Dabigatran etexilate Welding
Italy
Table of Contents
Patient Information Leaflet
Dabigatran etexilate Welding 75 mg hard capsules
dabigatran etexilate
Generic medicine
Please read all of this leaflet carefully before you take 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Dabigatran etexilate Welding is and what it is used for
- What you need to know before taking Dabigatran etexilate Welding
- How to take Dabigatran etexilate Welding
- Possible side effects
- How to store Dabigatran etexilate Welding
- Contents of the pack and other information
1. What Dabigatran etexilato Welding is and what it is used for
Dabigatran etexilato Welding contains the active substance dabigatran etexilato and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body that is involved in blood clot formation.
Dabigatran etexilato Welding is used in adults to:
- prevent the formation of blood clots in veins following surgery to replace the knee or hip.
Dabigatran etexilato Welding is used in children to:
- treat blood clots and prevent the formation of new blood clots.
2. What you should know before taking Dabigatran etexilato Welding
Do not take Dabigatran etexilato Welding
-
if you are allergic to dabigatran etexilato or to any of the other ingredients of this medicine (listed in section 6).
-
if your kidney function is severely reduced.
-
if you are currently experiencing bleeding.
-
if you have organ injuries that increase the risk of severe bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent brain or eye surgery).
-
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
-
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and
you are receiving heparin through it to keep it open, or when your heart rhythm is
being restored to normal via a procedure called trans-catheter ablation for atrial
fibrillation. -
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
-
if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
-
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
-
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
-
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
-
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.
Warnings and precautions
Talk to your doctor before taking Dabigatran etexilato Welding. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially one of the following:
- if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone a biopsy (surgical removal of tissue) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilato Welding” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced 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 weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
- if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
- if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.
Take special care with Dabigatran etexilato Welding
-
if you are scheduled for surgery: In this case, Dabigatran etexilato Welding will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilato Welding exactly at the times instructed by your doctor, both before and after the surgery.
-
if a procedure involves placement 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 etexilato Welding exactly at the times instructed by your doctor, both before and after the procedure.
-
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anaesthesia wears off, as urgent treatment may be required.
- if you fall or get injured during treatment, especially if you receive a blow to the head. Contact your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high 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, who will decide whether a change in therapy is needed.
Other medicines and Dabigatran etexilato Welding
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking
Dabigatran etexilato Welding 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 to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
- Medicines to treat irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a lower dose of Dabigatran etexilato Welding depending on the condition for which it was prescribed. See also section 3
- Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
- The combination 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 medicine used to treat depression
- Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
- Rifampicin or clarithromycin (two antibiotics)
- Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
- Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)
Pregnancy and breastfeeding
The effects of Dabigatran etexilato Welding on pregnancy and the unborn baby are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabigatran etexilato Welding.
You must not breastfeed while being treated with Dabigatran etexilato Welding.
Driving and using machines
Dabigatran etexilato Welding has no known effects on the ability to drive vehicles or use machinery.
3. How to take Dabigatran etexilate Welding
Dabigatran etexilate Welding capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. For treatment of children under 12 years of age as soon as they are able to ingest soft food, Dabigatran etexilate Welding coated granules are available.
Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor.
Take Dabigatran etexilate Welding as recommended for the following conditions:
Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabigatran etexilate Welding of 75 mg, because the risk of bleeding may increase.
For both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
Start treatment with Dabigatran etexilate Welding within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
Start treatment with Dabigatran etexilate Welding within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Treatment of blood clots and prevention of new blood clots in children
Dabigatran etexilate Welding should be taken twice daily, one dose in the morning and one 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 the patient's weight and age. Your doctor will determine the correct dose.
Your doctor may adjust the dose during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilate Welding in milligrams (mg). The doses depend on the patient’s weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilate Welding capsules
| Weight/age combinations | Single dose in mg | Total daily dose in mg | |
| Weight in kg | Age in years | ||
| from 11 to less than 13 kg | from 8 to less than 9 years | 75 | 150 |
| from 13 to less than 16 kg | from 8 to less than 11 years | 110 | 220 |
| from 16 to less than 21 kg | from 8 to less than 14 years | 110 | 220 |
| from 21 to less than 26 kg | from 8 to less than 16 years | 150 | 300 |
| from 26 to less than 31 kg | from 8 to less than 18 years | 150 | 300 |
| from 31 to less than 41 kg | from 8 to less than 18 years | 185 | 370 |
| from 41 to less than 51 kg | from 8 to less than 18 years | 220 | 440 |
| from 51 to less than 61 kg | from 8 to less than 18 years | 260 | 520 |
| from 61 to less than 71 kg | from 8 to less than 18 years | 300 | 600 |
| from 71 to less than 81 kg | from 8 to less than 18 years | 300 | 600 |
| 81 kg or more | from 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 Welding
Dabigatran etexilate Welding can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew or remove the granules from the capsule, as this may increase the risk of bleeding.
Instructions for opening blister packs
The following images illustrate how to remove Dabigatran etexilate Welding capsules from the blister
Separate one unit from the entire blister along the perforated line
Lift the aluminium foil on the back and remove the capsule.
- Do not push the capsules through the aluminium foil of the blister.
- The aluminium foil of the blister should only be lifted when a capsule needs to be removed.
Switching anticoagulant treatment
Do not change your anticoagulant treatment without receiving specific instructions from your doctor.
If you take more Dabigatran etexilate Welding than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.
If you forget to take Dabigatran etexilate Welding
Prevention of blood clots after knee or hip replacement surgery: Continue with the remaining daily doses of Dabigatran etexilate Welding at the usual time the next day.
Do not take a double dose to make up for the forgotten dose.
Treatment and prevention of recurrence of blood clots in children: The missed dose may still be taken up to 6 hours before the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for the missed dose.
If you stop taking Dabigatran etexilate Welding
Take Dabigatran etexilate Welding exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Welding.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate Welding acts on the blood coagulation system; therefore, most of the side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not resolve spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.
Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Abnormal liver function test results
Uncommon (may affect up to 1 in 100 people):
- Bleeding which may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or following a wound, after surgery
- Haematoma formation or haematoma occurring after surgery
- Presence of blood in faeces, detected by laboratory testing
- Decrease in the number of red blood cells in the blood
- Decrease in blood cell proportion
- Allergic reaction
- Vomiting
- Diarrhoea with loose or liquid stools
- Feeling unwell
- Wound discharge (leakage of fluid from the surgical wound)
- Increased liver enzymes
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Rare (may affect up to 1 in 1,000 people):
- Bleeding
- Bleeding which may occur in the brain, from a surgical incision, injection site, or venous catheter insertion site
- Blood-stained discharge from the venous catheter insertion site
- Coughing up blood or blood-stained sputum
- Decrease in the number of platelets in the blood
- Decrease in the number of red blood cells after surgery
- Severe allergic reaction causing difficulty in breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with raised, dark red, itchy nodules due to an allergic reaction
- Sudden skin change altering its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Gastric acid reflux into the oesophagus
- Abdominal or stomach pain
- Indigestion
- Difficulty swallowing
- Fluid leaking from a wound
- Fluid leaking from a wound after surgery
Not known (frequency cannot be estimated from available data):
- Breathing difficulties or wheezing
- Decrease in number or even absence of white blood cells (which help fight infections)
- Hair loss
Treatment of blood clots and prevention of recurrence 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
- Pronounced skin rash with raised, dark red, itchy nodules due to an allergic reaction
- Sudden skin change altering its colour and appearance
- Haematoma formation
- Nosebleeds
- Gastric acid reflux into the oesophagus
- Vomiting
- Feeling unwell
- Diarrhoea with 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 which may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Decrease in blood cell proportion
- Itching
- Coughing up blood or blood-stained sputum
- Abdominal or stomach pain
- 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
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
- Breathing difficulties or wheezing
- Bleeding
- Bleeding which may occur in a joint or from a wound, surgical incision, injection site, or venous catheter insertion site
- Bleeding from haemorrhoids
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Abnormal liver function test results
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Dabigatran etexilate Welding
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister after Exp or EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Dabigatran etexilate Welding contains
- The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
- The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
- The capsule shell contains carrageenan, potassium chloride, titanium dioxide and hypromellose.
- The printing ink (black) contains shellac, black iron oxide and potassium hydroxide.
Description of the appearance of Dabigatran etexilate Welding and the contents of the pack
Dabigatran etexilate Welding 75 mg is a hard capsule (approximately 18 × 6 mm) with an opaque white cap and an opaque white body. "75" is printed on the body of the hard capsule.
This medicine is available in packs of 10 × 1, 30 × 1 or 60 × 1 hard capsules in blisters of OPA/Al/PVC//Al.
Unit dose blister:
This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules in perforated, detachable OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Welding GmbH & Co KG
Esplanade 39
20354 Hamburg
Germany
Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000
Malta
or
Laboratori Fundacio Dau
C/c 12-14 Poligono Industrial Zona Franca De Barcelona
08040 Barcelona
Spain
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Patient Information Leaflet
Dabigatran etexilate Welding 110 mg hard capsules
dabigatran etexilate
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Dabigatran etexilate Welding is and what it is used for
- What you need to know before taking Dabigatran etexilate Welding
- How to take Dabigatran etexilate Welding
- Possible side effects
- How to store Dabigatran etexilate Welding
- Contents of the pack and other information
1. What Dabigatran etexilato Welding is and what it is used for
Dabigatran etexilato Welding contains the active substance dabigatran etexilato and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body involved in blood clot formation.
Dabigatran etexilato Welding is used in adults for:
- preventing the formation of blood clots in the veins following hip or knee replacement surgery.
- preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one other risk factor.
- treating blood clots in the veins of the legs and lungs and preventing blood clots from recurring in the veins of the legs and lungs.
Dabigatran etexilato Welding is used in children for:
- treating blood clots and preventing the formation of new blood clots.
2. What you should know before taking Dabigatran etexilate Welding
Do not take Dabigatran etexilate Welding
-
if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
-
if your kidney function is severely reduced.
-
if you are currently experiencing bleeding.
-
if you have organ lesions that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
-
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
-
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and heparin is administered through it to keep it open, or when your heartbeat is restored to normal via a procedure called catheter ablation for atrial fibrillation.
-
if you have severely reduced liver function or a liver disease that could potentially 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 transplant rejection.
-
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
-
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
-
if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.
Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Welding. You may also need to contact your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially any of the following:
- if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you underwent a biopsy (surgical removal of tissue) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the esophagus or stomach.
- if you have gastroesophageal reflux (stomach acid flowing back into the esophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Welding” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
- if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
- if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.
Take special care with Dabigatran etexilate Welding
- if you are scheduled for surgery: In this case, Dabigatran etexilate Welding will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Welding exactly at the time instructed by your doctor, both before and after surgery.
- if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
- It is very important to take Dabigatran etexilate Welding exactly at the time instructed by your doctor, both before and after the procedure.
Contact your doctor immediately if you experience numbness or weakness in the legs or problems
with bowel or bladder function after the anaesthesia wears off, as urgent treatment may be needed.
- if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
- if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.
Other medicines and Dabigatran etexilate Welding
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilate Welding 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 for fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
- Medicines for irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatran etexilate Welding depending on the condition for which it has been prescribed. See section 3.
- Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
- The combination 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 medicine used to treat depression
- Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
- Rifampicin or clarithromycin (two antibiotics)
- Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
- Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)
Pregnancy and breastfeeding
The effects of Dabigatran etexilate Welding on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so.
If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabigatran etexilate Welding.
You must not breastfeed during treatment with Dabigatran etexilate Welding.
Driving and using machines
Dabigatran etexilate Welding has no known effect on the ability to drive vehicles or operate machinery.
3. How to take Dabigatran etexilate Welding
Dabigatran etexilate Welding capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. For the treatment of children under 12 years of age, once they are able to ingest soft food, Dabigatran etexilate Welding granules with enteric coating are available.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Welding as recommended for the following conditions:
Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabigatran etexilate Welding of 75 mg, because the risk of bleeding may increase.
For both types of surgery, treatment must not be initiated if there is active bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
Begin treatment with Dabigatran etexilate Welding within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
Begin treatment with Dabigatran etexilate Welding within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including 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.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Welding of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at increased risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Dabigatran etexilate Welding as directed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may be treated with Dabigatran etexilate Welding once your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilate Welding as directed by your doctor.
Treatment and prevention of blood clots in children
Dabigatran etexilate Welding should be taken twice daily, one dose in the morning and one 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 the patient's weight and age. Your doctor will determine the correct dose.
Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilate Welding in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilate Welding capsules
| Weight/age combinations | Single dose in mg | Total daily dose in mg | |
| Weight in kg | Age in years | ||
| from 11 to less than 13 kg | from 8 to less than 9 years | 75 | 150 |
| from 13 to less than 16 kg | from 8 to less than 11 years | 110 | 220 |
| from 16 to less than 21 kg | from 8 to less than 14 years | 110 | 220 |
| from 21 to less than 26 kg | from 8 to less than 16 years | 150 | 300 |
| from 26 to less than 31 kg | from 8 to less than 18 years | 150 | 300 |
| from 31 to less than 41 kg | from 8 to less than 18 years | 185 | 370 |
| from 41 to less than 51 kg | from 8 to less than 18 years | 220 | 440 |
| from 51 to less than 61 kg | from 8 to less than 18 years | 260 | 520 |
| from 61 to less than 71 kg | from 8 to less than 18 years | 300 | 600 |
| from 71 to less than 81 kg | from 8 to less than 18 years | 300 | 600 |
| 81 kg or more | from 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 etexilato Welding
Dabigatran etexilato Welding can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.
Instructions for opening the blister packs
The following images illustrate how to remove Dabigatran etexilato Welding capsules from the blister
Separate one blister unit from the entire blister along the perforated line
Lift the aluminium foil on the back and remove the capsule.
- Do not push the capsules through the aluminium foil of the blister.
- The aluminium foil of the blister should be lifted only when a capsule needs to be removed.
Switching anticoagulant treatment
Do not change your anticoagulant treatment without receiving specific instructions from your doctor.
If you take more Dabigatran etexilato Welding than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.
If you forget to take Dabigatran etexilato Welding
Prevention of blood clots after knee or hip replacement surgery: Continue with the remaining daily doses of Dabigatran etexilato Welding at the usual time the next day.
Do not take a double dose to make up for the missed dose.
Use in adults: prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
Use in children: treatment of blood clots and prevention of recurrence of blood clots.
A missed dose may still be taken up to 6 hours before the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for a missed dose.
If you stop taking Dabigatran etexilato Welding
Take Dabigatran etexilato Welding exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilato Welding.
If you have any 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 gets them.
Dabigatran etexilato Welding acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not resolve spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):
- Decrease in the amount of haemoglobin present in the blood (the substance contained in red blood cells)
- Abnormal liver function test results
Uncommon (may affect up to 1 in 100 people):
- Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
- Formation of haematoma or haematoma occurring after surgery
- Presence of blood in faeces, detected by laboratory test
- Decrease in the number of red blood cells in the blood
- Decrease in the proportion of blood cells
- Allergic reaction
- Vomiting
- Diarrhoea with unformed or liquid stools
- Feeling unwell
- Wound discharge (leakage of fluid from the surgical wound)
- Increased liver enzymes
- Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
Rare (may affect up to 1 in 1,000 people):
- Bleeding
- Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of insertion of a catheter into a vein
- Blood-stained discharge from the site of insertion of a catheter into a vein
- Coughing up blood or sputum stained with blood
- Decrease in the number of platelets in the blood
- Decrease in the number of red blood cells in the blood after surgery
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Sudden skin alteration changing its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Reflux of gastric juices into the oesophagus
- Abdominal or stomach pain
- Indigestion
- Difficulty swallowing
- Fluid leaking from a wound
- Fluid leaking from a wound after surgery
Not known (frequency cannot be estimated from the available data):
- Difficulty breathing or wheezing
- Decrease in the number or even absence of white blood cells (which help fight infections)
- Hair loss
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots arising from irregular heartbeat
Common (may affect up to 1 in 10 people):
- Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
- Decrease in the number of red blood cells in the blood
- Abdominal or stomach pain
- Indigestion
- Diarrhoea with unformed or liquid stools
- Feeling unwell
Uncommon (may affect up to 1 in 100 people):
- Bleeding
- Bleeding that may occur from haemorrhoids, rectum or brain
- Formation of haematoma
- Coughing up blood or sputum stained with blood
- Decrease in the number of platelets in the blood
- Decrease in the amount of haemoglobin present in the blood (the substance contained in red blood cells)
- Allergic reaction
- Sudden skin alteration changing its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Reflux of gastric juices into the oesophagus
- Vomiting
- Difficulty swallowing
- Abnormal liver function test results
Rare (may affect up to 1 in 1,000 people):
- Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of insertion of a catheter into a vein
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Decrease in the proportion of blood cells
- Increased liver enzymes
- Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
Not known (frequency cannot be estimated from the available data):
- Difficulty breathing or wheezing
- Decrease in the number or even absence of white blood cells (which help fight infections)
- Hair loss
In a clinical study, the rate of heart attacks was higher with Dabigatran etexilato Welding than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs
Common (may affect up to 1 in 10 people):
- Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
- Indigestion
Uncommon (may affect up to 1 in 100 people):
- Bleeding
- Bleeding that may occur in a joint or from a wound
- Bleeding that may occur from haemorrhoids
- Decrease in the number of red blood cells in the blood
- Formation of haematoma
- Coughing up blood or sputum stained with blood
- Allergic reaction
- Sudden skin alteration changing its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Reflux of gastric juices into the oesophagus
- Feeling unwell
- Vomiting
- Abdominal or stomach pain
- Diarrhoea with unformed or liquid stools
- Abnormal liver function test results
- Increased liver enzymes
Rare (may affect up to 1 in 1,000 people):
- Bleeding that may occur from a surgical incision, or from the injection site, from the site of insertion of a catheter into a vein, 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
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Difficulty swallowing
Not known (frequency cannot be estimated from the available data):
- Difficulty breathing or wheezing
- Decrease in the amount of haemoglobin present in the blood (the substance contained in red blood cells)
- Decrease in the proportion of blood cells
- Decrease in the number or even absence of white blood cells (which help fight infections)
- Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
- Hair loss
In the clinical study programme, the rate of heart attacks was higher with Dabigatran etexilato Welding than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.
Treatment of blood clots and prevention of formation of new 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
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Sudden skin alteration changing its colour and appearance
- Formation of haematoma
- Nosebleed
- Reflux of gastric juices into the oesophagus
- Vomiting
- Feeling unwell
- Diarrhoea with unformed 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 that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
- Decrease in the amount of haemoglobin present in the blood (the substance contained in red blood cells)
- Decrease in the proportion of blood cells
- Itching
- Coughing up blood or sputum stained with blood
- Abdominal or stomach pain
- Inflammation of the oesophagus and stomach
- Allergic reaction
- Difficulty swallowing
- Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
Not known (frequency cannot be estimated from the 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 that may occur in a joint or from a wound, surgical incision, injection site or site of insertion of a catheter into a vein
- Bleeding that may occur from haemorrhoids
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Abnormal liver function test results
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Dabigatran etexilate Welding
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister after Scad or EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Dabigatran etexilate Welding contains
- The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
- The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
- The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.
- The printing ink for the capsule contains shellac, black iron oxide and potassium hydroxide.
Description of the appearance of Dabigatran etexilate Welding and the contents of the pack
Dabigatran etexilate Welding 110 mg are hard capsules (approximately 19 × 7 mm) with an opaque blue cap and an opaque blue body. "110" is printed on the body of the hard capsule.
This medicine is available in packs of 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1 hard capsules, in multipacks of 3 packs of 60 × 1 hard capsules (180 hard capsules) or in multipacks of 2 packs of 50 × 1 hard capsules (100 hard capsules) in OPA/Al/PVC//Al blisters.
Unit-dose blisters:
This medicine is available in packs containing 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1 hard capsules, in a multiple pack containing 3 packs of 60 × 1 hard capsules (180 hard capsules) or in a multiple pack containing 2 packs of 50 × 1 hard capsules (100 hard capsules) in perforated, detachable OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Welding GmbH & Co KG
Esplanade 39
20354 Hamburg
Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000
Malta
or
Laboratori Fundacio Dau
C/c 12-14 Poligono Industrial Zona
Franca De Barcelona
08040 Barcelona
Spain
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Package leaflet: Information for the patient
Dabigatran etexilate Welding 150 mg hard capsules
dabigatran etexilate
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Dabigatran etexilate Welding is and what it is used for
- What you need to know before taking Dabigatran etexilate Welding
- How to take Dabigatran etexilate Welding
- Possible side effects
- How to store Dabigatran etexilate Welding
- Contents of the pack and other information
1. What Dabigatran etexilato Welding is and what it is used for
Dabigatran etexilato Welding contains the active substance dabigatran etexilato and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body involved in blood clot formation.
Dabigatran etexilato Welding is used in adults for:
- preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
- treating blood clots in the veins of the legs and lungs and preventing blood clots from re-forming in the veins of the legs and lungs.
Dabigatran etexilato Welding is used in children for:
- treating blood clots and preventing the formation of new blood clots.
2. What you should know before taking Dabigatran etexilato Welding
Do not take Dabigatran etexilato Welding
- if you are allergic to dabigatran etexilato or to any of the other ingredients of this medicine (listed in section 6).
- if your kidney function is severely reduced.
- if you are currently experiencing bleeding.
- if you have organ injuries that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
- if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
- if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heart rhythm is being restored to normal via a procedure called trans-catheter ablation for atrial fibrillation.
- if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
- if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
- if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection episodes.
- if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
- if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
- if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.
Warnings and precautions
Talk to your doctor before taking Dabigatran etexilato Welding. You may also need to contact your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially one of the following:
- if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone a biopsy (surgical removal of tissue) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgical intervention).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (stomach acid flowing back into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilato Welding” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (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 for use in children: if the child has an infection around or within the brain.
- if you have had a heart attack or if you have been diagnosed with conditions that increase your risk of having a heart attack.
- if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.
Take special care with Dabigatran etexilato Welding
- if you are scheduled for surgery: In this case, Dabigatran etexilato Welding will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilato Welding exactly at the times instructed by your doctor, both before and after surgery.
- if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
- it is very important to take Dabigatran etexilato Welding exactly at the times instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in the legs, or bowel or bladder problems after the anaesthesia wears off, as urgent treatment may be needed.
- if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high 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, who will decide whether a change in therapy is needed.
Other medicines and Dabigatran etexilato Welding
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilato Welding 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 for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
- Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a reduced dose of Dabigatran etexilato Welding depending on the condition for which it has been prescribed. See section 3.
- Medicines to prevent transplant rejection episodes (e.g. tacrolimus, cyclosporine)
- The combination 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 medicine used to treat depression
- Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
- Rifampicin or clarithromycin (two antibiotics)
- Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
- Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)
Pregnancy and breastfeeding
The effects of Dabigatran etexilato Welding on pregnancy and the unborn baby are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabigatran etexilato Welding.
You must not breastfeed during treatment with Dabigatran etexilato Welding.
Driving and using machines
Dabigatran etexilato Welding has no known effects on the ability to drive vehicles or operate machinery.
3. How to take Dabigatran etexilato Welding
Dabigatran etexilato Welding capsules can be used in adults and children aged 8 years and older who are able to swallow whole capsules. For treatment of children under 12 years of age, as soon as they are able to swallow soft food, Dabigatran etexilato Welding coated granules are available.
Always take this medicine exactly as your doctor has instructed. If you are in doubt, consult your doctor.
Take Dabigatran etexilato Welding as recommended for the following conditions:
Prevention of blockage in blood vessels of the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including 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.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilato Welding of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Take Dabigatran etexilato Welding according to your doctor’s instructions.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may be treated with Dabigatran etexilato Welding after your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilato Welding according to your doctor’s instructions.
Treatment of blood clots and prevention of new blood clots in children.
Dabigatran etexilato Welding must be taken twice daily, one dose in the morning and one 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 the patient’s weight and age. Your doctor will determine the correct dose.
Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the individual and total daily doses of Dabigatran etexilato Welding in milligrams (mg). The doses depend on the patient’s weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilato Welding capsules
| Weight/age combinations | Single dose in mg | Total daily dose in mg | |
| Weight in kg | Age in years | ||
| from 11 to less than 13 kg | from 8 to less than 9 years | 75 | 150 |
| from 13 to less than 16 kg | from 8 to less than 11 years | 110 | 220 |
| from 16 to less than 21 kg | from 8 to less than 14 years | 110 | 220 |
| from 21 to less than 26 kg | from 8 to less than 16 years | 150 | 300 |
| from 26 to less than 31 kg | from 8 to less than 18 years | 150 | 300 |
| from 31 to less than 41 kg | from 8 to less than 18 years | 185 | 370 |
| from 41 to less than 51 kg | from 8 to less than 18 years | 220 | 440 |
| from 51 to less than 61 kg | from 8 to less than 18 years | 260 | 520 |
| from 61 to less than 71 kg | from 8 to less than 18 years | 300 | 600 |
| from 71 to less than 81 kg | from 8 to less than 18 years | 300 | 600 |
| 81 kg or more | from 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 Welding
Dabigatran etexilate Welding can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.
Instructions for opening the blister pack
The following images illustrate how to remove Dabigatran etexilate Welding capsules from the blister:
Separate one unit of the blister from the entire blister along the perforated line.
Lift the aluminium foil on the back and remove the capsule.
- Do not push the capsules through the aluminium foil of the blister.
- The aluminium foil of the blister should be lifted only when a capsule needs to be removed.
Switching anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.
If you take more Dabigatran etexilate Welding than you should
Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken an excessive number of capsules. Specific treatment options are available.
If you forget to take Dabigatran etexilate Welding
The missed dose can still be taken if it is within 6 hours before the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for the missed dose.
If you stop taking Dabigatran etexilate Welding
Take Dabigatran etexilate Welding exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Welding.
If you have any 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 gets them.
Dabigatran etexilate Welding acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to frequency of occurrence.
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots resulting from irregular heartbeat
Common (may affect up to 1 in 10 people):
- Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
- Decrease in the number of red blood cells in the blood
- Stomach or abdominal pain
- Indigestion
- Diarrhea with loose or watery stools
- Feeling unwell
Uncommon (may affect up to 1 in 100 people):
- Bleeding
- Bleeding that may occur from hemorrhoids, rectum, or brain
- Formation of hematoma
- Coughing up blood or sputum stained with blood
- Decrease in the number of platelets in the blood
- Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
- Allergic reaction
- Sudden skin changes altering its color and appearance
- Itching
- Stomach or intestinal ulcer (including esophageal ulcer)
- Inflammation of the esophagus and stomach
- Gastric acid reflux into the esophagus
- Vomiting
- Difficulty swallowing
- Abnormal liver function test results
Rare (may affect up to 1 in 1,000 people):
- Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site into a vein
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
- Decrease in proportion of blood cells
- Increase in liver enzymes
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems
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 study, the rate of heart attacks was higher with Dabigatran etexilate Welding than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):
- Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
- Indigestion
Uncommon (may affect up to 1 in 100 people):
- Bleeding
- Bleeding that may occur in a joint or from a wound
- Bleeding that may occur from hemorrhoids
- Decrease in the number of red blood cells in the blood
- Formation of hematoma
- Coughing up blood or sputum stained with blood
- Allergic reaction
- Sudden skin changes altering its color and appearance
- Itching
- Stomach or intestinal ulcer (including esophageal ulcer)
- Inflammation of the esophagus and stomach
- Gastric acid reflux into the esophagus
- Feeling unwell
- Vomiting
- Stomach or abdominal pain
- Diarrhea with loose or watery stools
- Abnormal liver function test results
- Increase in liver enzymes
Rare (may affect up to 1 in 1,000 people):
- Bleeding that may occur from a surgical incision, injection site, catheter insertion site into a vein, or 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
- Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
- Difficulty swallowing
Not known (frequency cannot be estimated from available data):
- Difficulty breathing or wheezing
- Decrease in the amount of hemoglobin in the blood (the substance contained 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 study program, the rate of heart attacks was higher with Dabigatran etexilate Welding than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.
Treatment of blood clots and prevention of formation of new 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
- Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
- Sudden skin changes altering its color and appearance
- Formation of hematoma
- Nosebleeds
- Gastric acid reflux into the esophagus
- Vomiting
- Feeling unwell
- Diarrhea with loose or watery stools
- Indigestion
- Hair loss
- Increase in liver enzymes
Uncommon (may affect up to 1 in 100 people):
- Decrease in the number of white blood cells (which help fight infections)
- Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, urinary tract (including blood in urine turning it pink or red), or under the skin
- Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
- Decrease in proportion of blood cells
- Itching
- Coughing up blood or sputum stained with blood
- Stomach or abdominal pain
- Inflammation of the esophagus and stomach
- Allergic reaction
- Difficulty swallowing
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems
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 that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site into a vein
- Bleeding that may occur from hemorrhoids
- Stomach or intestinal ulcer (including esophageal ulcer)
- Abnormal liver function test results
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Dabigatran etexilato Welding
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, after Scad or EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
- Pack contents and other information What Dabigatran etexilato Welding contains
- The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
- The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
- The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.
- The printing ink contains shellac, iron oxide black and potassium hydroxide.
Description of the appearance of Dabigatran etexilato Welding and pack contents
Dabigatran Welding 150 mg is a hard capsule (approximately 22 × 8 mm) with an opaque blue cap and an opaque white body. "150" is printed on the body of the hard capsule.
This medicine is available in packs of 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1 hard capsules, in multipacks containing 3 packs of 60 × 1 hard capsules (180 hard capsules) or in multipacks containing 2 packs of 50 × 1 hard capsules (100 hard capsules) in OPA/AL/PVC//AL blisters.
Unit dose blisters:
This medicine is available in packs containing 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1 hard capsules, in a multiple pack containing 3 packs of 60 × 1 hard capsules (180 hard capsules) or in a multiple pack containing 2 packs of 50 × 1 hard capsules (100 hard capsules) in perforated, detachable OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Welding GmbH & Co
KG
Esplanade 39
20354 Hamburg
Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000
Malta
or
Laboratorios Fundacio Dau
C/c 12-14 Poligono Industrial Zona Franca De Barcelona
08040 Barcelona
Spain
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder: