ASS

ASS Dexcel 100 mg tablets

Important notes (mandatory information)

ASS Dexcel 100 mg Tablets. Active ingredient: Acetylsalicylic acid (Ph.Eur.). Areas of application: for unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries) - as part of standard therapy; for acute heart attack - as part of standard therapy; for the prevention of another heart attack after the first heart attack (for reinfarction prophylaxis); after operations or other interventions on arterial blood vessels (after arterial vascular surgical or interventional procedures, e.g. after aortocoronary vein bypass [ACVB], with percutaneous transluminal coronary angioplasty [PTCA]); for the prevention of transient cerebral ischemia (TIA: transient ischemic attacks) and cerebral infarction after precursor stages (e.g. temporary paralysis of the face or arm muscles or temporary loss of vision) have occurred.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

ASS Dexcel 100 mg Tablets
Active ingredient: Acetylsalicylic acid (Ph.Eur.)

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

What this leaflet contains

1. WHAT IS ASS DEXCEL 100 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASS DEXCEL 100 MG?
3. HOW TO TAKE ASS DEXCEL 100 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ASS DEXCEL 100 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ASS DEXCEL 100 MG AND WHAT IS IT USED FOR?

ASS Dexcel 100 mg contains the active ingredient acetylsalicylic acid. ASS Dexcel 100 mg inhibits, among other things, the adhesion and clumping of platelets (thrombocytes) and thus prevents the formation of blood clots (thrombi) (platelet aggregation inhibition).

ASS Dexcel 100 mg is used:

• for unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries) – as part of standard therapy.
• for acute heart attack – as part of standard therapy.
• for the prevention of another heart attack after the first heart attack (for reinfarction prophylaxis).
• after operations or other interventions on arterial blood vessels (after arterial vascular surgical or interventional procedures, e.g. after aortocoronary vein bypass [ACVB], with percutaneous transluminal coronary angioplasty [PTCA]).
• for the prevention of transient cerebral ischemia (TIA: transient ischemic attacks) and cerebral infarction after precursor stages (e.g. temporary paralysis of the face or arm muscles or temporary loss of vision) have occurred.

Note

ASS Dexcel 100 mg is not intended for the treatment of pain.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASS DEXCEL 100 MG?

ASS Dexcel must not be taken:

• if you are allergic to acetylsalicylic acid, salicylates or any of the other ingredients of this medicine listed in section 6.
• if you have had hypersensitivity (allergic) reactions to certain medicines for pain, fever or inflammation (salicylates or other non-steroidal anti-inflammatory drugs) in the past with asthma attacks or in other ways.
• with acute gastric and intestinal ulcers.
• with pathologically increased bleeding tendency (hemorrhagic diathesis).
• with liver and kidney failure.
• with severe, non-drug-controlled heart muscle weakness (heart failure).
• if you are taking 15 mg or more of methotrexate per week at the same time.
• in the last 3 months of pregnancy at a dosage of more than 150 mg acetylsalicylic acid per day (see also section "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Please talk to your doctor or pharmacist before taking ASS Dexcel:

• if you are hypersensitive (allergic) to other pain and anti-inflammatory medicines, other medicines for rheumatism or other allergy-triggering substances.
• if you are taking non-steroidal anti-inflammatory drugs at the same time, such as ibuprofen and naproxen (medicines for pain, fever or inflammation) (see also under 2. "Weakening of the effect").
• if you have other allergies (e.g. with skin reactions, itching, hives).
• with bronchial asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or chronic respiratory diseases.
• if you are taking anticoagulants at the same time (e.g. coumarin derivatives, heparin – with the exception of low-dose heparin treatment).
• with gastric and intestinal ulcers or a history of gastrointestinal bleeding.
• with impaired liver function.
• with impaired kidney function or reduced cardiovascular circulation (e.g. vascular disease of the kidneys, heart muscle weakness, reduction in blood volume, major operations, blood poisoning or major bleeding): acetylsalicylic acid can further increase the risk of renal dysfunction and acute renal failure.
• before operations (even minor procedures, such as tooth extraction): there may be an increased tendency to bleed. Please inform your doctor or dentist if you have taken ASS Dexcel.
• in patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated degradation or breakdown of red blood cells or a specific form of anemia. This risk can be increased by factors such as high dosage, fever or acute infections.

What else do you need to watch out for?
Acetylsalicylic acid reduces uric acid excretion in low doses. In appropriately susceptible patients, this can under certain circumstances trigger a gout attack. If you cut or injure yourself, it may take a little longer than usual for the bleeding to stop. This is related to the effect of ASS Dexcel. Minor cuts and injuries (e.g. when shaving) are usually insignificant. In the event of unusual bleeding (at an unusual location or of unusual duration), contact your doctor. Acetylsalicylic acid-containing medicines should not be used for a long time or in higher doses without consulting a doctor.

Children and adolescents

ASS Dexcel should only be used in children and adolescents with febrile illnesses on the instructions of a doctor and only if other measures do not work. If persistent vomiting occurs during these illnesses, this may be a sign of Reye's syndrome, a very rare but life-threatening illness that requires immediate medical attention.

Taking ASS Dexcel with other medicines

Tell 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 active ingredients or groups of preparations can be influenced by simultaneous treatment with ASS Dexcel.

Increased effect up to increased risk of side effects:

• Anticoagulant medicines (e.g. coumarin, heparin) and blood clot dissolving medicines: Acetylsalicylic acid can increase the risk of bleeding if it has been taken before blood clot dissolving treatment. Therefore, if you are to undergo such treatment, you must watch out for signs of external or internal bleeding (e.g. bruises).
• Other platelet aggregation inhibitors (medicines that inhibit the adhesion and clumping of platelets), e.g. ticlopidine, clopidogrel: increased risk of bleeding.
• Medicines containing cortisone or cortisone-like substances (with the exception of products that are applied to the skin or in cortisone replacement therapy for Addison's disease): the risk of gastrointestinal bleeding and ulcers is increased.
• Alcohol: the risk of gastrointestinal ulcers and bleeding is increased.
• Pain and anti-inflammatory medicines (non-steroidal analgesics/antiphlogistics) and medicines for rheumatism with salicylic acid: increased risk of bleeding and ulcers in the gastrointestinal tract.
• Blood sugar lowering medicines (antidiabetics) such as insulin, tolbutamide, glibenclamide (so-called sulfonylureas) in combination with acetylsalicylic acid in higher doses: blood sugar levels can drop.
• Digoxin (medicine to strengthen the heart).
• Methotrexate (medicine for the treatment of cancer or certain rheumatic diseases).
• Valproic acid (medicine for the treatment of seizures of the brain [epilepsy]).
• Selective serotonin reuptake inhibitors (certain medicines for the treatment of depression): the risk of bleeding in the gastrointestinal tract increases.

Weakening of the effect:

• Special medicines that cause increased urine output (diuretics: so-called aldosterone antagonists, such as spironolactone and canrenoate; loop diuretics, such as furosemide).
• Certain blood pressure lowering medicines (especially ACE inhibitors).
• Urinary medicines for gout (e.g. probenecid, benzbromarone).
• Some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid), such as ibuprofen and naproxen: Weakening of the inhibition of adhesion and clumping of platelets caused by ASS Dexcel; this can reduce the protection against heart attack and stroke caused by ASS Dexcel.
• Metamizole (medicine for the treatment of pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of platelets and formation of 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 heart protection.

Before using acetylsalicylic acid, please tell your doctor what other medicines you are already taking. If you take acetylsalicylic acid regularly, talk to your doctor before taking another medicine. This also applies to non-prescription medicines. ASS Dexcel should therefore not be used together with any of the above substances without the doctor's express instructions.

Taking ASS Dexcel with food, drinks and alcohol

Please note that acetylsalicylic acid should not be taken together with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

In the first and second trimesters of pregnancy, you should only take ASS Dexcel on the instructions of your doctor. In the last three months of pregnancy, you must not take acetylsalicylic acid, the active ingredient in ASS Dexcel, at a dosage of more than 150 mg per day due to an increased risk of complications for mother and child before and during birth (see also section "ASS Dexcel must not be taken"). Acetylsalicylic acid up to 150 mg per day may only be taken in the last trimester of pregnancy on the instructions of your doctor.

Breastfeeding

The active ingredient acetylsalicylic acid and its degradation products pass into breast milk in small amounts. Since adverse effects for the infant have not been reported to date, discontinuation of breastfeeding is usually not necessary when a daily dose of up to 150 mg is used. If higher doses (over 150 mg daily dose) are taken, breastfeeding should be discontinued.

Fertility

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can impair fertility in women. This effect is reversible after discontinuation of the medication.

Driving and using machines

No special precautions are required.

3. HOW TO TAKE ASS DEXCEL 100 MG?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• For unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries): A daily dose of 1 ASS Dexcel tablet (corresponding to 100 mg acetylsalicylic acid per day) is recommended.
• For acute heart attack: A daily dose of 1 ASS Dexcel tablet (corresponding to 100 mg acetylsalicylic acid per day) is recommended.
• For the prevention of another heart attack after the first heart attack (reinfarction prophylaxis): A daily dose of 3 ASS Dexcel tablets (corresponding to 300 mg acetylsalicylic acid per day) is recommended.
• After operations or other interventions on arterial blood vessels (after arterial vascular surgical or interventional procedures; e.g. after ACVB; with PTCA): A daily dose of 1 ASS Dexcel tablet (corresponding to 100 mg acetylsalicylic acid per day) is recommended. The most favorable time to start treatment with ASS Dexcel after aortocoronary vein bypass (ACVB) appears to be 24 hours after the operation.
• For the prevention of transient cerebral ischemia (TIA) and cerebral infarction after precursor stages have occurred: A daily dose of 1 ASS Dexcel tablet (corresponding to 100 mg acetylsalicylic acid per day) is recommended.

Method of administration

Take the tablets with plenty of water, preferably after a meal. Do not take on an empty stomach! For treatment of acute heart attack, the first tablet should be chewed or crushed.

Duration of use

ASS Dexcel is intended for long-term use. The duration of use is determined by the treating physician.

If you have taken more ASS Dexcel than you should

Dizziness and ringing in the ears can be signs of serious poisoning, especially in children and the elderly. If you suspect an overdose of ASS Dexcel, please notify your doctor immediately. Depending on the severity of an overdose/poisoning, he can decide on the measures that may be necessary.

If you forget to take ASS Dexcel

Do not take double the dose if you have forgotten the previous dose. Continue taking as described in the dosage instructions or as prescribed by your doctor.

If you stop taking ASS Dexcel

Please do not interrupt or stop treatment with ASS Dexcel without first discussing it with your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Gastrointestinal disorders

Common:

• Gastrointestinal complaints such as heartburn, nausea, vomiting, abdominal pain and diarrhea.
• Minor blood loss from the gastrointestinal tract (microbleeding).

Uncommon:

• Gastric or intestinal bleeding. After prolonged use of ASS Dexcel, anemia (iron deficiency anemia) can occur due to hidden blood loss from the stomach or intestinal tract
• Gastric or intestinal ulcers, which can very rarely lead to a perforation.
• Gastrointestinal inflammation.

Not known:

• In the case of previous damage to the intestinal mucosa, membranes can form in the intestinal space with possible subsequent narrowing. If black stools or bloody vomiting (signs of severe gastric bleeding) occur, you must notify your doctor immediately (see also section "Countermeasures").

Skin and subcutaneous tissue disorders

Uncommon: