VIVIN C "330 MG + 200 MG EFFERVESCENT TABLETS" 20 TABLETS"

Name
VIVIN C 330 mg/200 mg effervescent tablets
Acetylsalicylic acid/ascorbic acid


What it is and what it is used for
VIVIN C contains the active ingredients acetylsalicylic acid (an inhibitor of prostaglandin synthesis 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 muscular pain (of the muscles);
- feverish states and flu and cold syndromes.

Contact 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 substances (acetylsalicylic acid and ascorbic acid), to other analgesics (painkillers)/antipyretics (fever relievers)/non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
- if you have a known tendency to haemorrhage (loss of blood from blood vessels);
- if you suffer from gastropathies (stomach diseases), for example gastroduodenal ulcer (lesion that occurs in the stomach or the first part of the intestine);
- if you have asthma (narrowing of the lower airways resulting in breathing difficulties);
- if you have a history of gastrointestinal bleeding (in the stomach and intestines) or perforation (serious injury to the wall of the stomach or intestine) related to previous active treatments (directed immediately to the treatment of an illness or injury);
- if you have a history of bleeding or recurrent peptic ulcer (erosion of the inner lining of the stomach, intestine or lower oesophagus) (two or more distinct episodes of proven ulceration or bleeding);
- if you suffer from severe renal (decreased kidney function), 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 last three months of pregnancy, do not take a dose of acetylsalicylic acid higher than 100 mg per day (see "Pregnancy, breast-feeding 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
Talk to 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 colecoxib, valdecoxib, lumiracoxib, etc. (see "Other medicines and VIVIN C").

Take VIVIN C with caution if:
- are taking medicines at the same time which could increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used as anti-inflammatories and in some cases of allergic reactions), anticoagulants (medicines that inhibit blood clotting), selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression or obsessive-compulsive disorder), or anti-platelet agents (which reduce the aggregation of platelets) such as aspirin (see "Other medicines and VIVIN C") or if you are taking heparins;
- have had a gastrointestinal disease such as ulcerative colitis or Crohn's disease (chronic inflammatory bowel disease) in the past, as these conditions may be exacerbated (made worse) (see section 4 "Possible side effects");
- if you have had hypertension (increased blood pressure) and/or heart failure in the past, since fluid retention (tendency to retain fluids in the body) and oedema (accumulation of fluids in the tissues) have been reported in association with NSAID therapy. The risk is higher in patients treated with diuretics.

It is advisable to consult your doctor if you experience :
- glucose-6-phosphate dehydrogenase deficiency (an enzyme whose genetically determined absence leads to a disease characterized by reduced survival of red blood cells);
- gastric and intestinal disorders;
- reduced renal function (mild to moderate reduction in kidney function);
- any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in early treatment;
- if you are in the first or second trimester of pregnancy (see "Pregnancy, breast-feeding and fertility");
- if you are diabetic, as salicylates may increase the hypoglycaemic effect of sulfonylureas.

If gastrointestinal bleeding or ulceration occurs while taking VIVIN C, stop treatment immediately and do not restart without first consulting your doctor.

Stomach and intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal (GI) events.

The risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses of NSAIDs in patients who have had ulcers in the past, particularly if complicated by bleeding or perforation (see section 4 "Possible side effects"). Patients who are accustomed to drinking large quantities of alcohol are at increased risk of bleeding.

In these cases, treatment should be started at the lowest available dose and the possibility of using concomitant gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. The use of gastro-protective agents should also be considered if low dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events are being taken (see "Other medicines and VIVIN C").

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 3 "How to take VIVIN C").

Serious skin reactions, some of them fatal, including exfoliative dermatitis (severe erythema with peeling of the skin), Stevens-Johnson syndrome (a serious disease of the skin and mucous membranes 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 peels off in sheets), have been reported very rarely in association with the use of NSAIDs (see section 4 "Possible side effects"). Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.

Stop treatment with VIVIN C at the first appearance of skin rash (sudden redness of the skin), mucosal lesions or any other sign of hypersensitivity (allergy) .

Acetylsalicylic acid and other NSAIDs may cause allergic reactions including asthma attacks, runny nose, angioedema (swelling of the skin and mucous membranes of the face) or urticaria (small itchy spots on the skin).
In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe.

Acetylsalicylic acid changes uricemia (level of uric acid in the blood).

Surgery
If you are undergoing surgery (even minor surgery, such as tooth extraction) and have taken acetylsalicylic acid or another NSAID in the previous few days, there is an increased risk of bleeding and you should inform your surgeon due to the possible effects on coagulation.

Metrorrhagia or menorrhagia: Concomitant intake of acetylsalicylic acid may increase the risk of greater intensity and duration of bleeding.

Children and adolescents
Taking 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 that requires immediate medical attention, have been observed in children with viral infections (especially chickenpox and flu-like conditions) who have been treated with acetylsalicylic acid. This disease manifests itself with persistent vomiting and signs of progressive damage to the central nervous system such as torpor (slowing of normal mental activity) up to convulsions (involuntary contractions of certain muscles) and coma, signs of liver damage and hypoglycemia (decrease in blood glucose concentration values).

Elderly people
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 3 "How to take VIVIN C"). The risk is higher with increased doses of NSAIDs, therefore these patients should start treatment with the lowest available dose and the possibility of using concomitant gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
People over 70 years of age, especially if they are 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 following the intake of VIVIN C are gastrointestinal in nature:
- nausea, vomiting, diarrhoea, flatulence (gas in the gastrointestinal tract), constipation (difficulty emptying the bowel), dyspepsia (pain or discomfort in the upper abdomen associated with food intake), abdominal pain, ulcerative stomatitis (serious inflammation of the oral mucosa, characterised by the presence of ulcers on the cheeks, tongue and lips), exacerbation of colitis (inflammation of the intestine at the level of the part called the colon) and Crohn's disease (see "Warnings and precautions");
- peptic ulcer (erosion of the inner lining of the stomach, intestine or lower esophagus), even perforated;
- gastrointestinal bleeding which may manifest itself with haematemesis (vomiting blood) and melena (presence of blood in the stool) and sometimes be fatal, or remain occult (i.e. does not manifest itself) and cause iron deficiency anaemia (reduction in the quantity of haemoglobin resulting from 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 following the intake of VIVIN C are :
- edema (accumulation of fluid in the body's tissues), hypertension and heart failure;
- bullous reactions (with the formation of blisters on the skin), up to the most serious ones such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see "Warnings and precautions");
- haemorrhagic syndromes, such as epistaxis (nosebleeds), gum haemorrhages, thrombocytopenia (reduction of platelets in the blood), purpura (a haemorrhagic disease characterised by the appearance of red-purple spots that do not disappear when pressed), with increased bleeding time; this effect may last for 4-8 days even after stopping the administration of VIVIN C and may cause a haemorrhagic risk in patients undergoing surgery;
- chronic hemolysis (destruction of red blood cells caused by increased amount of vitamin C, greater than 1 gram, in the body), in patients with G6PD deficiency;
- hypersensitivity (allergy) reactions such as angioedema (rapid swelling of the tissues under the skin and under the mucous membranes), Quincke's edema (rapid swelling of the tissues of the face, hands, feet, genitals and mucous membranes), urticaria (skin rash characterised by the appearance of raised lesions generally accompanied by itching), erythema (redness and burning sensation of the skin), asthma, anaphylactic reactions (rapidly appearing allergic reactions);
- ringing in the ears (tinnitus), sensation of decreased hearing, headache, dizziness;
- delayed delivery;
- 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.