VIVIN 330 mg/200 mg Tablets

Зміст інструкції

1. VIVIN C 330 mg/200 mg effervescent tablets
   1. WHAT VIVIN C IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING VIVIN C
   3. HOW TO TAKE VIVIN C
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VIVIN C
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

VIVIN C 330 mg/200 mg effervescent tablets

acetylsalicylic acid/ascorbic acid

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days of use at the maximum dose or after 5 days of continuous use.

Contents of this leaflet:

• 1. What VIVIN C is and what it is used for
• 2. What you need to know before you take VIVIN C
• 3. How to take VIVIN C
• 4. Possible side effects
• 5. How to store VIVIN C
• 6. Contents of the pack and other information

1. WHAT VIVIN C 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 (joint) and muscular (muscle) pain;
• febrile states and influenza-like and common cold syndromes.

Consult a 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.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VIVIN C

Do not take VIVIN C

• if you are allergic to the active ingredients (acetylsalicylic acid and ascorbic acid), to other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a confirmed tendency to bleeding (blood loss from blood vessels);
• if you suffer from gastropathies (diseases affecting the stomach), such as gastro-duodenal ulcer (lesion occurring at the level of the stomach or the first part of the intestine);
• if you have asthma (narrowing of the lower airways with resulting breathing difficulties);
• if you have a history of gastrointestinal bleeding (at the level of the stomach and intestine) or perforation (serious injury to the wall of the stomach or intestine) related to previous active treatments (directly aimed at curing a disease or injury);
• 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 kidney (decreased kidney function), heart or liver failure;
• 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 greater 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 taking medicines at the same time that could increase the risk of ulceration or bleeding, such as oral corticosteroids (drugs used as anti-inflammatory agents and in some cases of allergic reactions), anticoagulants (drugs that inhibit blood clotting), selective serotonin reuptake inhibitors (SSRIs, medicines used to treat 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 had a gastrointestinal disease in the past such as ulcerative colitis or Crohn's disease (chronic inflammatory diseases of the intestine), as these conditions may be exacerbated (worsened) (see section 4 “Possible side effects”);
• you have had high blood pressure and/or heart failure in the past, as fluid retention (tendency to retain fluids in the body) and edema (fluid accumulation in the tissues) have been reported in association with therapy with NSAIDs. The risk is higher in patients treated with diuretics.

It is advisable to consult your doctor if you present:

• glucose-6-phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, causes a disease characterized by reduced survival of red blood cells);
• gastric and intestinal disorders;
• reduced kidney function (decreased kidney function from mild to moderate);
• 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 may increase the hypoglycemic effect of sulfonylureas.

If you experience gastrointestinal bleeding or ulceration while 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 (diseases affecting the stomach or intestine), bleeding from the stomach and
intestine, ulceration or perforation have been reported, which can be fatal.
The risk of gastrointestinal bleeding, ulceration or perforation is greater with high doses of NSAIDs
in patients who have had ulcers in the past, especially if complicated by bleeding or
perforation (see section 4 “Possible side effects”). Individuals with a habit of consuming
large amounts of alcohol are more exposed to the risk of bleeding.
In these cases, treatment should be started at the lowest available dose and the possibility of using gastro-protective agents (e.g. misoprostol or
proton pump inhibitors) should be considered. The use of gastro-protective agents should also be considered
even if you are taking low doses of acetylsalicylic acid or other drugs that may increase the
risk of gastrointestinal events (see “Other medicines and VIVIN C”).
Side effects can be minimized by using the lowest effective dose for the shortest
duration possible necessary to control symptoms (see section 3 “How to take VIVIN
C”).
Serious skin reactions (of the skin), some of which have been fatal, including exfoliative dermatitis (severe erythema with
shedding 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 comes 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 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 a rash (sudden redness
of the skin), mucous membrane 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 skin of the face 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 (level of uric acid in the blood).
Surgery
If you are to undergo surgery (even minor, such as dental extractions) and in the
days before you have used acetylsalicylic acid or another NSAID, there is an increased risk of
bleeding and you should inform the surgeon about the possible effects on coagulation.
Menorrhagia or metrorrhagia: concomitant use 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”).
In children with viral infections (especially chickenpox and flu-like conditions) and treated with acetyl
salicylic acid, cases of Reye's syndrome have been observed, a very rare but life-threatening disease
requiring immediate medical intervention. This condition manifests 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 some muscles) and coma, signs of liver damage (liver) and
hypoglycemia (decrease in glucose concentration values in the blood).

Elderly
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially bleeding and
gastrointestinal perforations, which can 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 gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Individuals over 70 years of age, especially if they are undergoing other treatments, should take this
medicine only after consulting a doctor.

Other medicines and VIVIN C
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
other medicine.
Do not take VIVIN C together with these medicines (see “Do not take VIVIN C”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin (anticoagulant).

Caution should be exercised in patients taking concomitant medications that could increase the
risk of ulceration or bleeding or other adverse effects. Therefore, unless otherwise prescribed
medically, do not take VIVIN C if you are taking:

• corticosteroids, which may increase the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”);
• anticoagulants, which may increase the risk of bleeding, duodenal mucosa lesions, potentiation of the effects of these drugs and displacement of anticoagulants (see “Warnings and precautions”);
• low molecular weight heparin and fractionated heparins: increase the risk of bleeding;
• anagrelide, a drug used to decrease high levels of platelets in the blood and which may therefore increase the risk of bleeding;
• antiplatelet agents and selective serotonin reuptake inhibitors; in this case, concomitant administration with NSAIDs (such as VIVIN C) increases the risk of gastrointestinal bleeding (see “Warnings and precautions”);
• methotrexate (antineoplastic and antirheumatic drug used to treat some pathologies such as leukemia, lymphoma, rheumatoid arthritis, lupus and psoriasis at doses less than 15 mg/week), as this association, especially for prolonged periods, may increase the adverse effects of this medicine;
• diuretics (drugs to increase the amount of urine excreted) and antihypertensives: increases the risk of acute renal failure;
• pemetrexed a medicine used in the treatment of tumors;
• antidiabetics (drugs that reduce blood glucose concentration) such as sulfonylureas; concomitant administration with VIVIN C may increase the effects and side effects of these medicines;
• valproic acid: acetylsalicylic acid reduces the binding of valproic acid to serum albumin, increasing its plasma concentrations;
• metamizole (substance used to reduce pain and fever) may decrease the effect of acetylsalicylic acid on platelet aggregation (blood cells that attach and form a blood clot), if taken simultaneously. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection;
• urinary alkalinizers (e.g. antacids, citrates): reduce the absorption of the medicine;
• digoxin and lithium: acetylsalicylic acid reduces the excretion by the kidneys of digoxin and lithium with resulting increase in their plasma concentrations;
• carbonic anhydrase inhibitors (acetazolamide): reduced elimination of acetazolamide which may cause severe acidosis and increased toxicity to the central nervous system;
• phenytoin: increased effect of phenytoin;
• Metoclopramide and domperidone: increased effect of acetylsalicylic acid due to increased absorption rate;
• uricosurics (e.g.: probenecid, benzbromarone and sulfinpyrazone): decrease of the uricosuric effect;
• varicella vaccine: it is recommended not to administer salicylates to patients who have received varicella vaccination for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred following the use of salicylates during varicella infection;
• zafirlukast, a drug used in asthma whose blood concentration may increase;
• alcohol: increased risk of intestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
If you continue or start treatment with VIVIN C during pregnancy according to your doctor's instructions, then
use VIVIN C as recommended by your doctor and do not use a dose higher than the recommended one.
Pregnancy – last trimester
Do not take VIVIN C at a dose higher than 100 mg per day in the last 3 months of pregnancy as
it may harm the fetus or cause problems during childbirth. This medicine can cause problems with the kidneys
and heart of the fetus. In addition, it may affect your and your baby's tendency to bleed and delay or
prolong labour more than expected.
If you take VIVIN C at low doses (up to 100 mg per day inclusive), a strict obstetric monitoring is necessary
as recommended by your doctor.
Pregnancy – first and second trimester
You should not take VIVIN C in the first 6 months of pregnancy unless absolutely necessary and under
medical advice. If you need treatment during this period or during attempts to conceive,
the lowest dose should be used for the shortest possible time. If taken for more than a few days
from the 20th week of pregnancy onwards, VIVIN C can cause kidney problems in the fetus, reducing the levels
of amniotic fluid surrounding the baby (oligohydramnios) or a narrowing of a blood vessel
(ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor
may recommend additional monitoring.
In the early stages of pregnancy, the intake of prostaglandin synthesis inhibitors, such as
acetylsalicylic acid, at dosages between 100 and 500 mg per day or higher than 500 mg per day may increase
the risk of abortion (termination of pregnancy), heart malformations and gastroschisis (defect of
the abdominal wall of the fetus); in studies conducted on the population, the absolute risk of
heart malformations increased from less than 1% to about 1.5%; it has been observed that the risk
increases with dose and duration of therapy.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small quantities: VIVIN C should not be taken during
breastfeeding.
Fertility
If acetylsalicylic acid is used by a woman who is trying to conceive, the dose and duration of treatment
must be kept as low as possible.

Driving and operating machinery
VIVIN C does not alter the ability to drive vehicles or operate machinery.

VIVIN C effervescent tablets contains sodium.This medicine contains 485 mg of sodium (main component
of table salt) per tablet. This is equivalent to 24.25% of the maximum recommended daily intake
with the diet of an adult.

VIVIN C effervescent tablets contains sodium benzoate.This medicine contains 48 mg of sodium
benzoate per tablet equivalent to 48 mg / 3500mg.
The sodium content per effervescent tablet should be taken into consideration in people with reduced
kidney function, with high blood pressure or with heart failure who are following a low-sodium diet.

3. HOW TO TAKE VIVIN C

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 tablets, if necessary, up to 3-4 times a day.
Do not exceed the recommended dose and, especially if you are elderly, adhere to the minimum dosages: 1 tablet at most
3 times a day.
VIVIN C is not indicated for use in the pediatric population.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after three days of use
at the maximum dose or after 5 days of continuous use of VIVIN C.
Method of administration
Dissolve 1 or 2 tablets of VIVIN C in half a glass of water (non-carbonated).
Take this medicine on a full stomach.

If you take more VIVIN C than you should
In case of taking an excessive dose of the medicine, immediately contact a poison control center or the
nearest hospital.
Salicylate toxicity (a dosage higher than 100 mg/kg/day for 2 consecutive days can induce
toxicity) may be the consequence of chronic excessive doses or acute overdose,
potentially life-threatening and including accidental ingestion in children.
Moderate intoxication: ringing in the ears, a sensation of reduced hearing acuity, headache, dizziness
are the distinctive signs of an excessive dose of the medicine and can be controlled by reducing the dosage.
Severe poisoning: symptoms include fever, hyperventilation (breathing too deeply), ketosis (acetone),
respiratory alkalosis (alteration of the acid-base balance following alterations in breathing), metabolic
acidosis (accumulation of acidic molecules in the body), coma, cardiovascular collapse, respiratory
insufficiency, severe hypoglycemia (decrease in blood glucose concentration).
In these cases, necessary support measures are taken to limit the absorption of the drug in the
gastrointestinal tract through:

• gastric lavage (forced emptying of the stomach);
• administration of activated charcoal (substance that absorbs the excess drug on its surface);
• control of the acid-base balance;
• alkaline diuresis (alkalinize the urine);
• compensate for dehydration (excessive fluid loss) with adequate fluid administration;
• supportive symptomatic treatment.

If you forget to take VIVIN C
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. 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 side effects that can occur more commonly following the intake of VIVIN C are
of a gastrointestinal nature:

• nausea, vomiting, diarrhea, flatulence (presence of gas in the gastrointestinal tract), constipation (difficulty in emptying the intestines), dyspepsia (presence of pain or discomfort localized in the upper abdomen associated with food intake), abdominal pain, ulcerative stomatitis (severe inflammation of the oral mucosa, characterized by the presence of ulcers in the cheeks, tongue and lips), exacerbation of colitis (inflammation of the intestine at the portion called 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 can manifest with hematemesis (emission of blood with vomiting) and melena (presence of blood in the stool) and sometimes be fatal, or remain occult (i.e. does not manifest) and cause iron deficiency anemia (reduction in the amount of hemoglobin 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 can occur following the intake of VIVIN C are:

• edema (accumulation of fluids at the level of the body's tissues), hypertension and heart failure;
• bullous reactions (with formation of blisters on the skin), up to the more serious ones such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see “Warnings and precautions”);
• bleeding syndromes, such as epistaxis (bleeding from the nose), gum bleeding, thrombocytopenia (reduction of platelets in the blood), purpura (hemorrhagic disease characterized by the appearance of reddish-purple spots that do not disappear with pressure), with increased bleeding time;

this effect can last for 4-8 days even after discontinuation of VIVIN C administration
and can cause bleeding 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 the subcutaneous and submucosal tissues), Quincke's edema (rapid swelling of the tissues at the level of face, hands, feet, genitals and mucous membranes), urticaria (skin eruption characterized by the appearance of raised lesions generally accompanied by itching), erythema (redness and burning sensation on the skin), asthma, anaphylactic reactions (rapidly occurring allergic reactions);
• tinnitus (at the level of the ears), sensation of hearing loss, headache, dizziness;
• delayed labor;
• formation of oxalate and uric acid stones at the level of 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 experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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.

5. HOW TO STORE VIVIN C

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not store VIVIN C at a temperature above 25°C.
Keep the tube tightly closed to protect the medicine from humidity.
After the first opening of the tube, the shelf life of the medicine is 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What VIVIN C contains
Each effervescent tablet contains:

Active ingredients: acetylsalicylic acid 330 mg/ascorbic acid 200 mg.

Other ingredients: glycine, anhydrous citric acid, sodium bicarbonate, sodium benzoate.

Description of the appearance of VIVIN C and contents of the pack
Effervescent tablets of white colour.
Tube containing 10 or 20 effervescent tablets.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 – Florence.

Manufacturer
E-Pharma Trento S.p.A., via Provina 2, Trento (Italy)