Apixaban Olpha

Package Leaflet: Information for the User

Apixaban Olpha, 2.5 mg, Film-Coated Tablets

Apixaban

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What Apixaban Olpha is and what it is used for
• 2. Important information before taking Apixaban Olpha
• 3. How to take Apixaban Olpha
• 4. Possible side effects
• 5. How to store Apixaban Olpha
• 6. Contents of the pack and other information

1. What Apixaban Olpha is and what it is used for

Apixaban Olpha contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots from forming by blocking factor Xa, which is an important part of the blood clotting process.
Apixaban Olpha is used in adults:
to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of blood clots in the legs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the leg to the lungs, it can block blood flow to the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.
Blood clots can break loose and travel to the brain, causing a stroke, or to other organs, reducing blood flow to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
to treat blood clots in the legs (deep vein thrombosis) and blood clots in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the legs and/or lungs.

2. Important information before taking Apixaban Olpha

When not to take Apixaban Olpha

• If you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• If you have excessive bleeding,
• If you have an organ diseasethat increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent bleeding in the brain),
• If you have liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• If you are taking medicines to prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when the patient has an intravenous or intra-arterial line and heparin is being administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the patient's vein) for irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• Increased risk of bleeding, such as:
• Bleeding disorders, including conditions that result in reduced platelet activity,
• Very high blood pressurethat is not controlled with medication,
• If you are over 75 years old,
• If your body weight is 60 kg or less,
• Severe kidney disease or if you are on dialysis,
• Liver disease or a history of liver disease.
• This medicine should be used with caution in patients with signs of liver function changes.
• Tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will advise you to take this medicine at least 5 hours after the catheter is removed,
• Heart valve replacement,
• If your doctor determines that your blood pressure is unstable or that other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Apixaban Olpha

• If you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

In case of surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. If you are unsure whether a procedure may be associated with bleeding, you should ask your doctor.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age.

Apixaban Olpha and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take. Some medicines may increase the effect of Apixaban Olpha, and some may reduce its effect. Your doctor will decide whether you should receive Apixaban Olpha while taking other medicines and how closely you should be monitored.
The following medicines may increase the effect of Apixaban Olpha and increase the risk of unwanted bleeding:

• Some antifungal medicines(e.g., ketoconazole and others);
• Some antiviral medicines used to treat HIV/AIDS(e.g., ritonavir);
• Other medicines used to reduce blood clotting(e.g., enoxaparin and others);
• Pain-relieving or anti-inflammatory medicines(e.g., acetylsalicylic acid or naproxen), especially if you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding;
• Medicines used to treat high blood pressure or heart disease(e.g., diltiazem);
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Olpha to prevent blood clots:

• Medicines used to prevent seizures or fits(e.g., phenytoin and others);
• St. John's Wort(a herbal supplement used in depression);
• Medicines used to treat tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Apixaban Olpha on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.
It is not known whether Apixaban Olpha passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding or stop/restart taking this medicine.

Driving and using machines

Apixaban Olpha has not been shown to affect the ability to drive or use machines.

Apixaban Olpha contains lactose (a type of sugar) and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially 'sodium-free'.

3. How to take Apixaban Olpha

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Apixaban Olpha can be taken with or without food. To get the best effect, it is recommended to take the tablets at the same time every day.
If you have problems swallowing the tablets whole, talk to your doctor about other ways to take Apixaban Olpha. The tablet can be crushed just before taking and mixed with water or 5% glucose solution, juice, or apple puree.

Instructions for crushing tablets:

Crush the tablet with a pestle in a mortar.
Carefully transfer all the powder to a suitable container, then mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or one of the above-mentioned liquids to prepare a mixture.
Swallow (drink) the mixture.
Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and swallow (drink) the liquid after rinsing.
If necessary, your doctor may give you a crushed Apixaban Olpha tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Apixaban Olpha should be taken as recommended in the following indications:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Apixaban Olpha 2.5 mg tablet twice a day. For example, one tablet in the morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient has undergone major hip replacement surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heart rhythm (arrhythmia) and at least one additional risk factor
The recommended dose is one Apixaban Olpha 5 mgtablet twice a day.
The recommended dose is one Apixaban Olpha 2.5 mgtablet twice a day if:

• the patient has severe kidney problems,
• two or more of the following conditions are met:
• the patient's blood test results suggest reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromole/L) or higher),
• the patient is 80 years old or older,
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one in the evening. Your doctor will decide how long to continue treatment.
Treatment of blood clots in the legs and blood clots in the blood vessels of the lungs
The recommended dose is twoApixaban Olpha 5 mgtablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is oneApixaban Olpha 5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one Apixaban Olpha 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long to continue treatment.

Your doctor may switch your anticoagulant treatment as follows:

Switching from Apixaban Olpha to other anticoagulants
Stop taking Apixaban Olpha. Anticoagulant treatment (e.g., heparin) should be started at the time of the next scheduled dose.
Switching from other anticoagulants to Apixaban Olpha
Stop taking other anticoagulants. Apixaban Olpha treatment should be started at the time of the next scheduled dose of the other anticoagulant, and then continue as usual.
Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban Olpha
Stop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Apixaban Olpha.
Switching from Apixaban Olpha to treatment with a vitamin K antagonist (e.g., warfarin)
If your doctor tells you to start taking a vitamin K antagonist, you should continue taking Apixaban Olpha for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you when to stop taking Apixaban Olpha.

Patients undergoing cardioversion

Patients with irregular heart rhythm who require a procedure to restore a normal heart rhythm (cardioversion) should take this medicine at the times specified by their doctor to prevent blood clots in the blood vessels of the brain and other blood vessels.

Taking more Apixaban Olpha than recommended

If you have taken more Apixaban Olpha than recommended, contact your doctor immediately.
Take the package with you, even if it is empty.
If you have taken more Apixaban Olpha than recommended, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apixaban Olpha

Take the dose as soon as you remember and:
take the next dose at the usual time
then continue taking the medicine as before.

If you have any doubts about taking the medicine or if you have missed more than

one dose, ask your doctor, pharmacist, or nurse.

Stopping Apixaban Olpha treatment

Do not stop taking this medicine without consulting your doctor, as the risk of blood clots may be higher if you stop taking Apixaban Olpha too early.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Apixaban Olpha can cause side effects, although not everybody gets them.
Apixaban Olpha can be used in three different medical conditions. The known side effects and their frequency may vary in each of these conditions and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Apixaban Olpha to prevent blood clots after hip or knee replacement surgery.

Common side effects (may affect up to 1 in 10 people)

• Anemia, which can cause tiredness or pale skin;
• Bleeding, including:
• bruises and swelling;
• Nausea (feeling sick).

Uncommon side effects (may affect up to 1 in 100 people)

• Reduced platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including bruises and swelling, bleeding or fluid leakage from the wound or injection site;
• from the stomach or intestines, or black stools;
• blood in the urine;
• from the nose;
• from the genital tract;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Itching.

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

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and blood in the sputum when coughing;
• from the rectum;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of the blood vessels), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruising.

The following side effects may occur when taking Apixaban Olpha to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• into the eyes;
• from the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruises and swelling;
• Anemia, which can cause tiredness or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Bleeding:
• into the brain or spinal cord;
• into the mouth or blood in the sputum when coughing;
• into the abdominal cavity or from the genital tract;
• black stools;
• bleeding after surgery, including bruises and swelling, bleeding or fluid leakage from the wound or injection site;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• Reduced platelet count (which can affect blood clotting);
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;

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

• Bleeding:
• into the lungs or throat;
• into the abdominal cavity;
• into the muscle.

Very rare side effects (may affect up to 1 in 10,000 people)

• -A skin rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).

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

• Vasculitis (inflammation of the blood vessels), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruising.

The following side effects may occur when taking Apixaban Olpha to treat or prevent the recurrence of blood clots in the legs and blood clots in the blood vessels of the lungs.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruises and swelling;
• from the stomach, intestines, or rectum;
• from the mouth;
• from the genital tract;
• Anemia, which can cause tiredness or pale skin;
• Reduced platelet count (which can affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• into the eyes;
• into the mouth or blood in the sputum when coughing;
• black stools;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruises and swelling, bleeding or fluid leakage from the wound or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs.

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

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity.
• A skin rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of the blood vessels), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruising.

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 Drug Safety 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 medicine.

5. How to store Apixaban Olpha

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 and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
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 Apixaban Olpha contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other ingredients are:

• Tablet core: lactose[see section 2 "Apixaban Olpha contains lactose(a type of sugar) and sodium"], microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate,
• Coating: Opadry II Yellow(hypromellose (E 464), lactose monohydrate[see section 2 "Apixaban Olpha contains lactose(a type of sugar) and sodium"], titanium dioxide (E 171), triacetin, yellow iron oxide (E 172)).

What Apixaban Olpha looks like and contents of the pack

Yellow, round, biconvex film-coated tablets with "I1" engraved on one side and plain on the other.
PVC/PVDC/Aluminum blisters containing 10 or 14 film-coated tablets.
Packaging containing 20, 60, or 168 film-coated tablets in a cardboard box.
HDPE bottle with a PP cap and a guarantee ring containing 200 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Patient Alert Card: Information for Use

Inside the Apixaban Olpha packaging, next to the patient leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.
The Patient Alert Card contains information to help you and to alert other doctors that you are taking Apixaban Olpha. You should always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is facilitated by perforated edges).
• 3. Fill in the following points or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: … mg twice a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing Authorization Holder

Olpha AS
Rupnicu iela 5
Olaine, Olaines novads, LV-2114
Latvia
Email: [email protected]

Importer

Olpha AS
Rupnicu iela 5
Olaine, Olaines novads, LV-2114
Latvia

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

Czech Republic, Estonia, Germany, Poland, Spain, Italy: Apixaban Olpha
Slovakia:
Apixaban Olpha 2.5 mg
France:
APIXABAN OLPHA 2.5 mg, film-coated tablet
Lithuania:
Apixaban Olpha 2.5 mg film-coated tablets
Latvia:
Apixaban Olpha 2.5 mg apvalkotās tabletes

Date of last revision of the leaflet: