Dabigatran etexilate medical valley

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dabigatran etexilate Medical Valley is and what it is used for
2. Important information before taking Dabigatran etexilate Medical Valley
3. How to take Dabigatran etexilate Medical Valley
4. Possible side effects
5. How to store Dabigatran etexilate Medical Valley
6. Contents of the pack and other information

1. What Dabigatran etexilate Medical Valley is and what it is used for

Dabigatran etexilate Medical Valley contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body responsible for blood clot formation.

Dabigatran etexilate Medical Valley is used in adults to:

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

Dabigatran etexilate Medical Valley is used in children to:

• treat blood clots and to prevent recurrence of blood clots.

2. Important information before taking Dabigatran etexilate Medical Valley

When not to take Dabigatran etexilate Medical Valley

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney problems.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or intracranial bleeding, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter, when heparin is administered through the catheter to maintain its patency, or during restoration of normal heart rhythm by a procedure called

catheter ablation in atrial fibrillation.

• if the patient has severe liver problems or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Medical Valley, discuss this with your doctor.
If symptoms occur during treatment with this medicine or if the patient undergoes a surgical procedure, consult a doctor.
The patient should inform the doctor if they currently have or have had in the past any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
  • if the patient has recently experienced bleeding.
  • if the patient has undergone a surgical biopsy within the last month.
  • if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
  • if the patient has inflammation of the oesophagus or stomach.
  • if the patient has gastro-oesophageal reflux (acid reflux into the oesophagus).
  • if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate Medical Valley and other medicines”.
  • if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
  • if the patient has an infection in the heart (bacterial endocarditis).
  • if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) and/or foamy urine).
  • if the patient is over 75 years of age.
  • if the patient is an adult weighing 50 kg or less.
  • only when used in children: if the child has an infection around or within the brain.
• if the patient has had a heart attack or has been diagnosed with a condition that increases the risk of myocardial infarction.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise particular caution when using Dabigatran etexilate Medical Valley

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran etexilate Medical Valley is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Medical Valley exactly as directed by the doctor both before and after surgery.
• if surgery requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• It is very important to take Dabigatran etexilate Medical Valley exactly as directed by the doctor both before and after surgery.
• The patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs or problems with the bowel or bladder after the anaesthetic wears off, as urgent medical care may be needed.
  • if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical attention should be sought. The doctor will assess whether there is an increased risk of bleeding.
  • if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment needs to be changed.

Dabigatran etexilate Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, the patient should inform the doctor before taking Dabigatran etexilate Medical Valley if they are taking any of the following medicines :

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these are applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Dabigatran etexilate Medical Valley depending on the condition for which the medicine was prescribed. See also section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's wort, a herbal medicine used to treat depression.
• Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran etexilate Medical Valley has on pregnancy or the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran etexilate Medical Valley.
Breastfeeding should not be undertaken during treatment with Dabigatran etexilate Medical Valley.

Driving and operating machinery
Dabigatran etexilate Medical Valley has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran etexilate Medical Valley

Dabigatran etexilate Medical Valley capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate strengths and pharmaceutical forms are available for treating children under 8 years of age.
This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor.
Take Dabigatran etexilate Medical Valley exactly as directed below:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran etexilate Medical Valley is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking verapamil-containing medications who also have reduced renal function by more than half should take a reduced dose of 75 mg of Dabigatran etexilate Medical Valley due to an increased risk of bleeding.
In both types of surgery, treatment should not be initiated if there is active bleeding from the surgical site. If treatment cannot be started by the day after surgery, it should be initiated with a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Dabigatran etexilate Medical Valley should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, two capsules once daily should be taken for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran etexilate Medical Valley should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, two capsules once daily should be taken for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran etexilate Medical Valley should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on age and body weight. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless otherwise instructed by the doctor.
Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for dabigatran etexilate in capsule form

Single doses requiring combination of more than one capsule:
300 mg: two capsules of 150 mg or four capsules of 75 mg
260 mg: one capsule of 110 mg and one capsule of 150 mg
or one capsule of 110 mg and two capsules of 75 mg
220 mg: as two capsules of 110 mg
185 mg: as one capsule of 75 mg and one capsule of 110 mg
150 mg: as one capsule of 150 mg or two capsules of 75 mg

How to take Dabigatran etexilate Medical Valley
Dabigatran etexilate Medical Valley can be used in adults and children aged 8 years or older who are able to swallow capsules whole.

Dabigatran etexilate Medical Valley may be taken with or without food. The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant therapy
Do not change anticoagulant medication without receiving detailed instructions from your doctor.

If you take more Dabigatran etexilate Medical Valley than you should
Taking too high a dose of this medicine increases the risk of bleeding. If you have taken too many Dabigatran etexilate Medical Valley capsules, contact your doctor immediately. Specific treatment methods are available.

If you forget to take Dabigatran etexilate Medical Valley
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran etexilate Medical Valley at the usual time on the next day. Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
A missed dose may be taken if there are still more than 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.

Stopping Dabigatran etexilate Medical Valley
Dabigatran etexilate Medical Valley should be taken exactly as prescribed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of developing a blood clot may be higher if treatment is stopped prematurely.

Contact your doctor if you experience gastrointestinal discomfort after taking Dabigatran etexilate Medical Valley.

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 Medical Valley affects the blood clotting system; therefore, most adverse effects are related to bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close monitoring or change your treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

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

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Common (may occur in up to 1 in 10 people):

• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results.

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

• Bleeding from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, due to injury or after injury or surgical procedure
• Bruising or haematoma occurring after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell count
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid leaking from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disorders

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decrease in platelet count in the blood
• Decrease in red blood cell count after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy nodules occurring as a result of an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from wound
• Fluid discharge from surgical wound

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

Treatment and prevention of recurrence of blood clots in children
Common (may occur in up to 1 in 10 people):

• Decrease in red blood cell count
• Decrease in platelet count
• Skin rash consisting of dark red, raised, itchy nodules occurring as a result of an allergic reaction
• Sudden change in skin colour and appearance
• Bruising
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in white blood cell count (which help fight infections)
• Bleeding into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disorders

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 into joints, wound, surgical incision site, injection site, or site of intravenous catheter insertion
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the medicine Dabigatran etexilate Medical Valley

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Aluminium-Aluminium (OPA/Aluminium/PVC//Aluminium) foil blisters: Do not store above 30°C.
Aluminium-Aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) foil blisters with moisture-absorbing coating: No special storage instructions for this medicine.
White HDPE bottle: Store in the original packaging to protect from moisture.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Dabigatran etexilate Medical Valley contains

• The active substance is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesilate, equivalent to 75 mg of dabigatran etexilate.

The other components are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose, talc.
• Capsule shell: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose.

What Dabigatran etexilate Medical Valley looks like and contents of the pack
Capsules size 2, approximately 18 mm long, with a white, opaque cap and a white, opaque body, filled with pellets ranging from white to pale yellow in colour.
The capsules are packed in blisters made of moisture-absorbing foil – Aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) and blisters made of Aluminium – Aluminium (OPA/Aluminium/PVC//Aluminium), or in a white HDPE bottle with a moisture absorber in the form of silica gel in the cap (PP).
Pack sizes:
Blisters containing 10, 10x1 (unit dose blister), 30, 30x1 (unit dose blister), 60, 60x1 (unit dose blister), 100 and 180 hard capsules, in cardboard boxes.
Bottle containing 100 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]
Importer/Manufacturer
Laboratorios Liconsa S.A
Avda. Miralcampo 7
Polígono Industrial Miralcampo
Azuqueca de Henares
19200 Guadalajara
Spain
This medicinal product is authorised in the following names in the Member States of the European Economic Area:
Croatia Dabigatraneteksilat Liconsa 75 mg tvrde kapsule
Denmark Dabigatran etexilate Medical Valley
Spain Dabigatran etexilate Liconsa 75 mg
Netherlands Dabigatran etexilaat Xiromed 75 mg harde capsules
Iceland Dabigatran etexilate Medical Valley 75 mg hörð hylki
Germany Dabigatranetexilat AXiromed 75 mg Hartkapseln
Norway Dabigatran etexilate Medical Valley
Poland Dabigatran etexilate Medical Valley
Romania Dabigatran etexilate Liconsa 75 mg capsule
Sweden Dabigatran etexilate Medical Valley 75 mg hårda kapslar