Paracetamol Cooper 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

ParacetamolCooper 1g tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of this medicine contained in this leaflet or those provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days in adults (3 days for children aged 16 years or over, or with body weight above 50 kg), or if fever persists for more than 3 days.

Contents of the leaflet

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

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

Paracetamol Cooper is a medicine used to relieve pain and reduce fever (an analgesic and antipyretic medicine).

Paracetamol Cooper is used for the treatment of mild to moderate pain and febrile conditions in adults and children aged 16 years and older (or with a body weight above 50 kg).

2. What you need to know before taking Paracetamol Cooper

Do not take Paracetamol Cooper

• 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 Cooper:

• If you have kidney problems.
• If you have liver problems, for example, a disorder called Gilbert's syndrome, severe hepatic insufficiency (Child-Pugh > 9), liver inflammation, or if you are taking medicines that affect liver function.
• If you have haemolytic anaemia (a reduction in red blood cells that may cause yellowing of the skin and lead to weakness or difficulty breathing).
• If you have an enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency).
• If you regularly consume excessive amounts of alcohol.
• If you are dehydrated (your body does not have all the water or fluid it should) or have severe malnutrition (your body does not have the correct amount of nutrients needed to maintain healthy tissue and organ function).
• If you are asthmatic and sensitive to acetylsalicylic acid.

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

You have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

You should not use paracetamol frequently over a long period, as prolonged or frequent use may cause liver problems. Speak with your doctor or pharmacist if you intend to take paracetamol for a longer period.

Long-term use, high doses, or misuse of analgesics may cause headaches that should not be treated with higher doses of this medicine.

Do not use this medicine without speaking to a doctor if you have alcohol addiction or any liver injury. Do not use this medicine with alcohol. The effect of alcohol is not increased when taking this medicine.

Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose will not increase pain relief but could cause severe liver damage. Symptoms of liver damage usually appear after a few days. Therefore, it is very important that you inform your doctor as soon as possible if you have taken more than the recommended dose.

Children

The use of this medicine is not recommended in children under 16 years of age or weighing less than 50 kg.

Other medicines and Paracetamol Cooper

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

Do not use any other medicine containing paracetamol.

Paracetamol Cooper may affect other medicines or be affected by them. Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).
• Metoclopramide and domperidone (used to treat nausea —feeling unwell— or vomiting).
• Colestiramine (used to lower blood cholesterol levels). Paracetamol should be taken at least one hour before or four hours after taking this medicine.
• Chloramphenicol (used to treat infections).
• Zidovudine (used to treat AIDS).
• Warfarin and other medicines used to thin the blood, if you need to take a painkiller daily for a long period.
• Probenecid (used to treat gout).
• Substances that induce liver enzymes, for example, rifampicin (used to treat infections) and medicines used to treat epilepsy, such as barbiturates, phenytoin, carbamazepine.
• Propantheline (used to treat gastrointestinal ulcers).

Pregnancy and breastfeeding

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.

Paracetamol may be used during pregnancy if necessary. You should use the lowest possible dose that relieves pain or fever and use it for the shortest possible time. Consult your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Although paracetamol is excreted in breast milk in small amounts, no adverse effects have been reported in breastfed infants. Paracetamol, at the recommended doses, can be used during breastfeeding.

Driving and using machines

This medicine has no effects expected to alter the ability to drive or operate machinery; however, it may cause dizziness or drowsiness. If this occurs, do not drive or operate machinery.

Paracetamol Cooper contains sodium

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

3. How to take Paracetamol Cooper

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 16 years and over (or weighing more than 50 kg):

Take half a tablet or one tablet every 4\–6 hours (3\–4 times daily), but do not exceed the maximum daily dose of 3 tablets (3,000 mg).

The tablet may be divided into equal doses. Treatment should be initiated with the lowest effective dose (half a tablet). Do not take more than one tablet at a time.

This medicine is not recommended for use in children under 16 years of age.

• Doses should be spaced at least 4 hours apart.
• Do not use this medicine in combination with other medicines containing paracetamol.
• Do not exceed the recommended dose.

Follow the instructions provided in this leaflet unless your doctor has given you different advice.

Inform your doctor if you find this medicine too strong or too weak.

If you take more Paracetamol Cooper than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately. There is a risk of liver damage, even if you feel well. To prevent liver damage, it is important that your doctor starts treatment as soon as possible (preferably within 10\–12 hours after the overdose).

Symptoms may include: nausea (feeling unwell), vomiting, anorexia (weight loss), sweating, and malaise. In this case, the patient should go immediately to hospital.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Paracetamol Cooper

Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking ParacetamolCoopery and contact a doctor or go immediately to the nearest hospital if you experience any of the following serious adverse effects

Very rare (affects less than 1 user in 10,000)

• Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (angioedema)

• Severe allergic reaction or hypersensitivity reaction with fever, rash, swelling, and sometimes low blood pressure

• Serious skin reactions (Stevens-Johnson syndrome)

• Blood disorders:

• Decrease in platelet count, which may make you more prone to bruising or bleeding

• Decrease in white blood cell count, causing fever with signs of local infection, such as sore throat or mouth irritation

• Decrease in red blood cells, which may cause anemia, with symptoms such as fatigue and paleness

• Breathing difficulties in patients with acetylsalicylic acid sensitivity

Other adverse effects

Frequent (may affect up to 1 in 10 people)

• Nausea (feeling unwell)
• Vomiting
• Mild drowsiness (drowsiness)

Uncommon (may affect up to 1 in 100 people)

• Dizziness (giddiness)
• Drowsiness (drowsiness)
• Nervousness

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

• Diarrhea, abdominal pain (including cramps and burning sensation), constipation
• Erythema (redness of the skin)
• Burning sensation in the pharynx

Very rare (affects less than 1 user in 10,000)

• Hepatic disorders

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

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Clinical and epidemiological data suggest that long-term use of painkillers may cause kidney problems.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Cooper

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

Do not use this medicine after the expiry date stated on the blister pack, carton, or bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and other information

Composition of ParacetamolCooper

• The active substance is paracetamol.
• The other components and excipients are sodium starch glycolate (type A), povidone K30, pregelatinized corn starch, and stearic acid.

Appearance of the product and contents of the container

Paracetamol Cooper is presented as uncoated, elongated, biconvex tablets of white to off-white color, scored on both sides.

The tablet can be divided into equal doses.

Paracetamol Cooper is available in blisters containing 8 or 10 tablets.

Paracetamol Cooper is also available in blisters of 16, 20, 30, or 40 tablets or in white plastic bottles sealed with a white to off-white cushion containing 100 tablets. These pack sizes are only available by prescription or for dose dispensing/hospital use.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer

APL Swift Services Ltd

HF26, Hal Far Industrial Estate

Hal Far, Birzebbugia

BBG3000

Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/.