Patient Information Leaflet: Package Insert

Paracetamol Aurovitas Spain 500 mg Tablets EFG

Read this leaflet carefully before you start to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Paracetamol Aurovitas Spain contains the active ingredient paracetamol, which belongs to a group of medicines called analgesics.

Paracetamol is used to relieve pain and helps to reduce fever. The tablets can alleviate mild to moderate pain (for example, headache or toothache) and/or febrile states.

This medicine can be used in adults and adolescents, but it is not suitable for children under 10 years.

Do not takeParacetamol Aurovitas Spain

• If you are allergic toparacetamolor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takethis medication:

• If you have a kidney or liver disease (including Gilbert's syndrome or acute hepatitis).
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.
• If you have hemolytic anemia (abnormal breakdown of red blood cells).
• If you regularly consume large amounts of alcohol. Never take more than 2 g of paracetamola day.
• If you are asthmatic and sensitive to acetylsalicylic acid.
• In case of dehydration or chronic malnutrition.

If you are being treated with any medication for epilepsy, consult your doctor before taking paracetamol, as when used together, it reduces the effectiveness and increases the risk of liver damage, especially with high doses of paracetamol.

If you have high fever, signs of secondary infection, or if symptoms persist for more than 3 days, consult your doctor or pharmacist.

Headache due to analgesic abuse should not be treated by increasing the analgesic dose. In these cases, the use of analgesics should be done after consulting a doctor.

Do not take more paracetamol than recommended in section 3. How to take Paracetamol Aurovitas Spain.

It is recommended to avoid the simultaneous use of this medication with other medications containing paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

Paracetamol Aurovitas Spainuse with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Paracetamol Aurovitas Spain with other medications containing paracetamol.

If you are taking any of the following medications, consult your doctor before taking paracetamol:

• Metoclopramide or domperidone (medications used to treat nausea and vomiting).
• Colestiramine (used to lower cholesterol).
• Warfarin and other coumarin derivatives (medications to make the blood thinner), especially if you need to take paracetamol every day for a long period of time.
• Salicylamide (a pain medication).
• Probenecid (a medicationusedto treat gout).
• Isoniazid or rifampicin (medications used to treat tuberculosis).
• Lamotrigine or phenytoin (medications used to treat epilepsy).
• Barbiturates or carbamazepines (medications that produce relaxation and sleep).
• St. John's Wort (a medication used to treat depression).
• Chloramphenicol (an antibiotic).
• Zidovudine (a medication used to treat AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

If you are to undergo any laboratory tests (such as blood tests, urine tests, skin allergy tests, etc.) inform your doctor that you are taking this medication, as it may alter the results of these tests.

Paracetamol Aurovitas Spainuse with food, drinks, and alcohol

When taking paracetamol, it is recommended to avoid the consumption of alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

In case of necessity, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Paracetamol is excreted in breast milk but in insignificant amounts. Therapeutic doses of paracetamol can be administered during breastfeeding.

Fertility

No adverse effects on fertility have been reported with the normal use of paracetamol.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No adverse effects on your ability to drive or operate machinery are expected.

Paracetamol Aurovitas Spaincontains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablet can be divided into equal doses.

The recommended dose is:

Adults, elderly people and adolescents 16 years or older (with a weight of more than 55 kg):

Take one or two 500 mg tablets up to 4 times a day. The maximum daily dose of paracetamol should not exceed 6 tablets (3 g).

Children and adolescents 10 to 15 years old (with a weight between 40 and 55 kg):

Take one 500 mg tablet up to 4 times a day. The daily dose of paracetamol should not exceed 4 tablets (2 g).

Not recommended for children under 10 years old.

Doses should be spaced at least 4 hours apart and no more than 4 doses in 24 hours should be administered.

The tablets should be swallowed whole with sufficient water.

• This medication is not suitable for children under 10 years old.
• At least 4 hours should pass between two doses.
• It should not be used in combination with other preparations containing paracetamol.
• The indicated dose should not be exceeded.
• The tablet is scored to facilitate its use in children.
• If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

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

• Adults with a weight of less than 50 kg.
• Mild to moderate liver insufficiency, Gilbert syndrome (familial non-hemolytic jaundice).
• Dehydration.
• Chronic malnutrition.

Follow these instructions unless your doctor has told you otherwise.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Administration form

Swallow the tablet with a glass of water.

If you take moreParacetamolAurovitasSpainthan you should

In case of overdose, seek medical assistance immediately, even if you feel well, due to the risk ofsevere late liver damage. The symptoms of paracetamol overdose are nausea, vomiting, and loss of appetite. Generally, there is no loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeParacetamolAurovitasSpain

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose, simply take your regular dose when it is due.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects are listed below and are classified as:

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

• Various blood disorders including agranulocytosis, thrombocytopenia, thrombotic purpura, hemolytic anemia, leucopenia, platelet disorders (coagulation disorders) and disorders of the hematopoietic cells (blood cell disorders in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disorder.
• Edema (abnormal accumulation of fluid under the skin).
• Abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting.
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellow discoloration of the skin and eyes), liver necrosis (death of liver cells).
• Skin rash, itching, sweating, urticaria, red spots on the skin, angioedema with symptoms such as facial swelling, lips, throat, or tongue.
• Dizziness, general discomfort, fever, sedation, interaction with other medications.
• 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 sugar levels.
• Hepatotoxicity (liver damage caused by chemical substances).
• Turbid urine and kidney disorders.
• Bronchospasm (difficulty breathing) in patients sensitive to acetylsalicylic acid and other anti-inflammatory medications.
• Hematuria (blood in the urine).
• Anuria (inability to urinate).

Unknown frequency(frequency cannot be estimated from available data)

• Acute generalized exanthematous pustulosis (drug eruption characterized by numerous small, sterile pustules, mainly non-follicular).
• Severe skin rash or skin peeling.
• Stevens-Johnson syndrome (severe skin disorder potentially fatal).
• Redness of the skin, blisters, or rash due to paracetamol ingestion.

Once you stop taking the medicine, these side effects should disappear. If any of them worsen, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Paracetamol Aurovitas Spain

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are: pregelatinized cornstarch, anhydrous colloidal silica, low-viscosity hydroxypropylcellulose, sodium carboxymethyl starch (Type A) from potato, talc, magnesium stearate.

Appearance of the product and content of the container

Uncoated white or off-white tablets, round, with the marks “A” and “8” on each side of the groove on one face and smooth on the other.

Paracetamol Aurovitas Spain is available in blister packs of 16, 20, 30, 40, and 100 tablets.

Only some sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora, 2700-487

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: October 2022

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ).