Dabigatran etexilate Sandoz 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Sandoz 150 mg hard capsules EFG

dabigatran etexilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before taking Dabigatran etexilate Sandoz

3. How to take Dabigatran etexilate Sandoz

4. Possible side effects

5. Storage of Dabigatran etexilate Sandoz

6. Contents of the pack and other information

1. What Dabigatran Etexilate Sandoz is and what it is used for

Dabigatran Etexilate Sandoz contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Dabigatran etexilate is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor,
• treat blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Dabigatran etexilate is used in children to:

• treat blood clots and to prevent blood clots from forming again.

2. What you need to know before taking Dabigatran etexilate Sandoz

Do not take Dabigatran etexilate Sandoz

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6),
• if your kidney function is severely reduced,
• if you currently have bleeding,
• if you have a disease in an organ that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery),
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines,
• if you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching between anticoagulant treatments, while you have a venous or arterial catheter and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation,
• if your liver function is severely reduced or you have a liver disease that could be life-threatening,
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections,
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation,
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm,
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C,
• if you have had an artificial heart valve implanted that requires lifelong anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting dabigatran etexilate. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are scheduled for surgery.

Tell your doctor if you have or have had any disorders or illnesses, especially any of the following:

• If you have an increased risk of bleeding, for example:

• if you have recently had bleeding,

• if you have undergone surgical tissue removal (biopsy) within the last month,

• if you have suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment),

• if you have inflammation of the oesophagus or stomach,

• if you have gastro-oesophageal reflux (stomach acid flowing back into the oesophagus),

• if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatran etexilate Sandoz” below,

• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam,

• if you have an infection in the heart (bacterial endocarditis),

• if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark [concentrated]/foamy urine),

• if you are over 75 years old,

• if you are an adult and weigh 50 kg or less,

• only if used in children: if the child has an infection in or around the brain.

• if you have had a heart attack or have been diagnosed with conditions that increase the risk of heart attack,

• if you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in such cases.

Take special care with Dabigatran etexilate Sandoz

• if you need to undergo surgery:

In this case, dabigatran etexilate should be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatran etexilate before and after surgery exactly as directed by your doctor,

• if surgery requires placement of a catheter or injection into the spinal column (e.g., for epidural or spinal anaesthesia or pain relief):

• it is very important that you take dabigatran etexilate before and after surgery exactly as directed by your doctor,

• inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after the anaesthesia wears off, as this situation requires urgent medical attention.

• if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical help. You may need to be examined by a doctor, as you may have an increased risk of bleeding,

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

Other medicines and Dabigatran etexilate Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking dabigatran etexilate if you are taking any of the following medicines:

• medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid),
• medicines to treat fungal infections (e.g., ketoconazole, itraconazole), except if applied only to the skin,
• medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a lower dose of dabigatran etexilate depending on the condition for which it has been prescribed. See section 3,
• medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine),
• a combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C),
• anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac),
• St. John’s wort, a herbal remedy for depression,
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors,
• rifampicin or clarithromycin (two antibiotics),
• antiviral medicines for HIV (e.g., ritonavir),
• certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The effects of dabigatran etexilate on pregnancy and the unborn child are unknown. You should not use this medicine during pregnancy unless your doctor tells you it is safe. If you are of childbearing age, you should avoid becoming pregnant during treatment with dabigatran etexilate.

Breastfeeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive and use machines.

Dabigatran etexilate Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; hence, it is essentially “sodium-free”.

3. How to take Dabigatran etexilate Sandoz

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Other age-appropriate pharmaceutical forms are available for the treatment of children under 12 years of age once they are able to swallow soft foods.

Always follow your doctor's instructions exactly on how to take this medicine. If you are unsure, consult your doctor again.

Take Dabigatran etexilate Sandoz as recommended for the following conditions:

Prevention of systemic or cerebral vascular occlusion due to blood clot formation associated with irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs

The recommended dose is 300 mg given as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg given as one 110 mg capsule twice daily.

If you are taking medications containing verapamil, you will be prescribed a reduced dose of dabigatran etexilate of 220 mg given as one 110 mg capsule twice daily, as your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg given as one 110 mg capsule twice daily.

You may continue taking this medicine if it becomes necessary to restore your normal heart rhythm through a procedure called cardioversion or through a catheter ablation procedure for atrial fibrillation. Take dabigatran etexilate exactly as directed by your doctor.

If you have had a medical device (vascular stent) placed in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may receive treatment with dabigatran etexilate once your doctor has determined that normal blood coagulation control has been achieved. Take dabigatran etexilate exactly as directed by your doctor.

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

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

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor instructs you to stop any of them.

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

Table 1: Dosing table for dabigatran etexilate capsules

Weight/Age Combinations	Single Dose in mg	Total Daily Dose in mg
Weight in kg	Age in years
11 to less than 13 kg	8 to less than 9 years	75	150
13 to less than 16 kg	8 to less than 11 years	110	220
16 to less than 21 kg	8 to less than 14 years	110	220
21 to less than 26 kg	8 to less than 16 years	150	300
26 to less than 31 kg	8 to less than 18 years	150	300
31 to less than 41 kg	8 to less than 18 years	185	370
41 to less than 51 kg	8 to less than 18 years	220	440
51 to less than 61 kg	8 to less than 18 years	260	520
61 to less than 71 kg	8 to less than 18 years	300	600
71 to less than 81 kg	8 to less than 18 years	300	600
81 kg or more	10 to less than 18 years	300	600

Single doses requiring combinations of more than one capsule:

300 mg:	two 150 mg capsules or four 75 mg capsules
260 mg:	one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules
220 mg:	two 110 mg capsules
185 mg:	one 75 mg capsule plus one 110 mg capsule
150 mg:	one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Sandoz

Dabigatran etexilate can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or empty the contents of the capsule, as this may increase the risk of bleeding.

Instructions for blister pack

• Push the capsules through the foil of the blister pack.

Instructions for bottle

• Press and turn to open.
• After removing the capsule, replace the cap on the bottle and close the bottle tightly immediately after taking your dose.

Changing anticoagulant treatment

Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabigatran etexilate Sandoz than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dabigatran etexilate Sandoz

A missed dose can be taken up to 6 hours before the next scheduled dose.

A missed dose should be omitted if less than 6 hours remain before the next dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Dabigatran etexilate Sandoz

Take dabigatran etexilate exactly as prescribed by your doctor. Do not stop your treatment with this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking dabigatran etexilate.

If you have any further questions about the use of this medicine, ask 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 acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Episodes of major or severe bleeding may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, this bleeding may not be evident.

If you experience any bleeding episode that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.

The possible adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of stroke or systemic embolism due to blood clots
developed after irregular heartbeat

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

• bleeding may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin,
• decrease in the number of red blood cells in the blood,
• abdominal pain or stomach ache,
• indigestion,
• frequent loose or liquid stools,
• feeling nauseous

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

• bleeding,
• bleeding may occur from haemorrhoids, rectum, or brain,
• formation of bruises,
• coughing up blood or blood-stained sputum,
• decrease in the number of platelets in the blood,
• decrease in the amount of haemoglobin in the blood (the substance present in red blood cells),
• allergic reaction,
• sudden change in the skin affecting its colour and physical appearance,
• itching,
• ulcer in the stomach or intestine (including oesophageal ulcer),
• inflammation of the oesophagus and stomach,
• reflux of gastric juice into the oesophagus,
• vomiting,
• difficulty swallowing,
• abnormalities in liver function tests.

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

• bleeding may occur in a joint, at a surgical incision site, in a wound, at the site of an injection, or at the site of a venous catheter insertion,
• severe allergic reaction causing difficulty breathing or dizziness,
• severe allergic reaction causing swelling of the face or throat,
• skin rash with dark red, raised, itchy bumps caused by an allergic reaction,
• decrease in proportion of blood cells,
• increased liver enzymes,
• yellowing of the skin or whites of the eyes, caused by liver or blood problems.

Frequency not known (frequency cannot be estimated from available data):

• difficulty breathing or wheezing,
• decrease in number or even absence of white blood cells (which help fight infections),
• hair loss.

In a clinical trial, the rate of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and/or lungs

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

• bleeding may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin,
• indigestion.

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

• bleeding,
• bleeding may occur in a joint or wound,
• bleeding may occur from haemorrhoids,
• decrease in the number of red blood cells in the blood,
• formation of bruises,
• coughing up blood or blood-stained sputum,
• allergic reaction,
• sudden change in the skin affecting its colour and physical appearance,
• itching,
• ulcer in the stomach or intestine (including oesophageal ulcer),
• inflammation of the oesophagus and stomach,
• reflux of gastric juice into the oesophagus,
• feeling nauseous,
• vomiting,
• abdominal pain or stomach ache,
• frequent loose or liquid stools,
• abnormalities in liver function tests,
• increased liver enzymes.

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

• bleeding may occur at a surgical incision site, at the site of an injection, at the site of a venous catheter insertion, or from the brain,
• decrease in the number of platelets in the blood,
• severe allergic reaction causing difficulty breathing or dizziness,
• severe allergic reaction causing swelling of the face or throat,
• skin rash with dark red, raised, itchy bumps caused by an allergic reaction,
• difficulty swallowing.

Frequency not known (frequency cannot be estimated from available data):

• difficulty breathing or wheezing,
• decrease in the amount of haemoglobin in the blood (the substance present in red blood cells),
• decrease in proportion of blood cells,
• decrease in number 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 problems,
• hair loss.

In the clinical trial programme, the rate of heart attacks with dabigatran etexilate was higher than with warfarina. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with 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 with dark red, raised, itchy bumps caused by an allergic reaction,
• sudden change in the skin affecting its colour and physical appearance,
• formation of bruises,
• nosebleed,
• reflux of gastric juice into the oesophagus,
• vomiting,
• feeling nauseous,
• frequent loose or liquid stools,
• indigestion,
• hair loss,
• increased liver enzymes.

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

• decrease in the number of white blood cells (which help fight infections),
• bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin,
• decrease in the amount of haemoglobin in the blood (the substance present in red blood cells),
• decrease in proportion of blood cells,
• 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 problems.

Frequency 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 in a joint or wound, at a surgical incision site, at the site of an injection, or at the site of a venous catheter insertion,
• bleeding may occur from haemorrhoids,
• ulcer in the stomach or intestine (including oesophageal ulcer),
• abnormalities in liver function tests.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran etexilate Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging, blister pack or bottle after CAD/EXP. The expiry date refers to the last day of the month indicated.

Blister pack and bottle

Store below 30°C.

Bottle

After opening, the medicine should be used within 60 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at a pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Dabigatran etexilate Sandoz

• The active substance is dabigatran etexilate. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).

• The other components are:

• capsule contents: tartaric acid, hypromellose (E464), talc, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate.

• capsule coating: titanium dioxide (E171) and hypromellose (E464).

• black printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).

Nature of the medicinal product and package contents

Hard capsule.

Size "0" hard capsule with an opaque white cap marked with "MD" and an opaque white body marked with "150" in black ink, containing a mixture of white to pale yellow pellets and pale yellow granules.

Dabigatran etexilate Sandoz is available in:

Opa/Al/desiccant PE-Al/PE blisters containing 10, 30, 60, 100, 180 and 200 hard capsules.

Opa/Al/desiccant PE-Al/PE blisters containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 100 x 1, 180 x 1 and 200 x 1 hard capsules in perforated unit-dose blisters.

Multiple pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) in Opa/Al/desiccant PE-Al/PE perforated unit-dose blisters.

Multiple pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in Opa/Al/desiccant PE-Al/PE perforated unit-dose blisters.

Polypropylene bottle with child-resistant polypropylene screw cap containing desiccant. Pack sizes of 60 hard capsules (1 bottle), 120 hard capsules (2 bottles of 60 hard capsules), and 180 hard capsules (3 bottles of 60 hard capsules).

Do not ingest the desiccant.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

Sachsen-Anhalt

39179 Barleben,

Germany

or

Pharmadox Healthcare LTD

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

or

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57,

Ljubljana, 1526,

Slovenia

Date of the most recent revision of this leaflet: 09/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/