Order Paracetamol KRKA 500mg 16 tablets in our organic pharmacy, to relieve pain and fever . Comment on advice for use and dosage with our partner Avis checked after your purchase.
Paracetamol KRKA 500mg 16 tablets is formulated with paracetamol. Paracetamol is an analgesic ingredient commonly used to relieve aches and pains . In addition, it can be used to reduce fever.
Oral route.
The tablets are to be swallowed as is with a drink (eg water, milk, fruit juice).
In adults and children over 50 kg , the usual dosage is:
1 tablet at 500 mg (1 g) per dose, to be renewed if necessary after at least 4 hours without exceeding 3 tablets per day .
Be careful not to exceed 3 grams of paracetamol per day (except medical advice) taking into account all medicines containing paracetamol in their formula.
What are the side effects and contraindications?
Paracetamol KRKA 500mg 16 tablets may cause certain side effects. However, they do not always appear in everyone.
Comment on the recommendations for use and dosage of Paracetamol KRKA 500mg 16 tablets with our partner Avis checked after your purchase .
Active substance: Paracetamol 500mg
The other ingredients being: sodium starch glycolate (type A), povidone (K-30), pregelatinized corn starch, stearic acid.
Presentation
Paracetamol KRKA 500mg 16 tablets comes in the form of a box of 16 scored tablets to be taken orally.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on : 04/03/2025
PARACETAMOL KRKA 500 mg, tablet
Paracetamol
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor 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 pain persists for more than 5 days, or fever for more than 3 days, or if there are any other signs of insufficient efficacy.
What does this leaflet contain?
1. What is PARACETAMOL KRKA 500 mg, tablet and what is it used for?
2. What do I need to know before taking PARACETAMOL KRKA 500 mg, Tablet?
3. How do I take PARACETAMOL KRKA 500 mg, tablet?
4. What are the possible side effects?
5. How do I keep PARACETAMOL KRKA 500 mg, Tablet?
6. Package contents and other information.
1. WHAT IS PARACETAMOL KRKA 500 mg, tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: N02BE01
PARACETAMOL KRKA 500 mg, tablet contains paracetamol. Paracetamol is an analgesic (pain reliever) and an antipyretic (fever reducer).
It is indicated for adults and children weighing 27 kg (approx. 8 years) and over, to reduce fever and/or relieve mild to moderate pain (e.g. headaches, flu, toothache, aches and pains, painful menstruation, painful attacks of arthrosis).
Carefully read "Dosage" in section 3.
For children under 27 kg, other paracetamol presentations are available: ask your doctor or pharmacist for advice.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING PARACETAMOL KRKA 500 mg, tablet?
Never take PARACETAMOL KRKA 500 mg, tablet
- if you are allergic to paracetamol or any of the other ingredients listed in section 6.
- if you have severe liver disease.
If in doubt, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOL KRKA 500 mg, tablet:
- if you are an adult weighing less than 50 kg,
- if you have kidney or liver disease,
- if you are elderly,
- if you regularly drink alcohol or have recently stopped drinking alcohol,
- in cases of chronic malnutrition, fasting, emaciation, anorexia or cachexia (low reserves or hepatic glutathione deficiency),
- in cases of dehydration,
- in case of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (may lead to hemolytic anemia),
- in cases of Gilbert's syndrome (non-hemolytic familial jaundice).
During treatment with PARACETAMOL KRKA 500 mg, tablet, tell your doctor immediately ifyou have any serious illnesses, 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.
In the event of acute viral hepatitis, discontinue treatment and consult your doctor.
Long-term, incorrect and/or high-dose use of this drug in patients with chronic headaches may cause headaches to develop or worsen. Do not increase your dose of analgesics, but consult your doctor.
Children and adolescents
In children being treated with paracetamol, the combination with another fever-reducing drug (antipyretic) is justified only if it is effective. The combination should only be initiated and monitored by a physician.
Other drugs and PARACETAMOL KRKA 500 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription.
This medication contains from paracetamol. Other medications contain.
Check that you do not take not other medicines containing paracetamol, including if these are medicines obtained without aprescription .
Donot combine them, so of do not exceed recommendeddailydose .
Consult your doctor or pharmacist:
- if you are taking any medicines that are potentially toxic to the liver. Paracetamol toxicity may be increased.
- if you or your child have been prescribed a uric acid or blood sugar test, as this medication may alter the results.
- if you are taking a drug that slows clotting (oral anticoagulants). At high doses, PARACETAMOL KRKA 500 mg, tablet may increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.
- if you are taking flucloxacillin (antibiotic), as there is a serious risk of blood and fluid abnormalities (known as metabolic acidosis), which must be treated urgently (see section 2).
PARACETAMOL KRKA 500 mg, tablet with alcohol
Consumption of alcoholic beverages during treatment is not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breast-feeding
If required, this drug may be used during pregnancy and lactation.
You should use the lowest possible dose to relieve pain and/or fever, and take it for the shortest possible time. Contact your doctor if the pain and/or fever do not subside, or if you need to take the medication more frequently.
Fertility
It is possible that paracetamol may impair fertility in women, reversible on discontinuation of treatment.
Driving vehicles and using machines
Paracetamol has no or negligible effect on the ability to drive vehicles and use machines.
PARACETAMOL KRKA 500 mg, tablet contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE PARACETAMOL KRKA 500 mg, Tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults and children weighing 27 kg (approx. 8 years) and over.
Use the lowest effective dose for the shortest possible duration. Use the 1000 mg dose in cases of pain and/or fever not relieved by a 500 mg dose of paracetamol.
Dosage depends on weight. Ages are given for information only. If you don't know your child's weight, you should weigh him/her to determine the most appropriate paracetamol dosage. The recommended daily dose of paracetamol should be divided into several doses, without exceeding the maximum doses shown in the table below.
|
Weight (approximate age) |
Maximum dose per administration |
Interval between two doses |
Maximum dose per day |
|
Child 27 kg 40 kg (approx. 8 to 12 years) |
500 mg (1 tablet) |
6 hours minimum |
2000 mg per day or 2 g (4 tablets) per day |
|
Children 41 kg 49 kg (approx. 13 to 15 years) |
500 mg (1 tablet) |
4 hours minimum |
3000 mg per day or 3 g (6 tablets) per day |
|
Adults and children over 50 kg (about 15 years old) |
500 mg to 1000 mg or 500 mg to 1 g (1 to 2 tablets) |
4 hours minimum |
3000 mg per day, i.e. 3 g (6 tablets) |
Caution: To avoid the risk of overdosage, check that paracetamol is not included in the composition of other medicines, including over-the-counter products. Respect the maximum recommended dose or the dose prescribed by your doctor: a higher dose will not relieve your pain any more, but may have serious consequences for your liver.
Adults weighing less than 50 kg, chronic malnutrition, dehydration, the elderly: ask your doctor or pharmacist for advice.
Hepatic insufficiency, chronic alcoholism and Gilbert's syndrome: never exceed 2000 mg (2 g) paracetamol per day.
Renal insufficiency: Dosage must be adapted to the degree of renal insufficiency. Consult your doctor before taking this medication.
If you feel that the effect of this medicine is too strong or too weak, do not exceed the dose. Ask your doctor or pharmacist for advice.
Method of administration
Take by mouth.
The tablets should be swallowed whole with a glass of water.
Duration of treatment
Frequent or prolonged use without medical supervision is not recommended.
Unless medically indicated, treatment duration is limited to 5 days for pain and 3 days for fever.
If symptoms persist or worsen beyond this period, or if new symptoms appear, discontinue treatment and consult your doctor immediately.
If you have taken more PARACETAMOL KRKA 500 mg, tablet than you should have
Stop treatment and consult immediately your doctor or seek medical advice immediately.
Overdose can be fatal.
Overdose can cause liver damage, brain inflammation, coma and even death, particularly in high-risk populations such as young children, the elderly and in certain situations (liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, recent weight loss, Gilbert's syndrome and in patients treated concomitantly with certain drugs). Inflammation of the pancreas, kidney failure and a simultaneous reduction in red blood cells, white blood cells and platelets have also been reported.
Within the first 24 hours, the main symptoms of toxicity are nausea, vomiting, paleness, malaise, sweating, loss of appetite and abdominal pain.
If you forget to take PARACETAMOL KRKA 500 mg, tablet
Do not take a double dose to make up for the single dose you forgot to take.
If you stop taking PARACETAMOL KRKA 500 mg, tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Rare side effects Rare side effects: may affect up to 1 in 1,000 people.
- skin redness, rash, urticaria. Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- blood spots on the skin (purpura). Stop treatment immediately and inform your doctor. Treatment may be reintroduced only on the advice of your doctor.
Very rare side effects May affect up to 1 in 10,000 people.
- severe skin reactions. Treatment should be stopped immediately, your doctor informed and paracetamol-containing drugs should never be taken again.
- biological changes requiring a blood test: abnormally low levels of certain white blood cells (leukopenia, neutropenia) or of certain blood cells such as platelets (thrombocytopenia), which may lead to nose or gum bleeding. In this case, consult a physician.
Undesirable effects of undetermined frequency frequency cannot be estimated from available data
- Skin rash or redness, or allergic reaction manifested by sudden swelling of the face and neck which may cause difficulty in breathing (angioedema), or by sudden malaise with a drop in blood pressure (anaphylactic shock).
Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- diarrhoea, abdominal pain, abnormal liver function tests, a serious condition which can make the blood more acidic (known as metabolic acidosis), in patients with serious illnesses taking paracetamol (see section 2).
- Rounded, itchy, red patches of rash with a burning sensation, leaving coloured spots which may appear in the same places if the drug is taken again (erythema pigmentum fixata), difficulty in breathing (bronchospasm), particularly if you have already experienced difficulty in breathing with other drugs such as non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, consult a physician.
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 contribute to providing more information on drug safety.
5. HOW TO CONSERVE PARACETAMOL KRKA 500 mg, tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging.
The expiration date refers to the last day of that month.
No special storage precautions.
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. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PARACETAMOL KRKA 500 mg tablet contains
- The active substance is :
Paracetamol.................................................................................................................. 500 mg
For one tablet.
- The other components are: sodium starch glycolate (type A), povidone (K-30), pregelatinized corn starch, stearic acid. See section 2 " PARACETAMOL KRKA 500 mg, tablet contains sodium".
What PARACETAMOL KRKA 500 mg, tablet is and what it contains
White, oblong tablet with "500" engraved on one side and nothing on the other, measuring 17.5 mm × 7.3 mm × 5.7 mm.
PARACETAMOL KRKA 500 mg, tablet is packaged in blister packs of 10, 12, 16, 20, 24, 30 or 100 tablets, or in opaque white bottles of 500 tablets.
Not all presentations may be marketed.
Marketing authorization holder
KRKA, D.D., NOVO MESTO
MARJEKA CESTA 6
8501 NOVO MESTO
SLOVENIA
Marketing authorization holder
KRKA FRANCE
12-14 RUE DE L'EGLISE
75015 PARIS
KRKA, D.D., NOVO MESTO
MARJEKA CESTA 6
8501 NOVO MESTO
SLOVENIA
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Detailed information on this drug is available on the ANSM (France) website:
Health education advice :
WHAT TO DO IN CASE OF FEVER :
Normal body temperature varies from person to person, ranging from 36.5°C to 37.5°C. A rise in temperature above 38°C can be considered a fever, but it is not advisable to treat fever with medication below 38.5°C.
This medicine is reserved for adults and children weighing 27 kg (approx. 8 years) and over.
If fever troubles are too troublesome, you can take this medication, which contains paracetamol, at the dosage indicated.
To avoid any risk of dehydration, remember to drink frequently.
With this medication, fever should fall rapidly. Nevertheless :
- If other unusual signs appear,
- If fever persists for more than 3 days or worsens,
- If headaches become severe, or if vomiting occurs,
CONSULT YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IN CASE OF PAIN :
The intensity of pain perception and the ability to resist it vary from person to person.
- If there is no improvement after 5 days of treatment,
- If the pain is violent, unexpected and comes on suddenly (particularly a strong pain in the chest) and/or, on the contrary, recurs regularly,
- If it is accompanied by other signs such as general malaise, fever, unusual swelling of the painful area or reduced strength in a limb,
- If it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY.
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