Paracetamol Doc Generici

Package leaflet: Information for the patient

PARACETAMOLO DOC Generici 500 mg tablets

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 to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What PARACETAMOLO DOC Generici is and what it is 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

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

PARACETAMOLO DOC Generici contains the active substance paracetamol, which belongs to a group of medicines known as analgesics and antipyretics, as they act by relieving pain (analgesic action) and reducing body temperature in cases of fever (antipyretic action).
PARACETAMOLO DOC Generici is used to reduce fever and to relieve 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 substance 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 are alcohol-dependent

Warnings and precautions
Talk to 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 causing yellowish discoloration of the skin), or acute hepatitis, or if you are taking other medicines that affect liver function
• if you have haemolytic anaemia, characterised by a low number of red blood cells in the blood
• if you are alcohol-dependent; in this case, the dose should be reduced (see section 3 - Use in patients with chronic alcoholism)
• if you have severe kidney problems (severe renal failure)
• if you have a rare inherited disorder characterised 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, inform your doctor immediately if:

• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid 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, as higher doses do not increase pain relief but may instead cause severe liver or kidney damage (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.
Sudden discontinuation of analgesics after prolonged misuse at high doses may cause headache, fatigue, muscle pain, nervousness, and withdrawal symptoms, which resolve within a few days. Until then, avoid taking other painkillers and do not restart them without first consulting your doctor.
Taking this medicine may alter the results of certain laboratory tests, such as measurements of uric acid levels (uricaemia) or blood sugar (glycaemia).
Other medicines and PARACETAMOLO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and 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 affect gastric emptying
• colestyramine, a medicine used to lower cholesterol levels in the blood. If you need to take this medicine, take it 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 blood and fluid disturbances (known as metabolic acidosis with high anion gap), which require urgent treatment.

PARACETAMOLO DOC Generici and alcohol
Avoid consuming alcohol during treatment with PARACETAMOLO DOC Generici.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, PARACETAMOLO DOC Generici may be used during pregnancy and breastfeeding following careful assessment of the benefit-risk balance. It is advisable to use the lowest possible dose that relieves 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 pain and/or fever do not improve or if you need to take the medicine more frequently.
Driving and using machines
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 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.
Swallow the tablet with a glass of water. If you have difficulty swallowing, you may divide the tablet into two equal parts.

Recommended dose in adults is 1 tablet at a time, 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 may be taken, repeated if necessary no sooner than 4 hours later.

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

• Children weighing less than 21 kg ( under 6 years of age ): use of this medicine is not recommended for this age group. Other formulations and dosages are available for these patients.
• Children weighing between 21 and 25 kg (approximately 6 to 10 years of age ): the recommended dose is half a tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day (3 tablets).
• Children weighing between 26 and 40 kg (approximately 8 to 13 years of age ): the recommended dose is 1 tablet, repeated if necessary after 6 hours, without exceeding 4 doses per day (4 tablets).
• Adolescents weighing between 41 and 50 kg (approximately 12 to 15 years of age ): the recommended dose is 1 tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.
• Adolescents weighing more than 50 kg (approximately over 15 years of age ): the recommended dose is 1 tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.

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

Use in patients with chronic alcoholism
Chronic alcohol consumption may increase paracetamol toxicity. If you regularly consume alcohol, consult your doctor before taking this medicine. Take the tablets at intervals of at least 8 hours and do not exceed 4 tablets per day (2 g of paracetamol).

The tablet may 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 immediately to the nearest emergency department.
Overdose can have very serious consequences and may even lead to death. Immediate treatment is essential due to the risk of severe liver damage, which may be delayed.
Symptoms may be limited to nausea, vomiting, loss of appetite, pallor, and 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 the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following side effects may occur, listed below by frequency:

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

• changes in the production of blood components (bone marrow depression): changes in platelet levels, disorders of stem cells, reduction in red blood cells (non-haemolytic anaemia)
• allergic reactions (excluding angioedema), bronchospasm (more likely in asthmatic patients sensitive to aspirin or NSAIDs)
• depression, confusion, hallucinations
• tremor, headache (cephalalgia)
• blurred vision
• fluid retention and swelling (oedema)
• bleeding (haemorrhage)
• abdominal pain, diarrhoea, nausea, vomiting
• diseases of the pancreas (acute and chronic pancreatitis, exocrine pancreatic disorders)
• liver problems (impaired liver function, liver failure, hepatic necrosis), yellowing 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-related disorders (severe renal failure, interstitial nephritis, haematuria, anuria).

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

• liver damage (hepatotoxicity)
• allergic reactions
• reduction in platelets (thrombocytopenia), white blood cells (leucopenia, neutropenia), and red blood cells (haemolytic anaemia) in the blood
• reduction in blood sugar levels (hypoglycaemia)
• 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 the available data):

• severe condition leading to increased acidity of the blood (called metabolic acidosis) in patients with serious underlying illness using paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What PARACETAMOLO DOC Generici contains

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are: pregelatinized maize starch, stearic acid, povidone.

Description of the appearance of PARACETAMOLO DOC Generici and pack contents
Blister 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 Milan, Italy.
Manufacturer

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

Patient information leaflet

PARACETAMOLO DOC Generici 1000 mg tablets

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 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

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

PARACETAMOLO DOC Generici contains the active substance paracetamol, which belongs to a group of
medicines known as analgesics and antipyretics, as they act by relieving pain (analgesic effect) and
reducing body temperature in case of fever (antipyretic effect).
PARACETAMOLO DOC Generici is used to reduce fever and to provide relief from mild to
moderate pain.

2. What you should know before taking PARACETAMOL DOC Generics

Do not take PARACETAMOL DOC Generics:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is a child or adolescent under 15 years of age
• if you have severe kidney problems (severe renal failure)
• if you are an alcohol abuser

Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOL DOC Generics.
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 causing yellowish skin discoloration), or acute hepatitis, or if you are taking other medicines that affect liver function
• if you have hemolytic anemia, characterized by a low number of red blood cells in the blood
• if you abuse alcohol; in this case, the dose should be reduced (see section 3 - Use in patients with chronic alcoholism)
• if you have severe kidney problems (severe renal failure)
• if you have a rare inherited disorder 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 PARACETAMOL DOC Generics, inform your doctor immediately 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 with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid 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 effect, but may instead cause severe liver or kidney damage (analgesic nephropathy). For this
reason, contact your doctor as soon as possible if you have taken more PARACETAMOL DOC Generics than
recommended in this leaflet.
Sudden discontinuation of analgesics after prolonged misuse at high doses may cause headache, fatigue, muscle pain, nervousness, and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not restart them without consulting your doctor.
Taking this medicine may alter the results of certain laboratory tests, such as measurements of uric acid levels (uricemia) or blood sugar (glycemia).
Other medicines and PARACETAMOL DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Take this medicine with caution and 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 affect stomach emptying
• cholestyramine, a medicine used to lower cholesterol levels in the blood. If you need to take this medicine, take it 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 blood and fluid disturbances (called metabolic acidosis with high anion gap) that require urgent treatment.

PARACETAMOL DOC Generics and alcohol
Avoid consuming alcohol during treatment with PARACETAMOL DOC Generics.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, PARACETAMOL DOC Generics may be used during pregnancy and breastfeeding following careful assessment of the benefit-risk balance. It is advisable to use the lowest possible dose that relieves 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 pain and/or fever do not improve or if you need to take the medicine more frequently.
Driving and using machines
The use of PARACETAMOL DOC Generics does not affect the ability to drive or operate machinery.

3. How to take PARACETAMOLO DOC Generici

Take this medicine exactly 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.
Take the tablet with a little water. If you have difficulty swallowing, you may divide the tablet into 2
equal parts.
This medicine is intended for use in adults and adolescents over 15 years of age only.
The recommended dose is 1 tablet of 1000 mg, which may 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 15 years of age and with a body weight
below 50 kg.
Use in patients with kidney or liver problems (hepatic insufficiency or renal impairment)
If you have liver or kidney problems, consult your doctor or pharmacist before taking this
medicine. The dose should be reduced or the dosing interval prolonged.
Use in patients with chronic alcoholism
Chronic alcohol consumption may increase the toxicity of paracetamol. If you regularly consume alcohol, consult your doctor before taking this medicine and take the tablets at intervals of at least 8 hours and do not exceed 2 tablets per day (2 g of paracetamol).
The tablet may 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 department immediately.
Overdose can have very serious consequences and may even lead to death. Immediate treatment is essential due to the risk of severe liver damage, which may be delayed.
Symptoms may be limited to nausea, vomiting, loss of appetite, pallor, and 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 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 will experience them.
The following side effects may occur, classified below according to frequency:
Rare (may affect up to 1 in 1,000 people):

• changes in the production of blood components (bone marrow depression): changes in platelet levels, disorders of stem cells, reduction in red blood cells (non-haemolytic anaemia)
• allergic reactions (excluding angioedema), bronchospasm (more likely in asthmatic patients sensitive to aspirin or NSAIDs)
• depression, confusion, hallucinations
• tremor, headache (cephalalgia)
• blurred vision
• fluid retention and swelling (oedema)
• bleeding (haemorrhage)
• abdominal pain, diarrhoea, nausea, vomiting
• diseases of the pancreas (acute and chronic pancreatitis, diseases of the exocrine pancreas)
• liver problems (impaired liver function, liver failure, liver necrosis), yellowing 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-related disorders (severe renal failure, interstitial nephritis, haematuria, anuria)

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

• liver damage (hepatotoxicity)
• allergic reactions
• reduction in platelets (thrombocytopenia), white blood cells (leucopenia, neutropenia) and red blood cells (haemolytic anaemia) in the blood
• reduction in blood sugar levels (hypoglycaemia)
• 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 the available data):

• severe condition causing increased acidity of the blood (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PARACETAMOLO DOC Generici contains

• The active substance is paracetamol. Each tablet contains 1000 mg of paracetamol.
• The other components are: pregelatinized maize starch, stearic acid, povidone.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy
Manufacturer
Special Product’s line S.p.A. - Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) - Italy.