Aspirin 500mg, 20 tablets

active ingredients

• 500 mg acetylsalicylic acid

ingredients

• Zinc(stearate, palmitate, oleate)
• hypromellose
• carnauba wax
• Silica, colloidal
• Silica, colloidal
• sodium

Indication :

• The medicine contains acetylsalicylic acid (Ph.Eur.) and is an analgesic and antipyretic medicine. The preparation is used for the symptomatic treatment of fever and/or mild to moderate pain, e.g. B. Headaches, pain in the context of a flu infection, toothache and muscle pain.

• The medicine is intended for use in adults and adolescents aged 12 years and over (weighing 40 kg and over). Ask your doctor or pharmacist about other medicines containing acetylsalicylic acid for patients weighing less than 40 kg. If you do not feel better after 3 days (applies to fever) or 3-4 days (applies to pain), you must contact your doctor.

Dosage :

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• dosage

  • Use in adults and adolescents (from 16 years of age)

    • The recommended single dose is 1 tablet; if necessary, the dose can be repeated at intervals of at least 4 hours.

    • For higher fever or more severe pain, the recommended single dose is 2 tablets; this dose can also be repeated at least 4 hours apart if necessary.

    • The total daily dose must not exceed 6 tablets.

  • Use in elderly patients (over 65 years of age)

    • The recommended single dose is 1 tablet, if necessary the dose can be repeated at least 4 hours apart.

    • The total dose must not exceed 4 tablets.

  • Use in adolescents aged 12-15 years (body weight 40-50 kg):

    • The dosage depends on the adolescent’s body weight; age is for informational purposes only.

    • The recommended single dose is 1 tablet, if necessary the dose can be repeated at least 4 hours apart.

    • The total daily dose must not exceed 6 tablets.

  • Use in special patient groups

    • Patients with impaired liver or kidney function or with circulatory problems (e.g. heart failure or significant bleeding): Consult your doctor or pharmacist for advice.

    • Children under 12 years (weighing less than 40 kg): Do not use without a doctor's prescription.

• Do not take this medicine for more than 3 days (for fever) or 3-4 days (for pain), unless directed to do so by your doctor.

• If you take more than you should

  • It is possible that symptoms such as ringing in the ears, hearing loss, headache or dizziness may occur during treatment; these are typical signs of an overdose

  • If you suspect an overdose, stop taking it and contact a doctor immediately.

• If you forgot the application

  • Do not take a double dose to make up for a forgotten dose. If you have any further questions about the intake, ask your doctor or pharmacist.

way :

• To take. Swallow the tablet with plenty of liquid.

Side effects :

• Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Frequencies:

  • Not known; Frequency cannot be estimated from the available data.

  • All of these side effects are very serious and may require urgent medical attention or hospitalization. Tell your doctor or go to the nearest hospital straight away if you notice any of the following:

    • Bleeding (nosebleeds, bleeding gums, red spots under the skin, etc.)

    • allergic reactions such as B. skin rash, asthma attack or swelling of the face associated with breathing problems

    • headache, dizziness, hearing loss, ringing in the ears (tinnitus); such symptoms are usually signs of an overdose

    • cerebral hemorrhage

    • stomach pain

    • gastrointestinal bleeding. These side effects are particularly common with high doses.

    • Increase in liver enzymes, which largely return to normal after stopping treatment, hepatic dysfunction (mainly liver cells are affected).

    • Hives (urticaria), skin reactions

    • Reye's syndrome (depressed level of consciousness, abnormal behavior or vomiting) in a child with a viral disease who has taken acetylsalicylic acid.

• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions :

• Taking together with other medicines

  • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. The following definitions are used in the further text:

    • Acetylsalicylic acid is used to treat rheumatic diseases in high doses (so-called "anti-inflammatory" doses); these are defined as follows: 1 g or more as a single dose and/or 3 g or more per day.

    • Acetylsalicylic acid is used to treat pain and fever in the following doses: 500 mg or more in a single dose and/or a maximum of 3 g per day.

    • The drug must not be used;

      • if you are being treated with methotrexate at doses greater than 20 mg per week. In this case, acetylsalicylic acid must not be used in high doses and not to treat pain and fever.

      • if you are being treated with oral anticoagulants (oral anticoagulants) or have ever had a stomach or duodenal ulcer. In this case, acetylsalicylic acid must not be used in high (anti-inflammatory) doses and not to treat fever and pain.

  • Talk to your doctor or pharmacist before using acetylsalicylic acid with any of the following medicines:

    • Oral anticoagulants (oral anticoagulants) if acetylsalicylic acid is used to treat pain and fever and you have had a stomach or duodenal ulcer.

    • nonsteroidal anti-inflammatory drugs when acetylsalicylic acid is used in high (anti-inflammatory) doses or to treat pain and fever.

    • Heparins when used in curative doses or in elderly patients (>/= 65 years) when acetylsalicylic acid is used in high (anti-inflammatory) doses, especially to treat pain and fever.

    • Medicines used to dissolve blood clots (thrombolytics).

    • clopidogrel

    • ticlopidine

    • Uric acid-lowering drugs (uricosurics) used to treat gout (e.g. benzbromarone, probenecid)

    • Glucocorticoids (other than hydrocortisone replacement therapy) when acetylsalicylic acid is used in high (anti-inflammatory) doses.

    • Pemetrexet in patients with mild to moderate renal impairment

    • anagrelide

    • medicines that drain water (diuretics)

    • Angiotensin converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists

    • Methotrexate in doses up to 20 mg per week

    • Drugs for topical treatment of gastrointestinal disorders, antacids and activated charcoal

    • deferasirox

    • selective serotonin reuptake inhibitors (eg, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)

  • To avoid possible drug interactions, you should also tell your doctor or pharmacist about any other medicines you are taking.

• Consumed with alcohol

  • The drug must not be taken together with alcohol.

Contraindications :

• The medicine must not be taken

  • if you are allergic to acetylsalicylic acid or other salicylates or any of the other ingredients of this medicine.

  • if you have had an allergic reaction (e.g. hives, angioedema, severe runny nose, shock) to acetylsalicylic acid or a similar medicine (especially non-steroidal anti-inflammatory drugs) in the past with asthma or an allergic reaction.

  • if you have an ulcer in your stomach or intestines (including duodenal ulcer).

  • if you bleed frequently or are at increased risk of bleeding.

  • if you have severely reduced kidney, liver or heart function.

  • if you are being treated with methotrexate at doses greater than 20 mg/week.

  • if you are being treated with oral anticoagulants (medicines that thin the blood and prevent clotting).

  • After the 5th month of pregnancy (it has been more than 24 weeks since your last menstrual period).

• If you are not sure whether you can use this medicine, ask your doctor or pharmacist.

Pregnancy and lactation :

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• pregnancy

  • In the first five months of pregnancy you should only use this medicine or any other product containing acetylsalicylic acid after consulting your doctor. If you are more than 6 months pregnant (if it is more than 24 weeks since your last menstrual period) you must under no circumstances use this medicine as this may cause serious harm to you or your baby.

  • If you have taken this medicine while pregnant, contact your doctor immediately.

• lactation

  • This medicine can pass into breast milk. As a precaution, use is not recommended during breastfeeding.

• childbearing

  • This product belongs to a group of medicines that may affect a woman's ability to become pregnant. This effect disappears after stopping the drug.

Patient Notes :

• Warnings and Precautions

  • Talk to your doctor or pharmacist before taking this medicine

    • if you are being treated with other products containing acetylsalicylic acid to avoid overdose.

    • if you have taken high doses of acetylsalicylic acid for a long time and headaches occur with this treatment; do not increase the dose, but seek advice from your doctor or pharmacist.

    • if you regularly use painkillers, especially if you combine several painkillers at the same time; this can lead to impaired kidney function.

    • if you suffer from G6PD deficiency (decrease in the enzyme glucose-6-phosphate dehydrogenase); in this inherited disease that affects red blood cells, higher doses of acetylsalicylic acid can lead to destruction of red blood cells (haemolysis).

    • if you have ever had an ulcer in your stomach or intestines, bleeding in your stomach or intestines or inflammation of the lining of the stomach (gastritis).

    • if you have impaired kidney or liver function.

    • if you have asthma; in some patients the onset of asthma attacks may be due to allergic reactions to nonsteroidal anti-inflammatory drugs or to acetylsalicylic acid. In this case, the use of this medicine is not recommended.

    • if you have heavy menstrual bleeding.

    • if bleeding in the gastrointestinal tract occurs during treatment (hemorrhage, blood in the stool, blackening of the stool); in this case you must stop the treatment and call your doctor or an emergency medical service immediately.

    • if you are also taking medicines that thin the blood and prevent it from clotting (anticoagulants).

    • Even in small doses, acetylsalicylic acid increases the risk of bleeding. This also applies if the intake was several days ago. Tell your doctor, surgeon, anesthesiologist or dentist if you are going to have an operation; this also applies to small operations.

    • Acetylsalicylic acid changes the concentration of uric acid in the blood; this must be taken into account if you are taking medicines for gout.

    • The use of this medicine during breast-feeding is not recommended.

  • Children

    • Reye's syndrome (a rare but very serious disease causing mainly neurological and hepatic damage) has been observed in children with viral diseases treated with acetylsalicylic acid. For this reason:

      • should acetylsalicylic acid be used in children with a viral disease such as B. flu or chickenpox should only be used after consulting a doctor;

      • the doctor must be informed immediately if dizziness or fainting, unusual behavior or vomiting is observed in a child that has contained acetylsalicylic acid.

• Ability to drive and use machines

  • Acetylsalicylic acid has no influence on the ability to drive and use machines.

The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine with liquid (e.g. 1 glass of water). You can also give the medicine mixed with water to make it easier to take.

Duration of use?
You should not use the drug for more than 3-4 days without medical advice.

overdose?
An overdose can cause dizziness, ringing in the ears, blurred vision and breathing disorders. If you suspect an overdose, contact a doctor immediately.

Forgot to take?
Continue taking it as normal (i.e. not double the amount) at the next prescribed time.

In general, pay attention to a conscientious dosage, especially for babies, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Ulcers in the digestive tract, such as
- Increased bleeding tendency
- Kidney failure
- Liver failure

Under certain circumstances - talk to your doctor or pharmacist:
- Stomach or duodenal problems that are chronic and recurring
- Bronchial asthma
- Heart diseases that are not controlled by medication
- Restricted kidney function
- Restricted liver function
- Tendency to gout attacks

Which age group should be considered?
- Children under 12 years of age: The medicine may only be used after consulting a doctor or under medical supervision.

What about pregnancy and lactation?
- Pregnancy: According to current knowledge, the drug should not be used.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

What adverse effects may occur?

- Gastrointestinal complaints, such as:
  - heartburn
  - nausea
  - vomiting
  - stomach pain
  - ulcers in the digestive tract, which can very rarely break through
- microbleeding (barely visible or noticeable bleeding from the smallest vessels), especially in the gastrointestinal area
- Allergic reactions, especially in asthmatics, such as:
  - hypersensitivity reactions of the skin
  - attacks of shortness of breath
- bleeding, such as nosebleeds, bleeding gums, with possible prolonged bleeding times
For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Storage

The medicinal product must be stored away from heat.

What should you consider?
- In case of pain or fever, do not use longer than specified in the leaflet without medical advice!
- With long-term use of painkillers, headaches caused by the painkiller can occur. Talk to your doctor to prevent your headache from becoming chronic.
- The habitual use of painkillers can lead to permanent kidney damage. If several painkillers are combined, or if one painkiller contains several active ingredients, the risk increases.
- In children and adolescents with febrile illnesses, the drug may only be given on medical advice. It can cause something called Reye's syndrome, a rare but life-threatening condition that causes prolonged vomiting.
- Caution: Patients with nasal polyps, chronic respiratory infections, asthma or people who are prone to allergic reactions such as hay fever: the drug can trigger an asthma attack or a severe allergic skin reaction. Therefor consult your doctor before usage.
- Before an operation - this also includes minor interventions such as tooth extraction - state how you are taking/using the medicine, as the bleeding time may be longer.
- Be careful if you are allergic to zinc!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.
- Consumption of alcohol should be avoided as far as possible during long-term treatment . Occasional alcohol consumption in small amounts is allowed, but not with the drug.

How does the ingredient of the medicine work?

The active ingredient has analgesic, antipyretic and anti-inflammatory at the same time. It blocks the formation of certain messenger substances in the body, so-called prostaglandins. These are significantly involved in the development of pain, fever and inflammation.
Blood clotting is also affected by acetylsalicylic acid. The substance prevents the platelets (thrombocytes) from clumping together and thus improves the flow of the blood.

What is included in medicines?

Manufacturer: Bayer Vital GmbH