Gribero

Package Leaflet: Information for the Patient

Gribero, 110 mg, Hard Capsules

Dabigatran Etexilate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Gribero and What is it Used For
• 2. Important Information Before Taking Gribero
• 3. How to Take Gribero
• 4. Possible Side Effects
• 5. How to Store Gribero
• 6. Contents of the Package and Other Information

1. What is Gribero and What is it Used For

Gribero contains dabigatran etexilate as the active substance and belongs to a group of medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.

Gribero is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat and prevent the recurrence of blood clots in the legs and lungs.

Gribero is used in children to:

• treat and prevent the recurrence of blood clots.

2. Important Information Before Taking Gribero

When Not to Take Gribero

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6).
• if you have severe kidney impairment.
• if you are currently bleeding.

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• if you have a condition that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be inherited, of unknown cause, or due to the use of other medications.
• if you are taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a venous catheter, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver impairment or liver disease that may lead to death.
• 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.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and Precautions

Before starting to take Gribero, discuss it with your doctor. If symptoms occur or if the patient needs to undergo surgery, consult a doctor.

The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as recent bleeding, recent biopsy, recent major trauma (e.g., bone fracture, head injury, or any trauma requiring surgical treatment), esophageal or gastric inflammation, or gastroesophageal reflux disease. If you are taking medications that may increase the risk of bleeding. See "Gribero and Other Medications" below. If you are taking nonsteroidal anti-inflammatory medications, such as diclofenac, ibuprofen, or piroxicam. If you have a heart infection (bacterial endocarditis). If you have reduced kidney function or are dehydrated (feeling thirsty and producing less urine). If you are over 75 years old. If you are an adult and weigh 50 kg or less. Only in children: if the child has an infection around or in the brain.

In case of a heart attack or if the patient has been diagnosed with conditions that increase the risk of a heart attack.

If the patient has liver disease affecting blood test results. In such cases, the use of this medication is not recommended.

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When to Exercise Particular Caution When Taking Gribero

• if the patient needs to undergo surgery: in such cases, it is necessary to temporarily discontinue the use of Gribero due to the increased risk of bleeding during and after surgery. It is very important to take Gribero before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or pain relief): it is very important to take Gribero before and after surgery exactly as the doctor has instructed. The patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention may be necessary.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should immediately seek medical attention. The doctor will check if the patient may have an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide whether to change the treatment.

Gribero and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

In particular, tell your doctor before taking Gribero if you are taking any of the following medications:

• Medications that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medications used to treat fungal infections (e.g., ketoconazole, itraconazole), unless they are used only on the skin.
• Medications used to treat heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Gribero, depending on the condition for which it was prescribed. See also section 3.
• Medications used to prevent organ rejection (e.g., tacrolimus, cyclosporine).
• A combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a herbal medication used to treat depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both are antibiotics).
• Antiviral medications used to treat AIDS (e.g., ritonavir).
• Certain medications 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 have a child, consult your doctor before taking this medication.

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The effect of Gribero on pregnancy and the unborn child is not known. Do not take this medication during pregnancy unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Gribero.

Do not breastfeed while taking Gribero.

Driving and Using Machines

Gribero has no or negligible influence on the ability to drive and use machines.

Gribero Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per hard capsule, which is considered "sodium-free".

3. How to Take Gribero

Gribero capsules can be used in adults and children aged 8 years or older who can swallow the capsules whole. There are other age-appropriate formulations for the treatment of children under 12 years old, as long as they can swallow soft foods.

This medication should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor.

Take Gribero Exactly as Follows:

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 each).

If kidney function is reducedby 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 each).

In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Gribero is 150 mg once daily(taken as 2 capsules of 75 mg each).

Patients taking medications containing verapamilwith reduced kidney functionby more than half should take a reduced dose of 75 mg of Gribero due to the increased risk of bleeding.

In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once daily.

Prevention of blood clots in the brain and other blood vessels in the body, which form during irregular heart rhythm, and treatment of blood clots in the legs and lungs, as well as prevention of recurrent blood clots in the legs and lungs

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

In patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.

Patients taking medications containing verapamilshould receive a reduced dose of Gribero, 220 mg taken as one 110 mg capsule twice daily, due to the increased risk of bleeding.

In patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice daily.

Treatment can be continued if the patient needs to restore normal heart rhythm using a procedure called cardioversion. Take Gribero exactly as your doctor has instructed.

In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Gribero after the doctor has confirmed that blood clotting is under control. Take Gribero exactly as your doctor has instructed.

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

Take Gribero twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.

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

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

Table 1: Gribero Dosing Table in Capsule Form

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Doses requiring the combination of more than one capsule: 300 mg: two 150 mg capsules or four 75 mg capsules; 260 mg: one 110 mg capsule and one 150 mg capsule or one 110 mg capsule and two 75 mg capsules; 220 mg: two 110 mg capsules; 185 mg: one 75 mg capsule and one 110 mg capsule; 150 mg: one 150 mg capsule or two 75 mg capsules.

How to Take Gribero

Gribero can be taken with or without food. Swallow the capsules whole with a glass of water to help them reach the stomach. Do not crush, chew, or open the capsules, as this may increase the risk of bleeding.

Instructions for Blister Packs

Press the capsules through the blister foil.

Instructions for Bottles

Press and turn to open the bottle.

After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

Changing Anticoagulant Medication

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

Taking a Higher Dose of Gribero Than Recommended

Taking too much of this medication increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatments are available.

Missing a Dose of Gribero

Prevention of blood clots after hip or knee replacement surgery

Continue taking the missed daily dose of Gribero at the same time the next day. Do not take a double dose to make up for the missed dose.

Treatment of blood clots in the brain and other blood vessels in the body, which form during irregular heart rhythm, and treatment of blood clots in the legs and lungs, as well as prevention of recurrent blood clots in the legs and lungs

In adults: Prevention of blood clots in the brain and other blood vessels in the body, which form during irregular heart rhythm, and treatment of blood clots in the legs and lungs, as well as prevention of recurrent blood clots in the legs and lungs

In children: Treatment of blood clots and prevention of recurrent blood clots

Take the missed dose up to 6 hours before the next scheduled dose.

If there are less than 6 hours until the next scheduled dose, do not take the missed dose.

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

Stopping Treatment with Gribero

Take Gribero exactly as your doctor has instructed. Do not stop taking this medication without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Consult your doctor if you experience indigestion after taking Gribero.

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

4. Possible Side Effects

Like all medications, Gribero can cause side effects, although not everybody gets them.

Gribero affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Major or severe bleeding can occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location. In some cases, these bleedings may not be visible.

If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (unusual weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to monitor you closely or change your medication.

If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.

Side effects are grouped by frequency:

Prevention of blood clots after hip or knee replacement surgery

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

• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Nosebleeds, gastrointestinal or urinary tract bleeding, or bleeding under the skin
• Formation of hematomas after surgery
• Blood in the stool, as detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Wound exudate (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or eyes) due to liver or blood disease

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

• Bleeding
• Bleeding into the brain, from the surgical site, from the injection site, or from the catheter insertion site
• Blood-tinged sputum or coughing up blood
• Decreased platelet count
• Decreased red blood cell count after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal or gastric inflammation
• Gastroesophageal reflux disease (GERD)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound exudate

Frequency Not Known(frequency cannot be estimated from the available data):

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Prevention of blood clots in the brain and other blood vessels in the body, which form during irregular heart rhythm

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

• Bleeding from the nose, gastrointestinal tract, urinary tract, or under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding from hematomas, from the rectum, or into the brain
• Formation of hematomas
• Blood-tinged sputum or coughing up blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal or gastric inflammation
• Gastroesophageal reflux disease (GERD)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding into the joint, from the surgical site, from the injection site, or from the catheter insertion site
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or eyes) due to liver or blood disease

Frequency Not Known(frequency cannot be estimated from the available data):

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots in the legs and lungs, as well as prevention of recurrent blood clots in the legs and lungs

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

• Bleeding from the nose, gastrointestinal tract, urinary tract, or under the skin
• Indigestion

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

• Bleeding
• Bleeding into the joint or due to trauma
• Bleeding from hematomas
• Decreased red blood cell count
• Formation of hematomas
• Blood-tinged sputum or coughing up blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal or gastric inflammation
• Gastroesophageal reflux disease (GERD)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding from the surgical site, from the injection site, or from the catheter insertion site, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

Frequency Not Known(frequency cannot be estimated from the available data):

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice (yellowing of the skin or eyes) due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in those taking warfarin. The overall number of events was low.

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

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

• Decreased red blood cell count
• Decreased platelet count
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease (GERD)
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (which helps fight infections)
• Bleeding into the stomach, brain, rectum, penis, vagina, or urinary tract, or under the skin
• Decreased hemoglobin levels in the blood
• Decreased hematocrit
• Itching
• Blood-tinged sputum or coughing up blood
• Abdominal pain or stomach pain
• Esophageal or gastric inflammation
• Allergic reaction
• Difficulty swallowing
• Jaundice (yellowing of the skin or eyes) due to liver or blood disease

Frequency Not Known(frequency cannot be estimated from the available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into the joint, from the wound, from the surgical site, from the injection site, or from the catheter insertion site
• Bleeding from hematomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Gribero

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

Do not use this medication after the expiry date stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of the month stated.

Blisters and bottles:

Store below 30°C.

Bottle:

After opening, use within 60 days.

Do not throw away any medications via wastewater or household waste. Ask your pharmacist how to throw away medications no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Gribero Contains

• The active substance is dabigatran etexilate. Each capsule contains 110 mg of dabigatran etexilate (as mesylate).
• Other ingredients are:
• Capsule contents: tartaric acid (as pellets), hypromellose (2910), talc, hydroxypropyl cellulose (353 cps - 658 cps), croscarmellose sodium, magnesium stearate.
• Capsule shell: titanium dioxide (E 171), hypromellose
• Black ink for printing: shellac, propylene glycol (E 1520), potassium hydroxide, iron oxide black (E 172)

What Gribero Looks Like and Contents of the Package

Hard capsule.

The capsule is size 1 with a white, opaque cap with the imprint "MD" and a white, opaque body with the imprint "110" in black ink. The capsule contains a mixture of pellets in white to light yellow and light yellow granules.

Gribero is available as:

OPA/Aluminum/PE + desiccant/Aluminum/PE blisters containing 10, 30, 60, 100, 180, and 200 hard capsules, in a cardboard box.

Perforated OPA/Aluminum/PE + desiccant/Aluminum/PE blisters divided into single doses, 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 a cardboard box.

Polypropylene bottle with a polypropylene child-resistant cap, containing a desiccant and 60 hard capsules, in a cardboard box.

Do not swallow the desiccant.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

Manufacturer/Importer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben, Germany

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57

Ljubljana, 1526

Slovenia

For further information on this medication, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria

Gribero 110 mg – Hartkapseln

Bulgaria

Gribero 110 mg hard capsules

Czech Republic

Gribero

Estonia

Gribero

Greece

Gribero

Croatia

Gribero 110 mg tvrde kapsule

Lithuania

Gribero 110 mg kietosios kapsulės

Latvia

Gribero 110 mg cietās kapsulas

Poland

Gribero

Romania

Gribero 110 mg capsule

Slovenia

Gribero 110 mg trde kapsule

Slovakia

Gribero 110 mg tvrdé kapsuly

Date of Last Revision of the Package Leaflet:12/2024

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