PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986The medicine is dispensed without a doctor’s prescription.

CARTIA™Enteric Coated TabletsEach enteric coated tablet contains:100 mg Acetylsalicylic Acid.Inactive Ingredients: See section 6 of the leaflet.Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine and does not contain all of the available information. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet as you may want to read it again.If you are unsure whether you should use Cartia, speak with the doctor or pharmacist.The medicine is not intended for children and adolescents under 18 years of age. You must swallow the medicine correctly. Consult the pharmacist if you need further information.

1. WHAT IS THE MEDICINE INTENDED FOR?The medicine is intended for the primary prevention of coronary heart disease in high-risk patients and for secondary prevention of arterial thrombotic cardiovascular and cerebrovascular diseases.Therapeutic group: Non-steroidal anti-inflammatories.Cartia is an enteric coated )protected( tablet containing low-dose aspirin )100 mg(. Low-dose aspirin helps to reduce blood platelet aggregation and the tendency to blood clots.Cartia may be useful if you are at risk of: angina, transient ischemic attacks )mini-strokes(, stroke )due to a blood clot( or heart attacks if you already suffer from heart or blood vessel disease.The dose of aspirin in Cartia is less than you would need to take for headache or other pain. If you need an additional painkiller for relief of these symptoms, it is recommended to take another medicine )e.g., paracetamol(.

2. BEFORE USING THE MEDICINE Do not use the medicine if:

• You are sensitive )allergic( to the active ingredient or to any of the other ingredients contained in the medicine )see section 6 of the leaflet( or to other medicines from the same group. Signs ofan allergic reaction are: itchy skin rash, shortness of breath andswelling of the face or tongue. If in the past you have felt unwell after taking aspirin, inform the doctor or pharmacist before taking the first dose.

• You are pregnant or breastfeeding.• You suffer, or have suffered in the past, from bleeding or blood

clotting disorders )such as: hemophilia, Von Willebrand’s disease or hypothrombinemia – bleeding due to decreased levels of clottingfactors(.

• You suffer, or have suffered, from stomach bleeding after treatmentwith aspirin or other non-steroidal anti-inflammatory medicines.

• You suffer from gastritis or an active or previous stomach ulcer.• You suffer, or have suffered in the past, from gout.• You suffer from severe kidney or liver problems.• Do not use this medicine in children and adolescents up to 20

years of age with fever-accompanying diseases such as the flu or chicken pox )for fear of Reye’s syndrome(.

Before using Cartia medicine, inform the doctor if:• You suffer, or have suffered in the past, from asthma.• You have bleeding tendency or are taking anticoagulants )such as

warfarin(.• You suffer from kidney or liver problems.• You have taken aspirin in the past and felt unwell.• You suffer from hypertension or dehydration.• It is recommended to stop taking aspirin at least one week before

undergoing surgery, including dental surgery or blood donation, as aspirin use prolongs the time for blood to clot, unless otherwiseinstructed by a doctor.

• If you are sensitive to any type of food or medicine, inform the doctor before taking the medicine.

• Use with caution in the elderly as this demographic group is more prone to side effects. If you are taking, or have recently taken, other medicines, including

non-prescription medicines and nutritional supplements, tell the doctor or pharmacist before commencing treatment. It is especially important to inform the doctor or pharmacist if you are taking:• Anticoagulants )such as heparin, warfarin(• Other non-steroidal anti-inflammatory medicines, such as ibuprofen,

used to treat pain or inflammation• Medicines used to treat gout )such as probenecid(• Anti-inflammatory medicines )such as prednisone(• Medicines for regulating blood pressure )such as medicines belonging

to the beta-blocker group(• Antidiabetic medicines of the sulphonylurea class• Medicines containing other salicylates or aspirin• Medicines containing methotrexate, chlorpropamide, sulphinpyrazone

or spironolactone• Medicines containing corticosteroids• Valproic acid and phenytoin )for treatment of epilepsy(• Medicines for the treatment of glaucoma )such as acetazolamide(• Vasodilators of the angiotensin converting enzyme inhibitor type )ACE

inhibitors( in order to lower blood pressure• Antacids• Diuretics• SSRI antidepressants

Use of the medicine and foodThe medicine can be taken with or without food. Food does not alter the effect of Cartia.

Use of the medicine and alcohol consumptionIt is preferable to minimize alcohol consumption during treatment with the medicine.If you consume 3 or more alcoholic beverages a day, consult the doctor whether you should use this medicine or use a different medicine, as this medicine may cause stomach bleeding.

Pregnancy and breastfeedingDo not take the medicine if you are pregnant, plan on becoming pregnant, or think that you may be pregnant, unless the doctor has advised you otherwise.Do not take the medicine in the last trimester of pregnancy unless the doctor has advised you otherwise, and then the maximum daily dose should not exceed 100 mg. Regular use or treatment with a high dose of acetylsalicylic acid during the later months of pregnancy may cause serious complications in the health of the mother or the fetus.Do not take the medicine if you are breastfeeding, as some of the acetylsalicylic acid may pass into breast milk, which may cause damage to your baby.

Driving and operating machineryUse extreme caution while driving or operating dangerous machinery until it is clear to you how Cartia affects you. Cartia may cause dizziness in certain people.

3. HOW SHOULD YOU USE THE MEDICINE?• Check with the doctor or pharmacist if you are unsure.This medicine for the prevention of platelet aggregation is takenaccording to the doctor’s instructions.

The medicine is not intended for children and adolescents under 18 years of age.• The usual dosage, unless otherwise instructed by a doctor, is one

tablet per day, every day at the same time. Take the first tablet on the appropriately marked day and continue in the direction of thearrow.

• Taking Cartia at the same time during the day will help you not to forget to take the medicine.

• Do not exceed the recommended dose.Swallow the tablet whole with a glass of water. The medicine can be taken with or without food.

• Do not crush, chew, or halve the tablet. The tablet has an enteric )protective( coating, which prevents it from being released in thestomach and therefore reduces the risk of stomach problems. The aspirin continues through to the small intestine, where it is absorbed gradually into the bloodstream.Allow a lapse of at least two hours between taking this medicine and taking antacids for heartburn.

• If you accidentally take too high a dosage: If you took a overdose, orif a child has accidentally swallowed the medicine, refer immediately to a doctor or proceed to a hospital emergency room and bring the package of the medicine with you, even if you feel no discomfort or show no signs of poisoning.

• If you forget to take the medicine:If you forgot to take this medicine at the required time, take the tablet as soon as you remember. In the case where you would take the nextdose within 12 hours, skip the missed dose, and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

• Using more than the recommended dose can increase the risk of unwanted side effects.Do not take medicines in the dark! Check the label and the doseeach time you take medicine. Wear glasses if you need them.If you have further questions regarding use of the medicine, consult a doctor or pharmacist.

4. SIDE EFFECTSAs with any medicine, use of Cartia may cause side effects in some users. Do not be alarmed by the list of side effects. You may not experience any of them.Most of the side effects of Cartia are relatively mild and will likely disappear without stopping the use of Cartia; however, some of the side effects require medical attention, and therefore, tell the doctor or pharmacist about side effects which are ongoing or bothersome.Mild side effects:Tell the doctor or pharmacist if the following side effects are ongoing or bothersome: heartburn, nausea, indigestion, vomitingMore serious side effects:Stop treatment and refer immediately to a doctor if you experience any of the following symptoms:• Increased bleeding )e.g., If you are bruising easily, or suffering from

nose bleeds(• Stomach bleeding – symptoms can include bloody stools or vomit• Itching or rashAs with all medicines, there is a very small risk of serious allergicreaction. Refer immediately to a doctor or proceed to the nearest hospital if you experience any of the following symptoms:• Swelling of the limbs, face, eyes, inner nose, mouth or throat• Difficulty breathing or swallowing, coughing or wheezing• Hives )appearance of red, prominent, itchy bumps(, itchiness

)especially of the hands and feet(, reddening of the skin )especially around the ears(, or severe skin reactions

• Unusual and severe tiredness and weakness appearing suddenly• Kidney failure• Altered liver function )increased levels of the aminotransferase

enzyme(• Decreased levels of blood platelets• Appearance of purple spots on the skin which may indicate

bleedingAdditional signs of allergy to aspirin may include:• Asthma, runny nose, or inflammation of the nasal mucosa.• Swelling with fluid in tissues )edema(.• Redness, itchy rashes or pustular eruptions.Additional rare side effects that have been reported with aspirin:• An increase in uric acid levels in the blood.• Dizziness, tinnitus )ringing in the ears(, vertigo and deafness.• Stomach ulcers.Since the dose of aspirin in Cartia is low, the likelihood of these side effects is low.If you experience a side effect, if one of the side effects worsens, or if you experience a side effect not mentioned in the leaflet, you must consult the doctor.Reporting side effects:Side effects can be reported to the Ministry of Health by clicking on the link “Reporting Side Effects from Drug Treatment” found on the Ministry of Health homepage )www.health.gov.il( that directs you to the online form for reporting side effects, or by entering the link:https://forms.gov.il/globaldata/getsequence/getsequence.aspx?form Type=AdversEffectMedic@moh.gov.ilIn addition, you can report to Perrigo via the following address: www.perrigo-pharma.co.il

5. HOW SHOULD THE MEDICINE BE STORED?• Avoid poisoning! This medicine and any other medicine, should be

kept in a closed place out of the reach of children and/or infants in order to avoid poisoning. Do not induce vomiting unless explicitlyinstructed to do so by the doctor.

• Do not use the medicine after the expiry date )exp. date( appearing on the carton packaging. The expiry date refers to the last day of that month.

• Do not use if the packaging is torn or damaged.• Store in the original packaging.• Store below 25°C. Do not leave the medicine inside the car on a hot

day. Do not store the medicine in the bathroom or near a sink. Heat and humidity may damage certain medicines.

• Do not dispose of medicines in wastewater or in the household garbage. Ask the pharmacist how to dispose of medicines that you no longer need. These measures will help protect the environment.

6. FURTHER INFORMATION• In addition to the active ingredient the medicine also contains the

following inactive ingredients:Guar gum, Methylacrylic acid copolymer, Talc, Titanium dioxide, Triethyl citrate, Colloidal anhydrous silica, Sodium bicarbonate, Sodium lauryl sulphate, Hypromellose 6cP, Triacetin, Polyvinyl alcohol, PEG 3350, FD&C Yellow #6 • The tablets do not contain sucrose, gluten or tartrazine.

The medicine contains 0.05 mg sodium.• What does the medicine look like and what are the contents of the

package:Cartia is an orange-colored tablet with an enteric )protective( coating. The tablets come in a blister package containing 28 tablets.

• Registration holder and address: Perrigo Israel Agencies Ltd., 1 Rakefet St., Shoham.

• Manufacturer name and address: Aspen Pharma Pty Ltd., Dandenong, Victoria, Australia.

• This leaflet was checked and approved by the Ministry of Health in January 2014.

• Registration number of the medicine in the National Drug Registry of the Ministry of Health: 5089.26384

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New Item Code:019863

ASPEN Artwork Panel

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Page:2 of 2

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Product Name:CARTIA

Drawing Version:01

Drawing Ref. Number:180x648mm_LEF019_MB421

Number of Colours:1

Market:Israel

Originated by:David Leiva

Originated at:APTL

Originated on:15 Nov 2018

Amended on:N/A

Manufacturing Site:Aspen Dandenong

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