Afogatran 110mg Capsule 10’S

INTRODUCTION

AFOGATRAN 110MG CAPSULE contains Dabigatran etexilate which belongs to theroup of medicines called Anticoagulants. It is used to prevent stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation and venous thromboembolic events in patients who have undergone orthopaedic surgery.

It is also used to treat acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevents recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE). This medicine is also used in children to treat blood clots and to prevent blood clots from reoccurring.

Avoid taking AFOGATRAN 110MG CAPSULE, if you currently have bleeding disorders, organ disease of the body that increases the risk of serious bleeding such as stomach ulcer, injury or bleeding in the brain, severely reduced kidney or liver function.

Before taking AFOGATRAN 110MG CAPSULE, inform your doctor if you have increased bleeding risks such as s bone fracture, head injury or any injury requiring surgical treatment, lung or heart problems.

AFOGATRAN 110MG CAPSULE is not recommended for use in pregnant and breastfeeding women. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

Your doctor will prescribe the right dose depends on your child’s age body weight and disease condition. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

The most common side effects of taking AFOGATRAN 110MG CAPSULE are stomachache, indigestion, frequent loose or liquid bowel movements and or nausea. Consult your doctor if any of these above side effectsets worse.

USES OF AFOGATRAN 110MG CAPSULE

It is used to:

Prevent stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation
Prevent venous thromboembolic events in patients who have undergone orthopaedic surgery
Treat acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Prevent recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE)
Treat blood clots and to prevent blood clots from reoccurring (in children)
HOW AFOGATRAN 110MG CAPSULE WORKS

AFOGATRAN 110MG CAPSULE works by blocking thrombin (blood central clotting agent) that results in the prevention of blood clots thereby preventing the occurrence of stroke, heart attack, deep vein thrombosis and pulmonary embolism.

DIRECTIONS FOR USE

Take AFOGATRAN 110MG CAPSULE as advised by your physician. Swallow AFOGATRAN 110MG CAPSULE with alass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF AFOGATRAN 110MG CAPSULE
COMMON
Bleeding (nose, stomach or bowel, from penis/vagina or urinary tract)
Stomachache
Indigestion
Frequent loose or liquid bowel movements
Nausea
UNCOMMON
Bleeding (joint, from or after an injury or after an operation, from piles, from the rectum or in the brain)
Haematoma, formation or bruising occurring after an operation
Coughing of blood or blood stained sputum
Allergic reactions
Sudden change in color and appearance of the skin
Itching
Ulcer in the stomach or bowel
Inflammation of theullet and stomach
Reflux ofastric juice into theullet
Vomiting
Wound secretion (liquid exuding from the surgical wound)
Yellowing of the skin or whites of the eyes (liver or blood problems)
Difficulty in swallowing
RARE
Sign of allergic skin reaction such as skin rash notable for dark red, raised, itchy bumps

Stop taking AFOGATRAN 110MG CAPSULE and contact your doctor if you experience any of the following side effects:

Signs of excessive bleeding such as exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling
Serious allergic reaction which causes difficulty in breathing or dizziness
HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and relax andet enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Limit your consumption of alcohol, as it can aggravate your dizziness. Consult and inform your doctor if the symptom does not improve.

Nausea and Vomiting:

Try to take AFOGATRAN 110MG CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptomets worse.

Indigestion:

Try to have smaller and more frequent meals and eat slowly. Try to reduce consumption of tea, coffee, cola or alcohol and lose weight if you are obese. Consult and inform your doctor if the symptom does not improve.

WARNING & PRECAUTIONS
PREGNANCY

AFOGATRAN 110MG CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

BREASTFEEDING

AFOGATRAN 110MG CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

DRIVING AND USING MACHINES

AFOGATRAN 110MG CAPSULE has no known effects to affect the ability to drive or use machines. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

ALCOHOL

Avoid Consumption of alcohol while taking AFOGATRAN 110MG CAPSULE. Consult your doctor for advice.

KIDNEY

AFOGATRAN 110MG CAPSULE is not recommended for use in patients with severely reduced kidney function. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

LIVER

AFOGATRAN 110MG CAPSULE is not recommended for use in patients with severe liver disease or reduced liver function. Consult your doctor for advice before taking AFOGATRAN 110MG CAPSULE.

ALLERGY

Do not take AFOGATRAN 110MG CAPSULE if you are allergic to Dabigatran etexilate or any of the other ingredients of this medicine.

LUNGS

AFOGATRAN 110MG CAPSULE should be used with caution in patients with lung problems such as pulmonary embolism (blood clot in lungs). Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

HEART DISEASE

AFOGATRAN 110MG CAPSULE is not recommended for use if you have received an artificial heart valve that requires permanent blood thinning. It should be used with caution in patients with heart problems such as heart attack, bacterial endocarditis (infection in the heart). Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

OTHERS

AFOGATRAN 110MG CAPSULE is not recommended for use if you:

Have bleeding problems

Before taking AFOGATRAN 110MG CAPSULE, inform your doctor if you:

Have increased bleeding risk such as surgical tissue removal (biopsy), serious injury (bone fracture, head injury or any injury requiring surgical treatment), inflammation of theullet or stomach, reflux ofastric juice into theullet
Have symptoms of dehydration such as feeling thirsty and passing reduced amounts of dark-coloured (concentrated) or foaming urine

Use in pediatrics:

AFOGATRAN 110MG CAPSULE is recommended for use in children and adolescents (from 8 to 18 years of age) to treat and reduce the risk of recurrence of blood clot disorder. Your doctor will prescribe the right dose depends on your child’s age, body weight and disease condition. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

Use ineriatrics:

AFOGATRAN 110MG CAPSULE is used with caution in elderly patients (aged 75 years or above). Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking AFOGATRAN 110MG CAPSULE, inform your doctor, if you are taking any of the following medicine:

Aspirin (medicines used to reduce fever and relieves mild to moderate pain)
Ibuprofen, naproxen, diclofenac (medicines used to reduce fever and relieve mild to moderate pain)
Warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid (medicines used to reduce blood clotting)
Medicines to treat fungal infections (Ex. ketoconazole, itraconazole)
Medicines to treat abnormal heart beats (Ex. amiodarone, dronedarone, quinidine, verapamil)
Medicines used to prevent organ rejection after transplantation (Ex. tacrolimus, cyclosporine)
Glecaprevir and pibrentasvir (used to treat hepatitis C)
Citalopram, dapoxetine, escitalopram fluoxetine, St. John’s wort, desvenlafaxine, duloxetine, levomilnacipran (used for depression)
Rifampicin or clarithromycin (used for bacterial infection)
Ritonavir (used for AIDS)
Medicines used for epilepsy (Ex. carbamazepine, phenytoin)

Overdosage:

If you or anyone else accidentally takes too much of AFOGATRAN 110MG CAPSULE, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS
Drug :   Dabigatran etexilate
Pharmacological Category :   Anticoagulants
Therapeutic Indication :   Prevent stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation, Venous thromboembolic events in patients who have undergone orthopaedic surgery, Blood clot disorders
Dosage Forms :   Capsule, Tablet
MORE INFORMATION
Keep the medicine out of reach in children
Store AFOGATRAN 110MG CAPSULE at room temperature
FAQs ABOUT AFOGATRAN 110MG CAPSULE

What AFOGATRAN 110MG CAPSULE is used for?

AFOGATRAN 110MG CAPSULE is used to prevent stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation and venous thromboembolic events in patients who have undergone orthopaedic surgery.

How should AFOGATRAN 110MG CAPSULE be taken?

Take AFOGATRAN 110MG CAPSULE as advised by your physician. Swallow AFOGATRAN 110MG CAPSULE with alass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

What are the side effects of AFOGATRAN 110MG CAPSULE?

The most common symptoms of taking AFOGATRAN 110MG CAPSULE are stomachache, indigestion , frequent loose or liquid bowel movements and nausea. Consult your doctor if any of these above side effectsets worse.

What happens if you stop taking AFOGATRAN 110MG CAPSULE?

Do not stop taking AFOGATRAN 110MG CAPSULE without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. Consult your doctor if you have any queries regarding stopping the medicine.

Is AFOGATRAN 110MG CAPSULE safe to use in children?

AFOGATRAN 110MG CAPSULE is recommended for use in children and adolescents (from 8 to 18 years of age) to treat and reduce the risk of recurrence of blood clot disorder. Your doctor will prescribe the right dose depends on your child’s age, body weight and disease condition. Consult your doctor before taking AFOGATRAN 110MG CAPSULE.

REFERENCES

1. KD. Tripathi. Drugs Affecting Coagulation, Bleeding and Thrombosis. Seventh edition. 2013. Page – 623.

2. Boehringer Ingelheim. Safety of Dabigatran Etexilate in Blood Clot Prevention in Children. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in June 2020] [Accessed on 30th May 2022] https://clinicaltrials.gov/ct2/show/NCT02197416

3. Eline A Dubois and Adam F Cohen. Dabigatran etexilate. NIH National Library of Medicine, National center for biotechnology information. PMC PubMed Central. July 2010. [Accessed on 30th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2909802/

4. Teerapat Nantsupawat, Suthipong Soontrapa, Nopakoon Nantsupawat, David Sotello, Saranapoom Klomjit, Selcuk Adabag and Alejandro Perez-Verdia. Risk factors and prevention of dabigatran-relatedastrointestinal bleeding in patients with atrial fibrillation. NIH National Library of Medicine, National center for biotechnology information. PMC PubMed Central. February 2018. [Accessed on 30th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5828263/

5. Boehringer Ingelheim Pharmaceuticals, Inc. PRADAXA. [Revised in June 2021] [Accessed on 30th May 2022] https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf

6. Boehringer Ingelheim InternationalmbH. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.6228.pdf

7. Boehringer Ingelheim InternationalmbH. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.6229.pdf

8. Boehringer Ingelheim InternationalmbH. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.4703.pdf

9. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration (EMC). [Revised in November 2015] [Accessed on 30th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf

PRODUCT DETAILS
Net Qty
1 N
Item Weight
17.5
Ingredient
DABIGATRAN ETEXILATE 110MG
Hsn Code
30049099
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