Acetylsalicylic acid Sandoz GmbH

Package leaflet: Information for the user

Acetylsalicylic acid Sandoz GmbH 100 mg gastro-resistant tablets

Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Acido acetilsalicilico Sandoz GmbH is and what it is used for

Acido acetilsalicilico Sandoz GmbH 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 becomes blocked and oxygen supply 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 Sandoz GmbH is used as a preventive treatment. It is taken to reduce the
risk of blood clot formation and thus prevent further:

• heart attacks
• strokes
• cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain).

Acido acetilsalicilico Sandoz GmbH is also used to prevent the formation of blood clots after certain types of heart surgery performed to widen or unblock blood vessels.
This medicine is not recommended for use in emergency situations.

2. What you need to know before taking Acetylsalicylic Acid Sandoz GmbH

Do not take Acetylsalicylic Acid Sandoz GmbH if

• you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are commonly used for arthritis, rheumatism, and pain.
• you have previously experienced an asthma attack or swelling of certain body parts, such as face, lips, throat, or tongue (angioedema), after taking salicylates or NSAIDs.
• you have a history of gastrointestinal bleeding or perforation (stomach or intestinal failure) caused by previous treatment with NSAIDs.
• you currently have or have ever had a stomach or small intestine ulcer, or any other type of bleeding such as haemorrhagic stroke (bleeding inside or around the brain).
• you have ever had blood clotting disorders.
• you have severe liver or kidney problems.
• you have severe heart problems that may cause shortness of breath and swelling of the ankles.
• you are in the last three months of pregnancy; you must not use doses exceeding 100 mg per day (see section “Pregnancy and breastfeeding”).
• you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.

Warnings and precautions
Consult your doctor before taking Acetylsalicylic Acid Sandoz GmbH:

• if you have kidney or liver problems
• if you have or have ever had ulcers or bleeding in the stomach or small intestine
• if you have high blood pressure
• if you have 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 periods
• if you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency

You must contact your doctor immediately if symptoms worsen or if you experience serious or unexpected side effects, such as unusual signs of bleeding, severe skin reactions, or any other signs of a severe allergic reaction (see section “Possible side effects”).
Inform your doctor if you are planning any surgical procedure (even minor, such as tooth extraction), as acetylsalicylic acid makes the blood thinner, which could increase the risk of bleeding. This effect may last for 4–8 days after stopping acetylsalicylic acid.
Be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as in this case concomitant use of acetylsalicylic acid may lead to worsening of kidney function.
This medicine is not suitable for use as a painkiller or antipyretic.
Do not take Acetylsalicylic Acid Sandoz GmbH together with other medicines containing acetylsalicylic acid (such as aspirin) or with other painkillers and anti-inflammatory medicines (NSAIDs, such as ibuprofen).
If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist.

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

Other medicines and Acetylsalicylic Acid Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:
The effect of treatment may be altered if acetylsalicylic acid is taken together with other medicines for:

• thinning the blood/preventing blood clots (e.g. warfarin, heparin, clopidogrel, ticlopidine, dipyridamole, cilostazol, alteplase)
• high blood pressure (e.g. diuretics, ACE inhibitors, angiotensin II receptor antagonists, calcium channel blockers)
• regulating heart rhythm (digoxin)
• pain and inflammation (e.g. metamizole, NSAIDs such as ibuprofen, other medicines containing acetylsalicylic acid, or steroids). Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blood clot) when taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for the prevention of heart attacks, strokes, and angina
• gout (e.g. probenecid, sulfinpyrazone)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate at doses exceeding 15 mg per week – see section “Do not take Acetylsalicylic Acid Sandoz GmbH if” above)
• diabetes (e.g. glibenclamide, insulin)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• hormone replacement therapy when adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

Acetylsalicylic Acid Sandoz GmbH with alcohol
Drinking alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.
Therefore, alcohol consumption is not recommended.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you continue or start treatment with this medicine during pregnancy as instructed by your doctor, use it as directed and do not exceed the recommended dose.

Pregnancy – third trimester
Do not take this medicine at doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect your tendency to bleed and that of your baby, and may cause delayed or prolonged labour.
If you take this medicine at low doses (up to and including 100 mg per day), careful obstetric monitoring is required as advised by your doctor.

Pregnancy – first and second trimester
You should not take this medicine during the first six months of pregnancy unless absolutely necessary and recommended by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days from week 20 of pregnancy onwards, this medicine may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding women should not take acetylsalicylic acid unless advised by a doctor.

Driving and using machines
Acetylsalicylic Acid Sandoz GmbH does not affect or has a negligible effect on the ability to drive or use machinery.

Acetylsalicylic Acid Sandoz GmbH contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Acetylsalicylic Acid Sandoz GmbH

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Adults and adolescents (aged 16 years and older)
Prevention of heart attacks,
Prevention of stroke,
Prevention of cardiovascular problems in patients suffering from stable or unstable angina (a type
of chest pain),
Prevention of blood clots after certain types of heart surgery:
The recommended dose is 75 to 150 mg once daily.
This medicine should not be used at higher doses unless advised by your doctor, and in such
cases the dose should not exceed 300 mg per day.
This medicine is intended for long-term use.
Elderly
Recommended dose as for adults. In general, acetylsalicylic acid should be used with caution
in elderly patients, who are more susceptible to adverse events. Treatment should be reviewed
regularly at regular intervals.
Use in children and adolescents
Acetylsalicylic acid must not be administered to children and adolescents under 16 years of age,
unless prescribed by a doctor (see section 2 “Children and Adolescents”).
Method of administration
For oral use.
Swallow the tablets whole with sufficient liquid (half a glass of water). The tablets have an enteric coating that prevents irritating effects on the intestine and therefore must not be crushed, broken or chewed.
If you take more Acetylsalicylic Acid Sandoz GmbH than you should
If you (or someone else) accidentally take too many tablets, inform your doctor immediately or
contact the nearest emergency department immediately. Show the doctor any remaining tablets or
the empty packaging.
Symptoms of overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting and abdominal pain. A significant overdose may lead
to faster breathing (hyperventilation), fever, excessive sweating, restlessness,
seizures, hallucinations, low blood sugar levels, coma and shock.
If you forget to take Acetylsalicylic Acid Sandoz GmbH
If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up
for the missed tablet.
If you stop taking Acetylsalicylic Acid Sandoz GmbH
Do not discontinue or stop treatment with Acetylsalicylic Acid Sandoz GmbH without first discussing it
with your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are stomach or intestinal disorders, including nausea and vomiting.
If you notice any of the following rare but serious side effects, stop taking
Acido acetilsalicilico Sandoz GmbH and contact a doctor immediately:
Rare side effects, may affect up to 1 in 1,000 people

• Sudden wheezing, swelling of lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction)
• Reddening of the skin with blisters or peeling, which may be associated with high fever and joint pain. This could be due to erythema multiforme, Stevens-Johnson syndrome or Lyell syndrome
• Unusual bleeding, such as coughing up blood, blood in vomit or urine, or black stools
• Changes in behaviour with nausea and vomiting could be an early sign of Reye's syndrome, a potentially life-threatening condition requiring immediate medical treatment (see also section 2 "Children and adolescents")

Other side effects:
Common side effects, may affect up to 1 in 10 people:

• Nausea, vomiting, diarrhoea
• Indigestion
• Increased tendency to bleed

Uncommon side effects, may affect up to 1 in 100 people:

• Hives
• Runny nose
• Breathing difficulties

Rare side effects, may affect up to 1 in 1,000 people:

• Severe bleeding in the stomach or intestines, cerebral haemorrhage; changes in red blood cell count
• Cramps in the lower airways, asthma attacks
• Inflammation of blood vessels
• Bruising with purplish spots (skin bleeding)
• Abnormal, heavy or prolonged menstrual periods

Side effects with unknown frequency, frequency cannot be estimated from the available data:

• Ringing in the ears (tinnitus) or reduced hearing ability
• 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 or low blood sugar levels

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acetylsalicylic acid Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
Do not use this medicine after the expiry date stated on the blister and 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. This will help protect the environment.

6. Package contents and other information

What Acido acetilsalicilico Sandoz GmbH contains

• The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other components are: Tablet core: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, and potato starch. Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, triacetin, talc.

Description of the appearance of Acido acetilsalicilico Sandoz GmbH and package contents
Acido acetilsalicilico Sandoz GmbH 100 mg gastro-resistant tablets are white, round, biconvex, 8.1 x 3.8 mm in size, without a break line.
The gastro-resistant tablets are packaged in PVC/Al blisters.
Pack sizes:
30, 50, 60, 90 and 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10,
6250 Kundl
Austria

Representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
G.L. Pharma GmbH
Industriestrasse 1
8502 Lannach
Austria

Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben
Saxony-Anhalt
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France ACIDE ACETYLSALICYLIQUE SANDOZ 100 mg, comprimé gastro-résistant
Italy Acido acetilsalicilico Sandoz GmbH
Portugal Ácido Acetilsalicílico Sandoz
Slovenia Acetilsalicilna kislina Sandoz 100 mg gastrorezistentne tablete