Genericon ASS 500 mg 20 tablets

ASS Genericon contain the active ingredient acetylsalicylic acid (ASA). This has an analgesic, fever-reducing and anti-inflammatory effect.

When is ASS Genericon used?
Symptomatic treatment of mild to moderate pain such as headaches, toothaches and period pains.
For the relief of pain and fever associated with colds and flu-like infections.

If you do not feel better after 3-4 days or if you feel worse if you experience new symptoms (e.g. reddening or swelling), you must consult a doctor as these can be signs of a serious illness.

Contraindications

ASS Genericon must not be taken:

• if you are allergic to acetylsalicylic acid, other salicylates or any of the other ingredients of this medicine (listed in section 6);
• if you have had an asthma attack or other hypersensitivity reaction to certain pain-relieving medicines - acetylsalicylic acid or substances with a similar mechanism of action (non-steroidal anti-inflammatory drugs) in the past;
• if you suffer from acute gastrointestinal ulcers;
• if you have a history of gastrointestinal bleeding, ulceration or perforation related to previous NSAID (Non-Steroidal Anti-Inflammatory Drug) therapy;
• if you have active gastrointestinal ulcers/bleeding or you have a history of bleeding, ulceration or perforation in the gastrointestinal tract;
• if you suffer from a pathologically increased tendency to bleed (haemorrhagic diathesis);
• if you suffer from severe liver dysfunction;
• if you suffer from severe renal impairment;
• if you suffer from severe heart muscle weakness (heart failure);
• if you are taking 15 mg per week or more of methotrexate (a medicine used to treat cancer or certain rheumatic diseases) at the same time;
• if you are taking high doses of anticoagulants (medicines used to “thin blood”) and salicylates at the same time;
• in the last three months of pregnancy.

ASS Genericon must not be given to children under the age of one year.

interactions

Taking other medicines and ASS Genericon 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 drugs or groups of preparations listed below can be influenced if they are treated with ASS Genericon at the same time.

Contraindicated (prohibited) 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 ASS Genericon.
If you are taking anticoagulants (medicines for "blood thinning"), you must not take ASS Genericon in high doses.

Combinations that require special care:

• Methotrexate in doses below 15 mg/week (drugs for the treatment of cancer or certain rheumatic diseases): There is a risk of increased (side) effects of methotrexate.
• Anticoagulant medicines, blood clot-dissolving medicines), other medicines that prevent blood platelets from sticking and clumping together (platelet aggregation inhibitors)/medicines that inhibit hemostasis (haemostasis inhibitors): Bleeding can occur as a result of the increased effect.
• ASS Genericon may increase the risk of bleeding if taken before a treatment to break up blood clots. Therefore, you must be alert for signs of external or internal bleeding (eg bruising) if you are to have this type of treatment. A medical check-up is absolutely necessary.
• Other analgesic and anti-inflammatory drugs (nonsteroidal 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 upper gastrointestinal bleeding increases.
• Certain drugs for the treatment of heart muscle weakness and for the treatment of certain cardiac arrhythmias (digoxin) - increased effect up to an increased risk of side effects. Appropriate monitoring and, if necessary, dose adjustment by the doctor are recommended.
• Certain medicines for gout (e.g. probenecid, benzbromarone). Possible weakening of the effect of the gout medication. It is recommended to use another pain reliever.
• Drugs for diabetes (e.g. insulin, sulfonylureas): Hypoglycaemia can occur due to increased effects. More frequent blood glucose self-monitoring is recommended.
• Certain medicines for drainage and lowering blood pressure (diuretics): There is a risk of severe kidney dysfunction. If taken at the same time, make sure you drink enough fluids. Certain diuretics (e.g. furosemide) can weaken the antihypertensive effect, which is why 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 muscle weakness (“ACE inhibitors”, aldosterone antagonists): There is a risk of severe kidney dysfunction, and the antihypertensive effect may be reduced. If taken at the same time, make sure you 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 effective gastrointestinal preparations: magnesium, aluminum and calcium salts, oxides and hydroxides.
• certain antibiotics (so-called sulfonamides) – there is a risk of increased side effects.
• Thyroid hormones - should be taken 4 - 5 hours before ASS Genericon tablets.
• Pentoxifylline (medicine used to treat circulatory disorders) - the risk of bleeding is increased.
• Metamizole (medicine used to treat pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood platelets stick together and form a blood clot) if taken at the same time. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardiac protection.

Please also note that higher doses of ASS Genericon can alter the results of laboratory tests. Therefore, inform your doctor about taking ASS Genericon.

Taking ASS Genericon together with alcohol
Please avoid drinking alcohol during treatment with ASS Genericon, the side effects of the drug can be increased (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy, breast-feeding and fertility
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:
First and second trimester of pregnancy:
During the first six months of pregnancy and if you are planning to have children, you may take ASS Genericon after consulting your doctor. The dose should be kept as low and the treatment as short as possible.

Third trimester of pregnancy:
You must not take ASS Genericon in the last three months of pregnancy due to 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 (maldevelopments in the circulatory system and/or kidney dysfunction up to kidney failure).
During birth, there may be increased bleeding in both mother and child and the birth process may be delayed/extended.

Breast-feeding:
The active ingredient acetylsalicylic acid and its breakdown products are excreted in small amounts in breast milk. If ASS Genericon is used for a short time and if low doses are taken, it will not be necessary to interrupt breastfeeding. However, it is recommended that you stop breast-feeding if you are using it for a long time or if you are taking high doses.

Fertility:
ASS Genericon belongs to a group of medicines (Non-Steroidal Anti-Inflammatory Drugs) that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

application

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 recommended dose is:

Adults and adolescents from 12 years of age
Single dose: 1-2 tablets (equivalent to 500 mg-1000 mg acetylsalicylic acid).
Daily dose: 3 to a maximum of 6 tablets (equivalent to 1500-3000 mg acetylsalicylic acid).
The maximum daily dose of 6 tablets (equivalent to 3000 mg acetylsalicylic acid) must not be exceeded.

The score line is only for dividing the tablet for easier swallowing and not for dividing into equal doses.

Use in children under 12 years
Medicines containing acetylsalicylic acid (ASA) may only be given to children under 12 years of age if prescribed by a doctor.
Dosing for children is not possible with the present ASA dosage form. If the administration of ASS Genericon is necessary for children under 12 years of age, the use of a medicinal product that enables an adjusted dosage is indicated.

Method of administration:
For oral use. Please take the tablets with plenty of liquid (e.g. a glass of water). This promotes the onset of action. You can also break up the tablets with a little water on a spoon to make it easier to swallow. Please drink plenty of liquid. Do not take on an empty stomach.

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

ASS Genericon may not be taken for longer than 3-4 days in the case of pain and for no longer than 3 days in the case of fever without a doctor's prescription. If pain or fever persists during this time or even worsens when new symptoms appear (eg redness or swelling), you must see your doctor as these can be signs of a serious illness.

Special patient
groups Elderly people (from 65 years of age) and underweight people:
Particular caution is required in elderly patients because of possible comorbidities or being underweight (see sections "ASA Genericon must not be taken" and "Warnings and precautions"). In particular, it is recommended that the lowest effective dose be used in elderly and underweight individuals.

Patients with liver dysfunction:
If you suffer from liver dysfunction, the dose must be reduced or the interval between two intakes increased. If you have severe liver dysfunction, you must not take ASS Genericon.

Patients with kidney dysfunction:
If you suffer from kidney dysfunction, the dose must be reduced or the interval between two intakes increased. If you have severe kidney dysfunction, you must not take ASS Genericon.

side effects

Like all medicines, ASS Genericon can have side effects, although not everyone gets them.

The following side effects are possible and are listed according to their frequency:
very common: may affect more than 1 in 10 people
common: may affect up to 1 in 10 people uncommon: may
affect up to 1 in 100 people
rare: may affect up to 1 in 1,000 people affects
very rare: may affect up to 1 in 10,000 people
not known: frequency cannot be estimated from the available data

Frequently:

• Discomfort in the gastrointestinal area such as heartburn, nausea, vomiting, abdominal pain.

Occasionally:

• Hypersensitivity reactions such as skin reactions.
• Reddening of the skin, hives (urticaria), itching.

Rarely:

• Hypersensitivity reactions of the respiratory tract, the gastrointestinal tract and the cardiovascular system, especially in asthmatic patients. Signs of a hypersensitivity reaction can be: drop in blood pressure, attacks of shortness of breath, runny nose, blocked nose, life-threatening shock or swelling of the skin and mucous membranes.
• Severe skin reactions such as rash with redness, blistering and peeling skin.
• Gastrointestinal inflammation, gastrointestinal ulcers, gastrointestinal bleeding, which very rarely can lead to anemia due to iron deficiency.
• Perforation of a gastrointestinal ulcer, especially in elderly patients.
• Stop taking ASS Genericon if you have abdominal pain, black stools, vomit blood or vomit like coffee grounds and tell a doctor immediately.

Rare to very rare:

• Serious bleeding such as B. Cerebral haemorrhages, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants, which can be life-threatening in individual cases, have been reported.

Very rare:

• drop in blood sugar
• Acetylsalicylic acid reduces uric acid excretion in low doses. In vulnerable patients, this can potentially trigger a gout attack.
• Reye's syndrome (rare but life-threatening condition that occurs in children and adolescents with febrile illnesses, particularly chickenpox and influenza-like illnesses (see also Section 2: Warnings and precautions).

Not known:

• Anemia due to blood loss, breakdown of red blood cells, anemia due to blood breakdown.
• Drug hypersensitivity, allergic swelling and swelling of the skin and mucous membranes, 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 due to heart disease.
• Bleeding with prolonged bleeding such as nosebleeds, gum bleeding, skin bleeding, bleeding in the urinary and genital organs (urogenital tract), bleeding both during and after surgery, bruising or muscle bleeding. This effect can last for 4 to 8 days after you stop taking ASS Genericon 500 mg tablets.
• Asthma, runny nose, stuffy nose.
• Indigestion, gastrointestinal pain, upper abdominal pain.
• Hepatic dysfunction, elevations in liver values. Sudden, reversible severe hepatotoxic episodes have been reported, particularly in patients with a history of liver damage and in patients with rheumatic diseases such as those with juvenile arthritis, rheumatic fever or systemic lupus erythematosus (in these patients the doctor will monitor liver function regularly).
• Restriction of renal function, acute renal failure.
• Swelling due to fluid retention, high blood pressure and heart failure have been reported with non-steroidal anti-inflammatory drug (NSAID) treatment.
• Medicines such as ASS Genericon may be associated with a small increased risk of heart attack or stroke (particularly at high doses and during long-term treatment).

composition

The active substance is: acetylsalicylic acid (ASA).
Each tablet contains 500 mg acetylsalicylic acid.

The other ingredients are: lactose, potato starch, colloidal anhydrous silica, glycerol monostearate.