Gribero

Package Leaflet: Information for the Patient

Gribero, 75 mg, Hard Capsules

Dabigatranum etexilatum

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

• Keep this 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the 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 pack 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 medicines called anticoagulants. Its action involves blocking a substance in the body responsible for the formation of blood clots.
Gribero is used in adults to:

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

Gribero is used in children to:

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

2. Important information before taking Gribero

When not to take Gribero

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in case of severe liver impairment or liver disease that can lead to death.

Warnings and precautions

Before starting treatment with Gribero, discuss it with your doctor. If symptoms occur during treatment with this medication 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:

When to exercise special caution when taking Gribero

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it is very important to take Gribero before and after surgery exactly as the doctor has prescribed.
you should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.

Gribero and other medications

Tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take.
In particular, you must 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, aspirin).
• 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 transplant 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., aspirin, ibuprofen, diclofenac).
• St. John's Wort, a herbal remedy 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 are planning to have a baby, ask your doctor for advice before taking this medicine.
The effect of Gribero on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy unless your doctor considers it necessary. 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.
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Gribero contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means it is essentially '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 prescribed by your doctor. If you are unsure, consult your doctor.

Take Gribero exactly as prescribed:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg).
If kidney function is reducedby more than half or in patients 75 years of age or older, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Gribero is 150 mg once daily(taken as 2 capsules of 75 mg).
Patients taking medications containing verapamil, with reduced kidney functionby more than half, should take a reduced dose of 75 mgof Gribero due to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Gribero treatment should be started with a single capsule within 1 to 4 hours after the end of the surgical procedure. Then, 2 capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Gribero treatment should be started with a single capsule within 1 to 4 hours after the end of the surgical procedure. Then, 2 capsules should be taken once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Gribero should be taken 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 body weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medications should be continued, unless the doctor advises stopping any of them.
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Table 1 shows the single and total daily doses of Gribero in milligrams (mg). Doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1 Gribero Dosing Table in Capsule Form

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. The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for blisters

Press the capsules through the blister foil.

Instructions for the bottle

Press and turn to open the bottle.
After removing the capsule and taking the dose, the bottle should be tightly closed with the cap immediately.

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 treatment methods are available.
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Missing a dose of Gribero

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
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 and prevention of recurrent blood clots in children.
A missed dose can be taken 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

Gribero should be taken exactly as prescribed by your doctor. Do not stop taking this medication without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Contact your doctor if you experience nausea 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 medicines, 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. Severe or heavy 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 bleeding occurs that does not stop on its own, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to closely monitor the patient or change the medication.
In case of a severe allergic reaction that can cause breathing difficulties or dizziness, contact your doctor immediately.
Side effects are grouped by frequency below.
Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
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):

• Bleeding from the nose, stomach, intestines, penis, or vagina, or urinary tract (including urine discoloration due to blood), or bleeding under the skin, into a joint, due to injury or after surgery
• Formation of hematomas or bruising 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 secretion (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or whites of the 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, injection site, or catheter insertion site
• Blood-tinged secretion from the catheter insertion site
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased red blood cell count after surgery
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark 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 and stomach inflammation
• Acid reflux (stomach acid flowing back into the esophagus)
• Abdominal pain or stomach pain
• Nausea
• Difficulty swallowing
• Fluid leaking from the wound
• Fluid leaking from the surgical wound

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

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

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 in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Acid reflux (stomach acid flowing back into the esophagus)
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Nausea
• 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, intestines, rectum, penis, or vagina, or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Esophageal and stomach inflammation
• Allergic reaction
• Difficulty swallowing
• Jaundice (yellowing of the skin or whites of the eyes due to liver or blood disease)

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

• Absent white blood cell count (which helps fight infections)
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into a joint, from a wound, surgical site, injection site, or catheter insertion site
• Bleeding from hemangiomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
Side effects can also be reported 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, the medication should be used within 60 days.
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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gribero contains

• The active substance is dabigatran etexilate. Each capsule contains 75 mg of dabigatran etexilate (as mesylate)
• Other ingredients are:
• Capsule contents: tartaric acid (in the form of pellets), hypromellose (2910), talc, hydroxypropylcellulose (353 cps - 658 cps), sodium croscarmellose, 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 pack

Hard capsule.
A size 2 capsule with a white, opaque cap with the imprint "MD" and a white, opaque body with the imprint "75", printed with 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
To obtain more detailed information on this medication, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

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

Austria
Gribero 75 mg – Hartkapseln
Bulgaria
Gribero 75 mg hard capsules
Czech Republic
Gribero
Estonia
Gribero
Greece
Gribero
Croatia
Gribero 75 mg tvrde kapsule
Lithuania
Gribero 75 mg kietosios kapsulės
Latvia
Gribero 75 mg cietās kapsulas
Poland
Gribero
Romania
Gribero 75 mg capsule
Slovenia
Gribero 75 mg trde kapsule
Slovakia
Gribero 75 mg tvrdé kapsuly
Date of last revision of the leaflet:12/2024
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