Painkiller useful in the symptomatic treatment of fever and flu.
Indications
Cibalginafor 400 mg granules for oral solution is indicated in case of pain of various origins and nature: headache, toothache, neuralgia, muscle and osteoarticular pain, menstrual pain.
Composition
Active ingredients
Ibuprofen 400 mg Excipients with known effects aspartame, sucrose, potassium bicarbonate
Excipients
Sucrose, potassium bicarbonate, orange flavoring, acesulfame potassium, aspartame.
Directions for use and Dosage
Adults, Elderly and adolescents over 12 years: one sachet 2-3 times a day.
Warnings
Do not exceed the dose of 1200 mg (3 tablets or 3 sachets) in 24 hours. Elderly patients should stick to the minimum doses indicated. If use of the medicine is necessary for more than one day, the patient should be advised to discontinue use. 3 days in adolescents, or in case of worsening of symptoms, a doctor should be consulted.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Do not administer to children under 12 years of age;
- Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis, angioedema and/or asthma;
- Severe or active peptic ulcer;
- History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
- Severe hepatic or renal insufficiency. - Severe heart failure (NYHA class IV);
- Third trimester of pregnancy;
- Cibalginafor should not be administered to patients with clinical conditions that increase the tendency to bleed;
Undesirable effects
| Blood and lymphatic system disorders |
| Very rare: | Thrombocytopenia, anaemia, leukopenia, pancytopenia, agranulocytosis¹. |
| Immune system disorders |
| Uncommon: | Hypersensitivity reactions including urticaria and pruritus |
| Very rare: | Anaphylactic reaction, angioedema. |
| Nervous system disorders |
| Uncommon: | Headache, dizziness. |
| Very rare: | Aseptic meningitis² |
| Ear and labyrinth disorders |
| Very rare: | Tinnitus, hearing impaired. |
| Gastrointestinal disorders |
| Uncommon: | Abdominal pain, nausea, dyspepsia. |
| Rare: | Vomiting. |
| Very rare: | Peptic ulcer, gastrointestinal perforation or haemorrhage, melaena, haematemesis, ulcerative stomatitis, gastritis. Worsening of colitis and Crohn's disease. |
| Hepatobiliary disorders |
| Very rare: | Abnormal liver function tests, abnormal liver function, jaundice, hepatitis. |
| Skin and subcutaneous tissue disorders |
| Uncommon: | Rash. |
| Very rare: | Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis. |
| Not known: | Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), photosensitivity reactions. |
| Renal disorders |
| Very rare: | Renal failure, papillary necrosis³. |
1) The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding.
2) The first symptoms are: neck tension, headache, nausea, vomiting, fever, disorientation
3) Especially with prolonged use
Pregnancy and breastfeeding
- Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Cibalginafor should not be administered unless clearly necessary. If Cibalginafor is used by women attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: – cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); – renal dysfunction that may progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: – possible prolongation of bleeding time, an antiplatelet effect that may occur even at very low doses; – inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Cibalginafor is contraindicated during the third trimester of pregnancy.
- Breastfeeding: Like other NSAIDs, ibuprofen passes into breast milk in small amounts. Although no adverse effects in breastfeeding infants are known to date, caution should be exercised when ibuprofen is administered to a breastfeeding woman.
- Fertility: There is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause a reduction in female fertility by affecting ovulation. This effect, however, is reversible upon discontinuation of treatment.
Format
12 sachets
Product Code:FRCM172147
Price Trend
This product has been on sale since 07/07/2022
In the last 30 days, the product's lowest price
was 8,35 €
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