Paracetamol Aurobindo Pharma

Package leaflet: Information for the patient

Paracetamol Aurobindo Pharma 500 mg tablets

Equivalent medicine
[for SOP packages only:]
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 instructed 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

[for RR packages only:]
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult 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, because 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:

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

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

Paracetamolo Aurobindo Pharma contains the active substance paracetamol, which belongs to a group of medicines called analgesics (painkillers).
Paracetamolo Aurobindo Pharma 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 Pharma 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 Paracetamol Aurobindo Pharma

Do not take Paracetamol Aurobindo Pharma

• 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 Paracetamol Aurobindo Pharma:

• if you have kidney or liver disease (including Gilbert's syndrome or acute hepatitis);
• if you have a deficiency of a specific enzyme called glucose-6-phosphate dehydrogenase;
• if you have haemolytic anaemia (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 for epilepsy, consult your doctor before taking paracetamol, as concomitant use may reduce the effectiveness of paracetamol and increase the risk of liver damage, particularly with high-dose acetaminophen regimens.
If you have high fever, signs of secondary infection, or symptoms persisting for more than 3 days, consult your doctor or pharmacist.
Headache caused by excessive use of analgesics should not be treated by increasing the dose.
In such cases, analgesics should only be used after consulting a doctor.
Do not take more paracetamol than recommended in section 3 “How to take Paracetamol Aurobindo Pharma”. Concomitant use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without discussing it with your doctor.
During treatment with Paracetamol Aurobindo Pharma, inform your doctor immediately if:
You suffer from serious conditions, including severe renal 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 imbalance in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
Other medicines and Paracetamol Aurobindo Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Paracetamol Aurobindo Pharma in combination with other medicines containing
paracetamol.
Inform 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 used to thin the blood), especially if you need to take paracetamol daily for a prolonged period;
• salicylamide (an analgesic);
• 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 herbal remedy used to treat depression);
• chloramphenicol (an antibiotic);
• zidovudine (a medicine used to treat AIDS);
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

If you are scheduled for laboratory tests (blood tests, urine tests, allergy tests, etc.), you must inform your doctor that you are taking this medicine, as it may affect the results of these tests.
Paracetamol Aurobindo Pharma with food, drinks and alcohol
Alcohol should be avoided during treatment with Paracetamol Aurobindo Pharma.
Pregnancy, breast-feeding and fertility
Pregnancy
If necessary, Paracetamol Aurobindo Pharma may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and to take it for the shortest possible duration.
Contact your doctor if pain and/or fever do not improve, or if you need to take the medicine more frequently.
Breast-feeding
Paracetamol is excreted in breast milk, but only in negligible amounts. Therapeutic doses of paracetamol may be used during breast-feeding.
Fertility
No harmful effects on fertility are known with normal use of paracetamol.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Paracetamol Aurobindo Pharma is not expected to affect the ability to drive or use machinery.
Paracetamol Aurobindo Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Paracetamol Aurobindo Pharma

[for SOP packages only:]
Dosage
Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
[for RR packages only:]
Dosage
Take this medicine exactly as instructed by your doctor. 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 one to two tablets of Paracetamol Aurobindo Pharma 500 mg at a time, up to a maximum of 3000 mg in 24 hours.
The maximum daily dose of paracetamol must not exceed six tablets (3000 mg).
Children aged 10 to 15 years (weighing between 40 and 55 kg):
Take one tablet of Paracetamol Aurobindo Pharma 500 mg at a time, up to a maximum of 2000 mg in 24 hours.
The daily dose of paracetamol must not exceed 2000 mg.
Not recommended for children under 10 years of age.
The tablet should be swallowed whole with plenty of water.
Paracetamol Aurobindo Pharma is not suitable for children under 10 years of age.

• At least 4 hours must elapse between doses.
• Do not use in combination with other preparations containing paracetamol.
• Do not exceed the recommended dose.
• Paracetamol Aurobindo Pharma tablets have a break line to facilitate splitting for use in children.
• If pain persists for more than 5 days or fever lasts more than 3 days or worsens, or if new symptoms appear, stop treatment and consult your doctor.

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

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

Follow these instructions unless your doctor has advised you otherwise.
If you feel that Paracetamol Aurobindo Pharma 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 Paracetamol Aurobindo Pharma than you should:
SEEK IMMEDIATE MEDICAL HELP IN CASE OF OVERDOSE,
EVEN IF YOU FEEL WELL, DUE TO THE RISK OF SEVERE DELAYED LIVER DAMAGE.
Symptoms of paracetamol overdose include nausea, vomiting and reduced appetite. Loss of consciousness usually does not occur.
If you forget to take Paracetamol Aurobindo Pharma
Do not take a double dose to make up for the missed tablet. Instead, continue taking the next dose at the scheduled time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamolo Aurobindo Pharma can cause side effects, although not everybody gets them.
The possible side effects are listed below and classified as follows:
Rare side effects (may affect up to 1 in 1,000 people):

• Various blood disorders such as agranulocytosis, thrombocytopenia, thrombocytopenic purpura, haemolytic anaemia, leucopenia, platelet disorders (coagulation disorders), and disorders of stem cells (disorders of cells that form blood in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disorders.
• Oedema (abnormal accumulation of fluid under the skin).
• Abdominal pain, gastrointestinal bleeding, diarrhoea, 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, pruritus, sweating, urticaria, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat or tongue.
• Dizziness, general malaise, 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, breathing difficulties, sweating, nausea, hypotension, shock, and anaphylaxis.
• Low blood glucose levels.
• Hepatotoxicity (liver damage caused by chemicals).
• Cloudy urine and kidney disorders.
• Bronchospasm (difficulty breathing) in patients sensitive to aspirin and other anti-inflammatory medicines.
• Haematuria (blood in urine).
• Enuresis (inability to urinate).

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

• Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness taking paracetamol (see section 2).
• Acute generalized exanthematous pustulosis (drug-induced eruption characterized by numerous small sterile pustules, mainly non-follicular).
• Severe skin rash or skin peeling.
• Stevens-Johnson syndrome (a serious, life-threatening skin disorder).
• Skin redness, blisters or rash due to taking paracetamol.

These side effects should disappear as soon as you stop taking the medicine. If any of the side effects worsen, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Paracetamol Aurobindo Pharma

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. Package contents and other information

What Paracetamol Aurobindo Pharma contains

• The active substance is paracetamol.

Each tablet contains 500 mg of paracetamol.

• The other components are: pregelatinized starch (maize), anhydrous colloidal silica, hydroxypropylcellulose (low viscosity grade), sodium starch glycolate (type A), talc, magnesium stearate.

Description of the appearance of Paracetamol Aurobindo Pharma and contents of the pack
Tablet.
Paracetamol Aurobindo Pharma 500 mg:
White to almost white, uncoated, round tablets, marked with “A” and “8” separated by a
score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Paracetamol Aurobindo Pharma is available in blister packs containing 16, 20, 30, 40 and 100
tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Paracetamol Aurobindo Pharma
Portugal: Paracetamol Limeg
Spain: Paracetamol Aurovitas Spain 500 mg/1g tablets EFG