What Warfarin Orion is and what it is used for
Warfarin Orion is used to preventing or treat blood clots or their complications. Warfarin Orion reduces the risk of blood clots.
This medicine is used to:
- prevent and treat deep vein thrombosis (blood clots in the blood vessels of the legs) and pulmonary embolism (blood clots in the blood vessels of the lungs)
- prevent the formation of blood clots in some patients with atrial fibrillation (a heart rhythm disorder)
- prevent new blood clots after a major heart attack
- prevent the formation of blood clots in some patients with prosthetic valves (after heart valve replacement).
The warfarin contained in Warfarin Orion may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Warfarin Orion
Do not take Warfarin Orion:
- if you are allergic to warfarin sodium or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant in the first third of pregnancy, or the last four weeks of pregnancy (see also the Pregnancy and breast-feeding section)
- if you have an increased tendency to bleed ( hemophilia, von Willebrand’s disease, lack of platelets ( thrombocytopenia ), or impaired function of the platelets).
- if you have severe liver dysfunction or liver cirrhosis (cirrhosis).
- if you have untreated or uncontrolled high blood pressure.
- if you have recently had a brain hemorrhage.
- if you tend to fall frequently due to neurological or other problems with your health.
- if you have recently had surgery on the nervous system or the eye, or if you are going to undergo such surgery shortly.
- if you have previously had to bleed in the gastrointestinal tract (e.g. ruptured stomach ulcer, bloody or black stools, bloody vomit) or to bleed in the urinary tract (unexplained blood in the urine).
- if you have inflammation in a heart valve ( endocarditis ) or the pericardium (pericarditis) or if you have fluid accumulation in the pericardium.
- in the case of dementia, psychosis, alcoholism, or in any other situation where this type of treatment cannot be given safely
- if you take St. John’s wort ( Hypericum perforatum )
- if you are taking other medicines that prevent blood clots (e.g. dabigatran, apixaban, rivaroxaban, edoxaban) except when changing blood thinning treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Warfarin Orion.
- if you are already using, start using or stop using other medicines during treatment with Warfarin Orion (see section Other medicines and Warfarin Orion).
- if you have hyper- or hypothyroidism (increased or decreased function of the thyroid gland).
- if you have heart failure associated with sudden worsening (periods of increased fluid retention ( edema ) and shortness of breath).
- if you have other forms of impaired liver function than those mentioned above, or jaundice.
- if you have impaired kidney function.
- if you are going to undergo dental or other surgery soon, consult your doctor.
Major changes in eating habits should be avoided because the amount of vitamin K in the food can affect the effectiveness of the treatment with warfarin. Transition to a vegetarian diet, extreme diet, depression, vomiting, or diarrhea are conditions that can affect the treatment.
Other medicines and Warfarin Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines
Many medicines affect the effect of Warfarin Orion, either by increasing or decreasing it. Glucosamine (against osteoarthritis ) can increase the effect of Warfarin Orion.
Treatment with new or old medicines must not be started or stopped without first consulting a doctor. Any changes in concomitant medication may alter the balance of coagulation therapy and more frequent blood tests may be required.
If you need painkillers, you should contact a doctor. Most over-the-counter pain relievers must not be used with Warfarin Orion. However, if temporary pain relief or fever reduction is needed, medicines containing only paracetamol as an active ingredient can be used.
Natural Remedies and Natural Remedies
If you are already using any of the following herbal remedies, consult a doctor before discontinuing that treatment. Ginkgo ( Ginkgo biloba ), garlic ( Allium sativum ), dong Quai preparation ( Angelica Sinensis ), papaya ( Carica papaya ), and danshen ( Salvia miltiorrhiza ) may increase the effect of Warfarin Orion. St. John’s wort ( Hypericum perforatum ) and ginseng ( Panax spp. ), on the other hand, can reduce the effect. Treatment with these agents must therefore not be started or stopped during treatment with WarfarinOrion, without consulting a doctor.
Warfarin Orion with food, drink, and alcohol
Taking vitamin K reduces the effect of Warfarin Orion. Therefore, the intake of food containing vitamin K should be kept as constant as possible during warfarin treatment. Sudden changes in eating habits should be avoided. The biggest sources of vitamin K are green vegetables, leaves, and herbs.
Some foods that contain plenty of vitamin K are listed below. It is not necessary to avoid the use of these, but the daily intake should be as regular as possible:
amaranth leaves, avocado, broccoli, Brussels sprouts, cabbage, rapeseed oil, leaves from pear squash, chives, cilantro, cucumber skin (but not cucumber without skin), endive, kale, kiwi, lettuce leaves, mint leaves, mustard leaves, olive oil, parsley, peas, pistachios, red seaweed, spinach leaves, spring onions, soybeans, soybean oil, tea leaves (but not brewed tea), turnips, watercress.
Cranberry juice and other products containing cranberries may increase the effect of warfarin. Concomitant use should therefore be avoided.
Do not drink large amounts of alcohol while taking warfarin. Heavy alcohol intake and concurrent liver failure can enhance the effect of warfarin.
Warfarin Orion and smoking
Smoking can affect the effect of warfarin. You may need to do laboratory tests more often if you have smoked for a long time and if you stop smoking while being treated with warfarin. Contact your doctor if this applies to you
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Warfarin Orion should not be used during the first third of pregnancy, nor the last four weeks of pregnancy. If possible, Warfarin Orion should be avoided throughout pregnancy but in special circumstances treatment under the supervision of a specialist physician may be considered.
Warfarin is not excreted in breast milk. Breastfeeding can therefore continue during treatment with Warfarin Orion.
Driving ability and use of machinery
Warfarin Orion does not affect the ability to drive or use machines.
Warfarin Orion contains lactose
The tablets contain lactose (51.4 mg/tablet). If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Other excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Warfarin Orion
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
It is necessary to do laboratory tests at regular intervals. The dosage is adjusted individually for you and the dosage may differ from day to day. It is necessary to follow the dosing instructions and to take the agreed laboratory samples.
If you have taken too much Warfarin Orion
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Do not induce vomiting. If a large overdose has been ingested, medical charcoal can be taken as first aid, but a doctor must still be contacted immediately as further treatment may be required.
If you forget to take Warfarin Orion
If you forget a dose and discover it within 12 hours, you can take the missed dose immediately. Take the next dose as usual. If more than 12 hours have passed since you forgot to take a dose, divide the missed dose into two or three parts and take it together with the next dose so that the weekly dose does not change. If you have missed more than one dose, you must contact your doctor for further instructions. Do not take a double dose to make up for a missed dose.
If you stop taking Warfarin Orion
If treatment with Warfarin Orion is stopped, the anticoagulant effect may persist for 2-5 days.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following during treatment with Warfarin Orion:
- Increased tendency to bruise, nose or gum bleeding, blood in the urine, black or bloody stools, bloody vomiting, heavy or prolonged menstrual bleeding. These symptoms may be signs of an excessively high effect of warfarin.
- Painful skin rash. In rare cases, warfarin can cause serious skin conditions, including a condition called calciphylaxis which may start as a painful skin rash but can lead to other serious complications. This side effect is more common in patients with chronic kidney disease.
Other side effects that may occur:
Common (may affect up to 1 in 10 users):
Bleeding, nausea, vomiting, diarrhea.
Rare (may affect up to 1 in 1,000 users):
Coumarin-induced tissue damage, “purple toe syndrome” (purple-colored and painful skin change on toes or soles of feet).
Very rare (may affect up to 1 in 10,000 users):
Hypersensitivity reaction, which usually manifests itself as skin rash, temporary increase in liver enzyme values, bile pain, vein inflammation, temporary hair loss, prolonged painful erection (usually at the beginning of treatment), calcification in the airways, a fatty clot in blood vessels.
Has been reported (occurring in an unknown number of users):
Accumulation of calcium in the blood vessel wall, leads to enlarging and painful ulcers in the skin.
Impaired kidney function in severe anticoagulation and the presence of blood in the urine (anticoagulation-related nephropathy ).
Reporting of side effects are
If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly to:
The Swedish Medicines Agency
Box 26
751 03 Uppsala
By reporting side effects, you can contribute to increasing information about drug safety.
How to store Warfarin Orion
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is 2.5 mg of warfarin sodium per tablet.
- Other ingredients are lactose, corn starch, calcium phosphate, povidone, and magnesium stearate.
Appearance and package sizes of the medicine
White to off-white, round biconvex uncoated tablet, 7 mm in diameter. Cross notches on both sides.
The tablet can be divided into two equal parts.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI- 02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orion Indie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
This medicine is approved in the European Economic Area under the names:
Denmark: Warfarin Orion
Norway: Warfarin Orion 2.5 mg tablets