Dabigatran etexilate reddy

Package leaflet: Information for the patient

Dabigatran etexilate Reddy, 110 mg, hard capsules
dabigatran etexilate
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dabigatran etexilate Reddy is and what it is used for
2. What you need to know before taking Dabigatran etexilate Reddy
3. How to take Dabigatran etexilate Reddy
4. Possible side effects
5. How to store Dabigatran etexilate Reddy
6. Contents of the pack and other information

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

Dabigatran etexilate Reddy contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is responsible for blood clot formation.

Dabigatran etexilate Reddy is used in adults to:

• prevent the formation of blood clots in veins following hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in patients with a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the legs and lungs and to prevent recurrence of blood clots in the legs and lungs.

Dabigatran etexilate Reddy is used in children to:

• treat blood clots and to prevent recurrence of blood clots.

2. Important information before taking Dabigatran etexilate Reddy

When not to take Dabigatran etexilate Reddy

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney function impairment.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or intracranial bleeding, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter, when heparin is administered through the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation to restore normal heart rhythm.
• if the patient has severe liver function impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has a mechanical heart valve, requiring continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Reddy, discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone a surgical procedure, consult a doctor.
The patient should inform the doctor if they currently have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding.
• if the patient has undergone a surgical tissue biopsy within the last month.
• if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has inflammation of the oesophagus or stomach.
• if the patient has gastro-oesophageal reflux (acid reflux into the oesophagus).
• if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate Reddy and other medicines”.
• if the patient is taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection in the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated] or foamy urine).
• if the patient is over 75 years of age.
• if the patient is an adult with a body weight of 50 kg or less.
• only when used in children: if the child has an infection around or within the brain.
• if the patient has had a heart attack or has been diagnosed with conditions increasing the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise special caution when using Dabigatran etexilate Reddy

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran etexilate Reddy is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Reddy exactly as directed by the doctor both before and after surgery.
• if surgery involves insertion 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 Reddy exactly as directed by the doctor both before and after surgery.
• The patient should immediately inform the doctor if numbness or weakness in the lower limbs or problems with the bowel or bladder occur after the anaesthesia wears off, as urgent medical attention is required.
• if the patient falls or injures themselves during treatment, especially if the head is injured. Immediate medical attention is required. The doctor will assess whether there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran etexilate Reddy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, the patient should tell the doctor before taking Dabigatran etexilate Reddy if they 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 used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Dabigatran etexilate Reddy depending on the condition for which the medicine was prescribed. See section 3.
• Medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
• Anti-inflammatory and pain medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac).
• St. John’s wort, a herbal medicine used to treat depression.
• Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran etexilate Reddy has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should use contraception to prevent pregnancy while taking Dabigatran etexilate Reddy.
Breastfeeding is not recommended during treatment with Dabigatran etexilate Reddy.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.

Driving and using machines
Dabigatran etexilate Reddy has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran etexilate Reddy

Dabigatran etexilate Reddy capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Dabigatran etexilate is also available as coated granules for the treatment of children under 12 years of age, once they are able to swallow soft food.

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

Take Dabigatran etexilate Reddy exactly as directed below:

Prevention of blood clots after hip or knee replacement surgery

The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).

If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

For patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran etexilate Reddy is 150 mg once daily (taken as 2 capsules of 75 mg).

Patients taking verapamil-containing medicines who also have reduced renal function (by more than half) should take a reduced dose of Dabigatran etexilate Reddy of 75 mg due to an increased risk of bleeding.

In both types of surgery, treatment should not be initiated if there is active bleeding from the surgical site. If treatment cannot be started within the day following surgery, it should be initiated with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran etexilate Reddy should begin with one capsule taken within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran etexilate Reddy should begin with one capsule taken within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.

Prevention of blood clots in the brain and other parts of the body by preventing clot formation due to irregular heart function, and treatment and 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.

For patients aged 80 years or older, the recommended dose is 220 mg, taken as one 110 mg capsule twice daily.

Patients taking verapamil-containing medicines should receive Dabigatran etexilate Reddy at a reduced dose of 220 mg, taken as one 110 mg capsule twice daily, due to a possible increased risk of bleeding.

In patients with potentially increased risk of bleeding, the doctor may recommend treatment with a dose of 220 mg, taken as one 110 mg capsule twice daily.

Treatment with this medicine may be continued if the patient requires restoration of normal heart rhythm via a procedure called cardioversion. Dabigatran etexilate Reddy should be taken exactly as prescribed by the doctor.

In case of implantation of a medical device (stent) into a blood vessel to maintain its patency, using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran etexilate Reddy, once the doctor has confirmed adequate control of blood coagulation. Dabigatran etexilate Reddy should be taken exactly as prescribed by the doctor.

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

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

The recommended dose depends on body weight and age. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medications unless the doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran etexilate Reddy in milligrams (mg). Doses are based on the patient's body weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilate Reddy capsules

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

How to take Dabigatran etexilate Reddy
Dabigatran etexilate Reddy can be taken with or without food. The capsule should be swallowed whole with a glass of water to help it pass into the stomach. Do not break, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

• To open the bottle, press down and turn the cap.
• After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

Switching anticoagulant therapy
Do not switch anticoagulant medication without receiving detailed instructions from your doctor.

Taking more Dabigatran etexilate Reddy than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of Dabigatran etexilate Reddy
Prevention of blood clots after surgery (joint replacement) of the hip or knee
Continue taking the missed daily dose of Dabigatran etexilate Reddy at the usual time on the next day.
Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of blood clots in the brain and other blood vessels by preventing clots caused by irregular heart rhythm, and treatment and prevention of recurrence of blood clots in the veins of the legs and lungs
Use in children: Treatment of blood clots and prevention of recurrence of blood clots

A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken.
Do not take a double dose to make up for a missed dose.

Stopping Dabigatran etexilate Reddy
Dabigatran etexilate Reddy should be taken exactly as prescribed by your doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Reddy.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dabigatran etexilate Reddy affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or profuse bleeding may occur, which is the most serious adverse effect, and regardless of its location, it may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, or if symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.
In case of a severe allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

Possible adverse effects listed below are grouped according to their frequency of occurrence:

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

• Decreased haemoglobin concentration in the blood (a substance present in red blood cells)
• Abnormal liver function test results

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

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into a joint, following trauma or after a surgical procedure
• Formation of haematomas or bruises following a surgical procedure
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased proportion of blood cells (decreased haematocrit)
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid oozing from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorder

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decreased platelet count in the blood
• Decreased number of red blood cells in the blood after a surgical procedure
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from wound
• Discharge of fluid from surgical wound

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

• Difficulty breathing or wheezing
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of blood clots in blood vessels of the brain and body by preventing formation of clots caused by irregular heart rhythm

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

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

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

• Bleeding
• Bleeding may occur from haemorrhoids, from the rectum, or into the brain
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Decreased platelet count in the blood
• Decreased haemoglobin concentration in the blood (a substance present in red blood cells)
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding into a joint, from the surgical incision site, from a wound, from the injection site, or from the site of intravenous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Decreased proportion of blood cells (decreased haematocrit)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorder

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

• Difficulty breathing or wheezing
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

In clinical trials, the number of heart attacks with Dabigatran etexilate Reddy was numerically higher than with warfarin. The overall number of events was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and lungs

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

• Bleeding may occur from the nose, into the stomach or intestines, from the anus, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur into a joint or following trauma
• Bleeding may occur from haemorrhoids
• Decreased number of red blood cells in the blood
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or watery stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding from the surgical incision site, from the injection site, from the site of intravenous catheter insertion, or into the brain
• Decreased platelet count in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decreased haemoglobin concentration in the blood (a substance present in red blood cells)
• Decreased proportion of blood cells (decreased haematocrit)
• Decreased number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorder
• Hair loss

In clinical trials, the number of heart attacks with Dabigatran etexilate Reddy was numerically higher than with warfarin. The overall number of events was low. No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.

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

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

• Decreased number of red blood cells in the blood
• Decreased platelet count in the blood
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of haematomas
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the anus, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased haemoglobin concentration in the blood (a substance present in red blood cells)
• Decreased proportion of blood cells (decreased haematocrit)
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain 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 disease or blood disorder

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 may occur into a joint, from a wound, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Adverse effects can also be reported directly to the marketing authorisation holder. Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Dabigatran etexilate Reddy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton: "Expiry date (EXP)" or on the bottle after: "EXP". The expiry date refers to the last day of the stated month.
After first opening, the medicine should be used within 2 months. Keep the bottle tightly closed.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dabigatran etexilate Reddy contains

• The active substance is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), hypromellose 2910 (5 cps), purified water.
• The black printing ink contains shellac, iron oxide black (E172) and potassium hydroxide.

What Dabigatran etexilate Reddy looks like and contents of the pack
Dabigatran etexilate Reddy 110 mg is a hard capsule with a white opaque cap and a white opaque body, printed in black ink on the cap.
The medicine is available in HDPE bottles with a child-resistant screw cap made of polypropylene, with cellulose mass seals and a silica gel desiccant container (HDPE) as a moisture absorber, packed in a cardboard box.
Pack sizes: 1 bottle containing 60 hard capsules, and multipacks containing 120 (2 bottles of 60) or 180 (3 bottles of 60) hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0
Manufacturer/Importer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Rual Laboratories S.R.L.
Splaiul Unirii nr. 313, Corp Cladire H, Etaj 1, Sector 3
030138 Bucharest
Romania
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.,
Str. Daniel Danielopolu, nr. 30-32,
Spațiul 2, Etaj 5, Sectorul 1
014134 Bucharest
Romania
This medicinal product is authorised in the Member States of the European Economic Area under the following names: