Privenax 150 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Privenax 150 mg hard capsules EFG

dabigatran etexilate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Privenax is and what it is used for
2. What you need to know before taking Privenax
3. How to take Privenax
4. Possible side effects
5. How to store Privenax
6. Contents of the pack and other information

1. What Privenax is and what it is used for

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

Dabigatran is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heart rhythm called non-valvular atrial fibrillation and have at least one additional risk factor.

• treat blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Dabigatran is used in children to:

• treat blood clots and to prevent blood clots from recurring.

2. What you need to know before taking Privenax

Do not take Privenax

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

Warnings and precautions

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

Tell your doctor if you have or have had any disorder or illness, especially any of the following:

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

  • if you have recently had bleeding.
  • if you have undergone surgical tissue removal (biopsy) within the last month.
  • if you have suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
  • if you have inflammation of the esophagus or stomach.
  • if you have problems with gastric juice reflux into the esophagus.
  • if you are taking medicines that may increase the risk of bleeding. See “Other medicines and dabigatran” below.
  • if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
  • if you have an infection in the heart (bacterial endocarditis).
  • if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored [concentrated]/foamy urine).
  • if you are over 75 years old.
  • if you are an adult and weigh 50 kg or less.
  • only if used in children: if the child has an infection in or around the brain.

• If you have had a heart attack or have been diagnosed with conditions that increase the risk of having a heart attack.

• If you have a liver disease associated with changes in blood test results. The use of dabigatran is not recommended in this case.

Take special care with dabigatran

• If you need to undergo surgery:

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

• If surgery requires the placement of a catheter or an injection in the spine (e.g., for epidural or spinal anesthesia or for pain relief):

  • It is very important that you take dabigatran exactly at the times instructed by your doctor, both before and after surgery.
  • Inform your doctor immediately if you experience numbness or weakness in the legs or intestinal or bladder problems after anesthesia wears off, as this situation requires urgent medical attention.

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

• If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustments are needed.

Other medicines and dabigatran

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

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for treating fungal infections (e.g., ketoconazole, itraconazol), except when applied only to the skin
• Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing verapamil, your doctor may instruct you to use a reduced dose of dabigatran depending on the condition for which it has been prescribed. See section 3.

• Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine)

• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)

• Anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac)

• St. John’s wort, a herbal remedy for depression

• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors

• Rifampicin or clarithromycin (two antibiotics)

• Antiviral medicines for HIV/AIDS (e.g., ritonavir)

• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

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

Breastfeeding is not recommended during treatment with dabigatran.

Driving and using machines

Dabigatran has no known effects on the ability to drive or operate machinery.

3. How to take Privenax

Privenax capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole.

Always follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

Take this medicine as recommended for the following conditions:

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

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

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

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

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

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

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

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

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

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

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

Table 1: Dosing table for Privenax capsules:

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

Single doses requiring combinations of more than one capsule:

300 mg: two 150 mg capsules or
four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or
one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or
two 75 mg capsules

How to take Privenax

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

Instructions for opening the blisters

The following images illustrate how to remove Privenax capsules from the blister pack:

1

Separate an individual blister from the strip along the perforated line.

2

Peel back the backing foil and remove the capsule.

• Do not push the capsules through the blister foil.
• Do not peel back the blister foil until the capsule is needed.

Switching anticoagulant treatment

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

If you take more Privenax than you should

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

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

If you forget to take Privenax

A missed dose may be taken if it is within 6 hours before the next scheduled dose.

A missed dose should be omitted if less than 6 hours remain before the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Privenax

Take Privenax exactly as prescribed by your doctor. Do not stop treatment with Privenax without first consulting 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 indigestion after taking this medicine.

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

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

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

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

Prevention of stroke or systemic embolism due to blood clots caused by irregular heartbeat

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

• Bleeding may occur from the nose, stomach or intestines, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach ache
• Indigestion
• Frequent loose or watery stools
• Feeling nauseous

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, in a wound, at the site of an injection, or at the site of a venous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Decrease in the proportion of blood cells
• Increase in liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of leukocytes (which help fight infections)
• Hair loss

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

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

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

• Bleeding may occur from the nose, stomach or intestines, rectum, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur in a joint or wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach ache
• Frequent loose or watery stools
• Abnormal liver function tests
• Increase in liver enzymes

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

• Bleeding may occur at a surgical incision site, at the site of an injection, at the site of a venous catheter insertion, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of leukocytes (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders
• Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran was higher than with warfarina. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

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

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nosebleeds
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent 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 leukocytes (which help fight infections)
• Bleeding may occur in the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach ache
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Absence of leukocytes (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, at a surgical incision site, at the site of an injection, or at the site of a venous catheter insertion
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse effects

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

5. Storage of Privenax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister pack after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Privenax

• 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 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose and FD&C Blue No. 2/indigo carmine (E-132).

Appearance of the product and contents of the pack

Privenax 150 mg consists of pellets ranging in colour from whitish to pale yellow, contained in hard capsules size 0 with a blue cap and white or whitish body.

Privenax is available in packs containing 10 x 1 or 60 x 1 hard capsules in single-dose perforated blisters made of aluminium/OPA-AL-PVC.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel, 50,

08950 – Esplugues de Llobregat (Barcelona)

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid –Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Malta – Privenax 150 mg hard capsules

Portugal – Dabigatran etexilate Pharmakern 150 mg capsules

Spain – Privenax 150 mg hard capsules EFG

Date of the most recent review of this summary: June 2024

Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.