PRADAXA. 150 mg. 60 capsules
Pradaxa e medicament for use in reducing the risk of obstruction of blood vessel in the brain or body of a blood clot in adults.
PRADAXA. 150 mg. 60 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 e medicine used to lower the risk of blockage of a blood vessel in the brain or the body of a blood clot in adults with abnormal heart rhythm (atrial fibrillation) and additional risk factors. Pradaxa is kravorazrezhdashto drug that reduces the risk of blood clots .
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 you are taking ketoconazole or itraconazole oral medicines to treat 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 do maintain 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 ;
are taking anti-inflammatory drugs , 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 . It may be necessary 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 not taken other drugs.
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 verapamil treatment with Pradaxa should be reduced to 220 mg, taken as one 110 mg capsule twice daily, because your risk of bleeding may be increased. Pradaxa and verapamil containing medicines should not be taken simultaneously;
Medicines for fungal infections ( eg ketoconazole , itraconazole ), unless they are only applied on the skin ;
Medicines to prevent organ rejection after transplantation ( 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 300 mg, administered as a capsule of 150 mg twice daily.
If you are 80 years or older , the recommended dose of Pradaxa is 220 mg, taken as a capsule of 110 mg twice daily.
If you are taking medicines containing verapamil treatment with Pradaxa should be reduced to 220 mg, taken as one 110 mg capsule twice daily, because your risk of bleeding may be increased.
If you are at increased risk of bleeding , your doctor may prescribe a dose of Pradaxa 220 mg administered as a 110 mg capsule twice 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 card;
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 .
Switching from Pradaxa treatment to treatment with anticoagulants, vitamin - K antagonists (eg phenprocoumon ):
Your doctor should do blood tests to tell you when to start treatment with anticoagulants, vitamin - K antagonists.
Changing from anticoagulant treatment containing vitamin K antagonists (eg phenprocoumon ) to treatment with Pradaxa:
Stop taking medicine containing vitamin K antagonist. Your doctor should do blood tests to tell you when to start treatment with Pradaxa.
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.
Immediately tell your doctor 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
Missed dose can be administered up to 6 hours before the time of the next. Missed doses should not be accepted if the time remaining until the next dose is less than 6 hours. 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 vessel occlusion in patients with heart rhythm disorders .
If you have any further questions on the use of this medicine, 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 adverse reactions and that , regardless of location , can lead to disabling, life-threatening condition or even death. In some cases , these bleeding may 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):
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 ) or subcutaneously ;
decrease in the number of red blood cells;
stomach pain or bloating;
frequent passing of loose or watery stools ;
Uncommon ( may affect up to 1 in 100 people):
bleeding can occur from hemorrhoids in the rectum or in the brain ;
coughing up blood or bloody sputum ;
decrease in blood platelets ;
decrease in hemoglobin (the substance in red blood cells) ;
sudden changes in the color and appearance of the skin ;
ulcers in the stomach or intestines ;
inflammation of the esophagus and stomach ;
return of gastric juices into the esophagus ;
difficulty swallowing ;
abnormal liver laboratory tests.
Rare (may affect up to 1 in 1000 people):
Bleeding can occur in the joints, surgical incision of injury from the site of injection or placement of a catheter into a vein ;
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 ;
reduction in the percentage of red blood cells;
elevated liver enzymes;
yellowing of the skin or whites of the eyes caused by liver problems or blood problems .
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 .
During the clinical study , the occurrence of myocardial infarction after administration of Pradaxa were numerically more than warfarin . In general , the frequency of occurrence was low .
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 150 mg dabigatran etexilate (as mesylate ) .
The other ingredients are: tartaric acid, acacia, hypromellose , dimethicone 350, hydroxypropyl cellulose and talc .
The capsule contains : carrageenan , potassium chloride , titanium dioxide , indigo carmine , sunset yellow ( E110 ), hypromellose and purified water.
The black printing ink containing: 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 150 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 "R150".
Pradaxa 150 mg hard capsules are available in packs of 10 x 1, 30 x 1 , 60 x 1 multipack comprising 3 packs of 60 x 1 capsules (180 capsules ) or multipack comprising 2 packs of 50 x 1 hard capsules (100 capsules ) in all aluminum perforated unit dose blisters. Moreover , Pradaxa 110 mg hard capsules are available in packs of 60 x 1 capsules in aluminum perforated unit dose blisters white .
Pradaxa 150 mg hard capsules are also available in polypropylene ( plastic ) bottles of 60 capsules .
Not all pack sizes may be marketed.