Aspirin Direct 500 mg granules 20 sachets

Aspirin Direkt contains the active ingredient acetylsalicylic acid (ASA). This has an analgesic, antipyretic and anti-inflammatory effect.

When is Aspirin Direct used?
Symptomatic treatment of mild to moderate pain such as headaches, toothache and menstrual pain.
For the relief of pain and fever in colds and flu-like infections.
If you do not feel better or even worse with pain after 3-4 days and with fever after 3 days, when new symptoms appear (for example, redness or swelling), it is imperative to consult a doctor, as these can be signs of a serious illness.
Aspirin Direct is used in adults and adolescents over 12 years of age. Please note the information for children (see point 2).

Contraindications

Do not take Aspirin Direct,

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

Aspirin Direct should not be given to children under one year of age.

Interactions

The effect of the following drugs or groups of preparations can be influenced by simultaneous treatment with Aspirin Direct.
If you are taking methotrexate (medicines used to treat cancer or certain rheumatic diseases) at doses of 15 mg/week or more, do not take Aspirin Direct.
If you are taking anticoagulants (medicines to "thin the blood"), you must not take Aspirin Direkt in high doses.

Combinations that require special care:

• Methotrexate at doses below 15 mg/week (medicines used to treat cancer or certain rheumatic diseases) - there is a risk of increased (side) effects of methotrexate.
• Anticoagulant medicines, blood clot-dissolving medicines/other medicines that inhibit platelets sticking together and clumping together (antiplatelet agents)/medicines to inhibit hemostasis (haemostasis inhibitors) - bleeding can occur due to increased action. Aspirin Direct may increase the risk of bleeding if taken before a treatment designed to dissolve blood clots. Therefore, you need to pay close attention to signs of external or internal bleeding (for example, bruising) if you are to undergo such treatment. A medical check-up is absolutely necessary.
• Other analgesic and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs) at high doses of acetylsalicylic acid: increased risk of ulcers and bleeding in the gastrointestinal tract; an overdose is also possible.
• Certain medicines used to treat depression (selective serotonin reuptake inhibitors): the risk of bleeding in the gastrointestinal tract increases.
• Certain medicines for the treatment of cardiac insufficiency and for the treatment of certain cardiac arrhythmias (digoxin): Enhancement 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 (eg, probenecid, benzbromarone). Weakening of the effect of gout remedies possible. It is recommended to use another painkiller.
• Medicines for diabetes (e.g. insulin, sulfonylureas): hypoglycaemia can occur due to increased effect. More frequent blood glucose self-checks are recommended.
• Certain medicines for dehydration and lowering blood pressure (diuretics): there is a risk of severe renal dysfunction. When taken at the same time, it is important to ensure sufficient fluid intake. Certain dehydrating agents (e.g. furosemide) may weaken the antihypertensive effect, so blood pressure checks 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 renal dysfunction and the antihypertensive effect may also be reduced. When taken at the same time, it is important to ensure sufficient fluid intake. Blood pressure checks are recommended.
• Certain medicines for epilepsy (valproic acid): There is a risk of increased (side) effects of valproic acid.

Please also note that:
Aspirin Direct in higher doses may alter the results of laboratory tests, so inform your doctor about taking Aspirin Direct.

Taking Aspirin Direct together with alcohol
Please avoid drinking alcohol during the treatment period with Aspirin Direct, it could increase the side effects of the drug (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy, breastfeeding and reproductive function
If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Pregnancy:First and second trimester of pregnancy:
During the first six months of pregnancy and if you want to have children,
you should only take Aspirin Direkt after consulting your doctor. The aim is to keep the dose low and the treatment as short as possible.
Third trimester of pregnancy: In the last three months of pregnancy,
you must not take Aspirin Direkt because of an increased risk of complications for both mother and baby.
Due to the acetylsalicylic acid component, there is a risk of developmental disorders in the unborn child (malformations in the circulatory system and/or renal dysfunction up to kidney failure).
During childbirth, there may be increased bleeding in mother and child and delay/prolongation of the birth process.

Lactation:
The active ingredient acetylsalicylic acid and its degradation products are excreted in breast milk in small quantities. With short-term use of Aspirin Direct and low dose, interruption of breastfeeding will not be necessary. However, if you use or take high doses for a longer period of time, you should stop weaning.

Reproductive function:
Aspirin Direct belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect women's fertility. This effect is reversible (reversible) after discontinuation of the drug.

Aspirin Direct contains aspartame and sodium
This medicine contains 5 mg of aspartame per sachet as a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare congenital condition in which phenylalanine builds up because the body can't break it down sufficiently.
This medicinal product contains 19 mg (1 sachet) or 38 mg (2 sachets) of sodium (the main ingredient in table salt). This corresponds to 0.95% and 1.9% of the maximum daily dietary sodium intake recommended for an adult, respectively

Application

Always take Aspirin Direkt exactly as described in this leaflet or exactly as your doctor has told you. Please check with your doctor or pharmacist if you are unsure.
Unless otherwise prescribed by the doctor, the usual dose is:

Age: Adults and adolescents aged 12 and
over Single dose: 1–2 sachets of granules (equivalent to 500 mg – 1000 mg acetylsalicylic acid)Total daily dose: 3 – maximum 6 sachets of granules (equivalent to 1500 – 3000 mg acetylsalicylic acid) The maximum daily dose of 6 sachets of granules (equivalent to 3000 mg acetylsalicylic acid)
must not be exceeded.

Use in children under 12 years of age:
Medicines containing ASA (such as aspirin direct) should only be given to children under 12 years of age with a doctor's prescription.
Aspirin Direkt is not suitable for children, as children's dosages are not possible with this dosage form.

Method of administration For oral use
.
Put Aspirin Direct granules in the mouth directly on the tongue. The granules dissolve in saliva and can then be swallowed. If desired, some liquid can be drunk afterwards.
Do not take on an empty stomach.

Duration of use
The single dose, if necessary, can be taken at intervals of 4-8 hours up to 3 times a day.
However, the total daily dose of a maximum of 6 sachets of granules must not be exceeded.
Aspirin Direct can be taken for no more than 3-4 days in case of pain and no more than 3 days in case of fever without a doctor's order. If pain or fever persists during this time, or even gets worse when new symptoms appear (such as redness or swelling), you need to see your doctor, as these may be signs of a serious illness.

Special patient groups:Elderly people (65 years of age and older) and underweight people:

In elderly patients, special caution should be exercised due to possible comorbidities or underweight (see sections "Do not take Aspirin Direct" and "Warnings and precautions"). In particular, it is recommended to use the lowest effective dose in the elderly and underweight.
Patients with hepatic impairment:
If they suffer from hepatic impairment, the dose must be reduced or the interval between two doses must be extended. In case of severe liver dysfunction, you must not take Aspirin Direct.
Patients with renal impairment:
If you suffer from renal impairment, the dose must be reduced or the interval between two doses must be extended. In case of severe renal dysfunction, you must not take Aspirin Direct.

Side effects

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

The following side effects are possible and listed according to their frequency:

Common (may affect up to 1 in 10 people): gastrointestinal
complaints such as heartburn, nausea, vomiting, abdominal pain.

Uncommon (may affect up to 1 in 100 people):
Hypersensitivity reactions, such as skin reactions.
Redness of the skin, hives (urticaria), itching.

Rare (may affect up to 1 in 1,000 people):
Hypersensitivity reactions of the respiratory, gastrointestinal and cardiovascular systems, especially in asthma patients. Signs of a hypersensitivity reaction may include: drop in blood pressure, bouts of shortness of breath, runny nose, nasal congestion, life-threatening shock or swelling of the skin and mucous membrane.
Severe skin reactions such as rash with redness, blistering and peeling of the skin.
Gastrointestinal inflammation, gastrointestinal ulcers, gastrointestinal bleeding, which very rarely can lead to anemia due to iron deficiency.
Breakthrough of a gastrointestinal ulcer, especially in elderly patients. In case of abdominal pain, blackening of the stool, vomiting of blood or vomiting like coffee grounds, discontinue aspirin directly and inform the doctor immediately.

Rare to very rare:
Serious haemorrhages such as cerebral haemorrhage, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulant medicines, have been reported, which can be life-threatening in individual cases.

Very rare (may affect up to 1 in 10,000 people):
drop in blood sugar.
Acetylsalicylic acid reduces uric acid excretion in low doses. In patients at risk for this, this can trigger a gout attack under certain circumstances.

Not known (frequency cannot be estimated from the available data):
Anemia due to blood loss or decay, decay of red blood cells.
Drug hypersensitivity, allergic swelling and swelling of the skin and mucous membrane, severe allergic reaction up to life-threatening shock.
Cerebral hemorrhage and cranial hemorrhage.
Dizziness, headaches, impaired hearing, ringing in the ears and mental confusion can already be signs of an overdose.
Shortness of breath caused by heart disease.
Bleeding with prolonged bleeding time such as nosebleeds, bleeding gums, skin bleeding, bleeding of the urinary and genital organs (genitourinary tract), bleeding both during and after surgery, bruising or muscle bleeding. This effect can last for 4 to 8 days after stopping taking Aspirin Direct.
Asthma, runny nose, nasal congestion.
Indigestion, pain in the gastrointestinal tract, pain in the upper abdomen.
Liver dysfunction, increases in liver function tests. Sudden, regressive severe hepato-damaging episodes have been reported, particularly in patients with a history of liver damage and in rheumatism patients, such as those with juvenile arthritis, rheumatic fever or systemic lupus erythematosus. (In these patients, the doctor will check liver function regularly). Restriction of renal function, acute renal failure.
Swelling due to water retention in tissues, hypertension and heart failure have been reported in association with nonsteroidal anti-inflammatory drugs (NSAIDs) treatment.
The use of medicines such as Aspirin Direct may be associated with a slightly increased risk of suffering a heart attack or stroke (especially at high doses and as part of long-term treatment).

Composition

The active ingredient is acetylsalicylic acid. 1 sachet of granules contains 500 mg of acetylsalicylic acid (ASA).

• The other ingredients are mannitol, sodium bicarbonate, sodium dihydrogen citrate, ascorbic acid, cola flavor, orange flavor, citric acid, aspartame.

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