Neo Borocillina inflammation and pain: detailed information

Patient Information Leaflet

Neo Borocillina Inflammation and Pain 400 mg oral solution granules

ibuprofen
Please read all of 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.

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 your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

1. What Neo Borocillina Infiammazione e Dolore is and what it is used for

Neo Borocillina Infiammazione e Dolore contains the active substance ibuprofen, which belongs to the class of medicines known as non-steroidal anti-inflammatory and anti-rheumatic drugs (NSAIDs). It works by reducing pain (analgesic action) and inflammation (anti-inflammatory action), and by lowering body temperature in case of fever (antipyretic action).
Neo Borocillina Infiammazione e Dolore is used to treat:

pains of various origin and nature:
sore throat associated with pharyngitis, pharyngo-tonsillitis, and post-tonsillectomy (surgical removal of the tonsils)
headache
toothache
neuralgia
bone, joint, and muscle pain (musculoskeletal pain)
menstrual pain
symptoms of fever and influenza.

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment, if the condition recurs repeatedly, or if you have noticed any recent change in its characteristics.

2. What you need to know before taking Neo Borocillina Inflammation and Pain

Do not take Neo Borocillina Inflammation and Pain:

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to acetylsalicylic acid or to other medicines used to relieve pain (analgesics), reduce fever (antipyretics), or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs)
if you have experienced an allergic reaction after taking acetylsalicylic acid or other NSAIDs, with narrowing of the bronchi (bronchospasm), or associated with inflammation and constriction of the airways (asthma), nasal congestion (rhinitis), or skin rash (urticaria)
if you have a severe or active stomach and/or intestinal ulcer (gastroduodenal ulcer), or other stomach diseases (gastropathies)
if you have had gastrointestinal bleeding and/or perforation after previous treatment with other medicines
if you have had repeated episodes of gastrointestinal bleeding or ulcers (peptic hemorrhage/ulcer) (two or more distinct episodes of confirmed ulceration or bleeding)
if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency)
if you suffer from severe heart disorders (severe heart failure)
if you are in the last three months of pregnancy or if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility")
if the patient is a child under 12 years of age
if you have phenylketonuria, because this medicine contains aspartame and may be harmful to people with phenylketonuria (see section "Warnings and precautions")
if you have lost a large amount of fluids (severe dehydration) due to vomiting, diarrhea, or insufficient fluid intake.

Warnings and precautions
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see the paragraphs below on gastrointestinal and cardiovascular risks).
Talk to your doctor or pharmacist before taking Neo Borocillina Inflammation and Pain:

if you are elderly, as this may increase the risk of adverse reactions to NSAIDs, gastrointestinal bleeding, and stomach and/or intestinal perforation, which can be fatal
if you have high blood pressure and/or heart failure, as fluid retention, hypertension, and edema have been reported during treatment with NSAIDs
if you are taking other medicines such as oral anti-inflammatory drugs (oral corticosteroids), blood thinners like warfarin, or antiplatelet agents (e.g. acetylsalicylic acid), or antidepressants (serotonin reuptake inhibitors), as these may increase the risk of bleeding or ulceration
if you are taking other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors
if you have heart problems, including heart attack, angina (chest pain), history of heart attack, coronary 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 TIA, transient ischemic attack)
if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke
if you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines
if you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), sinus inflammation (sinusitis), or have allergies or a history of allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or skin and throat swelling (angioedema), especially if you have previously had allergic reactions to other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs)
if you have an infection – see the section “Infections” below.

Take this medicine with caution:

if you are a woman planning a pregnancy (see section “Pregnancy, breastfeeding and fertility”)
if you are a woman with fertility problems or undergoing fertility investigations, as you should discontinue treatment with Neo Borocillina Inflammation and Pain
if you have had a stomach ulcer, especially if complicated by bleeding or perforation, you should start with the lowest dose of Neo Borocillina Inflammation and Pain (see section “Do not take Neo Borocillina Inflammation and Pain”). As a precaution, your doctor may prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors
if you have suffered or suffer from gastrointestinal diseases such as ulcerative colitis or Crohn's disease, as these conditions may worsen
if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events
if you have lost a significant amount of fluids, or if you develop swelling, heart problems, or high blood pressure
if you have reduced kidney function, heart or liver dysfunction, or if you are elderly or taking medicines for high blood pressure, as you may be more prone to kidney problems. In addition, habitual concomitant use of multiple painkillers may further increase this risk
if you have a blood clotting disorder or are taking anticoagulant medicines (see section “Other medicines and Neo Borocillina Inflammation and Pain”)
if you suffer from a disease affecting multiple organs and tissues (systemic lupus erythematosus) or connective tissue disease (e.g. in bones and cartilage), as rare cases of "aseptic meningitis" have been observed in patients treated with ibuprofen. Although aseptic meningitis is more likely in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without chronic concomitant diseases
if you are taking medicines for pain, heart conditions, or high blood pressure (see section “Other medicines and Neo Borocillina Inflammation and Pain”)

Anti-inflammatory/pain-relief 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 duration of treatment. Discontinue treatment and contact your doctor if, during treatment with Neo Borocillina Inflammation and Pain, you experience:

gastrointestinal bleeding or ulceration. During treatment with NSAIDs, including ibuprofen, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal, and may happen at any time during treatment, with or without warning symptoms or previous history of serious gastrointestinal events. If you experience unusual stomach or intestinal symptoms, or gastrointestinal bleeding, especially at the beginning of treatment, stop taking the medicine and consult your doctor.

Infections
Neo Borocillina Inflammation and Pain may mask symptoms of infection such as fever and pain. Therefore, treatment with Neo Borocillina Inflammation and Pain may 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.

Skin reactions
Serious skin reactions have been reported with Neo Borocillina Inflammation and Pain. Stop taking Neo Borocillina Inflammation and Pain and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, especially within the first month of treatment, as these may be early signs of a very serious, potentially fatal skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis) (see section 4).

Medicines such as Neo Borocillina Inflammation and Pain may:

cause kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, or renal failure); therefore, your doctor may monitor your kidney function during prolonged use, especially in patients with systemic lupus erythematosus
cause eye disorders; therefore, periodic ophthalmological examinations are recommended during long-term treatment. If you experience vision disturbances, stop treatment with Neo Borocillina Inflammation and Pain.

Children and adolescents
Neo Borocillina Inflammation and Pain must not be administered to children under 12 years of age.
In dehydrated adolescents, there is a risk of impaired kidney function.

Elderly patients
Elderly patients have a higher risk of adverse reactions, especially gastrointestinal bleeding and perforation, which are usually more severe and may be fatal.
If you are elderly, you should take the lowest dose of Neo Borocillina Inflammation and Pain.
As a precaution, your doctor may prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.

Other medicines and Neo Borocillina Inflammation and Pain
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Consult your doctor if you are taking:

anticoagulant medicines (i.e. substances that thin the blood and prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan)
diuretics (medicines used to lower blood pressure)
corticosteroids (anti-inflammatory medicines)
antidepressants such as selective serotonin reuptake inhibitors (medicines for depression)
acetylsalicylic acid, COX-2 inhibitors, or other NSAIDs (medicines used to treat inflammation), as these may increase possible side effects, particularly those affecting the stomach and intestine
lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to have blood tests
methotrexate, a medicine used to treat cancer or rheumatoid arthritis
moclobemide, a medicine used to treat depression
aminoglycosides (antibiotic medicines)
cardiac glycosides (medicines used to treat certain heart conditions). Medicines such as Neo Borocillina Inflammation and Pain may worsen heart disease
cholestyramine (a medicine used to lower blood lipids)
cyclosporine (a medicine used after organ transplantation), as medicines such as Neo Borocillina Inflammation and Pain may increase the risk of kidney damage
herbal extracts such as Ginkgo biloba, as taking them together with medicines like Neo Borocillina Inflammation and Pain may increase the risk of gastrointestinal bleeding
mifepristone (a medicine used in women to induce abortion)
quinolone antibiotics (medicines used to treat infections), as taking them together with medicines like Neo Borocillina Inflammation and Pain may increase the risk of seizures
sulfonylureas (medicines used to treat diabetes); if concomitant treatment is necessary, your doctor may order blood tests
tacrolimus (a medicine used to prevent and treat organ transplant rejection); concomitant administration with Neo Borocillina Inflammation and Pain may increase the risk of kidney damage
zidovudine and ritonavir (medicines used to treat AIDS); if concomitant treatment is necessary, your doctor may order blood tests
probenecid (a medicine used to treat gout)
CYP2C9 inhibitors such as voriconazole and fluconazole (medicines used to treat fungal infections)
bisphosphonates (medicines used to treat bone diseases), as they may increase gastrointestinal side effects
oxpentifylline (a medicine used to treat leg ulcers), as it may increase gastrointestinal side effects
baclofen (a medicine used to relax muscles)

Other medicines may also affect or be affected by treatment with Neo Borocillina Inflammation and Pain. Therefore, always consult your doctor or pharmacist before using Neo Borocillina Inflammation and Pain with other medicines.

Neo Borocillina Inflammation and Pain and alcohol
Do not drink alcohol during treatment with Neo Borocillina Inflammation and Pain, as it may increase possible side effects, especially those affecting the gastrointestinal tract or central nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Neo Borocillina Inflammation and Pain may negatively affect pregnancy and/or embryonic/fetal development.

Pregnancy
During the first and second trimesters of pregnancy, Neo Borocillina Inflammation and Pain should not be used unless strictly necessary and under medical supervision. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible duration should be used.
Do not take Neo Borocillina Inflammation and Pain during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause lung, kidney, and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor.
From week 20 of pregnancy, Neo Borocillina Inflammation and Pain may cause kidney problems in the fetus if taken for more than a few days, reducing the level of amniotic fluid 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
Ibuprofen passes into breast milk; therefore, do not take Neo Borocillina Inflammation and Pain if you are breastfeeding.

Fertility
If you have difficulty becoming pregnant or are undergoing fertility investigations, discontinue use of Neo Borocillina Inflammation and Pain, as this medicine may temporarily impair fertility.

Driving and using machines
Neo Borocillina Inflammation and Pain does not impair the ability to drive or use machinery.
However, you should exercise caution if performing activities requiring alertness, and during treatment, be aware of possible drowsiness, dizziness, or depression.

Neo Borocillina Inflammation and Pain contains sucrose, aspartame, sodium, and potassium
Neo Borocillina Inflammation and Pain 400 mg granules for oral solution contain:

Sucrose: If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 2.1 g of sucrose (sugar) per sachet. This should be considered in patients with diabetes mellitus.
Aspartame: This medicine contains 50 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body's inability to properly metabolize it.
Sodium: This medicine contains 45 mg of sodium (main component of table salt) per sachet: This corresponds to 2.25% of the maximum recommended daily dietary intake for an adult.
Potassium: This medicine contains 94 mg of potassium per sachet. This should be considered in patients with reduced kidney function or those on a low-potassium diet.

3. How to take Neo Borocillina Inflammation and Pain

Take this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 (for example, fever and pain)
persist or worsen (see section 2).
Adults and adolescents aged 12 years and older

The recommended dose is 1 sachet, 2–3 times a day. Take the medicine with food. Dissolve the contents of one sachet in a glass of water, stirring with a teaspoon until fully dissolved, and drink the solution immediately after preparation.
Do not exceed 3 sachets per day.
If you are elderly, use the lowest possible dose.

Consult your doctor:

if the patient is an adolescent aged between 12 and 18 years who has taken Neo Borocillina Inflammation and Pain for 3 days and further treatment is needed
if, after 3 days of treatment, you notice a worsening of the illness symptoms.

If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you. If you have severe liver disease (severe hepatic insufficiency), do not take Neo Borocillina Inflammation and Pain.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible time (see section “Warnings and precautions”).
If you take more Neo Borocillina Inflammation and Pain than you should
If you have taken more Neo Borocillina Inflammation and Pain than recommended, or if your child has accidentally ingested this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), abdominal pain, headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, deep sleep with reduced response to normal stimuli (lethargy), chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold, breathing difficulties, uncontrolled body movements (seizures), and loss of consciousness may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, the following may occur: lowering of body temperature (hypothermia), kidney-related effects, bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, disorientation, excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia) may also occur.
If you take significantly high doses of ibuprofen, you may experience severe kidney and liver damage.
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
If you forget to take Neo Borocillina Inflammation and Pain
Do not take a double dose to make up for the missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you develop an ulcer, bleeding of the stomach and/or intestine, or skin and/or mucosal lesions, you must stop treatment with Neo Borocillina Infiammazione e Dolore and consult your doctor. These side effects usually occur more frequently in elderly patients.
The use of Neo Borocillina Infiammazione e Dolore may cause side effects, generally mild or moderate, or more serious allergic-type reactions, although rarely.
If you experience any of the following symptoms, STOP using Neo Borocillina Infiammazione e Dolore IMMEDIATELY and consult your doctor or go to the nearest hospital, where you will receive appropriate and specific treatment:

skin rashes or lesions
mucosal lesions
signs of allergic reaction, even severe (erythema, itching, urticaria, skin blisters, asthma, breathing difficulties, rapid heartbeat, swelling of the skin and mucous membranes, anaphylactic shock)
severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome)
visual disturbances
yellowing of the skin (jaundice)
bleeding, ulceration, and perforation of the stomach and intestine, which may be fatal, particularly in elderly patients.

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 cells).
In case of an allergic reaction such as those listed above, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is necessary. Rarely, serious adverse reactions, sometimes fatal, have been reported after ibuprofen use, even in the absence of known allergy.
The risk of experiencing such symptoms is higher during the initial stages of treatment: in most cases, the reaction occurs within the first month of treatment.
Additionally, you may experience other side effects reported also with other medicines similar to Neo Borocillina Infiammazione e Dolore, listed below by frequency:
Common (may affect up to 1 in 10 people)

dizziness
malaise
fatigue

Uncommon (may affect up to 1 in 100 people)

inflammation of the stomach (gastritis)
insomnia, anxiety
numbness of limbs or other body parts (paraesthesia), drowsiness
nasal congestion (rhinitis) (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease)
difficulty breathing (bronchospasm, dyspnea)
temporary interruption of breathing (apnea)
hearing impairment
ringing in the ears (tinnitus)
vertigo
liver disorders (altered liver function)
inflammation of the liver (hepatitis)
yellowing of the skin and eyes (jaundice)
kidney disorders (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
allergic reactions such as skin rashes of various forms, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, difficulty breathing (bronchospasm or dyspnea), asthma attacks with low blood pressure
skin becomes sensitive to light
visual disturbances

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

intestinal perforation
reduction in blood cell counts: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia), inhibition of platelet aggregation
depression, confusion, hallucinations
inflammation of the optic nerve (optic neuritis)
inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders – see section 2 “Warnings and precautions” – with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
eye disorders leading to visual disturbances, inflammation of the optic nerve (toxic optic neuropathy)
increased concentration of non-protein nitrogen in the blood (hyperazotemia)
swelling due to fluid accumulation in tissues (edema)
disease that may affect various organs and tissues of the body (lupus erythematosus)
abnormal liver function tests: increased transaminases, increased alkaline phosphatase
abnormal blood tests: reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid

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

inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
awareness of your own heartbeat (palpitations)
heart disease (heart failure)
heart attack (myocardial infarction)
accumulation of fluid around the lungs (acute pulmonary edema)
liver disease (liver failure)
increased blood pressure (hypertension)
severe allergic reactions, which may include symptoms such as swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that may be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
in very rare cases, severe skin infections and soft tissue disorders (necrotizing fasciitis) may occur during chickenpox infection

Not known (frequency cannot be estimated from the available data)

feeling of heaviness in the stomach
nausea
vomiting
diarrhea
passing gas (flatulence)
constipation
difficulty digesting
stomach pain
heartburn
blood in the stool
blood in vomit
lesions inside the mouth
worsening of inflammatory bowel diseases (colitis, Crohn's disease)
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 Neo Borocillina Infiammazione e Dolore if you develop these symptoms and contact your doctor immediately. See also section 2.

Side effects generally tend to resolve upon discontinuation of treatment.
Following the instructions provided in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 Neo Borocillina Infiammazione e Dolore

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Scad.". The expiry date refers to the last day of that month.
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 Neo Borocillina Infiammazione e Dolore contains

The active substance is ibuprofen. Each sachet contains 512 mg of dihydrated sodium ibuprofen (equivalent to 400 mg of ibuprofen).
The other components are sucrose, potassium bicarbonate, mint flavour, acesulfame potassium, aspartame (E951).

Description of the appearance of Neo Borocillina Infiammazione e Dolore and the contents of the pack
Neo Borocillina Infiammazione e Dolore 400 mg is presented as an oral solution granulate in sachets.
Pack contents: 12 sachets.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 - 38123 Trento (TN)