PARACETAMOLO 1000 mg Tabletki

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

Paracetamolo Aurobindo Italia 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Paracetamolo Aurobindo Italia and what is it used for

Paracetamolo Aurobindo Italia contains the active ingredient paracetamol, which belongs to a group of
medicines called analgesics (pain relievers).
Paracetamolo Aurobindo Italia is used to relieve pain and to reduce fever. The tablets
can treat mild to moderate pain and/or fever (e.g. headache and toothache).
Paracetamolo Aurobindo Italia can be used in adults and adolescents but is not suitable for
use in children under 10 years of age.

2. What you need to know before taking Paracetamolo Aurobindo Italia

Do not take Paracetamolo Aurobindo Italia

• 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 Aurobindo Italia:

• if you suffer from kidney or liver disease (including Gilbert's syndrome or acute hepatitis);
• if you suffer from a deficiency of a certain enzyme called glucose-6-phosphate dehydrogenase;
• if you suffer from hemolytic anemia (abnormal breakdown of red blood cells);
• if you regularly consume large amounts of alcohol. Never take more than 2000 mg per day;
• if you are asthmatic and sensitive to acetylsalicylic acid;
• in case of dehydration or chronic malnutrition.

If you are taking medicines to treat epilepsy, you should consult your doctor before taking
paracetamol, as concurrent use reduces effectiveness and increases the risk of liver damage
from paracetamol, especially with treatments involving high doses of acetaminophen.
If you have a high fever, signs of a secondary infection, or symptoms persist for more than 3 days,
consult your doctor or pharmacist.
Headache caused by excessive use of painkillers should not be treated by increasing the dose.
In those cases, painkillers should only be used after consulting a doctor.
Do not take more paracetamol than recommended in section 3 “How to take Paracetamolo
Aurobindo Italia”. Concurrent use of this medicine with other medicines containing
paracetamol, such as medicines for influenza and the common cold, should be avoided as high
doses can lead to liver damage. Do not use more than one medicine containing paracetamol
without discussing it with your doctor.

Other medicines and Paracetamolo Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Do not use Paracetamolo Aurobindo Italia in association with other medicines containing
paracetamol.
Tell your doctor before taking paracetamol if you are using any of the following medicines:

• metoclopramide or domperidone (medicines used to treat nausea and vomiting)
• cholestyramine (used to lower cholesterol)
• warfarin and other coumarin derivatives (medicines to thin the blood), especially if you need to take paracetamol every day for a prolonged period
• salicylamide (a pain reliever)
• probenecid (a medicine used to treat gout)
• isoniazid or rifampicin (medicines used to treat tuberculosis)
• lamotrigine or phenytoin (medicines used to treat epilepsy)
• barbiturates or carbamazepine (medicines that cause relaxation and drowsiness)
• St John's wort (a medicine used to treat depression)
• chloramphenicol (an antibiotic)
• zidovudine (a medicine used to treat AIDS).

If you are about to undergo laboratory tests (blood tests, urine tests, allergy tests, etc.) you should
inform your doctor that you are taking this medicine as it may affect the results of
these tests.

Paracetamolo Aurobindo Italia with food, beverages and alcohol
Alcohol should be avoided while taking Paracetamolo Aurobindo Italia.

Pregnancy, breastfeeding and fertility
Pregnancy
Studies with paracetamol do not indicate adverse effects on pregnancy or on the health of the unborn baby.
During pregnancy, you can take paracetamol at the recommended doses.
During pregnancy, paracetamol should not be taken for long periods, at high doses, or in
combination with other medicines.

Breastfeeding
Paracetamol is excreted in breast milk but in negligible amounts. Therapeutic doses of paracetamol can be used during breastfeeding.

Fertility
No harmful effects on fertility are known with normal use of paracetamol.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is not expected that Paracetamolo Aurobindo Italia will impair the ability to drive vehicles or
use machines.

3. How to take Paracetamolo Aurobindo Italia

Dosage
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

The recommended dose is:
Adults, elderly and children over 16 years of age (weighing more than 55 kg):
Take from half to one tablet of Paracetamolo Aurobindo Italia 1000 mg at a time, up to 3 times
within 24 hours.
The maximum daily dose of paracetamol must not exceed 3 tablets per day (3000 mg).
The use of Paracetamolo Aurobindo Italia is not suitable for children under 16 years of age and for this
age group more appropriate formulations/dosages are available.
The tablet should be swallowed whole with plenty of water.
Paracetamolo Aurobindo Italia is not suitable for children under 10 years of age.

• At least 4 hours must pass between two administrations.
• Do not use in association with other preparations containing paracetamol.
• Do not exceed the recommended dose.
• Paracetamolo Aurobindo Italia has a fracture line to facilitate breaking for use in children.
• If the pain persists for more than 5 days or the fever lasts for more than 3 days or worsens, or other symptoms appear, you should stop treatment and consult your doctor.

In the following situations, you should not exceed the maximum daily dose of 60 mg/kg per day (up to 2
g per day):

• adults weighing less than 50 kg
• mild to moderate hepatic insufficiency, Gilbert's syndrome (non-hemolytic familial jaundice)
• dehydration
• chronic malnutrition

Follow these instructions unless your doctor has advised otherwise.
If you feel that Paracetamolo Aurobindo Italia is too strong or too weak, talk to your doctor or
pharmacist.

Method of administration:
Swallow the tablet with a glass of water.

If you take more Paracetamolo Aurobindo Italia than you should:
SEEK IMMEDIATE MEDICAL ATTENTION IN CASE OF OVERDOSE,
EVEN IF YOU FEEL WELL due to the risk of serious delayed liver damage.
Symptoms of paracetamol overdose are nausea, vomiting and loss of appetite. Loss of consciousness generally does not
occur.

If you forget to take Paracetamolo Aurobindo Italia
Do not take a double dose to make up for the forgotten tablet. Instead, continue to
take the next dose at the scheduled time.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamolo Aurobindo Italia can cause side effects, although not everybody gets them.
The possible side effects are listed below and classified as:

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

• Numerous blood disorders such as agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hemolytic anemia, leukopenia, platelet disorders (coagulation disorders) and stem cell disorders (disorders of the cells that form blood in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disturbances.
• Edema (abnormal accumulation of fluid under the skin).
• Abdominal pain, bleeding in the stomach or intestines, diarrhea, nausea, vomiting.
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), hepatic necrosis (death of liver cells).
• Skin rash, itching, sweating, hives, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat or tongue.
• Dizziness, general feeling of discomfort, fever, sedation, interaction with other medicines.
• Overdose and poisoning.

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

• Pancytopenia (reduction in the number of blood cells)
• Allergic reactions requiring discontinuation of treatment, including angioedema, difficulty breathing, sweating, nausea, hypotension, shock and anaphylaxis.
• Low blood glucose level.
• Hepatotoxicity (damage caused to the liver by chemical substances).
• Cloudy urine and kidney disorders.
• Bronchospasm (difficulty breathing) in patients sensitive to aspirin and other anti-inflammatory medicines.
• Hematuria (blood in the urine).
• Enuresis (inability to urinate).

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

• Acute generalized exanthematous pustulosis (drug-related rash characterized by numerous small sterile pustules, mainly non-follicular).
• Severe skin rash or peeling of the skin.
• Stevens-Johnson syndrome (a serious skin disorder, life-threatening).
• Redness of the skin, blisters or rash due to paracetamol intake.

These side effects should disappear as soon as you stop taking the medicine. If
any of the side effects gets serious, contact your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Paracetamolo Aurobindo Italia

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 pack 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

• The active ingredient is paracetamol. Each tablet contains 1000 mg of paracetamol.
• The other ingredients are: Pregelatinized starch (corn), anhydrous colloidal silica, hydroxypropylcellulose (low viscosity grade), sodium starch glycolate (type A), talc, magnesium stearate.

Description of the appearance of Paracetamolo Aurobindo Italia and contents of the pack
Tablet.
Paracetamolo Aurobindo Italia 1000 mg:
White to almost white, uncoated, oval tablets, imprinted with “A” and “9” separated by a
score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Paracetamolo Aurobindo Italia is available in blister packs of 10, 12, 16, 20, 24, 30, 32, 40 and 50
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma Italia s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Paracetamol AB 1000 mg tablets
Czech Republic: Paracetamol Aurovitas
Italy: Paracetamolo Aurobindo Italia
Netherlands: Paracetamol Sanias 1000 mg, tablets
Poland: Paracetamol Aurovitas
Portugal: Paracetamol Aurobindo 1000 mg
Spain: Paracetamol Aurobindo Pharma 1 g comprimidos EFG