Privenax 110 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Privenax 110 mg hard capsules EFG

dabigatran etexilate

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 for:

• preventing the formation of blood clots in the veins after knee or hip replacement surgery.

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

• treating blood clots in the veins of your legs and lungs and to prevent blood clots from reoccurring in the veins of your legs and lungs.

Dabigatran is used in children for:

• treating blood clots and preventing blood clots from forming again.

2. What you need to know before taking Privenax

Do not take Privenax

• 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 currently have bleeding.
• if you have a disease in an 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 medications.
• if you are taking medications to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, while you have a venous or arterial catheter and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or you have a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medication used to treat abnormal heart rhythm.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medication 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 starting dabigatran. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery.

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

• If you are at increased risk of bleeding, for example:

  • if you have recently experienced bleeding.
  • if you have undergone surgical tissue removal (biopsy) within the last month.
  • if you have suffered a severe 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 gastroesophageal reflux (stomach acid flowing back into the esophagus).
  • if you are receiving medications 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 (concentrated)/foamy urine).
  • if you are over 75 years of age.
  • if you are an adult patient weighing 50 kg or less.
  • only when 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.

Exercise special caution with dabigatran

• If you need to undergo surgery:

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

• If a surgical procedure requires placement of a catheter or an injection into the spinal column (e.g., for epidural or spinal anesthesia or for pain relief):

  • It is very important that you take dabigatran exactly at the times indicated 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 the anesthesia wears off, as this situation requires urgent medical attention.

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

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

Other medicines and dabigatran

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking dabigatran 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, itraconazole), 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 amiodarone, quinidine, or 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 containing 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 during pregnancy and on the fetus are unknown. You must not use dabigatran during pregnancy unless your doctor specifically indicates it is safe. 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 use of 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 situations:

Prevention of blood clots after knee or hip replacement surgery

The recommended dose is 220 mg once daily (administered as 2 capsules of 110 mg).

If your renal 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 (administered as 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

If you are taking medications containing verapamil and your renal function is reduced by more than half, you should be prescribed a reduced dose of dabigatran of 75 mg, because your risk of bleeding may increase.

In 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, dosing should begin with 2 capsules once daily.

After knee replacement surgery

Begin treatment with dabigatran 1–4 hours after surgery, taking one single capsule. Then take 2 capsules once daily for a total of 10 days.

After hip replacement surgery

Begin treatment with dabigatran 1–4 hours after surgery, taking one single capsule. Then take 2 capsules once daily for a total of 28–35 days.

Prevention of stroke or systemic embolism due to blood clots caused by irregular heartbeat, and treatment of blood clots in the legs and lungs, including prevention of recurrence of blood clots in the 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 taken as one 110 mg capsule twice daily, because your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a 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 using a procedure called cardioversion. Take dabigatran exactly as directed by your doctor.

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

Treatment of blood clots and prevention of recurrent 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 any of them.

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

Table 1: Dosing table for Privenax capsules:

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

Single doses requiring combinations of more than one capsule:

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

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

220 mg: two 110 mg capsules

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

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

How to take 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 blister packs

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

1

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

2

Peel off the backing foil and remove the capsule.

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

Changing 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Privenax

Prevention of blood clot formation after knee or hip replacement surgery

Take the remaining daily doses of dabigatran at the same time on the following day.

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

Use in adults: Prevention of cerebral or systemic vascular obstruction due to blood clot formation caused by 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.

Use in children: Treatment of blood clots and prevention of recurrence of blood clots.

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

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

If you stop taking Privenax

Take Privenax exactly as prescribed. Do not stop your treatment with Privenax without first consulting your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking 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 affects blood clotting; therefore, most adverse effects are related to signs such as bruising or bleeding. Major or serious bleeding episodes 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, these bleedings may not be obvious.

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 monitoring 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 listed below, grouped according to their frequency of occurrence.

Prevention of blood clot formation after knee or hip replacement surgery

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

• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Abnormalities in liver function tests

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

• Bleeding from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, or at or after an injury or surgery
• Bruising or bruise formation after surgery
• Detection of blood in stool in a laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or watery stools
• Feeling the need to vomit
• Wound discharge (leakage of fluid from a surgical wound)
• Increase in liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Bleeding
• Bleeding may occur in the brain, at a surgical incision site, at an injection site, or at the site of a venous catheter insertion
• Bloody discharge from the site of a venous catheter insertion
• Coughing up blood or sputum with blood streaks
• 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
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

Prevention of stroke or systemic embolism due to blood clots caused by abnormal heart rhythm

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

• Bleeding from the nose, stomach or intestine, penis/vagina, 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 pain
• Indigestion
• Frequent loose or watery stools
• Feeling the need to vomit

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 intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, at a wound, at an injection site, or at the site of a venous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Decrease in 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 from the nose, stomach or intestine, rectum, penis/vagina, 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 intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling the need to vomit
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or watery stools
• Abnormalities in 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 an injection site, at the site of a venous catheter insertion, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of 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 warfarin. 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 caused by an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling the need to vomit
• 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 from the stomach or intestine, brain, rectum, penis/vagina, 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 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 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, at an injection site, or at the site of a venous catheter insertion
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormalities in 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 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 must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 110 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 110 mg consists of whitish to pale yellow pellets contained in blue, size 1 hard capsules.

Privenax is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminum/OPA-AL-PVC unit-dose blisters.

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 (EEA) under the following names:

Malta – Privenax 110 mg hard capsules

Portugal – Dabigatran etexilate Pharmakern 110 mg capsules

Spain – Privenax 110 mg hard capsules EFG

Date of the most recent review of this leaflet: 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/.