Dabigatran etexilate reddy

Package leaflet: Information for the patient

Dabigatran etexilate Reddy, 75 mg, hard capsules
dabigatran etexilate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult 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.

Table of contents of the leaflet

1. What Dabigatran etexilate Reddy is and what it is used for
2. Important information 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 responsible for blood clot formation.
Dabigatran etexilate Reddy is used in adults to:

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

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 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. gastric ulcer, brain trauma or intracranial haemorrhage, 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 via the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe liver 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 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 you have experienced symptoms or undergone a surgical procedure while being treated with this medicine, consult your doctor.
The patient should inform the doctor if they currently have or have previously 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 non-steroidal anti-inflammatory drugs (NSAIDs), 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 and their body weight is 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 conditions diagnosed to increase 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 particular caution when taking 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 before and after surgery.
• if surgery requires 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 before and after surgery.
• The patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical care may be needed.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical attention should be sought. The doctor will assess whether there may be 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 you are currently taking, have recently taken, or plan to take. In particular, tell your doctor before taking Dabigatran etexilate Reddy 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 used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are used only topically on 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 also section 3.
• Medicines used to prevent rejection of transplanted organs (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-noradrenaline 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 on the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should use contraception to prevent pregnancy while taking Dabigatran etexilate Reddy.
Breastfeeding should not be performed while taking Dabigatran etexilate Reddy.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 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 a coated granule formulation for use in children under 12 years of age, once they are able to swallow soft food.

This medicine should always be taken exactly as your doctor has told you. If you are unsure, consult your doctor.

Take Dabigatran etexilate Reddy exactly as described 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 kidney 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).
In 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 kidney function by more than half should receive a reduced dose of 75 mg of Dabigatran etexilate Reddy 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 at a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran etexilate Reddy should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran etexilate Reddy should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 28 to 35 days.

Treatment and prevention of recurrence 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. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medicines unless your 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 facilitate passage into the stomach. Do not crush, 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 specific 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 (hip or knee replacement):
Continue taking the missed daily dose of Dabigatran etexilate Reddy at the same time on the next day.
Do not take a double dose to make up for the missed dose.

Treatment and prevention of recurrent blood clots in children:
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, 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 exactly as prescribed by the doctor. Do not stop taking this medicine without consulting your doctor first, 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 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 involve 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, such bleeding may not be visible.
If you experience bleeding that does not stop on its own, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close observation or change your treatment.
In case of a severe allergic reaction, which may cause difficulty breathing or dizziness, seek immediate medical attention.

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

Prevention of blood clots after surgery (hip or knee replacement)

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

• Decrease in hemoglobin 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, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from hemorrhoids, rectum, under the skin, into joints, due to injury or after injury or surgical procedure
• Formation of hematomas or bruises following surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell volume fraction (decreased hematocrit)
• 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 due to liver or blood disease

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• 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 following surgery
• 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 color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Inflammation of the esophagus and stomach
• Regurgitation of stomach contents into the esophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from wound
• Fluid discharge from surgical wound

Frequency unknown (frequency cannot be estimated from available data):

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

Treatment 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Formation of hematomas
• Nosebleeds
• Regurgitation of stomach contents into the esophagus (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 white blood cells (which help fight infections)
• Bleeding may occur from the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in hemoglobin concentration in the blood (a substance present in red blood cells)
• Decrease in blood cell volume fraction (decreased hematocrit)
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disease

Frequency unknown (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 into joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
• Bleeding from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting of adverse effects
If you experience any adverse effects, 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 to the marketing authorization holder. Reporting adverse effects helps 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 the bottle tightly closed.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 75 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 75 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-absorbing agent, all contained in a cardboard box.
Pack sizes: 1 bottle containing 60 hard capsules, and multi-packs 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 countries under the following names: