75 and 160 mg tablets of
acetylsalicylic acid
What Acetylsalicylic Acid GL Pharma is and what it is used for
Acetylsalicylic acid GL Pharma contains acetylsalicylic acid, which is low does belong to the group of drugs platelet aggregation inhibitors. Platelets ( platelets ) are small cells in the blood that cause the blood to coagulate and can cause blood clots to form. When a blood clot occurs in an artery, blood flow is stopped and the oxygen supply is turned off. When this happens in the heart, it can cause a heart attack or angina pectoris (angina); in the brain, it can cause strokes.
Acetylsalicylic acid GL Pharma is taken to reduce the risk of blood clots and thus further prevent:
– heart attacks
– stroke
– heart vascular problems in patients suffering from stable or unstable angina Pectoris (a type of chest pain).
Acetylsalicylic acid GL Pharma is used to prevent the formation of blood clots after certain types of heart surgery performed to dilate vessels or remove the clot.
Acetylsalicylic acid GL Pharma is also used to treat acute myocardial infarction.
Acetylsalicylic acid contained in Acetylsalicylic acid GL Pharma may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you take Acetylsalicylic acid GL Pharma
Do not take Acetylsalicylic acid GL Pharma
– if you are allergic to acetylsalicylic acid, other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are commonly used for arthritis or rheumatism and pain) or any of the other ingredients of Acetylsalicylic acid GL Pharma (listed in section 6)
– if you have had an asthma attack or swelling of certain parts of the body, e.g. face, lips, throat, or tongue ( angioedema ) after taking salicylates or NSAIDs -preparat
– if you have or have had stomach ulcers or bleeding in the stomach/intestines caused by previous NSAID treatment
– if you have or have had recurrent ulcers in the stomach/intestines or any other type of bleeding, e.g. stroke
– if you have ever had problems with your blood not coagulating properly
– if you have severe liver or kidney problems
– if you have severe heart problems that can cause shortness of breath and swollen ankles
– if you are pregnant in the last 3 months of pregnancy, do not use doses above 100 mg/day (see section “Pregnancy and breast-feeding”).
– if you are taking the medicine methotrexate (eg for cancer or rheumatism) at doses above 15 mg/week.
Warnings and cautions
Talk to your doctor or pharmacist before taking Acetylsalicylic acid GL Pharma if you:
– have problems with kidneys, liver, or heart
– have or have ever had sores or bleeding (eg in the stomach or small intestine)
– has high blood pressure
– have asthma, hay fever, nasal polyps, or chronic respiratory disease; Acetylsalicylic acid can trigger an asthma attack
– have ever had gout
– have heavy menstrual bleeding
– if you do not have the enzyme et glucose -6-phosphate dehydrogenase (G6PD).
You must see a doctor immediately if the symptoms worsen or if you get serious or unforeseen side effects, e.g. unusual bleeding, severe skin reactions, or other signs of severe allergy (see section “Possible side effects”).
Tell your doctor if you know you are having surgery (even minor procedures such as tooth extraction) as acetylsalicylic acid is a blood thinner and there may be an increased risk of bleeding.
You should make sure that you do not become dehydrated (feeling thirsty and dry mouth ) as intake of acetylsalicylic acid in such cases can impair kidney function.
This medicine is not suitable as an analgesic or antipyretic.
If any of the above applies to you or if you are not sure, talk to your doctor or pharmacist.
Children and young people
Acetylsalicylic acid GL Pharma can cause Reye’s syndrome if given to children. Reye’s syndrome is a very serious disease that affects the brain and liver and can be life-threatening.
Acetylsalicylic acid GL Pharma should therefore not be given to children under 16 years of age unless recommended by a doctor.
Other medicines and Acetylsalicylic acid GL Pharma
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
The effect of the treatment can be affected if acetylsalicylic acid is taken at the same time as certain other medicines, for example:
– blood-thinning drugs, which prevent and dissolve blood clots (eg warfarin, heparin, clopidogrel, alteplase)
– drugs that counteract organ rejection after transplantation (cyclosporine, tacrolimus)
– antihypertensive drugs (eg diuretics and ACE inhibitors )
– drugs that affect the heart rhythm ( digoxin )
– medicines for manic-depressive illness (lithium)
– painkillers and anti-inflammatory drugs (eg NSAIDs: such as ibuprofen or steroids )
– Metamizole (a substance that reduces pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation ( blood cells that attach to each other and form a blood clot) when taken at the same time. Therefore, this combination should be used with caution in patients taking a low dose of acetylsalicylic acid for cardiac protection.
– medicines for gout (eg probenecid)
– medicines for epilepsy ( valproate, phenytoin )
– medicines for glaucoma, ie increased pressure in the eye (acetazolamide) when used with high doses of acetylsalicylic acid (at least 500 mg)
– medicines for cancer or rheumatoid arthritis (methotrexate in doses below 15 mg/week)
– medicines for diabetes (glibenclamide, insulin )
– antidepressants (selective serotonin reuptake inhibitors ( SSRIs ) such as sertraline or paroxetine )
hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or for the treatment of inflammation, including rheumatic diseases and intestinal inflammations (cortisone preparations).
Acetylsalicylic acid GL Pharma with alcohol
Alcohol consumption can increase the risk of gastrointestinal bleeding and increase bleeding time.
Pregnancy, breastfeeding, and fertility
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.
Pregnant women should not take acetylsalicylic acid during pregnancy unless directed to do so by their doctor. During the last three months of pregnancy Acetylsalicylic acid, GL Pharma should not be used unless prescribed by a doctor and the daily dose should not exceed 100 mg (see section “Do not take Acetylsalicylic acid Pharma”). Normal or high doses of this medicine during the late part of pregnancy can cause serious complications in the mother or baby.
Breast-feeding women should not take acetylsalicylic acid unless instructed to do so by their doctor.
Acetylsalicylic acid can affect fertility in women and is therefore not recommended for women trying to conceive.
Driving and using machines
Acetylsalicylic acid GL Pharma is not expected to affect your ability to drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Acetylsalicylic acid GL Pharma contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Acetylsalicylic acid GL Pharma
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults
Prevention of myocardial infarction:
The recommended dose is 75-160 mg once daily.
Stroke prevention:
The recommended dose is 75‑300 mg once daily.
Prevention of cardiovascular problems in patients with stable or unstable angina Pectoris (a type of chest pain):
The recommended dose is 75-160 mg once daily
Prevention of blood clots after certain types of heart surgery:
The recommended dose is 75-160 mg once daily.
Treatment of acute myocardial infarction:
The recommended starting dose is 150-500 mg followed by a lower dose (75-160 mg) thereafter.
This medicine should not be used in higher doses unless your doctor recommends it.
Older
As for adults. In general, acetylsalicylic acid should be used with caution in elderly patients who may experience more side effects. The treatment should be reviewed regularly.
Children and young people
Acetylsalicylic acid should not be given to children or adolescents under 16 years of age unless prescribed by a doctor (see section “Warnings and precautions”).
Length of treatment time
Long-term treatment with the lowest possible dose.
The tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water).
Symptoms of an overdose may include tinnitus, hearing loss, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A larger overdose can lead to faster than normal breathing (hyperventilation), fever, sweating, restlessness, seizures, hallucinations, low blood sugar, pulmonary edema, coma, and shock.
If you forget to take Acetylsalicylic acid GL Pharma
If you miss a dose, wait until it is time for your next dose and then continue as usual. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Acetylsalicylic acid GL Pharma
Talk to your doctor before stopping Acetylsalicylic acid GL Pharma
If you have any further questions on the use of this product, 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 Acetylsalicylic acid GL Pharma and contact your doctor immediately.
– Sudden wheezing, swelling of the lips, face, or body, rash, fainting, or difficulty swallowing (severe allergic reaction ).
– Reddening of the skin with blisters or flaking which may be linked to fever and joint pain. This can be erythema multiforme, Stevens-Johnson syndrome, or Lyell’s syndrome.
– Abnormal bleeding, such as coughing up blood, vomiting blood or urine, or black stools.
Other side effects include:
Common (may affect more than 1 user in 10)
– Nausea, vomiting, diarrhea.
– Digestive problems
Increased tendency to bleed.
Uncommon (may affect up to 1 in 100 people)
Hives
– Runny nose
– Breathing difficulties.
Rare (may affect up to 1 in 1,000 people)
– severe bleeding in the stomach or intestines, brain hemorrhage, changes in the number of blood s
– Lower respiratory tract cramps, asthma attack
– Inflammation of the blood vessels
– Bruises with purple tone (superficial bleeding)
– Severe rash such as erythema multiforme and its life-threatening forms Stevens-Johnson syndrome and Lyell’s syndrome
– Hypersensitivity reactions, e.g. swelling of the lips, face, or body, or shock.
– Reye’s syndrome (a very rare disease in children that affects the brain and liver (see section 2 Children and adolescents)
– Abnormally heavy or long menstrual periods.
Has been reported (occurs in an unknown number of users)
– tinnitus ( tinnitus ) or hearing
– Headache
– Dizziness
– Ulcers in the stomach or small intestine and perforation
Prolonged bleeding time
– Renal impairment, acute renal failure
– Hepatic impairment, elevated liver enzymes
– High levels of uric acid or low levels of sugar in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Acetylsalicylic acid GL Pharma
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Other information
Content declaration
– The active substance is acetylsalicylic acid. The tablets contain 75 and 160 mg of acetylsalicylic acid, respectively.
– The other ingredients are:
lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, potato starch.
What the medicine looks like and the contents of the pack
75 mg: a white, round, biconvex tablet with a diameter of approximately 7.0 mm.
160 mg: a white, round, biconvex tablet with a diameter of approximately 9.0 mm.
Pack sizes :
10, 20, 28, 30, 50, 56, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
GL Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Manufacturer:
GL Pharma GmhH, 8502 Lannach, Austria
Local representative
Nordic Drugs AB
Box 30035
20061 Limhamn