VIVIN C*20EFF TABS 330MG+200MG

VIVIN C

What it is and what it is used for
VIVIN C contains the active ingredients acetylsalicylic acid (a prostaglandin synthesis inhibitor with anti-inflammatory and analgesic activity) and ascorbic acid (vitamin C). VIVIN C is used in adults for the symptomatic treatment of: - headache and toothache, neuralgia (severe pain caused by irritation of one or more nerves), menstrual pain (associated with the menstrual cycle), rheumatic pain (of the joints) and muscle pain (of the muscles); - feverish states and flu-like symptoms and colds. Consult your doctor if you do not feel better or if you feel worse after 3 days of use at the maximum dose or after 5 days of continuous use.

What you need to know before taking the medicine
Do not take VIVIN C - if you are allergic to the active ingredients (acetylsalicylic acid and ascorbic acid), to other analgesics / antipyretics / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine listed in paragraph 6); - if you have a confirmed tendency to bleeding (blood loss from blood vessels); - if you suffer from gastropathies (stomach diseases), for example gastro-duodenal ulcer (lesion that occurs in the stomach or the first part of the intestine); - if you have asthma (narrowing of the lower airways with consequent breathing difficulties); - if you have a history of gastrointestinal bleeding (in the stomach and intestine) or perforation (severe lesion of the stomach or intestinal wall) related to previous active treatments (directly aimed at treating a disease or lesion); - if you have a history of recurrent bleeding or peptic ulcer (erosion of the inner lining of the stomach, intestine or lower esophagus) (two or more distinct episodes of demonstrated ulceration or bleeding); - if you suffer from severe renal (kidney dysfunction), cardiac (heart) or hepatic (liver) insufficiency; - if you are taking methotrexate (at doses of 15 mg/week or more) or warfarin (see "Other medicines and VIVIN C"); - if you are in the third trimester of pregnancy, do not take a dose of acetylsalicylic acid higher than 100 mg per day (see "Pregnancy, breastfeeding and fertility"); - if you are breastfeeding. This medicine is also contraindicated in children and adolescents under 16 years of age (see "Children and adolescents").

Warnings and precautions
Consult your doctor or pharmacist before taking VIVIN C. Avoid taking VIVIN C in combination with other NSAIDs (non-steroidal anti-inflammatory drugs), including selective COX-2 inhibitors, such as celecoxib, valdecoxib, lumiracoxib, etc. (see "Other medicines and VIVIN C"). Take VIVIN C with caution if: - you are simultaneously taking medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used as anti-inflammatory drugs and in some cases of allergic reactions), anticoagulants (medicines that inhibit blood clotting), selective serotonin reuptake inhibitors (SSRIs, medicines used for the treatment of depression or obsessive-compulsive disorders), or antiplatelet agents (which reduce platelet aggregation) such as aspirin (see "Other medicines and VIVIN C") or if you are taking heparins; - you have a history of gastrointestinal disease such as ulcerative colitis or Crohn's disease (chronic inflammatory bowel diseases), as these conditions may be exacerbated (aggravated) (see paragraph 4 "Possible side effects"); - if you have a history of hypertension (high blood pressure) and/or heart failure, as fluid retention (tendency to retain fluids in the body) and edema (fluid accumulation in tissues) have been reported in association with NSAID therapy. The risk is greater in patients treated with diuretics. It is advisable to consult your doctor if you have: - glucose-6-phosphate dehydrogenase deficiency (an enzyme whose genetically determined absence leads to a disease characterized by reduced red blood cell survival); - gastric and intestinal disorders; - reduced kidney function (mild to moderate reduction in kidney function); - any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment; - if you are in the first or second trimester of pregnancy (see "Pregnancy, breastfeeding and fertility"); - if you are diabetic, as salicylates can increase the hypoglycemic effect of sulfonylureas. If bleeding or gastrointestinal ulceration occurs while you are taking VIVIN C, stop treatment immediately and do not resume it without first consulting your doctor. During treatment with all NSAIDs, at any time, with or without warning symptoms or a history of serious gastrointestinal events (stomach or intestinal diseases), bleeding in the stomach and intestine, ulceration or perforation, which can be fatal, have been reported. The risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses of NSAIDs in patients who have had a history of ulcers, especially if complicated by bleeding or perforation (see paragraph 4 "Possible side effects"). Individuals with a habit of consuming high amounts of alcohol are at greater risk of bleeding. In these cases, treatment should be initiated at the lowest available dose and the possibility of using gastroprotective agents (e.g., misoprostol or proton pump inhibitors) concurrently should be considered. The use of gastroprotective agents should also be considered if low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events are being taken (see "Other medicines and VIVIN C"). Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 3 "How to take VIVIN C"). Serious skin reactions (of the skin), some of which fatal, including exfoliative dermatitis (severe erythema with skin peeling), Stevens-Johnson syndrome (severe skin and mucous membrane disease often caused by an acute allergic reaction to drugs) and toxic epidermal necrolysis (the most severe degree of Stevens-Johnson syndrome in which the skin detaches in sheets), have been reported very rarely in association with the use of NSAIDs (see paragraph 4 "Possible side effects"). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Stop treatment with VIVIN C at the first appearance of skin rash (sudden reddening of the skin), mucosal lesions or any other sign of hypersensitivity (allergy). Acetylsalicylic acid and other NSAIDs can cause allergic reactions including asthma attacks, runny nose, angioedema (swelling of the facial skin and its mucous membranes) or urticaria (small spots on the skin accompanied by itching). In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe. Acetylsalicylic acid modifies uricemia (uric acid level in the blood). Surgery If you are undergoing surgery (even minor, e.g., tooth extractions) and have used acetylsalicylic acid or another NSAID in the preceding days, there is an increased risk of bleeding and you should inform the surgeon about the possible effects on coagulation. Metrorrhagia or menorrhagia: concomitant use of acetylsalicylic acid may increase the risk of greater intensity and duration of bleeding. Children and adolescents The use of VIVIN C is contraindicated in children and adolescents under 16 years of age (see "Do not take VIVIN C"). Cases of Reye's syndrome, a very rare but life-threatening disease requiring immediate medical attention, have been observed in children with viral infections (especially chickenpox and flu-like conditions) treated with acetylsalicylic acid. This pathology manifests with persistent vomiting and signs of progressive central nervous system damage such as lethargy (slowing of normal mental activities) leading to convulsions (involuntary contractions of some muscles) and coma, signs of liver injury and hypoglycemia (decrease in blood glucose concentration values). Elderly patients Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforations, which can be fatal (see paragraph 3 "How to take VIVIN C"). The risk is higher with increased doses of NSAIDs, so such patients should start treatment with the lowest available dose and the possibility of using gastroprotective agents (e.g., misoprostol or proton pump inhibitors) concurrently should be considered. Individuals over 70 years of age, especially if undergoing other treatments, should take this medicine only after consulting their doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are dependent on both the dose and the duration of treatment. The most common side effects that may occur after taking VIVIN C are gastrointestinal in nature: - nausea, vomiting, diarrhea, flatulence (presence of gas in the gastrointestinal tract), constipation (difficulty in emptying the intestine), dyspepsia (presence of pain or discomfort located in the upper abdomen associated with food intake), abdominal pain, ulcerative stomatitis (severe inflammation of the oral mucosa, characterized by the presence of ulcers on the cheeks, tongue and lips), exacerbation of colitis (inflammation of the intestine in the colon portion) and Crohn's disease (see "Warnings and precautions"); - peptic ulcer (erosion of the inner lining of the stomach, intestine or lower esophagus), also perforated; - gastrointestinal bleeding that can manifest as hematemesis (vomiting blood) and melena (presence of blood in the stools) and sometimes be fatal, or remain occult (i.e., not manifest) and cause iron deficiency anemia (reduction in the amount of hemoglobin resulting from an iron deficiency); such bleeding is more frequent with increasing dosage, particularly in elderly patients (see "Warnings and precautions"); - gastritis (less frequently). Other side effects that may occur after taking VIVIN C are: - edema (fluid accumulation in the body's tissues), hypertension and heart failure; - bullous reactions (with the formation of blisters on the skin), up to the most severe ones such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see "Warnings and precautions"); - hemorrhagic syndromes, such as epistaxis (nosebleed), gingival bleeding, thrombocytopenia (reduction of platelets in the blood), purpura (hemorrhagic disease characterized by the appearance of red-violet spots that do not disappear with pressure), with increased bleeding time; this effect can last for 4-8 days even after stopping VIVIN C administration and can cause hemorrhagic risk in patients undergoing surgery; - chronic hemolysis (destruction of red blood cells caused by an increase in the amount of vitamin C, greater than 1 gram, in the body), in patients with G6PD deficiency; - hypersensitivity reactions (allergy) such as angioedema (rapid swelling of subcutaneous and submucosal tissues), Quincke's edema (rapid swelling of tissues in the face, hands, feet, genitals and mucous membranes), urticaria (skin rash characterized by the appearance of raised lesions generally accompanied by itching), erythema (redness and burning sensation on the skin), asthma, anaphylactic reactions (rapid onset allergic reactions); - tinnitus (in the ears), feeling of reduced hearing, headache, dizziness; - delayed childbirth; - formation of oxalate and uric acid stones in the kidneys and urinary tract caused by high doses of vitamin C (greater than 1 gram); - rhinitis (runny nose), dyspnea (difficulty breathing); - bronchospasm (abnormal contraction of the smooth muscles of the bronchi or bronchioles), asthma attacks Reporting of side effects If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.