Acetylsalicylsyra Teva
Package leaflet: Information for the user
Acetylsalicylsyra Actavis 75 mg, 150 mg and 160 mg tablets
Acetylsalicylic acid
<[Prescription only:]>
<Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.>
<[Non-prescription:]>
<Read allof thisleafletcarefully beforeyou starttaking thismedicine because itcontainsimportant information foryou.
Alwaystakethismedicineexactlyas described in thisleafletor asyourdoctor, pharmacist, or nursehas 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. This includes any possible side effects not listed in this leaflet. See section 4.
<[To be completed nationally]>
What is in this leaflet:
1. What Acetylsalicylsyra Actavis is and what it is used for
2. What you need to know before you take Acetylsalicylsyra Actavis
3. How to take Acetylsalicylsyra Actavis
4. Possible side effects
5. How to store Acetylsalicylsyra Actavis
6. Contents of the pack and other information
1. What Acetylsalicylsyra Actavis is and what it is used
Acetylsalicylsyra Actavis contains acetylsalicylic acid, which in low doses belong to a group of medicines called anti-platelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are involved in thrombosis. When a blood clot occurs in an artery it stops the blood flowing and cuts off the oxygen supply. When this happens in the heart it can cause a heart attack or angina; in the brain it can cause a stroke.
Acetylsalicylsyra Actavis is taken to reduce the risk of blood clots forming and thereby prevent further:
- heart attacks
- strokes
- cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain).
Acetylsalicylsyra Actavis is also used in the treatment of acute heart attack and to prevent the formation of blood clots after certain types of heart surgery in order to widen or to unblock the blood vessels.
2. What you need to know before you take Acetylsalicylsyra Actavis
Do not take Acetylsalicylsyra Actavis if you
- are allergic to acetylsalicylic acid or any of the ingredients of this medicine (listed in section 6)
- are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain
- have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs
- currently have or have ever had an ulcer in your stomach or small intestine or any other type of bleeding like a stroke
- have ever had the problem of your blood not clotting properly
- have severe liver or kidney problems
- suffer from gout
- are in your last 3 months of pregnancy; you must not use higher doses than 100 mg per day (see section “Pregnancy and breast-feeding”)
- are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses higher than 15 mg per week
Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylsalicylsyra Actavis if you:
-
have trouble with your kidneys, liver or heart
-
have or have ever had problems with your stomach or small intestine
-
have high blood pressure
-
are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack
-
have ever had gout
-
have heavy menstrual periods
You must immediately seek medical advice, if your symptoms get worse or if you experience severe or unexpected side effects e.g. unusual bleeding symptoms, serious skin reactions or any other sign of serious allergy (see section “Possible side effects”).
Inform your doctor if you are planning to have an operation (even a minor one, such as tooth extraction) since acetylsalicylic acid is blood-thinning there may be an increased risk of bleeding.
Acetylsalicylic acid may cause Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease which affects the brain and liver and can be live threatening. For this reason, Acetylsalicylsyra Actavis should not be given to children aged under 16 years, unless on the advice of a doctor.
You should take care not to become dehydrated (you may feel thirsty with a dry mouth) since the use of acetylsalicylic acid at the same time may result in deterioration of kidney function.
This medicinal product is not suitable as a pain killer or fever reducer.
If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist.
Other medicines and Acetylsalicylsyra Actavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as some other medicines for:
- thinning of the blood/prevention of clots (e.g. warfarin, heparin, clopidogrel)
- rejection of organ after transplantation (cyclosporine, tacrolimus)
- high blood pressure (e.g. diuretics and ACE-inhibitors)
- regulation of the heart beat (digoxin)
- manic-depressive illness (lithium)
- pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)
- gout (e.g. probenecid)
- glaucoma (acetazolamide)
- cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week)
- diabetes (e.g. glibenclamide)
- depression (selective serotonin re-uptake inhibitors (SSRIs) such as sertraline or paroxetine).
- use as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation of the intestines (corticosteroids)
- antacids (indigestion medicine)
Acetylsalicylsyra Actavis with alcohol
Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Acetylsalicylic acid should not be taken during pregnancy unless advised by a doctor.
You should not take Acetylsalicylsyra Actavis if you are in the last 3 months of pregnancy, unless you are advised to do so by your doctor and then the daily dose should not exceed 100 mg (see section “Do not take Acetylsalicylsyra Actavis”). Regular or high doses of this medicinal product during late pregnancy can cause serious complications in the mother or baby.
You should not take acetylsalicylic acid during breast-feeding unless advised by your doctor.
Driving and using machines
Acetylsalicylsyra Actavis should not affect your ability to drive and use machines.
3. How to take Acetylsalicylsyra Actavis
<[Prescription only:]>
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
<[Non-prescription only:]>
Alwaystakethismedicineexactlyas described in this leaflet or asyour doctoror pharmacisthas told you.Checkwith yourdoctoror pharmacistif you arenot sure.
Adults
Prevention of heart attacks:
- The recommended dose is 75-160 mg once daily.
Prevention of strokes:
- The recommended dose is 75-325 mg once daily.
Prevention of cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain):
- The recommended dose is 75-160 mg once daily.
Prevention formation of blood clots after certain types of heart surgery:
- The recommended dose is 75-160 mg once daily.
Acute heart attack
- The recommended dose is 150-450 mg, taken as soon as possible after onset of symptoms.
Elderly
As for adults. In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.
Use in children and adolescents
Acetylsalicylic acid should not be administered to children and adolescents younger than 16 years, unless prescribed by a doctor (see section “Warnings and precautions”).
Method of administration
For oral use.
[For child resistant blister packs only:]
Instructions for use of child resistant blisters:
1. Do not try and push the tablet directly out of the pocket. The tablet cannot be pushed out through the foil. Instead the foil must be peeled back.
2. First, separate one blister cell from the rest of the strip at the perforations
3. Then carefully peel off the backing to open the pocket
4. You can then remove the tablet from the pocket
[For child resistant bottles only:]
Instructions for use of child resistant bottles:
Push down the lid and turn to open
If you take more Acetylsalicylsyra Actavis than you should
If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or contact immediately the nearest casualty department. Show any leftover medicines or the empty packet to the doctor.
Symptoms of overdose may include ringing in ears, hearing problems, headache, dizziness, confusion, nausea, vomiting and abdominal pain. A large overdose can lead to more rapid breathing than normal (hyperventilation), fever, excess sweating, restlessness, seizures, hallucinations, low blood sugar, coma and shock.
If you forget to take Acetylsalicylsyra Actavis
If you miss a dose, wait until it is time for your next dose, then go on as normal.
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Acetylsalicylsyra Actavis and contact a doctor immediately:
- Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction).
- Reddening of the skin with blisters or peeling andmay be associated with a high fever and joint pains. This could by erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome.
- Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.
Common side effects (may affect up to 1 in 10 people):
- Indigestion.
- Increased tendency for bleeding.
Uncommon side effects (may affect up to 1 in 100 people):
- Hives.
- Runny noses.
- Breathing difficulty.
Rare side effects (may affect up to 1 in 1000 people):
- Severe bleeding in the stomach or intestines, brain haemorrhage; altered number of blood cells.
- Nausea and vomiting.
- Cramps in the lower respiratory tract, asthma attack.
- Inflammation in the blood vessels.
- Bruising with purple spots (cutaneous bleeding).
- Severe skin reactions such as rash known as erythema multiforme and it’s life threatening forms Stevens-Johnson syndrome and Lyell’s syndrome.
- Hypersensitivity reactions, such as swelling of e.g. lips, face or body, or shock.
- Abnormal heavy or prolonged menstrual periods
Side effects with unknown frequency (frequency cannot be estimated from the available data)
- Ringing in your ears (tinnitus) or reduced hearing ability.
- Headache.
- Vertigo.
- Ulcers in stomach or small intestine and perforation.
- Prolonged bleeding time.
- Impaired kidney function.
- Salt or water retention which may cause swelling of hands, feet, legs, stomach, breasts or face.
- Impaired liver function.
- High level of uric acid in the blood.
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 via [To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Acetylsalicylsyra Actavis
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton or tablet container/blister after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Acetylsalicylsyra Actavis contains
The active substance is acetylsalicylic acid. Each tablet contains 75, 150 or 160 mg of acetylsalicylic acid.
The other ingredients are: microcrystalline cellulose, maize starch, colloidal anhydrous silica, stearic acid.
What Acetylsalicylsyra Actavis looks like and contents of the pack
Acetylsalicylsyra Actavis 75 mg tablets are oval, white, biconvex tablets, 9.0 x 5.0 mm.
Acetylsalicylsyra Actavis 150 mg tablets are oval, white, biconvex tablets, 11.5 x 6.5 mm with a score-line on one side. The tablets can be divided into equal halves.
Acetylsalicylsyra Actavis 160 mg tablets are round, white, biconvex tablets with a diameter of 8.7 mm with a score-line on one side. The tablets can be divided into equal halves.
Pack sizes:
75 mg tablets:
Blister packs: 28, 50, 500 or 1000 tablets.
Tablet containers: 100, 500 or 1000 tablets.
150 mg tablets:
Tablet containers: 100 or 500 tablets.
160 mg tablets:
Tablet containers: 100, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
<[To be completed nationally]>
Manufacturer
<[To be completed nationally]>
Balkanpharma Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
This medicinal product is authorised in the Member States of the EEA under the following names:
<{Nameof theMemberState}> <{Nameof themedicinalproduct}>
<{Nameof theMemberState}> <{Nameof themedicinalproduct}>
This leaflet was last approved in 20 September 2016.