Gribero

Package Leaflet: Information for the Patient

Gribero, 150 mg, Hard Capsules

Dabigatranum etexilatum

Read the package leaflet carefully before taking the medicine, 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 medicine 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 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 blood clot formation.
Gribero is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

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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Warnings and precautions

Before starting treatment with Gribero, discuss it with your doctor. If symptoms occur or the need for surgery arises during treatment with this medicine, consult your 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

Gribero and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, tell your doctor before taking Gribero if you are taking any of the following
medicines:

• Medicines that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g., ketoconazole, itraconazole), unless they are used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing verapamil, the doctor may recommend a lower dose of Gribero, depending on the condition for which it was prescribed. See also section 3.
• Medicines used to prevent organ rejection (e.g., tacrolimus, cyclosporine).
• A combination medicine 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 medicine used to treat depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both are antibiotics).
• Antiviral medicines used to treat AIDS (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 are planning to have a baby, ask your doctor for advice before taking this medicine.
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The use of Gribero in pregnancy is not recommended, 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.

Gribero contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which 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 of age, as long as they can swallow soft foods.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor.

Take Gribero exactly as follows:

Prevention of blood clots in the brain and the rest of the body, formed during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
In patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.
Patient taking medicines containing verapamilshould receive reduced dose treatment with Gribero of 220 mg taken as one 110 mg capsule twice a daydue to the potential 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 a day.
Treatment with this medicine can be continued if the patient needs to restore normal heart rhythm using a procedure called cardioversion or catheter ablation in atrial fibrillation. Gribero should be taken as instructed by the doctor.
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 adequate blood clotting control has been achieved. Gribero should be taken as instructed by the doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Gribero should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time each 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. All other medicines should be continued unless the doctor instructs otherwise.
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 Capsule Dosing Table

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. They should not be broken, chewed, or the pellets emptied 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.
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Changing anticoagulant medicine

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

Taking a higher dose of Gribero than recommended

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

Missing a dose of Gribero

A missed dose can be taken up to 6 hours before the next scheduled dose.
If it is less than 6 hours before the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Gribero

Gribero should be taken as instructed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Gribero.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gribero affects blood clotting, so most side effects are related to symptoms such as bruising or bleeding. Major or severe bleeding may 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.
In case of bleeding that does not stop by itself or signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.
In case of a severe allergic reaction that may cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below by frequency:

• Bleeding may occur from the nose, into the stomach or intestines, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decrease in 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 may occur from hemorrhoids, the rectum, or the brain
• Hematoma formation
• Coughing up blood or sputum stained with blood
• Decrease in platelet count
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease (GERD)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into a joint, from a surgical wound, from an injury, from an injection site, or from a catheter insertion site
• Severe allergic reaction causing difficulty breathing 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
• Decrease in white blood cell count
• Increased liver enzyme activity
• Jaundice or 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
• Decrease in or absence of white blood cells (which help fight infections)
• Hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in patients taking warfarin. The overall number of events was small.
Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs
Common(may affect up to 1 in 10 people):

• Bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur into a joint or due to trauma
• Bleeding may occur from hemorrhoids
• Decrease in red blood cell count
• Hematoma formation
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• 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 may occur from a surgical wound, from an injection site, or from a catheter insertion site, or bleeding from the brain
• Decrease in platelet count
• Severe allergic reaction causing difficulty breathing 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
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in red blood cell count
• Decrease in or absence of white blood cells (which help fight infections)
• Jaundice or 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 patients taking warfarin. The overall number of events was low. No difference in the number of heart attacks was observed in patients treated with dabigatran compared to those treated with placebo.
Treatment of blood clots and prevention of recurrence of blood clots in children
Common(may affect up to 1 in 10 people):

• Decrease in red blood cell count
• Decrease in 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
• Hematoma formation
• 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):

• Decrease in white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, from the brain, from the rectum, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in red blood cell count
• Itching
• Coughing up blood or sputum stained with blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or 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 may occur into a joint, from a wound, from a surgical wound, from an injection site, or from a catheter insertion site
• Bleeding may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including those 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 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
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 medicine.

5. How to store Gribero

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of that month.
Blisters 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Contents of the pack and other information

What Gribero contains

• The active substance is dabigatran etexilate. Each capsule contains 150 mg of dabigatran etexilate (as mesylate)
• The other ingredients are:
• Capusle contents: tartaric acid (in the form of pellets), hypromellose (2910), talc, hydroxypropylcellulose (353 cps - 658 cps), croscarmellose sodium, magnesium stearate.
• Capusle 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.
The capsule is size 0 with a white, opaque cap with the imprint "MD" and a white, opaque body with the imprint "150" in black ink. The capsule contains a mixture of pellets in white to light yellow and light yellow granules.
Gribero is available as:
Blisters OPA/Aluminum/PE + desiccant/Aluminum /PE containing 10, 30, 60, 100, 180, and 200 hard capsules, in a cardboard box.
Perforated blisters OPA/Aluminum/PE + desiccant/Aluminum/PE 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
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Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
Ljubljana, 1526
Slovenia
To obtain more detailed information on this medicine, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

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

Austria
Gribero 150 mg – Hartkapseln
Bulgaria
Gribero 150 mg hard capsules
Czech Republic
Gribero
Estonia
Gribero
Greece
Gribero
Croatia
Gribero 150 mg tvrde kapsule
Lithuania
Gribero 150 mg kietosios kapsulės
Latvia
Gribero 150 mg cietās kapsulas
Poland
Gribero
Romania
Gribero 150 mg capsule
Slovenia
Gribero 150 mg trde kapsule
Slovakia
Gribero 150 mg tvrdé kapsuly
Date of last revision of the leaflet:12/2024
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