CONSULT A PHYSICIAN.
In this leaflet :
1. WHAT IS ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet and WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING ASPEGIC ADULTS 1000 mg, powder for drinkable solution in a sachet?
3. HOW DO I TAKE ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ASPEGIC ADULTS 1000 mg, powder for drinkable solution in sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet and WHAT IS IT USED FOR?
Pharmacotherapeutic class
OTHER ANALGESICS AND ANTIPYRETICS.
This medicine contains aspirin.
It is indicated in case of pain and/or fever such as headaches, flu-like conditions, dental pain, aches and pains and in the treatment of certain rheumatic conditions in adults (from 15 years of age).
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ASPEGIC ADULTS 1000 mg, powder for drinkable solution in sachet-dose?
List of information needed before taking the medicine
Not applicable.
You should never use ASPEGIC ADULTS 1000 mg, powder for oral solution in sachet-dose, in the following cases:
- allergy to aspirin or a related drug (including non-steroidal anti-inflammatory drugs) or to any of the other components
- history of asthma induced by the administration of aspirin or a related drug (especially non-steroidal anti-inflammatory drugs),
- after 5 months of pregnancy (24 weeks of amenorrhea), for doses above 100 mg per day,
- ulcer of the stomach or duodenum in progress,
- bleeding disease or risk of bleeding
- severe liver disease,
- severe kidney disease,
- severe heart disease,
- treatment with methotrexate used at doses greater than 20 mg/week
- treatment with oral anticoagulants, and in case of a history of peptic ulcer, when aspirin is used in high doses, especially in the treatment of rheumatic conditions, fever or pain(see Use of other drugs).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Be careful with ASPEGIC ADULTS 1000 mg, powder for oral solution in sachet:
Warnings
- In case of association with other drugs, to avoid the risk of overdose, check the absence of aspirin in the composition of the other drugs.
- In case of headaches occurring during prolonged use of high doses of aspirin, you should not increase the doses, but take the advice of your doctor or pharmacist.
Regular use of analgesics, in particular several analgesics in combination, can lead to kidney damage.
- Reye's Syndromes (a rare but very serious disease combining mainly neurological disorders and liver damage) have been observed in children with viral diseases receiving aspirin.
As a result:
- in the event of viral illness, such as chicken pox or a flu-like episode: do not give aspirin to a child without the advice of a physician,
- If a child taking aspirin becomes unconscious, vomits or exhibits behavioral problems, seek medical attention immediately.
- Aspirin should be used only on the advice of your physician:
o if treating rheumatic disease,
o in case of G6PD deficiency (hereditary red blood cell disease), as high doses of aspirin may have caused hemolysis (destruction of red blood cells),
o if you have a history of stomach or duodenal ulcers, GI bleeding or gastritis
o in case of kidney or liver disease,
o in case of asthma: the occurrence of asthma attacks in some individuals may be related to an allergy to non-steroidal anti-inflammatory drugs or aspirin. In this case, this medication is contraindicated,
o in case of heavy menstruation,
o in case of treatment with:
§ other non-steroidal anti-inflammatory drugs when aspirin is used in high doses,
§ oral anticoagulants, and in the absence of a history of peptic ulcer disease, when aspirin is used in low doses for the treatment of pain and fever
§ heparins in curative doses and/or in patients over 65 years of age,
§ drugs used in the treatment of gout,
§ clopidogrel,
§ ticlopidine.
(see Taking or using other medicines).
- During treatment: in case of gastrointestinal bleeding (discharge of blood from the mouth, presence of blood in the stool, black stool), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY
- Due to the presence of lactose, this medication should not be used in cases of galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
- This medicine is reserved for adults and children from 15 years old.
|
This medicine contains aspirin.
You or your child should not take other medicines containing aspirin and/or non-steroidal anti-inflammatory drugs at the same time as this medicine.
Read the package inserts of other medications you or your child is taking carefully to make sure they do not contain aspirin and/or non-steroidal anti-inflammatory drugs.
|
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use
- Pain or fever:
o This dosage is only suitable for adults and children aged 15 years and over.
o For children under 15 years of age, take a more appropriate dosage.
o Ask your doctor or pharmacist for advice.
o If the pain persists for more than 5 days or the fever for more than 3 days, or in case of insufficient efficacy or any other sign, do not continue the treatment without the advice of your doctor.
o Aspirin increases the risk of bleeding at very low doses, even when taken for several days. WARN YOUR TREATMENT PHYSICIAN, SURGEON, ANESTHESIST OR DENTIST, if surgery, even minor, is planned.
- Rheumatology:
o At high doses used in rheumatology, it is recommended to watch for signs of overdose: ringing in the ears, decreased hearing or dizziness. If any of these symptoms occur SEEK MEDICAL ATTENTION IMMEDIATELY.
- Aspirin alters uricemia (the amount of uric acid in the blood).
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE
Interactions with other drugs
Taking or using other medications
This medication SHOULD NOT BE USED in combination with methotrexate (used at doses greater than 20 mg/week), with oral anticoagulants when aspirin is used as an anti-inflammatory, for pain or for fever (aspirin doses ≥ 500 mg per day), and in a patient with a history of peptic ulcer disease
This drug SHOULD BE AVOIDED in combination with oral anticoagulants when aspirin is used as an anti-inflammatory, for pain, or for fever (aspirin doses ≥500 mg daily), and in a patient without a history of peptic ulcer disease, with other nonsteroidal anti-inflammatory drugs when aspirin is used in high doses and in a patient with a history of peptic ulcer disease, heparins in curative doses and/or in a subject over 65 years of age, drugs used in the treatment of gout, with clopidogrel or ticlopidine (blood-thinning drugs).
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including medication obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
Ask your doctor or pharmacist for advice before taking any medication.
Pregnancy
Low doses, less than 100 mg per day:
Low doses of acetylsalicylic acid, less than 100 mg per day, may be prescribed in exceptional circumstances requiring specialized supervision.
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 given to a woman who wishes to become pregnant or is less than six months pregnant, the dose should be as low as possible and the duration of treatment as short as possible.
At doses higher than 100 mg per day, acetylsalicylic acid is contraindicated after 5 months of pregnancy (24 weeks of amenorrhea). You should NEVER take this medication during the third trimester of pregnancy because its effects on your child may have serious consequences, particularly in terms of cardiopulmonary and renal health, even with a single dose.
If you have taken this medication while pregnant, talk to your obstetrician gynecologist so that appropriate monitoring can be offered to you.
Breastfeeding
As acetylsalicylic acid passes into breast milk, this medication is not recommended during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notorious effect:lactose.
3. HOW TO TAKE ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
This presentation is reserved for adults (from 15 years).
In case of pain, in case of fever:
- For adults and children weighing more than 50 kg (from about 15 years of age):
The maximum recommended daily dosage is 3 g of acetylsalicylic acid, i.e. 3 sachets per day.
The usual dosage is 1 sachet to 1 g, to be repeated as needed after a minimum of 4 hours, without exceeding 3 sachets per day.
- For the elderly:
The maximum recommended daily dosage is 2 g of aspirin, i.e. 2 sachets per day. The usual dosage is 1 sachet to 1 g, to be renewed if necessary after a minimum of 4 hours, without exceeding 2 sachets per day.
In case of rheumatic affections:
It is necessary to follow the recommendations of your doctor.
IN CASE OF DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Mode and way of administration
Oral way.
Pour the contents of the sachet into a glass then add a small quantity of drink (for example water, milk, fruit juice).
Frequency of administration
Frequency of administration:
- In case of pain, in case of fever: systematic intake avoids oscillations of pain or fever.
They should be regularly spaced at least 4 hours apart.
- In case of rheumatic diseases: follow your doctor's advice.
Duration of treatment
In case of pain, in case of fever:
|
The duration of use is limited:
- to 5 days in case of pain,
- to 3 days in case of fever.
|
If the pain persists for more than 5 days or the fever for more than 3 days or if they worsen, do not continue the treatment without the advice of your doctor(see Precautions for use).
In case of rheumatic diseases: follow the advice of your doctor.
Symptoms and instructions in case of overdose
If you have taken more ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet than you should have:
During treatment, ringing in the ears, a sensation of decreased hearing, headaches, dizziness may occur: these usually reflect an overdose of aspirin.
DISCONTINUE YOUR TREATMENT AND NOTIFY A DOCTOR.
In case of accidental poisoning (especially common in young children), SEEK MEDICAL ATTENTION IMMEDIATELY.
Instructions in case of missed dose(s)
If you forget to take ASPEGIC ADULT 1000 mg, powder for oral solution in a sachet
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet is likely to have side effects, although not everyone is subject to them.
- Treatment should be stopped immediately and your doctor notified in the following cases
o digestive bleeding(see Special Warnings). The higher the dosage used, the more frequent these are,
o allergic reactions such as skin rash, asthma attack, angioedema (facial hives with breathing difficulties)
o Ringing in the ears, sensation of decreased hearing, headaches, dizziness: these signs usually indicate an overdose of aspirin,
- Tell your doctor if you have abdominal pain, nosebleeds or gum bleeds.
Stomach ulcers have been reported.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE ASPEGIC ADULTS 1000 mg, powder for oral solution in sachet-dose?
Keep out of the reach and sight of children.
Do not use ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet after the expiration date mentioned on the box.
Store at a temperature not exceeding +25°C and keep the sachets in the outer packaging, away from moisture.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist what to do with unused medication. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does ASPEGIC ADULTS 1000 mg, powder for oral solution in a sachet, contain?
The active substance is:
DL-acetylsalicylate lysine ........................................................................................................... 1800 mg
(Corresponding amount of acetylsalicylic acid .......................................................................... 1000 mg
For one dose sachet.
The other components are:
Glycine, tangerine flavor, ammonium glycyrrhizate.
Pharmaceutical form and content
What is ASPEGIC ADULTS 1000 mg, powder for drinkable solution in sachet-dose and what is in the outer packaging?
Powder for oral solution, sachet-dose, boxes of 10, 15, 20, 30 and 50.
Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris
Operator
SANOFI-AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris
Manufacturer
SANOFI WINTHROP INDUSTRIE
196, avenue du Maréchal Juin
45200 AMILLY
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the package insert
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this drug is available on the Afssaps website (France).
Information reserved for health professionals
Not applicable.
ADVICE / HEALTH EDUCATION
"WHAT TO DO IN CASE OF FEVER":
A child is considered to have a fever when his temperature exceeds 38°C.
Fever is a natural and frequent reaction of the organism to fight against infections, it is very rare that it is the only sign of a serious disease or that it leads to complications.
Français
English
