Dabigatran etexilate reddy

Package leaflet: Information for the patient

Dabigatran etexilate Reddy, 150 mg, hard capsules
dabigatran etexilate
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse effects, 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 should 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 blood clots in the brain (stroke) and in other blood vessels in the body in patients who have an irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor.
• to treat blood clots in the veins of the legs and lungs, and to prevent recurrence of blood clots in the veins of 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 impairment of kidney function.
• 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. gastric ulcer, brain injury or intracranial hemorrhage, 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.
• if the patient has severe impairment of liver function 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 had a mechanical heart valve implanted, which requires 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 surgery, consult a doctor.
The patient should inform the doctor if they currently have or have previously had any medical conditions or diseases, especially the following:

• 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 esophagus or stomach.
• if the patient has gastroesophageal reflux (acid reflux into the esophagus).
• 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 within 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 and weighs 50 kg or less.
• only when used in children: if the child has an infection around or within the brain.
• if the patient has previously had a heart attack or has been diagnosed with conditions that increase the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such a case, use of this medicine is not recommended.

When to exercise special caution when taking Dabigatran etexilate Reddy

• if the patient needs to undergo surgery: In such a case, 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 the surgical procedure requires insertion of a catheter or administration of a spinal or epidural injection (e.g. for spinal or epidural anesthesia 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 bowel or bladder function occur after the anesthesia wears off, as urgent medical care is required.

• if the patient falls or sustains an injury 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 disorder called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the 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 you are currently taking, have recently taken, or plan to take. In particular, tell your doctor before taking Dabigatran etexilate Reddy if the patient is taking
any of the following medicines :

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, tikagrelor, 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 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 organ rejection after transplantation (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-relieving 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-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran etexilate Reddy has on pregnancy or the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran etexilate Reddy.
Breastfeeding should not be undertaken during treatment with Dabigatran etexilate Reddy.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, 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 use machines.

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 the doctor. If in doubt, consult the doctor.

Take Dabigatran etexilate Reddy exactly as directed below:

Prevention of blood clots in blood vessels of the brain and body by preventing the formation of clots that may occur 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.

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

Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran etexilate Reddy of 220 mg taken as one 110 mg capsule twice daily due to the potential 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 through a procedure called cardioversion or catheter ablation for atrial fibrillation. Dabigatran etexilate Reddy should be taken as directed by the doctor.

In the 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 after the doctor has confirmed adequate control of blood coagulation. Dabigatran etexilate Reddy should be taken as directed by the doctor.

Treatment and prevention of 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 ideally be 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). The doses depend 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 the use of 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 medication
Do not switch anticoagulant medication without receiving specific instructions from your doctor.

Taking more Dabigatran etexilate Reddy than prescribed
Taking too much of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatment methods are available.

Missed dose of Dabigatran etexilate Reddy
A missed dose may be taken if there is still at least 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Dabigatran etexilate Reddy
Dabigatran etexilate Reddy should be taken as directed 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 gastrointestinal discomfort after taking Dabigatran etexilate Reddy.

If you have any further 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 will experience them.
Dabigatran etexilate Reddy affects the blood clotting system, therefore most of the adverse reactions are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop spontaneously, or 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 monitoring or change the treatment.
In case of a severe allergic reaction, which may cause difficulty in breathing or dizziness, contact your doctor immediately.

The possible side effects listed below are grouped according to their frequency of occurrence:

Prevention of blood clots in blood vessels in the brain and body by preventing the formation of clots that occur due to irregular heart function

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
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach ache
• 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 bruises (bruising)
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin concentration in the blood (the 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 food from the stomach into the oesophagus (reflux)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results in laboratory tests

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

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

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

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

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

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 injury
• Bleeding may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of bruises (bruising)
• Coughing up blood or blood-stained 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 food from the stomach into the oesophagus (reflux)
• Nausea
• Vomiting
• Abdominal pain or stomach ache
• Frequent passage of loose or watery stools
• Abnormal liver function test results in laboratory tests
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical incision site, from an injection site, from the site of insertion of an intravenous catheter, or bleeding into the 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
• Skin rash appearing as 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
• Decrease in haemoglobin concentration in the blood (the substance present in red blood cells)
• Decrease in blood cell count (decreased haematocrit)
• Decrease in the number of, 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 disease
• Hair loss

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

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
• Skin rash appearing as dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of bruises (bruising)
• Nosebleeds
• Regurgitation of food from the stomach 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):

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin concentration in the blood (the substance present in red blood cells)
• Decrease in blood cell count (decreased haematocrit)
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach ache
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

Not known (frequency cannot be estimated from 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 may occur into a joint, from a wound, from a surgical incision site, from an injection site, or from the site of insertion of an intravenous catheter
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory tests

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Reddy

Keep this medicine out of the 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. Store in a tightly closed bottle. Keep 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 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, acacia 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 150 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 closure made of polypropylene, including cellulose-based seals and a silica gel desiccant container (HDPE) as a moisture absorber, all contained 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 European Economic Area member states under the following names: