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CIBALGINAFOR 400 MG GRANULES FOR ORAL SOLUTION IN SACHET 12 SACHETS IN PAPER/PE/AL/SURLYN
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Descrizione
Pagamenti
Spedizioni
Name
Cibalginafor 400 mg granules for oral solution in sachet
Ibuprofen
What it is and what it is used for
Cibalginafor contains the active ingredient ibuprofen which belongs to the class of medicines known as analgesics, anti-inflammatory and nonsteroidal antirheumatic drugs. Cibalginafor works by reducing pain, inflammation and fever.
Cibalginafor is indicated for the treatment of pain of various origins and natures, including:
• heachache
• toothache
• neuralgia
• bone and joint pain
• muscle pain
• menstrual cramps
• as an adjunctive therapy in the treatment of fever and influenza symptoms.
Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment, if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
What you need to know before taking the medicine
Do not take Cibalginafor
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics), fever (antipyretics), non-steroidal anti-inflammatory drugs (NSAIDs), in particular when the allergy is associated with swelling of the nasal mucosa (nasal polyposis) or asthma;
• if you have had a severe ulcer in your stomach or upper intestine;
• if you have an ongoing ulcer;
• if you have had bleeding or ulcers that occur repeatedly (two or more distinct episodes of proven ulceration or bleeding);
• if you have had bleeding (haemorrhage) from the stomach and/or intestine or perforation after previous treatments with other medicines;
• if you have any diseases that make you bleed more easily;
• if you have severe liver or kidney failure;
• if you have a severe form of heart failure;
• if you are in the last three months of pregnancy (see section "Pregnancy, breast-feeding and fertility");
• if the patient is a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cibalginafor.
Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop Cibalginafor immediately and contact your doctor or emergency services immediately if you notice any of these signs.
Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Cibalginafor if you have:
• heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
Consult your doctor before taking Cibalginafor :
• if you are using other medicines that may modify the effect of Cibalginafor (see section "Other medicines and Cibalginafor")
• if you are in the first 6 months of pregnancy or if you are breast-feeding (see section "Pregnancy, breast-feeding and fertility").
Take special care and ask your doctor or pharmacist for advice :
• if you are a woman and are planning a pregnancy;
• if you are a woman and have fertility problems or are undergoing fertility investigations, because you should stop treatment with Cibalginafor;
• if the patient is an adolescent with dehydration problems;
• if you have asthma;
• if you have seasonal colds on an allergic basis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps);
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• if you have liver or kidney problems, except if you have a severe form of liver or kidney failure because in these cases you should not take Cibalginafor (see section 2 "Do not take Cibalginafor"). If you are in any doubt, ask your doctor;
• if you have hepatic porphyria;
• if you have or have had ulcerative colitis or Crohn's disease because these conditions may get worse;
• if you are using medicines that increase urine production (diuretics) or other medicines that may affect the way your kidneys work;
• if you have low body fluid volume (for example before or after major surgery);
• if you are undergoing or have undergone major surgery;
• if you have or have had heart problems, except if you have had a severe form of heart failure because in this case you should not take Cibalginafor (see paragraph 2 "Do not take Cibalginafor"). If you are in any doubt, ask your doctor;
• if you have stomach or intestinal problems, unless you have one or more conditions for which you should not take Cibalginafor (see section "Do not take Cibalginafor");
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin), corticosteroids given by mouth, injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Cibalginafor");
• if you have an autoimmune disease e.g. lupus erythematosus or connective tissue disease;
• if you have an infection – see section “Infections” below.
In these cases, your doctor will monitor you closely and periodically reassess the need for treatment with Cibalginafor. In addition, your doctor may perform periodic tests (such as monitoring of kidney function) to evaluate your condition during treatment with Cibalginafor.
Skin reactions
Serious skin reactions 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) have been reported in association with ibuprofen treatment.
Stop using Cibalginafor and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Stop taking Cibalginafor and contact your doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
Infections
Cibalginafor may hide the symptoms of infections such as fever and pain. It is therefore possible that Cibalginafor may delay adequate treatment of the infection, which could increase the risk of complications.
This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.
Stop treatment and inform your doctor if during treatment with Cibalginafor you develop :
• gastrointestinal bleeding or ulceration;
• sudden or severe skin reactions, as severe skin reactions that can be fatal have been reported very rarely;
• mucosal lesions or any other signs of allergic reaction;
• fluid retention and swelling from fluid accumulation (edema);
• signs and symptoms of liver problems or if liver function parameters are abnormal (visible in blood tests);
• unusual symptoms in the stomach and intestines especially at the beginning of treatment with Cibalginafor;
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, profound tiredness, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis);
• tension in the back of the neck, headache, nausea, vomiting, fever, disorientation because you may be suffering from aseptic meningitis. Patients with autoimmune diseases (Systemic Lupus Erythematosus, connective tissue disease) seem to be more predisposed to developing aseptic meningitis;
• symptoms of an infection (e.g. headache, fever) or if you notice worsening of an infection as Cibalginafor may hide the signs and symptoms of infection.
In these cases, the doctor will evaluate whether to continue or stop treatment with Cibalginafor.
Other important information :
• Gastrointestinal bleeding, ulceration or perforation, which may be fatal, may occur during treatment with NSAIDs, including ibuprofen, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. You should take the lowest effective dose of ibuprofen to reduce the risk of gastrointestinal toxicity and your doctor may prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 "How to take Cibalginafor").
• Avoid using ibuprofen during treatment with other NSAIDs administered by mouth, injection and rectal administration, including cyclooxygenase-2 selective inhibitors, because it increases the possibility of you experiencing side effects.
• Cases of aseptic meningitis have been reported during treatment with ibuprofen, although they are more likely in patients with lupus erythematosus or connective tissue diseases.
Children
Cibalginafor should not be given to children under 12 years of age.
Elderly patients
Elderly patients are more likely to experience adverse reactions, especially stomach or intestinal bleeding and perforation, which are usually more severe and can be fatal.
If you are elderly you should take the lowest dose of Cibalginafor.
As a precaution, your doctor may check your kidney function and prescribe medications that work by protecting the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Tell your doctor about any unusual stomach and intestinal symptoms, especially when you first start taking this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
If any of these effects occur during treatment with Cibalginafor, it is advisable to stop using the medicine and consult your doctor.
Stop using ibuprofen and see your doctor immediately if you notice any of the following symptoms:
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
Medicines such as Cibalginafor may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Uncommon side effects (may affect up to 1 in 100 people)
• allergic reactions including hives and itching
• heachache
• dizziness
• abdominal pain
• nausea
• difficulty digesting (dyspepsia)
• skin rash
Rare side effects (may affect up to 1 in 1,000 people)
• vomit
Very rare side effects (may affect up to 1 in 10,000 people)
• reduction in the number of platelets in the blood (thrombocytopenia)
• anemia
• reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis)
• reduction in the number of all cells present in the blood (pancytopenia)
• severe allergic reaction
• swelling due to fluid accumulation (angioedema)
• aseptic meningitis (infection of the meninges, membranes of the brain)
• ringing and buzzing in the ears (tinnitus)
• hearing impairment
• ulcer of the stomach or upper part of the intestine (peptic ulcer)
• perforation or bleeding from the stomach and/or intestines
• dark stools with blood (melena)
• vomiting blood due to bleeding from the stomach, esophagus and duodenum (hematemesis)
• inflammation of the mucosa of the mouth with ulceration (ulcerative stomatitis)
• inflammation of the stomach (gastritis)
• worsening of inflammation of the colon (colitis)
• worsening of chronic inflammatory disease of the digestive system (Crohn's disease)
• changes in tests to assess liver function
• liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
• skin and mucous membrane reactions, even serious ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• kidney failure
• damage to kidney tissue (papillary necrosis) (particularly in long-term therapy)
Unknown side effects (frequency cannot be estimated from the available data)
• widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Cibalginafor if you develop these symptoms and contact your doctor immediately. See also section 2.
• the skin becomes sensitive to light.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Following the instructions in the package leaflet reduces the risk of side effects.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Cibalginafor 400 mg granules for oral solution in sachet
Ibuprofen
What it is and what it is used for
Cibalginafor contains the active ingredient ibuprofen which belongs to the class of medicines known as analgesics, anti-inflammatory and nonsteroidal antirheumatic drugs. Cibalginafor works by reducing pain, inflammation and fever.
Cibalginafor is indicated for the treatment of pain of various origins and natures, including:
• heachache
• toothache
• neuralgia
• bone and joint pain
• muscle pain
• menstrual cramps
• as an adjunctive therapy in the treatment of fever and influenza symptoms.
Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment, if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
What you need to know before taking the medicine
Do not take Cibalginafor
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics), fever (antipyretics), non-steroidal anti-inflammatory drugs (NSAIDs), in particular when the allergy is associated with swelling of the nasal mucosa (nasal polyposis) or asthma;
• if you have had a severe ulcer in your stomach or upper intestine;
• if you have an ongoing ulcer;
• if you have had bleeding or ulcers that occur repeatedly (two or more distinct episodes of proven ulceration or bleeding);
• if you have had bleeding (haemorrhage) from the stomach and/or intestine or perforation after previous treatments with other medicines;
• if you have any diseases that make you bleed more easily;
• if you have severe liver or kidney failure;
• if you have a severe form of heart failure;
• if you are in the last three months of pregnancy (see section "Pregnancy, breast-feeding and fertility");
• if the patient is a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cibalginafor.
Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop Cibalginafor immediately and contact your doctor or emergency services immediately if you notice any of these signs.
Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Cibalginafor if you have:
• heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
Consult your doctor before taking Cibalginafor :
• if you are using other medicines that may modify the effect of Cibalginafor (see section "Other medicines and Cibalginafor")
• if you are in the first 6 months of pregnancy or if you are breast-feeding (see section "Pregnancy, breast-feeding and fertility").
Take special care and ask your doctor or pharmacist for advice :
• if you are a woman and are planning a pregnancy;
• if you are a woman and have fertility problems or are undergoing fertility investigations, because you should stop treatment with Cibalginafor;
• if the patient is an adolescent with dehydration problems;
• if you have asthma;
• if you have seasonal colds on an allergic basis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps);
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• if you have liver or kidney problems, except if you have a severe form of liver or kidney failure because in these cases you should not take Cibalginafor (see section 2 "Do not take Cibalginafor"). If you are in any doubt, ask your doctor;
• if you have hepatic porphyria;
• if you have or have had ulcerative colitis or Crohn's disease because these conditions may get worse;
• if you are using medicines that increase urine production (diuretics) or other medicines that may affect the way your kidneys work;
• if you have low body fluid volume (for example before or after major surgery);
• if you are undergoing or have undergone major surgery;
• if you have or have had heart problems, except if you have had a severe form of heart failure because in this case you should not take Cibalginafor (see paragraph 2 "Do not take Cibalginafor"). If you are in any doubt, ask your doctor;
• if you have stomach or intestinal problems, unless you have one or more conditions for which you should not take Cibalginafor (see section "Do not take Cibalginafor");
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin), corticosteroids given by mouth, injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Cibalginafor");
• if you have an autoimmune disease e.g. lupus erythematosus or connective tissue disease;
• if you have an infection – see section “Infections” below.
In these cases, your doctor will monitor you closely and periodically reassess the need for treatment with Cibalginafor. In addition, your doctor may perform periodic tests (such as monitoring of kidney function) to evaluate your condition during treatment with Cibalginafor.
Skin reactions
Serious skin reactions 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) have been reported in association with ibuprofen treatment.
Stop using Cibalginafor and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Stop taking Cibalginafor and contact your doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
Infections
Cibalginafor may hide the symptoms of infections such as fever and pain. It is therefore possible that Cibalginafor may delay adequate treatment of the infection, which could increase the risk of complications.
This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.
Stop treatment and inform your doctor if during treatment with Cibalginafor you develop :
• gastrointestinal bleeding or ulceration;
• sudden or severe skin reactions, as severe skin reactions that can be fatal have been reported very rarely;
• mucosal lesions or any other signs of allergic reaction;
• fluid retention and swelling from fluid accumulation (edema);
• signs and symptoms of liver problems or if liver function parameters are abnormal (visible in blood tests);
• unusual symptoms in the stomach and intestines especially at the beginning of treatment with Cibalginafor;
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, profound tiredness, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis);
• tension in the back of the neck, headache, nausea, vomiting, fever, disorientation because you may be suffering from aseptic meningitis. Patients with autoimmune diseases (Systemic Lupus Erythematosus, connective tissue disease) seem to be more predisposed to developing aseptic meningitis;
• symptoms of an infection (e.g. headache, fever) or if you notice worsening of an infection as Cibalginafor may hide the signs and symptoms of infection.
In these cases, the doctor will evaluate whether to continue or stop treatment with Cibalginafor.
Other important information :
• Gastrointestinal bleeding, ulceration or perforation, which may be fatal, may occur during treatment with NSAIDs, including ibuprofen, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. You should take the lowest effective dose of ibuprofen to reduce the risk of gastrointestinal toxicity and your doctor may prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 "How to take Cibalginafor").
• Avoid using ibuprofen during treatment with other NSAIDs administered by mouth, injection and rectal administration, including cyclooxygenase-2 selective inhibitors, because it increases the possibility of you experiencing side effects.
• Cases of aseptic meningitis have been reported during treatment with ibuprofen, although they are more likely in patients with lupus erythematosus or connective tissue diseases.
Children
Cibalginafor should not be given to children under 12 years of age.
Elderly patients
Elderly patients are more likely to experience adverse reactions, especially stomach or intestinal bleeding and perforation, which are usually more severe and can be fatal.
If you are elderly you should take the lowest dose of Cibalginafor.
As a precaution, your doctor may check your kidney function and prescribe medications that work by protecting the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Tell your doctor about any unusual stomach and intestinal symptoms, especially when you first start taking this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
If any of these effects occur during treatment with Cibalginafor, it is advisable to stop using the medicine and consult your doctor.
Stop using ibuprofen and see your doctor immediately if you notice any of the following symptoms:
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
Medicines such as Cibalginafor may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Uncommon side effects (may affect up to 1 in 100 people)
• allergic reactions including hives and itching
• heachache
• dizziness
• abdominal pain
• nausea
• difficulty digesting (dyspepsia)
• skin rash
Rare side effects (may affect up to 1 in 1,000 people)
• vomit
Very rare side effects (may affect up to 1 in 10,000 people)
• reduction in the number of platelets in the blood (thrombocytopenia)
• anemia
• reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis)
• reduction in the number of all cells present in the blood (pancytopenia)
• severe allergic reaction
• swelling due to fluid accumulation (angioedema)
• aseptic meningitis (infection of the meninges, membranes of the brain)
• ringing and buzzing in the ears (tinnitus)
• hearing impairment
• ulcer of the stomach or upper part of the intestine (peptic ulcer)
• perforation or bleeding from the stomach and/or intestines
• dark stools with blood (melena)
• vomiting blood due to bleeding from the stomach, esophagus and duodenum (hematemesis)
• inflammation of the mucosa of the mouth with ulceration (ulcerative stomatitis)
• inflammation of the stomach (gastritis)
• worsening of inflammation of the colon (colitis)
• worsening of chronic inflammatory disease of the digestive system (Crohn's disease)
• changes in tests to assess liver function
• liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
• skin and mucous membrane reactions, even serious ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• kidney failure
• damage to kidney tissue (papillary necrosis) (particularly in long-term therapy)
Unknown side effects (frequency cannot be estimated from the available data)
• widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Cibalginafor if you develop these symptoms and contact your doctor immediately. See also section 2.
• the skin becomes sensitive to light.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Following the instructions in the package leaflet reduces the risk of side effects.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
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NOTA BENE: le informazioni presenti nelle schede prodotto che potrete consultare in questo sito non devono essere interpretate come consulenza medica e non intendono, né possono sostituire le prescrizioni mediche. Le immagini, se presenti, sono fornite al solo scopo illustrativo e non costituiscono elemento identificativo.