ASS Genericon 500 mg tablets

ASS Genericon contain the active substance acetylsalicylic acid (ASS).

Application

The active substance acetylsalicylic acid (ASA) has analgesic, antipyretic and anti-inflammatory effects.

ASA Genericon is used to treat mild to moderate pain of various kinds, such as headaches, toothaches and period pains.
For colds and flu-like infections, ASS Genericon reduces fever and fights pain.

If you do not feel better or even worse after 3-4 days, consult your doctor.

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

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How is it applied?

What is ASS Genericon and what is it used for?

ASS Genericon contain the active substance acetylsalicylic acid (ASS). This has an analgesic, antipyretic and anti-inflammatory effect.

When is ASA Genericon used?
Symptomatic treatment of mild to moderate pain such as headaches, toothaches and period pains.
To relieve pain and fever in colds and flu-like infections..

If you do not feel better or even worse after 3-4 days of pain, 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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What should you pay attention to before taking it?

What should you be aware of before taking ASS Genericon?

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,
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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
  inflammatory drugs) - with asthma attacks or in any other way hypersensitivity,
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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 (a 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") and salicylates in high doses at the same time,
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• in the last three months of pregnancy.

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

Warnings and precautions.
Please talk to your doctor or pharmacist before taking ASS Genericon.

Particular caution is required when taking ASS Genericon in the following cases

• Hypersensitivity to painkillers, certain medicines for inflammation or rheumatism or in the presence of other allergies.
• 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 if you have a history of gastrointestinal bleeding.
• Patients with reduced kidney function or patients with reduced cardiovascular function (e.g. vascular disease, cardiac insufficiency, volume loss, major surgery, sepsis or major bleeding events), as acetylsalicylic acid, the active ingredient of ASA Genericon, may increase the risk of renal dysfunction and bleeding.ure, the active ingredient in ASS Genericon, 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 ASS Genericon.
• Patients with a so-called "glucose-6-phosphate dehydrogenase deficiency" (a congenital metabolic disease): ASA Genericon can cause a breakdown of the red
  blood cells or anaemia due to a breakdown of the red blood cells. The administration of ASA Genericon in glucose-6-phosphate dehydrogenase deficiency must therefore take place under medical supervision.
• in case of poor nutritional status and insufficient fluid intake.
  in case of pathologically prolonged or increased menstrual bleeding (danger of increased or prolonged menstrual bleeding).

ASS Genericon must not be used without a doctor's orders for more than 3-4 days in the case of pain and for more than 3 days in a row in the case of fever.
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 look out for?
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 ASS Genericon) inhibits (even at very low doses) the platelets from sticking together. There is therefore an increased risk of bleeding both during and after surgery (including minor procedures such as tooth extraction), which can continue for several days after you stop taking it.

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, look out for signs of illness in the gastrointestinal tract while taking ASS Genericon.

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, anticoagulants, or other medicines.These include cortisone, anticoagulants (such as ASA 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 beginning of a course of treatment.
Treatment with ASS Genericon in combination with an antacid should be considered in these cases.

Warning signs of bleeding in the gastrointestinal tract or signs of side effects of a Gastrointestinal disease can be:
Abdominal pain, vomiting of blood, coffee-like vomiting, black colouring of stools. In these cases, please stop taking ASS Genericon immediately and seek medical advice without delay.

Hypersensitivity reactions:
ASS Genericon 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, urticaria.

Gout attack:
ASS Genericon increases 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 may under some circumstances
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 ASS Genericon) (the so-called "Reye's syndrome"), which may be related to acetylsalicylic acid. It also occurs in young adults.
Acetylsalicylic acid-containing medicines such as ASS Genericon must therefore only be administered to children under 12 years of age and adolescents with febrile illnesses on a doctor's prescription and only if other measures are not effective.

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 ASS Genericon must be discontinued immediately and medical help sought without delay.

Also after the chickenpox vaccination, it is recommended to refrain from taking ASS Genericon for 6 weeks to be on the safe side.

Children:
Acetylsalicylic acid-containing medicines, such as ASA Genericon, 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 ASS Genericon!

Do not use painkillers for a long time or in higher doses without medical advice.

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 ASS Genericon is taken for a longer period of time, checks (e.g. liver function, kidney function, blood count, blood clotting) are indicated.

Vascular diseases:
The use of medicines such as ASS Genericon 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. At
high fever, signs of new infection (e.g. redness, swelling) or persistence of symptoms (such as pain or fever) for more than three days, medical advice must be sought.
Procreative capacity:
ASS Genericon may affect the reproductive capacity of women (see section "Pregnancy, lactation and reproductive capacity").

Taking ASS Genericon with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

The effect of the following medicinal products or groups of medicinal products may be influenced by simultaneous treatment with ASS Genericon.

Contraindicated (not allowed) 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 to "thin the blood"), you must not take ASA Genericon in high doses.

Combinations that require special care:

• Methotrexate in doses below 15 mg/week (medicinal products for the treatment of
  cancerous diseases or of certain rheumatic diseases): There is a risk of increased (side) effects of methotrexate.
• Anticoagulant medicines, blood clot dissolving medicines), other medicines that inhibit the adhesion and clumping of blood platelets
  (antiplatelet medicines)/pharmaceuticals to inhibit haemostasis
  (haemostasis inhibitors): Bleeding may occur due to an increase in effect.
• ASS Genericon may increase the risk of bleeding if taken before a treatment designed 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-rheumatics) 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 upper gastrointestinal tract increases.
• Certain medicines 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 are recommended.
• Certain medicines for gout (e.g. probenecid, benzbromarone).
  Possible weakening of the effect of gout medicines. It is recommended to use a different
  painkiller.
• Drugs for diabetes (e.g. insulin, sulphonylureas): hypoglycaemia may occur due to
  enhanced 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, therefore
  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 muscle weakness ("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 against epilepsy (valproic acid): There is a risk of increased (side) effects of valproic acid.
• Locally effective gastrointestinal preparations: magnesium, aluminium and calcium salts, oxides and hydroxides.
• Certain antibiotics (so-called sulphonamides) - there is a risk of increased side effects.
• Thyroid hormones - the intake should take place 4 - 5 hours before ASS Genericon tablets.
• Pentoxifylline (medicines for the treatment of circulatory disorders) - the risk of bleeding is increased.

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

Taking ASS Genericon together with alcohol.
Please avoid drinking alcohol during the treatment period with ASS Genericon, it may increase the side effects of the medicine (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy, breastfeeding. and reproductive capacity
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist before taking this medicine.
for advice.

Pregnancy:
First and second trimester:
During the first six months of pregnancy and if you wish to have a baby, 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:
Do not take ASS Genericon during the last three months of pregnancy because of an increased risk of complications for mother and baby.

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, the mother and child may bleed more and the birth process may be delayed or prolonged.

Breastfeeding time:
The active substance acetylsalicylic acid and its degradation products pass into breast milk in small amounts. If ASS Genericon is used for a short time and low doses are taken, it will not be necessary to interrupt breast-feeding. However, it is recommended that you stop breastfeeding if you use the medicine for a long time or take high doses.

Procreative capacity:
ASS Genericon belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect women's ability to reproduce. This effect is reversible after discontinuation of the medicinal product.

Driving ability and ability to operate machines
ASS Genericon has no or negligible effect on the ability to drive and use machines.
Nevertheless, do not drive a vehicle or use dangerous tools or machines if your attention is impaired - such as by possible side effects like drowsiness, headache, dizziness or confusion.

ASS Genericon contains lactose.
Please therefore only take ASS Genericon after consulting your doctor if you are known to suffer from a sugar intolerance.

How should the medicine be taken?

How to take ASS Genericon?

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

The break notch is only for dividing the tablet for easier swallowing and not for dividing into equal doses.

Use in children under 12 years of age
Medicinal products containing acetylsalicylic acid (ASA) may only be given to children under 12 years of age on a doctor's prescription.
With the present ASA dosage form, children's doses are not possible. If the administration of ASA Genericon is necessary for children under 12 years of age, the use of a medicinal product that allows an adapted dosage is therefore indicated.

Type of administration:
To be taken.
Please take the tablets with plenty of liquid (e.g. a glass of water). This promotes the onset of action. To make it easier to swallow, you can also dissolve the tablets on a spoon in a little water and take them. Please drink plenty of fluids. Do not take on an empty stomach.

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.

ASS Genericon 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
Older persons (65 years and over) and underweight persons:
In elderly patients, special caution is indicated because of possible concomitant diseases or underweight (see sections "ASS Genericon 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 interval between two doses must be increased. If you have severe liver dysfunction, you must not take ASA
Patients with kidney dysfunction:
If you suffer from kidney dysfunction, the dose must be reduced or the time interval between two doses must be increased. You must not take
ASS Genericon if you have severe kidney dysfunction.

If you have taken more ASS Genericon than you shouldOverdoses can be a danger, especially for elderly patients and young children.Overdoses can be dangerous, especially for elderly patients and young children (overdoses during treatment or accidental poisoning can be fatal).

Discomfort in case of moderate poisoning:
Noise in ears, hearing disturbances, sweating, nausea, vomiting, headache and dizziness.

Discomfort in severe poisoning:
Fever, accelerated breathing, unconsciousness (coma), life-threatening shock, respiratory failure, severe drop in blood sugar.

If you suspect an overdose with ASS Genericon, 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 ASS Genericon can be life-threatening.

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

If you forget to take ASS Genericon
Do not take twice the amount if you have forgotten to take it before.

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

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What are the possible side effects?

How to store ASS Genericon?

Store this medicine out of the reach of children.

Do not store above 25 °C.

Store in the original packaging to protect the contents from light.

You must not use this medicine after the expiry date which is stated on the carton and blister pack. 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 stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How to store ASS Genericon?

Keep this medicine out of the reach of children.

Do not store above 25 °C.

Store in the original packaging to protect the contents from light.

You must not use this medicine after the
expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What ASA Genericon contains
- The active substance is: acetylsalicylic acid (ASA). Each tablet contains 500 mg acetylsalicylic acid.
- The other ingredients are: Lactose, potato starch, highly dispersed silicon dioxide, glycerol monostearate.

What ASA Genericon looks like and contents of the pack
ASS Genericon are white round tablets, domed on both sides, with a break notch. The break notch is only for dividing the tablet for easier swallowing and not for dividing into equal doses.

ASS Genericon is available in blister packs of 20 or 60 tablets.

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