VIVIN 500 mg Tabletka

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1. VIVIN 500 mg tablets
   1. WHAT IS VIVIN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING VIVIN
   3. HOW TO TAKE VIVIN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VIVIN
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

VIVIN 500 mg tablets

acetylsalicylic acid

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 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days of use at the maximum dose or after 5-7 days of continuous use.

Contents of this leaflet:

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

1. WHAT IS VIVIN AND WHAT IT IS USED FOR

VIVIN contains the active ingredient acetylsalicylic acid with antipyretic activity (reduces fever),
anti-inflammatory and analgesic activity.
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 states and influenza-like and common cold syndromes.

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 ingredients, 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 diseases of the stomach, such as gastro-duodenal ulcer);
• if you have asthma;
• if you have hypophosphatemia (low phosphate concentration in the blood);
• if you have a history of gastrointestinal bleeding or perforation (serious injury to the wall of the stomach or intestine) related to previous pharmacological treatments
• if you have a history of recurrent bleeding or peptic ulcer (lesion at the level of the stomach or intestine) (two or more distinct episodes of demonstrated ulceration or bleeding);
• if you suffer from kidney failure (decreased 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 should not take a dose of acetylsalicylic acid greater than 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
Consult your doctor or pharmacist before taking VIVIN.
Stop treatment if you experience prolonged vomiting and deep 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 taking drugs 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) such as warfarin, selective serotonin reuptake inhibitors (SSRIs, drugs used to treat depression or obsessive-compulsive disorders), or antiplatelet agents (which reduce platelet aggregation) such as aspirin (see “Other medicines and VIVIN”);
• you suffer from a gastrointestinal disease such as ulcerative colitis or Crohn's disease (chronic inflammatory diseases of the intestine), as these conditions may be aggravated (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 the tissues) have been reported in association with NSAID therapy.

Consult your doctor if:

• you have a glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic disease that causes the destruction of red blood cells
• you have chronic or recurrent gastric and intestinal disorders;
• you are over 70 years of age, especially in the presence of concomitant therapies, as you are at risk of greater side effects, especially gastrointestinal bleeding and perforations, which can be fatal (see section 3 “How to take VIVIN”);
• you are to undergo surgery as taking VIVIN before surgery may hinder the stopping of bleeding during surgery (intraoperative hemostasis).
• impaired kidney function.

If gastrointestinal bleeding or ulceration occurs while you are taking VIVIN, stop
treatment immediately.
During treatment with all NSAIDs, at any time, with or without warning symptoms or a history of
serious gastrointestinal events (diseases of 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, and in the elderly (see section 4 “Possible side effects”). In these cases, treatment
should be started at the lowest available dose and the possibility of using gastroprotective agents (e.g.
misoprostol or proton pump inhibitors) should 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”).
If you have suffered from gastrointestinal toxicity in the past (i.e. problems with the stomach and
intestine caused
by the use of certain drugs, including NSAIDs), especially if you are elderly, you should report any
abdominal symptoms (especially gastrointestinal bleeding) to your doctor, particularly in the early stages of
treatment.
Acetylsalicylic acid and other NSAIDs can cause serious 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”). The onset of reactions occurs in most cases within the first month of treatment.
The use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with
a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). It is not
possible
to exclude a similar risk for acetylsalicylic acid when it is administered at a daily dose of 1–
2 tablets 2–3 times a day.
Side effects can be minimized by using the lowest effective dose for the shortest
duration of treatment 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
appreciable results.

Children and adolescents
Taking VIVIN is contraindicated in children and adolescents under 16 years of age (see “Do not
take VIVIN”).

Other medicines and VIVIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Caution should be exercised if you take concomitant medicines that could increase the risk of
ulceration or bleeding or other side effects. Therefore, unless otherwise prescribed by your doctor, do not
take VIVIN if you are taking:

• corticosteroids, which can increase the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”);
• anticoagulants, such as warfarin, coumarin derivatives and heparin; NSAIDs may increase the effects of these drugs (see “Warnings and precautions”);
• antiplatelet agents and selective serotonin reuptake inhibitors; concomitant administration with NSAIDs (such as VIVIN) increases the risk of gastrointestinal bleeding (see “Warnings and precautions”);
• methotrexate (antineoplastic and antirheumatic drug used to treat some diseases such as leukemia, lymphoma, rheumatoid arthritis, lupus and psoriasis), as this association, especially for prolonged periods, may increase the side effects of this medicine;
• non-steroidal anti-inflammatory drugs (NSAIDs), as this association, especially for prolonged periods, may increase the effects and side effects of the medicine;
• antidiabetics (drugs that reduce glucose concentration in the blood) such as sulfonylureas; concomitant intake with VIVIN may increase the effects and side effects of these medicines;
• spironolactone, furosemide (medicines used to reduce blood pressure) and antigout medicines (used to treat gout, a metabolic disease characterized by recurrent attacks of acute inflammatory arthritis with pain, redness and swelling of the joints), the effectiveness of these drugs may be reduced following the concomitant administration of VIVIN.

Take VIVIN with caution during treatment with the following medicines:

• diuretics or antihypertensives (ACE inhibitors and angiotensin II receptor antagonists), as NSAIDs may reduce their antihypertensive effect. Also, if you have impaired kidney function (for example if you are

dehydrated or if you are elderly with reduced kidney function), co-administration may lead to a
further deterioration of kidney function, especially if you are elderly, generally reversible.
You should be adequately hydrated and monitoring of
kidney function should be considered after starting concomitant therapy.
Metamizole (a 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
concurrently. Therefore, this combination should be used with caution in patients
taking low-dose aspirin for cardioprotection.
Do not take any medicine orally (by mouth) within 1-2 hours of taking VIVIN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you continue or start treatment with VIVIN during pregnancy according to your doctor's instructions, then
use VIVIN as recommended by your doctor and do not use a dose higher than recommended.
Pregnancy – last trimester
Do not take VIVIN 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 labor more than expected.
If you take VIVIN at low doses (up to 100 mg per day inclusive), strict obstetric monitoring as
recommended by your doctor is necessary.
Pregnancy – first and second trimester
You should not take VIVIN 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 may cause kidney problems in the fetus by 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, there may be an increased risk of abortion, heart malformations
and gastroschisis.
Breastfeeding
Consult your doctor before taking VIVIN during breastfeeding.
Fertility
The use of VIVIN is not recommended in women who intend to become pregnant.
If you have fertility problems or are undergoing fertility investigations, stop taking
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 using machines
VIVIN does not impair or negligibly impairs the ability to drive vehicles or operate machinery.
VIVIN contains less than 1 mmol (23 mg) of sodiumper tablet, i.e. it is essentially “sodium-free”

3. HOW TO TAKE VIVIN

Take this medicine following exactly the instructions in this leaflet or as indicated 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 a day.
Do not exceed the recommended dose and, especially if you are elderly, adhere to the minimum dosages indicated above.
Consult your doctor if you do not notice any improvement or if your symptoms worsen 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 fluids (water), on a full stomach.

If you take more VIVIN than you should
In case of taking an excessive dose of the medicine, the following symptoms may occur: dizziness and tinnitus (ringing in the ears), which may be accompanied by nausea, vomiting and gastrointestinal disturbances.
In more severe cases, confusion, drowsiness, collapse, convulsions, respiratory, renal and sometimes even bleeding disorders are observed.
If you have taken an excessive dose of the medicine, consult your doctor who will take the necessary supportive measures to limit the absorption of the drug in the gastrointestinal tract through gastric lavage (forced emptying of the stomach), administration of emetic agents (which induce vomiting) or aspiration.
In case of milder poisoning, your doctor will have you drink plenty of fluids.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur more commonly following the intake of VIVIN are of a
gastrointestinal nature:

• nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia (presence of pain or discomfort localized in the upper part of the abdomen associated with food intake), abdominal pain, melena (presence of blood in the stool), hematemesis (emission of blood with vomiting), ulcerative stomatitis (severe inflammation of the oral mucosa, characterized by the presence of ulcers at the level of the cheeks, tongue and lips), exacerbation of colitis (inflammation of the intestine at the level of 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);
• perforation or gastrointestinal bleeding sometimes fatal, especially in elderly patients (see “Warnings and precautions”);
• gastritis (less frequently).

Other side effects:

• Hypersensitivity reactions, such as bronchial spasms, skin manifestations, oto-vestibular disorders (ringing in the ears).
• reduction of platelets (thrombocytopenia) and delays in delivery;
• bleeding episodes such as epistaxis (nosebleeds), gum bleeding;
• bullous reactions (with the formation of blisters at the level of the skin), up to the more serious ones such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see “Warnings and precautions”).
• edema (accumulation of fluids at the level of the body's tissues), hypertension and heart failure;
• increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) especially at high doses and for long-term treatments.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://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

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.
This medicine does not require any particular storage conditions.
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 contains
Each tablet contains:

Active ingredients: Acetylsalicylic acid 500 mg.

Other ingredients: starch, sodium lauryl sulfate, colloidal silica.

Description of the appearance of VIVIN and contents of the pack
The tablets are supplied in packs containing 20 tablets of 500 mg.

Marketing Authorisation 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)