ПАРАЦЕТАМОЛО 500 mg Таблетка

Содержание инструкции

1. PARACETAMOLO DOC Generici 500 mg tablets
   1. What is PARACETAMOLO DOC Generici and what is it used for
   2. What you need to know before taking PARACETAMOLO DOC Generici
   3. How to take PARACETAMOLO DOC Generici
   4. Possible side effects
   5. How to store PARACETAMOLO DOC Generici
   6. Contents of the pack and other information
2. PARACETAMOLO DOC Generici 1000 mg tablets
   1. What is PARACETAMOLO DOC Generici and what it is used for
   2. What you need to know before you take PARACETAMOLO DOC Generici
   3. How to take PARACETAMOLO DOC Generici
   4. Possible side effects
   5. How to store PARACETAMOLO DOC Generici
   6. Contents of the pack and other information

PARACETAMOLO DOC Generici 500 mg tablets

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

1. What is PARACETAMOLO DOC Generici and what is it used for

PARACETAMOLO DOC Generici contains the active ingredient paracetamol belonging 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 DOC Generici is used to lower fever and provide relief from mild to
moderate pain.
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 DOC Generici

Do not take PARACETAMOLO DOC Generici:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems (severe renal failure)
• if you abuse alcohol

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO DOC Generici.
Never exceed the recommended dose.
Take this medicine with caution:

• if you have liver problems such as hepatic insufficiency, Gilbert's syndrome (an inherited condition that presents with a yellowish discoloration of the skin) or acute hepatitis and if you are taking other medicines that alter liver function
• if you suffer from hemolytic anemia, characterized by a low number of red blood cells in the blood
• if you abuse alcohol, in this case the dose must be reduced (see section 3 - Use in people suffering from chronic alcoholism)
• if you have severe kidney problems (severe renal failure)
• if you have a rare inherited disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase
• if you weigh less than 50 kg
• if you suffer from malnutrition and dehydration

During treatment with PARACETAMOLO DOC Generici, 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 combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take
other products containing paracetamol at the same time.
Do not take higher doses than those recommended because a higher dose does not increase the pain-relieving
action, but can instead cause serious damage to the liver or kidneys (analgesic nephropathy). For this reason, contact
your doctor as soon as possible if you have taken more PARACETAMOLO DOC Generici than recommended in
this leaflet.
The sudden interruption of taking painkillers after a prolonged period of misuse at high
doses can cause headache, fatigue, muscle pain, nervousness and withdrawal symptoms that
resolve within a few days. Until then, avoid taking other painkillers and do not start
taking them again without consulting your doctor.
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 DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Take this medicine with cautionand inform your doctor if you are taking the following medicines:

• probenecid (a medicine used to treat gout)
• rifampicin, a medicine used to treat tuberculosis
• medicines used to treat epilepsy (carbamazepine, phenytoin, phenobarbital, primidone)
• zidovudine, a medicine used to treat AIDS
• medicines used to treat nausea (metoclopramide and domperidone)
• medicines that alter stomach emptying
• cholestyramine, a medicine used to lower cholesterol levels in the blood. If you need to take this medicine, do so at least one hour after taking paracetamol
• warfarin and other medicines used to thin the blood (anticoagulants).
• flucloxacillin (antibiotic), due to a serious risk of alterations in blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently.

PARACETAMOLO DOC Generici with alcohol
Avoid taking alcohol during treatment with PARACETAMOLO DOC Generici.

Pregnancy and breastfeeding
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 necessary, PARACETAMOLO DOC Generici can be used during pregnancy and breastfeeding
after a careful assessment of the risk/benefit ratio. It is advisable to use the lowest possible
dose that reduces pain and/or fever and to take it for the shortest possible time. Avoid taking the medicine
in combination with other medicines. Contact your doctor if the pain and/or fever does not decrease or if you have to
take the medicine more often.

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

3. How to take PARACETAMOLO DOC Generici

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.
Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.
Take the tablet with a little water. If you have difficulty swallowing, you can divide the tablet into 2 equal parts
. The recommended dosein adults is 1 tablet at a time, to be repeated if necessary after 4 hours, up to a
maximum of 6 tablets per day (3 g of paracetamol). In case of severe pain or high fever, 2 tablets
of 500 mg to be repeated if necessary after not less than 4 hours.

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

• Children weighing less than 21 kg (under 6 years): the use of this medicine is not indicatedfor this age group. Other formulations and dosages are available for this group of patients.
• Children weighing between 21 and 25 kg (approximately between 6 and 10 years): the recommended dose is half a tablet, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets).
• 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 (4 tablets).
• 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 patients with kidney or liver problems (hepatic insufficiency or renal impairment)
If you have liver or kidney problems, ask your doctor or pharmacist for advice before taking this
medicine. The dose must be reduced or the administration interval must be prolonged.

Use in patients suffering from chronic alcoholism
Chronic alcohol consumption can worsen the toxicity of paracetamol. If you regularly consume alcohol, consult your
doctor before taking the medicine and take the tablets at an interval of at least 8 hours and
without exceeding 4 tablets per day (2 g of paracetamol).
The tablet can be divided into equal parts.

If you take more PARACETAMOLO DOC Generici than you should
In case of overdose with PARACETAMOLO DOC Generici, inform your doctor or go to the nearest
emergency room.
Overdose has very serious consequences and can even lead to death. Immediate treatment is essential, due to the risk of severe liver damage, even delayed.
Symptoms may be limited to nausea, vomiting, loss of appetite, pallor, abdominal pain and may
not reflect the severity of the overdose or the risk of organ damage.

If you forget to take PARACETAMOLO DOC Generici
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, classified below according to their frequency:

Rare(may affect up to 1 in 1,000 people):

• alterations in the production of blood components (bone marrow depression): alterations in platelet levels, stem cell disorders, reduction of red blood cells (non-hemolytic anemia)
• allergies (excluding angioedema), bronchospasm (more likely in asthmatic subjects sensitive to aspirin or NSAIDs)
• depression, confusion, hallucinations
• tremor, headache
• altered vision
• accumulation of fluids and swelling (edema)
• bleeding (hemorrhage)
• abdominal pain, diarrhea, nausea, vomiting
• diseases of the pancreas (acute and chronic pancreatitis, exocrine pancreatic diseases)
• liver problems (impaired liver function, liver failure, hepatic necrosis), yellowish discoloration of the skin and whites of the eyes (jaundice)
• itching, skin rashes, sweating, bruising (purpura)
• swelling of the face, tongue and throat (angioedema), urticaria
• dizziness, malaise, fever, sedation
• overdose and poisoning
• kidney impairment (severe renal failure, interstitial nephritis, hematuria, anuria).

Very rare(may affect up to 1 in 10,000 people):

• liver damage (hepatotoxicity)
• allergic reactions
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia) and red blood cells (hemolytic anemia) in the blood
• reduction of blood sugar level (hypoglycemia)
• sterile pyuria (cloudy urine) and kidney problems
• severe skin reactions (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).

Not known(frequency 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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 DOC Generici

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 DOC Generici contains

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

Description of the appearance of PARACETAMOLO DOC Generici and contents of the pack
Blisters containing white, round, biconvex tablets with a break line.
PARACETAMOLO DOC Generici is available in packs of 10, 20 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.

Manufacturer

• Special Product’s line S.p.A. - Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) - Italy.

PARACETAMOLO DOC Generici 1000 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is PARACETAMOLO DOC Generici and what it is used for

PARACETAMOLO DOC Generici 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 DOC Generici is used to reduce fever and relieve mild to
moderate pain.

2. What you need to know before you take PARACETAMOLO DOC Generici

Do not take PARACETAMOLO DOC Generici:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is a child or adolescent under the age of 15
• if you suffer from severe kidney problems (severe renal insufficiency)
• if you abuse alcohol

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO DOC Generici.
Never exceed the recommended dose.
Take this medicine with caution:

• if you suffer from liver problems such as hepatic insufficiency, Gilbert's syndrome (an inherited disease that presents with a yellowish discoloration of the skin) or acute hepatitis and are taking other medicines that alter liver function
• if you suffer from hemolytic anemia, characterized by a low number of red blood cells in the blood
• if you abuse alcohol, in this case the dose must be reduced (see section 3 - Use in people suffering from chronic alcoholism)
• if you have severe kidney problems (severe renal insufficiency)
• if you have a rare inherited disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase
• if you weigh less than 50 kg
• if you suffer from malnutrition and dehydration

During treatment with PARACETAMOLO DOC Generici, 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). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take
other products containing paracetamol at the same time.
Do not take higher doses than those recommended because a higher dose does not increase the
pain-relieving action, but can instead cause serious damage to the liver or kidneys (analgesic nephropathy). For this
reason, contact your doctor as soon as possible if you have taken more PARACETAMOLO DOC Generici than
recommended in this leaflet.
The sudden discontinuation of taking analgesics after a prolonged period of misuse at high doses can cause headache, fatigue, muscle pain, nervousness and withdrawal symptoms that
resolve within a few days. Until then, avoid taking other pain relievers and do not start
taking them again without consulting your doctor.
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 DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Take this medicine with cautionand inform your doctor if you are taking the following medicines:

• probenecid (a medicine used to treat gout)
• rifampicin, a medicine used to treat tuberculosis
• medicines used to treat epilepsy (carbamazepine, phenytoin, phenobarbital, primidone)
• zidovudine, a medicine used to treat AIDS
• medicines used to treat nausea (metoclopramide and domperidone)
• medicines that alter stomach emptying
• cholestyramine, a medicine used to lower cholesterol levels in the blood. If you need to take this medicine, do so at least one hour after taking paracetamol.
• warfarin and other medicines used to thin the blood (anticoagulants)
• flucloxacillin (antibiotic), due to a serious risk of alterations in blood and fluids (so-called metabolic acidosis with elevated anion gap) which must be treated urgently.

PARACETAMOLO DOC Generici with alcohol
Avoid taking alcohol during treatment with PARACETAMOLO DOC Generici.

Pregnancy and breastfeeding
If you are pregnant, suspect 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 necessary, PARACETAMOLO DOC Generici can be used during pregnancy and breastfeeding
after a careful assessment of the risk/benefit ratio. It is advisable to use the lowest possible dose
that reduces pain and/or fever and take it for the shortest possible time. Avoid taking the medicine
in combination with other medicines. Contact your doctor if the pain and/or fever does not subside or if you have to
take the medicine more often.

Driving and using machines
The use of PARACETAMOLO DOC Generici does not affect the ability to drive or use machines.

3. How to take PARACETAMOLO DOC Generici

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have
doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.
Take the tablet with a little water. If you have difficulty swallowing, you can divide the tablet into 2
equal parts.
The use of this medicine is reserved for adults and adolescents over 15 years of age.
The recommended doseis 1 tablet of 1000 mg, to be repeated if necessary, up to a maximum of 3
tablets per day (3 g of paracetamol).

Use in children and adolescents
This medicine is not suitable for children and adolescents under the age of 15 and with a body weight
less than 50 kg.

Use in patients with kidney or liver problems (hepatic insufficiency or renal impairment)
If you have liver or kidney problems, ask your doctor or pharmacist for advice before taking this
medicine. The dose must be reduced or the administration interval must be prolonged.

Use in people suffering from chronic alcoholism
Chronic alcohol consumption can worsen the toxicity of paracetamol. If you regularly consume alcohol, consult
your doctor before taking the medicine and take the tablets at intervals of at least 8 hours and
without exceeding 2 tablets per day (2 g of paracetamol).
The tablet can be divided into equal parts.

If you take more PARACETAMOLO DOC Generici than you should
In case of overdose with PARACETAMOLO DOC Generici, inform your doctor or go to the nearest
emergency room.
Overdose has very serious consequences and can even lead to death. Immediate treatment is essential, due to the risk of serious liver damage, even delayed.
Symptoms may be limited to nausea, vomiting, loss of appetite, paleness, abdominal pain and may
not reflect the severity of the overdose or the risk of organ damage.

If you forget to take PARACETAMOLO DOC Generici
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, listed below according to their frequency:

Rare(may affect up to 1 in 1,000 people):

• alterations in the production of blood components (bone marrow depression): alterations in platelet levels, stem cell diseases, reduction of red blood cells (non-hemolytic anemia)
• allergies (excluding angioedema), bronchospasm (more likely in asthmatic subjects sensitive to aspirin or NSAIDs)
• depression, confusion, hallucinations
• tremor, headache
• altered vision
• accumulation of fluids and swelling (edema)
• bleeding (hemorrhage)
• abdominal pain, diarrhea, nausea, vomiting
• diseases of the pancreas (acute and chronic pancreatitis, exocrine pancreatic diseases)
• liver problems (impaired liver function, liver failure, liver necrosis), yellowish discoloration of the skin and whites of the eyes (jaundice)
• itching, skin rashes, sweating, bruising (purpura)
• swelling of the face, tongue and throat (angioedema), urticaria
• dizziness, malaise, fever, sedation
• overdose and poisoning
• kidney problems (severe renal failure, interstitial nephritis, hematuria, anuria)

Very rare(may affect up to 1 in 10,000 people):

• liver damage (hepatotoxicity)
• allergic reactions
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia) and red blood cells (hemolytic anemia) in the blood
• reduction of blood sugar level (hypoglycemia)
• sterile pyuria (cloudy urine) and kidney problems
• severe skin reactions (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)

Not known(frequency 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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 DOC Generici

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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PARACETAMOLO DOC Generici contains

• The active ingredient is paracetamol. Each tablet contains 1000 mg of paracetamol
• The other ingredients are: pregelatinized corn starch, stearic acid, povidone.

Description of the appearance of PARACETAMOLO DOC Generici and contents of the pack
Blister containing white, elongated tablets with a break line.
PARACETAMOLO DOC Generici is available in packs of 8 or 16 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy

Manufacturer

• Special Product’s line S.p.A. - Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) - Italy.