Dabigatran Etexilate Capsules contains the active substance Dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot Formation.

Dabigatran Etexilate Capsules is used in adults to:

-  prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form

of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.

-  treat blood clots in the veins of your legs and lungs and to prevent blood clots from reoccuring In the vein of your legs and lungs.

-     if you are allergic to Dabigatran etexilate or any of the 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 disease in an organ of the body that increases the risk of serious bleeding (e.g. Stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).

-     if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.

-     if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while having a venous or arterial line and you get heparin through this line to keep it open.

-    if you have a severely reduced liver function or liver  disease which could possibly cause  death.

-      if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections.

-     if you are taking cyclosporine, a medicine to prevent organ rejection after transplantation.

-     if you are taking dronedarone, a medicine used to treat abnormal heart beat.

-                                        if you have received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Talk to your doctor before taking Dabigatran Etexilate Capsules. You may also need to talk to your doctor during treatment with Dabigatran Etexilate Capsules if you experience symptoms or if you have to undergo surgery. Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:

-            if you have an increased bleeding risk, such as

•                      if you have been recently bleeding.

•                      if you have had a surgical tissue removal (biopsy) in the past month.

•                      if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical                    treatment).

•                      if you are suffering from an inflammation of the gullet or stomach.

•                      if you have problems with reflux of gastric juice into the gullet.

•                      if you are receiving medicines which could increase the risk of bleeding. See 'Other medicines and Dabigatran Etexilate Capsules ' below.

•                      if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.

•                      if you are suffering from an infection of the heart (bacterial endocarditis).

•                     if you know you have impaired kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark- coloured (concentrated) urine).

•                      if you are older than 75 years.

•                      If you weigh 50 kg or less.

-     If you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.

-   if you have a liver disease that is associated with changes in the blood tests. The use of Dabigatran Etexilate Capsules is not recommended in this case.

Take special care with Dabigatran Etexilate Capsules

-      if you need to have an operation:

In this case Dabigatran Etexilate Capsules will need to be stopped temporarily due to an Increased bleeding risk during and shortly after an operation. It is very important to take Dabigatran Etexilate Capsules before and after the operation exactly at the times you have been told by your doctor.

-                     if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

-      it is very important to take Dabigatran Etexilate Capsules before and after the operation exactly at the times you have been told by your doctor.

•                 tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

•              if you fall or injure yourself during treatment, especially if you hit your head. Please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.

-     if you fall or injure yourself during treatment, especially if you hit your head, please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.

-  if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

Children and adolescents

Dabigatran Etexilate Capsules is not recommended in children and adolescents below 18 years old.

Other medicines and Dabigatran Etexilate Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular you should tell your doctor before taking Dabigatran Etexilate Capsules, if you are taking one of the medicines listed below:

-   Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).

- Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin

- Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking verapamil containing medicines, your doctor will tell you to use a reduced dose of Dabigatran Etexilate Capsules. See section 3.

- Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)

- Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)

- St. John´s wort, a herbal medicine for depression

- Antidepressant medicines called selective serotonin re-uptake inhibitors or serotoninnorepinephrine Re-uptake inhibitors

- Rifampicin or clarithromycin (two antibiotics)

-  Anti-viral medicines for AIDS (e.g. ritonavir)

-  Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

The effects of Dabigatran Etexilate Capsules on pregnancy and the unborn child are not known. You should not take Dabigatran Etexilate Capsules if you are pregnant unless your doctor advises you that it is safe to do so. If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Dabigatran Etexilate Capsules.

You should not breast-feed while you are taking Dabigatran Etexilate Capsules.

Driving and using machines

Dabigatran Etexilate Capsules has no known effects on the ability to drive or use machines.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

If you are 80 years or older, the recommended dose of Dabigatran Etexilate Capsules is 220 mg taken as one 110 mg capsule twice daily.

If you are taking verapamil-containing medicines, you should be treated with a reduced Dabigatran Etexilate Capsules dose of 220 mg taken as one 110 mg capsule twice a day, because your bleeding risk may be increased.

If you have a potentially higher risk for bleeding, your doctor may decide to prescribe a dose of Dabigatran Etexilate Capsules 220 mg taken as one 110 mg capsule twice a day.

You can continue to take Dabigatran Capsules if your heart beat needs to be restored to normal by a procedure Called cardio version or by a procedure called catheter ablation for atrial fibrillation. Take Dabigatran Capsules as your physician has told you.

If a medical device (stent) has been deployed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stenting, you can be treated with Dabigatran Capsules after your physician has decided that normal control of blood coagulation is achieved. Take Dabigatran Capsules as your physician has told you.

How to take Dabigatran Etexilate Capsules

Dabigatran Etexilate Capsules can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach. Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding.

Instructions for opening the blisters

The following pictogram illustrates how to take Dabigatran Etexilate Capsules out of the blister

Tear off one individual blister from the blister card along the perforated line

Peel off the backing foil and remove the capsule.

·            Do not push the capsules through the blister foil.

·            Do not peel off the blister foil until a capsule is required.

Instructions for the bottle

•          Push and turn for opening.

•          After removing the capsule, place the cap back on the bottle and tightly close the bottle right away after you take your dose.

Change of anticoagulant treatment

Without specific guidance from your doctor do not change your anticoagulant treatment.

If you take more Dabigatran Etexilate Capsules than you should

Taking too much Dabigatran Etexilate Capsules increases the risk of bleeding. Contact your doctor immediately if you have taken too many Dabigatran Etexilate Capsules. Specific treatment options are available.

If you forget to take Dabigatran Etexilate Capsules

A forgotten dose can still be taken up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dabigatran Etexilate Capsules

Take Dabigatran Etexilate Capsules exactly as prescribed. Do not stop taking Dabigatran Etexilate Capsules without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking Dabigatran Etexilate Capsules.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Dabigatran Etexilate Capsules affects blood clotting, so most side effects are related to signs such as bruising or bleeding. Major or severe bleeding may occur, these constitute the most serious side effects and, regardless of location, may become disabling, life-threatening or even lead to death. In some cases these bleedings may not be obvious.

If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to keep you under closer observation or change your medicine.

Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats

Common (may affect up to 1 in 10 people):

-                      Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

-                      A fall in the number of red cells in the blood

-                      Belly ache or stomach ache

-                      Indigestion

-                      Frequent loose or liquid bowel movements

-                      Feeling sick

Uncommon (may affect up to 1 in 100 people):

-                      Bleeding may happen from piles, into the rectum, or in the brain.

-                      Haematoma formation

-                      Coughing of blood or blood stained sputum

-                      A fall in the number of platelets in the blood

-                      A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)

-                      Allergic reaction

-                      Sudden change of the skin which affects its colour or appearance

-                      Itching

-                      Ulcer in the stomach or bowel (incl. ulcer in the gullet)

-                      Inflammation of the gullet and stomach

-                      Reflux of gastric juice into the gullet

-                      Vomiting

-                      Difficulty in swallowing

-                      Unusual laboratory test results on liver function Rare (may affect up to 1 in 1,000 people):

-                      Bleeding may happen into a joint, from a surgical incision, from an injury, from the site of entry of an injection or from the site of entry 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 notable for dark red, raised, itchy bumps caused by an allergic reaction

-                      A decrease in the proportion of red cells in the blood

-                      Liver enzymes increased

-                      Yellowing of the skin or whites of the eyes, caused by liver or blood problems Not known (frequency cannot be estimated from the available data):

-          Difficulty in breathing or wheezing

In a clinical trial the rate of heart attacks with Dabigatran Etexilate Capsules was numerically higher than with warfarin. The overall occurrence was low.

Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the veins of your legs and/or lungs

Common (may affect up to 1 in 10 people):

-                      Bleeding may happen from the nose, into the stomach or bowel, into the rectum, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

-                      Indigestion

Uncommon (may affect up to 1 in 100 people):

-                      Bleeding

-                      Bleeding may happen into a joint or from an injury

-                      Bleeding may happen from piles

-                      A fall in the number of red cells in the blood

-                      Haematoma formation

-                      Coughing of blood or blood stained sputum

-                      Allergic reaction

-                      Sudden change of the skin which affects its colour and appearance

-                      Itching

-                      Ulcer in the stomach or bowel

-                      Inflammation of the gullet and stomach

-                      Reflux of gastric juice into the gullet

-                      Feeling sick

-                      Vomiting

-                      Belly ache or stomach ache

-                      Frequent loose or liquid bowel movements

-                      Unusual laboratory test results on liver function

-                      Liver enzymes increased

Rare (may affect up to 1 in 1,000 people):

-                      Bleeding may happen, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein or from the brain

-                      A fall in the number of platelets in the blood

-                      Serious allergic reaction which causes difficulty in breathing or dizziness

-                      Serious allergic reaction which causes swelling of the face or throat

-                      Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction

-                      Difficulty in swallowing

-                      A decrease in the proportion of red cells in the blood

Not known (frequency cannot be estimated from the available data):

-                      Difficulty in breathing or wheezing

-                      A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)

-                      A fall in the number of red cells in the blood

-                      Yellowing of the skin or whites of the eyes, caused by liver or blood problems

In the trial program the rate of heart attacks with Dabigatran Etexilate Capsules was higher than with warfarin. The overall occurrence was low. No imbalance in the rate of heart attacks was observed in patients treated with Dabigatran versus patients treated with placebo.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

,

•  Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC) o Fax: +966-11-205-7662

o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

o  Toll free phone: 8002490000

o  E-mail: npc.drug@sfda.gov.sa

o  Website: www.sfda.gov.sa/npc

Other GCC States:

Please contact the relevant competent authority.

•  Store below 30°C.

•  Store in the original package in order to protect from moisture.

•  Keep this medicine out of the sight and reach of children.

•  Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of the month.

•  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.