PRADAXA. 75 mg. 30 capsules

PRADAXA. 75 mg. 30 capsules
€ 69.00
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Pradaxa is a medicine that contains the active substance dabigatran etexilate. It works by blocking a substance in the body that is involved in the formation of blood clots.
Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults. 

PRADAXA. 75 mg. 30 capsules

 
 
What Pradaxa is and what it is used
Pradaxa is a medicine that contains the active substance dabigatran etexilate . It works by blocking a substance in the body that is involved in the formation of blood clots.
Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults.

2 . What you should know before taking Pradaxa
Do not take Pradaxa:
if you are allergic to dabigatran etexilate or any other ingredients of this medicine (listed in Section 6) ;
if you have severely reduced kidney function;
If you are currently bleeding ;
if you have a body in the body, which creates a risk of serious bleeding ;
if you have an increased tendency to bleed , which can be congenital, of unknown origin or caused by other drugs ;
if you have severely reduced liver function or liver disease, which may cause death ;
if taking ketoconazole or itraconazole oral medicament for the treatment of fungal infections ;
if you are taking cyclosporine or tacrolimus , medicines protective organ rejection after transplantation;
if you are taking dronedarone medicine to help prevent recurrence of irregular heartbeat ;
if you are taking medicines to prevent blood clots (eg , warfarin, rivaroxaban , apixaban , heparin ), except in case of anticoagulant treatment or until you put a catheter into a vein or artery , through which flows heparin to maintain it open ;
if you put artificial heart valves .
Warnings and Precautions
Talk to your doctor before taking Pradaxa. You also need to talk to your doctor during treatment with Pradaxa, if you experience symptoms or if you have a surgery .
Tell your doctor if you have or have had any medical conditions or diseases, especially any of those included in the following list :
if you have liver disease , which is associated with changes in blood tests , the use of Pradaxa is not recommended ;
if you have an increased risk of bleeding , as may be the case in the following situations :
if you have recently had bleeding ;
if you have had a surgical sample of body tissue for examination ( biopsy) in recent months;
if you had a serious injury (eg bone fracture , head injury or any injury requiring surgery ) ;
If you suffer from inflammation of the esophagus or stomach ;
if you have problems with regurgitation of gastric juice into the esophagus ;
if you are taking drugs that may increase the risk of bleeding , such as aspirin ( acetylsalicylic acid) , clopidogrel, ticagrelor ;
if you are taking anti- PHARMACEUTICAL , such as diclofenac , ibuprofen , piroxicam ;
if you have a heart infection (bacterial endocarditis ) ;
If you know that you have impaired kidney function or if you suffer from dehydration (symptoms include thirst and release of reduced amount of dark colored (concentrated ) urine ) ;
If you are over 75 years ;
if you weigh 50 kg or less.
if you have or if you are established under conditions that increase the risk of heart attack ;
if a surgery . Pradaxa should be stopped temporarily because of the increased risk of bleeding during or shortly after surgery. If possible , Pradaxa should be discontinued at least 24 hours before surgery. In patients with a higher risk of bleeding , the doctor may decide to stop treatment early ;
If you have to undergo emergency surgery . If possible, surgery should be postponed for at least 12 hours after the last dose. If surgery can not be delayed , there may be an increased risk of bleeding. Your doctor will assess the risk of bleeding and urgency of the operation;
if you have a tube ( catheter ) into the back: In your back may be a tube , such as an anesthetic or pain relief during and after surgery. If you are prescribed Pradaxa after removal of the catheter , your doctor should examine you regularly ;
if you fall or injure yourself during treatment , especially if you hit your head , please seek medical attention . You may need to review your doctor as you may be at increased risk of bleeding.
Children and adolescents
Pradaxa should not be used in children and adolescents under 18 years.

Other medicines and Pradaxa
Tell your doctor or pharmacist if you are taking , have recently taken or to priemate other medicines.
For instance :
Medicines that reduce blood clotting (eg warfarin , phenprocoumon , heparin , clopidogrel, prasugrel , ticagrelor , rivaroxaban ) ;
Inflammatory drugs and pain relievers (eg, aspirin) ;
St. John's wort herbal medicine to treat depression ;
Drugs for the treatment of depression , called selective reuptake inhibitors of serotonin or serotonin - selective norepinephrine reuptake inhibitors ;
Rifampicin or clarithromycin, two antibiotics ;
Medicines to treat abnormal heart rhythm ( eg, amiodarone, dronedarone , quinidine, verapamil) . If you are taking medicines containing amiodarone , quinidine or verapamil should be treated with a reduced dose of 150 mg Pradaxa, taken once a day and two capsules of 75 mg, because your bleeding risk may be increased . Pradaxa and these drugs should be taken at the same time. If you are taking medicines containing verapamil, and your kidney function is decreased by more than half , you should be treated with a reduced dose of 75 mg Pradaxa, because your bleeding risk may be increased ;
Medicines for fungal infections ( eg ketoconazole , itraconazole ), unless they are only applied on the skin ;
Medicines to prevent organ rejection after transplantation ( eg, tacrolimus , cyclosporine ) ;
Antivirals against AIDS (eg ritonavir) ;
Medicines to treat epilepsy ( eg carbamazepine, phenytoin) .
Pregnancy and lactation
Effects of Pradaxa on pregnancy and the unborn child are not known. You should not take Pradaxa, if you are pregnant unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential should avoid becoming pregnant while taking Pradaxa.
You should not breast-feed while taking Pradaxa.

Driving and using machines
There are no known effects of Pradaxa on ability to drive and use machines.

Pradaxa contains sunset yellow (E110)
This medicine contains a coloring called sunset yellow (E 110) , which can cause allergic reactions.

3 . How to take Pradaxa
Always take this medicine exactly as your doctor tells you . If you are unsure about anything, ask your doctor.
The recommended dose is 220 mg once daily (taken as two capsules of 110 mg).
If your kidney function is decreased by more than half , or you are aged 75 years or more , the recommended dose is 150 mg once daily (taken as two capsules of 75 mg).
If you are taking medicines containing amiodarone , quinidine or verapamil , the recommended dose is 150 mg once daily ( taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil, and your kidney function is decreased by more than half , you should be treated with a reduced dose of 75 mg Pradaxa, because your bleeding risk may be increased .

After knee replacement surgery
You should start treatment with Pradaxa within 1-4 hours after the operation , taking a single capsule. Then you should take 2 capsules once daily for a total of 10 days.

After hip replacement
You should start treatment with Pradaxa within 1-4 hours after the operation , taking a single capsule. Then you should take 2 capsules once daily for a total of 28-35 days.
Both surgeries should not be initiated if there is bleeding from the site of surgery . If treatment can not be started the day after surgery , dosing should be initiated with 2 capsules once daily.
Pradaxa can be taken with or without food. The capsule should be swallowed whole with a little water. Do not crush , chew the capsule and remove the pellets from the capsule as this may increase the risk of bleeding.

When taking Pradaxa capsules out of the blister pack, please observe the following guidelines :
take the capsules by peeling off the foil blister ;
Do not push the capsules in blister foil ;
do not peel off the blister foil , before you need to take capsule.
When taking Pradaxa capsules out of the bottle , please observe the following guidelines :
push and turn to open the bottle.
Changing treatment with anticoagulants :
Changing from treatment with Pradaxa to anticoagulant treatment given by injection : Do not start treatment with injectable anticoagulant ( eg heparin) within 24 hours after the last dose of Pradaxa;
Changing from treatment with injectable anticoagulant to treatment with Pradaxa: Start taking Pradaxa 0-2 hours before the time when it should be the next injection .
If you take more than the dose of Pradaxa
If you take more than the dose Pradaxa, you are at increased risk of bleeding. Your doctor can perform a blood test to determine the risk of bleeding. Tell your doctor immediately if you take more than the prescribed dose of Pradaxa. If bleeding occurs , it may require surgery or treatment with blood transfusions .

If you forget to take Pradaxa
Continue with your remaining daily doses of Pradaxa at the same time the next day. Do not take a double dose to make up for missed doses.

If you stop taking Pradaxa
Take Pradaxa exactly as prescribed . Do not stop taking Pradaxa, before checking first with your doctor. Stop taking Pradaxa may increase the risk of blood clot formation in patients treated after knee or hip replacement surgery .

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Pradaxa works on the clotting process , so most side effects are associated with events such as bruising or bleeding.
May experience major or severe bleeding , which is the most serious side effects, which , regardless of location , can lead to disabling, life-threatening condition or even death. In some cases this bleeding can not be visible .
If you experience bleeding that does not stop or if signs of excessive bleeding ( extreme weakness , fatigue , pallor , dizziness , headache or sudden swelling ) , immediately consult your doctor. Your doctor may decide to monitor you more closely or adjust your treatment .
Tell your doctor immediately if you experience a serious allergic reaction which causes difficulty in breathing or dizziness .

Adverse reactions are listed below , grouped by how often they appear.
Common ( may affect up to 1 in 10 people):
decline in the quantity of hemoglobin (a substance found in red blood cells) ;
abnormal liver function tests.
Uncommon ( may affect up to 1 in 100 people):
Bleeding may occur from the nose , stomach or intestines, penis / vagina or urinary tract (including blood in the urine that stains the urine pink or red ) from hemorrhoids in the rectum under the skin , joints, on or after injury , or after surgery ;
Haematoma formation or bruising after surgery ;
blood in stools by laboratory tests ;
decrease in the number of red blood cells;
reduction in the percentage of red blood cells;
allergic reactions;
vomiting ;
frequent passing of loose or watery stools ;
nausea ;
separation of a small amount of liquid from the incision in a surgical procedure ;
wound secretion ( removal of fluid from the surgical wound ) .
Rare (may affect up to 1 in 1000 people):
bleeding ;
Bleeding can occur in the brain , by surgical incision , by placement of the injection or placement of the catheter into the vein ;
separation of bloody fluid placement of venous catheters ;
coughing up blood or bloody sputum ;
decrease in blood platelets ;
decrease in the number of red blood cells after the operation ;
serious allergic reaction which causes difficulty in breathing or dizziness ;
serious allergic reaction which causes swelling of the face or throat ;
skin rash due to allergic reactions resulting in dark red , itchy bumps ;
sudden changes in the color and appearance of the skin ;
itching;
ulcers in the stomach or intestines ;
inflammation of the esophagus and stomach ;
return of gastric juices into the esophagus ;
stomach pain or bloating;
indigestion ;
difficulty swallowing ;
removal of fluid from the wound ;
removal of fluid from the wound after surgery.
Not known ( data can not be estimated frequency ):
difficulty breathing or wheezing .
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .

5 . How to store Pradaxa
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle after " EXP" . The expiry date refers to the last day of that month.

Blisters: Store in the original package to protect from moisture.
Bottle: Once opened, the drug should be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.

Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
What does Pradaxa
The active substance dabigatran, which is administered in the form of 75 mg of dabigatran etexilate or ( as mesylate ) .
The other ingredients are: tartaric acid, acacia, hypromellose , dimethicone 350, hydroxypropyl cellulose and talc .
The capsule comprises : carrageenan, potassium chloride , titanium dioxide, indigo carmine , sunset yellow (E 110) , hypromellose and purified water.
The black printing ink contains shellac , N- butyl alcohol, isopropyl alcohol, industrial methylated spirit , iron oxide black , propylene glycol and purified water .

Pradaxa looks like and contents of the pack
Pradaxa is a hard capsule .
Pradaxa 75 mg hard capsules have a light blue opaque cap and cream opaque body . The logo of the company Boehringer Ingelheim is printed on the cap and the body of the capsule is printed code "R75".
Pradaxa 75 mg hard capsules are available in packs of 10 x 1, 30 x 1, 60 x 1 capsules in aluminum perforated unit dose blisters. Moreover , Pradaxa 75 mg hard capsules are available in packs of 60 x 1 capsules in aluminum perforated unit dose blisters white .
Pradaxa 75 mg hard capsules are also available in polypropylene ( plastic ) bottles of 60 capsules .
Not all pack sizes may be marketed.
 
 
€ 69.00
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