Aspegic 500mg 30 sachets powder

In this manual :

1. WHAT IS ASPEGIC 500 mg, powder for oral solution in a sachet and WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING ASPEGIC 500 mg, powder for oral solution in a sachet?

3. HOW DO I TAKE ASPEGIC 500 mg, powder for oral solution in a sachet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE ASPEGIC 500 mg, powder for oral solution in a sachet?

6. ADDITIONAL INFORMATION

1. WHAT IS ASPEGIC 500 mg, powder for oral solution in a sachet and WHAT IS IT USED FOR?

This medicine is an analgesic (pain reliever) and an antipyretic (fever reducer).

This medicine contains aspirin.

It is indicated:

- In case of pain and/or fever such as headaches, flu-like conditions, toothache, aches and pains in adults and children weighing more than 30 kg (approximately 9 to 15 years)

- In the treatment of certain rheumatic conditions in adults and children weighing more than 20 kg (about 6 years) after medical advice. Medical supervision is necessary.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ASPEGIC 500 mg, powder for drinkable solution in a sachet?

If your doctor has told you that you are intolerant to certain sugars, contact him or her before taking this medicine.

Do not take ASPEGIC 500 mg, powder for oral solution in a sachet if you

- known allergy to aspirin or a related drug (especially non-steroidal anti-inflammatory drugs) or to any of the other components of this medicine (see composition),

- history of asthma induced by the administration of aspirin or a related medicinal product (especially non-steroidal anti-inflammatory drugs),

- during the last trimester of pregnancy for doses above 100 mg per day,

- an active stomach or duodenal ulcer

- bleeding disease or risk of bleeding,

- severe liver disease,

- severe kidney disease,

- severe heart disease,

- treatment with methotrexate used in doses greater than 20 mg/week when aspirin is used in high doses as an anti-inflammatory (≥ 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),

- treatment with oral anticoagulants, in case of a history of peptic ulcer and when aspirin is used in high doses as an anti-inflammatory (≥ 1 g per intake and/or ≥ 3 g per day) especially in the treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per intake and/or < 3 g per day).

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Be careful with ASPEGIC 500 mg, powder for drinkable solution in sachet:

Special Warnings

- This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

- In case of association with other medicines, to avoid the risk of overdose, check the composition of the other medicines for the absence of aspirin.

- 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 painkillers, especially several painkillers in combination, can lead to kidney damage.

- Reye's syndromes (a rare but very serious disease mainly involving neurological disorders and liver damage) have been observed in children with viral diseases receiving aspirin.

Therefore:

- in cases of viral illness, such as chickenpox or a flu-like episode: do not give aspirin to a child without medical advice,

- If a child taking aspirin develops consciousness or behavioural problems and vomits, seek medical attention immediately.

Aspirin should only be used on the advice of your doctor:

- when treating rheumatic disease,

- in case of G6PD deficiency (hereditary red blood cell disease), as high doses of aspirin may have caused haemolysis (destruction of red blood cells),

- if you have a history of stomach or duodenal ulcers, gastrointestinal bleeding or gastritis,

- in case of kidney or liver disease,

- in case of asthma: the occurrence of asthma attacks in some people may be related to an allergy to non-steroidal anti-inflammatory drugs or aspirin. In this case, this medication is contraindicated,

- in case of heavy menstruation,

- in case of treatment with :

o oral anticoagulants, when aspirin is used in high doses especially in the treatment of fever or pain (≥ 500 mg per dose and/or < 3 g per day) and in the absence of a history of peptic ulcer

o oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in the absence of a history of peptic ulcer,

o non-steroidal anti-inflammatory drugs, when aspirin is used in high doses as an anti-inflammatory (≥ 1 g per intake and/or ≥ 3 g per day) especially in the treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per intake and/or < 3 g per day),

o glucocorticoids (except hydrocortisone in replacement therapy), when aspirin is used in high doses as an anti-inflammatory (≥ 1 g per intake and/or ≥ 3 g per day) especially in the treatment of rheumatic conditions,

o heparins used in curative doses and/or in subjects over 65 years of age, when aspirin is used in high doses as an anti-inflammatory (≥ 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 per day),

o drugs used in the treatment of gout,

o clopidogrel,

o pemetrexed in subjects with low to moderate renal function,

o ticlopidine.

During treatment: in case of gastrointestinal haemorrhage (discharge of blood through the mouth, presence of blood in the stools, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY.

It is necessary to remember that if your child is less than 1 month old, medical advice is required before using aspirin.

Precautions for use

Pain or fever

This dosage is suitable for adults and children from 30 kg (about 9 to 15 years)

- For children under 30 kg (about 9 years), this dosage is not suitable: consult your doctor.

Ask your doctor or pharmacist for advice.

- If the pain persists for more than 5 days or the fever for more than 3 days, or in the event of insufficient efficacy or the occurrence of any other sign, do not continue the treatment without the advice of your doctor.

- Aspirin increases the risk of bleeding at very low doses, even when taken for several days. PREVENT YOUR TREATMENT DOCTOR, SURGEON, ANESTHESIST OR DENTIST, in the event that surgery, even minor, is envisaged.

Rheumatology after medical advice

This dosage is suitable for adults and children from 20 kg (about 6 years)

- For children weighing less than 20 kg (i.e. about 6 years), this dosage is not suitable: consult your doctor.

- At high doses used in rheumatology, it is recommended to monitor the appearance of signs of overdose: ringing in the ears, reduced hearing or dizziness. If any of these symptoms occur: CONSULT A PHYSICIAN IMMEDIATELY.

- Aspirin alters uricemia (the amount of uric acid in the blood).

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

PHARMACIST.

Taking or using other medications

This medicine SHOULD NOT BE USED in combination with methotrexate used in doses greater than 20 mg/week, when aspirin is used in high doses, especially in the treatment of rheumatic conditions (≥ 1 g per dose and/or ≥ 3 g per day), fever or pain (≥ 500 mg per dose and/or < 3 g per day).

This medicine SHOULD NOT BE USED in combination with other oral anticoagulants, when aspirin is used in high doses, especially in the treatment of rheumatic conditions (≥ 1 g per dose and/or ≥ 3 g per day), fever or pain (≥ 500 mg per dose and/or < 3 g per day), and in case of a history of peptic ulcer disease.

This drug SHOULD BE AVOIDED in association with:

- oral anticoagulants when aspirin is used in high doses for the treatment of fever or pain (≥ 500 mg per dose and/or < 3 g per day) and in the absence of a history of peptic ulcer disease,

- oral anticoagulants when aspirin is used in low doses as an antiplatelet agent (50-375 mg per day) and in the absence of a history of peptic ulcer disease,

- nonsteroidal anti-inflammatory drugs when aspirin is used in high doses, especially in the treatment of rheumatic conditions (≥ 1 g per dose and/or ≥ 3 g per day), fever or pain (≥ 500 mg per dose and/or < 3 g per day),

- glucocorticoids (except hydrocortisone in replacement therapy), when aspirin is used in high doses (≥ 1 g per dose and/or ≥ 3 g per day), especially in the treatment of rheumatic conditions,

- heparins used in curative doses and/or in subjects over 65 years of age, when aspirin is used in high doses, especially in the treatment of rheumatic conditions (≥ 1 g per dose and/or ≥ 3 g per day), fever or pain (≥ 500 mg per dose and/or < 3 g per day),

- drugs used in the treatment of gout,

- clopidogrel,

- pemetrexed in patients with low to moderate renal function,

- ticlopidine (see "Use caution with ASPEGIC 500 mg, powder for oral solution in a sachet", paragraph "Special warnings").

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT YOU ARE TAKING.

Not applicable.

Not applicable.

Pregnancy and lactation

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 specialist supervision.

For doses above 100 mg per day

At these doses, unless absolutely necessary, acetylsalicylic acid should not be prescribed during the first two trimesters of pregnancy. If acetylsalicylic acid is administered 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 above 100 mg per day, acetylsalicylic acid is contraindicated after 5 months of pregnancy (24 weeks of amenorrhea). You should NEVER take this medicine 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 if you take it only once.

If you have taken this medicine while pregnant, talk to your obstetrician-gynecologist so that appropriate monitoring can be arranged.

Breastfeeding

This medicine passes into breast milk. As a precautionary measure, it should not be used while breast-feeding.

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

Not applicable.

Not applicable.

List of excipients with a notable effect: lactose.

3. HOW TO TAKE ASPEGIC 500 mg, powder for oral solution in a sachet

Not applicable.

Dosage

In case of pain, in case of fever:

This presentation is for adults and children weighing 30 kg or more (approximately 9 to 15 years).

The dosage of aspirin depends on the weight of the child; the ages are given for information only.

If you do not know the child's weight, you should weigh the child to determine the most appropriate dose.

Aspirin is available in many dosages, allowing the treatment to be adapted to each child's weight.

The recommended daily dose of aspirin is about 60 mg/kg/day, divided into 4 or 6 doses, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

- For children weighing 30 to 40 kg (approximately 9 to 13 years), the dosage is 1 sachet per dose, repeated if necessary after 6 hours, not to exceed 4 sachets per day.

- For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 sachet per dose, to be repeated if necessary after 4 hours, without exceeding 6 sachets per day.

- For adults and children weighing more than 50 kg (from about 15 years old): The maximum recommended daily dosage is 3 g of aspirin, or 6 sachets per day. The usual dosage is 1 sachet of 500 mg, to be repeated if necessary after at least 4 hours. In the event of more intense pain or fever, 2 x 500 mg sachets, to be repeated as necessary after at least 4 hours, without exceeding 6 sachets per day.

- For the elderly:
The maximum recommended daily dose is 2 g of aspirin, i.e. 4 sachets per day.
The usual dose is 1 sachet of 500 mg, repeated as necessary after at least 4 hours. In the event of more intense pain or fever, 2 x 500 mg sachets, to be repeated as necessary after at least 4 hours, without exceeding 4 sachets per day.

In case of rheumatic diseases, after medical advice:

This presentation is reserved for adults and children weighing more than 20 kg (about 6 years).

It is necessary to follow the recommendations of your doctor.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Method and route of administration

Oral use.

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

Frequency of administration:

Systematic intake avoids oscillations in pain or fever:

In adults: intakes should be regularly spaced at least 4 hoursapart.

In children: doses should be taken at regular intervals, including at night, preferably 6 hours apart and at least 4 hours apart: follow the dosage specified above.

In rheumatic diseases: the interval between doses should be at least 4 hours.

Duration of treatment

In case of pain, in case of fever:

If pain persists for more than 5 days or fever for more than 3 days or if it gets worse, do not continue treatment without your doctor's advice (see "Precautions for use").

In case of rheumatic diseases: follow the advice of your doctor.

If you have taken more ASPEGIC 500 mg, powder for oral solution in a sachet than you should have:

During treatment, ringing in the ears, a feeling of decreased hearing, headaches, and dizziness may occur: these usually indicate an overdose of aspirin.

STOP TAKING YOUR MEDICATION OR YOUR CHILD'S MEDICATION AND SEEK MEDICAL ATTENTION.

In case of accidental poisoning (especially common in young children), SEEK MEDICAL ATTENTION IMMEDIATELY.

If you forget to take ASPEGIC 500 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.

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, ASPEGIC 500 mg, powder for oral solution in a sachet, is likely to have side effects, although not everyone is subject to them.

Stop your treatment immediately and tell your doctor if you experience any of the following

- gastric and intestinal bleeding (see "Special warnings"). The higher the dosage used, the more frequent these are,

- cerebral haemorrhages,

- allergic reactions such as skin rash, asthma attack, angioedema (facial hives with breathing difficulties),

- ringing in the ears, sensation of decreased hearing, headache, dizziness: these signs usually indicate an overdose of aspirin,

- Reye's syndrome (onset of consciousness or behavioural disturbance and vomiting) in a child with a viral illness receiving aspirin ("Be careful with ASPEGIC 500 mg powder for oral solution in a sachet", section "Special Warnings")

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

Tell your doctor if you experience abdominal pain, nosebleeds or bleeding gums.

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 CONSERVE ASPEGIC 500 mg, powder for oral solution in sachet?

Keep out of the reach and sight of children.

Do not use ASPEGIC 500 mg, powder for oral solution in a sachet after the expiry date stated on the box.

The expiry date refers to the last day of the month.

Store at a temperature not exceeding 25°C and keep the sachets in the outer packaging, protected from moisture.