ASPIRIN TBL 500MG N100 (BAYER)

ATC code: N02BA01 

Active substances: Acidum Acetylsalicylicum

Vendor, principal: Bayer Consumer Care. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ASPIRIN 500MG N20

Package leaflet: Information for the user Aspirin 500 mg tablets

Acetylsalicylic acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist 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. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What Aspirin is and what it is used for
2.   What you need to know before you use Aspirin
3.   How to use Aspirin tablets
4.   Possible side effects
5.   How to store Aspirin tablets
6.   Contents of the pack and other information

1. What Aspirin is and what it is used for

Aspirin contains acetylsalicylic acid, which has an analgesic, antipyretic and anti-inflammatory effect. Aspirin tablets are used in case of mild pain, fever, and rheumatic diseases.

2. What you need to know before you use Aspirin Do not use Aspirin tablets:

if you are allergic to acetysalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
-   if you have or have ever had asthma induced by salicylates or similar substances, especially non-steroidal anti-inflammatory drugs;
-   if you have acute gastrointestinal ulcers;
-   if you have a predilection for bleeding or haemorrhage;
-   if you have severe kidney, liver or heart failure;
-   if you have been prescribed treatment with 15 mg or more of methotrexate per week;
-   if you are in the last trimester of pregnancy.

Warnings and precautions

Take special care with Aspirin:
-   if you are hypersensitive to analgesics, anti-inflammatory or anti-rheumatic medicines or other allergens;
-   if you have or have ever had a gastrointestinal ulcer, including chronic or recurring peptic ulcer disease or gastrointestinal bleeding;
-   if you have been prescribed anticoagulation therapy;
-   if you have a renal function disorder or cardiovascular circulation disorders (e.g. renovascular disease, congestive heart failure, hypovolemia, major surgery, sepsis, or major bleeding);
-   if you have the metabolic disorder glucose-6-phosphate dehydrogenase deficiency;
-   if you have hepatic function disorders;
-   if you have impaired uric acid excretion;
-   if you are pregnant (first or second trimester of pregnancy) or breast-feeding.
Even small doses of acetylsalicylic acid reduce the excretion of uric acid. This may intensify the progression of gout in patients with impaired excretion of uric acid.
Acetlsalicylic acid can trigger a bronchospasm and cause asthma attacks or other hypersensitivity reactions. Risk factors include existing bronchial asthma, hay fever, nasal polyps (adenoids), or chronic respiratory disease.
Acetylsalicylic acid can cause a predilection for bleeding during or after surgery (including minor surgical procedures, such as pulling teeth).
Acetylsalicylic acid is not recommended for children and adolescents under the age of 16 in case of viral infections with fever (incl. chickenpox, influenza), as this may lead to Reye’s syndrome (a life-threatening condition characterised by encephalopathy (impairment of the central nervous system), abnormal hepatic function; prolonged vomiting as the first symptom). Reye’s syndrome is a very rare but possibly life-threatening condition that requires immediate medical attention.
Ask your doctor or pharmacist for advice before using Aspirin tablets.

Other medicines and Aspirin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use with Aspirin tablets can increase the activity and side effects of the following medicines:
-   methotrexate (medicine used in the treatment of malignant diseases, psoriasis, and rheumatoid arthritis);
-   anticoagulants (medicines inhibiting blood clotting);
-   non-steroidal anti-inflammatory drugs;
-   selective serotonine reuptake inhibitors (SSRI) (medicines used in the treatment of depression);
-   digoxine (medicine used in the treatment of heart failure);
-   insulin and sulfonylurea formulations (medicines used in the treatment of diabetes);
-   valproic acid (epilepsy medicine).
Concomitant use of glucocorticoids (hormonal medicines used in the treatment of chronic and acute inflammations) will reduce the effect of salicylates due to their increased secretion.
Concomitant use with Aspirin tablets can decrease the effect of the following medicines:
-   diuretics (medicines that increase urine excretion);
-   angiotensin converting enzyme (ACE) inhibitors (medicines reducing blood pressure);
-   uricosuric preparations (medications that promote the excretion of uric acid).

Aspirin and alcohol

Consumption of alcohol while using the medicine increases the risk of gastrointestinal bleeding and prolongs the bleeding time.

Pregnancy and breast-feeding

Using Aspirin tablets is not recommended during pregnancy. During the first and second trimester of pregnancy, Aspirin tablets can only be used under the doctor’s prescription. Aspirin tablets must not be used in the last trimester of pregnancy.
As adverse effects on the child have not been observed in case of occasional use, breast-feeding does not have to be discontinued as a rule. However, in case of regular use or large doses, breast-feeding must be discontinued expediently.

Driving and using machines

Aspirin does not affect the ability to drive or use machines.

3. How to use Aspirin tablets

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Aspirin tablets should not be used for longer than 3-5 days without talking to a doctor.
Check with your doctor or pharmacist if you are not sure.
Adults and children over the age of 12: the usual dose is 1-2 tablets as a single dose, which may be repeated in 4-8 hours. The maximum daily dose of 4 g (8 tablets) should not be exceeded.
Children and adolescents: see “Warnings and precautions”.
Aspirin 500 mg tablets are not suitable to children under the age of 12 due to the large content of the active substance. It is recommended to use tablets with a lower acetylsalicylic acid content in children under the age of 12.
Aspirin tablets should be taken with a glass of water, preferably after a meal.
If you feel that the effect of Aspirin tablets is too strong or too weak, talk your doctor or pharmacist.

If you take more Aspirin tablets than you should

Overdose may lead to dizziness, murmur in the ears, impaired hearing, sweating, nausea, vomiting, headache and confusion; breathing may become rapid and/or deep.
Severe poisoning may induce dyspnoea, respiratory arrest, very high fever, gastrointestinal bleeding, heart rhythm abnormalities, reduced blood pressure, cardiac arrest, unconsciousness or coma caused by the sudden decrease in cerebral blood supply, cramps.
If you get the described overdose symptoms or suspect overdose, talk to your doctor immediately. Take the pack with you to the doctor.

If you forgot to take Aspirin tablets

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Possible effects include symptoms of gastrointestinal irritation, such as indigestion, stomach pain; in rare cases, gastrointestinal inflammation and ulcer that can, in very rare cases, cause bleeding and perforation of the gastrointestinal ulcer.
Increased risk of bleeding (bleeding, bruises, nosebleeds, bleeding from urinary conduits and reproductive organs, and bleeding gums during or after a surgical procedure). Severe gastrointestinal or cerebral haemorrhages have occurred in rare or very rare cases, which can, in individual cases, be life-threatening.
Bleeding can cause acute or chronic anaemia / iron deficiency anaemia, the symptoms of which include fatigue and paleness.
Development of haemolysis (rupturing of red blood cells) and haemolytic anaemia has been reported in patients with severe glucose-6-phosphate hydrogenase deficiency.
Development of renal damage and acute renal failure has been reported.
Hypersensitivity reactions (asthma, rash, hives, swelling, itchiness, rhinitis, nasal congestion, changes in heart rate or rhythm, shortness of breath or breathing difficulties; in very rare cases, anaphylactic reactions, incl. anaphylactic shock, the symptoms of which include sweating, nausea, bluish-red discolouration of the skin or mucous membranes, severe loss of blood pressure, loss of consciousness, even coma, etc.) can also occur.
Very rare cases of abnormalities in hepatic function have been observed.
Dizziness and murmur in the ears have also been reported, which may be symptoms of an overdose.

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 www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aspirin tablets

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C.
Do not use this medicine after the expiry date which is stated on the carton. 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 Aspirin tablets contain

-   The active substance is acetylsalicylic acid. One tablet contains 500 mg of acetylsalicylic acid.
-   The excipients are powdered cellulose and corn starch.

What Aspirin tablets look like and contents of the pack

20, 50 or 100 tablets in a polypropylene/aluminium blister pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

UAB Bayer Sporto 18 LT-09238 Vilnius Lithuania

Manufacturer:

Bayer Bitterfeld GmbH Ortsteil Greppin Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bayer OÜ Löötsa 2, Tallinn Phone: +372 655 8565
This leaflet was last revised in July 2015
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