NOTICE
ANSM - Updated on : 17/07/2025
Product name
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet
Paracetamol
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 3 days.
What does this leaflet contain?
1. What is PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet and what is it used for?
2. What do I need to know before taking PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet?
3. How do I take PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet?
4. What are the possible side effects?
5. How do I keep PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet?
6. Package contents and other information.
1. WHAT IS PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: other analgesics and antipyretics, anilides - ATC code: N02BE01.
Paracetamol is an analgesic (pain reliever) and an antipyretic (fever reducer).
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet is used to treat mild to moderate pain and/or fever in adults and children aged 16 or over (or weighing more than 50 kg).
2. WHAT DO I HAVE TO KNOW BEFORE TAKING PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet?
Never take PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet:
- if you are allergic to paracetamol or any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet :
- if you have kidney problems;
- if you suffer from liver problems (e.g. Gilbert's syndrome, severe hepatic insufficiency (Child-Pugh > 9), liver inflammation) or if you are taking medicines which affect liver function;
- if you suffer from hemolytic anemia (a reduction in the number of red blood cells that can cause pale yellow skin, weakness or shortness of breath);
- if you have an enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency);
- if you regularly consume excessive quantities of alcohol;
- if you are dehydrated (your body does not have as much water or fluid as it should) or very malnourished (your body does not have the adequate amount of nutrients it needs to maintain healthy tissues and organs);
- if you are asthmatic and sensitive to acetylsalicylic acid (aspirin).
Talk to your doctor or pharmacist before taking PARACETAMOL VIATRIS CONSEIL 1000 mg, tablet:
- if you have any serious medical conditions, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you are malnourished, chronically alcoholic or also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients who regularly take paracetamol for a prolonged period or who take paracetamol in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
You should not use paracetamol frequently over a long period, as prolonged or frequent use may cause liver problems. Talk to your doctor or pharmacist if you plan to take paracetamol for a longer period.
Long-term, high-dose or incorrect use of analgesics may cause headaches which should not be treated with higher doses of PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet.
Do not use PARACETAMOL VIATRIS CONSEIL 1000 mg, comprimé sécable without consulting a doctor if you have an alcohol problem or if your liver is damaged.
Do not use PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet with alcohol. The effect of alcohol is not increased by PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet.
Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose does not increase pain relief, but may cause serious liver damage. Symptoms of liver damage normally appear after a few days. It is therefore very important that you contact your doctor as soon as possible if you have taken more than the recommended dose.
Children
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet should not be used in children under 16 years of age or weighing less than 50 kg.
Other medicines and PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Do not take any other medicines containing paracetamol.
PARACETAMOL VIATRIS CONSEIL 1000 mg, comprimé sécable may interact with other medicines. Tell your doctor or pharmacist if you are taking :
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (known as metabolic acidosis), which must be treated as an emergency (see section 2).
- metoclopramide or domperidone (drugs used to treat nausea and vomiting);
- cholestyramine (used to lower cholesterol). Paracetamol should be taken at least one hour before or four hours after taking this medication;
- chloramphenicol (used to treat infections);
- zidovudine (used to treat AIDS);
- warfarin and other medicines used to thin the blood, particularly if you need to take pain relief medication daily over a long period of time;
- probenecid (a drug used to treat gout);
- substances that activate liver enzymes, such as rifampicin (used to treat infections) or drugs used to treat epilepsy, such as barbiturates, phenytoin or carbamazepine;
- propantheline (a drug used to treat peptic ulcers).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose to reduce your pain and/or fever, and take it for the shortest possible time.
Contact your doctor if pain and/or fever are not reduced, or if you need to take the medication more often. Although paracetamol is excreted in breast milk in small quantities, no adverse effects have been reported in breast-fed infants. Paracetamol at recommended doses may be used briefly during breastfeeding.
Driving and use of machinery
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet does not affect driving or the use of machinery, but may cause dizziness or drowsiness. If this occurs, do not drive or operate machinery.
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
The recommended dose is :
Adults and adolescents aged 16 or over (or weighing over 50 kg)
Dosage is one-half (½) to one tablet per dose, repeated if necessary every 4 to 6 hours (3 to 4 times a day), up to a maximum of 3 tablets (3000 mg) per 24 hours.
Tablets can be divided into equal doses. Treatment should preferably be started with the lowest possible effective dose (half a tablet). Do not take more than 1 tablet at a time.
- This medicine must not be used in children under 16 years of age.
- Take at least 4 hours apart.
- Do not use in combination with other medicines containing paracetamol.
- The indicated dosage must not be exceeded.
Be sure to follow the above instructions, except on medical advice.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
If you have taken more PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet than you should have
If you have taken more paracetamol than you should have, contact your doctor or pharmacist immediately.
There is a risk of liver damage, even if you feel well. To prevent liver damage, it's important that your doctor can start treatment as soon as possible (preferably within 10-12 hours of an overdose).
Symptoms may include nausea (feeling unwell), vomiting, anorexia (weight loss), sweating and malaise. In this case, go to hospital immediately.
If you forget to take PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet
Do not take a double dose to make up for the one you forgot to take.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, PARACAMET may cause undesirable effects, but these do not always occur in everyone.
Stop taking PARACETAMOL VIATRIS CONSEIL 1000 mg, comprimé sécable and contact your doctor or go immediately to the nearest hospital if you have any of these serious side effects.
Very rare (affecting less than 1 in 10,000 users):
- swelling ofthe face, tongue or throat, difficulty swallowing, hives and difficulty breathing (angioedema);
- severe allergic or hypersensitivity reaction with fever, rash, swelling and sometimes a drop in blood pressure;
- severe skin reactions (Stevens-Johnson syndrome);
- blood disorders:
o decrease in platelets, which can make you more vulnerable to bruising or bleeding,
o decrease in the number of white blood cells, causing fever accompanied by symptoms of local infection such as sore throat/mouth,
o decrease in red blood cell count, which may cause anemia, accompanied by symptoms such as fatigue and paleness;
- breathing difficulties in patients sensitive to aspirin.
Other side effects
Common (may affect up to 1 in 10 people)
- nausea (feeling of sickness);
- vomiting;
- slight drowsiness.
Uncommon (may affect up to 1 in 100 people)
- dizziness;
- drowsiness;
- nervousness.
Rare (may affect up to 1 in 1,000 people)
- diarrhea, abdominal pain (including cramps and burning), constipation;
- erythema (redness of the skin);
- burning sensation in the pharynx.
Very rare (affects less than 1 in 10,000 users):
- liver disorders.
Undetermined frequency (cannot be estimated on the basis of available data)
- a serious condition that can cause the blood to become more acidic (known as metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
Clinical and epidemiological data suggest that long-term administration of analgesics (painkillers) may cause kidney problems.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the pack or blister after EXP. The expiration date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet contains
- The active substance is :
paracetamol................................................................................................................. 1000 mg
for one tablet.
- The other components are :
sodium starch glycolate, povidone, pregelatinized corn starch, stearic acid.
What is PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet and what does it contain?
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet is a white to off-white, biconvex, oblong, uncoated tablet with a scoring bar on both sides.
The tablet can be divided into equal doses.
PARACETAMOL VIATRIS CONSEIL 1000 mg, scored tablet is available in boxes of 8 and 10 tablets in blister packs.
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1, RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
APL SWIFT SERVICES (MALTA) LTD
HF26, HAL FAR INDUSTRIAL ESTATE
HAL FAR, BIRZEBBUGIA
BBG3000
MALTA
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed later by the holder].
The last date on which this leaflet was revised was :
[to be completed at a later date by the registrant]
Other
Detailed information on this drug is available on the ANSM (France) website.