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Dabigatran (Sandoz) TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: dabigatran

Brand name

(ARTG)

: DABIGATRAN SANDOZ dabigatran etexilate (as mesilate) 110 mg capsule blister pack

Consumer Medicine Information (CMI)

Read the CMI leaflet for facts you need to know before, during and after taking your medicine.

For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).


What this medicine is used for

(ARTG)

Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see Section 4.2 Dose and method of administration for details of treatment duration).,Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Capsule
  • Oral
  • White to light yellow coloured pellets in size 1 capsule with white opaque cap imprinted MD and white opaque body imprinted 110 with black ink

Storage conditions

(ARTG)

  • Store below 25 degrees Celsius
  • Shelf lifetime is 36 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 10 capsules pack
  • 60 capsules pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient dabigatran

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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