Therapeutic indications Zentiva Paracetamol 1000 mg 8 Effervescent tablets
PARACETAMOL ZENTIVA is an analgesic (pain reliever) and an antipyretic (fever reducer).
The active substance of this medicine is paracetamol.
It is used to treat pain and/or fever, for example in the case of headaches, flu, toothache, aches and pains and painful periods.
It may also be prescribed by your doctor for osteoarthritis pain.
Contraindications
Never take PARACETAMOL ZENTIVA 1000 mg, scored effervescent tablet:
- If you are allergic (hypersensitive) to paracetamol or any of the other components contained in this medicine, mentioned in section 6.
- If you have severe liver disease.
- To treat a child under 6 years of age because he or she may swallow wrongly and choke. Use another form.
This medicine contains paracetamol. Other medicines contain paracetamol.
Make sure you are not taking any other medicines that contain paracetamol, including medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose.
(see "Dosage" and "Symptoms and Instructions in Case of Overdose")
Precautions and special warnings
Talk to your doctor or pharmacist before taking PARACETAMOL ZENTIVA 1000 mg, scored effervescent tablet.
This medicine contains paracetamol. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose (see Dosage).Be careful with PARACETAMOL ZENTIVA
- If pain persists for more than 5 days or fever for more than 3 days, or if it is not effective enough or if any other signs occur, do not continue treatment without your doctor's advice.
- Taking paracetamol can cause liver problems
- You should ask your doctor's advice before taking this medicine:
o If you weigh less than 50 kg,
o If you have liver disease or severe kidney disease,
o If you frequently drink alcohol or have recently stopped drinking alcohol,
o If you suffer from dehydration,
o If you suffer from chronic malnutrition, if you are fasting, if you have lost a lot of weight recently, if you are over 75 years old or if you are over 65 years old and have long term illnesses, if you have AIDS or chronic viral hepatitis if you have cystic fibrosis (a genetic and hereditary disease characterized by severe respiratory infections), or if you have Gilbert's disease (a hereditary disease associated with increased levels of bilirubin in the blood)
o if you are allergic to aspirin and/or non-steroidal anti-inflammatory drugs.
- The consumption of alcoholic beverages during treatment is not recommended.
- In case of recent withdrawal from chronic alcoholism, the risk of liver damage is increased.
- When administered to children, the dose depends on their weight (see "How to take PARACETAMOL ZENTIVA 1000 mg, scored effervescent tablet").
- In case of acute viral hepatitis, stop your treatment and consult your doctor
Blood tests
Tell your doctor if you are taking PARACETAMOL ZENTIVA and need to have a blood test because this medicine may affect your blood uric acid (uricemia) and blood sugar (glucose) levels.
This medicine contains sodium. This medicine contains 408 mg of sodium per effervescent tablet. To be taken into account in patients controlling their dietary sodium intake.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medication.
Do not take other medications containing paracetamol. You may overdose.
If you are taking an oral anticoagulant treatment (warfarin or a VKA), taking PARACETAMOL ZENTIVA 1000 mg, scored effervescent tablet at maximum doses (4 g/day) for more than 4 days requires increased monitoring of biological tests, including the INR. In this case, consult your doctor.
The effectiveness of paracetamol may be reduced if you are taking chelating resins at the same time, a drug that lowers the level of cholesterol in the blood (respect an interval of more than 2 hours between the 2 doses).
If you are taking flucloxacillin (an antibiotic) at the same time as paracetamol, you may experience metabolic acidosis (blood that is too acidic and causes an increase in respiratory rate).
The toxicity of paracetamol may be increased if you are taking :
- drugs that are potentially toxic to the liver,
- drugs that promote the production of the toxic metabolite of paracetamol such as anti-epileptic drugs (phenobarbital, phenytoin, carbamazepine, topiramate)
- rifampin (an antibiotic),
- at the same time as alcohol.
Use during pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breastfeeding
This medicine can be used during pregnancy and breastfeeding. Use the lowest dose that reduces your pain and/or fever, for the shortest time possible and as infrequently as possible. Contact your doctor or midwife if the pain and/or fever does not go away or if you need to take this medicine more frequently during your pregnancy.
Fertility
It is possible that paracetamol may affect fertility in women, reversibly when treatment is stopped.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Always follow the dose prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
This presentation is reserved for adults and children weighing more than 50 kg (i.e. from about 15 years of age).
For children weighing less than 50 kg, there are other presentations of paracetamol whose dosage is more appropriate. Do not hesitate to ask your doctor or pharmacist for advice.
Dosage for adults and children from 50 kg (i.e. from about 15 years old)
The usual dose is one half to one 1000 mg scored effervescent tablet per dose, to be repeated if necessary after at least 4 hours.
Warning: this presentation contains 1000 mg of paracetamol per scored effervescent tablet: never take 2 scored effervescent tablets at the same time.
Dose of paracetamol never to be exceeded
- In an adult or child weighing more than 50 kg:
It is generally not necessary to exceed 3 grams of paracetamol per day (i.e., 3 scored effervescent tablets per day).
However, if you have more severe pain, and only on the advice of your doctor, the total dose may be increased to 4 grams of paracetamol per day (i.e. 4 scored effervescent tablets per day).
NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL A DAY (taking into account all medications containing paracetamol in their formula).
In cases of severe kidney disease (severe renal failure), doses should be spaced 8 hours apart, and the total dose per day should not exceed 3 tablets (3 g).
- Special situations:
The maximum daily dose should not exceed 60 mg/kg/day (not to exceed 3 g/day) per day in the following situations:
o if you weigh less than 50 kg,
o If you have liver disease or severe kidney disease,
o if you frequently drink alcohol or have recently stopped drinking alcohol
o if you suffer from dehydration,
o if you suffer for example from chronic malnutrition, if you are fasting, if you have lost a lot of weight recently, if you are over 75 years old or if you are over 65 years old and have long term illnesses, if you have AIDS or chronic viral hepatitis if you have cystic fibrosis (a genetic and hereditary disease characterized by severe respiratory infections), or if you have Gilbert's disease (a hereditary disease associated with increased levels of bilirubin in the blood).
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
How to take Zentiva Paracetamol 1000 mg 8 Effervescent tablets
This medicine is used by mouth.
You should dissolve the tablet in a glass of water. Wait for the complete dissolution before drinking immediately after the content of the glass.
The tablets are scored, which means that you can cut them into 2 equal parts if necessary.
Frequency of administration
Regular doses help to prevent the pain or fever from returning: see "Dosage" section.
In children, the doses should be regularly spaced, including at night, preferably 6 hours apart, and at least 4 hours apart.
In adults, doses should be taken at least 4 hours apart.
In case of severe kidney disease (severe renal failure), you should wait at least 8 hours between each dose.
If you feel that the effect of PARACETAMOL ZENTIVA is too strong or too weak, consult your doctor or pharmacist.
Duration of treatment
Except on medical advice, the duration of treatment is limited to :
- 5 days in case of pain,
- 3 days in case of fever
If the pain persists more than 5 days or the fever more than 3 days, if they worsen, do not continue the treatment without the advice of your doctor.
Symptoms and instructions in case of overdose
If you have taken more PARACETAMOL ZENTIVA 1000 mg, scored effervescent tablet than you should have
Consult your doctor or pharmacist or emergency medical services immediately.
Overdose may result in liver disease (liver failure), gastrointestinal bleeding, brain disease (encephalopathy), coma and even death, especially in high-risk populations such as young children, the elderly and in certain situations (liver disease, alcoholism, chronic malnutrition). In the first 24 hours, the main symptoms of intoxication are: nausea, vomiting, loss of appetite, abdominal pain, pallor.
Overdose can also lead to: pancreatic damage (pancreatitis), hyperamylasemia (increased amylase levels in the blood), kidney disease (acute renal failure), and a blood problem in which red blood cells, white blood cells, and platelets are all reduced in number resulting in:
- fatigue, shortness of breath and pallor ;
- frequent infections with high fever and chills, sore throat or mouth ulcers;
- a tendency to bleed or bruise spontaneously, nosebleeds.
Instructions in case of missed dose(s)
If you forget to take PARACETAMOL ZENTIVA 1000 mg, scored effervescent tablet:
Do not take a double dose to make up for the dose you forgot to take.
Description of possible side effects
Like all medicines, this drug may cause side effects, but they do not always occur in everyone.
- Rarely, an allergic reaction may occur:
o pimples and/or redness on the skin,
o hives,
o sudden swelling of the face and neck that may cause difficulty in breathing (angioedema)
o sudden malaise with a significant drop in blood pressure (anaphylactic shock).
If an allergy occurs, you should stop taking this medication immediately and consult your doctor promptly. In the future, you should never take any medication containing paracetamol.
- Very rare cases of serious skin reactions have been reported.
- Exceptionally, this medication may decrease the number of certain blood cells: white blood cells (leukopenia, neutropenia), platelets (thrombocytopenia), which may manifest as nose or gum bleeds. In this case, consult a physician.
- Other possible side effects (frequency cannot be estimated based on available data): disturbances in liver function, significant decrease in certain white blood cells that can cause serious infections (agranulocytosis), destruction of red blood cells (hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency), 'rash in rounded red patches with itching and burning, leaving colored spots and which can appear in the same places in the event of resumption of the drug (erythema pigmentata fixe), localized pain in the chest which can radiate towards the left shoulder and the jaw of allergic origin (syndrome of Kounis), difficulty in breathing (bronchospasm). In this case, consult a doctor.
Storage conditions
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box.
For the box of 8 tablets (tube packaging): Store the primary package tightly closed, away from moisture.
For the box of 54 or 100 tablets (heat-sealed film packaging): No special storage precautions.
Do not dispose of any medication in the sewer or with household waste. Ask your pharmacist to dispose of any medication you no longer use. These measures will help to protect the environment''.
Active ingredients
Paracetamol................................................................................................................. 1000 mg
For one scored effervescent tablet.
Other components
citric acid anhydrous, mannitol, sodium saccharin, sodium lauryl sulfate, povidone K90, sodium bicarbonate, sodium carbonate anhydrous, leucine, orange flavour*.
*Composition of the orange flavour: essential oil of orange, concentrated juice of orange, acetic aldehyde, ethyl butyrate, citral, aldehyde C6, linalol, terpineol, ethyl acetate, butylhydroxyanisole, gum arabic, maltodextrin
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