ASPEGIC 1 000mg BAGS ADULT 30

NOTICE

ANSM - Last updated: 31/07/2017

Name of the medicinal product

ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose

DL-Lysine Acetylsalicylate

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Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medicine by following the instructions in this leaflet or by your doctor or pharmacist.

· 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, or your pharmacist. 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 feel less well after 3 days.

Do not use this medication for children.

What is in this leaflet?

1. What is ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose and in which cases it is used?

2. What should I know before taking ASPEGIC ADULTS 1000 mg powder for oral solution in a sachet-dose?

3. How to take ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose?

4. What are the possible side effects?

5. How to store ASPEGIC ADULTS 1000 mg powder for oral solution in a sachet-dose?

6. Package contents and other information.

1. WHAT IS ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS - ATC code: N01BA02.

This medicine contains aspirin. Aspirin belongs to the family of non-steroidal anti-inflammatory drugs.

Aspirin can be used to calm pain (analgesic), lower fever (antipyretic) and / or decrease inflammation.

ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose contains 1000 mg of aspirin. It is used in cases of pain and / or fever such as headaches, flu-like conditions, dental pain, aches, and in the treatment of certain rheumatic diseases in adults (from 15 years).

2. BEFORE YOU TAKE ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose?

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Never take ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose:

· If you are allergic (hypersensitive) to aspirin or any of the other ingredients of ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose, mentioned in section 6.

· If you are allergic (hypersensitive) to a drug of the same family as aspirin (non-steroidal anti-inflammatory drugs).

· If you have ever had asthma caused by taking aspirin or medication from the same family.

· If you are currently suffering from an ulcer of the stomach or duodenum.

· If you have any bleeding or if your doctor has identified a risk of bleeding in your area.

· If you have severe liver, kidney or heart disease.

· in pregnancy from the beginning of the ^6th month (beyond 24 weeks of gestation) for doses of aspirin above 100 mg daily.

· If you are taking any other medicines, make sure that the combination with ASPEGIC ADULTS 1000 mg powder for oral solution in a sachet-dose is not contraindicated (see section 'Other medicines and ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose '').

· If you have a mastocytosis (disease of the cells involved in allergic reactions) because there is a risk of severe allergic reactions

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

Before taking ASPEGIC ADULTS 1000 mg, powder for oral solution in sachet-dose

ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose is available without a prescription. However, you should consult your doctor before taking this medication if you:

· rheumatic diseases,

· inherited red blood cell disease, also known as G6PD deficiency (as high doses of aspirin may cause destruction of red blood cells),

· history of stomach or duodenal ulcer or inflammation of the stomach (gastritis),

· history of digestive bleeding (vomiting of blood or presence of blood in the stool),

· kidney or liver disease,

· abundant rules,

· if you are already taking another anti-inflammatory or anticoagulant treatment (refer to "Other medicines and ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose" for more details)

· viral disease, in particular varicella or influenza-like illness: cases of Reye's syndrome (rare, very severe disease associating mainly neurological disorders and liver damage) have been observed in children and adolescents with viral disease and receiving aspirin.

If your child is less than one month old, you should first consult your doctor before taking any medicine containing aspirin, regardless of dosage.

During treatment, consult your doctor immediately if you have:

· bleeding or pain in the abdomen,

· an asthma attack. This may be a sign of an allergy to aspirin or a nonsteroidal anti-inflammatory drug.

In case of prolonged administration of large doses of painkillers, you should not increase the doses of ASPEGIC ADULT 1000 mg powder for oral solution in sachet-dose in case of headaches.

Regular use of pain-relieving drugs can lead to kidney complications.

If you have to undergo an operation

Aspirin increases the risk of bleeding even at very low doses, even when taking this drug is several days old.

Tell your doctor, surgeon, anesthesiologist or dentist about the use of this medication if you are undergoing any operation or intervention, even a minor one.

Blood tests

Tell your doctor if you need to take a blood test because aspirin can alter the level of uric acid in the blood.

Children and Youth

Not applicable.

Other drugs and ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose

Never take large doses of ASPEGIC ADULT 1000 mg powder for oral solution in a sachet-dose (see paragraph '' Dosage ''):

· If you are taking doses greater than 20 mg / week of methotrexate (a drug used to treat certain cancers and rheumatism).

· If you are taking an oral anticoagulant (a medicine used to thin the blood) and you have a history of stomach ulcer or duodenal ulcer.

Unless otherwise advised by your doctor, you should not take:

· high doses of ASPEGIC ADULTS 1000 mg powder for oral solution in a sachet-dose (see paragraph '' Dosage '') if you already take:

o an oral anticoagulant or a heparin (medicines used to thin the blood),

o a non-steroidal anti-inflammatory drug or a corticosteroid (drugs used to treat a rheumatic disease, pain or inflammation).

· low doses of ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose (50 to 375 mg per day) if you are already taking:

o an oral anticoagulant (a drug used to thin the blood) and you have a history of stomach or duodenal ulcer.

· ASPEGIC ADULTS 1000 mg, powder for oral solution in sachet-dose regardless of the dose, if you are already taking a medicine based on:

o ticlopidine or clopidogrel (medicines used to thin the blood),

o benzbromarone or probenecid (drugs used to treat gout),

o levothyroxine (medication used to treat insufficiency of thyroid gland secretion),

o Pemetrexed (a drug to treat certain cancers),

Anagrelide (a drug used to decrease the number of platelets in the blood),

o defibrotide (a drug used to treat a condition in which blood vessels in the liver are damaged and obstructed by blood clots),

o acetazolamide (a drug used to reduce eye pressure or the level of carbon dioxide in the blood),

o ticagrelor (medication used to prevent platelet aggregation).

Varicella vaccine : It is recommended to wait 6 weeks after vaccination before taking this medication.

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose with food and beverages

Alcohol use should be avoided during treatment due to increased risk of gastrointestinal injury.

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 any medicine.

Pregnancy

Low doses, up to 100 mg daily :

Throughout pregnancy, if necessary, your specialist physician may prescribe aspirin at very low doses (less than or equal to 100 mg per day) in exceptional circumstances requiring specialized monitoring. If this is the case, it is very important to strictly follow your doctor's prescription, without exceeding the prescribed doses, and NOT to take ANY other medicine containing aspirin (including non-prescription drugs).

For doses above 100 mg per day:

· from 0 to 5 months of pregnancy (up to the 24th week of amenorrhea), your doctor should not prescribe this medicine unless absolutely necessary. In this case, the dose should be as low as possible and the treatment time should be as short as possible.

· from 6 months to the end of pregnancy (from the 25th week of amenorrhea), this medication is contraindicated, you should NEVER take this medication because its effects on your child can have serious consequences even fatal, especially on a cardiopulmonary and renal plan and this even with a single intake.

If you are taking this medication while you are pregnant, talk to your obstetrician gynecologist immediately so that appropriate monitoring is available.

feeding

Aspirin passes into breast milk, this medication is not recommended during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

It has been proven that this drug can decrease female fertility by acting on ovulation. This effect is reversible upon discontinuation of treatment.

Sport

Not applicable.

Driving and using machines

Not applicable.

ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose contains lactose.

This medication contains a sugar (lactose) which decomposes into galactose and glucose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

If your doctor has already told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose?

Dosage

This presentation is reserved for adults (from 15 years).

In case of pain and / or fever

· For adults and children weighing more than 50 kg (from about 15 years of age): The maximum recommended daily dose is 3 g of acetylsalicylic acid, ie 3 sachets per day.

The usual dosage is 1 sachet to 1000 mg , to be renewed if necessary after 4 hours minimum, without exceeding 3 sachets per day.

· For the elderly: the maximum recommended daily dose is 2 g of aspirin, ie 2 sachets per day.

Dosage usual is from 1 sachet to 1000 mg , to be renewed if necessary after 4 hours minimum, without exceeding 2 sachets per day.

In case of rheumatic diseases

Your doctor will tell you how much to take.

IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.

Method and route of administration

Oral use.

Pour the contents of the sachet into a glass and add a small amount of drink (eg water, milk, fruit juice).

Frequency of administration:

Taken at regular intervals, avoid peaks of fever or pain.

In case of pain and / or fever, the catch should be regularly spaced at least 4 hours (see paragraph '' Dosage '').

In the case of rheumatic diseases, the spacing between catches must be at least 4 hours . In all cases, comply with the advice of your doctor.

Duration of treatment

Stop treatment and see your doctor immediately:

· if the pain persists more than 5 days or the fever lasts more than 3 days,

· if the pain or fever get worse,

· if you find that the treatment is not effective enough,

· or if any new signs occur (eg stiff neck, diarrhea, vomiting ...).

If you take more ASPEGIC ADULTS 1000 mg powder for oral solution in a sachet-dose than you should:

Immediately consult your doctor or pharmacist.

Overdose can be fatal, especially in children. The main symptoms of poisoning are: ringing in the ears, a feeling of hearing loss, headaches, dizziness, or even more severe fever, severe hypoglycemia (lowering of sugar levels in the blood), rapid fall in blood pressure, accelerated breathing and loss of consciousness (coma).

If these signs occur, you should immediately stop treatment and go to a hospital for treatment.

Lung edema not associated with heart failure can occur in acute and chronic overdose with aspirin (see 4. What are the side effects?). This edema can be fatal in case of overdose.

If you forget to take ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose:

Do not take a double dose to make up for the single dose that you have forgotten to take.

If you stop taking ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose may cause side effects, although not everybody gets them.

· Ulceration of the esophagus, stomach, and intestine, perforation of digestive ulcer, perforation of the intestine.

These reactions may or may not be associated with visible or non-visible gastrointestinal bleeding (black stools, stool blood, or oral rejection), regardless of the dose of aspirin, and in patients with or without warning signs or of serious gastrointestinal history. High doses increase the risk of bleeding.

· Life-threatening bleeding (hemorrhage).

· Cerebral haemorrhage (bleeding in the brain) that can be life-threatening, especially in the elderly. If this happens, tell your doctor immediately.

· Decrease in the number of platelets in the blood.

· Destruction of red blood cells (haemolytic anemia) in patients with G6PD deficiency.

· Abnormally low levels of certain blood cells (pancytopenia, bicytopenia, aplastic anemia), depletion of blood cell production (medullary insufficiency), abnormally low levels of certain white blood cells that can lead to serious infections (leukopenia, neutropenia, agranulocytosis).

· Allergic reaction: pimples and / or redness on the skin, hives, abrupt swelling of the face or neck, which can lead to difficulty breathing (angioedema), abrupt malaise with a significant drop in blood pressure (anaphylactic shock).

· Rash in rounded red patches with itching and burning sensation, leaving colored spots and appearing in the same places when the drug is resumed.

· Ear tinnitus, hearing loss, 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")

· Inflammation of blood vessels which may be associated with damage to the joints, kidney, skin and gastrointestinal tract

· Increased liver enzymes, liver damage (mainly liver cells).

· Chronic liver disease (chronic hepatitis).

· Acute inflammation of the pancreas during an allergic reaction related to acetylsalicylic acid.

· Edema (swelling due to fluid build-up in tissues) if you are taking high doses of ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose .

· Lung edema not related to heart failure in long-term use and in the context of an allergic reaction to aspirin.

· Localized pain in the chest that can radiate to the left shoulder and jaw of allergic origin (Kounis syndrome)

· Kidney disease (kidney failure)

In all cases, stop treatment immediately and seek prompt medical attention.

Other possible side effects:

· Abdominal pain,

· Bleeding (nose, gums), small red spots on the skin (purpura).

· Inflammation of the esophagus, stomach, duodenum and colon.

· Presence of blood in sperm (hematospermia)

In these cases, you should consult your doctor.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose?

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 carton.

Store at a temperature not exceeding + 25 ° C and keep the sachets in the outer carton, protected 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 ASPEGIC ADULTS 1000 mg contains, powder for oral solution in sachet-dose

· The active substance is:

DL lysine acetylsalicylate .............................................. ........................................... 1800 mg

(Corresponding amount of acetylsalicylic acid ............................................ .......... 1000 mg)

For a sachet-dose.

· The other components are: glycine, mandarin aroma, ammonium glycyrrhizate.

What is ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose and contents of the pack

Powder for oral solution, sachet-dose, boxes of 10, 15, 20, 30 and 50.

Marketing Authorization Holder

SANOFI AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Marketing Authorization Operator

SANOFI AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Maker

SANOFI WINTHROP INDUSTRIE

196 AVENUE DU MARECHAL JUNE

45200 AMILLY

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:

{month YYYY}

Other

Detailed information on this medicine is available on the ANSM website (France).

Health Education Council:

WHAT TO DO IN CASE OF FEVER OR PAIN?

A child is considered to have a fever when the temperature exceeds 38 ° C.

Fever is a natural and frequent reaction of the body to fight infections, it is very rare that it is the only sign of a serious illness or that it leads to complications.

What has to be done :

Generally it is only above 38.5 ° C that treatment is envisaged; however this should not be systematic, especially if the fever is well supported by the child.

1) Before giving a medication for fever, always:

· remove blankets and superfluous layers of clothing,

· present often to drink to the child,

· do not overheat the room (about 18-20 ° C).

These 3 simple measures are sufficient in many cases to lower the fever.

Other measures are available (warm baths, ice packs, moist wraps ...), they are not necessarily more effective and will only be considered if they do not increase the child's ill-being.

2) In a second step, the child may be given a fever medication (called antipyretic medication).

Read carefully the paragraphs "Warnings and precautions" and "Other drugs and ASPEGIC ADULTS 1000 mg powder for oral solution in sachet-dose".

How should a fever medicine be used?

· respect the doses and delays between catches,

· give only one medication (do not combine or alter medications differently without medical advice),

· check that the child does not otherwise receive the same medicine (syrup, sachets, suppositories ...) or under another brand name.

If fever persists for several days, if new signs (especially stiffness of the neck, diarrhea, vomiting ...) or fever is badly supported (child slaughtered, losing its reactivity ...), you do not should not hesitate to consult a doctor.

WHAT TO DO IF PAIN?

You should consult a doctor:

· if you do not feel any improvement after 5 days of treatment,

· if the pains return regularly,

· if accompanied by fever,

· if they awaken your child at night.

VIDAL OF THE FAMILY

aspegic