ПАРАЦЕТАМОLO 500 mg Таблетка

Содержание инструкции

1. PARACETAMOLO MARCO VITI 100 mg/ml oral drops, solution
   1. What is PARACETAMOLO MARCO VITI and what is it used for
   2. What you need to know before using PARACETAMOLO MARCO VITI
   3. How to take PARACETAMOLO MARCO VITI
   4. Possible side effects
   5. How to store PARACETAMOLO MARCO VITI
   6. Contents of the pack and other information
2. PARACETAMOLO MARCO VITI 500 mg tablets
   1. What is PARACETAMOLO MARCO VITI and what is it used for
   2. What you need to know before taking PARACETAMOLO MARCO VITI
   3. How to take PARACETAMOLO MARCO VITI
   4. Possible side effects
   5. How to store PARACETAMOLO MARCO VITI
   6. Contents of the pack and other information
3. PARACETAMOLO MARCO VITI 120 mg/5 ml oral solution
   1. What is PARACETAMOLO MARCO VITI and what is it used for
   2. What you need to know before taking PARACETAMOLO MARCO VITI
   3. How to take PARACETAMOLO MARCO VITI
   4. Possible side effects
   5. How to store PARACETAMOLO MARCO VITI
   6. Contents of the pack and other information
4. PARACETAMOLO MARCO VITI 240 mg oral solution in sachets
   1. What is PARACETAMOLO MARCO VITI and what is it used for
   2. What you need to know before taking PARACETAMOLO MARCO VITI
   3. How to take PARACETAMOLO MARCO VITI
   4. Possible side effects
   5. How to store PARACETAMOLO MARCO VITI
   6. Contents of the pack and other information

PARACETAMOLO MARCO VITI 100 mg/ml oral drops, solution

Paracetamol

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

• 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.

Contents of this leaflet:

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

1. What is PARACETAMOLO MARCO VITI and what is it used for

PARACETAMOLO MARCO VITI is a solution in drops for oral use that contains the active ingredient paracetamol, belonging to a group of medicines known as analgesics and antipyretics, as they work by relieving pain and inflammation (analgesic and anti-inflammatory action) and lowering body temperature in case of fever (antipyretic action).
PARACETAMOLO MARCO VITI is used in children weighing less than 12 kgto lower fever (antipyretic) in case of influenza, infectious diseases characterized by the appearance of blisters and bubbles on the skin such as measles and rubella (exanthematous diseases), respiratory tract disorders.
This medicine is also used to relieve pain (analgesic) in case of headache (cephalalgia), nerve and muscle pain (neuralgia, myalgia) and other painful manifestations of moderate intensity and of various origins.
Consult your doctor if the child does not feel better or if they feel worse after 3 days of treatment.

2. What you need to know before using PARACETAMOLO MARCO VITI

Do not use PARACETAMOLO MARCO VITI

• if the child is allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6);
• if the child suffers from a condition that leads to the destruction of red blood cells (severe hemolytic anemia);
• if the child's liver function is severely impaired (severe hepatocellular insufficiency).

Warnings and precautions
Consult your doctor or pharmacist before using PARACETAMOLO MARCO VITI
Use this medicine with caution:

• if the child suffers from eating disorders (anorexia, bulimia, cachexia);
• if the child is malnourished (low hepatic glutathione reserves) or dehydrated;
• if the child has a reduction in circulating blood volume (hypovolemia);
• if the child suffers from severe liver problems (mild to moderate hepatocellular insufficiency, Gilbert's syndrome (inherited condition with the presence of a yellowish discoloration of the skin), severe hepatic insufficiency, acute hepatitis) and is taking other medicines that alter liver function;
• if the child has a rare inherited disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase.

During treatment with PARACETAMOLO MARCO VITI, immediately inform your doctor if you
suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins
circulate in the blood causing organ damage) or if you are
also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when
paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in
association with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
During treatment with this medicine, do not use other products containing
paracetamol at the same time and inform your doctor if you are taking other medicines.
The use of high doses of the medicine or for prolonged periods of time can cause damage to the
kidneys and blood, which can also be serious. For this reason, if the child suffers from severe
kidney problems (renal insufficiency), the medicine should only be taken when absolutely
necessary and under the direct supervision of a doctor.
Stop treatment immediately and consult your doctor if the child experiences allergic
reactions (see also section “Possible side effects”).
If it is necessary to take this medicine for a long time, tests to monitor
liver function and blood tests (blood count) will be necessary.
Taking this medicine may alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood.

Other medicines and PARACETAMOLO MARCO VITI
Inform your doctor or pharmacist if the child is taking, has recently taken or might
take any other medicine.
Use this medicine with cautionand inform your doctor or pharmacist if the child is taking:

• medicines that alter stomach emptying (such as anticholinergics, opioids, prokinetics);
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• chloramphenicol, a medicine used to treat infections;
• warfarin and other medicines used to thin the blood (anticoagulants);
• rifampicin, a medicine used to treat tuberculosis;
• cimetidine, a medicine used to treat stomach disorders;
• medicines used to treat epilepsy (glutethimide, phenobarbital, carbamazepine);
• zidovudine, a medicine used to treat AIDS;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs to be treated urgently (see section 2).

PARACETAMOLO MARCO VITI contains:

• Propylene glycol:

this medicine contains approximately 240 mg of propylene glycol per 10-drop dose (approximately
600 mg of propylene glycol in 1 ml).
If the child is under 5 years of age, talk to your doctor or pharmacist before giving
this medicine, especially if the child is taking other medicines containing
propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.

• Sorbitol:this medicine contains approximately 48 mg of sorbitol per 10-drop dose (120 mg of sorbitol in 1 ml). Sorbitol is a source of fructose, if your doctor has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or the child) take this medicine.
• Sodium:this medicine contains less than 1 mmol (23 mg) of sodium in the entire 30 ml bottle, i.e. it is essentially “sodium-free”.
• Ethanol (contained in the flavors):this medicine contains 3.2 mg of alcohol (ethanol) per 10-drop dose (which is equivalent to 8 mg/ml). The amount per 10-drop dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Pregnancy, breastfeeding and fertility
The following information is provided for information only, as it is not appropriate for
children.
In case of pregnancy or breastfeeding, this medicine should only be taken when
absolutely necessary and under the direct supervision of a doctor.

Driving and operating machinery
The following information is provided for information only, as it is not appropriate for
children.
The use of PARACETAMOLO MARCO VITI does not impair the ability to drive or operate machinery.

3. How to take PARACETAMOLO MARCO VITI

Use PARACETAMOLO MARCO VITI following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.

Use in newborns and children (from 3.2 kg and under 12 kg)
In children, it is essential to respect the dose calculated based on body weight and not on age, which is approximate and provided for informational purposes only.
If the child's age does not correspond to the weight shown in the table, always refer to the body weight when choosing the dose, as indicated in the following table:
In children under 3 months of age, in case of jaundice(yellowing of the skin, sclera and mucous membranes caused by excessive increase in bilirubin levels in the blood), it is advisable to reduce the single dose orally.
One drop of PARACETAMOLO MARCO VITI oral drops corresponds to 4 mg of paracetamol.
1 ml of solution corresponds to approximately 25 drops.
For children weighing between 7.2 and 11 kg, you can also use the other available formulation of PARACETAMOLO MARCO VITI 120 mg/5 ml oral solution, as the dosage per weight range is identical to that provided for the drops.
For children weighing 12 kg or more, it is recommended to use PARACETAMOLO MARCO VITI 120 mg/5 ml oral solution.

Use in subjects with severe kidney problems
In case of severe kidney problems (severe renal insufficiency with creatinine clearance less than 10 ml/min), the interval between one administration and the next must be at least 8 hours.

Instructions for correct use
The oral solution contains 100 mg of paracetamol per ml of product.
To open the bottle, push the cap down and turn it simultaneously.
After use, close the bottle by screwing the cap on tightly.
Turn the bottle upside down and pour the number of drops corresponding to the dosage to be used into a little water (25-50 ml is sufficient) and give it to the child.

If you use more PARACETAMOLO MARCO VITI than you should
In case of overdose with PARACETAMOLO MARCO VITI, inform your doctor or go to the emergency room.
Overdose has very serious consequences and can even lead to death. This risk is greater in case of liver problems (liver disease), chronic alcoholism, malnutrition and in case of concomitant use of certain medications that affect the effectiveness of paracetamol (enzymatic inducers).
Immediate treatment is essential, due to the risk of serious liver damage, even if delayed.
Symptoms may be limited to loss of appetite, nausea, vomiting, worsening of general conditions and may not reflect the severity of the overdose or the risk of organ damage.

If you forget to use PARACETAMOLO MARCO VITI
Do not administer a double dose to compensate for missing a dose.
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 following side effects may occur:

Frequency not known(cannot be estimated from available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2);
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, agranulocytosis) and red blood cells (anemia) in the blood;
• allergic reactions (hypersensitivity reactions) such as hives, swelling of the face, tongue and throat (angioedema), swelling of the larynx (laryngeal edema) and severe allergic reaction (anaphylactic shock);
• dizziness;
• stomach and intestinal disorders (gastrointestinal reaction);
• liver problems (abnormal liver function, hepatitis);
• severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, skin rash);
• very rare cases of severe skin reactions have been reported;
• serious kidney problems (acute renal failure, interstitial nephritis);
• presence of blood in the urine (hematuria), failure to pass urine (anuria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 PARACETAMOLO MARCO VITI

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 after “Scad.” The
expiry date refers to the last day of that month. The validity after first opening of the
bottle is 12 months.
Store in the original packaging to protect the medicine from light.
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 PARACETAMOLO MARCO VITI contains

• The active ingredient is paracetamol. 1 ml of solution contains 100 mg of paracetamol.
• The other ingredients are: propylene glycol, Macrogol 6000, sorbitol, disodium edetate, sucralose, propyl gallate, liquid caramel (E150a), natural raspberry aroma, corrective aroma, purified water.

Description of the appearance of PARACETAMOLO MARCO VITI and contents of the pack
Pack containing an amber glass bottle closed by a polypropylene cap equipped
with a transparent glass dropper and a polyvinyl chloride pump containing 30 ml of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza - Italy

Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy

PARACETAMOLO MARCO VITI 500 mg tablets

Paracetamol

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 any 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.

Contents of this leaflet:

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

2. What is PARACETAMOLO MARCO VITI and what is it used for

PARACETAMOLO MARCO VITI contains the active ingredient paracetamol, which belongs to a
group of medicines known as analgesics and antipyretics, as they work by relieving pain
(analgesic action) and lowering body temperature in case of fever (antipyretic action).
PARACETAMOLO MARCO VITI is used to lower fever (antipyretic) in case of influenza,
infectious diseases characterized by the appearance of vesicles and blisters on the skin such as measles and rubella
(exanthematous diseases), and respiratory tract disorders. This medicine is also used to provide
relief from pain (analgesic) in case of headache, nerve and muscle pain
(neuralgia, myalgia) and other painful manifestations of moderate intensity and of various origins.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking PARACETAMOLO MARCO VITI

Do not take PARACETAMOLO MARCO VITI

• if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO MARCO VITI.
Take this medicine with caution:

• if you suffer from eating disorders (anorexia, bulimia, cachexia);
• if you are malnourished (low hepatic glutathione reserves) or dehydrated;
• if you have a reduction in circulating blood volume (hypovolemia);
• if you suffer from liver problems such as mild to moderate hepatocellular insufficiency, Gilbert's syndrome (an inherited disease that presents with a yellowish discoloration of the skin), severe liver failure, acute hepatitis, and if you are taking other medicines that alter liver function;
• if you have a rare inherited disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase;
• if you suffer from hemolytic anemia, characterized by a low number of red blood cells in the blood.

During treatment with PARACETAMOLO MARCO VITI, immediately inform your doctor if you
suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins
circulate in the blood causing organ damage) or if you are malnourished, chronic alcoholism or if you are
also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when
paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in
association with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.
During treatment with this medicine, do not use other medicines containing
paracetamol at the same time and inform your doctor if you are taking other medicines.
If you take high doses of the medicine or for prolonged periods of time, damage to
the kidneys and blood may occur, which may also be serious. For this reason, if you suffer from severe problems
with the kidneys (renal failure), take the medicine only when absolutely necessary and under the direct
control of your doctor.
Immediately stop treatment and consult your doctor if you experience allergic reactions.
If you take this medicine for a long time, undergo liver function tests
and blood tests (blood count).
Taking this medicine may alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood.

Other medicines and PARACETAMOLO MARCO VITI
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Use this medicine with cautionand inform your doctor or pharmacist if you are taking:

• medicines that alter stomach emptying (such as anticholinergics, opioids, prokinetics);
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• chloramphenicol, a medicine used to treat infections, as there may be an increase in toxic effects;
• warfarin and other medicines used to thin the blood (anticoagulants);
• rifampicin, a medicine used to treat tuberculosis;
• cimetidine, a medicine used to treat stomach disorders;
• medicines used to treat epilepsy (glutethimide, phenobarbital, carbamazepine);
• zidovudine, a medicine used to treat AIDS;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs to be treated urgently (see section 2).

PARACETAMOLO MARCO VITI with alcohol
Take this medicine with great caution if you regularly consume high amounts of alcohol
(chronic alcoholism). During treatment with PARACETAMOLO MARCO VITI, avoid the consumption
of alcoholic beverages (3 or more alcoholic beverages per day).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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 are pregnant or breastfeeding, take this medicine only when absolutely necessary
and under the direct control of your doctor.
If necessary, Paracetamol Marco Viti can be used during pregnancy. It is advisable to use the lowest
possible dose that relieves pain and/or fever and take it for the shortest possible time. Contact
your doctor if the pain and/or fever does not decrease or if you need to take the medicine more often.

Driving and operating machinery
The use of PARACETAMOLO MARCO VITI does not affect the ability to drive or operate
machinery.

3. How to take PARACETAMOLO MARCO VITI

Take PARACETAMOLO MARCO VITI following exactly the instructions contained in
this leaflet or the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.
The recommended dose in adults is 1-2 tablets (500 – 1000 mg), to be repeated if necessary, up
to a maximum of 6 tablets per day (3000 mg of paracetamol).

Use in children and adolescents
The dose is calculated based on body weight and age:

• Children weighing less than 25 kg: the use of this medicine is not indicatedfor this age group.
• Children weighing between 26 and 40 kg (approximately between 8 and 13 years): the recommended dose is 1 tablet, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day.
• Adolescents weighing between 41 and 50 kg (approximately between 12 and 15 years): the recommended dose is 1 tablet, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
• Adolescents weighing more than 50 kg (approximately over 15 years): the recommended dose is 1 tablet, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.

Use in people with severe kidney problems
If you suffer from severe kidney problems (severe renal insufficiency with creatinine clearance less than
10 ml/min), the interval between one administration and the next must be at least 8 hours.

If you take more PARACETAMOLO MARCO VITI than you should
In case of overdose with PARACETAMOLO MARCO VITI, inform your doctor or go to the
emergency room.
Overdose has very serious consequences and can also lead to death. This risk is
greater if you suffer from liver problems (liver diseases), if you regularly consume large amounts
of alcohol (chronic alcoholism), if you are malnourished and if you take certain medicines that affect the effectiveness
of paracetamol (enzyme inducers).
Immediate treatment is essential, due to the risk of serious liver damage, even
delayed.
Symptoms may be limited to loss of appetite, nausea, vomiting, worsening of general conditions
and may not reflect the severity of the overdose or the risk of damage to the
organs.

If you forget to take PARACETAMOLO MARCO VITI
Do not take a double dose to make up for a missed dose.
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 following side effects may occur:

Frequency not known(cannot be estimated from the available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2);
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, agranulocytosis) and red blood cells (anemia) in the blood;
• allergic reactions (hypersensitivity reactions) such as skin irritation (skin rash with erythema or urticaria), swelling of the face, tongue and throat (angioedema), swelling of the larynx (laryngeal edema) and severe allergic reaction (anaphylactic shock);
• dizziness;
• stomach and intestinal disorders (gastrointestinal reaction);
• liver problems (abnormal liver function, hepatitis);
• severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, skin rash);
• severe kidney problems (acute renal failure, interstitial nephritis);
• presence of blood in the urine (hematuria), failure to eliminate urine (anuria).

Very rare cases of severe skin reactions have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 PARACETAMOLO MARCO VITI

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 after “Exp.”. 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 waste water 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 PARACETAMOLO MARCO VITI contains

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: magnesium stearate, corn starch, povidone.

Description of the appearance of PARACETAMOLO MARCO VITI and contents of the pack
PARACETAMOLO MARCO VITI is available in a pack of 20 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza - Italy

Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy
Industria Farmaceutica Nova Argentia S.r.l. -Via G. Pascoli, 1 and sub-unit in Via Muoni 10 -
20064 Gorgonzola (Milan) – Italy

PARACETAMOLO MARCO VITI 120 mg/5 ml oral solution

Paracetamol

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.

Contents of this leaflet:

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

3. What is PARACETAMOLO MARCO VITI and what is it used for

PARACETAMOLO MARCO VITI contains the active ingredient paracetamol, which belongs to a
group of medicines known as analgesics and antipyretics, as they work by relieving pain and
inflammation (analgesic and anti-inflammatory action) and lowering body temperature in case of
fever (antipyretic action).
PARACETAMOLO MARCO VITI is used to reduce fever (antipyretic) in cases of influenza,
infectious diseases characterized by the appearance of vesicles and blisters on the skin such as measles and rubella
(exanthematous diseases), and respiratory tract disorders. This medicine is also used to provide
relief from pain (analgesic) in cases of headache, nerve and muscle pain
(neuralgia, myalgia) and other painful manifestations of moderate intensity and of various origins.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking PARACETAMOLO MARCO VITI

Do not take PARACETAMOLO MARCO VITI

• if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a condition that leads to the destruction of red blood cells (severe hemolytic anemia);
• if your liver function is severely impaired (severe hepatocellular insufficiency).

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO MARCO VITI.
Take this medicine with caution:

• if you suffer from eating disorders (anorexia, bulimia, cachexia);
• if you are malnourished (low hepatic glutathione reserves) or dehydrated;
• if you have a reduction in blood volume (hypovolemia);
• if you suffer from liver problems such as mild to moderate hepatocellular insufficiency, Gilbert's syndrome (an inherited disease that presents with a yellowish discoloration of the skin), severe liver failure, acute hepatitis, and if you are taking other medicines that alter liver function;
• if you have a rare inherited disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase.

During treatment with PARACETAMOLO MARCO VITI, immediately inform your doctor if
you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins
circulate in the blood causing organ damage) or if you are malnourished, chronic alcoholism or if you are
also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in
association with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.
During treatment with this medicine, do not use other products containing
paracetamol at the same time and inform your doctor if you are taking other medicines.
If you take high doses of the medicine or for prolonged periods of time, damage to
the kidneys and blood may occur, which may also be serious. For this reason, if you suffer from severe
kidney problems (renal insufficiency), take the medicine only when absolutely necessary and under the
direct control of your doctor.
Immediately stop treatment and consult your doctor if you experience allergic reactions
(see also section “Possible side effects”).
If you take this medicine for a long time, undergo liver function tests and
blood tests (blood count).
Taking this medicine may alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood.

Other medicines and PARACETAMOLO MARCO VITI
Inform your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Use this medicine with cautionand inform your doctor or pharmacist if you are taking:

• medicines that alter stomach emptying (such as anticholinergics, opioids, prokinetics);
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• chloramphenicol, a medicine used to treat infections;
• warfarin and other medicines used to thin the blood (anticoagulants);
• rifampicin, a medicine used to treat tuberculosis;
• cimetidine, a medicine used to treat stomach disorders;
• medicines used to treat epilepsy (glutethimide, phenobarbital, carbamazepine);
• zidovudine, a medicine used to treat AIDS;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs to be treated urgently (see section 2).

PARACETAMOLO MARCO VITI with alcohol
Take this medicine with great caution if you regularly consume high amounts of alcohol
(chronic alcoholism). During treatment with PARACETAMOLO MARCO VITI, avoid the consumption
of alcoholic beverages (3 or more alcoholic drinks per day).

PARACETAMOLO MARCO VITI contains

• sucrose:this medicine contains 7 g of sucrose per 20 ml dose (0.35 g of sucrose per ml). This should be taken into consideration in people affected by diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
• sodium:this medicine contains 43 mg of sodium (the main component of table salt) per 20 ml dose. This is equivalent to 2.1% of the maximum recommended daily intake with the diet of an adult;
• sodium benzoate: this medicine contains 100 mg of sodium benzoate per 20 ml dose;
• propylene glycol(in strawberry flavor): this medicine may contain up to 48 mg of propylene glycol per 20 ml dose.

Pregnancy, breastfeeding and fertility
If necessary, PARACETAMOLO MARCO VITI can be used during pregnancy. It is advisable to use
the lowest possible dose that reduces pain and/or fever and take it for the shortest possible time.
Contact your doctor if the pain and/or fever does not decrease or if you need to take
the medicine more often.

Driving and operating machinery
The use of PARACETAMOLO MARCO VITI does not impair the ability to drive or operate machinery.

3. How to take PARACETAMOLO MARCO VITI

Take PARACETAMOLO MARCO VITI following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.

Adults
The recommended dose is 20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
In adults, the maximum oral dose is 3000 mg of paracetamol per day (see “If you take more Paracetamolo Marco Viti than you should”).

Children (from 7.2 kg) and adolescents
In children up to 10 years of age, it is essential to respect the dose calculated based on body weight and not based on age. If the child's age does not correspond to the weight shown in the table, always refer to body weight when choosing the dose, as indicated in the following table:
This formulation is indicated for children weighing more than 7.2 kg (approximately over 5-6 months of age) and for adolescents.
For children weighing less than 7.2 kg (approximately under 6 months of age), it is recommended to use medicines based on paracetamol available on the market in the oral drop formulation, equipped with a dosing device suitable for achieving the necessary doses.
In children over 10 years of age, the ratio between weight and age is not homogeneous due to pubertal development which, for the same age, has a different impact on body weight depending on gender and the individual characteristics of the child. Therefore, over 10 years of age, the dose is indicated based on weight and age, as shown below.

• Children weighing between 33 and 40 kg (over 10 years of age and under 12 years of age): 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day.
• Adolescents weighing more than 40 kg (12 years of age or older): 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.

Use in people with severe kidney problems
If you suffer from severe kidney problems (severe renal insufficiency with creatinine clearance less than 10 ml/min), the interval between one administration and the next must be at least 8 hours.

Instructions for correct use
The oral solution contains 24 mg of paracetamol per ml of product.
The package contains a dosing rod to facilitate the calculation of the product dose based on body weight.
To measure the dose to be given to the child, the package contains a dosing syringe with markings corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml and 5 ml, and a measuring cup with markings corresponding to capacities of 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 13.5 ml, 15.5 ml, 17.5 ml and 19 ml.
To open the bottle, push the cap down and turn it simultaneously.
Insert the syringe into the bottle and gently pull the plunger, filling it up to the mark corresponding to the desired dose:
Insert the tip of the syringe into the child's mouth and exert slight pressure on the plunger to allow the solution to flow.
For dosages greater than 5 ml, pour the contents into the measuring cup. Repeat the operation until reaching the mark corresponding to the indicated dosage and administer to the child, encouraging them to drink.

In children over 10 years of age and in adults, for dosages equal to 20 ml, use the measuring cup, filling it 2 times up to the 10 ml mark.
Paracetamolo Marco Viti oral solution is also available in single-dose sachets of 10 ml.
The product must be used immediately after being taken from the bottle. Any remaining product in the measuring cup must be discarded.
After use, close the bottle by screwing the cap on tightly and wash the syringe and measuring cup with warm water. Let them dry, keeping them out of the reach and sight of children.

If you take more PARACETAMOLO MARCO VITI than you should
In case of an overdose with PARACETAMOLO MARCO VITI, inform your doctor or go to the emergency room.
Overdosage has very serious consequences and can even lead to death. This risk is greater if you have liver problems (liver disease), if you regularly consume large amounts of alcohol (chronic alcoholism), if you are malnourished and if you take certain medicines that affect the effectiveness of paracetamol (enzyme inducers).
Immediate treatment is essential, due to the risk of serious liver damage, even delayed.
Symptoms may be limited to loss of appetite, nausea, vomiting, worsening of general conditions and may not reflect the severity of the overdose or the risk of organ damage.

If you forget to take PARACETAMOLO MARCO VITI
Do not take a double dose to make up for the missed dose.
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 following side effects may occur:

Frequency not known(cannot be estimated from available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2);
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, agranulocytosis) and red blood cells (anemia) in the blood;
• allergic reactions (hypersensitivity reactions) such as urticaria, swelling of the face, tongue and throat (angioedema), swelling of the larynx (laryngeal edema) and severe allergic reaction (anaphylactic shock);
• dizziness;
• stomach and intestinal disorders (gastrointestinal reaction);
• liver problems (abnormal liver function, hepatitis);
• skin reactions (erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, skin rash);
• very rare cases of severe skin reactions have been reported;
• serious kidney problems (acute renal failure, interstitial nephritis);
• presence of blood in the urine (hematuria), failure to eliminate urine (anuria).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell 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 PARACETAMOLO MARCO VITI

Keep this medicine out of the sight and reach of children.
Use the oral solution within 12 months of opening the bottle.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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 PARACETAMOLO MARCO VITI contains

• The active ingredient is paracetamol. 5 ml of oral solution contains 120 mg of paracetamol.
• The other ingredients are: sucrose, Macrogol 6000, potassium sorbate (E 202), sodium benzoate (E 211), sodium saccharin, citric acid monohydrate, sodium citrate, strawberry aroma (propylene glycol), natural mandarin aroma, purified water.

Description of the appearance of PARACETAMOLO MARCO VITI and contents of the pack
PARACETAMOLO MARCO VITI 120 mg/5 ml oral solution is available in a pack containing
an amber glass bottle closed with a child-resistant cap, containing 120 ml of oral
solution. A dosing syringe and a measuring cup are included in the pack.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza - Italy

Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy

PARACETAMOLO MARCO VITI 240 mg oral solution in sachets

Paracetamol

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 to do.

• 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.

Contents of this leaflet:

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

4. What is PARACETAMOLO MARCO VITI and what is it used for

PARACETAMOLO MARCO VITI contains the active ingredient paracetamol, which belongs to a
group of medicines known as analgesics and antipyretics, as they work by relieving pain and
inflammation (analgesic and anti-inflammatory action) and lowering body temperature in case
of fever (antipyretic action).
PARACETAMOLO MARCO VITI is used to reduce fever (antipyretic) in cases of influenza,
infectious diseases characterized by the appearance of vesicles and blisters on the skin such as measles and rubella
(exanthematous diseases), and respiratory tract disorders. This medicine is also used to provide
relief from pain (analgesic) in cases of headache, nerve and muscle pain
(neuralgia, myalgia) and other painful manifestations of moderate intensity and of various origins.
See your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking PARACETAMOLO MARCO VITI

Do not take PARACETAMOLO MARCO VITI

• if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a condition that leads to the destruction of red blood cells (severe hemolytic anemia);
• if your liver function is severely impaired (severe hepatocellular insufficiency).

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO MARCO VITI.
Take this medicine with caution:

• if you suffer from eating disorders (anorexia, bulimia, cachexia);
• if you are malnourished (low hepatic glutathione reserves) or dehydrated;
• if you have a reduction in circulating blood volume (hypovolemia);
• if you suffer from liver problems such as mild to moderate hepatocellular insufficiency, Gilbert's syndrome (a hereditary disease that presents with a yellowish discoloration of the skin), severe liver failure, acute hepatitis, and if you are taking other medicines that alter liver function;
• if you have a rare hereditary disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase.

During treatment with PARACETAMOLO MARCO VITI, immediately inform your doctor if you
suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins
circulate in the blood causing organ damage) or malnutrition, chronic alcoholism, or if you are
also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in
association with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
During treatment with this medicine, do not use other products containing
paracetamol at the same time and inform your doctor if you are taking other medicines.
If you take high doses of the medicine or for prolonged periods of time, damage to the
kidneys and blood may occur, which may also be serious. For this reason, if you suffer from severe
kidney problems (renal insufficiency), take the medicine only when absolutely necessary and under the
direct control of your doctor.
Stop treatment immediately and consult your doctor if you experience allergic reactions
(see also section “Possible side effects”).
If you take this medicine for a long time, undergo liver function tests and
blood tests (blood count).
Taking this medicine may alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood.

Other medicines and PARACETAMOLO MARCO VITI
Inform your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Use this medicine with cautionand inform your doctor or pharmacist if you are taking:

• medicines that alter stomach emptying (such as anticholinergics, opioids, prokinetics);
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• chloramphenicol, a medicine used to treat infections;
• warfarin and other medicines used to thin the blood (anticoagulants);
• rifampicin, a medicine used to treat tuberculosis;
• cimetidine, a medicine used to treat stomach disorders;
• medicines used to treat epilepsy (glutethimide, phenobarbital, carbamazepine);
• zidovudine, a medicine used to treat AIDS;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs to be treated urgently (see section 2).

PARACETAMOLO MARCO VITI with alcohol
Take this medicine with great caution if you regularly consume high amounts of alcohol
(chronic alcoholism). During treatment with PARACETAMOLO MARCO VITI, avoid the consumption
of alcoholic beverages (3 or more alcoholic drinks per day).

PARACETAMOLO MARCO VITI contains

• sucrose:this medicine contains 7 g of sucrose per 20 ml dose (0.35 g of sucrose per ml). This should be taken into consideration in people affected by diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
• sodium:this medicine contains 43 mg of sodium (the main component of table salt) per 20 ml dose. This is equivalent to 2.1% of the maximum recommended daily intake with the diet of an adult;
• sodium benzoate: this medicine contains 100 mg of sodium benzoate per 20 ml dose;
• propylene glycol(in strawberry flavour): this medicine contains up to 48 mg of propylene glycol per 20 ml dose.

Pregnancy, breastfeeding and fertility
If necessary, PARACETAMOLO MARCO VITI can be used during pregnancy. It is advisable to use
the lowest possible dose that reduces pain and/or fever and take it for the shortest possible time.
Contact your doctor if the pain and/or fever does not decrease or if you need to take the
medicine more often.

Driving and operating machinery
The use of PARACETAMOLO MARCO VITI does not impair the ability to drive or operate machinery.

3. How to take PARACETAMOLO MARCO VITI

Take PARACETAMOLO MARCO VITI following the instructions provided in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.

This formulation is indicated for children and adolescents weighing more than 32 kg (approximately over 10 years of age) and for adults.
For children weighing less than 7.2 kg (approximately under 6 months of age), it is recommended to use paracetamol-based medicines available on the market in oral drop formulation, equipped with a dosing device suitable for achieving the necessary doses.
For children weighing between 7 kg and 32 kg (approximately between 7 months and 10 years of age), the multi-dose pack of Paracetamolo Marco Viti in a bottle equipped with a dosing syringe and measuring cup is available.
Children weighing between 33 and 40 kg (over 10 years of age and under 12 years of age):
20 ml of oral solution at a time, corresponding to 480 mg (2 sachets), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day.
Children and adolescents weighing more than 40 kg (12 years of age or older) and adults:
20 ml of oral solution at a time, corresponding to 480 mg (2 sachets), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
In adults, the maximum dose by oral route is 3000 mg of paracetamol per day (see “If you take more PARACETAMOLO MARCO VITI than you should”).

Use in people with severe kidney problems
If you suffer from severe kidney problems (severe renal insufficiency with creatinine clearance less than 10 ml/min), the interval between one administration and the next must be at least 8 hours.

Instructions for correct use
The oral solution contains 24 mg of paracetamol per ml of product.
The sachets contain 10 ml of oral solution corresponding to 240 mg of paracetamol and can be used for all situations where it is necessary to administer a dose of 20 ml, corresponding to the content of two sachets (for children weighing more than 32 kg, adolescents and adults).

If you take more PARACETAMOLO MARCO VITI than you should
In case of overdose with PARACETAMOLO MARCO VITI, inform your doctor or go to the emergency room.
Overdose has very serious consequences and can even lead to death. This risk is greater if you suffer from liver problems (liver diseases), if you regularly consume large amounts of alcohol (chronic alcoholism), if you are malnourished and if you take certain medicines that affect the effectiveness of paracetamol (enzyme inducers).
Immediate treatment is essential, due to the risk of serious liver damage, even delayed.
Symptoms may be limited to loss of appetite, nausea, vomiting, worsening of general conditions and may not reflect the severity of the overdose or the risk of organ damage.

If you forget to take PARACETAMOLO MARCO VITI
Do not take a double dose to make up for a missed dose.
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 following side effects may occur:

Frequency not known(cannot be estimated from available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2);
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, agranulocytosis) and red blood cells (anemia) in the blood;
• allergic reactions (hypersensitivity reactions) such as hives, swelling of the face, tongue and throat (angioedema), swelling of the larynx (laryngeal edema) and severe allergic reaction (anaphylactic shock);
• dizziness;
• stomach and intestinal disorders (gastrointestinal reaction);
• liver problems (abnormal liver function, hepatitis);
• skin reactions (erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, rash);
• very rare cases of severe skin reactions have been reported;
• serious kidney problems (acute renal failure, interstitial nephritis);
• presence of blood in the urine (hematuria), failure to pass urine (anuria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 PARACETAMOLO MARCO VITI

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 after “Exp.”. 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 in waste water 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 contains PARACETAMOLO MARCO VITI

• The active ingredient is paracetamol. 10 ml of oral solution contains 240 mg of paracetamol.
• The other ingredients are: sucrose, Macrogol 6000, potassium sorbate (E 202), sodium benzoate (E 211), sodium saccharin, citric acid monohydrate, sodium citrate, strawberry aroma (propylene glycol), natural mandarin aroma, purified water.

Description of the appearance of PARACETAMOLO MARCO VITI and contents of the pack
PARACETAMOLO MARCO VITI 240 mg oral solution, sachets is available in a pack
containing 20 sachets of 10 ml of oral solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza - Italy

Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy