NOTICE
ANSM - Last updated: 23/06/2017
Name of the medicinal product
ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet
Acetylsalicylic acid / ascorbic acid
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
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.
What is in this leaflet?
1. What is ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPON, effervescent tablet and in which cases is it used?
2. What should I know before taking ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet?
3. How to take ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet?
4. What are the possible side effects?
5. How to store ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet?
6. Package contents and other information.
1. WHAT IS ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS-ANILIDES - ATC code: N02BA01.
This medicine contains aspirin and vitamin C.
This medication is an analgesic (it calms the pain) and an antipyretic (it lowers the fever).
It is indicated in cases of fever and pain such as headaches, flu-like conditions, dental pain, aches, in adults and children from 20 kg (approximately from 6 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 VITAMINE C EFFERVESCENT TAMPONNE, effervescent tablet?
Never take ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet:
· If you are allergic to the active substance or to a related drug (including non-steroidal anti-inflammatory drugs) or any of the other ingredients of this medication mentioned in section 6.
· If you have a history of asthma caused by the administration of aspirin or a related drug (including non-steroidal anti-inflammatory drugs).
· Above 5 months of pregnancy completed (24 weeks of amenorrhea) for doses above 100 mg per day.
· 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.
· In case of renal calculus, due to the presence of vitamin C for doses higher than 1 g per day.
· If you are taking methotrexate at doses greater than 20 mg / week and aspirin is used as a high-dose anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g / day) treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day (see section "Other medicines and ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet").
· If you are taking oral anticoagulant therapy and have a history of stomach ulcer or duodenal ulcer and when aspirin is used at high doses, as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g / 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 VITAMIN C EFFERVESCENT TAMPONNE, 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 VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet.
· In case of combination with other medicines, 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 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:
· in case of treatment of a rheumatic disease,
· in the case of G6PD (red blood cell inheritance) deficiency, as high doses of aspirin may cause hemolysis (destruction of red blood cells),
· in the case of a history of stomach or duodenal ulcer, digestive hemorrhage or gastritis,
· in case of kidney or liver disease,
· 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,
· in case of abundant rules,
· in case of treatment by:
o 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,
o 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,
o 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),
o glucocorticoids (except hydrocortisone as an alternative treatment), when aspirin is used in high doses as an anti-inflammatory agent (≥ 1 g per dose and / or ≥ 3 g per day), particularly in the treatment of rheumatic diseases,
o 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),
o the drugs used in the treatment of gout,
o acetazolamide,
o anagrelide,
o clopidogrel,
o ticagrelor,
o pemetrexed in subjects with low to moderate renal function,
o ticlopidine,
o uricosuric drugs (see section "Other medicines and ASPIRINE UPSA VITAMINE C EFFERVESCENT TAMPONNE, 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 IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE .
This medicine contains aspirin and vitamin C. Other medicines contain it. Make sure that you or your child do not take any other medicines containing aspirin and / or nonsteroidal anti-inflammatory drugs and / or containing vitamin C, 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"). |
Pain or fever:
This dosage is adapted to the adult and the child from 20 kg (approximately from 6 years). For children under 20 kg (about 6 years), take a more suitable dosage.
Ask your doctor or pharmacist for advice.
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.
Aspirin alters uricemia (amount of uric acid in the blood).
Vitamin C should be used with caution in patients with iron metabolism disorders, predisposed to the formation of urinary or renal lithiasis (presence of crystals in the urine or kidneys) and in subjects deficient in glucose-6 phosphate dehydrogenase .
Due to a slightly stimulating effect due to the presence of vitamin C, it is advisable not to take this medication at the end of the day.
This medicine contains sodium. This medicine contains 485 mg of sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Children and Youth
Not applicable.
Other medicines and ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, 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 anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g daily), particularly in the treatment of rheumatic conditions or in the treatment of fever or pain (≥ 500 mg per dosage and / or <3 g daily), this medicinal product MUST NOT BE USED in combination:
o with methotrexate used at doses greater than 20 mg / week,
o with oral anticoagulants and in case of a history of stomach or duodenal ulcer.
This medication MUST BE AVOIDED in association with:
o 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,
o 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,
o 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 conditions or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day),
o glucocorticoids (except hydrocortisone as a substitute therapy), when aspirin is used at high doses as an anti-inflammatory agent (≥ 1 g per dose and / or ≥ 3 g per day), particularly in the treatment of rheumatic diseases,
o 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), in particular in the treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily),
o the drugs used in the treatment of gout,
o acetazolamide,
o anagrelide,
o clopidogrel,
o pemetrexed in subjects with low to moderate renal function,
o ticagrelor,
o ticlopidine,
o uricosuric drugs (see section "Warnings and Precautions").
At doses greater than 2 g / day in vitamin C, ascorbic acid may interfere with the following biological tests: creatinine and blood and urine glucose (glucose oxidase control).
Tell your doctor or pharmacist if you are taking deferoxamine to remove excess iron and aluminum from the blood.
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 VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet with food, drink and alcohol
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
This medication is intended for adults and children from 20 kg (approximately from 6 years). However, when used in exceptional circumstances in women of childbearing age, the following points should be noted:
Low doses, less than 100 mg daily
Low doses of acetylsalicylic acid of less than 100 mg per day may be prescribed in exceptional circumstances requiring specialized surveillance.
For doses above 100 mg per day
At these doses, and unless absolutely necessary, acetylsalicylic acid should not be prescribed during the first two trimesters of pregnancy. If acetylsalicylic acid is administered to a woman wishing to be pregnant or pregnant within six months, the dose should be as low as possible and the treatment period should be as short as possible.
At doses above 100 mg daily, acetylsalicylic acid is contraindicated beyond 5 months of pregnancy (24 weeks of amenorrhea). You should NOT take this medication during the third trimester of pregnancy because its effects on your child can have serious consequences, especially on a cardiopulmonary and renal plan, even with a single dose.
If you are taking this medication while you are pregnant, talk to your obstetrician gynecologist for appropriate monitoring.
feeding
Aspirin passes into breast milk, this medication is not recommended during breast-feeding.
ASK YOUR DOCTOR OR YOUR PHARMACIST BEFORE TAKING ALL MEDICINAL PRODUCTS.
Fertility
Not applicable.
Driving and using machines
ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet has no effect on the ability to drive and use machines.
ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet contains sodium (485 mg per tablet).
3. HOW TO TAKE ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, 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
This presentation is reserved for the adult and the child from 20 kg (approximately from 6 years).
In case of pain, in case of fever :
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.
· For children weighing 20 to 26 kg (about 6 to 10 years), the dosage is 1 effervescent tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 effervescent tablets per day.
· For children weighing 27 to 36 kg (about 8 to 12 years), the dosage is 1 effervescent tablet per dose, to be renewed if necessary after 4 hours, without exceeding 6 effervescent tablets per day.
· For children weighing 37 to 50 kg (approximately 11 to 15 years), the dosage is 2 effervescent tablets per dose, to be renewed if necessary after 6 hours, without exceeding 8 effervescent tablets per day.
· For adults and children weighing more than 50 kg (from about 15 years old): the recommended maximum daily dose is 3 g of aspirin or 9 effervescent tablets per day.
The usual dosage is 2 effervescent tablets at 330 mg, to be renewed if necessary after 4 hours minimum, without exceeding 9 effervescent tablets per day .
· For the elderly :
The maximum recommended daily dose is 2 g of aspirin, or 6 effervescent tablets per day.
The usual dosage is 1 effervescent tablet at 330 mg, to be renewed if necessary after 4 hours minimum. In case of pain or fever more intense, 2 tablets effervescent to 330 mg, to renew if necessary after 4 hours minimum, without exceeding 6 effervescent tablets per day .
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 : the systematic catches avoid the oscillations of pain or fever.
In adults : they should be regularly spaced, at least 4 hours.
In children : they should be evenly spaced, including at night, preferably 6 hours , and at least 4 hours (in accordance with the dosage specified above).
Due to the presence of vitamin C, avoid taking at the end of the day.
Duration of treatment
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 the fever more than 3 days, if they worsen, do not continue treatment without the advice of your doctor or pharmacist.
If you take more ASPIRINE UPSA VITAMINE C EFFERVESCENT BUFFER, effervescent tablet than you should have
· Concerning aspirin :
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.
THE TREATMENT OF YOUR CHILD MUST BE INTERRUPTED AND PREVENTION OF A DOCTOR.
In case of accidental poisoning (especially frequent in young children), CONSULT IMMEDIATELY A DOCTOR.
· Concerning vitamin C :
o Vitamin C may interfere with the following biological tests at doses greater than 2 g / day in vitamin C: blood and urine creatinine and glucose (glucose oxidase).
o In doses greater than 3 g / day in vitamin C, risk of hemolysis (destruction of red blood cells) in patients with glucose 6 phosphate dehydrogenase (specific enzyme of red blood cells).
If you forget to take ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet
Do not take or give a double dose to compensate for the simple dose that you have forgotten to take or give to your child.
If you stop taking ASPIRINE UPSA VITAMINEE C TAMPONNEE EFFERVESCENTE, effervescent tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Related to aspirin :
· Your treatment should be discontinued immediately and your doctor should be advised if:
o digestive haemorrhages (see section "Warnings and Precautions"). These are all the more frequent because the dosage used is high,
o allergic reactions such as rash, asthma attack, angioedema (facial urticaria with respiratory discomfort),
o headache, dizziness: these signs usually reflect an overdose of aspirin,
o 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 ulcer have been reported.
Related to vitamin C :
In doses above 1 g / day in vitamin C, possibility of: digestive disorders (gastric burns, diarrhea, abdominal pain), urinary disorders (discomfort with urine emission or abnormal coloring of the urine).
In doses greater than 3 g / day in vitamin C, risk of hemolysis in G6PD-deficient subjects (lack of an enzyme in red blood cells).
Cases of dizziness, urticaria and rash 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 VITAMINEE C TAMPONNEE EFFERVESCENTE, 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 not exceeding + 25 ° C. Keep the tube tightly closed, 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 VITAMINEE C EFFERVESCENT TAMPONNE, effervescent tablet contains
· The active substances are:
Acetylsalicylic acid................................................ .............................................. 330.00 mg
Ascorbic acid................................................ .................................................. .... 200.00 mg
· The other components are:
Glycine, anhydrous citric acid, sodium bicarbonate, sodium benzoate, povidone.
What is ASPIRINE UPSA VITAMINEE C EFFERVESCENT TAMPON, effervescent tablet and contents of the pack
Effervescent tablet, tube of 10, box of 2 tubes.
Marketing Authorization Holder
UPSA SAS
3, rue Joseph Monier
92500 RUEIL MALMAISON
Marketing Authorization Operator
UPSA SAS
3, rue Joseph Monier
92500 RUEIL MALMAISON
Maker
UPSA SAS
979, avenue des Pyrénées
47520 THE PASSAGE
or
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen
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}.
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council
WHAT TO DO IN THE EVENT OF FEVER:
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 from 20 kg (approximately from 6 years).
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.