CIBALGINA
CIBALGINA DUE FAST 200 MG GASTRO-RESISTANT TABLETS 12 TABLETS
CIBALGINA DUE FAST 200 MG GASTRO-RESISTANT TABLETS 12 TABLETS
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Description
Description
Name
Cibalgina Due Fast 200 mg gastro-resistant tablets
Ibuprofen
What is it and what is it for?
Cibalgina Due Fast contains the active ingredient ibuprofen, which belongs to the class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). Cibalgina Due Fast works by reducing pain, inflammation, and fever.
Cibalgina Due Fast is indicated for the treatment of pain of various origins and natures, including:
• heachache
• toothache
• neuralgia
• bone and joint pain
• muscle pain
• menstrual cramps
The medicine is also indicated as an adjunctive therapy in the treatment of fever and flu symptoms.
Talk to your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.
What you need to know before taking the medicine
Do not take Cibalgina Due Fast
• 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) such as non-steroidal anti-inflammatory drugs (NSAIDs), in particular when the allergy is associated with swelling of the nasal mucosa (nasal polyposis), asthma and swelling generally of the eyes, lips, tongue, throat, and presents with an asthmatic reaction (bronchospasm), hives or a severe cold (acute rhinitis) (see section "Warnings and precautions");
• 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 bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
• if you have a severe form of liver or kidney failure;
• if you have a severe form of heart failure;
• if you have an alteration in the production of blood cells, the cause of which is not known;
• if you are in the last 3 months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
• if the patient is a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cibalgina Due Fast.
Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop Cibalgina Due Fast immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Anti-inflammatory/painkiller medications 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 Cibalgina Due Fast 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 ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.
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 if you are undergoing fertility investigations, why should you stop treatment with Cibalgina Due Fast?
• if the patient is an adolescent with problems of dehydration, because in this case the medicine can cause kidney problems
• if you have asthma
• if you have seasonal colds caused by allergies (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
• if you have difficulty breathing (bronchospasm)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver, kidney, or heart problems, unless you have a severe form of liver, kidney, or heart failure, because in these cases you should not take Cibalgina Due Fast (see section 2 "Do not take Cibalgina Due Fast"). 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 stomach or intestinal problems, unless you have one or more conditions for which you should not take Cibalgina Due Fast (see section "Do not take Cibalgina Due Fast")
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids administered orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Cibalgina Due Fast")
• 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 Cibalgina Due Fast. Additionally, your doctor may perform periodic tests (such as monitoring your kidney function) to evaluate your condition during treatment with Cibalgina Due Fast.
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 Cibalgina Due Fast and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Stop taking Cibalgina Due Fast and contact your doctor immediately if you develop a 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
Cibalgina Due Fast may mask the symptoms of infections, such as fever and pain. Therefore, Cibalgina Due Fast may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact your doctor immediately.
Stop treatment and inform your doctor if during treatment with Cibalgina Due Fast 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 Cibalgina Due Fast
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis)
• Neck tension, headache, nausea, vomiting, fever, disorientation because you may be suffering from aseptic meningitis. Patients with autoimmune diseases (systemic lupus erythematosus, connective tissue disease) appear 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 Cibalgina Due Fast may hide the signs and symptoms of infection.
In these cases, the doctor will evaluate whether to continue or discontinue treatment with Cibalgina Due Fast.
Other important information :
• Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, may occur during treatment with NSAIDs, including ibuprofen. This 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 medications (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 Cibalgina Due Fast").
• Avoid using ibuprofen during treatment with other NSAIDs administered by mouth, injection and rectally, including selective cyclooxygenase-2 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
Cibalgina Due Fast is contraindicated in 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 dosage of Cibalgina Due Fast.
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.
Side effects depend on the dose and may vary from patient to patient.
If any of these effects appear during treatment with Cibalgina Due Fast, it is advisable to stop using the medicine and consult your doctor.
The most commonly observed adverse events involve the stomach and/or intestines. Stomach or upper intestinal ulcers (peptic ulcers), perforation, or bleeding from the stomach and/or intestines may occur, which can be fatal, especially in the elderly.
In particular, the risk of bleeding from the stomach and/or intestine depends on the dose and duration of treatment.
In addition to the side effects listed below, dark stools with blood (melena) and vomiting blood (hematemesis) due to bleeding from the stomach, esophagus and duodenum have been reported after administration of Cibalgina Due Fast.
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 Cibalgina Due Fast may be associated with a small increased risk of heart attack (infarction) or stroke (see section "Warnings and precautions").
Common side effects (may affect up to 1 in 10 people)
• difficulty digesting (dyspepsia)
• abdominal pain
• nausea
• vomit
• drowsiness
Uncommon side effects (may affect up to 1 in 100 people)
• allergic reactions including skin rash, hives, itching and asthma attacks
• heachache
• dizziness
• insomnia
• agitation
• irritability
• fatigue
• skin rash
Rare side effects (may affect up to 1 in 1,000 people)
• 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
• 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 a chronic inflammatory disease of the digestive system (Crohn's disease)
• kidney failure
• damage to kidney tissue (papillary necrosis) (particularly in long-term therapy)
• increased concentration of uric acid in the blood
Very rare side effects (may affect up to 1 in 10,000 people)
• worsening of inflammation associated with infection (e.g. development of necrotizing fasciitis)
• 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 (anaphylactic reaction)
• swelling due to fluid accumulation (angioedema)
• aseptic meningitis (infection of the meninges, membranes of the brain)
• changes in tests to evaluate liver function
• liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
• liver damage, particularly in long-term therapy
• skin and mucous membrane reactions, even severe ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Unknown side effects (frequency cannot be estimated from the available data)
• mental changes (psychotic reactions)
• depression
• vision problems
• irregular heartbeat (palpitations)
• swelling (edema)
• heart failure
• heart attack
• high blood pressure (hypertension)
• inflammation of the esophagus (esophagitis)
• inflammation of the pancreas (pancreatitis)
• small intestine obstructions due to the formation of a thin wall
• gas emission (flatulence)
• diarrhea
• constipation (constipation)
• formation of edema particularly in patients with high blood pressure or kidney problems (renal failure, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute kidney failure
• 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 Cibalgina Due Fast 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 an allergic reaction
potentially serious called Kounis syndrome.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
Cibalgina Due Fast 200 mg gastro-resistant tablets
Ibuprofen
What is it and what is it for?
Cibalgina Due Fast contains the active ingredient ibuprofen, which belongs to the class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). Cibalgina Due Fast works by reducing pain, inflammation, and fever.
Cibalgina Due Fast is indicated for the treatment of pain of various origins and natures, including:
• heachache
• toothache
• neuralgia
• bone and joint pain
• muscle pain
• menstrual cramps
The medicine is also indicated as an adjunctive therapy in the treatment of fever and flu symptoms.
Talk to your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.
What you need to know before taking the medicine
Do not take Cibalgina Due Fast
• 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) such as non-steroidal anti-inflammatory drugs (NSAIDs), in particular when the allergy is associated with swelling of the nasal mucosa (nasal polyposis), asthma and swelling generally of the eyes, lips, tongue, throat, and presents with an asthmatic reaction (bronchospasm), hives or a severe cold (acute rhinitis) (see section "Warnings and precautions");
• 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 bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
• if you have a severe form of liver or kidney failure;
• if you have a severe form of heart failure;
• if you have an alteration in the production of blood cells, the cause of which is not known;
• if you are in the last 3 months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
• if the patient is a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cibalgina Due Fast.
Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop Cibalgina Due Fast immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Anti-inflammatory/painkiller medications 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 Cibalgina Due Fast 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 ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.
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 if you are undergoing fertility investigations, why should you stop treatment with Cibalgina Due Fast?
• if the patient is an adolescent with problems of dehydration, because in this case the medicine can cause kidney problems
• if you have asthma
• if you have seasonal colds caused by allergies (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
• if you have difficulty breathing (bronchospasm)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver, kidney, or heart problems, unless you have a severe form of liver, kidney, or heart failure, because in these cases you should not take Cibalgina Due Fast (see section 2 "Do not take Cibalgina Due Fast"). 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 stomach or intestinal problems, unless you have one or more conditions for which you should not take Cibalgina Due Fast (see section "Do not take Cibalgina Due Fast")
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids administered orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Cibalgina Due Fast")
• 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 Cibalgina Due Fast. Additionally, your doctor may perform periodic tests (such as monitoring your kidney function) to evaluate your condition during treatment with Cibalgina Due Fast.
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 Cibalgina Due Fast and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Stop taking Cibalgina Due Fast and contact your doctor immediately if you develop a 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
Cibalgina Due Fast may mask the symptoms of infections, such as fever and pain. Therefore, Cibalgina Due Fast may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact your doctor immediately.
Stop treatment and inform your doctor if during treatment with Cibalgina Due Fast 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 Cibalgina Due Fast
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis)
• Neck tension, headache, nausea, vomiting, fever, disorientation because you may be suffering from aseptic meningitis. Patients with autoimmune diseases (systemic lupus erythematosus, connective tissue disease) appear 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 Cibalgina Due Fast may hide the signs and symptoms of infection.
In these cases, the doctor will evaluate whether to continue or discontinue treatment with Cibalgina Due Fast.
Other important information :
• Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, may occur during treatment with NSAIDs, including ibuprofen. This 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 medications (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 Cibalgina Due Fast").
• Avoid using ibuprofen during treatment with other NSAIDs administered by mouth, injection and rectally, including selective cyclooxygenase-2 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
Cibalgina Due Fast is contraindicated in 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 dosage of Cibalgina Due Fast.
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.
Side effects depend on the dose and may vary from patient to patient.
If any of these effects appear during treatment with Cibalgina Due Fast, it is advisable to stop using the medicine and consult your doctor.
The most commonly observed adverse events involve the stomach and/or intestines. Stomach or upper intestinal ulcers (peptic ulcers), perforation, or bleeding from the stomach and/or intestines may occur, which can be fatal, especially in the elderly.
In particular, the risk of bleeding from the stomach and/or intestine depends on the dose and duration of treatment.
In addition to the side effects listed below, dark stools with blood (melena) and vomiting blood (hematemesis) due to bleeding from the stomach, esophagus and duodenum have been reported after administration of Cibalgina Due Fast.
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 Cibalgina Due Fast may be associated with a small increased risk of heart attack (infarction) or stroke (see section "Warnings and precautions").
Common side effects (may affect up to 1 in 10 people)
• difficulty digesting (dyspepsia)
• abdominal pain
• nausea
• vomit
• drowsiness
Uncommon side effects (may affect up to 1 in 100 people)
• allergic reactions including skin rash, hives, itching and asthma attacks
• heachache
• dizziness
• insomnia
• agitation
• irritability
• fatigue
• skin rash
Rare side effects (may affect up to 1 in 1,000 people)
• 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
• 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 a chronic inflammatory disease of the digestive system (Crohn's disease)
• kidney failure
• damage to kidney tissue (papillary necrosis) (particularly in long-term therapy)
• increased concentration of uric acid in the blood
Very rare side effects (may affect up to 1 in 10,000 people)
• worsening of inflammation associated with infection (e.g. development of necrotizing fasciitis)
• 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 (anaphylactic reaction)
• swelling due to fluid accumulation (angioedema)
• aseptic meningitis (infection of the meninges, membranes of the brain)
• changes in tests to evaluate liver function
• liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
• liver damage, particularly in long-term therapy
• skin and mucous membrane reactions, even severe ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Unknown side effects (frequency cannot be estimated from the available data)
• mental changes (psychotic reactions)
• depression
• vision problems
• irregular heartbeat (palpitations)
• swelling (edema)
• heart failure
• heart attack
• high blood pressure (hypertension)
• inflammation of the esophagus (esophagitis)
• inflammation of the pancreas (pancreatitis)
• small intestine obstructions due to the formation of a thin wall
• gas emission (flatulence)
• diarrhea
• constipation (constipation)
• formation of edema particularly in patients with high blood pressure or kidney problems (renal failure, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute kidney failure
• 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 Cibalgina Due Fast 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 an allergic reaction
potentially serious called Kounis syndrome.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
CIBALGINA
CIBALGINA DUE FAST 200 MG GASTRO-RESISTANT TABLETS 12 TABLETS
CIBALGINA DUE FAST 200 MG GASTRO-RESISTANT TABLETS 12 TABLETS
MINSAN code: 029500030
Previous price: €8,50
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€8,50
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