Paracetamol Laboratori Alter: detailed information

Package leaflet: Information for the user

Paracetamol Laboratori Alter 500 mg tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.

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

Contents of this leaflet:

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

1. What Paracetamolo Laboratori Alter is and what it is used for

Paracetamol belongs to a group of medicines called analgesics and antipyretics. Paracetamol is indicated for the symptomatic treatment of mild to moderate pain (e.g. headache, toothache, menstrual pain) and fever.

2. What you need to know before taking Paracetamol Laboratori Alter

Do not take Paracetamolo Laboratori Alter
If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo Laboratori Alter:

if you have kidney disease
if you have liver disease (including Gilbert's syndrome and alcoholic liver disease)
if you have acute hepatitis
if you are taking other medicines that may affect liver function
if you have glucose-6-phosphate dehydrogenase deficiency
if you have haemolytic anaemia

Do not take other medicines containing paracetamol at the same time.
Contact your doctor immediately in case of overdose, even if you feel well, due to the risk of delayed severe liver damage.
Do not exceed the recommended dose.
Do not exceed 4 g (8 tablets) in 24 hours for adults, elderly and children over 16 years of age.
Do not exceed 2 g (4 tablets) in 24 hours for children over 10 years of age.
Paracetamol may interfere with the following laboratory tests:

uric acid when measured by the phosphotungstic acid method
blood glucose when measured by the glucose-oxidase-peroxidase method

Children
Do not use in children under 10 years of age. For children under 10 years of age, consult your doctor or pharmacist, as there are other pharmaceutical forms with doses more suitable for this patient group.

Other medicines and Paracetamolo Laboratori Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor or pharmacist if you are taking:

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (metabolic acidosis with high anion gap) that require urgent treatment and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

Ask your doctor or pharmacist for advice before taking these tablets if you are taking prescription medicines; in particular metoclopramide or domperidone (for nausea or vomiting) or cholestyramine (to lower blood cholesterol) or opioids [for acute pain] or chloramphenicol [for bacterial infections]. If you are taking medicines that thin the blood (anticoagulants, e.g. warfarin) and need to take a painkiller every day, inform your doctor due to the risk of bleeding. However, you may still take occasional doses of Paracetamolo Laboratori Alter together with anticoagulants.

Paracetamolo Laboratori Alter with food, drinks and alcohol
The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day – beer, wine, spirits... every day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
If necessary, Paracetamolo Laboratori Alter may be used during pregnancy. You should use the lowest possible dose that relieves pain and/or fever and use it for the shortest possible time.
Contact your doctor if pain and/or fever are not reduced or if you need to take the medicine more frequently.

Driving and using machines
No effects on the ability to drive or use machines have been reported.

3. How to take Paracetamol Laboratori Alter

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults, elderly and children aged 16 years and over: take one or two tablets up to 4
times a day. Do not exceed 4 g (8 tablets) in 24 hours.
Children aged 10 to 15 years: take one tablet up to 4 times a day. Do not exceed 2 g (4
tablets) in 24 hours.
Not recommended for children under 10 years of age.
The dose should not be repeated more frequently than every 4 hours, and no more than 4
doses should be taken within 24 hours.
If you take more Paracetamol Laboratori Alter than you should
If you have taken more paracetamol than you should, contact your doctor immediately or call the
poison information service. In case of overdose, go immediately to a medical centre,
even if you do not have any symptoms. Symptoms of overdose within the first 24 hours may include:
pallor, nausea, vomiting, loss of appetite, and abdominal pain.
Treatment of overdose is most effective within the first 4 hours after ingestion of the medicine.
Inform your doctor immediately in case of overdose, even if you feel well, due to the risk of delayed severe liver damage.
If your symptoms persist or your headache becomes continuous, call your doctor.
If you forget to take Paracetamol Laboratori Alter
Do not take a double dose to make up for the missed tablet. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
This medicine may cause the following side effects:
Rare (may affect up to 1 in 1,000 people): discomfort, drop in blood pressure (hypotension),
difficulty in breathing (bronchospasm), asthma, and increased levels of transaminases in the blood.
Very rare (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), angioedema (swelling), anuria (the body does not produce urine), haematuria (blood in the urine), and interstitial nephritis (kidney inflammation).
Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Very rare cases of serious skin reactions have been reported.
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 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 Laboratori Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 precautions.
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. Package contents and other information

What Paracetamol Laboratori Alter contains
The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other components are: pregelatinized maize starch (gluten-free), stearic acid, povidone,
crospovidone, microcrystalline cellulose and magnesium stearate (vegetable source).

Description of the appearance of Paracetamol Laboratori Alter and pack contents
Paracetamol Laboratori Alter is supplied as tablets for oral administration in containers containing 1, 10, 12, 16, 20, 30, 50 and 60 tablets.
Not all pack sizes may be marketed.
The tablet dimensions are 18.3 ± 0.2 mm (length) x 8.2 ± 0.2 mm (width) x 5.1 ± 0.2 mm (thickness).
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing the whole tablet.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
LABORATORI ALTER S.r.l.
Via Egadi, 7
20144 Milan, Italy

Manufacturer:
Toll Manufacturing Services, S.L.
c/Aragoneses, 15
28108 Alcobendas (Madrid)
Spain
or
FROSST IBÉRICA, S.A.
Vía Complutense, 140,
28805 Alcalá de Henares (Madrid)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany Paracetamol Farmalider 500 mg Tabletten
France Paracetamol Farmalider 500 mg, comprimé
Hungary Roxacet 500 mg tabletta
Italy Paracetamolo Laboratori Alter
Poland PARACETAMOL MEDICINAE
Portugal Paracetamol Farmalider
Romania Paracetamol Farmalider 500 mg Comprimate
United Kingdom Paracetamol 500 mg tablet

Package leaflet: information for the user

Paracetamol Laboratori Alter 1000 mg tablets

Generic 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 other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Paracetamolo Laboratori Alter is and what it is used for

2. What you need to know before taking Paracetamolo Laboratori Alter

Do not take Paracetamolo Laboratori Alter:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo Laboratori Alter:

if you have kidney disease
if you have liver disease (including Gilbert's syndrome and alcoholic liver disease)
if you have acute hepatitis
if you are taking other medicines that may affect liver function
if you have glucose-6-phosphate dehydrogenase deficiency
if you have haemolytic anaemia

Do not take other medicines containing paracetamol at the same time.
Immediately inform your doctor in case of overdose, even if you feel well, due to the risk of delayed severe liver damage.
Do not exceed the recommended dose.
Do not exceed 4 g (4 tablets) in 24 hours.
Paracetamol may interfere with the following laboratory tests:

uric acid when measured by the phosphotungstic acid method
blood glucose when measured by the glucose-oxidase-peroxidase method

Children
Do not use in children under 16 years of age. For children under 16 years of age, consult your doctor or pharmacist, as there are other pharmaceutical forms with doses more suitable for this patient group.
Other medicines and Paracetamolo Laboratori Alter
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor or pharmacist if you are taking:

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalances (metabolic acidosis with high anion gap) that require urgent treatment and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

Ask your doctor or pharmacist for advice before taking these tablets if you are taking prescription medicines; in particular metoclopramide or domperidone (for nausea [feeling unwell] or vomiting [feeling unwell]) or cholestyramine (to lower cholesterol in the blood) or opioids [for acute pain] or chloramphenicol [for bacterial infections]. If you are taking medicines that thin the blood (anticoagulants, e.g. warfarin) and need to take a painkiller daily, inform your doctor due to the risk of bleeding. However, occasional doses of Paracetamolo Laboratori Alter may still be taken together with anticoagulants.
Paracetamolo Laboratori Alter with food, drinks and alcohol
Taking paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day - beer, wine, spirits... every day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Pregnancy, breastfeeding and fertility
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 Laboratori Alter may be used during pregnancy. You should use the lowest possible dose that reduces pain and/or fever, and use it for the shortest possible time.
Contact your doctor if pain and/or fever are not reduced, or if you need to take the medicine more frequently.
Driving and using machines
The effect of paracetamol on the ability to drive vehicles and use machinery is none or negligible.

3. How to take Paracetamolo Laboratori Alter

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults (including elderly) and adolescents over 16 years of age: one tablet up to 4 times
daily as needed.
Do not take more frequently than every 4 hours.
Do not take more than 4 tablets in 24 hours.
Use in children: do not use in children and adolescents under 16 years of age.
If you think that the effect of Paracetamolo Laboratori Alter is too strong or too weak, inform your
doctor or pharmacist.
When less than 1000 mg of paracetamol per dose is required, use other pharmaceutical forms of paracetamol that are suitable for the required dose.
If you take more Paracetamolo Laboratori Alter than you should:
You must contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical centre or call the toxicology information service, indicating the medicine and the amount ingested.
If you have taken an overdose, consult a medical centre immediately even if you have no symptoms.
Symptoms of overdose within the first 24 hours include: pallor, nausea, vomiting, loss of
appetite, and abdominal pain.
Treatment of overdose is most effective within the first 4 hours after ingestion.
Contact your doctor immediately in case of overdose, even if you feel well, due to the risk of severe delayed liver damage.
If your symptoms persist or your headache becomes continuous, call your doctor.
If you forget to take Paracetamolo Laboratori Alter
Do not take a double dose to make up for the forgotten tablet. Simply take the missed dose when you remember, then take the following doses at the individually indicated intervals (at least 6 hours apart).
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 can cause side effects, although not everybody gets them.
This medicine may cause the following side effects:
Rare (may affect up to 1 in 1,000 people): discomfort, drop in blood pressure (hypotension), difficulty breathing (bronchospasm), asthma, increased blood transaminase levels.
Very rare (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), angioedema (swelling), anuria (failure to produce urine), haematuria (blood in urine), interstitial nephritis (kidney inflammation).
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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 website: 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 Laboratori Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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. Package contents and other information

What Paracetamolo Laboratori Alter contains
The active substance is paracetamol. Each tablet contains 1000 mg of paracetamol.
The other components are: pregelatinized corn starch (corn), stearic acid, povidone,
crospovidone, microcrystalline cellulose and magnesium stearate (vegetable source).
Description of the appearance of Paracetamolo Laboratori Alter and pack contents
Paracetamolo Laboratori Alter is supplied as oral tablets in containers containing 1, 6, 8, 10, 12, 18, 20, 30, 32 and 100 tablets.
Not all pack sizes may be marketed.
Tablet dimensions are 21.0 (length) ± 0.2 mm, 10.0 (width) ± 0.2 mm and 8.1 (thickness) ± 0.2 mm.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing the whole tablet.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
LABORATORI ALTER S.r.l.
Via Egadi, 7
20144 Milano
Manufacturer
Toll Manufacturing Services S.L
C/Aragoneses, 2
28108 Alcobendas (Madrid), Spain
or
FROSST IBÉRICA, S.A.
Vía Complutense, 140
28805 Alcalá de Henares, (Madrid), Spain
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Germany
France
Hungary
Italy
Poland
Portugal
Romania
United Kingdom