Apixaban Olpha

Package Leaflet: Information for the User

Apixaban Olpha, 5 mg, Film-Coated Tablets

Apixaban

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Apixaban Olpha is and what it is used for
• 2. Before you take 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. It helps to 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 forming in the heart in patients with an irregular heartbeat (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, blocking blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.

treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as prevent new blood clots from forming in the blood vessels of the legs and/or lungs.

2. Before You Take 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 a condition that increases the risk of severe bleeding(such as a recent stomach or intestinal ulcer, recent bleeding in the brain),
• If you have liver disease that increases the risk of bleeding(hepatic coagulopathy),
• If you are taking other medicines to prevent blood clotting(such as warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, and the patient has a venous or 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 vein) due to irregular heartbeat (arrhythmia).

Warnings and Precautions

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

• Increased risk of bleeding, such as:
• Bleeding disorders, including those that result in reduced platelet activity,
• Uncontrolled high blood pressure,
• 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.
• If you have a prosthetic heart valve,
• If your doctor determines that your blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be Extra Careful When Taking Apixaban Olpha

• If you have 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 period. 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 or have recently taken, as well as any medicines you plan to take.

Some medicines may increase the effect of Apixaban Olpha, and some may reduce its effect. Your doctor will decide whether you should take 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(such as ketoconazole and others);
• Some antiviral medicines used to treat HIV/AIDS(such as ritonavir);
• Other medicines used to reduce blood clotting(such as enoxaparin and others);
• Anti-inflammatory or pain-relieving medicines(such as 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(such as 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(such as phenytoin and others);
• St. John's Wort(a herbal supplement used in depression);
• Medicines used to treat tuberculosis or other infections(such as 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 and Sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This 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 results from your treatment, it is recommended to take the tablets at the same time every day.

If you have difficulty swallowing the tablets whole, talk to your doctor about other ways to take Apixaban Olpha. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple puree just before taking.

Instructions for Crushing Tablets:

Crush the tablet with a pestle in a mortar.

Carefully transfer the entire powder to a suitable container, then mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or one of the above-mentioned liquids to make 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 rinse.

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.

Take Apixaban Olpha as Directed by Your Doctor:

Preventing blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor

The recommended dose is one Apixaban Olpha 5 mg tablet twice daily.

The recommended dose is one Apixaban Olpha 2.5 mg tablet twice daily if:

• You have severe kidney problems,
• Two or more of the following conditions are met:
• your blood test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher),
• You are 80 years old or older,
• Your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long you should continue treatment.

Treating blood clots in the veins of the legs and blood clots in the lungs

The recommended dose is two Apixaban Olpha 5 mg tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening.

After 7 days, the recommended dose is one Apixaban Olpha 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.

Preventing new blood clots after completing 6 months of treatment

The recommended dose is one Apixaban Olpha 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.

Your doctor will decide how long you should continue treatment.

Your Doctor May Switch Your Treatment as Follows:

Switching from Apixaban Olpha to Other Anticoagulants

Stop taking Apixaban Olpha. Start taking other anticoagulants (such as heparin) at the time of the next scheduled dose.

Switching from Other Anticoagulants to Apixaban Olpha

Stop taking other anticoagulants. Start taking Apixaban Olpha at the time of the next scheduled dose of the other anticoagulant, and then continue with the usual dosing schedule.

Switching from Treatment with a Vitamin K Antagonist (such as 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 (such as 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 heartbeat who require cardioversion to restore a normal heart rhythm should take this medicine at the times specified by their doctor to prevent blood clots from forming in the blood vessels of the brain and other parts of the body.

What to Do If You Take More Apixaban Olpha Than You Should

If you take more Apixaban Olpha than you should, contact your doctor immediately. Take the package and any remaining tablets with you. If you take more Apixaban Olpha than you should, 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.

What to Do If You Miss a Dose of Apixaban Olpha

Take the dose as soon as you remember, and then:

take the next dose at the usual time

continue taking the medicine as you normally would.

If You Have Any Further Questions on the Use of This Product, Ask Your Doctor, Pharmacist, or Nurse.

Do not stop taking Apixaban Olpha without consulting your doctor, as stopping treatment too early may increase the risk of blood clots.

4. Possible Side Effects

Like all medicines, Apixaban Olpha can cause side effects, although not everybody gets them.

The most common 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 in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common Side Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• eye bleeding;
• stomach or intestinal bleeding;
• rectal bleeding;
• blood in urine;
• nosebleeds;
• gum bleeding;
• bruising and swelling;
• Anemia, which can cause fatigue 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:
• brain or spinal bleeding;
• mouth or throat bleeding, or blood in coughed-up sputum;
• abdominal or genital bleeding;
• black, tarry stools;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• hemorrhoids;
• blood in stool or urine detected by laboratory tests;
• muscle bleeding;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes.

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

• Bleeding:
• lung or throat bleeding;
• abdominal bleeding.

Very Rare Side Effects (may affect up to 1 in 10,000 people)

• A skin rash that may form 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 blood vessels), which can cause 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 new blood clots in the veins of the legs and blood clots in the lungs.

Common Side Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• nosebleeds;
• gum bleeding;
• blood in urine;
• bruising and swelling;
• stomach or intestinal bleeding;
• vaginal bleeding;
• Anemia, which can cause fatigue 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 (ALT) activity.

Uncommon Side Effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• eye bleeding;
• mouth or throat bleeding, or blood in coughed-up sputum;
• black, tarry stools;
• blood in stool or urine detected by laboratory tests;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• hemorrhoids;
• muscle bleeding;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes.

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

• Bleeding:
• brain or spinal bleeding;
• lung bleeding.

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

• Bleeding:
• abdominal or retroperitoneal bleeding.
• A skin rash that may form 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 blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin, or bruising;

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system via the contact details listed below. 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.

No special storage conditions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 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 croscarmellose [see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"], sodium lauryl sulfate, magnesium stearate,
• Coating:Opadry II Pink (hypromellose (E 464), lactose monohydrate[see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"], titanium dioxide (E 171), triacetin, iron oxide red (E 172)).

What Apixaban Olpha Looks Like and Contents of the Pack

Pink, oval, biconvex film-coated tablets with "I2" engraved on one side and plain on the other.

PVC/PVDC/Aluminum blisters containing 10 or 14 film-coated tablets.

Pack sizes: 28, 56, 60, or 168 film-coated tablets in a cardboard box.

HDPE bottle with a PP cap and a tamper-evident 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 package, along with 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 warn other doctors that you are taking Apixaban Olpha. Always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is made easier by the perforated edges).
• 3. Fill in the following or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: … mg twice daily
• 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 5 mg

France:

APIXABAN OLPHA 5 mg, film-coated tablet

Lithuania:

Apixaban Olpha 5 mg film-coated tablets

Latvia:

Apixaban Olpha 5 mg film-coated tablets

Date of Last Revision of the Leaflet: