Pradaxa 75 Mg Hard Capsules 60 Pieces ingredient Dabigatran

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

s. 8/10

- 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

p. 9/10

- 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.

s. 10/10

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.

License holder:

Boehringer Ingelheim Pharmaceuticals Trade Inc.

Büyükdere Cad., USO Center

No: 245, K: 13-14

34398 - Maslak, ISTANBUL

Tel: (0 212) 329 1100 Fax: (0 212) 329 1101

Manufacturer:

Boehringer Ingelheim Pharma GmbH & Co. KG KG,

Binger Strasse 173 D-55216 Ingelheim am Rhein,

Germany

These operating instructions have been approved on the date of the day (month / month / year).