Paracetamol Aurobindo Pharma Italia

Package leaflet: Information for the user

Paracetamol Aurobindo Pharma Italia 1000 mg effervescent powder for oral solution

Read all of 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Paracetamolo Aurobindo Pharma Italia belongs to the pharmacotherapeutic group of analgesics
(medicines that reduce pain), acting simultaneously as antipyretics (medicines that reduce fever), with weak anti-inflammatory effects.
Paracetamolo Aurobindo Pharma Italia is used to reduce fever and to relieve mild to moderate pain.

2. What you need to know before taking Paracetamol Aurobindo Pharma Italia

Do not take Paracetamol Aurobindo Pharma 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 Paracetamol Aurobindo Pharma Italia:

• 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 of paracetamol per day;
• if you are asthmatic and sensitive to acetylsalicylic acid;
• in case of dehydration or chronic malnutrition;
• if you weigh less than 50 kg.

If you are taking any medication for epilepsy, consult your doctor before taking paracetamol, as its concomitant use may reduce the effectiveness of antiepileptic drugs and increase the risk of liver damage from paracetamol, especially when high doses of acetaminophen are used.
Prolonged or frequent use is not recommended. Do not take other medicines containing paracetamol at the same time. Taking multiple daily doses in a single administration can severely damage the liver; in such cases, unconsciousness does not occur. However, immediate medical attention must be sought.
If you have high fever, signs of secondary or persistent infection, or symptoms lasting more than 3 days, your treatment should be reassessed.
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.
If you are alcohol-dependent or have liver damage, do not use paracetamol unless prescribed by your doctor, and do not take paracetamol together with alcohol. Paracetamol does not increase the effects of alcohol.
The risk of overdose is higher in patients with non-cirrhotic alcoholic liver disease. Caution should be exercised in cases of chronic alcoholism.
If you are concurrently taking other pain medications containing paracetamol, do not use paracetamol without first discussing it with your doctor or pharmacist.
Never take more paracetamol than recommended. A higher dose does not increase pain relief; instead, it may cause severe liver damage. Symptoms of liver damage may initially appear only after several days. It is therefore very important to contact your doctor as soon as possible if you have taken more Paracetamol Aurobindo Pharma Italia than recommended in this leaflet.
With incorrect long-term and high-dose use of painkillers, headaches may occur that cannot be treated with higher doses of the medicine.
In general, habitual use of painkillers, particularly a combination of different analgesic substances, may lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy).
Following incorrect long-term and high-dose use of analgesics, headaches may occur that cannot be treated with higher doses of the medicine.
Do not take Paracetamol Aurobindo Pharma Italia for prolonged periods or at high doses without discussing it with your doctor or dentist.

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

Medicines that may affect the effects of paracetamol:

• alcohol
• probenecid (a medicine used to treat gout)
• medicines that may damage the liver, e.g. phenobarbital (sleeping tablets), phenytoin, carbamazepine, primidone (medicines used to treat epilepsy), isoniazid, rifampicin (medicines used to treat tuberculosis), St. John's wort (a herbal remedy used to treat depression). Concurrent use of these medicines with paracetamol may cause liver damage
• metoclopramide or domperidone (medicines used to treat nausea). These medicines may increase the absorption and accelerate the onset of paracetamol's effect.
• medicines that slow stomach emptying. These may delay the absorption and onset of action of paracetamol.
• colestyramine (a medicine used to reduce high blood lipid levels). These may delay the absorption and onset of action of paracetamol. Therefore, do not take colestyramine within one hour after taking paracetamol.
• blood-thinning medicines (oral anticoagulants, particularly warfarin). Repeated use of paracetamol for more than one week increases the tendency to bleed. Therefore, long-term administration of paracetamol should only occur under medical supervision. Occasional use of paracetamol does not have significant effects on bleeding tendency.
  Concurrent use of paracetamol and zidovudine (a medicine used to treat HIV infections) increases the risk of reduced white blood cell count (neutropenia). This may affect the immune system and increase the risk of infections. Paracetamol Aurobindo Pharma Italia should therefore be used together with zidovudine only on medical advice.

Effects of taking paracetamol on laboratory tests
Tests for uric acid and blood sugar may be affected.

Paracetamol Aurobindo Pharma Italia and alcohol
Concomitant use of paracetamol and alcohol should be avoided.

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.
During pregnancy, paracetamol should not be taken for long periods, at high doses, or in combination with other medicines.
Paracetamol may be taken during pregnancy at the recommended doses.

Driving and using machines
The use of Paracetamol Aurobindo Pharma Italia does not affect the ability to drive or operate machinery.

Paracetamol Aurobindo Pharma Italia contains sucrose and aspartame:
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains 40.00 mg of aspartame per 1000 mg of oral solution powder.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

3. How to take Paracetamol Aurobindo Pharma Italia

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dose depends on the parameters included in the table below. The dose of Paracetamol
Aurobindo Pharma Italia is based on age and body weight.
The corresponding dose range depends on symptoms and the total maximum daily dose.
There should be a minimum interval of 6 hours between doses, meaning a maximum of
4 doses per day.
If symptoms persist for more than 3 days, you should contact your doctor.

1g sachets
Body weight Single dose [sachet] Maximum daily dose [sachets]
(age)
Over 55 kg 1 g paracetamol (1 sachet) 3 g paracetamol (3 sachets of 1 g)
(children above 16 years of age and adults)

The sachet is not recommended for children and adolescents under 16 years of age.

Method/Route of administration
Paracetamol Aurobindo Pharma Italia is for oral use only.
Shake the sachet before use. Pour the contents of the sachet into a glass and add a small amount of liquid (e.g. water, milk, fruit juice).

Special patient groups

Impaired renal function:
When administering paracetamol to patients with impaired renal function, it is recommended to reduce the dose and increase the minimum interval between doses to at least 6 hours, unless otherwise instructed by the doctor.
This medicine is not suitable for patients with impaired renal function when a reduced dose is required. More appropriate formulations are available for this situation.

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

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

Elderly patients
Experience indicates that the normal adult dose is usually appropriate. However, in frail, immobilized elderly patients or elderly patients with renal or hepatic impairment, a reduction in dose or frequency of administration may be appropriate.

Children and adolescents with low body weight
Paracetamol 1000 mg in sachets is not suitable for children or for individuals under 16 years of age and weighing less than 55 kg, as the dosage is not appropriate for this age group. Alternative formulations and dosages are available for these patients.

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

If you forget to take Paracetamol Aurobindo Pharma Italia
Do not take a double dose to make up for the forgotten dose.
If you have any questions 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 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 produce blood in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disorders.
• Oedema (abnormal accumulation of fluid under the skin).
• Abdominal pain, stomach or intestinal 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, itching, sweating, urticaria, red patches 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 (reduced 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 anti-inflammatory medicines.
• Haematuria (blood in the urine).
• Enuresis (inability to urinate).

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

• Acute generalised exanthematous pustulosis (drug-induced rash characterised 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 paracetamol intake.

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, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at http://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 Pharma Italia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the carton 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 Aurobindo Pharma Italia contains
The active substance is: paracetamol.
Each sachet contains 1000 mg of paracetamol.
The other components are:
sucrose, sodium saccharin, aspartame, povidone (K-30) and orange flavour.

Description of the appearance of Paracetamolo Aurobindo Pharma Italia and package contents
Powder for oral solution.
Paracetamolo Aurobindo Pharma Italia is available in packs of 10, 12, 16, 20 and 40 sachets.
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)
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 Member States of the European Economic Area under the following names:
Italy: Paracetamolo Aurobindo Pharma Italia
Portugal: Paracetamol Aurobindo
Spain: Paracetamol Aurovitas 1g powder for oral solution EFG