Aspirin Protect 100 mg film-coated tablets

Heart attacks and strokes are mostly the consequences of a sudden reduction in blood flow to the heart or brain.

Application

1. WHAT ARE ASPIRIN PROTECT 100 mg FILM TABLETS AND WHAT ARE THEY USED FOR?

Heart attacks and strokes are usually the result of a sudden reduction in blood flow to the heart or brain. A common cause is blood clots (thrombi) that block important blood vessels in the heart or brain, causing a lack of oxygen and damaging the heart and brain.

Aspirin Protect contains the active ingredient acetylsalicylic acid (ASA). Even at low doses, this inhibits the sticking together of blood platelets (platelet aggregation) and thus counteracts the formation of thrombi.

Aspirin Protect 100 mg film-coated tablets are used in adults

to prevent strokes after a stroke and when precursor stages have occurred (transient ischaemic attacks,TIA).
to prevent the formation of blood clots (thromboses) in the coronary vessels after a heart attack (reinfarction prophylaxis),
to prevent arterial thromboses after vascular surgery (e.g. after procedures to widen constricted arteries),
to prevent the formation of blood clots (thromboses) in the coronary vessels after a heart attack (reinfarction prophylaxis),
to prevent arterial thromboses after vascular surgery (e.g. after procedures to widen constricted arteries).
To prevent arterial thrombosis after vascular surgery (e.g. after procedures to widen narrowed coronary vessels such as percutaneous transluminal coronary angioplasty, PTCA),
To prevent cardiovascular events such as angina pectoris or myocardial infarction in patients with diabetes mellitus and high cardiovascular risk.

(For preconditions for use of Aspirin Protect 100 mg Film-Coated Tablets, see Warnings and Precautions section).

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How is it applied?

WHAT ARE ASPIRIN PROTECT 100 mg FILM TABLETS AND WHAT ARE THEY USED FOR?

Heart attacks and strokes are mostly the consequences of a sudden reduction in blood flow to the heart or brain. A common cause is blood clots (thrombi) that block important blood vessels in the heart or brain. This causes a lack of oxygen and damages the heart and brain.

Aspirin Protect contains the active substance acetylsalicylic acid (ASA). Even in low doses, this inhibits the sticking together of blood platelets (platelet aggregation) and thus counteracts the formation of thrombi.

Aspirin Protect 100 mg film-coated tablets are used in adults

.

• for the prevention of strokes after surviving a stroke and when precursor stages have occurred (transient ischaemic attacks,TIA),
• for the prevention of blood clot formation (thrombosis) in the coronary vessels after surviving a heart attack (reinfarction prophylaxis),
• For the prevention of arterial thromboses after vascular surgery (e.g. after procedures to widen narrowed coronary vessels such as percutaneous
  transluminal coronary angioplasty, PTCA),
• For the prevention of cardio-vascular (heart and vascular system related) events such as angina pectoris or heart attack in patients with diabetes mellitus and high cardiovascular risk.
  
  (For preconditions for use of Aspirin Protect 100 mg Film-Coated Tablets, see section Warnings and Precautions).

What should you pay attention to before taking it?

What SHOULD YOU BE AWARE OF BEFORE TAKING ASPIRIN PROTECT 100 mg FILM TABLETS?

Aspirin Protect 100 mg Film-Coated Tablets 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 a history of asthma attacks or other
reactions to certain pain-relieving medicines - acetylsalicylic acid or substances with a similar mechanism of action (non-steroidal anti-inflammatory drugs).br>- if you have a history of acute gastrointestinal ulcers,
- if you have a history of gastrointestinal bleeding, ulceration or rupture caused by previous therapy with NSAIDs (non-steroidal anti-inflammatory drugs),
- if you have a history of gastrointestinal bleeding, ulceration or rupture caused by previous therapy with NSAIDs (non-steroidal anti-inflammatory drugs).
- if you have active gastrointestinal ulcers/bleeding or a history of gastrointestinal bleeding, ulceration or rupture,
- if you have an increased tendency to bleed (haemorrhagic diathesis),
- if you have severe liver disease,
- if you have a history of severe liver disease.br>- if you have severe liver weakness,
- if you have severe kidney weakness,
- if you have severe heart muscle weakness (heart failure),
- if you are taking 15 mg or more of methotrexate (medicine used to treat cancer or certain rheumatic diseases) at the same time. of certain rheumatic diseases) per week,
- if you are taking anticoagulants (medicines to "thin the blood") at the same time, if salicylates are used in high doses,
- in the last 3 months of pregnancy,
- if you have hyperoxaluria (certain condition with a tendency to form kidney stones).

Warnings and precautions
.Before you start treatment with Aspirin Protect, your doctor must determine the appropriateness of use in your particular case.
Please seek immediate medical advice if, during use of Aspirin Protect, any of the following occurstaking Aspirin Protect your cardiovascular situation or brain function deteriorates or if serious or unexpected side effects occur.

Special care should be taken when taking Aspirin Protect 100 mg Film-Coated Tablets if you have
- hypersensitivity to painkillers, certain medicines for inflammation or rheumatism or if you have any other allergies.
- history of high blood pressure and/or heart muscle weakness. Fluid retention and swelling have been reported in association with acetylsalicylic acid treatment.
- concomitant treatment with anticoagulant medicines,
- known gastrointestinal ulcers, including chronic or recurrent gastrointestinal ulcers or history of gastrointestinal bleeding,
- impaired liver function,
- pending surgery (including minor procedures such as dental surgery). e.g. dental procedures): there may be an increased tendency to bleed. Please inform your doctor before all operations if you have taken Aspirin Protect 100 mg Film-Coated Tablets.
- Some non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen (painkillers) can weaken the effect of acetylsalicylic acid, the active ingredient in Aspirin Protect. You should consult a doctor before any planned use (See also Taking Aspirin Protect 100 mg Film Tablets with other medicines).
- Patients with impaired renal function or impaired cardiovascular circulation (renal vascular disease, decompensated heart failure, volume loss, major surgery, sepsis.major surgery, sepsis or severe haemorrhagic events), as acetylsalicylic acid may increase the risk of renal dysfunction and acute renal failure.

Before starting treatment, you must inform your doctor

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• If you are pregnant or think you are pregnant or intend to become pregnant,
.
• If you are breastfeeding,
• If you are taking other medicines, especially medicines containing
  acetylsalicylic acid or medicines for pain and rheumatism,
.
• if you suffer from other diseases or allergies.

Bleeding tendency:
Acetylsalicylic acid (the active ingredient in Aspirin Protect 100 mg film-coated tablets) inhibits platelets from sticking together (even at very low doses). There is therefore an increased risk of bleeding during and after operations (even minor procedures such as pulling a tooth), which can continue for several days after the intake has stopped.

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, while taking Aspirin Protect 100 mg Film-Coated Tablets, watch out for signs of illness in the gastrointestinal tract.

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 dose 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, anticoagulant medicines, or medicines that may increase the risk of bleeding. These include cortisone, anticoagulants, 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 start of treatment.
Treatment with Aspirin Protect 100 mg Film-Coated Tablets in combination with stomach medicine should be considered in these cases.

If you experience bleeding or ulcers in the gastrointestinal tract, the treatment with acetylsalicylic acid must be stopped.

Signs of gastrointestinal side effects may include:abdominal pain, vomiting of blood, coffee-like vomiting, blackening of the stools.In these cases, please stop taking Aspirin Protect 100 mg Film-Coated Tablets immediately and seek medical advice without delay.

Hypersensitivity reactions:
Aspirin Protect 100 mg Film-Coated Tablets may cause spasms of the bronchial muscles (bronchospasm), 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, hives).

Gout attack:
Aspirin Protect 100 mg film-coated tablets increase 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 can possibly trigger a gout attack.

Children and young people
There is no indication for the use of Aspirin Protect 100 mg Film-Coated Tablets 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 Aspirin Protect 100 mg film-coated tablets) (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 Aspirin Protect 100 mg Film-Coated Tablets should 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 Aspirin Protect 100 mg Film-Coated Tablets must be discontinued immediately and medical attention sought without delay.

Also after the chickenpox vaccination, it is recommended to refrain from taking Aspirin Protect 100 mg film-coated tablets for 6 weeks to be on the safe side.

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 Aspirin Protect 100 mg Film-Coated Tablets!

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 Aspirin Protect 100 mg Film-Coated Tablets are taken for a long time, checks (e.g. liver function, kidney function, blood count, blood clotting) are indicated.

Glucose-6-phosphate dehydrogenase deficiency:
In certain people with a so-called "glucose-6-phosphate dehydrogenase deficiency" (a congenital metabolic disorder), high doses of acetylsalicylic acid can trigger a breakdown of red blood cells. The administration of Aspirin Protect 100 mg Film-Coated Tablets in G-6-PD deficiency must therefore be carried out under medical supervision.

Vascular diseases:
The use of medicines such as Aspirin Protect 100 mg Film-Coated Tablets 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.

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.

Fertility
Aspirin Protect 100 mg Film-Coated Tablets may affect fertility in women (see section on pregnancy, breast-feeding and fertility).

Taking Aspirin Protect 100 mg Film-Coated Tablets with other medicines.

Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.
The effect of the following medicines or groups of medicines may be influenced by simultaneous treatment with Aspirin Protect 100 mg Film-Coated Tablets.

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 Aspirin Protect 100 mg Film-Coated Tablets.

If you are taking anticoagulants (medicines to "thin the blood"), you must not take Aspirin Protect 100 mg Film-Coated Tablets 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.
• em> Anticoagulantmedicines, blood clot dissolving medicines/other medicines that inhibit platelet adhesion and clumping (antiplatelet medicines) / medicines that inhibit haemostasis (haemostasis inhibitors) - bleeding may occur due to increased effect. Aspirin Protect 100 mg Film-Coated Tablets may increase the risk of bleeding if taken before a treatment intended 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 area, 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 an increased risk of side effects. A corresponding control and
  if necessary dose adjustment by the doctor is recommended.
• Certain medicines for gout (e.g. probenecid, benzbromarone).
  Possible weakening of the effect of the gout medicines.
• Drugs for diabetes (e.g. insulin, sulphonylureas): hypoglycaemia may occur due to an increase in 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
  hypertensive effect may be weakened, therefore blood pressure controls are recommended.
• Medicines containing cortisone or substances similar to cortisone (with the exception of products applied to the skin or hydrocortisone in cortisone replacement therapy for Addison's disease): increased risk of side effects 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.
• Some non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen, may reduce the effect of low-dose acetylsalicylic acid on platelet clumping and thus may limit the protective effect of Aspirin Protect 100 mg Film-Coated Tablets on the heart.They may limit the protective effect of Aspirin Protect 100 mg Film-Coated Tablets on the heart (see also Warnings and Precautions)
.

Please also note that:
Aspirin Protect 100 mg Film-Coated Tablets in higher doses may alter the results of laboratory tests, so inform your doctor about taking it

Taking Aspirin Protect 100 mg Film-Coated Tablets with alcohol.
Please avoid drinking alcohol during the treatment period with Aspirin Protect 100 mg Film-Coated Tablets, it could increase the side effects of the medicine (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy,lactation and fertility.
If you are pregnant or breast-feeding, or if you suspect you are pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Pregnancy:
First and second trimester: . . . .

While	the
Aspirin	Protect
The dose should be kept as low and the treatment as short as possible.
Third trimester:
During the last three months of pregnancy, you must not take Aspirin Protect 100 mg
Do not take film-coated tablets because of an increased risk of complications for mother and child
take.
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 the mother and baby and delay
/ Prolongation of the birth process come.

Breastfeeding time:
The active substance acetylsalicylic acid and its degradation products pass into breast milk in small amounts. With short-term use of Aspirin Protect 100 mg Film-Coated Tablets and low dose, interruption of breast-feeding will not be necessary. However, you should stop breastfeeding if you use the medicine for a long time or take high doses.

Procreative capacity:
Aspirin Protect 100 mg Film-Coated Tablets belong to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible after discontinuation of the medicinal product.

Driving ability and ability to operate machinery.

Aspirin Protect 100 mg Film-Coated Tablets have no or negligible effect on the ability to drive and use machines.

Never the less, do not drive vehicles or use dangerous tools or machines if your attention is impaired - such as by possible side effects like drowsiness, headache, dizziness or confusion.

How should the medicine be taken?

HOW TO TAKE ASPIRIN PROTECT 100 mg FILM TABLETS?

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Please ask your doctor or pharmacist if you are not quite sure.

Dosage:
Unless otherwise prescribed by the doctor, the usual dose for

• Adults:
  1 x daily 100 mg (1 film-coated tablet Aspirin Protect 100 mg)
• Children and adolescents:
  There is no indication for the use of Aspirin Protect 100 mg
  Film-coated tablets in children and adolescents.

Type of application:
For ingestion.
The enteric-coated film-coated tablets should be taken unchewed, preferably at least 30 minutes before a meal, with plenty of water.
The enteric-coated film-coated tablets must not be crushed, broken or chewed to ensure release in the intestine.
Usually, Aspirin Protect 100mg Film-Coated Tablets are used as a long-term preventive measure.
Note:
Higher-dose preparations are available for the use of acetylsalicylic acid for pain and/or fever.

Special patient groups:

Older persons (from 65 years) and underweight persons:
In elderly patients, special caution is indicated because of possible concomitant diseases or underweight (see sections "Aspirin Protect 100 mg Film-Coated Tablets 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, it is recommended to increase the time interval between two intakes. Do not take Aspirin Protect 100 mg Film-Coated Tablets if you have severe liver dysfunction. Aspirin Protect 100 mg Film-Coated Tablets should be used with particular caution if you have impaired liver function.

Patients with renal dysfunction:
If you suffer from kidney dysfunction, it is recommended to increase the time interval between two doses. You must not take Aspirin Protect 100 mg Film-Coated Tablets if you have severe kidney dysfunction. Aspirin Protect 100 mg Film-Coated Tablets should be used with particular caution if you have impaired kidney function.
If you take a large amount of Aspirin Protect 100 mg Film-Coated Tablets took more than you should.
Overdoses can be a danger, especially for elderly patients and especially for young children (overdoses in the course of treatment or accidental poisoning can be fatal).

Discomfort in moderate poisoning:
Nausea in the ears, hearing disorders, 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 you have taken an overdose of Aspirin Protect 100 mg Film-Coated Tablets, notify a doctor immediately. The doctor can decide on the necessary measures according to the severity of the overdose / poisoning. Poisoning with Aspirin Protect 100 mg Film-Coated Tablets can be life-threatening.

If you forget to take Aspirin Protect 100 mg Film-Coated Tablets have
Do not take double the amount if you have not taken the previous dose.
have forgotten.

If you stop taking Aspirin Protect 100 mg Film-Coated Tablets.
Please talk to your doctor if you want to stop treatment with Aspirin Protect 100 mg Film-Coated Tablets prematurely.

If you have any further questions about taking this medicine, contact
to your doctor or pharmacist.

Further information for healthcare professionals is contained in the
corresponding section at the end of the leaflet.

What are the possible side effects?

HOW TO STORE ASPIRIN PROTECT 100 mg FILM TABLETS?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". 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 ASPIRIN PROTECT 100 mg FILM TABLETS?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "use by". 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.

You are helping to protect the environment.

Special notes on the content

Contents of the pack and Further information
What Aspirin Protect 100 mg Film-Coated Tablets contain
The active ingredient is: Acetylsalicylic acid
One film-coated tablet contains 100 mg of acetylsalicylic acid.

The other ingredients are:
Tablet core: cellulose powder, maize starch.
Tablet coating: metacrylic acid copolymer type C, sodium lauryl sulphate, polysorbate 80, talc, triethyl citrate.

What Aspirin Protect 100 mg Film-Coated Tablets look like and contents of the pack
White, round film-coated tablets
The film-coated tablets are supplied in packs of 30 and 60.
Not all pack sizes may be marketed

.