Pradaxa 110 Mg Hard Capsules 60 Pieces ingredient Dabigatran

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.