Package leaflet: Information for the user

VIVIN 500 mg tablets

acetylsalicylic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment at the maximum dose or after 5-7 days of continuous use.

Contents of this leaflet:

What VIVIN is and what it is used for
What you need to know before taking VIVIN
How to take VIVIN
Possible side effects
How to store VIVIN
Contents of the pack and other information

1. WHAT VIVIN IS AND WHAT IT IS USED FOR

VIVIN contains the active substance acetylsalicylic acid, which has antipyretic (reduces fever), anti-inflammatory, and analgesic properties.
VIVIN 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, rheumatic and muscular pain;
febrile conditions and influenza-like syndromes or 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 5–7 days of continuous use.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VIVIN

Do not take VIVIN

if you are allergic to the active substances, salicylates, or any of the other ingredients of this medicine (listed in section 6);
if you have bleeding disorders (tendency to bleed);
if you suffer from stomach disorders, such as gastric or duodenal ulcer;
if you have asthma;
if you have hypophosphatemia (low phosphate levels in the blood);
if you have a history of gastrointestinal bleeding or perforation (serious damage to the wall of the stomach or intestine) related to previous drug treatments;
if you have a history of recurrent bleeding or peptic ulcer (lesion of the stomach or intestine; two or more distinct episodes of proven ulceration or bleeding);
if you suffer from renal failure (reduced kidney function);
if you suffer from severe heart failure (severe reduction in heart function);
if you are in the last three months of pregnancy, you must not take a dose of acetylsalicylic acid exceeding 100 mg per day (see "Pregnancy, breastfeeding and fertility").

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.
Discontinue treatment if you experience prolonged vomiting and profound drowsiness.
Avoid taking VIVIN in combination with other NSAIDs (non-steroidal anti-inflammatory drugs), including
selective COX-2 inhibitors (see "Other medicines and VIVIN").
Take VIVIN with caution if:

you are concurrently taking medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids (drugs used as anti-inflammatory agents and in some cases for allergic reactions), anticoagulants (drugs that inhibit blood clotting) such as warfarin, selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression or obsessive-compulsive disorders), or antiplatelet agents such as aspirin (see "Other medicines and VIVIN");
you suffer from gastrointestinal diseases such as ulcerative colitis or Crohn's disease (chronic inflammatory bowel diseases), as these conditions may worsen (see section 4 "Possible side effects");
you suffer from hypertension and/or heart failure, as fluid retention (tendency to retain fluids in the body) and edema (fluid accumulation in tissues) have been reported with NSAID therapy.

Consult your doctor if:

you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic disorder causing destruction of red blood cells;
you have chronic or recurrent gastrointestinal disorders;
you are over 70 years old, especially if taking concomitant medications, as you are at higher risk of adverse effects, particularly gastrointestinal bleeding and perforation, which may be fatal (see section 3 "How to take VIVIN");
you are scheduled for surgery, as taking VIVIN before surgery may interfere with stopping bleeding during the procedure (intraoperative hemostasis);
kidney function is impaired.

If gastrointestinal bleeding or ulceration occurs while taking VIVIN, stop treatment immediately.
During treatment with all NSAIDs, at any time and with or without warning symptoms or history of serious
gastrointestinal events (stomach or intestinal disorders), bleeding, ulceration or perforation of the stomach and
intestine have been reported, which may be fatal.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses of NSAIDs in patients
who have previously experienced ulcers, especially if complicated by bleeding or perforation, and in elderly
patients (see section 4 "Possible side effects"). In these cases, treatment should be initiated at the lowest
available dose, and concomitant use of gastroprotective agents (e.g., misoprostol or proton pump inhibitors)
should be considered, even when low-dose acetylsalicylic acid or other drugs increasing the risk of
gastrointestinal events are being taken (see "Other medicines and VIVIN").
If you have previously experienced gastrointestinal toxicity (i.e., stomach and intestinal problems caused by
certain drugs, including NSAIDs), particularly if you are elderly, inform your doctor of any abdominal symptoms
(especially gastrointestinal bleeding), especially during the initial stages of treatment.
Acetylsalicylic acid and other NSAIDs may cause severe skin reactions, some of which are fatal
(exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), especially in the early stages
of therapy (see section 4 "Possible side effects"). These reactions usually occur within the first month of
treatment.
The use of certain NSAIDs (especially at high doses and for long-term treatment) may be associated with a
slight increase in the risk of arterial thrombotic events (e.g., myocardial infarction or stroke). A similar risk
cannot be ruled out for acetylsalicylic acid when administered at a daily dose of 1–2 tablets 2–3 times daily.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to
control symptoms (see section 3 "How to take VIVIN").
Consult your doctor after 3 days of use at the maximum dose or after 5–7 days of continuous use without
noticeable improvement.
Children and adolescents
The use of VIVIN is contraindicated in children and adolescents under 16 years of age (see "Do not take
VIVIN").
Other medicines and VIVIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Caution is required if you are taking concomitant medications that could increase the risk of ulceration,
bleeding, or other adverse effects. Therefore, unless otherwise prescribed by your doctor, do not take VIVIN
if you are taking:

corticosteroids, which may increase the risk of gastrointestinal ulceration or bleeding (see "Warnings and precautions");
anticoagulants, such as warfarin, coumarin derivatives, and heparin; NSAIDs may enhance the effects of these drugs (see "Warnings and precautions");
antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs); in this case, concomitant administration with NSAIDs (such as VIVIN) increases the risk of gastrointestinal bleeding (see "Warnings and precautions");
methotrexate (an antineoplastic and antirheumatic drug used to treat conditions such as leukemias, lymphomas, rheumatoid arthritis, lupus, and psoriasis), as this combination, especially over prolonged periods, may increase adverse effects of this medicine;
non-steroidal anti-inflammatory drugs (NSAIDs), as this combination, especially over prolonged periods, may increase adverse effects and secondary manifestations of the drug;
antidiabetic agents (drugs that reduce blood glucose concentration) such as sulfonylureas; concomitant use with VIVIN may enhance the effects and side effects of these medicines;
spironolactone, furosemide (medicines used to reduce blood pressure), and antigout agents (used to treat gout, a metabolic disorder characterized by recurrent attacks of acute inflammatory arthritis with pain, redness, and swelling of joints, caused by deposition of uric acid crystals); the effectiveness of these drugs may be reduced following concomitant administration of VIVIN.

Take VIVIN with caution during treatment with the following medicines:

diuretics or antihypertensives (ACE inhibitors and angiotensin II antagonists), as NSAIDs may reduce their antihypertensive effect. Furthermore, if you have impaired kidney function (e.g., if you are
dehydrated or elderly with reduced kidney function), co-administration may lead to further deterioration of kidney function, especially in the elderly, which is generally reversible.
You should be adequately hydrated, and monitoring of kidney function should be considered after starting concomitant therapy.
Metamizole (a substance used to relieve pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blood clot) when taken simultaneously. Therefore, this combination should be used cautiously in patients taking low-dose aspirin for cardioprotection.
Do not take any oral medication (by mouth) within 1–2 hours after taking VIVIN.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you continue or start treatment with VIVIN during pregnancy as instructed by your doctor, follow your doctor’s advice and do not exceed the recommended dose.
Pregnancy – third trimester
Do not take VIVIN at a dose exceeding 100 mg per day during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. This medicine may cause kidney and heart problems in the fetus. It may also affect your and your baby's tendency to bleed and may delay or prolong labor beyond expected duration.
If you take VIVIN at low doses (up to 100 mg per day inclusive), strict obstetric monitoring is required as advised by your doctor.
Pregnancy – first and second trimesters
You should not take VIVIN during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, VIVIN may cause kidney problems in the fetus, reducing amniotic fluid levels surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is needed, your doctor may recommend additional monitoring.
In early pregnancy, there may be an increased risk of miscarriage, congenital heart defects, and gastroschisis.
Breastfeeding
Consult your doctor before taking VIVIN while breastfeeding.
Fertility
The use of VIVIN is not recommended in women intending to become pregnant.
If you have fertility problems or are undergoing fertility investigations, discontinue VIVIN.
If acetylsalicylic acid is used by a woman trying to conceive, the dose and duration of treatment should be kept as low as possible.
Driving and use of machines
VIVIN does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.
VIVIN contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially "sodium-free".

3. HOW TO TAKE VIVIN

Take this medicine exactly as stated 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, 2–3 times daily.
Do not exceed the recommended dose, and especially if you are elderly, adhere to the lower dosages indicated above.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days of use at the maximum dose or after 5–7 days of continuous use of VIVIN.

Method of administration
Swallow the tablets with or without liquid (water), with food.

If you take more VIVIN than you should
If you take an excessive dose of this medicine, the following symptoms may occur: dizziness and tinnitus (ringing in the ears), which may be accompanied by nausea, vomiting, and gastric disturbances.
In more severe cases, confusion, stupor, collapse, convulsions, respiratory disorders, kidney problems, and sometimes hemorrhages may occur.
In case of overdose, contact your doctor immediately. The doctor will initiate necessary supportive measures to limit drug absorption in the gastrointestinal tract, such as gastric lavage (forced emptying of the stomach), administration of emetic agents (to induce vomiting), or aspiration.
In cases of milder intoxication, the doctor may advise you to drink large amounts of fluids.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions most commonly observed following administration of VIVIN are gastrointestinal in nature:

nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia (presence of pain or discomfort localized in the upper abdomen associated with food intake), abdominal pain, melaena (presence of blood in faeces), haematemesis (vomiting blood), ulcerative stomatitis (severe inflammation of the oral mucosa, characterized by ulcers in the cheeks, tongue and lips), exacerbation of colitis (inflammation of the intestine in 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 oesophagus);
gastrointestinal perforation or bleeding, sometimes fatal, particularly in elderly patients (see "Warnings and precautions");
gastritis (less frequently).

Other adverse reactions:

Hypersensitivity reactions, such as bronchospasm, skin manifestations, otovestibular disorders (tinnitus);
reduction in platelets (thrombocytopenia) and delayed labour;
haemorrhagic episodes such as epistaxis (nosebleed), gingival bleeding;
bullous reactions (formation of blisters on the skin), up to the most severe forms such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see "Warnings and precautions");
oedema (fluid accumulation in body tissues), hypertension and heart failure;
increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke), especially at high doses and with long-term treatment.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VIVIN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via 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 PACKAGE AND OTHER INFORMATION

What VIVIN contains
Each tablet contains:
Active ingredient: Acetylsalicylic acid 500 mg.
Other components: starch, sodium lauryl sulfate, colloidal silicon dioxide.
Description of the appearance of VIVIN and contents of the package
The tablets are supplied in packages containing 20 tablets of 500 mg.
Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite S.r.l. – Via Sette Santi, 3 – 50131 Florence.
Manufacturer
S.I.I.T. S.r.l. - Via Ariosto n. 50 – 20090 Trezzano sul Naviglio (MI)