Package leaflet: Information for the user

BUSCOFEN 200 mg soft capsules

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.
Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

1. What Buscofen is and what it is used for

Buscofen contains ibuprofen, a medicine belonging to the class of analgesic-
anti-inflammatory drugs, i.e. medicines that fight pain and inflammation.
Buscofen is used in adults and adolescents from the age of 12 for:

treatment of pain of various origin and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscular pain);
reduction of symptoms associated with fever and flu-like conditions.
Consult a doctor if you do not feel better or if you feel worse after three days of treatment.

2. What you should know before taking Buscofen

Do not take Buscofen

If you are allergic to ibuprofen and/or to any of the other ingredients of this medicine (listed in section 6).
If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Buscofen”).
If you have previously experienced stomach or intestinal bleeding or perforation after taking other medicines.
If you suffer from stomach or intestinal diseases (e.g., active or severe gastrointestinal ulcer).
If you have previously had two or more separate episodes of stomach ulcer or bleeding.
If you suffer from severe liver or kidney disease.
If you suffer from serious heart disease (severe heart failure).
If you suffer from blood disorders (haematological dyscrasias).
If you are in the third trimester (7th–9th month) 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 are severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake).

Warnings and precautions
Take special care with Buscofen:
Allergic reactions to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Buscofen immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
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 acute generalized exanthematous pustulosis (AGEP). Stop using Buscofen and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Red, round or oval isolated patches and swelling of the skin, possibly accompanied by itching (fixed drug eruption), or widespread rashes that may progress to blistering (generalized bullous fixed drug eruption), have also been reported with ibuprofen treatment. Discontinue use of Buscofen and consult your doctor immediately if you notice any of these symptoms.

Talk to your doctor or pharmacist before taking Buscofen:

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, inflammation of the paranasal sinus mucosa (sinusitis), or have a history of allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after taking other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs).
If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Buscofen”).
If you are elderly or have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Buscofen”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Buscofen”).
If you have previously suffered from stomach or intestinal diseases related to medicines, especially if you are elderly, you should inform your doctor of any unusual stomach or intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.
If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Buscofen”. If gastrointestinal bleeding or ulceration occurs in patients taking Buscofen, treatment should be discontinued.
If you have suffered from or currently suffer from chronic intestinal diseases such as ulcerative colitis or Crohn’s disease, as these may worsen (see section 4 “Possible side effects”).
If you suffer from high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been observed with NSAID treatment. NSAIDs may reduce the effectiveness of medicines taken to lower blood pressure (see section “Other medicines and Buscofen”). Your doctor will prescribe Buscofen only after carefully evaluating your condition.
If your blood pressure remains high despite medication, or if you have heart or circulatory diseases (including in the brain or other body areas), or if you think you may be at risk for such conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
If you have lost a significant amount of fluids or 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. Additionally, habitual concurrent use of multiple painkillers may further increase this risk.
If you suffer from a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Buscofen”).
If you suffer from an autoimmune disease that can affect various organs and tissues (systemic lupus erythematosus), or from connective tissue disease affecting multiple body parts such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this 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 Buscofen”).
If you are planning to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
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).

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke (lack of blood flow to the brain), especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Buscofen 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 ischaemic attack);
High blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you smoke.

Medicines such as Buscofen may:

Be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
Cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If you experience visual disturbances, discontinue treatment with Buscofen.

Infections
Buscofen may mask symptoms of infections such as fever and pain. Therefore, Buscofen may delay appropriate treatment of infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the infection symptoms persist or worsen, consult your doctor immediately.
Adolescents
In dehydrated adolescents, there is a risk of kidney disease.
Other medicines and Buscofen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Buscofen may affect or be affected by other medicines. For example:
Do not take Buscofen together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Buscofen with other medicines, particularly:

Corticosteroids (medicines containing cortisone or cortisone-like substances, used to treat inflammation);
Medicines with anticoagulant effects (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 receptor antagonists such as losartan). Buscofen may reduce the effects of these medicines. If you are taking these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may ask you to have blood tests;
Selective serotonin reuptake inhibitors (medicines used to treat depression), as these may increase the risk of stomach or intestinal injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach (misoprostol or proton pump inhibitors);
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);
Sulfonylureas (medicines used to treat diabetes); if concurrent treatment is necessary, your doctor may order blood tests;
Aminoglycosides (antibiotic medicines);
Cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Buscofen may worsen heart disease;
Cholestyramine (a medicine used to lower blood lipids);
Cyclosporine (a medicine used in organ transplantation), as medicines like Buscofen may increase the risk of kidney damage;
Herbal extracts such as Ginkgo biloba, as these may increase the risk of gastrointestinal bleeding when taken with medicines like Buscofen;
Mifepristone (a medicine used in women to induce abortion);
Quinolone antibiotics (medicines used to treat infections), as taking them together with medicines like Buscofen may increase the risk of seizures;
Tacrolimus (a medicine used to prevent and treat organ transplant rejection), as concurrent administration with Buscofen may increase the risk of kidney damage;
Zidovudine and ritonavir (medicines used to treat AIDS); if concurrent treatment is necessary, your doctor may order blood tests;
Probenecid (a medicine used to treat gout);
Sulfinpyrazone (a medicine used after a heart attack to prevent another);
CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
Bisphosphonates (medicines for bone diseases), as they may increase gastrointestinal side effects;
Oxpentifylline (pentoxifylline) (a medicine for leg ulcers), as it may increase gastrointestinal side effects;
Baclofen (a medicine to relax muscles).

Other medicines may also affect or be affected by treatment with Buscofen.
Therefore, always consult your doctor or pharmacist before using Buscofen with other medicines.
Buscofen with alcohol
Do not drink alcohol during treatment with Buscofen, as it may increase the risk of possible side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Pregnancy
Do not take Buscofen during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. This medicine may cause kidney and heart problems in the fetus. It may also affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. Do not take Buscofen 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 the 20th week of pregnancy onwards, Buscofen may cause kidney problems in the fetus, leading 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.
Breastfeeding
Do not take Buscofen if you are breastfeeding, as ibuprofen passes into breast milk.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, stop using Buscofen, as this medicine may temporarily impair fertility.
Driving and using machines
Buscofen normally does not affect the ability to drive or operate machinery. However, if you perform an activity requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Buscofen.
This medicine contains sorbitol
This medicine contains 21.3 mg of sorbitol per capsule.

3. How to take Buscofen

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.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
The recommended dose is as follows:
Adults and adolescents over 12 years of age
1-2 soft capsules, two to three times a day.
The soft capsules must be swallowed whole, without chewing, preferably with food, and taken with a little water.
Buscofen may be taken on an empty stomach. However, in individuals with gastric intolerance, it is preferable to take the medicine with food.
If there is no noticeable improvement after 3 days of treatment, consult your doctor.
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).
Warning: do not exceed the dose of 6 soft capsules per day.
If you are elderly, you should follow the lowest doses indicated above.
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, do not take Buscofen.
Use in the elderly
Consult your doctor, who will adjust the recommended dose, especially if you have kidney and/or liver disorders.
Use in adolescents
Consult your doctor if the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.
If you take more Buscofen than you should
If you have taken more Buscofen than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and what actions to take.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach ache, deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowering of body temperature (hypothermia), kidney problems, gastrointestinal bleeding, deep unconsciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may also experience: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur. Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported.
If you take significantly high doses of ibuprofen, you may develop serious kidney and liver damage.
If you forget to take Buscofen
Do not take a double dose to make up for a missed dose.
If you stop taking Buscofen
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 everyone gets them.
The side effects of this medicine can be minimised by using the lowest dose among those recommended and by using the medicine only for the period necessary to control your symptoms.
If you develop a stomach ulcer or experience gastrointestinal bleeding and/or skin and/or mucosal lesions, you must stop treatment with Buscofen and consult your doctor.
These side effects are usually more frequent in elderly patients.
The use of Buscofen may cause side effects, generally mild or moderate, or more serious reactions, including allergic reactions, although rarely.
If you experience any of the following symptoms, STOP using Buscofen immediately and consult your doctor or go to the nearest hospital, where you will receive appropriate and specific treatment:

chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
skin eruptions or lesions,
mucosal lesions,
signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
skin peeling,
flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin desquamation, mouth, throat, nose, genital and eye ulcers. These severe skin reactions 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 occur at the beginning of treatment (generalised exanthematous pustulosis),
vision disturbances,
liver disease (hepatic dysfunction),
bleeding, ulceration and perforation of the stomach and intestines, which can be fatal, particularly in the elderly. If you experience any of the allergic reactions listed above, go to hospital immediately, as immediate access to appropriate emergency equipment, medications and medical personnel is required, since, although rarely, serious adverse reactions, sometimes fatal, have been reported following the use of ibuprofen, even in the absence of known allergy.

The risk of experiencing such symptoms is higher during the early stages of treatment: in most cases, the reaction occurs within the first month of treatment.
In addition, you may experience further side effects that have also been reported with other medicines similar to Buscofen, listed below according to 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
inflammation of the nasal mucosa (rhinitis)
breathing difficulties (bronchospasm, dyspnoea)
temporary cessation of breathing (apnoea)
vision disturbances
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 diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure)
hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), breathing difficulties (bronchospasm or dyspnoea), asthma attacks possibly accompanied by low blood pressure
skin reactions to light (photosensitivity)

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

reduction in blood cell counts: reduction in white blood cells (leucopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia)
reduced blood clotting ability
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 “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever or disorientation
eye disorders with vision disturbances and optic nerve pathology (toxic optic neuropathy)
swelling due to fluid accumulation in tissues
a disease that may affect various organs and tissues of the body (lupus erythematosus syndrome)
worsening of inflammation caused by an existing infection (e.g. development of necrotising fasciitis)
high levels of nitrogen in the blood
abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
abnormal blood tests (reduced haemoglobin, reduced haematocrit, 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)
sensation of feeling your own heartbeat (palpitations)
heart disease (heart failure)
heart attack (myocardial infarction)
presence of fluid in the lungs (acute pulmonary oedema)
liver disease (liver failure)
hypertension
severe allergic reactions, which may include symptoms such as severe asthma, 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)
severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from available data)

feeling of heaviness in the stomach
nausea
vomiting
diarrhoea
flatulence
constipation
difficulty digesting
abdominal pain
heartburn
blood in stools
blood in vomit
lesions inside the mouth
worsening of inflammatory bowel diseases (colitis, Crohn's disease)
increased risk of sudden reduction in blood circulation to the brain (stroke)
allergic reactions, anaphylaxis
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): 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 pustules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalised exanthematous pustulosis). Stop using Buscofen if you develop these symptoms and contact your doctor immediately. See also section 2
isolated round or oval red patches and skin swelling, possibly associated with itching (fixed drug eruption), or covering a large area of the body, possibly complicated by blister formation (generalised bullous fixed drug eruption)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor.
You may 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 Buscofen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, stored correctly.
It is important to always keep the medicine information available; therefore, retain both the
packaging and the leaflet.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Buscofen Contains
One soft capsule contains:

The active substance is ibuprofen. Each soft capsule contains 200 mg of ibuprofen.
The other components are: macrogol 600, potassium hydroxide, purified water, gelatin, partially dehydrated liquid sorbitol.

Description of the Appearance of Buscofen and Package Contents
Buscofen is available as soft gelatin capsules.
It is available in packages containing 12 or 24 soft gelatin capsules of 200 mg.
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

Health Education Notes
There are several types of pain, of different origin and nature, which, more or less frequently, everyone experiences in daily life: menstrual pain, headache, toothache, muscle and joint pain.

Menstrual pain (dysmenorrhea) is a very common condition; in addition to pain, mood changes (sadness, irritability), breast tenderness, and a feeling of generalized fatigue may occur.
Reducing or eliminating certain dietary substances such as coffee, salt, or chocolate, while favoring vitamin-rich foods such as fruit, as well as drinking warm herbal teas and chamomile, may help reduce these symptoms. Menstrual pain, which can sometimes be quite severe, can instead be treated with analgesics that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for the condition.

One of the most common types of pain is certainly headache (or cephalalgia). There are three main types of primary headache (i.e., not caused by other diseases): migraine, so-called because the intense pain is localized on only one side of the head; tension-type headache, the most common type, which causes a sensation of pressure or tightness around the head; and cluster headache, characterized by sudden, severe pain attacks affecting one eye or one cheekbone.

Sometimes headache may be a symptom of other diseases (allergies, anemia, myopia, intoxications, stomach disorders, cervical spondylosis, sinusitis, constipation, head trauma). If you suffer from headaches, it is important to try to identify potential triggering factors and prevent them (irregular eating habits, certain foods, smoking, alcohol, stress, excessive physical exertion, prolonged sun exposure, loud noises, strong perfumes, etc.). If headache attacks are recurrent, it is advisable to consult your doctor.

Package leaflet: information for the user

BUSCOFEN 200 mg coated tablets

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

Contents of this leaflet:

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

1. What Buscofen is and what it is used for

Buscofen contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, i.e. medicines that combat pain and inflammation.
Buscofen is used in adults and adolescents from the age of 12 for:

treatment of pain of various origin and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscular pain);
relief of symptoms associated with fever and flu-like conditions.
Consult your doctor if you do not feel better or feel worse after three days of treatment.

2. What you should know before taking Buscofen

Do not take Buscofen

If you are allergic to ibuprofen and/or to any of the other ingredients of this medicine (listed in section 6).
If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Buscofen”).
If you have previously experienced stomach or intestinal bleeding or perforation after taking other medications.
If you suffer from diseases of the stomach or intestines (e.g., active or severe gastrointestinal ulcer).
If you have previously had two or more separate episodes of stomach ulcer or bleeding.
If you suffer from severe liver or kidney disease.
If you suffer from severe heart disease (severe heart failure).
If you have blood disorders (haematological dyscrasias).
If you are in the third trimester (7th–9th month) 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 are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions
Take special care with Buscofen:
Allergic reactions to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen.
Immediately discontinue Buscofen and contact your doctor or emergency medical services if you notice any of these symptoms.
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 Buscofen and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Skin reactions such as isolated round or oval red patches and swelling of the skin, possibly accompanied by itching (fixed drug eruption), or widespread rashes that may progress to blistering (generalized bullous fixed drug eruption), have also been reported with ibuprofen treatment. Discontinue Buscofen and consult your doctor immediately if you notice any of these symptoms.

Talk to your doctor or pharmacist before taking Buscofen:

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), or inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or if you have or have had allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines for joint or muscle pain, fever, or inflammation (NSAIDs).
If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Buscofen”).
If you are elderly or have had ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Buscofen”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Buscofen”).
If you have previously suffered from stomach or intestinal diseases related to medication use, especially if you are elderly, inform your doctor of any unusual stomach or intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.
If you are taking other medicines that increase the risk of stomach or intestinal ulcers or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Buscofen”. If gastrointestinal bleeding or ulceration occurs in patients taking Buscofen, treatment should be discontinued.
If you have or have had chronic intestinal diseases such as ulcerative colitis or Crohn’s disease, as these may worsen (see section 4 “Possible side effects”).
If you suffer from high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been observed with NSAID treatment. NSAIDs may reduce the effectiveness of medicines taken to lower blood pressure (see section “Other medicines and Buscofen”). Your doctor will prescribe Buscofen only after carefully evaluating your condition.
If you have high blood pressure that is not controlled by medication and/or heart or cerebrovascular disease or other circulatory disorders, or if you think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
If you have lost a significant amount of fluid or 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. Habitual concurrent use of multiple painkillers may further increase this risk.
If you suffer from a blood clotting disorder or are taking medicines that slow blood coagulation (anticoagulants) (see section “Other medicines and Buscofen”).
If you suffer from an autoimmune disease that can affect various organs and tissues (systemic lupus erythematosus), or from a connective tissue disease affecting multiple body parts such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases.
If you are taking medicines to treat pain, heart disease, or high blood pressure (see section “Other medicines and Buscofen”).
If you plan to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
If you have difficulty becoming pregnant or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
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).

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small
increase in the risk of heart attack (“myocardial infarction”) or stroke (lack of blood flow to the
brain), especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Buscofen 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 ischaemic attack);
high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Medicines such as Buscofen may:

be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If you experience visual disturbances, discontinue treatment with Buscofen.

Infections
Buscofen may mask symptoms of infections such as fever and pain. Therefore, Buscofen may delay appropriate treatment of the 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.
Adolescents
In dehydrated adolescents, there is a risk of kidney disease.
Other medicines and Buscofen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Buscofen may affect or be affected by other medicines. For example:
Do not take Buscofen together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Buscofen with other medicines, especially:

corticosteroids (medicines containing cortisone or cortisone-like substances, used to treat inflammation);
medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Buscofen may reduce the effects of these medicines. If you are taking these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may request blood tests;
selective serotonin reuptake inhibitors (medicines used to treat depression), as these may increase the risk of stomach or intestinal injury or bleeding. Your doctor may therefore prescribe a medicine to protect the stomach (misoprostol or proton pump inhibitors);
lithium (a medicine used to treat mental disorders), or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may request blood tests;
methotrexate (a medicine used to treat cancer or rheumatoid arthritis);
moclobemide (a medicine used to treat depression);
sulfonylureas (medicines used to treat diabetes); if concomitant treatment is necessary, your doctor may request blood tests;
aminoglycosides (antibiotic medicines);
cardiac glycosides (medicines used to treat certain heart conditions). Medicines such as Buscofen may worsen heart disease;
cholestyramine (a medicine used to lower blood lipids);
cyclosporine (a medicine used in organ transplantation), as medicines such as Buscofen may increase the risk of kidney damage;
herbal extracts such as Ginkgo biloba, as taking them together with medicines like Buscofen 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 Buscofen may increase the risk of seizures;
tacrolimus (a medicine used to prevent and treat organ transplant rejection), as concomitant administration with Buscofen may increase the risk of kidney damage;
zidovudine and ritonavir (medicines used to treat AIDS); if concomitant treatment is necessary, your doctor may request blood tests;
probenecid (a medicine used to treat gout);
sulfinpyrazone (a medicine used after a heart attack to prevent another);
CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
bisphosphonates (medicines for treating bone diseases), as they may increase gastrointestinal side effects;
oxpentifylline (pentoxifylline) (a medicine for treating leg ulcers), as it may increase gastrointestinal side effects;
baclofen (a medicine for muscle relaxation).

Other medicines may also affect or be affected by Buscofen treatment.
Therefore, always consult your doctor or pharmacist before using Buscofen with other
medicines.
Buscofen and alcohol
Do not drink alcohol during treatment with Buscofen, as it may increase the risk of adverse effects.
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 any medicine.
Pregnancy
Do not take Buscofen during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. This medicine may cause kidney and heart problems in the fetus. It may also affect your and your baby’s tendency to bleed and may delay or prolong labour more than expected. You should not take Buscofen 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 the 20th week of pregnancy onwards, Buscofen may cause kidney problems in the fetus leading 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.
Breastfeeding
Do not take Buscofen if you are breastfeeding, as ibuprofen passes into breast milk.
Fertility
If you have difficulty becoming pregnant or are undergoing fertility investigations, discontinue use of Buscofen, as this medicine may temporarily impair fertility.
Driving and using machines
Buscofen generally does not affect the ability to drive or use machinery. However, if you perform activities requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Buscofen.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take Buscofen

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
The recommended dose is as follows:
Adults and adolescents over 12 years of age
1-2 film-coated tablets, two to three times a day.
The film-coated tablets should be swallowed whole, without chewing, preferably with food, and with a glass of water.
Buscofen may be taken on an empty stomach. However, in individuals with gastric tolerance problems, it is preferable to take the medicine with food.
If there is no noticeable improvement after 3 days of treatment, consult your doctor.
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).
Caution: do not exceed a dose of 6 film-coated tablets per day.
If you are elderly, follow the lower doses indicated above.
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, do not take Buscofen.
Use in the elderly
Consult your doctor, who will determine the appropriate dose for you by reducing the recommended dose, especially if you have kidney and/or liver disorders.
Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in adolescents, or if symptoms worsen.
If you take more Buscofen than you should
If you have taken more Buscofen 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 guidance on the actions to take.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach ache, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowering of body temperature (hypothermia), kidney problems, stomach and intestinal bleeding, deep 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, you may also experience: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur. Symptoms may include nausea, stomach ache, vomiting (possibly with blood traces), headache, ringing in the ears, confusion, and uncontrolled eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in urine, low potassium levels in blood, feeling cold, and breathing difficulties may be reported.
If you take significantly high doses of ibuprofen, severe kidney and liver damage may occur.
If you forget to take Buscofen
Do not take a double dose to make up for a forgotten dose.
If you stop taking Buscofen
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects of the medicine can be minimized by using the lowest dose among those recommended and by using the medicine only for the period necessary to control your symptoms.
If you develop a stomach ulcer or gastrointestinal bleeding, or skin and/or mucosal lesions, you must stop treatment with Buscofen and consult your doctor.
These adverse effects are usually more frequent in elderly patients.
The use of Buscofen may cause adverse effects, generally mild or moderate, or more severe reactions, including allergic reactions, although rarely.
If you experience any of the following symptoms, STOP immediately using Buscofen and consult a doctor or go to the nearest hospital, where you will receive appropriate and specific treatment:

chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
skin eruptions or lesions,
mucosal lesions,
signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
skin peeling,
flat, non-elevated reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin desquamation, 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 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),
visual disturbances,
liver disease (hepatic dysfunction),
bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal, particularly in the elderly. In case of any of the above-mentioned allergic reactions, go to hospital immediately, as immediate availability of equipment, medications, and trained personnel for emergency treatment is required, since severe, sometimes fatal, adverse effects have been reported following ibuprofen use, even in the absence of known allergy.

The risk of experiencing these symptoms is higher during the initial stages of treatment: in most cases, the reaction occurs within the first month of therapy.
In addition, you may experience other adverse effects that have also been reported with other medicines similar to Buscofen, listed below according to 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
inflammation of the nasal mucosa (rhinitis)
difficulty breathing (bronchospasm, dyspnea)
temporary cessation of breathing (apnea)
visual disturbances
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 diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), difficulty breathing (bronchospasm or dyspnea), asthma attacks possibly accompanied by low blood pressure
skin reactions to light (photosensitivity)

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

reduction in blood cells: reduction in white blood cells (leucopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia)
reduced blood clotting ability
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 “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
swelling due to fluid accumulation in tissues
a disease that may affect various organs and tissues of the body (lupus erythematosus syndrome)
worsening of infections caused by an existing infection (e.g., development of necrotizing fasciitis)
high levels of nitrogen in the blood
abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
abnormal blood tests (reduced haemoglobin, reduced haematocrit, 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)
sensation of feeling your own heartbeat (palpitations)
heart disease (heart failure)
heart attack (myocardial infarction)
fluid accumulation in the lungs (acute pulmonary edema)
liver disease (liver failure)
hypertension
severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from available data)

feeling of heaviness in the stomach
nausea
vomiting
diarrhoea
flatulence
constipation
difficulty digesting
abdominal pain
heartburn
blood in stools
blood in vomit
lesions inside the mouth
worsening of inflammatory bowel diseases (colitis, Crohn's disease)
increased risk of sudden reduction in blood circulation to the brain (stroke)
allergic reactions, anaphylaxis
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): 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)
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 Buscofen if you develop these symptoms and contact your doctor immediately. See also section 2
round or oval red patches and skin swelling, possibly associated with itching (fixed drug eruption), or covering a large area of the body, 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.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor. You may 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 Buscofen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, stored correctly.
It is important to always keep the medicine information available; therefore, retain both the carton and the package leaflet.
This medicine does not require any special storage conditions.
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 Buscofen contains
One coated tablet contains:

The active substance is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
The other components are: maize starch, sodium carboxymethylcellulose, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol 6000, talc, titanium dioxide, anti-foaming emulsion.

Description of the appearance of Buscofen and pack sizes
Buscofen is presented as coated tablets.
It is available in packs containing 20 coated tablets of 200 mg.

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

Manufacturer
Boehringer Ingelheim Pharma KG,
Birkendorfer Strasse 65,
88400 Biberach an der Riss
Germany
or
Istituto De Angeli S.r.l.
Loc. Prulli n. 103/c
50066 Reggello (FI)

Health Education Notes
There are several types of pain, of varying origin and nature, which, more or less frequently, everyone experiences in daily life: menstrual pain, headache, toothache, muscle and joint pain.

Menstrual pain (dysmenorrhea) is a very common disorder; in addition to pain, mood changes (sadness, irritability), breast tenderness, and a sensation of generalized fatigue may occur.
Reducing or eliminating from the diet substances such as coffee, salt, or chocolate, while favoring vitamin-rich foods such as fruit, as well as drinking warm herbal teas and chamomile, may help reduce these symptoms. Menstrual pain, which can sometimes be quite severe, can instead be treated with analgesics that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for the condition.

One of the most common types of pain is certainly headache (or cephalalgia). There are three main types of primary headache (i.e., not caused by other diseases): migraine, so-called because the intense pain is localized on only one side of the head; tension-type headache, the most common form, which feels like a tight band around the head; and cluster headache, characterized by attacks of sharp, stabbing pain affecting one eye or one cheekbone.

Sometimes headache may be a symptom of other diseases (allergies, anemia, myopia, intoxications, stomach disorders, cervical osteoarthritis, sinusitis, constipation, head trauma). If you suffer from headaches, it is important to try to identify the factors that may trigger them and prevent them (irregular eating habits, specific foods, smoking, alcohol, stress, excessive physical exertion, excessive sun exposure, loud noises, strong perfumes, etc.). If headache attacks are recurrent, it is advisable to consult your doctor.

Package leaflet: information for the user

BUSCOFEN 400 mg granules for oral solution

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 of treatment.

Contents of this leaflet:

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

1. What Buscofen is and what it is used for

Buscofen contains ibuprofen, a medicine belonging to the class of analgesic-
anti-inflammatory drugs, which are medicines that combat pain and inflammation.
Buscofen is used in adults and adolescents from 12 years of age for the treatment of
pain of various origin and nature (menstrual pain, headache, toothache, neuralgia,
musculoskeletal and muscular pain).
Consult your doctor if you do not feel better or feel worse after three days of treatment.

2. What you need to know before taking Buscofen

Do not take Buscofen

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 other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Buscofen”).
If you have previously experienced bleeding or perforation of the stomach or intestine after taking other medicines.
If you suffer from diseases of the stomach or intestine (e.g. active or severe gastrointestinal ulcer).
If you have previously had two or more separate episodes of stomach ulcer or bleeding.
If you suffer from severe liver or kidney disease.
If you suffer from serious heart disease (severe heart failure).
If you have blood disorders (hematologic dyscrasias).
If you are in the third trimester (7th–9th month) 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 are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake).
If you suffer from a metabolic disorder of amino acids, which constitute proteins, called phenylketonuria.

Warnings and precautions
Take special care with Buscofen:
Allergic reactions to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Buscofen immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
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 acute generalized exanthematous pustulosis (AGEP). Stop using Buscofen and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Skin reactions such as isolated round or oval red patches and swelling of the skin, possibly accompanied by itching (fixed drug eruption), or widespread rashes that may progress to blistering (generalized bullous fixed drug eruption), have also been reported with ibuprofen. Stop using Buscofen and consult your doctor immediately if you notice any of these symptoms.

Talk to your doctor or pharmacist before taking Buscofen:

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, inflammation of the mucosa of the paranasal sinuses (sinusitis), or suffer/have suffered from allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines for joint or muscle pain, fever, or inflammation (NSAIDs).
If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Buscofen”).
If you are elderly or have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Buscofen”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach or intestinal diseases (see section “Other medicines and Buscofen”).
If you have previously suffered from stomach or intestinal diseases related to medicines, especially if you are elderly, inform your doctor of any unusual stomach or intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.
If you are taking other medicines that increase the risk of stomach or intestinal ulcers or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Buscofen”. If gastrointestinal bleeding or ulceration occurs in patients taking Buscofen, treatment should be discontinued.
If you suffer from or have suffered from chronic intestinal diseases such as ulcerative colitis or Crohn’s disease, as these may worsen (see section 4 “Possible side effects”).
If you suffer from high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been observed with NSAID treatment. NSAIDs may reduce the effectiveness of medicines taken to lower blood pressure (see section “Other medicines and Buscofen”).
If your blood pressure remains uncontrolled despite medication, and/or you have heart or circulatory diseases affecting the brain or other body parts, or if you think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke).
If you have lost a significant amount of fluids, or if swelling, heart problems, or high blood pressure occur.
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. Additionally, habitual concurrent use of multiple painkillers may further increase this risk.
If you suffer from a blood clotting disorder or are taking medicines that slow blood coagulation (anticoagulants) (see section “Other medicines and Buscofen”).
If you suffer from an autoimmune disease that can affect various organs and tissues (systemic lupus erythematosus), or from a connective tissue disease affecting multiple body parts such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed rarely in patients treated with ibuprofen. Although this is more likely in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without chronic comorbidities.
If you are taking medicines for pain, heart disease, or high blood pressure (see section “Other medicines and Buscofen”).
If you plan to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
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).

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke (lack of blood flow to the brain),
especially when administered at high doses. Do not exceed the recommended dose or duration of
treatment.
You should discuss treatment with your doctor or pharmacist before taking Buscofen if you have:

heart problems including heart attack, angina (chest pain), history of heart attack, coronary 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 “TIA”, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Medicines like Buscofen may:

be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If you experience visual disturbances, stop treatment with Buscofen.

Infections
Buscofen may mask symptoms of infections such as fever and pain. Therefore, Buscofen may delay appropriate treatment of the 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.
Adolescents
In dehydrated adolescents, there is a risk of kidney disease.
Other medicines and Buscofen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Buscofen may affect or be affected by other medicines. For example:
Do not take Buscofen together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Buscofen with other medicines, particularly:

corticosteroids (medicines containing cortisone or cortisone-like substances, used to treat inflammation);
medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Buscofen may reduce the effects of these medicines. If you are taking these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may request blood tests;
selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach (misoprostol or proton pump inhibitors);
lithium (a medicine used to treat mental disorders) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may request blood tests;
methotrexate (a medicine used to treat cancer or rheumatoid arthritis);
moclobemide, a medicine used to treat depression;
sulfonylureas (medicines used to treat diabetes); if simultaneous treatment is necessary, your doctor may order blood tests;
aminoglycosides (antibiotic medicines);
cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Buscofen may worsen heart disease;
cholestyramine (a medicine used to lower blood lipids);
cyclosporine (a medicine used in organ transplantation), as medicines like Buscofen may increase the risk of kidney damage;
herbal extracts such as Ginkgo biloba, as they may increase the risk of gastrointestinal bleeding when taken with medicines like Buscofen;
mifepristone (a medicine used in women to induce abortion);
quinolone antibiotics (medicines used to treat infections), as taking them with medicines like Buscofen may increase the risk of seizures;
tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Buscofen may increase the risk of kidney damage;
zidovudine and ritonavir (medicines used to treat AIDS); if simultaneous treatment is necessary, your doctor may order blood tests;
probenecid, a medicine used to treat gout;
sulfinpyrazone (a medicine used after a heart attack to prevent another);
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 (pentoxifylline), 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 Buscofen.
Therefore, always consult your doctor or pharmacist before using Buscofen with other
medicines.
Buscofen and alcohol
Do not drink alcohol while taking Buscofen, as it may increase the risk of adverse effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Pregnancy
Do not take Buscofen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. This medicine may cause kidney and heart problems in the fetus. It may also affect your and your baby’s tendency to bleed and may delay or prolong labour more than expected. Do not take Buscofen 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 conceive, the lowest effective dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Buscofen may cause kidney problems in the fetus, leading 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 needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not take Buscofen if you are breastfeeding, as ibuprofen passes into breast milk.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, stop using Buscofen, as this medicine may temporarily impair fertility.
Driving and using machines
Buscofen generally does not affect the ability to drive or use machines. However, if you perform activities requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Buscofen.
Buscofen granules for oral solution contain sucrose, potassium, aspartame and sodium:

sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. Buscofen contains 2.15 g of sucrose (sugar) per sachet. This should be considered in patients with diabetes mellitus;
potassium: this medicine contains 87.82 mg of potassium per sachet. This should be considered in patients with reduced kidney function or those on a low-potassium diet;
aspartame (E 951): this medicine contains 20 mg of aspartame (E 951) per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body’s inability to properly metabolize it;
sodium: this medicine contains 44.56 mg of sodium (the main component of table salt) per sachet. This corresponds to 2.23% of the recommended maximum daily dietary intake for an adult.

3. How to take Buscofen

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.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.

The recommended dose is as follows:
Adults and adolescents over 12 years of age
1 sachet two to three times daily.
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.

Buscofen may be taken on an empty stomach. However, in individuals with gastric tolerance problems, it is preferable to take the medicine with food.

If there is no noticeable improvement after three days of treatment, consult your doctor.
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).
Warning: do not exceed 3 sachets per day.
If you are elderly, you should adhere to the lower doses indicated above.

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, do not take Buscofen.

Use in the elderly
Consult your doctor, who will determine the appropriate dose for you, possibly reducing the recommended dose, especially if you have kidney and/or liver disorders.

Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.

If you take more Buscofen than you should
If you have taken more Buscofen than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately to obtain advice on the risk and actions to take.

If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach ache, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.

Rarely, the following may occur: uncontrolled eye movements (nystagmus), lowering of body temperature (hypothermia), kidney effects, gastrointestinal bleeding, deep 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, you may also experience: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).

In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur. Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements.

At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may also occur.

If you take significantly high doses of ibuprofen, severe kidney and liver damage may occur.

If you forget to take Buscofen
Do not take a double dose to make up for the missed sachet.

If you stop taking Buscofen
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. The side effects of this medicine can be minimized by using the lowest dose among those recommended and by using the medicine only for the duration necessary to control your symptoms.

If you develop a stomach ulcer or experience gastrointestinal bleeding or skin and/or mucosal lesions, you must stop treatment with Buscofen and consult your doctor.
These side effects are usually more frequent in elderly patients.

The use of Buscofen may cause side effects, generally mild or moderate, or more serious reactions, including allergic reactions, although these are rare.

If you experience any of the following symptoms, STOP taking Buscofen immediately and consult a doctor or go to the nearest hospital, where you will receive appropriate and specific treatment:

chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
skin eruptions or lesions,
mucosal lesions,
signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
skin peeling,
flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin desquamation, mouth, throat, nose, genital, and 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 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),
vision disturbances,
liver disease (hepatic dysfunction),
bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal, particularly in the elderly.

If you experience any of the allergic reactions listed above, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is essential. Serious, and in rare cases fatal, adverse reactions have been reported following the use of ibuprofen, even in the absence of a known allergy.

The risk of experiencing such symptoms is higher during the early stages of treatment: in most cases, the reaction occurs within the first month of treatment.

In addition, you may experience other side effects that have also been reported with other medicines similar to Buscofen. These are listed below according to 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 (paresthesia), drowsiness
inflammation of the nasal mucosa (rhinitis)
breathing difficulties (bronchospasm, dyspnea)
temporary interruption of breathing (apnea)
vision disturbances
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 diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), breathing difficulties (bronchospasm or dyspnea), asthma attacks possibly associated with low blood pressure
skin reactions to light (photosensitivity)

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

reduction in blood cell counts: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), or platelets (thrombocytopenia)
reduced blood clotting ability
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 “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
swelling due to fluid accumulation in tissues
a disease that may affect various organs and tissues of the body (lupus-like syndrome)
worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
high levels of nitrogen in the blood
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)
fluid accumulation in the lungs (acute pulmonary edema)
liver disease (liver failure)
hypertension
severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin peeling (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
severe skin infections and soft tissue disorders may occur during varicella infection

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

feeling of heaviness in the stomach
nausea
vomiting
diarrhea
flatulence
constipation
difficulty digesting
abdominal pain
heartburn
blood in stools
blood in vomit
lesions inside the mouth
worsening of inflammatory bowel diseases (colitis, Crohn's disease)
increased risk of sudden reduction in blood circulation to the brain (stroke)
allergic reactions, anaphylaxis
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): 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 pustules under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Buscofen if you develop these symptoms and contact your doctor immediately. See also section 2
red, round or oval patches with swelling of the skin, possibly associated with itching (fixed drug eruption), or eruptions 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website 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 Buscofen

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 "Exp".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, correctly stored.
It is important to always keep the medicine information available; therefore, retain both the
packaging and the leaflet.
This medicine does not require any special storage conditions.
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 Buscofen Contains
One sachet contains:

The active substance is ibuprofen sodium dihydrate. Each sachet contains 512 mg of ibuprofen sodium dihydrate, equivalent to 400 mg of ibuprofen.
The other components are: sucrose, potassium bicarbonate, orange flavour, acesulfame potassium, aspartame (see section 2 “Buscofen contains sucrose, potassium, aspartame and sodium”).

Description of the Appearance of Buscofen and Contents of the Pack
Buscofen is presented as granules for oral solution.
It is available in packs of 10 sachets.

Marketing Authorization Holder and Manufacturer
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)

Manufacturer
E-Pharma Trento S.p.A. – Frazione Ravina – 38123 Trento (TN)

Health Education Notes
There are several types of pain, of various origins and nature, which, more or less frequently, everyone encounters in daily life: menstrual pain, headache, toothache, muscle and joint pain.

Menstrual pain (dysmenorrhea) is a very common disorder; in addition to pain, mood changes (sadness, irritability), breast tenderness, and a feeling of generalized fatigue may occur.

Eliminating or reducing substances such as coffee, salt, or chocolate from the diet, while favouring vitamin-rich foods like fruit, as well as drinking warm herbal teas and chamomile, may help reduce these symptoms. Menstrual pain, which can sometimes be quite severe, can instead be treated with analgesics that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for the condition.

One of the most common types of pain is certainly headache (or cephalalgia). There are three main types of primary headache (i.e., not caused by other diseases): migraine, so-called because the intense pain is localized on only one side of the head; tension-type headache, the most common type, which manifests as a feeling of pressure or tightness around the head; and cluster headache, characterized by attacks of sharp, stabbing pain affecting one eye or one cheekbone.

Sometimes headache may be a symptom of other diseases (allergies, anemias, myopia, intoxications, stomach disorders, cervical spondylosis, sinusitis, constipation, head trauma). When suffering from headaches, it is important to try to identify and prevent potential triggering factors (irregular eating habits, specific foods, smoking, alcohol, stress, excessive physical exertion, excessive sun exposure, loud noises, strong perfumes, etc.). If headache attacks are recurrent, it is advisable to consult your doctor.