Aspirin 500 mg chewable tablets

Aspirin 500 mg chewable tablets contain the active substance acetylsalicylic acid (ASA).

Application

1. WHAT ARE ASPIRIN 500 MG CHEWABLE TABLES AND WHAT ARE THEY USED FOR?

Aspirin 500 mg Chewable Tablets contain the active substance acetylsalicylic acid (ASA). This has a pain-relieving, antipyretic and anti-inflammatory effect.

When are Aspirin 500 mg chewable tablets used?
Symptomatic treatment of mild to moderate pain such as headaches, toothaches and period pains.
For the relief of pain and fever during colds and flu-like infections.

If you do not feel better or even worse after 3 - 4 days in the case of pain and after 3 days in the case of fever, if new complaints occur (e.g. redness or swelling), it is absolutely necessary to take this medicine.

If you do not feel better or even worse with pain after 3 days and with fever after 3 days, if new symptoms occur (e.g. redness or swelling), it is essential to consult a doctor, as these may be signs of a serious illness.

Please note the information for children (see section 2).

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How is it applied?

WHAT ARE ASPIRIN 500 MG CAUTABLETS AND WHAT ARE THEY USED FOR?

Aspirin 500 mg chewable tablets contain the active substance acetylsalicylic acid (ASA). This has an analgesic, antipyretic and anti-inflammatory effect.

When to use aspirin 500 mg chewable tablets?
Symptomatic treatment of mild to moderate pain such as headaches, toothaches and period pains.
For the relief of pain and fever in colds and flu-like infections.

If you do not feel better or even worse after 3 - 4 days in the case of pain and after 3 days in the case of fever, if new complaints appear (e.g. redness or swelling), it is essential to consult a doctor, as these may be signs of a serious illness.

Please note the information for children (see section 2).

What should you pay attention to before taking it?

What SHOULD YOU TAKE INTO ACCOUNT BEFORE TAKING ASPIRIN 500 MG CHEWABLE TABLES ?

Aspirin 500 mg Chewable Tablets must not be taken

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• If you are allergic to acetylsalicylic acid, other salicylates or to any of the other ingredients of this medicine listed in section 6
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• If you have reacted in the past to certain pain-relieving medicines - acetylsalicylic acid or substances with a similar mechanism of action (non-steroidal anti-inflammatory drugs) - with asthma attacks or in any other way hypersensitive,
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• If you suffer from acute gastrointestinal ulcers,
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• If you have a history of gastrointestinal bleeding, ulceration or rupture due to previous therapy with NSAIDs
  (non-steroidal anti-inflammatory drugs),
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• If you have active gastrointestinal ulcers/bleeding or a history of bleeding, ulcers or a breakthrough in the gastrointestinal area
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• If you suffer from a pathologically increased tendency to bleed (haemorrhagic diathesis)
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• If you suffer from severe liver dysfunction,
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• if you suffer from severe kidney dysfunction,
• If you suffer from severe heart muscle weakness (cardiac insufficiency)
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• If you are taking 15 mg per week or more of methotrexate (medicine used to treat cancer or certain rheumatic diseases) at the same time
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• If you are taking anticoagulants (medicines to "thin the blood") at the same time, if salicylates are used in high doses
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• in the last 3 months of pregnancy.

Aspirin 500 mg Chewable Tablets must not be given to children under one year of age.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Aspirin 500 mg Chewable Tablets.
Particular caution is required when taking Aspirin 500 mg Chewable Tablets in the following cases

• Hypersensitivity to painkillers, certain medicines for
  inflammation or rheumatism or in the presence of other allergies
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• High blood pressure and/or cardiac insufficiency in the medical history. Fluid retention and swelling have been reported in association with acetylsalicylic acid treatment.
• simultaneous treatment with anticoagulant medicines.
• Known gastrointestinal ulcers, including chronic or recurrent gastrointestinal ulcers, or a history of gastrointestinal bleeding
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• Patients with reduced kidney function or patients with reduced cardiovascular function (e.g. vascular disease, cardiac insufficiency, loss of volume, major surgery, blood poisoning or major bleeding events), as acetylsalicylic acid, the active ingredient ofure, the active ingredient in Aspirin 500 mg Chewable Tablets, may further increase the risk of renal dysfunction and acute
  renal failure.
• limited liver function.
• pending operations (also minor operations such as dental procedures): there may be an increased tendency to bleed. Please inform your doctor before all operations if you have taken Aspirin 500 mg Chewable Tablets.
• Patients with a so-called "glucose-6-phosphate dehydrogenase deficiency" (a congenital metabolic disorder): Aspirin 500 mg chewable tablets can cause a breakdown of the red blood cells or anaemia due to a breakdown of the red blood cells. The administration of aspirin 500 mg chewable tablets in glucose-6-phosphate dehydrogenase deficiency must therefore be carried out under medical
  supervision.

Aspirin 500 mg chewable tablets must not be used for longer than 3-4 days in the case of pain and for longer than 3 days in a row in the case of fever without a doctor's orders.
Possible side effects can be reduced by using the lowest dose that is sufficiently effective for the shortest period of time necessary to control the symptoms.

What else do you need to pay attention to?
Before you start treatment, you must inform your doctor.

• if you are pregnant or think you are pregnant or intend to become pregnant
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• If you are breastfeeding,
• If you are taking other medicines, especially medicines containing acetylsalicylic acid or medicines for pain and rheumatism,
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• if you suffer from other diseases or allergies.

Bleeding tendency:
Acetylsalicylic acid (the active ingredient in Aspirin 500 mg chewable tablets) inhibits (even at very low doses) platelets from sticking together. There is therefore an increased risk of bleeding both during and after operations (including minor procedures such as tooth extraction), which can continue for several days after the intake has ended.
can stop.

Rarely to very rarely, serious bleeding such as cerebral haemorrhage has also been reported, especially in patients with uncontrolled high blood pressure and/or concurrent treatment with anticoagulants. In individual cases, these can be potentially life-threatening.

Gastrointestinal disorders:
During treatment, serious - even life-threatening - bleeding, ulcers and/or breakthroughs may occur at any time, even without previous symptoms or corresponding gastrointestinal diseases in the history. Therefore, while taking Aspirin 500 mg Chewable Tablets, watch out for signs of illness in the gastrointestinal tract.

The risk increases with increasing dose, in elderly people, in people with a history of stomach ulcers (especially complications such as bleeding and perforation), in people with low body weight and in patients who are being treated with medicines that may increase the risk of ulcers or bleeding, such as
The risk increases with increasing doses in the elderly (especially if there is a history of complications such as bleeding or rupture), in people with low body weight and in patients who are being treated with medicines that may increase the risk of ulcers or bleeding, such as cortisone, anticoagulant medicines (e.g., anticoagulants).These include cortisone, anticoagulants (such as aspirin in small doses for the treatment of cardiovascular diseases), certain medicines for the treatment of depression (selective serotonin reuptake inhibitors).
These patients should receive the lowest possible dose and report any unusual gastrointestinal complaints (especially bleeding), especially at the start of treatment.
Treatment with Aspirin 500 mg Chewable Tablets in combination with gastroprotectant should be considered in these cases.

If you experience bleeding or ulcers in the gastrointestinal tract, treatment with Aspirin 500 mg Chewable Tablets must be stopped.

Signs of gastrointestinal side effects may include: abdominal pain, vomiting of blood, coffee-like vomiting, blackening of the stools.
In these cases, please stop taking Aspirin 500 mg Chewable Tablets immediately.
and seek medical advice immediately.

Hypersensitivity reactions:
Aspirin 500 mg chewable tablets may cause spasms of the bronchial muscles (bronchospasms), asthma attacks or other hypersensitivity reactions. Risk factors include pre-existing asthma, hay fever, nasal polyps or chronic respiratory diseases.
The same applies to patients who are also allergic to other substances (e.g. with skin reactions, itching, hives).

Gout attack:
Aspirin 500 mg chewable tablets increase the uric acid level in the blood by inhibiting the excretion of uric acid. In patients who are already prone to low uric acid excretion, this can possibly trigger a gout attack.

Treatment of fever in children and adolescents:
Very rarely, a severe life-threatening disease of the brain and liver has been observed in children and adolescents - especially during fever treatment of flu or chickenpox - during treatment with acetylsalicylic acid (active ingredient of Aspirin 500 mg chewable tablets), which may be related to acetylsalicylic acid (the so-called "Reye's syndrome"). It also occurs in young adults.

Acetylsalicylic acid-containing medicines such as Aspirin 500 mg chewable tablets must therefore only be administered to children under 12 years of age and adolescents with febrile illnesses on the advice of a doctor.
prescription and only administered if other measures do not work.
If prolonged vomiting, clouding of consciousness and/or abnormal behaviour (even after initial improvement of the general condition) occur as a result of the treatment, the intake of Aspirin 500 mg Chewable Tablets must be discontinued immediately and medical attention sought without delay.

Also after the chickenpox vaccination, it is recommended to refrain from taking aspirin 500 mg chewable tablets for 6 weeks to be on the safe side.

Children:
Acetylsalicylic acid-containing medicines, such as Aspirin 500 mg chewable tablets, should only be given to children under 12 years of age on a doctor's prescription.
With this ASA dosage form, children's dosages are not possible.
Always keep this medicine out of the sight and reach of children.
Headache due to painkillers:
Prolonged use of painkillers may cause headaches, which must not be treated by increased doses of the medicine.
Consult your doctor if you often suffer from headaches despite taking Aspirin 500 mg Chewable Tablets!

Kidney damage from painkillers:
The habitual use of painkillers can lead to permanent kidney damage (nephropathy), which can progress to kidney failure. This risk is particularly high if you take several different painkillers in combination.

Lab controls:
If Aspirin 500 mg chewable tablets are taken for a long time, checks (e.g. liver function, kidney function, blood count, blood clotting) are indicated.

Vascular diseases:
The use of medicines such as aspirin 500 mg chewable tablets could be associated with a slightly increased risk of having a heart attack or stroke. Any risk increases with the level of dosage and duration of use. Therefore, do not increase the recommended dosage and treatment duration of 3-4 days.

If you have heart problems, have already had a stroke or think you may be at increased risk of these conditions (such as: High blood pressure, diabetes, elevated cholesterol or if you are a smoker), talk to your doctor about this treatment.

Stopping the complaints:
The analgesic effect can mask the discomfort of a concomitant disease. In case of high fever, signs of a new infection (e.g. redness, swelling) or persistence of the symptoms (such as pain or fever) for more than three days, medical advice must be sought.

Fertility:
Aspirin 500 mg Chewable Tablets may affect fertility in women (see section on pregnancy, breast-feeding and fertility).

Diseases of the oesophagus:
Caution in patients with diseases of the oesophagus. In this case, the tablets should be taken with plenty of liquid.

Taking Aspirin 500 mg Chewable Tablets with other medicines Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

The effect of the following medicines or groups of medicines may be influenced by simultaneous treatment with Aspirin 500 mg Chewable Tablets.

Contraindicated combinations
If you are taking methotrexate (medicine used to treat cancer or certain rheumatic diseases) in doses of 15 mg/week or more, you must not take Aspirin 500 mg Chewable Tablets.

If you are taking anticoagulants (medicines to "thin the blood"), you must not take Aspirin 500 mg Chewable Tablets in high doses.

Combinations that require special care:

• Methotrexate in doses below 15 mg/week (medicinal products for the treatment of cancer or certain rheumatic diseases) - there is a risk of increased (side) effects of methotrexate.
• Anticoagulant medicines, medicines that dissolve blood clots/other medicines that inhibit platelet adhesion and clumping (antiplatelet medicines)/anticoagulant medicines (haemostasis inhibitors) - they may increase their effect and cause bleeding.
• Aspirin 500 mg chewable tablets may increase the risk of bleeding if taken before a treatment intended to dissolve blood clots. Therefore, you must pay close attention to signs of external or internal bleeding (e.g. bruising) if you are to undergo such treatment. A medical check-up is absolutely necessary.
• Other painkilling and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs) at high doses of acetylsalicylic acid : increased risk of ulcers and bleeding in the gastrointestinal tract, overdose is also possible.
• Certain medicines for the treatment of depression (selective serotonin reuptake inhibitors): the risk of bleeding in the gastrointestinal tract increases.
• Certain medicinal products for the treatment of cardiac insufficiency and for the treatment of certain cardiac arrhythmias (digoxin): intensification of the effect up to increased risk of side effects. Appropriate monitoring and, if necessary, dose adjustment by the doctor is recommended.
• Certain medicines for gout (e.g. probenecid, benzbromarone).
  Possible weakening of the effect of gout medicines. It is recommended to use another painkiller.
• Drugs for diabetes (e.g. insulin, sulphonylureas): hypoglycaemia may occur due to an increase in effect. More frequent
  blood glucose self-monitoring is recommended.
• Certain medicines for dehydration and lowering blood pressure (diuretics): there is a risk of severe kidney dysfunction. If taken at the same time, make sure to drink enough fluids. With certain dehydrating agents (e.g. furosemide), the
  blood pressure-lowering effect may be weakened, so blood pressure controls are recommended.
• Medicines containing cortisone or cortisone-like substances (with the exception of products applied to the skin or hydrocortisone in cortisone replacement therapy for Addison's disease): increased risk of side effects (bleeding or ulcers) in the gastrointestinal tract.
• Certain medicines for high blood pressure (antihypertensives) and/or cardiac insufficiency ("ACE inhibitors", aldosterone antagonists): there is a risk of severe kidney dysfunction, and the
  blood pressure-lowering effect may also be reduced. If taken at the same time, make sure to drink enough fluids. Blood pressure checks are recommended.
• Certain medicines for epilepsy (valproic acid): There is a risk of increased (side) effects of valproic acid.
• Locally active gastrointestinal preparations: magnesium, aluminium and calcium salts, oxides and hydroxides.

Please further note that:
Aspirin 500 mg Chewable Tablets in higher doses may alter the results of laboratory tests, so inform your doctor about taking Aspirin 500 mg Chewable Tablets.

Taking Aspirin 500 mg Chewable Tablets with alcohol.
Please avoid drinking alcohol during the treatment period with Aspirin 500 mg Chewable Tablets, it could increase the side effects of the medicine (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy, lactation and procreation/parturition
If you are pregnant or breast-feeding, or if you suspect you are pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Pregnancy:
First and second trimester:
During the first six months of pregnancy and if you wish to have a child, you should only take Aspirin 500 mg Chewable Tablets after consulting your doctor. The dose should be kept low and the treatment as short as possible.

Third trimester:
During the last three months of pregnancy, you must not take Aspirin 500 mg Chewable Tablets.
Do not take because of an increased risk of complications for mother and child.
Due to the acetylsalicylic acid component, there is a risk of developmental disorders in the unborn child (maldevelopment of the circulatory system and/or kidney dysfunction up to kidney failure).
During birth, there may be increased bleeding in the mother and child and delay/prolongation of the birth process.

Breastfeeding time:
The active substance acetylsalicylic acid and its degradation products pass into breast milk in small amounts. With short-term use of Aspirin 500 mg Chewable Tablets and low dose, interruption of breast-feeding will not be necessary. With prolonged use However, if you are taking high doses, you should stop breastfeeding.

Breeding ability:
Aspirin 500 mg chewable tablets belong to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible after discontinuation of the medicinal product.

Driving ability and ability to operate machinery.
Aspirin 500 mg Chewable Tablets have no or negligible effect on the ability to drive and use machines.

Nevertheless, do not drive vehicles or use dangerous tools or machinery if your attention is impaired - such as by possible
Side effects such as drowsiness, headache, dizziness or confusion.

Aspirin 500 mg chewable tablets contain aspartame, sodium and the colour E110.

Aspirin 500 mg chewable tablets contain the artificial sweetener aspartame and are therefore suitable for diabetics.

Aspirin 500 mg chewable tablets contain aspartame as a source of phenylalanine and may be harmful if you have phenylketonuria.

1 Aspirin 500 mg chewable tablet contains 32 mg sodium. If you are on a low salt diet
you must comply with, you should take this into account.

This medicinal product contains the dye E 110 (yellow orange S), which may cause allergic reactions.

How should the medicine be taken?

HOW TO TAKE ASPIRIN 500 MG CAUTABLETTEN?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:

Adults and adolescents aged 12 years and over:
Single dose: 1 - 2 chewable tablets (corresponding to 500 mg - 1000 mg acetylsalicylic acid).
Daily dose: 3 - maximum 6 chewable tablets (corresponding to 1500 - 3000 mg acetylsalicylic acid).
The maximum daily dose of 6 chewable tablets (corresponding to 3000 mg acetylsalicylic acid) must not be exceeded.
Use in children under 12 years of age:
Medicines containing ASA (such as Aspirin 500 mg Chewable Tablets) must only be given to children under 12 years of age on a doctor's prescription.
Aspirin 500 mg chewable tablets are not suitable for children, as children's doses are not possible with this dosage form.

Type of application
For ingestion (chewing).
Aspirin 500 mg chewable tablets are tablets to chew. They can be taken without or with water. Do not take on an empty stomach.
For patients lying down, the tablets should be taken with a generous amount of liquid.

Duration of use
The single dose may be taken at 4-8 hour intervals up to 3 times daily, if necessary. However, the total daily dose of a maximum of 6 tablets must not be exceeded.

Aspirin 500 mg chewable tablets must not be taken for more than 3-4 days for pain and for more than 3 days for fever without a doctor's prescription. If pain or fever persist during this time or even get worse, if new symptoms appear (e.g. redness or swelling), you must consult your doctor as these may be signs of a serious illness.

Special patient groups:
Olderly persons (65 years and over) and underweight persons:
In elderly patients, special caution is indicated because of possible concomitant diseases or underweight (see sections "Aspirin 500 mg Chewable Tablets must not be taken" and "Warnings and precautions"). In particular, it is recommended to use the lowest effective dose in elderly and underweight people.

Patients with liver dysfunction:
If you suffer from liver dysfunction, the dose must be reduced or the time interval between two doses must be extended. You must not take Aspirin 500 mg Chewable Tablets if you have severe liver dysfunction.

Patients with renal dysfunction:
If you suffer from renal dysfunction, the dose must be reduced or the time interval between two doses must be extended. You must not take Aspirin 500 mg Chewable Tablets if you have severe kidney dysfunction.

If you have taken more Aspirin 500 mg Chewable Tablets than you should
Overdoses can be dangerous, especially for elderly patients and young children.
Overdoses can be dangerous, particularly for elderly patients and especially for young children (overdoses in the course of treatment or accidental poisoning can be fatal).

Discomfort in case of moderate poisoning:
Noise in ears, hearing disturbances, sweating, nausea, vomiting, headache and dizziness. Symptoms of severe poisoning:
Fever, accelerated breathing, unconsciousness (coma), life-threatening shock, respiratory failure, severe drop in blood sugar.

If you suspect an overdose with Aspirin 500 mg Chewable Tablets, please notify a doctor immediately. This person can decide on the measures that may be necessary according to the severity of an overdose/poisoning. Poisoning with aspirin 500 mg chewable tablets can be life-threatening.

For more information for healthcare professionals, see the relevant section at the end of the leaflet.

If you have forgotten to take Aspirin 500 mg Chewable Tablets
Do not take twice the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

HOW TO STORE ASPIRIN 500 MG CAUTABLETS?

Do not store above 30 °C.

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton/film after "Use by". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. HOW TO STORE ASPIRIN 500 MG CAUTABLETS?

Do not store above 30°C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/film after "EXP". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. In this way, they contribute to the protection of the environment.

Special notes on the content

PACKAGE CONTENTS AND FURTHER INFORMATION

What Aspirin 500 mg Chewable Tablets contain

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• The active ingredient is acetylsalicylic acid.
  1 chewable tablet contains 500 mg acetylsalicylic acid (ASA).
• The other ingredients are calcium stearate, maize starch, mannitol, aspartame, ascorbic acid, citric acid, magnesium carbonate, starch, sodium carbonate, sodium carboxymethyl cellulose, special dry flavouring, mandarin juice flavouring, orange flavouring, yellow orange S (E110).

What Aspirin 500 mg Chewable Tablets look like and contents of the pack
Aspirin 500 mg chewable tablets are yellow-orange chewable tablets embossed with "Aspirin D" on one side and the Bayer Cross on the other, available in packs of 10.