Acetylsalicylic acid Krka

PACKAGE LEAFLET

Package leaflet: Information for the user

Acetylsalicylic Acid Krka 100 mg gastro-resistant tablets

Acetylsalicylic Acid
Please 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 for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Acetylsalicylic Acid Krka is and what it is used for
2. What you need to know before taking 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 Acido Acetilsalicilico Krka is and what it is used for

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

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

This medicine is not recommended for emergencies. It may only be used as 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 to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are commonly used for arthritis, rheumatism, and pain.
• if you have previously experienced an asthma attack or swelling of certain parts of the body, 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 blood clotting disorders.
• if you suffer from severe liver or kidney problems.
• if you have severe heart problems that may cause shortness of breath and swelling of the ankles.
• if you are in the last 3 months of pregnancy; you must not take doses exceeding 100 mg per day (see section "Pregnancy and breastfeeding").
• if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis treatment) at doses exceeding 15 mg per week.

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

• if you have kidney, liver, or heart problems.
• if you have or have previously had stomach or small intestine problems.
• if you have high blood pressure.
• if you suffer from asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may 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 must immediately contact your doctor if your symptoms worsen or if you experience serious or unexpected side effects, e.g. signs of unusual bleeding, severe skin reactions, or any other sign of a serious allergic reaction (see section "Possible side effects"). Inform your doctor if you are about to undergo surgery (even minor procedures such as tooth extraction), as acetylsalicylic acid makes the blood thinner and may therefore increase the risk of bleeding.

You should be careful not to become dehydrated (you may feel thirsty with a dry mouth), as using acetylsalicylic acid at the same time may lead to worsening of kidney function.

This medicine is not suitable for use as a painkiller or to reduce fever.

If any of these conditions apply to you, or if you are unsure, consult your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid, when administered to children, may cause Reye's syndrome. Reye's syndrome is a very rare condition affecting the brain and liver, which can be life-threatening.
For this reason, Acido acetilsalicilico Krka must not be given to children under 16 years of age, unless advised by a doctor.

Other medicines and Acido acetilsalicilico Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effectiveness of treatment may be affected if acetylsalicylic acid is taken at the same time as other medicines for:

• blood thinning / prevention of blood clots (e.g. warfarin, heparin, clopidogrel, alteplase)
• prevention of organ transplant rejection (cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics and ACE inhibitors)
• regulation of heart rhythm (digoxin)
• bipolar disorder (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 below 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 intestinal inflammation (corticosteroids)

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

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by a doctor.
You must not take Acido acetilsalicilico Krka during the last 3 months of pregnancy, except on medical prescription, and in such cases the daily dose must not exceed 100 mg (see section "Do not take Acido acetilsalicilico Krka"). Regular or high doses of this medicine during the later stages of pregnancy may cause serious complications in the mother or baby.
Breastfeeding women should not take acetylsalicylic acid unless advised by a doctor.

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

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

3. How to take Acetylsalicylic Acid Krka

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults

Prevention of heart attacks:

• The recommended dose is 75–160 mg once daily.

Prevention of stroke:

• The recommended dose is 75–325 mg once daily.

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 daily.

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

• The recommended dose is 75–160 mg once daily.

This medicine must not be used at higher doses without medical advice, and the dose must 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 susceptible to adverse reactions. Treatment should be reviewed regularly.

Use in children and adolescents

Acetylsalicylic acid must not be administered to children and adolescents under 16 years of age without medical prescription (see section "Warnings and precautions").

Method of administration

For oral use.

The tablets should be swallowed whole with an adequate amount of liquid (half a glass of water).

The tablets have a gastro-resistant coating which prevents irritating effects on the intestine, and therefore must not be broken, crushed, or chewed.

If you take more Acetylsalicylic Acid Krka than you should

If you (or someone else) accidentally take too many tablets, inform your doctor or contact the nearest emergency department immediately. Show the doctor the remaining medicine or the empty medicine pack.

Symptoms of overdose may include ringing in the ears, hearing problems, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A severe overdose may lead to breathing faster than normal (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar levels, coma, and shock.

If you forget to take Acetylsalicylic Acid Krka

If you miss a dose, wait until it is time to take the next dose, then continue as normal.

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

If you stop taking Acetylsalicylic Acid Krka

Do not stop taking Acetylsalicylic Acid Krka without first consulting your doctor.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you notice any of the following serious adverse effects, stop taking
Acido acetilsalicilico Krka and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling, possibly 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 vomit or urine, or dark stools.

Other adverse 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 (urticaria).
• Runny nose.
• Breathing difficulties.

Rare (may affect up to 1 in 1,000 people):

• Severe stomach or intestinal bleeding, cerebral haemorrhage; altered blood cell counts.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous haemorrhage).
• Severe skin reactions such as skin 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 condition in children affecting 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.
• Stomach or small intestine ulcers and perforation.
• Prolonged bleeding time.
• Impaired kidney function, acute kidney failure. Impaired liver function, increased liver enzymes.
• High levels of uric acid in the blood or low levels of blood sugar.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Acetylsalicylic Acid Krka

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30 °C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater 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 substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other ingredients are: Tablet core: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, potato starch. Tablet coating: talc, triacetin, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, sodium dodecyl sulfate*, 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: white, round, biconvex film-coated tablets with a diameter of approximately 8.1 mm.
Pack sizes:
Blister packs: 28, 30, 50, 56, 60, 84, 90, 100 and 168 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative in 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 authorized in the European Economic Area countries under the
following names:

This leaflet was last reviewed on: