Dabigatran etexilate Sandoz 110 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Sandoz 110 mg hard capsules EFG

dabigatran etexilate

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not 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.

Contents of the leaflet

What Dabigatran etexilate Sandoz is and what it is used for
What you need to know before taking Dabigatran etexilate Sandoz
How to take Dabigatran etexilate Sandoz
Possible side effects
How to store Dabigatran etexilate Sandoz
Contents of the pack and other information

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

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

Dabigatran etexilate is used in adults 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 in 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 recurrence of blood clots in the veins of your legs and lungs.

Dabigatran etexilate is used in children for:

treating blood clots and preventing the recurrence of blood clots.

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

Do not take Dabigatran etexilate Sandoz

if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6),
if your kidney function is severely reduced,
if you currently have bleeding,
if you have a disease in an organ 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 between anticoagulant treatments, while you have a venous or arterial catheter and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation,
if your liver function is severely reduced or you have a liver disease that could be life-threatening,
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections,
if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation,
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm,
if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C,
if you have had an artificial heart valve implanted that requires lifelong anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting dabigatran etexilate. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo 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 gastroesophageal reflux (acid reflux into the esophagus),
if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatran etexilate Sandoz” below,
if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam,
if you have an infection in the heart (bacterial endocarditis),
if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark [concentrated]/foamy urine),
if you are over 75 years old,
if you are an adult and weigh 50 kg or less,
only 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 tests. The use of this medicine is not recommended in this case.

Take special care with Dabigatran etexilate Sandoz

if you need to undergo surgery:

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

if surgery requires the placement of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia or for pain relief):
it is very important that you take dabigatran etexilate before and after surgery exactly as directed by your doctor,
inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after anesthesia ends, 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 your treatment needs to be adjusted.

Other medicines and Dabigatran etexilate Sandoz

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

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

Pregnancy and breastfeeding

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

The effects of dabigatran etexilate on pregnancy and the fetus are unknown. You should not use this medicine during pregnancy unless your doctor tells you it is safe. If you are of childbearing potential, you should avoid becoming pregnant while being treated with dabigatran etexilate.

Breastfeeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

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

Dabigatran etexilate Sandoz contains sodium

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

3. How to take Dabigatran etexilate Sandoz

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

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

Take Dabigatran etexilate Sandoz 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 medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

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

In both types of surgery, treatment must not be initiated if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, dosing should begin with 2 capsules once daily.

After knee replacement surgery

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

After hip replacement surgery

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

Prevention of systemic or cerebral vascular occlusion due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of venous blood clots in 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 is 220 mg administered as one 110 mg capsule twice daily.

If you are taking medicines containing verapamil, you should be prescribed a reduced dose of dabigatran etexilate of 220 mg taken 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 dose of 220 mg administered as one 110 mg capsule twice daily.

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

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

Treatment of blood clots and prevention of recurrence in children

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

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

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

Table 1: Dosing table for dabigatran etexilate capsules

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

Single doses requiring combinations of more than one capsule:

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

How to take Dabigatran Etexilate Sandoz

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

Instructions for the blister pack

Press the capsules through the foil of the blister pack.

Instructions for the bottle

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

Changing anticoagulant treatment

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

If you take more Dabigatran Etexilate Sandoz than you should

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

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

If you forget to take Dabigatran Etexilate Sandoz

Prevention of blood clots after knee or hip replacement surgery

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

Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of stroke or systemic embolism due to blood clots 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 their recurrence

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

A missed dose should be omitted if the time remaining before the next dose is less than 6 hours.

Do not take a double dose to make up for a missed dose.

If you stop taking Dabigatran Etexilate Sandoz

Take dabigatran etexilate exactly as prescribed. Do not stop treatment with this medicine 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 dabigatran etexilate.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Major or severe bleeding episodes may occur, which represent the most serious adverse effects and, regardless of their location, can lead to disability, be potentially life-threatening, 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 develop 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 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 intestines, penis/vagina or urinary tract (including blood in urine turning it pink or red), from hemorrhoids, rectum, under the skin, from a joint, or at the site of an injury or after surgery,
bruising or bruising 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 nauseous,
wound discharge (leakage of fluid from a surgical wound),
increased 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 the site of a surgical incision, at the 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 blood-streaked sputum,
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 due to an allergic reaction,
sudden change in the skin affecting color and physical appearance,
itching,
stomach or intestinal ulcer (including esophageal ulcer),
inflammation of the esophagus and stomach,
reflux of gastric juice into the esophagus,
abdominal pain or stomach ache,
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 formed as a result of irregular heartbeat

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

bleeding from the nose, stomach or intestines, 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 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 blood-streaked sputum,
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,
stomach or intestinal ulcer (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 the site of a surgical incision, at a wound, at the 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 due to an allergic reaction,
decrease in the proportion of blood cells,
increased 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 etexilate was numerically higher than with warfarin. The overall incidence was low.

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

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

bleeding from the nose, stomach or intestines, 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 may occur in a joint or at a wound,
bleeding may occur from hemorrhoids,
decrease in the number of red blood cells in the blood,
bruising,
coughing up blood or blood-streaked sputum,
allergic reaction,
sudden change in the skin affecting color and physical appearance,
itching,
stomach or intestinal ulcer (including esophageal ulcer),
inflammation of the esophagus and stomach,
reflux of gastric juice into the esophagus,
feeling nauseous,
vomiting,
abdominal pain or stomach ache,
frequent loose or watery stools,
abnormalities in liver function tests,
increased liver enzymes.

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

bleeding may occur at the site of a surgical incision, 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 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 etexilate was higher than with warfarina. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

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

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,
nasal bleeding,
reflux of gastric juice into the esophagus,
vomiting,
feeling nauseous,
frequent loose or watery stools,
indigestion,
hair loss,
increased 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 turning it 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 blood-streaked sputum,
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 at a wound, at a surgical incision, at an injection site, or at the site of a venous catheter insertion,
bleeding may occur from hemorrhoids,
stomach or intestinal ulcer (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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran etexilate Sandoz

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

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

Blister and bottle

Store below 30°C.

Bottle

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Sandoz

The active substance is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
The other components are:
capsule contents: tartaric acid, hypromellose (E464), talc, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate.
capsule coating: titanium dioxide (E171) and hypromellose (E464).
black printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).

Appearance of the product and contents of the pack

Hard capsule.

Size "1" hard capsule with an opaque white cap marked with "MD" and an opaque white body marked with "110" in black ink, containing a mixture of white to pale yellow pellets and pale yellow granules.

Dabigatran etexilate Sandoz is available in:

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

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

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

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

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

Do not ingest the desiccant.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

Sachsen-Anhalt

39179 Barleben,

Germany

Pharmadox Healthcare LTD

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57,

Ljubljana, 1526,

Slovenia

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

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