Patient Medication Information: uses, side effects, how to take - PMSC-Rivaroxaban
ABOUT THIS MEDICATION
What the medication is used for:
pmsc-RIVAROXABAN 10 mg, 15 mg and 20 mg tablets are used for the:
- Prevention of blood clots after major hip or knee surgery Blood clots could dislodge and travel to the lungs causing serious health risks. Your doctor has prescribed this medication for you because after such an operation you are at an increased risk of getting blood clots.
- Prevention of blood clots in your brain (stroke) and in other blood vessels in your body if you have atrial fibrillation Your doctor has prescribed this medication for you because you have a form of irregular heart rhythm called atrial fibrillation which can lead to blood clots forming and increases your risk of a stroke.
- Treatment and prevention of blood clots in the veins of your legs or lungs Your doctor has prescribed this medication for you because you have blood clots in the veins of your legs. This makes you at risk of a blood clot dislodging and traveling to the lungs causing serious health risks.
pmsc-RIVAROXABAN 2.5 mg tablet is used for the:
Prevention of stroke, heart attack and severe leg pain or death
Your doctor has prescribed this medication for you in combination with acetylsalicylic acid (ASA, ASPIRIN®) if you have:
a blockage in the blood vessels to the heart, called coronary artery disease, causing a lack of oxygen in your heart. This may occur with or without the
- narrowing of limb arteries that causes pain, a circulatory problem called peripheral artery disease; or
- confirmed peripheral artery disease and are at increased risk for stroke, heart attack or sudden severe blockage of blood flow to your limbs.
pmsc-RIVAROXABAN 1 mg/mL granules for oral suspension is used for the:
Treatment and prevention of blood clots in the veins or blood vessels of children’s lungs
The doctor has prescribed this medication to treat blood clots and prevent re-occurrence of clots in the veins or in the blood vessels of the lungs in full-term newborn babies, infants and toddlers, children and adolescents after at least 5 days of initial treatment with injectable medicines used to treat blood clots.
pmsc-RIVAROXABAN 15mg tablet is used for the:
Treatment and prevention of blood clots in the veins or blood vessels of children’s lungs
The doctor has prescribed this medication to treat blood clots and prevent re-occurrence of clots in the veins or in the blood vessels of the lungs in children and adolescents (aged less than 18 years and weighing from 30kg to 50kg) after at least 5 days of initial treatment with injectable medicines used to treat blood clots.
pmsc-RIVAROXABAN 20mg tablet is used for the:
Treatment and prevention of blood clots in the veins or blood vessels of children’s lungs
The doctor has prescribed this medication to treat blood clots and prevent re-occurrence of clots in the veins or in the blood vessels of the lungs in children and adolescents (aged less than 18 years and weighing more than 50kg) after at least 5 days of initial treatment with injectable medicines used to treat blood clots.
What it does:
pmsc-RIVAROXABAN is an anticoagulant. It helps prevent blood clots from forming by directly blocking the activity of clotting Factor-Xa.
When it should not be used:
If you or the child:
- have severe liver disease which leads to an increased risk of bleeding
- have active bleeding, especially if you are bleeding excessively
- are aware of body wounds or injuries at risk of bleeding, including bleeding in the brain or bleeding in your stomach or gut
- are taking certain oral medications to treat fungal infections or HIV/AIDS, such as NIZORAL®
- (ketoconazole), TYBOST® (cobicistat) or NORVIR® (ritonavir)
- are taking dronedarone
- are taking other anticoagulants (blood thinners) such as warfarin, apixaban, dabigatran, edoxaban, heparin or low molecular weight heparin (LMWH) including enoxaparin, dalteparin or heparin derivatives, such as fondaparinux
- are pregnant or are breastfeeding
- are allergic (hypersensitive) to rivaroxaban (active ingredient of pmsc-RIVAROXABAN) or any of the other ingredients of pmsc-RIVAROXABAN. The ingredients are listed in the “What the nonmedicinal ingredients are” section of this leaflet
What the medicinal ingredient is:
rivaroxaban
What the nonmedicinal ingredients are:
Film-coated tablets:
cellulose microcrystalline, croscarmellose sodium, ferric oxide red (10 mg, 15 mg, 20 mg), ferric oxide yellow (2.5 mg), hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, titanium dioxide
Granules for oral suspension:
citric acid (anhydrous), sweet and creamy flavor [consisting of flavoring substances, maltodextrin (maize), propylene glycol (E1520), arabic gum (Acacia gum, E414)], hypromellose 5 cP, mannitol, microcrystalline cellulose, carboxymethylcellulose sodium, sodium benzoate, sucralose, xanthan gum
What dosage forms it comes in:
Film-coated tablets, 2.5 mg 10 mg, 15 mg and 20 mg.
Granules for oral suspension, 1 mg/mL:
The granules for oral suspension are white granules in a glass bottle. Two pack sizes are available:
For children weighing less than 4kg
- 1 carton with one bottle (100 mL) containing 2.625 g granules, when reconstituted 51.7 mg rivaroxaban / bottle
- two 1 mL blue oral syringes and adapter
- one 50 mL syringe
For children weighing more than 4kg
- 1 carton with one bottle (250 mL) containing 5.25 g granules, when reconstituted 103.4 mg rivaroxaban / bottle
- two 5 mL blue oral syringes and adapter
- two 10 mL blue oral syringes and adapter
one 100 mL syringe
After preparation, each mL of suspension contains 1 mg of rivaroxaban.
WARNINGS AND PRECAUTIONS
Do not stop taking pmsc-RIVAROXABAN without first talking to your doctor. If you stop taking pmsc-RIVAROXABAN, blood clots may cause a stroke, heart attack, or other complications. This can be fatal or lead to severe disability.
As with other blood thinners, taking pmsc-RIVAROXABAN may result in serious or life-threatening bleeding from any site, including internal organs.
Take special care when using pmsc-RIVAROXABAN if you or the child:
have an increased risk of bleeding, as could be the case with conditions such as
- bleeding disorders
- very high blood pressure, not controlled by medical treatment
- active ulcer or a recent ulcer of the stomach or bowel
- a problem with the blood vessels in the back of the eyes (retinopathy)
- recent bleeding in the brain (stroke, intracranial or intracerebral bleeding)
- problems with the blood vessels in the brain or spinal column
- a recent operation on the brain, spinal column or eye
- a chronic disease of the airways in the lungs causing widening, damage and scarring (bronchiectasis), or a history of bleeding into the lungs
- are older than 75 years of age
- have a prosthetic heart valve
- if a doctor has told you that you or the child have antiphospholipid syndrome, a disease which can cause blood clots.
For the treatment and prevention of blood clots in the veins of your legs or lungs, pmsc-RIVAROXABAN is not recommended if your doctor determines that:
- you are not able to maintain an adequate blood pressure
- you are taking drugs to break down your blood clots
- you have been scheduled for emergency surgical removal of blood clots from your lung
Talk to the doctor or pharmacist before using pmsc-RIVAROXABAN if any of these apply to you or the child. The doctor may decide to keep you or the child under closer observation.
If you or the child are having surgery for any reason including an operation that involves a catheter or injection into the spinal column (e.g, for epidural or spinal anesthesia or pain reduction):
- it is very important that pmsc-RIVAROXABAN is taken before and after the procedure/injection or removal of a catheter exactly at the times you have been told by the doctor
- tell the doctor immediately if after anesthesia you or the child get numbness or weakness of the legs, or problems with the bowel or bladder , because urgent care is necessary
You should avoid pmsc-RIVAROXABAN 2.5 mg if you have had a prior stroke with bleeding in the brain (hemorrhagic stroke) or a prior stroke where there was a blockage of the small arteries that provide blood to the brain’s deep tissues (lacunar stroke).
You should avoid pmsc-RIVAROXABAN 2.5 mg for at least one month after having a stroke from a blood clot in the brain (ischemic non-lacunar stroke).
Lactose is a nonmedicinal ingredient in pmsc-RIVAROXABAN tablets. Do not take pmsc-RIVAROXABAN if you or the child have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
If you have severe kidney disease or reduced kidney function (for children younger than 1 year), you or the child may not be able to take pmsc-RIVAROXABAN because it may increase the chance of bleeding. The doctor will know how to determine kidney function.
pmsc-RIVAROXABAN is not recommended if you or the child have an artificial heart valve.
pmsc-RIVAROXABAN 2.5 mg and 10 mg film-coated tablets are not recommended in children younger than 18 years old.
pmsc-RIVAROXABAN is not recommended in children younger than 18 years of age for any condition other than the treatment and prevention of blood clots in the veins or blood vessels of children’s lungs.
Do not give pmsc-RIVAROXABAN granules for oral suspension to children under 6 months of age who
- at birth had less than 37 weeks of gestation, or
- weigh less than 2.6 kg, or
- had less than 10 days of breast or formula feeding
because dosing of pmsc-RIVAROXABAN cannot be reliably determined and has not been studied in these children.
pmsc-RIVAROXABAN granules for oral suspension contains 1.8 mg sodium benzoate in each mL oral suspension. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). This medicine contains less than 1 mmol sodium (23 mg) per mL.
Pregnancy and breastfeeding
If there is a chance that you or the child could become pregnant, use a reliable contraceptive while you are taking pmsc-RIVAROXABAN. If you or the child become pregnant while taking pmsc-RIVAROXABAN, immediately tell the doctor, who will decide how to continue treatment.
INTERACTIONS WITH THIS MEDICATION
Tell the doctor or pharmacist if you or the child are taking:
- anticoagulants (blood thinners) such as warfarin, heparin or low molecular weight heparin (LMWH) including enoxaparin, fondaparinux, bivalidrudin, apixaban, dabigatran, edoxaban, or anti-platelet agents, such as clopidogrel, ticlopidine, prasugrel, ticagrelor
- oral medications to treat fungal infections such as ketoconazole, itraconazole, posaconazole
- medications for HIV/AIDS such as ritonavir (NORVIR®), cobicistat (TYBOST®), and lopinavir/ritonavir (KALETRA®)
- are taking dronedarone
- anti-inflammatory and pain relieving medicines including non-steroidal anti-inflammatory drugs (NSAIDs) (e.g, naproxen [NAPROSYN®] or acetylsalicylic acid [ASPIRIN®])
- some antibiotics such as clarithromycin
- rifampicin
- anticonvulsants (to control seizures or fits) such as phenytoin, carbamazepine, phenobarbital
- medicines to treat depression and/or anxiety (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))
You or the child are at an increased risk for bleeding if you take pmsc-RIVAROXABAN with:
- NSAIDs
- antiplatelet agents such as ASA or clopidogrel
- antidepressants/anti-anxiety (SSRIs, SNRIs)
Low-dose pmsc-RIVAROXABAN 2.5 mg is prescribed together with low-dose ASA 75 mg – 100 mg. If you need to take another NSAID, your doctor will decide if it is beneficial for you to take it along with your pmsc-RIVAROXABAN / ASA treatment.
The use of pmsc-RIVAROXABAN with prasugrel or ticagrelor is not recommended.
Please tell the doctor or pharmacist if you or the child are taking or have recently taken any other medication, including medications obtained without a prescription as well as vitamins and herbal supplements, such as St. John’s Wort. Know the medicines you or the child takes. Keep a list of them and show it to the doctor and pharmacist when you or the child get a new medicine.
PROPER USE OF THIS MEDICATION
If you or the child are currently taking warfarin (another blood thinner taken by mouth) or receive other anticoagulant treatment given by injection, and the doctor has decided pmsc-RIVAROXABAN is appropriate for you or the child, make sure you ask the doctor exactly when and how best to switch and start taking pmsc-RIVAROXABAN.
Always follow the doctor’s instructions. Do not stop taking or giving pmsc-RIVAROXABAN without talking to the doctor first, because pmsc-RIVAROXABAN helps prevent the development of blood clots.
Swallow the tablet preferably with water. Try to take or give the tablet or oral suspension at the same time every day to help you to remember it. The doctor will decide how long you or the child must take pmsc-RIVAROXABAN.
Do not split the tablet in an attempt to provide a fraction of a tablet dose. If you or the child have trouble swallowing the tablet whole, talk to the doctor about other ways to take it. The doctor may prescribe pmsc-RIVAROXABAN granules for oral suspension to the child instead of the tablets.
The tablets may be crushed and mixed with applesauce. Take it right away after you have mixed it. A crushed 2.5 mg or 10 mg tablet can be taken with or without food. Eat food right after taking a crushed 15 mg or 20 mg tablet.
The doctor may give you or the child the crushed pmsc-RIVAROXABAN tablet also via a tube.
Prevention of blood clots after major hip or knee surgery
Usual dose: 10 mg once a day with or without food.
Take the first tablet 6 to 10 hours after your operation. Then take a tablet every day until your doctor tells you to stop.
If you have had a major hip operation, you will usually take pmsc-RIVAROXABAN for 35 days.
If you have had a major knee operation, you will usually take pmsc-RIVAROXABAN for 14 days.
Prevention of blood clots in your brain (stroke) and in other blood vessels in your body if you have atrial fibrillation
Usual dose: 20 mg once a day with food.
If your kidneys are not working properly, your doctor may prescribe 15 mg once a day with food.
To be sure that you get the full benefit from pmsc-RIVAROXABAN, it is important to take the 15 mg and 20 mg tablets with food.
If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention – PCI with an insertion of a stent), your doctor will reduce your dose to 15 mg once a day (or to 10 mg once a day in case your kidneys are not working properly) in combination with an antiplatelet agent (e.g, clopidogrel).
This is long-term treatment and you should continue to take pmsc-RIVAROXABAN until your physician says otherwise.
The recommended maximum daily dose is 20 mg.
Treatment and prevention of blood clots in the veins of your legs or lungs
Swallow the tablet preferably with water.
Day 1 to 21:
- 15 mg: Take 1 tablet TWICE a day (in the morning and evening) with food.
Day 22 onwards:
- 20 mg: Take 1 tablet ONCE a day with food.
After at least 6 months treatment, your doctor may decide to continue treatment with either one 20 mg tablet once a day or one 10 mg tablet once a day.
The 10 mg tablet may be taken with or without food.
This is long-term treatment and you should continue to take pmsc-RIVAROXABAN until your physician says otherwise.
Prevention of stroke, heart attack and severe leg pain or death
Usual dose: 2.5 mg twice a day with or without food. Take pmsc-RIVAROXABAN around the same time every day (for example, one tablet in the morning and one in the evening).
Also take 1 tablet of 75 mg – 100 mg of acetylsalicylic acid (ASA) once a day. Take the ASA tablet at the same time as one of your pmsc-RIVAROXABAN doses.
This is long-term treatment and you should continue to take your treatment until your physician says otherwise.
Treatment and prevention of blood clots in the veins or blood vessels of a child’s lungs
This medicine is available for children as granules for oral suspension. Prepare the oral suspension according to the Instructions for Use booklet that is provided with this medicine. Be sure to read and understand the Instructions for Use because it will show you how to prepare and administer the pmsc-RIVAROXABAN oral suspension.
This medicine is also available for children and adolescents weighing 30 kg or more as 15 mg or 20 mg tablets.
Always take or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. You should check with the doctor, pharmacist or nurse if you are not sure.
Make sure that the correct information on how much and how often to take or give pmsc-RIVAROXABAN is written on the designated field of the carton. If it is not written on the field, ask the pharmacist or doctor to provide the relevant information.
See the Instructions for Use booklet in the carton for how to prepare and administer a dose of pmsc-RIVAROXABAN granules for oral suspension.
How much to take
The dose of pmsc-RIVAROXABAN depends on body weight and will be calculated by the doctor as an amount (volume) in milliliters (mL) of oral suspension or as a tablet (either 15 mg or 20 mg). All materials to prepare and administer the oral suspension are provided with the granules (except for non-carbonated drinking water). The doctor will tell you how much of the oral suspension or which of the tablets (15 mg or 20 mg) you or the child must take.
Oral Suspension | Body weight [kg] | Single dose [mL] | Daily frequency of intake | Total daily dose [mg] (1 mL=1 mg) | Blue oral syringe for dose administration | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2.6 to under 3 | 0.8 | 3 times | 2.4 | 1 mL | ||||||
| 3 to under 4 | 0.9 | 3 times | 2.7 | 1 mL | ||||||
| 4 to under 5 | 1.4 | 3 times | 4.2 | 5 mL | ||||||
| 5 to under 6 | 1.6 | 3 times | 4.8 | 5 mL | ||||||
| 6 to under 7 | 1.6 | 3 times | 4.8 | 5 mL | ||||||
| 7 to under 8 | 1.8 | 3 times | 5.4 | 5 mL | ||||||
| 8 to under 9 | 2.4 | 3 times | 7.2 | 5 mL | ||||||
| 9 to under 10 | 2.8 | 3 times | 8.4 | 5 mL | ||||||
| 10 to under 12 | 3.0 | 3 times | 9.0 | 5 mL | ||||||
| 12 to under 30 | 5.0 | 2 times | 10.0 | 5 mL or 10 mL | ||||||
Tablets or oral suspension | 30 to under 50 | 15.0 | once | 15.0 | 10 mL | |||||
| 50 or more | 20.0 | once | 20.0 | 10 mL | ||||||
The child’s weight should be monitored and the dose
be adjusted by the doctor if necessary, especially for
children below 12 kg. This ensures that the correct dose of
pmsc-RIVAROXABAN is received.
It is important that the doses of pmsc-RIVAROXABAN are adjusted by the doctor only, never by yourself. Do not switch among the oral suspension, 15 mg tablet or 20 mg tablet without first talking to the doctor, pharmacist or nurse.
Children should keep scheduled doctor’s visits because their pmsc-RIVAROXABAN dosage should be adjusted as their weight changes. The doctor may also want to prescribe the tablets if the child is able to swallow them.
Take or give the tablet or oral suspension with feeding or with food.
Each pmsc-RIVAROXABAN dose has to be swallowed along with one typical serving of liquid. This typical serving may include liquid used for feeding.
If the doctor has told you to take or give pmsc-RIVAROXABAN:
- once daily, do this approximately 24 hours apart
- twice daily, do this approximately 12 hours apart
- three times daily, do this approximately 8 hours apart
Try to take or give pmsc-RIVAROXABAN at the same time every day to help you to remember it.
If you or the child spits up the dose or vomits
- less than 30 minutes after taking pmsc-RIVAROXABAN, take or give a new dose
- more than 30 minutes after taking pmsc-RIVAROXABAN, do not take or give a new dose. In this case, take or give the next pmsc-RIVAROXABAN dose at the usual time.
Contact the doctor if you or the child repeatedly spits up the dose or vomits after taking pmsc-RIVAROXABAN.
Overdose
Taking too much pmsc-RIVAROXABAN could increase the risk of bleeding.
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose
If you or the child are prescribed pmsc-RIVAROXABAN 10 mg, 15 mg, 20 mg tablets or granules for oral suspension once a day and you have missed a dose, take or give it as soon as you remember on the same day. If this is not possible, take or give the next pmsc-RIVAROXABAN dose on the following day at the usual time and then carry on taking or giving a pmsc-RIVAROXABAN dose once a day as normal. Do not take or give a double dose to make up for a forgotten dose.
If you are prescribed pmsc-RIVAROXABAN 15 mg tablets twice a day and you have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets on one day. If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day. On the following day you should carry on taking one 15 mg tablet twice a day.
If the child is prescribed pmsc-RIVAROXABAN granules for oral suspension twice daily and has missed a dose, take or give the missed morning dose as soon as you remember. You may take or give the forgotten dose together with the evening dose. A missed evening dose can only be taken or given on the same evening.
If the child is prescribed pmsc-RIVAROXABAN granules for oral suspension three times a day and they have missed a dose, do not make up for the missed dose. Continue with the next scheduled dose (given every 8 hours).
If you are prescribed pmsc-RIVAROXABAN 2.5 mg twice a day and you have missed a dose, take your next pmsc-RIVAROXABAN 2.5 mg tablet as normal.
On the following day, continue as prescribed by the doctor once, twice or three times daily.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, pmsc-RIVAROXABAN can cause side effects, although not everybody gets them.
As pmsc-RIVAROXABAN acts on the blood clotting system, most side effects are related to signs of bruising or bleeding. In some cases, bleeding may not be obvious, such as unexplained swelling.
Patients treated with pmsc-RIVAROXABAN may also experience the following side effects:
Nausea, vomiting, stomach ache, constipation, diarrhea, indigestion, and decreased general strength and energy.
In general, the side effects observed in children treated with pmsc-RIVAROXABAN were similar in type to those observed in adults and were primarily mild to moderate in severity.
Side effects that were observed more often in children include:
Very common: headache, fever, nose bleeding, vomiting.
Common: raised heartbeat, blood tests may show an increase in bilirubin, low number of platelets which are cells that help blood to clot, heavy menstrual bleeding observed in girls.
Uncommon: blood tests may show an increase in a subcategory of bilirubin (direct bilirubin).
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||
|---|---|---|---|---|---|---|---|
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and seek immediate emergency medical attention | |||||
| Only if severe | In all cases | ||||||
| Common | Bleeding from the surgical wound, an injury or other medical procedure | ✓ | |||||
| Unexpected bruising | ✓ | ||||||
| Reduction in red blood cells which can make your skin pale and cause weakness, tiredness, dizziness, headache, breathlessness, unusually fast heartbeat, or chest pain | ✓ | ||||||
| Bleeding into the eye | ✓ | ||||||
| Bleeding from stomach (blood in vomit) or bowel (blood in stools/black stools) | ✓ | ||||||
| Bleeding from hemorrhoids | ✓ | ||||||
| Bleeding under the skin | ✓ | ||||||
| Blood in your urine, (red/pink tinge to urine) | ✓ | ||||||
| Genital bleeding in post menopausal women | ✓ | ||||||
| Increased or more frequent menstrual bleeding | ✓ | ||||||
| Localized swelling | ✓ | ||||||
| Nose bleed lasting more than 5 minutes | ✓ | ||||||
| Pain or swelling in your limbs | ✓ | ||||||
| Low blood pressure (lightheaded-ness, dizziness, and/or fainting) | ✓ | ||||||
| Fever | ✓ | ||||||
| Unusually fast heartbeat | ✓ | ||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and seek immediate emergency medical attention |
|---|
| Only if severe | In all cases | |||||
|---|---|---|---|---|---|---|
| Itchy skin or rash | ✓ | |||||
| Bleeding gums for longer than 5 minutes when you brush your teeth | ✓ | |||||
| Un-common | Bleeding into the brain (sudden, severe and unusual headache) | ✓ | ||||
| Coughing up blood | ✓ | |||||
| Bleeding into a joint (stiff, sore, hot or painful joint) | ✓ | |||||
| Oozing from the surgical wound | ✓ | |||||
| Decreased urine output | ✓ | |||||
| Rare | Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, and difficulty swallowing or breathing | ✓ | |||||
| Unknown | Compartment Syndrome: increased pressure within legs or arms after a bleed, with pain, swelling, numbness or paralysis | ✓ | ||||
| Agranulocytosis [frequent infection with fever, sore throat, mouth ulcers (sign of decreased white blood cells)] | ✓ | |||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and seek immediate emergency medical attention |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Stevens-Johnson syndrome: Severe skin rash with redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking pmsc-RIVAROXABAN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep pmsc-RIVAROXABAN tablets and granules for oral suspension at room temperature (15°C-30°C).
After preparation, the reconstituted pmsc-RIVAROXABAN suspension can be used for 14 days. Store at room temperature (15°C to 30°C ) or in a refrigerator (2°C to 8°C). Do not freeze. If the suspension has been stored in the refrigerator, allow the suspension to adjust to room temperature prior to administration. See the Instructions for Use for complete details on preparation and administration of the oral suspension.
Keep out of the reach and sight of children.
Do not use pmsc-RIVAROXABAN after the expiry date which is stated on the bottle and on each blister after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
For more information, please contact your health professional or pharmacist first, or Pharmascience Inc. at 1-888-550-6060.
This document plus the full Product Monograph, prepared for health professionals can be found at: www.pharmascience.com or by contacting the manufacturer at the above-mentioned phone number.
Pharmascience Inc.
Montréal, Québec
H4P 2T4
www.pharmascience.com
Last revised: May 10, 2021
TM see www.bayer.ca/tm-mc