АКИДО 100 mg Enteric-coated tablet

Содержание инструкции

1. Acetylsalicylic acid Krka 100 mg gastro-resistant tablets
   1. What is Acido Acetilsalicilico Krka and what is it used for
   2. What you need to know before taking Acido acetilsalicilico Krka
   3. How to take Acido acetilsalicilico Krka
   4. Possible side effects
   5. How to store Acido acetilsalicilico Krka
   6. Package contents and other information

PACKAGE LEAFLET

Acetylsalicylic acid Krka 100 mg gastro-resistant tablets

Acetylsalicylic acid

Read this leaflet carefully before taking this medicine because it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What is Acetylsalicylic acid Krka and what it is used for
• 2. What you need to know before you take Acetylsalicylic acid Krka
• 3. How to take Acetylsalicylic acid Krka
• 4. Possible side effects
• 5. How to store Acetylsalicylic acid Krka
• 6. Contents of the pack and other information

1. What is Acido Acetilsalicilico Krka and what is it used for

Acido acetilsalicilico Krka contains acetylsalicylic acid, which at low doses belongs to a group of
medicines called antiplatelet agents. Platelets are small blood cells that
cause blood clotting and are involved in thrombosis. When a blood clot forms in
an artery, blood flow is blocked and oxygen supply is interrupted. When this
occurs in the heart, it can cause a heart attack or angina; in the brain it can cause a stroke.
Acido acetilsalicilico Krka is taken to reduce the risk of blood clot formation and
therefore prevent the following:

• heart attacks
• stroke
• cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain). Acido acetilsalicilico Krka is also used to prevent blood clot formation after certain types of heart surgery to widen or unblock blood vessels.

This medicine is not recommended for emergencies. It can only be used as a preventive
treatment.

2. What you need to know before taking Acido acetilsalicilico Krka

Do not take Acido acetilsalicilico Krka:

• 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 for arthritis or rheumatism and pain.
• if you have had asthma or some parts of your body have swollen, e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs.
• if you currently have or have ever had a stomach or small intestine ulcer or any other
• type of bleeding such as a stroke.
• if you have had problems with blood clotting.
• if you suffer from severe liver or kidney problems.
• if you have serious heart problems that can cause shortness of breath and swelling of the ankles.
• if you are in the last 3 months of pregnancy; you should not take doses higher than 100 mg per day (see section “Pregnancy and breastfeeding”).
• if you are taking a medicine called methotrexate (e.g. for the treatment of cancer or rheumatoid arthritis) at doses higher than 15 mg per week.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido acetilsalicilico Krka.

• if you have problems with your kidneys, liver or heart.
• if you have or have had problems with your stomach or small intestine.
• if you have high blood pressure.
• if you are asthmatic, hay fever, 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 glucose-6-phosphate dehydrogenase (G6PD) deficiency. You should immediately see a doctor if your symptoms worsen or if you experience serious or unexpected side effects, e.g. unusual bleeding symptoms, severe skin reactions or any other sign of a serious allergic reaction (see section “Possible side effects”). Tell your doctor if you are about to undergo surgery (even minor surgery, such as a tooth extraction), as acetylsalicylic acid thins the blood and therefore there may be an increased risk of bleeding.

You should be careful not to become dehydrated (you may feel thirsty with a dry mouth), as the use of acetylsalicylic acid at the same time can worsen kidney function.
This medicine is not suitable as a pain reliever or to reduce fever.
If any of these conditions apply to you, or if you are not sure, consult your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid, if given to children, can cause Reye's syndrome. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening.
For this reason, Acido acetilsalicilico Krka should not be given to children under the age of 16, unless advised by a doctor.

Other medicines and Acido acetilsalicilico Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effectiveness of the treatment may be affected if acetylsalicylic acid is taken
at the same time as other medicines for:

• thinning the blood/preventing blood clots (e.g. warfarin, heparin, clopidogrel, alteplase)
• organ transplant rejection (cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics and ACE inhibitors)
• regulating the heartbeat (digoxin)
• manic-depressive illness (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids)
• gout (e.g. probenecid)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate at doses less than 15 mg per week)
• diabetes (e.g. glibenclamide, insulin)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• use as hormone replacement therapy after destruction or removal of the adrenal glands or pituitary gland, or to treat inflammation, including rheumatic diseases and bowel inflammation (corticosteroids)

Acido acetilsalicilico Krka with food and drink and alcohol
Drinking alcohol may eventually increase the risk of gastrointestinal bleeding and prolong
bleeding time.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor for advice before taking this medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by a doctor.
You should not take Acido acetilsalicilico Krka in the last 3 months of pregnancy, unless prescribed
by your doctor and in this case the daily dose should not exceed 100 mg (see
section “Do not take Acido acetilsalicilico Krka”). Regular or high doses of this medicine
during the last part of pregnancy can cause serious complications in the mother or
child.
Women who are breastfeeding should not take acetylsalicylic acid unless advised by a doctor.

Driving and using machines
Acido acetilsalicilico Krka does not affect the ability to drive and use machines.

Acido acetilsalicilico Krka contains lactose
If you have been told that you have an intolerance to some sugars, tell your doctor before taking
this medicine.

3. How to take Acido acetilsalicilico Krka

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Adults
Prevention of heart attacks:

• The recommended dose is 75-160 mg once a day.

Prevention of strokes:

• The recommended dose is 75-325 mg once a day.

Prevention of cardiovascular problems in patients suffering from stable or unstable angina (a type
of chest pain):

• The recommended dose is 75-160 mg once a day.

Prevention of blood clot formation after some types of heart surgery:

• The recommended dose is 75-160 mg once a day.

This medicine should not be used at higher doses without medical advice, and then the dose should not
exceed 325 mg per day.
Elderly
As for adults. In general, acetylsalicylic acid should be used with caution in elderly patients who
are more prone to adverse reactions. Treatment should be reviewed at regular intervals.

Use in children and adolescents
Acetylsalicylic acid should not be administered to children and adolescents under 16 years of age,
without a doctor's prescription (see section “Warnings and precautions”).
Method of administration
For oral use.
The tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water).
The tablets have an enteric coating that prevents irritating effects on the intestine and therefore
should not be broken, crushed or chewed.

If you take more Acido acetilsalicilico Krka than you should
If you (or someone else) accidentally take too many tablets, you should inform your doctor or
contact the nearest emergency room immediately. Show the doctor the remaining medicine or the
empty box of this medicine.
Symptoms of an overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting and abdominal pain. A severe overdose can lead to
faster breathing than normal (hyperventilation), fever, excessive sweating,
restlessness, convulsions, hallucinations, low blood sugar, coma and shock.

If you forget to take Acido acetilsalicilico Krka
If you forget a dose, wait until the time to take the next one, then continue
normally.
Do not take a double dose to make up for a missed tablet.

If you stop taking Acido acetilsalicilico Krka
Do not stop taking Acido acetilsalicilico Krka without asking your doctor.
If you have any doubts about 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
Acido acetilsalicilico Krka and tell your doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin reddening with blisters or peeling, which may be associated with high fever and joint pain. This may be 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.

Other side effects include:
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 from the stomach or intestines, cerebral haemorrhage; altered blood cell count.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purplish spots (skin haemorrhage).
• Severe skin reactions such as rashes known as erythema multiforme and its life-threatening variants, Stevens-Johnson syndrome and Lyell's syndrome.
• Hypersensitivity reactions, such as swelling of, for example, 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”))
• Very heavy or prolonged menstrual periods.

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

• Ringing in the ears (tinnitus) or reduced hearing.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Impaired kidney function, acute renal failure. Impaired liver function, increased liver enzymes.
• High levels of uric acid in the blood or low levels of sugar in the blood.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Acido acetilsalicilico Krka

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30 °C.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Acido acetilsalicilico Krka contains

• The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch. Tablet coating: talc, triacetin, acrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30%, sodium dodecyl sulfate * and polysorbate 80*.

* may also contain sodium dodecyl sulfate and polysorbate 80

Description of the appearance of Acido acetilsalicilico Krka and package contents
Acido acetilsalicilico Krka 100 mg: film-coated tablets, white, round, biconvex with a
diameter of approximately 8.1 mm.
Packages:
Blisters: 28, 30, 50, 56, 60, 84, 90, 100 and 168 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy
Krka Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations: