UPSA Aspirin is a drug indicated for the symptomatic treatment of pain of mild to moderate and / or febrile states.
For warnings, precautions for use and contraindications, please consult the instructions for use.
ASPIRINE UPSA 500 mg tablet is recommended for adults and children over 9 years of age.
Oral use.
ACETYLSALICYLIC ACID 500 MG. EXCIPIENTS: MANNITOL; MALIC ACID; POVIDONE; SODIUM DIOCTYLSULFOSUCCINATE; CITRIC ACID ; SODIUM BICARBONATE ; DISODIUM CARBONATE; SODIUM SACCHARINATE; LEMON FLAVOR; (ASCORBIC ACID; CITRAL; LEMON ESSENTIAL OIL; MALTODEXTRIN; SUCROSE; MODIFIED STARCH (E 1450)); QSP 1 EFFERVESCENT TABLET.
ASPIRINE 500 mg is not recommended during pregnancy and lactation. It is essential to avoid overdose by checking the absence of acetylsalicylic acid in the composition of other drugs. The maximum recommended dose should not be exceeded.
Blister 20 tablets.
Stomach, back, headache, joint, dental pain. Analgesic drugs are not the only effective remedies to get rid of these little daily hassles.
Pain: A perception that varies from one individual to another
Pain is an extremely complex feeling to which everyone reacts in a completely different way. The same person can also react more or less strongly to pain depending on the time of day and the circumstances. Studies have shown that when we focus on pain, we feel it much more intensely. On the other hand, when our attention is diverted by something pleasant, we feel it less. Anxiety, stress and depression also reinforce one's perception of pain.
It is very important to intervene immediately so that the pain does not go from the acute stage to the chronic stage. In this context, analgesics are an effective aid. But any drug can, as we know, cause side effects. That is why painkillers not only are not suitable for everyone, but also that the dose cannot be increased infinitely. Hence the interest of alternative therapies which take over and make it possible to limit the use of analgesics.
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 23/06/2017
ASPIRINE UPSA 500 mg, effervescent tablet
Acetylsalicylic acid
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or if you feel less well after 3 days in case of fever or 5 days in case of pain.
1. What is ASPIRINE UPSA 500 mg, effervescent tablet and in which cases is it used?
2. What information should I take before taking ASPIRINE UPSA 500 mg, effervescent tablet?
3. How to take ASPIRINE UPSA 500 mg, effervescent tablet?
4. What are the possible side effects?
5. How to store ASPIRINE UPSA 500 mg, effervescent tablet?
6. Package contents and other information.
1. WHAT IS ASPIRINE UPSA 500 mg, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS-ANILIDES - ATC code: N02BA01
This medicine contains aspirin.
This medication is an analgesic (it calms the pain) and an antipyretic (it lowers the fever).
It is indicated :
· in case of pain and / or fever such as headaches, flu-like conditions, dental pain, body aches.
In this indication, this presentation is reserved for the adult and the child from 30 kg (about 9 to 15 years): read the instructions carefully, chapter "Posology".
· in the treatment of certain rheumatic affections.
In this indication, this presentation is reserved for adults and children from 20 kg.
For children of different weights, there are other aspirin presentations: ask your doctor or pharmacist for advice.
You should contact your doctor if you experience no improvement or feel less well after 3 days, in case of fever or 5 days in case of pain.
2. BEFORE YOU TAKE ASPIRINE UPSA 500 mg, effervescent tablet?
Do not take ASPIRINE UPSA 500 mg, effervescent tablet:
· If you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.
· In case of a history of asthma caused by the administration of aspirin or a related drug (including non-steroidal anti-inflammatory drugs).
· During the last trimester of pregnancy.
· In case of an ulcer of the stomach or the duodenum in evolution.
· If you have a hemorrhagic disease or bleeding risk.
· If you have severe liver disease.
· If you have a serious kidney disease.
· If you have a serious heart disease.
· If you are taking methotrexate therapy at doses greater than 20 mg / week and when aspirin is used as a high-dose anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g daily) treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily) (see section "Other medicinal products and ASPIRINE UPSA 500 mg, effervescent tablet").
· If you are taking oral anticoagulant therapy and have a history of stomach or duodenal ulcer and when aspirin is used at high doses, as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g per day), especially in the treatment of rheumatic conditions or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily) (see section "Other medicinal products and ASPIRINE UPSA 5 00 mg , effervescent tablet").
if in doubt, seek the advice of your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ASPIRINE UPSA 500 mg, effervescent tablet.
· If other medicines are combined, to avoid a risk of overdose, check the absence of aspirin in the composition of other medicines.
· In case of headaches occurring during prolonged use and with high doses of aspirin, you should not increase the doses but take the advice of your doctor or pharmacist.
The regular use of analgesics, in particular several analgesics in combination, can lead to kidney damage.
· Reye syndromes (a rare but very severe disease mainly associated with neurological disorders and liver damage) have been observed in children with viral diseases and receiving aspirin.
Consequently :
o in the event of a viral illness such as chickenpox or an episode of influenza: do not administer aspirin to a child without the advice of a doctor,
o in the event of a conscious or behavioral disorder and vomiting in a child taking aspirin, tell a doctor immediately.
Aspirin should only be used after advice from your doctor :
o in case of treatment of a rheumatic disease,
o in the case of G6PD (red blood cell inheritance) deficiency, as high doses of aspirin may cause hemolysis (destruction of red blood cells),
o in the case of a history of stomach or duodenal ulcer, digestive hemorrhage or gastritis,
o in case of kidney or liver disease,
o in asthma: the onset of an asthma attack in some subjects may be related to an allergy to nonsteroidal anti-inflammatory drugs or aspirin. In this case, this drug is contraindicated,
o in case of abundant menstruation or contraception by IUD,
o in case of treatment by:
§ of oral anticoagulants, when aspirin is used at high doses in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily) and in the absence of a history of ulcer stomach or duodenum,
§ of oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in case of a history of stomach or duodenal ulcer,
§ nonsteroidal anti-inflammatory drugs, when aspirin is used in high doses as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g per day), especially in the treatment of rheumatic diseases or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day),
§ glucocorticoids (except hydrocortisone as an alternative treatment), when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day), particularly in the treatment of rheumatic diseases,
§ heparins used in curative doses and / or in patients over 65 years of age, when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day) treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily),
§ the drugs used in the treatment of gout,
§ acetazolamide,
§ anagrelide,
§ clopidogrel,
§ pemetrexed in subjects with low to moderate renal function,
§ ticagrelor,
§ ticlopidine,
§ uricosuric drugs (see section "Other medicines and ASPIRINE UPSA 500 mg, effervescent tablet").
· During treatment: in the case of gastrointestinal haemorrhage (blood rejection through the mouth, presence of blood in the stool, stool coloration in black), STOP TREATMENT AND CONTACT IMMEDIATELY MEDICAL OR EMERGENCY MEDICAL SERVICE .
This medicine contains aspirin. Other medicines contain it. Make sure that you or your child do not take other medicines containing aspirin and / or nonsteroidal anti-inflammatory drugs, including medicines obtained without a prescription. Do not combine them, so as not to exceed the recommended daily dose. (see "Posology" and "Symptoms and Instructions for Overdose"). |
If the pain persists more than 5 days or the fever more than 3 days , or if there is insufficient efficacy or any other signs, do not continue treatment without the advice of your doctor.
Aspirin increases the risk of haemorrhage at very low doses even when the dose is several days old. PREVENT YOUR DOCTOR, THE SURGER, THE ANESTHESIST OR YOUR DENTIST, in case a surgical gesture, even minor, is envisaged.
At high doses used in rheumatology, it is recommended to monitor the appearance of signs of overdose: ringing in the ears, loss of hearing or dizziness. If any of these symptoms appear: SEE IMMEDIATELY A DOCTOR.
Aspirin alters uricemia (amount of uric acid in the blood).
This medicine contains sodium. This medicine contains 388.5 mg sodium per effervescent tablet. To be taken into account in patients controlling their sodium dietary intake.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Children and Youth
This medicine is reserved for adults and children over 30 kg in case of pain, in case of fever, and to adults and children over 20 kg in case of rheumatic disease. However it is necessary to remember that if your child is less than 1 month, medical advice is essential before using aspirin.
Ask your doctor or pharmacist for advice:
· in case of pain or in case of fever: take a dose more suitable for children under 30 kg (about 9 years),
· in case of rheumatic disease: take a dosage more suitable for children under 20 kg.
Other medications and ASPIRINE UPSA 500 mg, effervescent tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
When aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day), especially in the treatment of rheumatic conditions or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day), this medication should not be used in combination:
· with methotrexate used at doses greater than 20 mg / week,
· with oral anticoagulants and in case of a history of stomach or duodenal ulcer.
This medication MUST BE AVOIDED in association with:
· of oral anticoagulants, when aspirin is used at high doses in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily) and in the absence of a history of ulcer stomach or duodenum,
· of oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in case of a history of stomach or duodenal ulcer,
· nonsteroidal anti-inflammatory drugs, when aspirin is used in high doses as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g per day), especially in the treatment of rheumatic diseases or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day),
· glucocorticoids (except hydrocortisone as an alternative treatment), when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day), particularly in the treatment of rheumatic diseases,
· heparins used in curative doses and / or in patients over 65 years of age, when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day) treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily),
· the drugs used in the treatment of gout,
· acetazolamide,
· anagrelide
· clopidogrel,
· pemetrexed in subjects with low to moderate renal function,
· ticagrelor,
· ticlopidine,
· uricosuric drugs (see section "Warnings and Precautions").
In order to avoid possible interactions between several medicines, you should systematically report any other treatment in progress to your doctor or pharmacist.
ASPIRINE UPSA 500 mg, effervescent tablet with food and beverages
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication .
Pregnancy and breast feeding
Pregnancy
· During the FIRST AND SECOND QUARTERS of your pregnancy, your doctor may be required to prescribe this medication on an ad hoc basis.
· In the THIRD QUARTER of your pregnancy, you should NOT take this medication to YOURSELF, as its effects on your child can have serious consequences, especially on the cardiopulmonary and renal planes, even with single take.
However, in very special cases , your cardiologist or gynecologist may prescribe aspirin at very low doses that are not those used in the treatment of fever or pain. In this case, strictly observe the prescription of your doctor.
feeding
Aspirin passes into breast milk, this medication is not recommended during breast-feeding.
Fertility
Not applicable.
Driving and using machines
ASPIRINE UPSA 500 mg, effervescent tablet has no effect on the ability to drive and use machines ..
ASPIRINE UPSA 500 mg, effervescent tablet contains aspartame (E951) and sodium (388.5 mg per tablet).
3. HOW TO TAKE ASPIRINE UPSA 500 mg, effervescent tablet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
In case of pain, in case of fever:
This presentation is reserved for adults and children from 30 kg (approximately 9 years)
· For adults and children weighing more than 50 kg (from about 15 years old):
The maximum recommended daily dose is 3 g of aspirin, or 6 effervescent tablets per day.
The usual dosage is 1 500 mg effervescent tablet, to be renewed if necessary after 4 hours minimum. In case of pain or fever more intense, 2 tablets effervescent to 500 mg, to renew if necessary after 4 hours minimum, without exceeding 6 effervescent tablets per day.
· For the elderly :
The maximum recommended daily dose is 2 g aspirin, or 4 effervescent tablets per day.
The usual dosage is 1 500 mg effervescent tablet, to be renewed if necessary after 4 hours minimum. In case of pain or fever more intense, 2 tablets effervescent to 500 mg, to renew if necessary after 4 hours minimum, without exceeding 4 effervescent tablets per day.
· In children between 30 and 50 kg (approximately 9 to 15 years):
The dosage of aspirin depends on the weight of the child; the ages are mentioned for information purposes.
If you do not know the weight of the child, weigh it to give it the best dose.
Aspirin exists in many dosages, allowing the treatment to be adapted to the weight of each child.
The recommended daily dose of aspirin is approximately 60 mg / kg / day, divided into 4 or 6 doses, approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours .
o For children weighing 30 to 40 kg (approximately 9 to 13 years), the dosage is 1 effervescent tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 effervescent tablets per day.
o For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 effervescent tablet per dose, to be renewed if necessary after 4 hours, without exceeding 6 effervescent tablets per day.
In case of rheumatic affections:
This presentation is reserved for adults and children from 20 kg.
It is necessary to follow the recommendations of your doctor.
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
Method and route of administration
Oral use.
Drink immediately after dissolving the effervescent tablet in a large glass of water.
In addition, if your child has a fever greater than 38.5 ° C, you can improve the effectiveness of the drug treatment by:
· discover your child,
· make the drink,
· do not leave your child in a place too hot.
Frequency of Administration
In case of pain, in case of fever :
Systematic catches help to avoid oscillations of pain or fever.
· In adults and children over 15 years of age: catches must be spaced at least 4 hours apart.
· In children (30 to 50 kg, approximately 9 to 15 years of age), they should be regularly spaced, including at night, preferably 6 hours , and at least 4 hours: recommended dosage.
In case of rheumatic affections :
The spacing between sockets must be at least 4 hours.
Duration of treatment
In case of pain, in case of fever:
The duration of treatment is limited: · to 5 days in case of pain, · at 3 days in case of fever. |
If the pain persists more than 5 days or fever more than 3 days, if it worsens, do not continue treatment without the advice of your doctor or pharmacist.
In case of rheumatic affections:
Follow your doctor's advice.
If you take more ASPIRINE UPSA 500 mg, effervescent tablet than you should
During the course of the treatment, it is possible that there may be ringing in the ears, a feeling of hearing loss, headache, dizziness, usually as an overdose of aspirin.
TREATMENT AND PREVENTION OF A DOCTOR MUST BE INTERRUPTED.
In case of accidental poisoning (especially frequent in young children), CONSULT IMMEDIATELY A DOCTOR.
If you forget to take ASPIRINE UPSA 500 mg, effervescent tablet
Do not take (or give your child) double dose to compensate for the single dose you have forgotten to take (or give to your child).
If you stop taking ASPIRINE UPSA 500 mg, effervescent tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Immediately stop treatment and tell your doctor if:
· digestive haemorrhages (see section "Warnings and Precautions"). These are all the more frequent because the dosage used is high,
· allergic reactions such as rash, asthma attack, angioedema (facial urticaria with respiratory discomfort),
· headache, dizziness: these signs usually reflect an overdose of aspirin.
· Reye syndrome (onset of consciousness or behavioral disorder and vomiting) in a child with viral disease and receiving aspirin (see section "Warnings and Precautions").
Tell your doctor if you have abdominal pain, nosebleeds or gums.
Cases of stomach ulcers have been reported.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ASPIRINE UPSA 500 mg, effervescent tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature below 25 ° C and away from moisture.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ASPIRINE UPSA 500 mg contains: effervescent tablet
· The active substance is:
Acetylsalicylic acid ................................................ .................................................. ..... 500.0 mg
For an effervescent tablet.
· The other components are:
Sodium bicarbonate, anhydrous citric acid, anhydrous monosodium citrate, anhydrous sodium carbonate, aspartame, polyvidone, polyvinylpyrrolidone, orange flavor.
What is ASPIRINE UPSA 500 mg, effervescent tablet and contents of the pack
This medication is in the form of an effervescent tablet. Box of 20 or 32.
Marketing Authorization Holder
3, RUE JOSEPH MONIER
92500 RUEIL MALMAISON
Marketing Authorization Operator
3, RUE JOSEPH MONIER
92500 RUEIL MALMAISON
304, AVENUE OF DOCTOR JEAN BRU
47000 AGEN
or
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
{month YYYY}.
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
The normal body temperature varies from person to person and ranges from 36 ° C to 37 ° C. A rise in temperature above 38 ° C may be considered a fever.
This medication is intended for adults and children up to 30 kg in case of pain and / or fever such as headaches, flu-like conditions, dental pain, aches; and is intended for the adult and the child from 20 kg in the treatment of certain rheumatic affections.
If the disorders that the fever causes are too troublesome, you can take this drug that contains paracetamol in accordance with the indicated dosages.
To avoid any risk of dehydration, consider drinking frequently.
With this medication, the fever should drop rapidly. However :
· if other unusual signs appear,
· if the fever persists for more than 3 days or if it worsens,
· if the headache becomes violent, or in case of vomiting.
CONSULT YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IF PAIN:
The intensity of the perception of pain 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 occurs suddenly (including severe pain in the chest) and / or reverses regularly,
· if accompanied by other signs such as general malaise, fever, unusual swelling of the painful area, decreased strength in a limb,
· if it wakes you up at night.
CONSULT YOUR DOCTOR IMMEDIATELY.
Analgesic and antipyretic
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
ASPIRINE UPSA 500 mg: effervescent tablet (white, orange flavoring); box of 20.
Refunded at 65%. - price: 1.46 euro (s).
ASPIRINE UPSA 1000 mg: split effervescent tablet (white, orange flavoring); box of 20.
Refunded at 65%. - price: 2,49 euro (s).
UPSA Laboratory
| p cp | p cp | |
| Acetylsalicylic acid (aspirin) | 500 mg | 1,000 mg |
| Sodium | 388 mg | 460 mg |
| Lactose | 1.6 g | |
| aspartame | + | + |
Usual dosage:
Isolated pain and fever:
