other information

1. WHAT BUSCOFENACT IS AND WHAT IT IS USED FOR

BuscofenAct contains the active substance ibuprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve symptoms by altering the body's response to pain and fever.
BuscofenAct is indicated for the short-term symptomatic treatment of:

mild to moderate pain, such as headache, toothache, and menstrual pain;
fever and pain associated with the common cold.

BuscofenAct is indicated for adults and adolescents weighing more than 40 kg (from 12 years of age onwards).
Consult your doctor if you do not feel better or if you feel worse:

after 3 days in adolescents;
after 3 days in case of fever, or after 4 days for pain treatment in adults.

2. WHAT YOU SHOULD KNOW BEFORE TAKING BUSCOFENACT

Do not take BuscofenAct

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have ever experienced shortness of breath, asthma, runny nose, swelling or hives after taking acetylsalicylic acid or other NSAIDs;
if you have or have had a history of recurrent stomach/duodenal ulcers (peptic ulcer) or bleeding (two or more distinct episodes of proven ulceration or bleeding);
if you have had a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
if you suffer from severe heart failure;
if you suffer from severe liver failure or severe kidney failure;
if you suffer from cerebrovascular haemorrhage or other haemorrhages;
if you have haematological disorders of unknown origin;
if you are severely dehydrated (due to vomiting, diarrhoea or low fluid intake);
if you are in the last trimester of pregnancy. Do not use BuscofenAct in adolescents with body weight < 40 kg and in children under 12 years of age due to the high content of active ingredient.

Warnings and precautions
You should discuss treatment with your doctor or pharmacist before taking BuscofenAct:

if you suffer or have suffered from asthma or allergic diseases, as shortness of breath may occur;
if you have liver disorders;
if you have reduced kidney function;
if you have or have ever had intestinal disorders (ulcerative colitis or Crohn's disease);
if you have heart problems including heart attack, angina (chest pain), or if you have had a myocardial infarction, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-stroke" or "TIA", transient ischaemic attack);
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 suffer from certain skin conditions (Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease);
if you have any hereditary disorder related to blood cell production (acute intermittent porphyria);
if you have had high blood pressure and/or heart failure;
if you have undergone major surgery. In this case, medical supervision is particularly required;
if you suffer from hay fever, nasal polyps or chronic obstructive respiratory diseases, as in such cases the risk of allergic reactions is increased. Allergic reactions may manifest as asthma attacks (so-called "analgesic-induced asthma"), Quincke's oedema or urticaria;
if you have a chickenpox infection, it is advisable to avoid using BuscofenAct;
if you suffer from coagulation disorders;
in cases of prolonged administration of BuscofenAct, periodic monitoring of liver function, kidney function and blood count is necessary;
concomitant use of NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see section “Taking BuscofenAct with other medicines”) and should be avoided;
if you have an infection – see section “Infections” below;
if you develop a skin rash or cutaneous 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 rash, fever, swollen lymph nodes and increased levels of a type of white blood cells (eosinophilia).

Skin reactions
Serious skin reactions have been reported in association with ibuprofen treatment, including
exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using BuscofenAct and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
In association with ibuprofen treatment, isolated round or oval red patches and swelling of the skin have been reported, possibly accompanied by itching (fixed drug eruption), or eruptions covering a large area of the body, which may progress to blistering (generalized bullous fixed drug eruption). Discontinue use of BuscofenAct and consult your doctor immediately if you notice any of these symptoms.

Infections
BuscofenAct may mask symptoms of infections such as fever and pain. Therefore, BuscofenAct may delay appropriate treatment of the infection, which could increase 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, seek medical advice immediately.
These adverse effects can be minimized by using the lowest effective dose for the shortest duration of treatment. Elderly patients are at higher risk of adverse effects.
In general, habitual use of analgesics may lead to permanent kidney damage. This risk may be increased during physical exertion associated with loss of salts and dehydration. Therefore, this should be avoided.
Prolonged use of any type of painkiller for headache may lead to worsening of headache. If this occurs or is suspected, inform your doctor and discontinue treatment.
Medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite (or because of) regular use of headache medications.
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
Signs of an allergic reaction to this medicine, including respiratory problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen.
Stop BuscofenAct immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
If you think any of the above conditions apply to you, consult your doctor before using BuscofenAct.

Children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.
Do not use BuscofenAct in adolescents with body weight < 40 kg and in children under 12 years of age due to the high content of active ingredient.

Taking BuscofenAct with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
BuscofenAct may affect or be affected by other medicines. For example:

medicines with anticoagulant effect (i.e. substances that thin the blood and prevent clot formation, e.g. acetylsalicylic acid, warfarin, ticlopidine);
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Other medicines may also affect or be affected by treatment with BuscofenAct. Therefore, always consult your doctor or pharmacist before using BuscofenAct with other medicines.
In particular, inform your doctor or pharmacist if you are taking:
Acetylsalicylic acid or other NSAIDs, as this may increase the risk of gastrointestinal ulcers
(anti-inflammatory and analgesic drugs) or bleeding;
Digoxin (for heart failure), as the effect of digoxin may be enhanced;
Glucocorticoids (cortisone-containing drugs or substances similar to cortisone), as this may increase the risk of gastrointestinal ulcers or bleeding;
Antiplatelet agents, as this may increase the risk of bleeding;
Acetylsalicylic acid (at low dose), as the effect on platelet aggregation may be compromised;
Anticoagulants (such as warfarin), as ibuprofen may enhance the effects of these drugs;
Phenytoin (for epilepsy), as the effect of phenytoin may be enhanced;
Selective serotonin reuptake inhibitors (medicines used for depression), as this may increase the risk of gastrointestinal bleeding;
Lithium (a medicine for manic-depressive disorders and depression), as the effect of lithium may be enhanced;
Probenecid and sulfinpyrazone (gout medications), as excretion of ibuprofen may be delayed;
Medicines for high blood pressure and diuretics, as ibuprofen may reduce the effects of these drugs and there may be an increased risk to the kidney;
Potassium-sparing diuretics, as these may lead to hyperkalaemia;
Methotrexate (a medicine for cancer or rheumatism), as the effect of methotrexate may be enhanced;
Tacrolimus and cyclosporine (immunosuppressants), as kidney damage may occur;
Zidovudine (a medicine for treatment of HIV/AIDS), as use of BuscofenAct may lead to an increased risk of bleeding at joints or swelling in HIV-positive haemophiliacs;
Sulfonylureas (antidiabetic drugs), as possible interactions may occur;
Quinolone antibiotics;
CYP2C9 inhibitors,
as the risk of seizures may be increased;
Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (a substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased exposure to S(+)-ibuprofen by approximately 80% to 100% was observed. Dose reduction of ibuprofen should be considered when co-administered with strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole and fluconazole;
Mifepristone (for termination of pregnancy): Ibuprofen may reduce the effect of mifepristone.

Taking BuscofenAct with food, drinks and alcohol
Take the capsules with water. Patients with gastric problems are advised to take BuscofenAct with food. If taken shortly after eating, the onset of action of BuscofenAct may be delayed. If this occurs, do not take BuscofenAct more frequently than recommended in the section “How to take BuscofenAct” or before the correct interval between doses has passed.
Some adverse effects, such as those affecting the gastrointestinal system or central nervous system, may occur more frequently when alcohol is consumed concomitantly with BuscofenAct.

Pregnancy and breastfeeding
Inform your doctor if you become pregnant while taking BuscofenAct.
Do not take BuscofenAct during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take BuscofenAct during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to become pregnant, 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, BuscofenAct may cause kidney problems in the fetus, which may 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 is required for more than a few days, your doctor may recommend additional monitoring.
The drug passes into breast milk but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
This product belongs to a class of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the drug.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
When used for short-term treatment and at the recommended dosage, this medicine does not affect or has negligible impact on the ability to drive and use machines. If you experience adverse effects such as fatigue or dizziness, do not drive or operate machinery. Alcohol consumption increases the risk of these adverse effects.

BuscofenAct contains sorbitol
This medicine contains 95.94 mg of sorbitol in each capsule.
Sorbitol is a source of fructose. If your doctor has diagnosed you with intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which a person cannot metabolize fructose, talk to your doctor before taking or receiving this medicine.

3. HOW TO TAKE BUSCOFENACT

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the standard dose is:
Adults and adolescents with body weight > 40 kg (aged 12 years and older):
Initial dose: take 400 mg of ibuprofen (1 soft capsule); if needed, take an additional dose of 400 mg of ibuprofen (1 soft capsule), but do not exceed the total dose of 1200 mg of ibuprofen (3 soft capsules) within 24 hours.
The interval between doses must not be less than 6 hours.
Consult your doctor or pharmacist if you feel the effect of this medicine is stronger or weaker than expected.

Use in adolescents
If use of the medicine is required for more than 3 days in adolescents with body weight above 40 kg (aged 12 years and older), or if symptoms persist or worsen, consult a doctor.

Method of administration
For oral use.
Do not chew the capsules.

Duration of treatment
Only for short-term treatment.
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 are an adult, BuscofenAct must not be used for more than 3 days for fever or for more than 4 days for pain treatment. If symptoms persist or worsen, consult your doctor.

If you take more BuscofenAct than you should
If you have taken more BuscofenAct than you should, or if your child has accidentally taken this medicine, contact your doctor or the nearest hospital immediately to obtain advice on the risk and actions to take.
Symptoms of overdose may include: nausea, vomiting (possibly with traces of blood), stomach ache and abdominal pain, gastrointestinal bleeding, headache, dizziness, tinnitus, confusion and uncontrolled eye movements, liver dysfunction and kidney dysfunction, low blood pressure and bluish discoloration of the skin and mucous membranes (cyanosis).
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing problems have been reported.

If you have further questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience any of the following known adverse effects of NSAIDs, or if you have any doubts, stop taking this medicine and consult your doctor as soon as possible. Elderly patients are at higher risk of developing problems associated with adverse effects.
Stop taking BuscofenAct immediately and contact your doctor if any of the following conditions occur, as they may indicate serious adverse events:

severe stomach problems, burning sensation or abdominal pain;
vomiting blood or material resembling coffee grounds;
black stools or blood in the urine;
skin reactions such as itchy rashes;
difficulty breathing and/or swelling of the face or throat;
fatigue associated with loss of appetite;
sore throat associated with mouth ulcers, fatigue, and fever;
heavy nosebleeds and skin bleeding;
unusual fatigue associated with reduced urine output;
swelling of the face, feet, or legs;
chest pain;
vision disturbances;
flat, non-elevated reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. 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 early in treatment (generalized exanthematous pustulosis).

Inform your doctor if you experience any of the following adverse effects, if they worsen, or if you notice any unlisted adverse effect.
Frequency common (may affect up to 1 in 10 people)

gastrointestinal disorders such as heartburn, abdominal pain, nausea and indigestion, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding which may exceptionally lead to anemia.

Frequency uncommon (may affect up to 1 in 100 people)

gastrointestinal ulcers, sometimes with bleeding and perforation, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease;
disorders of the central nervous system such as headache, dizziness, insomnia, agitation, irritability or fatigue;
vision disturbances;
various skin rashes;
allergic reactions such as skin rashes, itching, and asthma attacks (possibly with a drop in blood pressure). Discontinue treatment with BuscofenAct and inform your doctor immediately.

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

tinnitus (ringing in the ears);
kidney damage (papillary necrosis) and elevated blood uric acid levels.

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

swelling (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment;
inflammation of the esophagus or pancreas, development of intestinal strictures in the small and large intestine (in the form of diaphragmatic and intestinal stenosis);
severe skin infections and soft tissue complications have occurred during varicella infection;
reduced urine output and swelling (especially in patients with high blood pressure or impaired kidney function), edema, and cloudy urine (nephrotic syndrome), inflammatory kidney diseases (interstitial nephritis) which may lead to acute kidney failure. If any of the above symptoms occur or if you feel generally unwell, stop taking BuscofenAct and consult your doctor immediately, as these could be early signs of kidney damage or kidney failure;
disorders in blood cell production. Early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, discontinue treatment immediately and consult your doctor. Do not self-medicate with painkillers or antipyretics;
psychotic reactions and depression;
worsening of infections-related inflammation (e.g., necrotizing fasciitis) has been observed with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen during use of BuscofenAct, consult your doctor immediately. Antibiotic therapy should be considered;
hypertension (high blood pressure), vasculitis, palpitations, heart failure, heart attack;
liver dysfunction (an early sign may be yellowing of the skin), liver damage—especially during long-term treatment—liver failure, acute inflammation of the liver (acute hepatitis);
symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, and altered consciousness have been observed with ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur;
severe skin reactions, such as rashes with redness and blister formation (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome), hair loss (alopecia);
severe generalized hypersensitivity reactions.

Frequency not known (cannot be estimated from available data)

a widespread, red, scaly rash with pustule formation under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized exanthematous pustulosis). Stop using BuscofenAct if you develop these symptoms and contact your doctor immediately. See also section 2.
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);
skin becomes sensitive to light;
round or oval red patches and swelling of the skin, possibly associated with itching (fixed drug eruption), or widespread over the body and possibly complicated by blister formation (generalized bullous fixed drug eruption);
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. Medicines such as BuscofenAct may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BUSCOFENACT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What BuscofenAct contains
The active substance is ibuprofen.
Each soft capsule contains 400 mg of ibuprofen.
The other components are:
Capsule contents
Macrogol 600
Potassium hydroxide
Purified water
Capsule shell
Gelatin
Liquid sorbitol
Purified water
Printing ink
Ingredients of Opacode WB black NS-78-17821:
Black iron oxide (E172)
Propylene glycol (E1520)
Hypromellose 6 cP

Description of the appearance of BuscofenAct and contents of the package
BuscofenAct is a transparent, soft gelatin capsule, pale yellow in colour and oval-shaped, 16-18 mm in length, with the logo “B400” printed in black ink.
BuscofenAct is available in blisters made of triplex (PVC/PE/PVDC) and aluminium.
Pack sizes: 6, 12 and 20 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan
Italy

Manufacturer
Opella Healthcare Poland Sp.z o.o.
Oddzial w Rzeszowie
ul. Lubelska 52
35-233 Rzeszów
Poland

This medicinal product is authorized in the EEA Member States under the following names:
Germany: Ibuprofen Sanofi 400 mg Weichkapseln
Italy: BuscofenAct 400 mg soft capsules

Buscofenact