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ASPIRIN Direct chewable tablets, acetylsalicylic acid

Bayer Vital GmbH

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Aspirin® direct chewable tablets



Active ingredient: acetylsalicylic acid

Areas of application: Mild to moderate pain such as headaches; toothache; period pains; painful symptoms that occur as part of colds (e.g. headache, sore throat and body aches); Fever. Please note the information for children.

Notes: The dye yellow orange S (E110) can cause hypersensitivity reactions. Contains aspartame. Note leaflet.

For risks and side effects, read the leaflet and ask your doctor or pharmacist. In case of pain or fever, do not use longer than specified in the leaflet without medical advice!

In case of pain or fever, do not use longer than specified in the leaflet without medical advice!

For a quick and well-tolerated effect on headaches

In case of pain or fever, do not use longer than specified in the leaflet without medical advice.

active ASPIRIN Direct chewable tablets, acetylsalicylic acid ingredients

  • 500 mg acetylsalicylic acid

ASPIRIN Direct chewable tablets, acetylsalicylic acid excipients

  • mannitol
  • magnesium carbonate
  • Starch, pregelatinized
  • citric acid
  • cornstarch
  • carmellose sodium
  • sodium
  • ascorbic acid
  • 16.5 mg aspartame
  • Calcium(palmitate,stearate)
  • Yellow Orange S
  • Flavorings, natural, nature-identical

ASPIRIN Direct chewable tablets, acetylsalicylic acid indication

  • The drug is an analgesic, antipyretic and anti-inflammatory drug (non-steroidal anti-inflammatory drug/analgesic).
  • The medicine is used for:
    • mild to moderately severe pain such as headaches, toothaches, menstrual pains, painful symptoms that occur in the context of colds (e.g. headaches, sore throats and body aches).
    • Fever.
  • If you do not feel better or if you feel worse after 4 days, contact your doctor.

ASPIRIN Direct chewable tablets, acetylsalicylic acid dosage

  • Always take the medicine exactly as described. Please check with your doctor or pharmacist if you are not sure.
  • dosage
    • The recommended dose is:
      • Children from 12 years
        • Single dose: 1 chewable tablet
        • Total daily dose: up to 3 chewable tablets
      • teenagers and adults
        • Single dose: 1 - 2 chewable tablets
        • Total daily dose: 3 - 6 chewable tablets

 

  • duration of use
    • If necessary, the single dose can be taken at intervals of 4 - 8 hours up to 3 times a day.
    • However, the total daily dose must not be exceeded.
    • Do not take the medicine for more than 4 days without medical or dental advice.

 

  • If you take more than you should
    • Ringing in the ears (tinnitus), hearing disorders, sweating, nausea, vomiting, headaches and dizziness can be signs of severe poisoning, especially in children and elderly patients.
    • If you suspect an overdose, please notify your doctor immediately.
    • Depending on the severity of an overdose/poisoning, the doctor can decide on the measures that may be required.

 

  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

ASPIRIN Direct chewable tablets, acetylsalicylic acid way

  • Chew the chewable tablets.
  • If desired, some liquid can be drunk afterwards, this promotes the onset of the effect.
  • You should not take the chewable tablets on an empty stomach.

side effects

  • Like all medicines, this medicine can cause side effects, although not everyone gets them.
  • The list of the following undesirable effects includes all known side effects from treatment with acetylsalicylic acid, including those from high-dose long-term therapy in rheumatism patients. The frequency information, which goes beyond individual cases, refers to short-term use of up to daily doses of a maximum of 6 chewable tablets.
  • Common (affects 1 to 10 users in 100)
    • Gastrointestinal complaints such as heartburn, nausea, vomiting, abdominal pain.
  • Uncommon (affects 1 to 10 users in 1000)
    • Hypersensitivity reactions such as skin reactions.
  • Rare (affects 1 to 10 users in 10,000)
    • serious bleeding such as B. bleeding in the brain, especially in patients with uncontrolled high blood pressure and / or simultaneous treatment with anticoagulants (anticoagulants), which can potentially be life-threatening in individual cases.
    • Gastrointestinal bleeding, which very rarely can lead to iron deficiency anemia. If you develop black stools or vomit blood, which can be signs of severe stomach bleeding, you must contact your doctor immediately.
    • Gastrointestinal ulcers, which very rarely can lead to perforation.
    • Hypersensitivity reactions of the respiratory, gastrointestinal and cardiovascular systems, especially in asthmatics. The following symptoms can occur: e.g. B. drop in blood pressure, attacks of shortness of breath, inflammation of the nasal mucosa, nasal congestion, allergic shock, swelling of the face, tongue and larynx (Quincke's edema).
    • Hypersensitivity reactions such as severe skin reactions (including severe feverish skin rashes involving the mucous membranes [erythema multiforme]).
    • Gastrointestinal inflammation.
  • Very rare (less than 1 in 10,000 people treated)
    • Elevations in liver values.
  • Not known (cannot be estimated from the available data)
    • Accelerated degradation or disintegration of red blood cells and a certain form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
    • Renal dysfunction and acute renal failure.
    • bleeding such as B. nosebleeds, bleeding gums, skin bleeding or bleeding of the urinary tract and the genitals with a possible prolongation of the bleeding time. This effect can last for 4 to 8 days after ingestion.
    • Headaches, dizziness, impaired hearing, ringing in the ears (tinnitus) and mental confusion may be signs of an overdose.
  • If you notice any of the above side effects, you should stop taking the medicine.
  • Notify your doctor so he can decide on the severity and any further action that may be needed.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

ASPIRIN Direct chewable tablets, acetylsalicylic acid interactions

  • Taking with other medicines
    • Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
    • The effect of the medicinal substances or groups of preparations listed below can be influenced if they are treated with the preparation at the same time.
    • Enhancement of the effect up to an increased risk of side effects:
      • Anticoagulants (e.g. coumarin, heparin) and blood clot-dissolving medicines: acetylsalicylic acid may increase the risk of bleeding if taken before clot-dissolving treatment. Therefore, if you are about to have such treatment, you must be alert for signs of external or internal bleeding (e.g. bruising).
      • Medicines that stop blood platelets from sticking and clumping together (antiplatelets), e.g. B. ticlopidine, clopidogrel: increased risk of bleeding.
      • Other pain and anti-inflammatory drugs (non-steroidal analgesics / anti-inflammatory drugs) at doses of 6 chewable tablets per day and more: increased risk of ulcers and bleeding in the gastrointestinal area.
      • Medicines containing cortisone or cortisone-like substances (except for products applied to the skin or used in cortisone replacement therapy for Addison's disease): increased risk of gastrointestinal side effects.
      • Alcohol: the risk of gastrointestinal ulcers and bleeding is increased.
      • digoxin (medicine to strengthen the heart).
      • Blood sugar-lowering medicines (antidiabetics): the blood sugar level can drop.
      • Methotrexate (medicine used to treat cancer or certain rheumatic diseases).
      • valproic acid (medicine used to treat seizures of the brain [epilepsy]).
      • Selective serotonin reuptake inhibitors (certain medicines used to treat depression): the risk of bleeding in the gastrointestinal tract increases.
    • Weakening of the effect:
      • Diuretics (medicines to promote urine excretion) at dosages of 6 chewable tablets per day and more.
      • ACE inhibitors (certain antihypertensive drugs) at dosages of 6 chewable tablets per day and more.
      • Uric acid excreting gout medicines (e.g. probenecid, benzbromarone).
  • Consumed with alcohol
    • Alcohol increases the risk of gastrointestinal ulcers and bleeding.

Contraindications

  • The medicine must not be taken
    • if you are allergic to acetylsalicylic acid, other salicylates or any of the other ingredients;
    • if you have had an asthma attack or other hypersensitivity to certain medicines for pain, fever or inflammation (salicylates or other nonsteroidal anti-inflammatory drugs) in the past;
    • in acute gastric and intestinal ulcers;
    • with a pathologically increased tendency to bleed;
    • in liver and kidney failure;
    • if you have severe heart muscle weakness that is not controlled by medication (heart failure);
    • if you are simultaneously taking 15 mg or more methotrexate per week;
    • in the last 3 months of pregnancy.

pregnancy ASPIRIN Direct chewable tablets, acetylsalicylic acid and breast feeding period

  • 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 taking this medicine.
  • pregnancy
    • You should not take the preparation in the first and second trimester of pregnancy. Therefore, be sure to consult your doctor before taking it.
    • In the last three months of pregnancy you must not take acetylsalicylic acid, the active substance of the preparation, because of an increased risk of complications for mother and child before and during birth.
  • lactation
    • Small amounts of the active ingredient acetylsalicylic acid and its breakdown products pass into breast milk. Since adverse consequences for the infant have not yet become known, it is not necessary to interrupt breastfeeding if the recommended dose is used occasionally. However, you should stop breast-feeding if you use it for a long time or if you take high doses.
  • childbearing
    • This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible after stopping the drug.

patient ASPIRIN Direct chewable tablets, acetylsalicylic acid notes

  • Warnings and Precautions
    • Please talk to your pharmacist before taking this medicine:
      • if you are hypersensitive to other painkillers (analgesics) / anti-inflammatories (antiphlogistics) / certain medicines for rheumatism (antirheumatics) or other allergy-causing substances;
      • if you have allergies (e.g. with skin reactions, itching, nettle fever), asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or chronic respiratory diseases;
      • with simultaneous treatment with anticoagulant drugs;
      • if you have a history of gastric or intestinal ulcers or gastrointestinal bleeding;
      • with impaired liver function;
      • if you have impaired kidney function or reduced heart and vascular blood flow (e.g. vascular disease of the kidneys, heart muscle weakness, reduction in blood volume, major surgery, blood poisoning or heavy bleeding): acetylsalicylic acid can further increase the risk of kidney dysfunction and acute kidney failure;
      • before operations (including minor procedures such as tooth extraction); there may be an increased tendency to bleed. Please tell your doctor or dentist if you have taken this medicine
      • in patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated breakdown or disintegration of red blood cells or a certain form of anemia. This risk can be due to factors such as B. high dosage, fever or acute infections.
    • If painkillers are taken over the long term, headaches can occur, which can lead to taking them again, which in turn can cause the headaches to persist.
    • The habitual use of painkillers can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). This risk is particularly high if you take several different painkillers in combination.
    • Acetylsalicylic acid reduces uric acid excretion in low doses. In patients who are at risk, this can possibly trigger a gout attack.
    • children and young people
      • The drug should only be used in children and adolescents with febrile illnesses on medical advice and only if other measures are ineffective. Prolonged vomiting associated with these conditions may be a sign of Reye's Syndrome, a very rare but life-threatening condition that requires immediate medical attention.

 

  • Driving and using machines
    • There are no special precautions required.