Pradaxa (Dabigatran) Hard Capsules 60 Capsules

INSTRUCTIONS FOR USE

• Excipients: tartaric acid, gum arabic, hypromellose, dimethicone 350, talc, hydroxypropyl cellulose, capsule sheath and printing ink: carrageenan, potassium chloride, titanium dioxide (E171), sunset yellow (E110), indigo carmin (E 132) , shellac, black iron oxide (E172), potassium hydroxide, hypromellose.

▼ This drug is subject to additional monitoring. This triangle will ensure the rapid identification of new safety information. You can help by reporting any side effects. You can check the end of Chapter 4 to learn how to report side effects.

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When you go to the doctor or hospital during the use of this medicine, tell your doctor that you are taking this medicine.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is PRADAXAye and what is it used for?

PRADAXA dabigatran is a drug that contains the active substance eteksilat. It acts by blocking a substance that provides clot formation in the blood.

PRADAXA 150 mg, opaque, light blue cover and opaque, yellow-colored body in the form of hard capsules. On the capsule cap, the Boehringer Ingelheim logo and the body of the capsule are printed as heim R150 Kaps. PRADAXA is available in blister packs containing 60 capsules.

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PRADAX to atrial fibrillation (abnormal heartbeat) and adult patients with additional risk factors will be used to reduce the risk of clogging caused by clot formation in the blood vessels of the brain or body. PRADAXA is a blood thinning drug that reduces the risk of blood clots in the blood.

PRADAXA is a medication used to treat clots in the veins of your legs and lungs and to prevent the formation of blood clots in the veins of your legs and lungs.

2. to be considered before using pradaxa

pradaxa Do NOT use in the following cases:

if;

- If you are hypersensitive (allergic) to one of the substances listed in Dabigatran etexilate or one of the - excipients aya aboveIf you

-have severekidney function

bleeding in youryou

- Ifhave a bleeding conditionIf you have a disease that increases the risk of serious bleeding in an organ - If you havebleed

-an increased tendency to. This condition may be due to congenital or other drugs, or the cause may not be known.

- If your liver function is significantly reduced or if you have a liver disease that can lead to death

- If you use ketoconazole or itraconazole for fungal infectionsIf you are using

-cyclosporine (a medication used to prevent organ rejection after organ transplant)

- To prevent recurrence of irregular heartbeats If you are using dronedaron

- When you are taking a blood coagulation medication (eg warfarin, rivaroxaban, apiksaban, or heparin), except when you are given heparin to keep the vein in your arteries / vein, during periods of change in your anticoagulant therapy or

if you have an artificial heart valve.

Use PRADAXA CAREFULLY:

Consult your doctor before using PRADAXA. During PRADAXA treatment, you may need to talk to your doctor again if you experience problems or need surgery. Tell your doctor if you have any medical problems or illnesses, or if they have been in the past, especially if someone listed below is concerned for you.

If;

- If you have a liver disease that changes your blood tests, the use of PRADAXA is not recommended.

- If you have an increased risk of bleeding, this may have occurred in the following cases:

- If you had bleeding shortly before

- If a tissue sample was taken from you in the past month (biopsy)

- If you have had a serious injury (such as bone fractures, head injuries or injuries that require surgery)

- If you have a complaint of inflammation in your throat or in your stomachIf you have complaints about

-gastric juice coming back to your throat (gastric reflux)

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- if you use medicines that may increase the risk of bleeding (aspirin (acetylsalicylic acid), clopidogrel, as ticagrelor is)

- Anti-inflammatory (anti-inflammatory) are getting drugs (eg diclofenac, ibuprofen, piroxicam)

- If you have infection in your heart (bacterial endocarditis)

- Kidney If you know that you have a disorder in your functions or have dehydration (a condition that shows signs of dehydration and a small amount of dark urine)if youif your

-are over 75 -

body weight is 50 kg or less.

- If you have had a heart attack or if it is determined that the conditions that will increase your risk of having a heart attack are valid for you

- If you have a planned operation. Since the risk of bleeding will increase, the use of PRADAXA will need to be temporarily discontinued during and immediately after the operation. If possible, PRADAXA should be stopped at least 24 hours prior to surgery. If you have a higher risk of bleeding, your doctor may decide to stop the drug earlier.

- If you have an unscheduled surgery. In this case, if possible, the operation should be postponed to at least 12 hours after the last dose. If surgery cannot be postponed, your risk of bleeding may increase. Your doctor will decide on the urgency of surgery and your risk of bleeding together.

- If you have a tube (catheter) in your back: Such a tube may have been applied during or after surgery to cut anesthesia or relieve pain. If PRADAXA is used after removal of the catheter, your doctor will examine you regularly.

- If you fall during treatment or if you hurt a place, especially if you hit your head, immediately contact the emergency room. You may need a doctor's check-up because there may be an increased risk of bleeding.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

PRADAXA use with food and drink:

PRADAXA should be swallowed whole or full stomach with some water.

Stop using PRADAXA if one of the following: IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:

if you have a non-spontaneous haemorrhage or have excessive signs of bleeding (unusual fatigue and exhaustion, pallor, dizziness, headache and unexplained swelling) Inform your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

If you experience a serious allergic effect, such as breathing difficulties or dizziness, contact your doctor immediately.

The following side effects known to occur with PRADAXA are grouped according to the frequency of occurrence: The

frequency classification is given as follows:

Very common: (can be seen in more than 1 of 10 patients); common (from 1 to 10 patients); not common (up to 1 in 100 patients); infrequent (up to 1 in 1000 patients); very rare (up to 1 in 10,000 patients can be seen); unknown (unpredictable).

Possible side-effects to prevent blockages in the brain or body vessels that can be caused by clotting after abnormal heartbeats are:

Common (10 people may affect up to 1 person)

- Bleeding; It may be in the form of nasal, stomach or intestine, penis / vagina or urethra (including the presence of blood in the urine, seeing pink or red spots in your urine) or subcutaneous bleeding.

- Red blood cell count in the blood

- Abdominal pain or stomach pain

- Digestive difficulty

- Frequent soft or watery defecation

- Nausea

Uncommon (may affect up to 1 person from 100 people)

- Bleeding

- Bleeding can occur from the tits, rectum or brain

- Hematoma formation regional blood collection)

- Coughing with blood or coming to bloody sputum

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- blood platelets (antiplatelet) number of falls

- a substance found in red blood cells in the blood (hemoglobin) in an amount falling

- allergic reactions

- sudden volume changes affecting the skin color and appearance

- Itching

- Stomach or wounds in the intestine (ulcer) (ulcers in the throat included)

- stomach and sore throat

- coming back toward the throat of gastric juice (reflux)

- vomiting

- dysphagia

- abnormal results on liver function in laboratory test

Rare (may affect up to 1 part of 1000)

- bleeding; it may be in the joint, from the surgical incision, from the wound, from the injection site, or from the place of access of the catheter to the balls.

- Severe allergic reaction leading to respiratory distress or dizzinessSevere allergic reaction

-leading to swelling in the face or throatAllergic reaction

-in the form of dark red, swollen, itchy bulky rash caused by skin allergy

Reduced blood glucose in the bloodReduced blood glucose levels

--- In liver enzymes elevation

- yellowing of the skin or eyebrows due to liver or blood problems None

known ()

difficulty in breathing- or breathing difficulty or wheezing In

a clinical study, the rate of heart attacks seen with PRADAXA was found to be greater than the number of warfarin. The frequency of total occurrence is low.

Possible side effects in the treatment of clots in the veins of your legs and lungs, including the prevention of recurrence of clots in your legs and / or your lungs, include:

Common (may affect up to 10 people)

- Bleeding; It may be in the form of nose, stomach or intestine, rectum, penis / vagina or urethra (including the presence of blood in the urine, seeing pink or red spots in your urine) or subcutaneous bleeding.

- Digestive difficulties

Uncommon (may affect up to 1 person to 100 people)

- Bleeding

- Joint hemorrhage, or bleeding within the wound site

- hemorrhoids, bleeding from the nipple

- fall in the number of red cells in the blood

- Hematoma formation

- cough with blood coming or bloody sputum arrive

- Allergic reactions

- Sudden changes affecting the color and appearance of the skin

- Itching

- Stomach or intestine wounds (ulcers)

- Inflammation of the stomach and throat

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- Gastric fluid return to the throat (reflux)

- Nausea

- Vomiting

- Abdominal or stomach pain

- Frequent soft or watery stools

-results of liver function in laboratory tests

- Increased liver enzymes

UnusualSparse (up to 1 in 1000 people)

- Bleeding; the surgical incision may be displaced, at the injection site, at the entrance of the catheter to your veins or as a brain hemorrhage.

- Reduced blood platelet count

- Severe allergic reaction leading to respiratory difficulty or dizzinessSevere allergic reaction

-leading to swelling in the face or throat

- Deep red skin, swollen, itchy bulky rash caused by skin allergy

- Difficulty swallowing

- Red blood cells in the blood percent reduction

Unknown (can not be estimated from the data available)

- difficulty breathing or wheezing

- hemoglobin in blood (red substance found in the blood cells) in an amount of fall

- decrease in the number of red cells in the blood

- yellowing of the liver or blood problems in the skin cause or consideration in the current

one In clinical research, the rate of heart attack with PRADAXA was higher than that of warfarin. The incidence of total occurrence was low. No difference was observed in the rate of heart attack in patients treated with dabigatran compared to patients treated with placebo.

Report side effects:

If you experience any side-effects that occur or are not included in the Instructions for Use, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site you encounter "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

If you experience any side effects or side effects not mentioned in these instructions, please inform your doctor or pharmacist.

5. Storage of

PRADAXA Keep PRADAXA out of the reach of children and in its packaging.

Store at room temperature below 25 ° C.

To protect from moisture, keep it in its original packaging. Do not place your capsules in another container (such as pill containers).

Use in accordance with expiration dates.

Do not use PRADAXA after the expiration date in the packaging.

The expiry date is the last day of the specified month.

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Medicines should not be disposed via waste water or household waste. Ask your pharmacist how to dispose of drugs that are no longer needed. These measures will help protect the environment.

Do not use PRADAXA if you notice defects in the product and / or its packaging.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

The effect of PRADAXA on pregnancy and the unborn child is unknown. Do not use this medicine during pregnancy unless your doctor specifically recommends it. If you are a woman of childbearing age, you should not get pregnant while taking PRADAXA. In this case, use an appropriate, reliable method of contraception.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

takingany

consult your doctor or pharmacist before medicine.

Do not breastfeed while using this medicine.

Use of tools and machinery PRADAXA has no known influence on the ability to drive and use machines.

Important information about some of the ingredients in the PRADAXA contains the

sunset yellow (E110) as a dyestuff in the PRADAXA capsule sheath. May cause allergic reactions.

Use with

other medicines If you have used any other medicines, including the drugs listed below, or if you have used it recently, inform your doctor:

- Drugs that reduce blood clotting (Ex: Warfarin, fenprokumon, heparin, klopidogrel, prasugrel , ticagrelor, rivaroxaban)

- Anti-inflammatory (anti-inflammatory) and analgesic drugs (eg aspirin)

- is a herbal product for depression St. John's Wort (worty wort)

- Selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors called depression drugs

- Rifampicin or clarithromycin (two antibiotics)

- Drugs used to treat your irregular heartbeats (eg, Amiodarone, dronedaron, quinidine, verapamil)

If you are taking medication containing verapamil, you should be treated with a reduced dose of PRADAXA to 220 mg, which is used as a capsule of 110 mg twice a day, because the risk of bleeding will increase. Medications containing PRADAXA and verapamil should also be taken.

- Only medications used for fungal infections (eg ketoconazole, itraconazole, posaconazole) can only be applied to the skin. Other forms should not be used.

- transplant drugs used to prevent organ rejection after (eg tacrolimus, cyclosporine)

- used for AIDS anti-viral drugs (eg ritonavir)

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