NOTICE
ANSM - Last updated: 06/07/2017
Description of the Medicine
ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet
Acetylsalicylic acid
© framed
Please read this leaflet carefully before you start taking this medication because it contains important information for you.
You should always take this medication exactly as prescribed by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· 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.
What is in this leaflet?
1. What is ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet and in which cases is it used?
2. What information should I take before taking ASPIRINE UPSA BUFFER EFFERVESCENT 1000 mg, effervescent tablet?
3. How to take ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet?
4. What are the possible undesirable effects?
5. How to store ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet?
6. Contents of the package and other information.
1. WHAT ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS-ANILIDES - ATC code: N02BA01
This medication contains aspirin.
This medication is an analgesic (it calms the pain) and an antipyretic (it lowers the fever).
It is indicated for pain and / or fever such as headaches, flu-like conditions, dental pain, aches and pains in the treatment of certain rheumatic diseases in adults and children over 50 kg (From about 15 years).
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 EFFERVESCENT BUFFER 1000 mg, effervescent tablet?
Never take ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet:
AT· If you are allergic to the active substance or to any of the other ingredients of this medication, listed in section 6.
AT· In case of phenylcontrauria (hereditary disease diagnosed at birth), due to the presence of aspartame,
AT· In the event of asthma events caused by the administration of aspirin or a related medication (including non-Steroidal anti-inflammatory drugs),
AT· During the last trimester of pregnancy,
AT· In the event of an ulcer of the stomach or of the duodenum in evolution,
AT· If you have bleeding or bleeding,
AT· If you have a serious liver disease,
AT· If you have a serious kidney disease,
AT· If you have a serious heart disease,
AT· If you are taking methotrexate therapy in doses greater than 20 mg / week and when aspirin is used in high doses as anti-inflammatory drugs (1 1 g per dose and / or 3 g per day), particularly 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 medicines and ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet '),
AT· If you are taking oral anticoagulant therapy and have an ulcer of the stomach or duodenum and when aspirin is used in high doses, such as anti-inflammatory drugs in particular for the treatment of rheumatic complaints, or in the treatment of fever or pain (500 mg per dose and / or 3 g daily) <3 g daily) (see section "Other medicines and ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet").
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet.
If your doctor has informed you of an intolerance to certain sugars, contact him / her before taking this medication.
AT· In case of combination of other medicines, to avoid a risk of overdose, check the absence of aspirin in the composition of other medicines.
AT· In case of headache during prolonged use and 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.
Aspirin should only be used after the advice of your doctor :
o in case of treatment of a rheumatic disease,
o in the event of a G6PD deficiency (red blood cell hereditary disease), as high doses of aspirin may have resulted in hemolyses (destruction of red blood cells)
o in the case of an ulcer of the stomach or duodenum, digestive haemorrhage or gastritis,
o in case of kidney or liver disease,
o in asthma: the onset of an asthma attack in some individuals may be related to an allergy to non-steroidal anti-inflammatory drugs or to aspirin. In this case, this medication is contraindicated,
o in the event of abundant regulation or sterile contraception,
o in case of treatment by:
AT§ of oral anticoagulants, when aspirin is used in high doses in the treatment of fever or pain (500 mg per dose and / or <3 g / day) ulcer history of stomach or duodenum,
AT§ of oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in the case of a history of stomach ulcer or duodenum © num,
AT§ non-steroidal anti-inflammatory drugs, when aspirin is used in high doses as anti-inflammatory drugs (â ‰ ¥ 1 g per dose and / or ¥ 3 g / day), especially in the treatment of rheumatic disorders, or in the treatment of fever or pain (500 mg per dose and / or <3 g per day),
AT§ glucocorticosteroids (except hydrocortisone as an alternative treatment), when aspirin is used at high doses as an anti-inflammatory agent (â ‰ ¥ 1 g per dose and / or ‰ 3 g per day) of rheumatic affections,
AT§ heparin used in curative doses and / or in subjects over 65 years of age, when aspirin is used in high doses as an anti-inflammatory agent (â,¬1 g per dose and or 3 g per day), especially in the treatment of rheumatic complaints or in the treatment of fever or pain (500 mg per dose and / or 3 g per day),
AT§ the medications used in the treatment of gout,
AT§ © lÂ'acà tazolamide,
AT§ lÂ'anagrà © lide,
AT§ clopidogrel,
AT§ pemetrexed in subjects with weak to moderate renal function,
AT§ the ticagr lor,
AT§ ticlopidine,
AT§ uricosuric (see section "Other medicines and ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet").
During treatment: in the case of gastrointestinal bleeding (blood discharge through the mouth, blood in the stools, stool coloration in black), STOP TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR SERVICE EMERGENCY MEDICAL.
This medication contains aspirin. Other medicines contain it.
Check that you or your child do not take other medicines containing aspirin and / or non-steroidal anti-inflammatory drugs, including if they are medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose.
( see "Dosage" and "Symptoms and Instructions for Overdose").
AT· If pain persists more than 5 days or fever more than 3 days , or in case of insufficient efficacy or any other sign, do not continue treatment and consult your doctor.
AT· Aspirin increases the risk of bleeding from very low doses and even when the dose is several days old. PREVENT YOUR DOCTOR, SURGER, ANESTHESIST OR YOUR DENTIST, in case a surgical gesture, even minor, is envisaged.
AT· 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 occur: CONSULT A DOCTOR IMMEDIATELY .
AT· Aspirin alters uricemia (amount of uric acid in the blood).
AT· The use of this medication is disliked in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (hepatitis Rarity).
AT· This medicine contains sodium. This medication contains 460 mg sodium per effervescent tablet. To be taken into account in patients controlling their sodium dietary intake.
AT· This medicine contains potassium. This medicinal product contains 4.86 mg potassium per effervescent tablet. To be taken into account in patients with renal insufficiency or in patients controlling their dietary intake of potassium.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Children and Youth
This dosage is reserved for adults and children over 50 kg (from about 15 years). For children (under 15 years), take a more suitable dosage. Ask your doctor or pharmacist for advice.
Other medicines and ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet
Inform your doctor or pharmacist if you are taking, have recently taken or could take any other medicines.
When aspirin is used in high doses as an anti-inflammatory agent (eg 1 g per dose and / or 3 g / day), especially in the treatment of rheumatic conditions or in the treatment of (500 mg per dose and / or <3 g daily), this medication should not be used in combination with:
AT· with methotrexate used at doses greater than 20 mg / week,
AT· with oral anticoagulants and in case of an ulcer of the stomach or duodenum.
This medication MUST BE AVOIDED in association with:
AT· of oral anticoagulants, when aspirin is used in high doses in the treatment of fever or pain (500 mg per dose and / or <3 g / day) ulcer history of stomach or duodenum,
AT· of oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in the case of a history of stomach ulcer or duodenum © num,
AT· non-steroidal anti-inflammatory drugs, when aspirin is used in high doses as anti-inflammatory drugs (â ‰ ¥ 1 g per dose and / or ¥ 3 g / day), especially in the treatment of rheumatic disorders, or in the treatment of fever or pain (500 mg per dose and / or <3 g per day),
AT· glucocorticosteroids (except hydrocortisone as an alternative treatment), when aspirin is used at high doses as an anti-inflammatory agent (â ‰ ¥ 1 g per dose and / or ‰ 3 g per day) of rheumatic affections,
AT· heparin used in curative doses and / or in subjects over 65 years of age, when aspirin is used in high doses as an anti-inflammatory agent (â,¬1 g per dose and or 3 g per day), especially in the treatment of rheumatic complaints or in the treatment of fever or pain (500 mg per dose and / or 3 g per day),
AT· the medications used in the treatment of gout,
AT· © lÂ'acà tazolamide,
AT· lÂ'anagrà © lide
AT· clopidogrel,
AT· pemetrexed in subjects with weak to moderate renal function,
AT· the ticagr lor,
AT· ticlopidine,
AT· uricosuria (see section "Warnings and Precautions").
In order to avoid possible interactions between several medicines, you must systematically report any other treatment in progress to your doctor or pharmacist.
ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, sparkling tablet with food and beverages
Not applicable.
Pregnancy, breastfeeding and fertility
If you are pregnant or nursing, planning to become pregnant or planning a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Pregnancy and breast feeding
Pregnancy
AT· During the FIRST AND SECOND QUARTERS of your pregnancy, your physician may be required to prescribe this medication on a case-by-case basis.
AT· During the THIRD QUARTER of your pregnancy, you MUST NOT take this medication YOURSELF because your effects on your child can have serious consequences, especially on a cardio-pulmonary and renal plane , and even with a single outlet.
However, in very special cases, your cardiologist in your gynecologist may prescribe aspirin at very low doses that are not the ones used in the treatment of fever or pain. In this case, strictly respect the prescription of your doctor.
feeding
Aspirin passes into breast milk, this medication is disliked during breastfeeding.
© FertilitÃ
Not applicable.
Driving and using machines
ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet has no effect on the ability to drive and use machines.
ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet contains aspartame (E951), lactose, potassium (4.86 per tablet) and sodium (460 mg per tablet).
3. HOW TO TAKE ASPIRINE UPSA EFFERVESCENT BUFFER 1000 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 you have any doubts.
Dosage
This presentation is reserved for adults and children over 50 kg (from about 15 years).
In case of pain, in case of fever:
For adults and children weighing more than 50 kg (from about 15 years):
The maximum recommended daily dose is 3 g of aspirin, 3 effervescent tablets per day.
The usual dosage is 1 tablet effervescent to 1000 mg, to renew if necessary after 4 hours minimum, without exceeding 3 effervescent tablets per day .
For the elderly :
The maximum recommended daily dose is 2 g of aspirin, or 2 effervescent tablets per day.
The usual dosage is 1 tablet effervescent to 1000 mg, to renew if necessary after 4 hours minimum, without exceeding 2 effervescent tablets per day .
In case of rheumatic affections:
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 contents of the effervescent tablet in a large glass of water.
Frequency of administration
In case of pain, in case of fever :
Systematic jacks prevent the oscillations of pain or fever.
They must be regularly spaced at least 4 hours .
In case of rheumatic affections :
The spacing between sockets should be at least 4 hours.
Duration of treatment
In case of pain, in case of fever:
The duration of the treatment is limited:
AT· At 5 days in case of pain,
AT· 3 days in case of fever.
If the pain persists more than 5 days or the fever more than 3 days or 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 EFFERVESCENT BUFFER 1000 mg, effervescent tablet than you should have "
During treatment, it is possible that there may be ringing in the ears, a feeling of hearing loss, headaches, dizziness: they usually translate into an overdose of aspirin.
YOU MUST INTERRUPT YOUR TREATMENT AND PREVENT A DOCTOR.
In case of accidental poisoning (especially frequent in young children), CONSULT IMMEDIATELY A DOCTOR.
If you forget to take ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet
Do not take a double dose to make up for the single dose that you forgot to take.
If you stop taking ASPIRINE UPSA BUFFER EFFERVESCENT 1000 mg, effervescent tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
Immediately stop your treatment and notify your doctor if:
o digestive haemorrhages (see section "Warnings and Precautions"). These are all the more frequent as the dosage used is high,
o allergic reactions like skin rash, asthma attack, Quincke's anemia (hives with respiratory distress),
o tinnitus, ear tingling, hearing loss, headache, dizziness: these signs usually reflect an overdose of aspirin.
Notify your doctor if you experience abdominal pain, nosebleeds or gums.
Cases of stomach ulcer have been reported.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the package. The redemption date refers to the last day of that month.
Keep at temperatures below 25 ° C and away from moisture.
Do not throw any medicines into the sewer or the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ASPIRINE UPSA contains: EFFERVESCENTE 1000 mg tablet, effervescent tablet
AT· The active substance is:
Acetylsalicylic acid .............................................. .................................................. ... 1000.00 mg
For an effervescent tablet.
AT· The other components are:
Sodium bicarbonate, anhydrous citric acid, potassium benzoate, anhydrous lactose, aspartame, povidone, crospovidone, orange flavoring.
What is ASPIRINE UPSA EFFERVESCENT BUFFER 1000 mg, effervescent tablet and contents of the outer packaging
This medication is in the form of an effervescent tablet. Box of 10 or 20.
Holder of the marketing authorization
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Operator of the marketing authorization
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Maker
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
or
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last day on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
{month YYYY}.
Other
Detailed information on this medicinal product can be found on the website of the ANSM (France).
Health Education Council:
Normal body temperature varies from person to person and is between 36 ° C and 37 ° C. A temperature rise above 38 ° C may be considered a fever.
This medication is intended for adults and children over 50 kg (from about 15 years).
If the disorder that the fever causes is too troublesome, you can take this medication that contains paracetamol in accordance with the dosages indicated.
To avoid any risk of dehydration, consider frequent drinking.
With this medication, the fever must go down quickly. Nevertheless:
AT· if other unusual signs appear,
AT· if the fever persists for more than 3 days or if it worsens,
AT· 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.
AT· If there is no improvement after 5 days of treatment,
AT· if the pain is violent, unexpected and occurs abruptly (including severe pain in the chest) and / or reverses regularly,
AT· if accompanied by other signs such as general discomfort, fever, unusual swelling of the painful area, decreased strength in a limb,
AT· if it wakes you up at night.
CONSULT YOUR DOCTOR IMMEDIATELY.