ASS TAD

ASS TAD 100 mg protect gastro-resistant film-coated tablets

Important notes (mandatory information)

ASS TAD 100 mg protect enteric-coated tablets. Active ingredient: Acetylsalicylic acid (Ph.Eur.). Indications: ASS TAD 100 mg protect is used to reduce the risk of blood clots forming and to prevent the following conditions: heart attacks, strokes and circulatory disorders in patients with stable or unstable angina pectoris (chest pain). ASS TAD 100 mg protect is also used to prevent blood clots forming after certain types of heart surgery to widen or keep blood vessels open.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

ASS TAD 100 mg protect enteric-coated tablets
Active ingredient: Acetylsalicylic acid (Ph.Eur.)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or healthcare professional has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist or healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What is in this leaflet

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

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

ASS TAD 100 mg protect contains acetylsalicylic acid, which in low doses belongs to a group of medicines called platelet aggregation inhibitors. Platelets are tiny cells in the blood that make the blood clot and can lead to thrombosis. The formation of a blood clot in an artery stops the blood flow and cuts off the oxygen supply. If this happens in the heart, it can cause a heart attack or angina pectoris; in the brain, it can lead to a stroke. ASS TAD 100 mg protect is used to reduce the risk of blood clots forming and to prevent the following conditions: heart attacks, strokes and circulatory disorders in patients with stable or unstable angina pectoris (chest pain). ASS TAD 100 mg protect is also used to prevent blood clots forming after certain types of heart surgery to widen or keep blood vessels open. The doctor should decide when to start treatment and what the appropriate dosage is. This medicine is not suitable for emergency situations. It can only be taken for prevention.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASS TAD 100 MG PROTECT?

ASS TAD 100 mg protect must not be taken:

• if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used to treat arthritis (inflammation of the joints) or rheumatism and pain;
• if you have reacted to taking salicylates or NSAIDs with asthma attacks or with swelling of certain parts of the body, e.g. face, lips, throat or tongue (angioedema);
• if you currently have or have had a stomach or small intestine ulcer or any other type of bleeding such as in a stroke;
• if you have bleeding disorders;
• if you have severe liver or kidney problems;
• if you suffer from a severe heart condition, possibly combined with shortness of breath or ankle swelling;
• if you are in the last 3 months of pregnancy, you must not use doses higher than 100 mg per day (see section "Pregnancy and breast-feeding");
• if you are taking a medicine called methotrexate (used e.g. for cancer or rheumatoid arthritis) in a dosage of more than 15 mg per week.

Warnings and precautions

Talk to your doctor or pharmacist before taking ASS TAD 100 mg protect:

• if you have kidney, liver or heart problems,
• if you have or have had stomach or small intestine problems,
• if you have uncontrolled high blood pressure,
• if you have asthma, hay fever, nasal swelling (nasal polyps) or other chronic respiratory diseases; acetylsalicylic acid can trigger an asthma attack,
• if you have ever had gout,
• if you have heavy menstrual bleeding,
• if you suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

If your symptoms worsen or if you experience severe or unexpected side effects, e.g. unusual bleeding symptoms, severe skin reactions or any other signs of allergic reactions, you must see a doctor immediately (see section "What are the possible side effects?"). Tell your doctor if you are due to have an operation (even minor surgery such as having a tooth extracted), as acetylsalicylic acid has a blood-thinning effect and there may be an increased risk of bleeding. You should make sure that you do not become dehydrated (you may feel thirsty and have a dry mouth), as taking acetylsalicylic acid can at the same time lead to a worsening of kidney function. This medicine is not suitable for treating pain or as an antipyretic. Should one or more of the above points apply to you or if you are not sure about this, please talk to your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid can trigger Reye's syndrome when given to children. Reye's syndrome is a very rare condition that damages the brain and liver and can be life-threatening. Therefore, ASS TAD 100 mg protect must not be given to children under 16 years of age, except on medical advice.

Taking ASS TAD 100 mg protect with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of the following medicines can be influenced by concomitant treatment with acetylsalicylic acid:

• blood-thinning/blood clot preventing or dissolving medicines (e.g. warfarin, heparin, clopidogrel, alteplase).
• medicines against organ rejection after a transplant (ciclosporin, tacrolimus).
• blood pressure lowering medicines (e.g. diuretics and ACE inhibitors).
• heart rate regulating medicines (digoxin).
• medicines for manic-depressive illnesses (lithium).
• painkillers and medicines against inflammation (e.g. NSAIDs such as ibuprofen or steroids).
• medicines for gout (e.g. probenecid).
• medicines for epilepsy (valproate, phenytoin).
• medicines for glaucoma (acetazolamide).
• medicines for cancer or rheumatoid arthritis (methotrexate in a dosage of less than 15 mg per week).
• medicines for diabetes mellitus (e.g. glibenclamide, insulin).
• medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine).
• medicines for hormone replacement therapy in the case of destruction or removal of the adrenal gland or pituitary gland or medicines for treating inflammation including rheumatic diseases and inflammation of the gastrointestinal tract (corticosteroids).

Taking ASS TAD 100 mg protect with food, drink and alcohol

Drinking alcohol may increase the risk of a gastrointestinal bleed as well as its duration.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnant women must not take acetylsalicylic acid without medical advice. in the last 3 months of pregnancy, you must only take ASS TAD 100 mg protect if your doctor has prescribed it and the daily dose does not exceed 100 mg (see section "ASS TAD 100 mg protect must not be taken"). Regular or high doses of this medicine during the last phase of pregnancy can trigger serious complications in the mother and child. Breast-feeding mothers must not take acetylsalicylic acid without medical advice.

Driving and using machines

ASS TAD 100 mg protect should not affect your ability to drive or use machines.

ASS TAD 100 mg protect contains lactose

Therefore, please only take ASS TAD 100 mg protect after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE ASS TAD 100 MG PROTECT?

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.

Adults:

• For the prevention of a heart attack: The recommended dose is 75 – 160 mg 1 time daily.
• For the prevention of a stroke: The recommended dose is 75 – 325 mg 1 time daily.
• For the prevention of circulatory disorders in patients with stable or unstable angina pectoris (chest pain): The recommended dose is 75 – 160 mg 1 time daily.
• For the prevention of blood clots after certain types of heart surgery: The recommended dose is 75 – 160 mg 1 time daily.

This medicine must not be used in a higher dose without medical advice and then the maximum daily dose of 325 mg must not be exceeded.

Elderly patients

Use as for adults. In general, acetylsalicylic acid should be used with caution in elderly patients, who are more susceptible to side effects. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Acetylsalicylic acid must not be used in children and adolescents under 16 years of age without a doctor's prescription (see section "Special care must be taken when taking ASS TAD 100 mg protect").

Method of administration

For oral use. Take the tablet whole with sufficient liquid (1/2 glass of water). Because of the enteric coating, the tablets must not be crushed, broken or chewed, as the tablet coating prevents irritation of the stomach.

If you take more ASS TAD 100 mg protect than you should

If you (or someone else) have accidentally taken too many tablets, please inform your doctor immediately or contact the nearest emergency department. Show the doctor the remaining medicine or the empty pack. Symptoms of an overdose may include ringing in the ears, hearing problems, headache, dizziness, confusion, nausea, vomiting and abdominal pain. A high overdose can lead to a faster than normal breathing rate (hyperventilation), fever, excessive sweating, restlessness, cramps, hallucinations, low blood sugar, coma and shock.

If you forget to take ASS TAD 100 mg protect

If you forget a dose, wait until the next dose and continue treatment as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking ASS TAD 100 mg protect

Do not stop taking ASS TAD 100 mg protect without asking your doctor.

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

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience one or more of the following serious side effects, stop taking ASS TAD 100 mg protect and see a doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling; possibly in conjunction with high fever and joint pain. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell syndrome.
• Unusual bleeding such as coughing up blood, blood in vomit or urine or black stools.

Other side effects

Common (may affect up to 1 in 10 people):

• Nausea, vomiting, diarrhoea.
• Indigestion.
• Increased tendency to bleed.

Uncommon (may affect up to 1 in 100 people):

• Hives.
• Runny nose.
• Difficulty breathing.

Rare (may affect up to 1 in 1,000 people):

• Severe bleeding in the stomach or intestine, brain haemorrhage; changes in the number of blood cells.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation in the blood vessels.
• Bruising (bleeding into the skin).
• Severe skin reactions such as rashes, also known as erythema multiforme, and its life-threatening forms Stevens-Johnson syndrome and Lyell syndrome.
• Hypersensitivity reactions such as swelling of the lips, face or body or shock.
• Reye's syndrome (a very rare condition in children that damages the brain and liver (see section 2 "Children and adolescents")).
• Unusually heavy or prolonged menstrual bleeding.

Not known (frequency cannot be estimated from the available data):

• Ringing in the ears (tinnitus) or impaired hearing.
• Headache.
• Dizziness.
• Stomach or small intestine ulcers and perforation.
• Prolonged bleeding time.
• Kidney dysfunction, acute kidney failure.
• Liver dysfunction, increase in liver enzymes.
• High uric acid level in the blood or low blood sugar level.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ASS TAD 100 MG PROTECT?

Keep this medicine out of the sight and reach of children. Do not store above 30°C. Do not use this medicine after the expiry date which is stated on the blister pack after "useable until:". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ASS TAD 100 mg protect contains

The active substance is: Acetylsalicylic acid (Ph.Eur). Each enteric-coated tablet contains 100 mg acetylsalicylic acid (Ph.Eur). The other ingredients of ASS TAD 100 mg protect are: Tablet core: Lactose monohydrate, microcrystalline cellulose, highly dispersed silicon dioxide, potato starch. Film coating: Talc, triacetin, methacrylic acid-ethyl acrylate copolymer-(1:1 ) dispersion 30% (Ph.Eur.), sodium dodecyl sulfate* and polysorbate 80*
* May contain sodium dodecyl sulfate and polysorbate 80.

What ASS TAD 100 mg protect looks like and contents of the pack

White, round, biconvex film-coated tablet with a diameter of approx. 8.1 mm.

Pack sizes

20, 28, 30, 50, 56, 60, 84, 90 and 100 enteric-coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

TAD Pharma GmbH