PARACETAMOL ADAIR 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Adair 1 g Coated Tablets EFG

paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. - If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

It is indicated for the treatment of symptoms of pain and fever.

2. What you need to know before you take Paracetamol Adair

Do not take Paracetamol Adair:

• If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Take special care with Paracetamol Adair:

• Do not take more than the recommended dose in section 3. How to take Paracetamol Adair.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have any kidney, liver, heart, or lung disease, or if you have anemia (reduced hemoglobin level in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.
• When being treated with any medication for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, take no more than 2 g/24 hours of paracetamol.
• If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, consult your doctor and reassess the clinical situation.
• In children under 15 years of age, consult your doctor or pharmacist, as there are other formulations with doses suitable for this group of patients.

Taking other medicines and Paracetamol Adair

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for treating tuberculosis: (isoniazid, rifampicin)
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used for the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Warnings and precautions

During treatment with Paracetamol Adair, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with laboratory tests:

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Adair with food, drinks, and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor... per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

In case of necessity, Paracetamol Adair 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 medicine more frequently.

Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

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

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

3. How to take Paracetamol Adair

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

Adults and children over 15 years: the usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 milligrams per dose.

Due to the dose, 1 g of paracetamol, it is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children: Do not use in children under 15 years.

If you think the action of Paracetamol Adair is too strong or too weak, tell your doctor or pharmacist. When lower doses of paracetamol are required, other paracetamol formulations that adapt to the required dosage should be used.

If you take more Paracetamol Adair than you should:

Consult your doctor or pharmacist immediately.

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

If you have taken an overdose, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning. Treatment of overdose is most effective if started within 4 hours of ingestion of the medicine.

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Paracetamol Adair

Do not take a double dose to make up for forgotten doses. Simply take the forgotten dose when you remember, taking the next doses with the indicated interval between them (at least 4 hours).

4. Possible side effects

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

Rare side effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (less than 1 in every 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and low blood sugar (hypoglycemia). Very rare cases of serious skin reactions have been reported.

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

Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Adair

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Adair:

Each tablet contains 1 g of paracetamol as the active ingredient.

The other ingredients (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and pack contents:

Paracetamol Adair is presented as oral tablets.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face.

In packs of 20 and 40 tablets and a clinical pack of 500 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat 08950 – Barcelona

Spain

Manufacturer

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Date of last revision of this leaflet:February 2025

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