Xarelto Starter Pack is used to treat or prevent blood clots (venous thromboembolism, or VTE). Blood clots can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE).

Xarelto Starter Pack is sometimes used to lower your risk of a blood clot coming back after you have received treatment for blood clots for at least 6 months in adults, and at least 5 days in children from birth to less than 18 years of age.

Xarelto Starter Pack is also given together with aspirin to lower the risk of stroke, heart attack, or other serious heart and blood circulation problems in adults with coronary artery disease (clogged arteries) or peripheral artery disease (reduced blood flow to the legs), including adults who recently had a procedure to improve blood flow to the legs.

Xarelto Starter Pack can also be used to prevent blood clots in adults that are not able to move as normal during and after a hospital stay or after a hip or knee replacement surgery.

Xarelto Starter Pack can be used to prevent blood clots in children 2 years and older that have undergone surgery for a heart disease present at birth.

Xarelto Starter Pack is also used to lower the risk of stroke and blood clots in adults with atrial fibrillation (a heart rhythm disorder).

Xarelto Starter Pack may also be used for purposes not listed in this medication guide.

Do not stop taking Xarelto Starter Pack without your doctor's advice. Stopping it suddenly can increase your risk of blood clots or stroke.

Some drugs can increase your risk of bleeding when used with Xarelto Starter Pack. Tell your doctor about all other medicines you use.

Call your doctor at once if you or your child have signs of bleeding such as: headaches, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, vomit that looks like coffee grounds or any bleeding that will not stop.

Xarelto Starter Pack can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not change your dose or stop taking this medication without your doctor's advice. Stopping suddenly can increase your risk of blood clots or stroke.

Tell any doctor who treats you that you are using Xarelto Starter Pack. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop using this medicine for a short time.

For some conditions, Xarelto Starter Pack should be taken with food. Whether you take the medicine with or without food may also depend on the tablet strength you take. Follow your doctor's dosing instructions very carefully.

If you cannot swallow a Xarelto Starter Pack tablet whole, crush it and mix the medicine with a small amount of applesauce. Swallow the mixture right away without chewing. If you are taking the 15 mg or 20 mg tablet, the dose should be immediately followed by food.

Follow your healthcare provider's instructions about giving Xarelto Starter Pack through a feeding tube if needed.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

If your child is taking the tablet, make sure it is swallowed whole. Xarelto Starter Pack should not be split to provide a smaller dose. Talk to your doctor about switching to the oral suspension (liquid).

If your child vomits within 30 minutes of taking the oral suspension (liquid), give a new full dose. If your child vomits more than 30 minutes after taking the oral suspension (liquid), do not give another dose. Give the next dose as scheduled.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Store at room temperature away from moisture and heat. Do not freeze the oral suspension (liquid).

You should not use Xarelto Starter Pack if you are allergic to it, or if you have active or uncontrolled bleeding.

Xarelto Starter Pack can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop.

Xarelto Starter Pack can cause a serious blood clot if you undergo a procedure such as a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause permanent or long-term paralysis.

Tell your doctor if you have or ever had:

• a history of problems with your spine or a spinal surgery;

• a history of difficult or repeated spinal taps;

• a thin tube (catheter) placed in your back to give you certain medicine;

• bleeding problems;

• an artificial heart valve;

• antiphospholipid syndrome, an immune system disorder that increases the risk of blood clots;

• taken NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and other medicines that prevent blood from clotting; or

• liver or kidney disease.

Taking Xarelto Starter Pack during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed a baby while you are using Xarelto Starter Pack. Ask your doctor about the risks.

If you take Xarelto Starter Pack 1 time each day: Take the medicine as soon as you remember, and then go back to your regular schedule. Do not take two doses in the same day.

If you take the 15-milligram tablet 2 times each day: Take the missed dose on the same day you remember it. You may take the missed morning dose with the evening dose. Take your next dose at the regular time and stay on your two times a day schedule.

If you take the 2.5-milligram tablet 2 times each day: Skip the missed dose and take your next dose at the regular time. Do not use two doses at one time.

If your child takes Xarelto Starter Pack 2 times each day: give the missed morning dose as soon as you remember. You may give the missed morning dose with the evening dose. If you miss an evening dose, skip the missed dose and then go back to the regular schedule.

If your child takes Xarelto Starter Pack 3 times each day: skip the missed dose and give the next dose at the regular time. Do not give two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose may cause excessive bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness, tingling, muscle weakness in your lower body, or loss of bladder or bowel control.

Xarelto Starter Pack can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as:

• bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual bleeding);

• pain, swelling, new drainage, or excessive bleeding from a wound;

• headaches, dizziness, weakness, feeling like you might pass out;

• urine that looks red, pink, or brown; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of Xarelto Starter Pack may include:

• bleeding;

• vomiting;

• cough; or

• stomach or gut inflammation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Xarelto Starter Pack, especially:

• ketoconazole;

• ritonavir;

• erythromycin, rifampin;

• carbamazepine, phenytoin;

• St. John's wort;

• medicine used to prevent blood clots--enoxaparin, warfarin, alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect Xarelto Starter Pack. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.