Package leaflet: Information for the patient

BUSCOFENPOCKET 400 mg oral powder in sachet

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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days in adolescents or, in adults, after 4 days for pain or 3 days for fever.

Contents of this leaflet

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

1. What BUSCOFENPOCKET is and what it is used for

Ibuprofen belongs to a group of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by modifying the body's response to pain, inflammation, and elevated body temperature.
BUSCOFENPOCKET is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, and/or fever.
BUSCOFENPOCKET 400 mg is recommended for adults and adolescents with a body weight of 40 kg or more (aged 12 years and older).

2. What you need to know before taking BUSCOFENPOCKET

Do not take BUSCOFENPOCKET

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have experienced shortness of breath, asthma, runny nose, hives, or angioedema (a severe allergic reaction causing swelling of the face or throat) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
if you have previously had gastrointestinal bleeding or perforation related to prior NSAID therapy;
if you currently have or have had recurrent peptic ulcers (peptic ulcer disease) or active or recurrent bleeding in the stomach or duodenum, or if you have had repeated episodes (two or more proven episodes of ulceration or bleeding) in the past;
if you suffer from severe liver, kidney, or heart failure;
if you have a brain hemorrhage (cerebrovascular bleeding) or any other active bleeding;
if you have an unknown origin blood formation disorder, e.g., thrombocytopenia;
if you are severely dehydrated (due to vomiting, diarrhea, or insufficient fluid intake);
during the last three months of pregnancy (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking BUSCOFENPOCKET if:

you suffer from certain inherited blood disorders (e.g., acute intermittent porphyria);
you suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
you have or have previously had intestinal diseases (ulcerative colitis or Crohn's disease), as these may worsen (see section 4 “Possible side effects”);
you have reduced kidney function;
you have liver problems;
you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g., prednisolone), blood-thinning drugs (e.g., warfarin), selective serotonin reuptake inhibitors (medicines used for depression), or antiplatelet agents (e.g., acetylsalicylic acid);
you are taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as their concomitant use should be avoided;
you have heart problems, including heart failure, angina pectoris (chest pain), history of heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack, "TIA");
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke;
you suffer from allergies (e.g., skin reactions to other substances, asthma, hay fever), nasal polyps, chronic nasal mucosal swelling, or chronic obstructive respiratory diseases, as you may be at higher risk of allergic reactions;
you have recently undergone major surgery;
you have blood clotting (thickening) disorders;
if you have chickenpox, it is advisable to avoid using BUSCOFENPOCKET;
you have an infection – see section “Infections” below;
you have ever developed a fixed drug eruption (round or oval patches of redness and swelling of the skin, blisters, hives, and itching) after taking ibuprofen (see section 4).

Signs of an allergic reaction to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking BUSCOFENPOCKET immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Generally, habitual intake of (various types of) painkillers may cause serious and permanent kidney damage. This risk may be increased during physical exertion associated with loss of salts and dehydration. Therefore, such use should be avoided.
With prolonged use of BUSCOFENPOCKET, regular monitoring of liver function tests, kidney function, and blood counts is required.
Prolonged use of any type of painkiller for headaches may worsen headache symptoms. If this occurs, consult your doctor for advice and discontinue treatment with BUSCOFENPOCKET.
If you have or have previously had asthma or allergic diseases, shortness of breath may occur.
Exercise particular caution with BUSCOFENPOCKET:
Serious skin reactions
Serious skin reactions have been reported 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 BUSCOFENPOCKET and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
With ibuprofen treatment, isolated round or oval red patches and swelling of the skin, possibly accompanied by itching (fixed drug eruption), or widespread skin eruptions that may progress to blistering (generalized bullous fixed drug eruption) have been reported. Discontinue use of BUSCOFENPOCKET and consult your doctor immediately if you notice any of these symptoms.
Infections
BUSCOFENPOCKET may mask symptoms of infections such as fever and pain. Therefore, BUSCOFENPOCKET could delay appropriate treatment of the infection, 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.
The use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially at high doses. Do not exceed the recommended dose or maximum treatment duration.
Potentially fatal gastrointestinal bleeding (bleeding in the stomach or intestines), ulceration, or perforation have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, stop taking this medicine immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of ulcers, particularly if complicated by bleeding or perforation (see section 2 “Do not take BUSCOFENPOCKET”), and in elderly patients. These patients should start treatment with the lowest available dose. For these patients, as well as for those requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered. If gastrointestinal bleeding or ulceration occurs during ibuprofen treatment, discontinue treatment and consult your doctor.
The use of NSAIDs together with alcohol may worsen adverse reactions caused by the active ingredient, particularly those affecting the gastrointestinal tract or central nervous system.
If any of the conditions listed above apply to you, consult your doctor before using BUSCOFENPOCKET.
Elderly
Elderly patients taking NSAIDs are at increased risk of adverse effects, particularly those related to the stomach and intestines. For further information, see section 4 “Possible side effects”.
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any unusual abdominal symptoms (particularly bleeding in the stomach or intestines), especially during the initial stages of treatment.
Children and adolescents
There is a risk of kidney impairment in dehydrated adolescents.
BUSCOFENPOCKET 400 mg is not suitable for children under 12 years of age or adolescents weighing less than 40 kg.
Other medicines and BUSCOFENPOCKET
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
BUSCOFENPOCKET may affect or be affected by other medicines. For example:

corticosteroids (such as prednisolone), as their use may increase the risk of gastrointestinal ulceration or bleeding;
other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as these may increase the risk of gastrointestinal bleeding and ulcers;
anticoagulant medicines (i.e., those that thin the blood/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine);
antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (medicines used for depression), as their use may increase the risk of gastrointestinal bleeding;
potassium-sparing diuretics: as this may lead to hyperkalemia;
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan) and diuretics (medicines promoting fluid elimination), as NSAIDs may reduce the effectiveness of these medicines and increase the risk of kidney impairment. In this case, ensure adequate daily water intake;
methotrexate (a medicine used for cancer or rheumatism), as the effect of methotrexate may be potentiated;
tacrolimus (a medicine used to suppress immune response), due to increased risk of kidney toxicity;
cyclosporine (a medicine used to suppress immune response), as kidney damage may occur;
zidovudine (a medicine for the treatment of AIDS), as the use of BUSCOFENPOCKET may increase the risk of joint bleeding or swelling-related bleeding in HIV-positive hemophiliacs;
sulfonylureas (diabetes medicines): NSAIDs may enhance the hypoglycemic effect of sulfonylureas. As a precaution, blood sugar levels should be monitored when these medicines are used together;
probenecid and sulfinpyrazone: as excretion of ibuprofen may be delayed. Ibuprofen may reduce the effect of these medicines;
aminoglycosides (antibiotics), as NSAIDs may increase aminoglycoside plasma concentrations;
digoxin (used to strengthen the heart), phenytoin (used to treat seizures), or lithium (used to treat certain psychiatric disorders): ibuprofen may increase plasma concentrations of these medicines;
quinolone antibiotics, as their concomitant use with NSAIDs may increase the risk of seizures;
cholestyramine, as taking ibuprofen together with cholestyramine may delay or reduce ibuprofen absorption. These medicines should be administered several hours apart;
CYP2C9 inhibitors such as voriconazole and fluconazole, as taking these medicines may increase ibuprofen plasma concentrations. A reduction in ibuprofen dose should be particularly considered when high doses are administered with voriconazole or fluconazole;
mifepristone, as NSAIDs may reduce the effect of mifepristone;
bisphosphonates and pentoxifylline, as their use may increase gastrointestinal side effects and the risk of bleeding or ulceration;
herbal extracts: Ginkgo biloba may increase the risk of bleeding.

Other medicines may also affect or be affected by BUSCOFENPOCKET. Therefore,
always consult your doctor or pharmacist before taking BUSCOFENPOCKET with other medicines.
BUSCOFENPOCKET with alcohol
Alcohol intake should be avoided during treatment with ibuprofen.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you become pregnant while taking BUSCOFENPOCKET.
Do not take BUSCOFENPOCKET during the last three months of pregnancy, as it may harm the fetus or cause delivery complications. 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 labor beyond normal duration.
You should not take BUSCOFENPOCKET during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy, BUSCOFENPOCKET may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing 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.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products are excreted in breast milk. Since no harmful effects on infants have been reported to date, breastfeeding usually does not need to be interrupted during short-term use of ibuprofen at recommended doses.
Fertility
BUSCOFENPOCKET belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and using machines
When taken as recommended, ibuprofen generally has negligible influence on the ability to drive or use machinery.
However, since side effects such as fatigue, dizziness, and visual disturbances may occur with ibuprofen use, reaction ability and participation in road traffic or operating machinery may be impaired in isolated cases. This is particularly true when combined with alcohol.
BUSCOFENPOCKET contains isomaltitol (E 953)
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take BUSCOFENPOCKET

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.
This medicine is intended for short-term use only. The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The recommended dose is:
Adults and adolescents weighing 40 kg or more (aged 12 years or older)
The initial dose is 1 sachet of BUSCOFENPOCKET. If needed, an additional sachet of BUSCOFENPOCKET may be taken. The interval between doses should be determined based on symptoms and the maximum daily dose. However, the interval between doses must not be less than six hours. Do not take more than 3 sachets of BUSCOFENPOCKET in 24 hours.
Children under 12 years of age and adolescents weighing less than 40 kg
BUSCOFENPOCKET 400 mg is not indicated for children under 12 years of age and adolescents weighing less than 40 kg.
Elderly
In elderly patients, the dosage is the same as for adults, but greater caution is required.
Patients with impaired renal or hepatic function
If you have reduced renal or hepatic function, always consult your doctor before taking BUSCOFENPOCKET. Your doctor will provide appropriate advice.
Method of administration
Place the oral powder on the tongue, allow it to dissolve, then swallow; water is not required.
For patients with a sensitive stomach, it is particularly recommended to take BUSCOFENPOCKET during meals.
Duration of treatment
Adults: this medicine should not be taken for more than 4 days in case of pain or 3 days in case of fever.
Adolescents (aged 12 years or older): this medicine should not be used for more than 3 days.
If symptoms persist or worsen, or if new symptoms occur, consult your doctor.
If you take more BUSCOFENPOCKET than you should
Seek immediate medical attention in case of overdose or accidental ingestion.
If you have taken more BUSCOFENPOCKET than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice regarding the risk and recommendations on actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
If you forget to take BUSCOFENPOCKET
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 experiences them.
Side effects may be minimized by using the lowest effective dose for the shortest time necessary to relieve symptoms.
You may experience one of the known side effects of NSAIDs. If this happens, or if you have any doubts, stop taking this medicine and consult your doctor as soon as possible.
Elderly patients taking this medicine are at higher risk of developing problems associated with side effects.

Stop taking this medicine and contact a doctor immediately if you experience:

signs of gastrointestinal bleeding such as severe abdominal pain, dark, tarry-looking stools, vomiting blood or dark particles resembling coffee grounds;
signs of rare but serious allergic reactions, such as worsening asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These may occur even after the first dose of this medicine. If any of these symptoms occur, call your doctor immediately;
flat, red spots on the trunk, often with central blisters, target-shaped or circular rashes, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
widespread skin 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 (generalized pustular eruption).

Contact your doctor if you experience any of the following side effects, if they worsen, or if you notice any unlisted effect.

Common (may affect up to 1 in 10 people):

dizziness or tiredness, headache;
stomach ache, indigestion, diarrhoea, heartburn, nausea, vomiting, flatulence, constipation;
various skin rashes.

Uncommon (may affect up to 1 in 100 people):

sneezing, blocked or runny nose or nasal itching (rhinitis);
hypersensitivity reactions with skin rash and itching, and asthma attacks (possibly with low blood pressure). In this case, inform your doctor immediately and stop taking ibuprofen;
sensation of tingling or numbness, drowsiness, restlessness, irritability;
difficulty sleeping, feeling of anxiety;
urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light;
visual disturbances. In this case, inform your doctor immediately and stop taking ibuprofen;
hearing problems, dizziness or vertigo, ringing in the ears (tinnitus);
difficulty breathing, wheezing or coughing, asthma or worsening of asthma;
inflammation of the stomach lining, gastrointestinal ulcers, sometimes with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
hepatitis, yellowing of the skin or eyes, reduced liver function;
nephrotic syndrome (fluid accumulation in the body (edema) and protein in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation in the body (edema), and general malaise may be signs of kidney disease or even kidney failure. If any of the above symptoms occur, stop taking BUSCOFENPOCKET and consult your doctor immediately.

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

feeling depressed or confused;
during treatment with ibuprofen, symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or altered consciousness have been observed. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed. If such symptoms occur, contact a doctor immediately;
optic nerve damage;
kidney tissue damage (papillary necrosis), particularly with long-term treatment, and increased uric acid and blood urea levels;
fluid retention (edema).

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

worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been reported with use of certain painkillers (NSAIDs). If signs of infection occur or worsen during use of BUSCOFENPOCKET, consult a doctor immediately. It should be assessed whether anti-infective/antibiotic therapy is indicated;
blood count abnormalities – pancytopenia, anaemia, leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unusual or unexplained bruising). In such cases, treatment must be stopped immediately and a doctor consulted. Do not take any painkillers or fever-reducing medicines (antipyretics);
psychotic reactions;
high blood pressure, heart failure, heart attack;
inflammation of blood vessels;
inflammation of the pancreas and oesophagus;
diaphragm-like intestinal stenosis;
liver failure or liver damage, particularly with long-term use, presenting as yellowing of the skin and eyes, pale stools or dark urine;
in very rare cases, severe skin infections and soft tissue complications have occurred during chickenpox infection;
hair loss (alopecia);
reduced urine output and increased tissue fluid accumulation (edema), particularly in patients with high blood pressure or impaired kidney function.

Not known (frequency cannot be estimated from available data)

a widespread, red, scaly rash, with pustules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using BUSCOFENPOCKET if you develop these symptoms and contact your doctor immediately. See also section 2;
a serious 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 swelling, blisters, urticaria, itching and isolated round or oval red patches (drug-induced fixed eruption), or widespread eruptions, 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 like this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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 BUSCOFENPOCKET

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 sachet after "EXP.". The expiry date refers to the last day of that month.
Do not store above 25 °C. Keep in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BUSCOFENPOCKET contains

The active substance is ibuprofen. Each single-dose sachet contains 400 mg of ibuprofen.
The other components are: Isomaltitol (E953); citric acid; acesulfame potassium (E 950); glycerol distearate (Type I); lemon flavour 502336 TP0551 (containing maize maltodextrins, alpha tocopherol (E 307)).

Description of the appearance of BUSCOFENPOCKET and contents of the pack
BUSCOFENPOCKET is an oral powder, white or almost white in colour, with a characteristic lemon aroma.
Pack sizes: 10, 12, 18, 20, 24, 30 single-dose sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)
Manufacturer
HERMES Pharma Ges.m.b.H
Schwimmschulweg 1a
9400 Wolfsberg
Austria

Buscofenpocket