Dabigatran etexilate Dr Reddy S: detailed information

Package leaflet: Information for the patient

Dabigatran etexilate Dr. Reddy’s 75 mg hard capsules

dabigatran etexilate
Generic medicine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Dr. Reddy’s is and what it is used for
What you need to know before taking Dabigatran etexilate Dr. Reddy’s
How to take Dabigatran etexilate Dr. Reddy’s
Possible side effects
How to store Dabigatran etexilate Dr. Reddy’s
Contents of the pack and other information

1. What Dabigatran etexilate Dr. Reddy’s is and what it is used for

Dabigatran etexilate Dr. Reddy’s contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking the action of a substance in the body that is involved in blood clot formation.
Dabigatran etexilate Dr. Reddy’s is used in adults for:

preventing the formation of blood clots in veins following knee or hip replacement surgery.

Dabigatran etexilate Dr. Reddy’s is used in children for:

treating blood clots and preventing the formation of new blood clots.

2. What you should know before taking Dabigatran etexilate Dr. Reddy’s

Do not take Dabigatran etexilate Dr. Reddy’s

if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
if your kidney function is severely reduced.
if you are currently experiencing bleeding.
if you have organ lesions that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal via a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Dr. Reddy’s. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical removal of tissue (biopsy) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Dr. Reddy’s” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
- if you are over 75 years of age.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Dr. Reddy’s

if you are scheduled for surgery: In this case, Dabigatran etexilate Dr. Reddy’s will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Dr. Reddy’s exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Dabigatran etexilate Dr. Reddy’s exactly at the times instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent medical care may be needed.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabigatran etexilate Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor before taking Dabigatran etexilate Dr. Reddy’s if you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines for treating irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Dr. Reddy’s depending on the condition for which it has been prescribed. See also section 3
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John's wort, a herbal medicine used to treat depression
Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for HIV/AIDS (e.g. ritonavir)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Dr. Reddy’s on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so.
If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabigatran etexilate Dr. Reddy’s.
You must not breastfeed during treatment with Dabigatran etexilate Dr. Reddy’s.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
Dabigatran etexilate Dr. Reddy’s has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran etexilate Dr. Reddy’s

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule, or one 110 mg capsule plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Dr. Reddy’s
Dabigatran etexilate Dr. Reddy’s can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew or remove the granules from the capsule, as this may increase the risk of bleeding.

The bottle opens by pressing and turning the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

Switching anticoagulant therapy
Do not change your anticoagulant treatment without receiving specific instructions from your doctor.

If you take more Dabigatran etexilate Dr. Reddy’s than you should
Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Dr. Reddy’s
Prevention of blood clots after knee or hip replacement surgery:
Continue with the remaining daily doses of Dabigatran etexilate Dr. Reddy’s at the usual time on the following day.
Do not take a double dose to make up for the missed dose.

Treatment and prevention of recurrence of blood clots in children:
The missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for the missed dose.

If you stop taking Dabigatran etexilate Dr. Reddy’s
Take Dabigatran etexilate Dr. Reddy’s exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach discomfort after taking Dabigatran etexilate Dr. Reddy’s.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Dabigatran etexilate Dr. Reddy’s acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not resolve spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects listed below are grouped according to how frequently they occur.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Abnormal liver function test results

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

Bleeding which may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, into a joint, from a wound or following a wound, after surgery
Bruising or haematoma occurring after surgery
Presence of blood in faeces detected by laboratory testing
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or liquid stools
Feeling unwell
Discharge from the wound (leakage of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Bleeding
- Bleeding which may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
- Blood-stained discharge from the catheter insertion site into a vein
- Coughing up blood or sputum stained with blood
- Decrease in the number of platelets in the blood
- Decrease in the number of red blood cells in the blood after surgery
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
- Sudden skin changes altering its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Reflux of gastric juices into the oesophagus
- Abdominal or stomach pain
- Indigestion
- Difficulty swallowing
- Fluid leaking from a wound
- Fluid leaking from a wound after surgery

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

Difficulty breathing or wheezing
Decrease in the number of, or even absence of, white blood cells (which help fight infections)
Hair loss

Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Bruising (haematoma formation)
Nosebleeds
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding which may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or sputum stained with blood
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding which may occur into a joint or from a wound, surgical incision, injection site, or catheter insertion site into a vein
Bleeding from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Dr. Reddy’s

Keep this medicine out of the sight and 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.
Once opened, the medicine should be used within 2 months. Keep the bottle tightly closed.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Dabigatran etexilate Dr. Reddy’s contains

The active substance is dabigatran. Each hard capsule contains dabigatran etexilate mesylate equivalent to 75 mg of dabigatran etexilate.
The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose 2910.
The black printing ink contains iron oxide black (E172), shellac (E904) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Dr. Reddy’s and contents of the pack
Dabigatran etexilate Dr. Reddy’s 75 mg are hard capsules with opaque white cap and body, printed with "75" in black ink on the cap.

This medicine is available in HDPE bottles with child-resistant screw caps made of polypropylene, lined with pulp liners and containing a silica gel desiccant (HDPE), packed in a carton with 60 hard capsules.
Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy
Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Rual Laboratories SRL,
Building H, 1st floor, sector 3,
Splaiul Unirii, 313
Bucharest, 030138,
Romania
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.,
Str. Daniel Danielopolu, nr. 30-32,
Spațiul 2, Etaj 5, Sectorul 1, Bucureşti, cod poștal 014134,
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Dabigatranetexilat Reddy 75 mg Hartkapseln
Czech Republic Dabigatran etexilate Reddy 75 mg tvrdé tobolky
Germany Dabigatran beta 75 mg Hartkapseln
Denmark Dabigatran etexilate Reddy 75 mg hårde kapsler
Spain Dabigatran Dr. Reddys 75 mg cápsulas duras EFG
Italy Dabigatran etexilato Dr. Reddy’s 75 mg capsule rigide
Netherlands Dabigatran etexilaat Reddy 75 mg harde capsules
Romania Dabigatran Dr. Reddy’s 75 mg capsule
Poland Dabigatran etexilate Reddy 75 mg kapsułki, twarde
Sweden Dabigatran etexilate Reddy 75 mg hårda kapslar
Slovakia Dabigatran etexilate Reddy 75 mg tvrdé kapsuly

Patient information leaflet

Dabigatran etexilate Dr. Reddy’s 110 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Dr. Reddy’s is and what it is used for
What you need to know before taking Dabigatran etexilate Dr. Reddy’s
How to take Dabigatran etexilate Dr. Reddy’s
Possible side effects
How to store Dabigatran etexilate Dr. Reddy’s
Contents of the pack and other information

1. What Dabigatran etexilato Dr. Reddy’s is and what it is used for

Dabigatran etexilato Dr. Reddy’s contains the active substance dabigatran etexilato and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body involved in blood clot formation.
Dabigatran etexilato Dr. Reddy’s is used in adults for:

preventing the formation of blood clots in the veins following surgery to replace the knee or hip.
preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs and preventing the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran etexilato Dr. Reddy’s is used in children for:

treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Dr. Reddy’s

Do not take Dabigatran etexilate Dr. Reddy’s

if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
if your kidney function is severely reduced.
if you are currently experiencing bleeding.
if you have organ lesions that increase the risk of severe bleeding (e.g. stomach ulcer, brain injuries or bleeding, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g.

warfarin, rivaroxaban, apixaban or heparin), except when switching from one
anticoagulant treatment to another, when a venous or arterial catheter is in place and
heparin is administered through it to keep it open, or when your heartbeat is
being restored to normal via a procedure called catheter ablation for atrial fibrillation.

if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Dr. Reddy’s. You may also need to
consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for
surgery.
Tell your doctor if you have or have had any medical condition or illness, especially any
of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you underwent a biopsy (surgical removal of tissue) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Dr. Reddy’s” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult and weigh 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Dr. Reddy’s

if you are scheduled for surgery:
In this case, Dabigatran etexilate Dr. Reddy’s will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Dr. Reddy’s exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Dabigatran etexilate Dr. Reddy’s exactly at the times instructed by your doctor, both before and after the procedure.
inform your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia wears off, as urgent treatment may be required.
- if you fall or get injured during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may decide that you need to be examined, as you may be at high risk of bleeding.
- if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

Other medicines and Dabigatran etexilate Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
In particular, you must inform your doctor before taking Dabigatran etexilate Dr. Reddy’s if
you are taking any of the following medicines:

Medicines that 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 applied topically to the skin only
Medicines to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil)
If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatran etexilate Dr. Reddy’s depending on the condition being treated. See section 3.
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal remedy used for depression
Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for HIV/AIDS (e.g. ritonavir)
Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Dr. Reddy’s on pregnancy and the unborn child are unknown. You must not
take this medicine during pregnancy unless your doctor tells you it is safe to do so.
If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabigatran etexilate
Dr. Reddy’s.
You must not breastfeed during treatment with Dabigatran etexilate Dr. Reddy’s.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
Dabigatran etexilate Dr. Reddy’s has no known effects on the ability to drive or operate
machinery.

3. How to take Dabigatran etexilate Dr. Reddy’s

Dabigatran etexilate Dr. Reddy’s capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 12 years of age who are able to swallow soft food, Dabigatran etexilate Dr. Reddy’s coated granules are available.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Dr. Reddy’s as recommended for the following conditions:
Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 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 reduced by more than half, you must take a reduced dose of Dabigatran etexilate Dr. Reddy’s of 75 mg, because the risk of bleeding may increase.
For both surgeries, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
You should start treatment with Dabigatran etexilate Dr. Reddy’s within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
You should start treatment with Dabigatran etexilate Dr. Reddy’s within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Dr. Reddy’s of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at increased risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heartbeat needs to be restored to normal by a procedure called cardioversion. Take Dabigatran etexilate Dr. Reddy’s as instructed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Dr. Reddy’s after your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilate Dr. Reddy’s as instructed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
Dabigatran etexilate Dr. Reddy’s should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilate Dr. Reddy’s in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilate Dr. Reddy’s capsules

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Dr. Reddy’s
Dabigatran etexilate Dr. Reddy’s can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

The bottle opens by pressing and turning the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

Switching anticoagulant therapy
Do not change your anticoagulant treatment without receiving specific instructions from your doctor.

If you forget to take Dabigatran etexilate Dr. Reddy’s
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Dr. Reddy’s at your usual time the next day.
Do not take a double dose to make up for a missed dose.

Use in adults: prevention of blood vessel blockages in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots.
Use in children: treatment of blood clots and prevention of recurrence of blood clots.

A missed dose may still be taken if there is still at least 6 hours before the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Dr. Reddy’s
Take Dabigatran etexilate Dr. Reddy’s exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Dr. Reddy’s.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate Dr. Reddy’s acts on the blood clotting system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of location, can be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Abnormal liver function test results

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

Bleeding which may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, into a joint, from a wound or after a wound, following surgery
Haematoma formation or haematoma occurring after surgery
Presence of blood in the faeces, detected by laboratory testing
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Frequent diarrhoea with unformed or liquid stools
Feeling unwell
Wound discharge (fluid leakage from the surgical wound)
Increased liver enzymes
Yellowing of the skin or the whites of the eyes, caused by liver or blood problems

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

Bleeding
Bleeding which may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
Blood-stained discharge from the catheter insertion site into a vein
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Abdominal or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

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

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat

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

Bleeding which may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal or stomach pain
Indigestion
Diarrhoea with unformed or liquid stools
Feeling unwell

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

Bleeding
Bleeding which may occur from haemorrhoids, rectum, or brain
Haematoma formation
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Vomiting
Difficulty swallowing
Abnormal liver function test results

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

Bleeding which may occur into a joint, from a surgical incision, wound, injection site, or catheter insertion site into a vein
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Decrease in the proportion of blood cells
Increased liver enzymes
Yellowing of the skin or the whites of the eyes, caused by liver or blood problems

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

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss

In a clinical study, the rate of heart attacks was higher with Dabigatran etexilate Dr. Reddy’s than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs

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

Bleeding which may occur from the nose, stomach or intestine, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Indigestion

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

Bleeding
Bleeding which may occur into a joint or from a wound
Bleeding which may occur from haemorrhoids
Decrease in the number of red blood cells in the blood
Haematoma formation
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhoea with unformed or liquid stools
Abnormal liver function test results
Increased liver enzymes

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

Bleeding which may occur from a surgical incision, injection site, catheter insertion site into a vein, or brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Decrease in the number or even absence of white blood cells (which help fight infections)
Yellowing of the skin or the whites of the eyes, caused by liver or blood problems
Hair loss

In the clinical study programme, the rate of heart attacks was higher with Dabigatran etexilate Dr. Reddy’s than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.

Treatment of blood clots and prevention of new blood clots in children

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Haematoma formation
Nosebleed
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with unformed or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding which may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or the whites of the eyes, caused by liver or blood problems

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding which may occur into a joint or from a wound, surgical incision, injection site, or catheter insertion site into a vein
Bleeding which may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Dr. Reddy’s

Keep this medicine out of the sight and 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.
Once opened, the medicine should be used within 4 months. Keep the bottle tightly closed.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Dr. Reddy’s contains

The active substance is dabigatran. Each hard capsule contains dabigatran etexilate mesylate equivalent to 110 mg of dabigatran etexilate.
The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine, and hypromellose (2910).
The printing black ink contains black iron oxide (E172), shellac (E904), and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Dr. Reddy’s and contents of the pack
Dabigatran etexilate Dr. Reddy’s 110 mg are hard capsules with opaque white cap and body, printed with "110" in black ink on the cap.
This medicine is available in HDPE bottles with child-resistant screw caps made of polypropylene, with pulp liners and a silica gel (HDPE) container as desiccant, containing 60 hard capsules packed in a carton. Not all pack sizes may be marketed.

Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Rual Laboratories SRL,
313, Splaiul Unirii,
Building H, 1st floor, sector 3,
Bucharest, 030138,
Romania
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.,
Str. Daniel Danielopolu, nr. 30-32,
Spațiul 2, Etaj 5, Sectorul 1, Bucureşti, cod poștal 014134,
Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Dabigatranetexilat Reddy 110 mg Hartkapseln
Czech Republic Dabigatran etexilate Reddy 110 mg tvrdé tobolky
Germany Dabigatran beta 110 mg Hartkapseln
Denmark Dabigatran etexilate Reddy 110 mg hårde kapsler
Spain Dabigatran Dr. Reddys 110 mg cápsulas duras EFG
Italy Dabigatran etexilato Dr. Reddy’s 110 mg capsule rigide
Netherlands Dabigatran etexilaat Reddy 110 mg harde capsules
Romania Dabigatran Dr. Reddy’s 110 mg capsule
Poland Dabigatran etexilate Reddy 110 mg kapsułki, twarde
Sweden Dabigatran etexilate Reddy 110 mg hårda kapslar
Slovakia Dabigatran etexilate Reddy 110 mg tvrdé kapsuly

Patient information leaflet

Dabigatran etexilate Dr. Reddy’s 150 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Dr. Reddy’s is and what it is used for
What you need to know before taking Dabigatran etexilate Dr. Reddy’s
How to take Dabigatran etexilate Dr. Reddy’s
Possible side effects
How to store Dabigatran etexilate Dr. Reddy’s
Contents of the pack and other information

1. What Dabigatran etexilate Dr. Reddy’s is and what it is used for

Dabigatran etexilate Dr. Reddy’s contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body involved in blood clot formation.
Dabigatran etexilate Dr. Reddy’s is used in adults for:

preventing blood clots in the brain (stroke) and in other blood vessels of the body when there is a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs and preventing blood clots from recurring in the veins of the legs and lungs.

Dabigatran etexilate Dr. Reddy’s is used in children for:

treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Dr. Reddy’s

Do not take Dabigatran etexilate Dr. Reddy’s

if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
if your kidney function is severely reduced.
if you are currently experiencing bleeding.
if you have organ injuries that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant to another, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heart rhythm is being restored to normal via a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Dr. Reddy’s. You may also need to
consult your doctor during treatment with this medicine if you develop symptoms or if you need to undergo surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone a biopsy (surgical removal of tissue) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you have inflammation of the oesophagus or stomach.
- if you suffer from gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Dr. Reddy’s” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase your risk of having a heart attack.
if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.
Be especially careful with Dabigatran etexilate Dr. Reddy’s
if you are scheduled for surgery: In this case, Dabigatran etexilate Dr. Reddy’s will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Dr. Reddy’s exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Dabigatran etexilate Dr. Reddy’s exactly at the times instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent treatment may be needed.
- if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
- if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabigatran etexilate Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilate Dr. Reddy’s if you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil)
If you are taking medicines containing verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Dr. Reddy’s depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
Combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal remedy used for depression
Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for HIV/AIDS (e.g. ritonavir)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Dr. Reddy’s on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so.
If you are a woman of childbearing potential, you must avoid pregnancy while being treated with Dabigatran etexilate Dr. Reddy’s.
You must not breastfeed during treatment with Dabigatran etexilate Dr. Reddy’s.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before receiving this medicine.

Driving and using machines
Dabigatran etexilate Dr. Reddy’s has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran etexilate Dr. Reddy’s

Dabigatran etexilate Dr. Reddy’s capsules can be used in adults and children aged 8 years and older who are able to swallow whole capsules. For the treatment of children under 12 years of age, as soon as they are able to swallow soft food, Dabigatran etexilate Dr. Reddy’s coated granules are available.
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Dr. Reddy’s as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.

The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Dr. Reddy’s of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Take Dabigatran etexilate Dr. Reddy’s as instructed by your doctor.

If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Dr. Reddy’s once your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilate Dr. Reddy’s as directed by your doctor.

Treatment of blood clots and prevention of new blood clots in children.

Dabigatran etexilate Dr. Reddy’s should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Table 1 shows the individual and total daily doses of Dabigatran etexilate Dr. Reddy’s in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilate Dr. Reddy’s capsules

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg
mg
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Dr. Reddy’s
Dabigatran etexilate Dr. Reddy’s can be taken with or without food. The capsule should be swallowed
whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

The bottle is opened by pressing and turning the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

Switching anticoagulant therapy
Do not change your anticoagulant treatment without receiving specific instructions from your
doctor.

If you take more Dabigatran etexilate Dr. Reddy’s than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Contact your doctor
immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Dr. Reddy’s
The missed dose can still be taken up to 6 hours before the next scheduled dose. If less than
6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Dr. Reddy’s
Take Dabigatran etexilate Dr. Reddy’s exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Dr. Reddy’s.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate Dr. Reddy’s acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be evident.
If you experience any bleeding that does not resolve spontaneously, or if you experience symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough examination or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped by frequency of occurrence.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots resulting from irregular heartbeat

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

Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal or stomach pain
Indigestion
Diarrhoea with loose or liquid stools
Feeling unwell

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

Bleeding
Bleeding that may occur from haemorrhoids, rectum, or brain
Formation of haematoma
Coughing up blood or bloody sputum
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Vomiting
Difficulty swallowing
Abnormal liver function test results

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

Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with dark red, swollen, itchy nodules caused by an allergic reaction
Decrease in proportion of blood cells
Increase in liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss
In a clinical study, the rate of heart attacks was higher with Dabigatran etexilate Dr. Reddy’s than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of re-formation of blood clots in the veins of the legs and/or lungs

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

Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Indigestion

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from haemorrhoids
Decrease in the number of red blood cells in the blood
Formation of haematoma
Coughing up blood or bloody sputum
Allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhoea with loose or liquid stools
Abnormal liver function test results
Increase in liver enzymes

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

Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with dark red, swollen, itchy nodules caused by an allergic reaction
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in proportion of blood cells
Decrease in the number or even absence of white blood cells (which help fight infections)
Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Hair loss

Treatment of blood clots and prevention of formation of new blood clots in children

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with dark red, swollen, itchy nodules caused by an allergic reaction
Sudden skin changes altering its colour and appearance
Formation of haematoma
Nosebleed
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or liquid stools
Indigestion
Hair loss
Increase in liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in proportion of blood cells
Itching
Coughing up blood or bloody sputum
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
Bleeding that may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function test results

5. How to store Dabigatran etexilate Dr. Reddy’s

Keep this medicine out of the sight and 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.
After opening, the medicine should be used within 2 months. Keep the bottle tightly closed.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Dr. Reddy’s contains

The active substance is dabigatran. Each hard capsule contains dabigatran etexilate mesylate equivalent to 150 mg of dabigatran etexilate.
The other components are tartaric acid, acacia gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine, and hypromellose (2910).
The black printing ink contains iron oxide black (E172), shellac (E904), and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Dr. Reddy’s and contents of the pack
Dabigatran etexilate Dr. Reddy’s 150 mg are hard capsules with opaque white cap and body, printed with "150" in black ink on the cap.
This medicine is available in HDPE bottles with child-resistant screw cap made of polypropylene, containing a pulp liner and a silica gel desiccant container (HDPE), packed in a carton box containing 60 hard capsules.

Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milano (MI)
Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Rual Laboratories SRL,
313, Splaiul Unirii,
Building H, 1st floor, sector 3,
Bucurest, 030138,
Romania
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.,
Str. Daniel Danielopolu, nr. 30-32,
Spațiul 2, Etaj 5, Sectorul 1, Bucureşti, cod poștal 014134,
Romania

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria Dabigatranetexilat Reddy 150 mg Hartkapseln
Czech Republic Dabigatran etexilate Reddy 150 mg tvrdé tobolky
Germany Dabigatran beta 150 mg Hartkapseln
Denmark Dabigatran etexilate Reddy 150 mg hårde kapsler
Spain Dabigatran Dr. Reddys 150 mg cápsulas duras EFG
Italy Dabigatran etexilato Dr. Reddy’s 150 mg capsule rigide
Netherlands Dabigatran etexilaat Reddy 150 mg harde capsules
Romania Dabigatran Dr. Reddy’s 150 mg capsule
Poland Dabigatran etexilate Reddy 150 mg kapsułki, twarde
Sweden Dabigatran etexilate Reddy 150 mg hårda kapslar
Slovakia Dabigatran etexilate Reddy 150 mg tvrdé kapsuly

PATIENT INFORMATION CARD
Dabigatran etexilate Dr. Reddy’s 75 mg/110 mg/150 mg capsules
[xxxx 20xx]
[logo ]

This card must always accompany the patient or the person caring for the pediatric patient
Please ensure you always use the latest version

Dear Patient / Caregiver of a pediatric patient,
Your doctor has prescribed treatment with Dabigatran etexilate Dr. Reddy’s for you or for the child. To use Dabigatran etexilate Dr. Reddy’s safely, please consider the important information provided in the package leaflet.
Since this card contains important information about your treatment or the child's treatment, it must always accompany you or the child to inform healthcare professionals about the treatment with Dabigatran etexilate Dr. Reddy’s.

Dabigatran etexilate Dr. Reddy’s – Information for the patient / caregiver of a pediatric patient
Regarding your treatment / the child's treatment

Dabigatran etexilate Dr. Reddy’s acts as a blood thinner. It is used to treat existing blood clots or to prevent the formation of dangerous blood clots.
When taking Dabigatran etexilate Dr. Reddy’s, follow your doctor’s / the child’s doctor’s instructions. Never skip a dose or stop taking Dabigatran etexilate Dr. Reddy’s without talking to your doctor / the child’s doctor.
Inform your doctor / the child’s doctor about all medicines you / the child are currently taking.
Before any surgical procedure or invasive intervention, inform the doctor / the child’s doctor that you / the child are taking Dabigatran etexilate Dr. Reddy’s.
Dabigatran etexilate Dr. Reddy’s capsules can be taken with or without food. The capsule should be swallowed whole with a glass of water. The capsule must not be broken or chewed, and the granules must not be removed from the capsule.

When to consult the doctor

Taking Dabigatran etexilate Dr. Reddy’s may increase the risk of bleeding. Seek immediate medical attention if you / the child experience any of the following possible signs or symptoms of bleeding: swelling, discomfort, pain or unusual headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding gums, cuts that bleed unusually long, abnormal menstrual flow or vaginal bleeding, blood in the urine (which may appear pink or brown), red/black stools, coughing up blood, vomiting blood or material resembling coffee grounds.
In case of falls or injuries, especially if there is a blow to the head, consult your doctor urgently.
Do not stop taking Dabigatran etexilate Dr. Reddy’s without consulting your doctor / the child’s doctor if you / the child experience heartburn, nausea, vomiting, stomach discomfort, bloating, or upper abdominal pain.

Dabigatran etexilate Dr. Reddy’s – Information for healthcare professionals

Dabigatran etexilate Dr. Reddy’s is an oral anticoagulant (direct thrombin inhibitor).
Dabigatran etexilate Dr. Reddy’s may need to be discontinued prior to surgery or invasive procedures.
In case of major bleeding, administration of Dabigatran etexilate Dr. Reddy’s must be stopped immediately.
A specific reversal agent (idarucizumab) is available for adult patients. The efficacy and safety of the specific reversal agent idarucizumab have not been established in pediatric patients. For details and recommendations on how to reverse the anticoagulant effect of Dabigatran etexilate Dr. Reddy’s, refer to the Summary of Product Characteristics for Dabigatran etexilate Dr. Reddy’s and idarucizumab.
Dabigatran etexilate Dr. Reddy’s is primarily eliminated via the renal route; adequate diuresis should be maintained. Dabigatran etexilate Dr. Reddy’s is dialyzable.

Please complete this section or ask your doctor / the child’s doctor to do so. Patient information
Patient’s name
Date of birth
Indication for which the anticoagulant is used
Dose of Dabigatran etexilate Dr. Reddy’s