PARACETAMOL PHARMEX 1 g ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Paracetamol Pharmex 1 g Powder for Oral Solution

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your fever worsens or persists after 3 days of treatment or if your pain lasts for more than 5 days.

Contents of the package leaflet:

1. What Paracetamol Pharmex is and what it is used for
2. What you need to know before taking Paracetamol Pharmex
3. How to take Paracetamol Pharmex
4. Possible side effects
5. Storage of Paracetamol Pharmex
6. Package contents and additional information

1. What Paracetamol Pharmex is and what it is used for

Paracetamol belongs to a group of medicines called analgesics (pain-relieving medicines) and antipyretics (fever-reducing medicines).

This medicine is used in adults and adolescents over 15 years old (with a body weight over 50 kg) for the relief of moderate-intensity pain and febrile conditions.

You should consult a doctor if your fever worsens or persists after 3 days of treatment or if your pain lasts for more than 5 days.

2. What you need to know before taking Paracetamol Pharmex

Do not take Paracetamol Pharmex:

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

Warnings and precautions

• Do not take more medicine than recommended in section 3 of this package leaflet. The total dose of paracetamol should not exceed 3 grams per day.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses of paracetamol can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately (see "If you take more than you should").

Consult your doctor or pharmacist before starting to take Paracetamol Pharmex.

• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day); chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.
• If you have kidney problems;
• If you have a deficiency of glucose-6-phosphate dehydrogenase;
Other medicines and Paracetamol Pharmex);
• Paracetamol can cause severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions and should discontinue the use of the medicine at the first sign of skin rash or any other sign of hypersensitivity.

Taking higher-than-recommended doses of paracetamol implies a very high risk of liver damage.

Other medicines and Paracetamol Pharmex

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine.

This is especially important if you are using any of the following medicines, as it may be necessary to change the dose of some of them or interrupt treatment:

• Medicines to prevent blood clot formation: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptic medicines (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat depression and convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to reduce cholesterol levels in the blood: (cholestyramine)
• Medicines to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines for the treatment of high blood pressure and cardiac arrhythmias: Propranolol.
• Salicylamide, a medicine to treat fever and pain, can prolong the elimination half-life of paracetamol.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and can occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.

Interference with analytical tests:

If you need to undergo any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results. Paracetamol can alter the values of analytical determinations of uric acid and glucose.

Taking Paracetamol Pharmex with food, drinks, and alcohol

Taking paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) can cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your 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 medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Paracetamol passes into breast milk, so breastfeeding women should talk to their doctor or pharmacist before taking this medicine.

Fertility

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

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

Paracetamol Pharmex contains sucrose and sodium:

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

3. How to take Paracetamol Pharmex

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

In case of doubt, ask your doctor or pharmacist.

This medicine is administered orally, dissolving the entire contents of the sachet in a glass of water.

Adults and adolescents over 15 years old (and weighing over 50 kg).

The recommended dose is 1 sachet every 6-8 hours, not exceeding 3 grams (3 sachets) of paracetamol in 24 hours.

Always use the lowest effective dose.

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of side effects such as liver damage.

The administration of this medicine is subject to the appearance of pain or fever. As these disappear, you should discontinue treatment.

Elderly patients

Experience indicates that the normal adult dose is usually adequate. However, in elderly, fragile, and immobile patients or in elderly patients with renal or hepatic insufficiency, it may be convenient to reduce the dose or frequency of administration.

Patient with kidney disease:consult your doctor before taking this medicine.

Patient with moderate to severe kidney disease should not take this medicine.

Patient with liver disease:consult your doctor before taking this medicine. Take the amount of medicine prescribed by your doctor with a minimum interval of 8 hours between each dose. Do not take more than 2 sachets in 24 hours, divided into 2 doses.

Use in children and adolescents

Due to the dose of paracetamol, this medicine should not be used in children under 15 years old or with a body weight under 50 kg.

If you take more Paracetamol Pharmex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

The symptoms of an overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have ingested an overdose, you should go to a medical center immediately, even if you have not noticed symptoms. Symptoms usually do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment for an overdose is more effective if started within 4 hours after taking the medicine.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects have been reported:

Uncommon:may affect up to 1 in 1,000 people.

• discomfort
• low blood pressure (hypotension)
• increased levels of transaminases in the blood.

Rare:may affect up to 1 in 10,000 people

• kidney disease,
• cloudy urine,
• allergic dermatitis (skin rash),
• jaundice (yellowing of the skin),
• blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia),
• hypoglycemia (low blood sugar level).
• Rarely, cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es/

5. Storage of Paracetamol Pharmex

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Pharmex

The active ingredient is paracetamol. Each sachet contains 1 g of paracetamol.

The other ingredients (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, and orange flavor.

Appearance of Paracetamol Pharmex and package contents

White-yellowish homogeneous powder, dispersible in water, and with an orange flavor.

It is presented in packages containing 10 sachets.

Marketing authorization holder and manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba) - Spain

Date of the last revision of this package leaflet:January 2024

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