ASS AL

ASS AL Protect 100 mg magensaftres.Tabletten

Important notes (mandatory information)

ASS AL Protect 100 mg enteric-coated tablets Active ingredient: Acetylsalicylic acid. Areas of application: to reduce the risk of blood clots and prevent the following conditions: heart attack, stroke, cardiovascular problems in patients with stable or unstable angina pectoris (chest pain).

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


Patient information: Information for the user
ASS AL Protect 100 mg enteric-coated tablets
Active ingredient: Acetylsalicylic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information. This medicine is available without a prescription. To get the best results from treatment, you must use ASS AL Protect carefully.
o Keep this leaflet. You may need to read it again.
o Ask your pharmacist if you need more information or advice.
o If your condition worsens or does not improve, you must see a doctor.
o If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

What this leaflet contains
1. WHAT IS ASS AL PROTECT AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASS AL PROTECT
3. HOW TO TAKE ASS AL PROTECT
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ASS AL PROTECT
6. FURTHER INFORMATION

1. WHAT IS ASS AL PROTECT AND WHAT IS IT USED FOR?
ASS AL Protect contains acetylsalicylic acid, which belongs to a group of medicines called platelet aggregation inhibitors in low doses. Platelets are tiny cells in the blood that cause the blood to clot and can lead to thrombosis. The occurrence of a blood clot in an artery stops the flow of blood and cuts off the oxygen supply. If this happens in the heart, it can lead to a heart attack or angina pectoris (chest pain); in the brain, it can lead to a stroke.

ASS AL Protect is used to reduce the risk of blood clots and prevent the following conditions

o Heart attack
o Stroke
o Cardiovascular problems in patients with stable or unstable angina pectoris (chest pain).
ASS AL Protect is also used to prevent blood clots from forming after certain types of heart surgery to widen or keep blood vessels open. This medicine is not suitable for emergencies. It can only be taken for prevention.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASS AL PROTECT
ASS AL Protect must NOT be taken
o if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine listed in section 6,
o if you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used to treat arthritis (joint inflammation) or rheumatism and pain,
o 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),
o if you currently have or have had an ulcer in your stomach or small intestine or another type of bleeding such as a stroke,
o if your blood is clotting poorly,
o if you have severe liver or kidney problems,
o in the last 3 months of pregnancy at a dose of more than 100 mg per day (see section "Pregnancy and breast-feeding"),
o if you are taking a medicine called methotrexate (used e.g. for cancer or rheumatoid arthritis) at a dose of more than 15 mg per week.

Warnings and precautions

Please talk to your doctor or pharmacist before taking ASS AL Protect if

o you have kidney, liver or heart problems,
o you have or have had stomach or small intestine problems,
o you have high blood pressure,
o you have asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or other chronic respiratory diseases; acetylsalicylic acid can trigger an asthma attack,
o you have ever had gout,
o you have heavy menstrual bleeding.
If your symptoms worsen or if you experience severe or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions or any other signs of allergic reactions, you must see a doctor immediately (see section "What side effects are possible?").
Tell your doctor if you are scheduled for surgery (even minor surgical procedures such as tooth extraction), as acetylsalicylic acid has a blood-thinning effect and may increase the risk of bleeding.
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 AL Protect should not be given to children under 16 years of age unless directed by a doctor.
You should drink plenty of fluids (you may be thirsty and have a dry mouth), as taking acetylsalicylic acid can also lead to a worsening of kidney function.
This medicine is not suitable for treating pain or as an antipyretic.
If one or more of the above points apply to you or if you are not sure, please talk to your doctor or pharmacist.

Taking ASS AL Protect with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines, including those you get without a prescription.

The effect of the following medicines may be affected if taken at the same time as acetylsalicylic acid

o anticoagulant/antiplatelet medicines (e.g. warfarin, heparin, clopidogrel)
o medicines to prevent organ rejection after a transplant (ciclosporin, tacrolimus)
o blood pressure lowering medicines (e.g. diuretics and ACE inhibitors)
o heart rate regulating medicines (digoxin)
o medicines for manic-depressive illness (lithium)
o pain relievers and anti-inflammatories (e.g. NSAIDs such as ibuprofen or steroids)
o medicines for gout (e.g. probenecid)
o medicines for epilepsy (valproate, phenytoin)
o medicines for glaucoma (acetazolamide)
o medicines for cancer or rheumatoid arthritis (methotrexate at a dose of less than 15 mg per week)
o medicines for diabetes (e.g. glibenclamide)
o medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
o medicines for hormone replacement therapy in the event 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 AL Protect with food and drink
Drinking alcohol may increase the risk of gastrointestinal bleeding and its duration.

Pregnancy and breast-feeding
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.
Pregnancy
Pregnant women should not take acetylsalicylic acid without medical advice. In the last 3 months of pregnancy, you should only take ASS AL Protect if your doctor has prescribed it and the daily dose does not exceed 100 mg (see section "ASS AL Protect must not be taken..."). Regular or high doses of this medicine during the last phase of pregnancy can cause serious complications in the mother and child.
Breast-feeding
Breast-feeding mothers should not take acetylsalicylic acid without medical advice.

Driving and using machines
ASS AL Protect should not affect your ability to drive or use machines.

3. HOW TO TAKE ASS AL PROTECT
Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults for the prevention of a heart attack
o The recommended dose is 100 mg once a day.

For the prevention of a stroke
o The recommended dose is 100 mg once a day.

For the prevention of cardiovascular problems in patients with stable or unstable angina pectoris (chest pain)
o The recommended dose is 100 mg once a day.

For the prevention of blood clots after certain types of heart surgery
o The recommended dose is 100 mg once a day.
The usual dose for long-term use is 100 mg (1 tablet) once a day. ASS AL Protect should not be used at a higher dose without medical advice. The maximum daily dose is 300 mg.

Elderly patients
Use as in 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.

Children and adolescents
Acetylsalicylic acid should 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 AL Protect").

Method of administration
For oral use. Swallow the tablet whole with plenty of liquid (½ glass of water). Because of the enteric coating, the tablets should not be crushed, broken or chewed, as the tablet coating prevents irritation of the stomach.

If you have taken more ASS AL Protect than you should
If you (or someone else) have accidentally taken too many tablets, please notify your doctor immediately or contact the nearest emergency room. Show the doctor the remaining medicine or the empty package. 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 faster than normal breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, low blood sugar, coma, and shock.

If you forget to take ASS AL Protect
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, ASS AL Protect can have side effects, although not everybody gets them. If you experience one or more of the following serious side effects, stop taking ASS AL Protect and see a doctor immediately

o Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
o 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's syndrome.
o Unusual bleeding such as coughing up blood, blood in vomit or urine, or black stools.

Other side effects

Common (1 to 10 in 100 treated)

o Indigestion.
o Increased bleeding tendency.

Uncommon (1 to 10 in 1,000 treated)

o Hives.
o Runny nose.
o Difficulty breathing.

Rare (1 to 10 in 10,000 treated)

o Severe bleeding in the stomach or intestines, brain hemorrhage; changes in the number of blood cells.
o Nausea and vomiting.
o Convulsions in the lower respiratory tract, asthma attack.
o Inflammation in the blood vessels.
o Bruising (bleeding into the skin).
o Severe skin reactions such as rashes, also known as erythema multiforme, and its life-threatening forms Stevens-Johnson syndrome and Lyell's syndrome.
o Hypersensitivity reactions such as swelling of the lips, face or body or shock.
o Unusually heavy or prolonged menstrual bleeding

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

o Ringing in the ears (tinnitus) or impaired hearing.
o Headache.
o Dizziness.
o Stomach or small intestine ulcers and perforation.
o Prolonged bleeding time.
o Impaired kidney function.
o Impaired liver function.
o High uric acid levels in the blood.

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly

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 AL PROTECT
Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton or container. The expiry date refers to the last day of the month indicated. Do not store above + 25ºC. Store in the original package to protect from moisture. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, you help to protect the environment.

6. FURTHER INFORMATION
What ASS AL Protect contains

The active ingredient is acetylsalicylic acid. 1 enteric-coated tablet contains 100 mg acetylsalicylic acid. The other ingredients are

Tablet core: Microcrystalline cellulose, corn starch, highly dispersed silicon dioxide, stearic acid.(Ph. Eur.) [vegetable].
Film coating: Methacrylic acid-ethyl acrylate copolymer (1:1) (Ph.Eur.) (Type C), sodium dodecyl sulfate, polysorbate 80, triethyl citrate, talc.

What ASS AL Protect looks like and contents of the pack
Round, white, biconvex tablet with a diameter of 7.2 mm.
ASS AL Protect is available in packs of 50 and 100 enteric-coated tablets.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel

This leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 11/2014

Active ingredient: Acetylsalicylic acid. Areas of application: to reduce the risk of blood clots and prevent the following conditions: heart attack, stroke, cardiovascular problems in patients with stable or unstable angina pectoris (chest pain).