What Waran is and what it is used for
The active substance warfarin inhibits the blood’s ability to clot (coagulate) and thereby prevents the formation of blood clots in the blood vessels.
Waran is used in case of increased propensity for blood clots.
The warfarin contained in Waran may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Waran
Do not use Waran
- if you are allergic to warfarin or any of the other ingredients of this medicine (listed in section 6)
- if you have a greatly increased tendency to bleed or ongoing bleeding
- in case of severe liver disease
- if you use herbal remedies containing St. John’s wort ( Hypericum perforatum )
- during the first third and the last four weeks of pregnancy, see Pregnancy and breastfeeding.
Warnings and precautions
Tell the doctor if you:
- already using, before you start using or stop using other medicines during treatment with Waran (see also Other medicines and Waran)
- have diseases of the blood vessels of the brain (cerebrovascular diseases)
- have thyroid disorders
- has heart failure with liver damage
- have reduced kidney function
- have reduced liver function
- have uncontrolled high blood pressure
- previously had bleeding, for example, brain bleeding or bleeding in the gastrointestinal tract
- have protein C deficiency or protein S deficiency (disorders that can lead to an increased risk of blood clots).
Major changes in eating habits should be avoided because the amount of vitamin K in the food can affect the effectiveness of treatment with Waran. Examples of this are switching to an exclusively vegetarian diet or extreme dieting. Conditions that affect food absorption, such as diarrhea and vomiting, can also affect the effect of Waran.
Before surgical procedures or tooth extraction, you must inform the doctor or dentist that you are being treated with Waran.
Other medicines and Waran
Consult a doctor if you use, before you start using, or stop using other medicines, even non-prescription ones, natural medicines such as St. John’s wort or other natural products, vitamins, and dietary supplements, during treatment with Waran.
Medicines containing acetylsalicylic acid or NSAIDs (anti-inflammatory drugs, e.g. ibuprofen, naproxen, diclofenac ) give an increased tendency to bleed together with Waran and should not be used as a rule.
For temporary pain conditions, cold symptoms, and fever, only medicines containing paracetamol should be used. Take as low a dose as possible, because even paracetamol in high doses can affect the effect of Waran. Regular use of paracetamol should be avoided.
Glucosamine (against osteoarthritis ) can enhance the effect of Waran.
Many other medicines affect the therapeutic effect of Waran, which means that it may be necessary to change the dosage or take other precautions when Waran is taken at the same time as several other medicines. It is therefore essential that treating physicians are aware of all other concomitant medications.
Waran with food and drink
Cranberries should be avoided during treatment with Waran.
The daily intake of vitamin K-rich foods such as cabbage, broccoli, spinach, and avocado should be as even as possible. Changes in the amount of vitamin K in food can affect Warren’s effect.
Alcohol can affect the effect of Waran.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy: Risk of harmful effects to the fetus. Therefore, do not use Waran during pregnancy other than on a specific prescription from a doctor. During the first third and the last four weeks of pregnancy, Waran should not be used.
Breastfeeding: No known risks.
Fertility: Women of childbearing potential should use effective contraception during treatment with Waran.
Driving ability and use of machinery
The warranty does not affect the ability to drive or use machines.
The product contains lactose
The product contains lactose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Waran is next to “sodium-free”
Waran contains less than 23 mg of sodium per dose, i.e. is almost “sodium-free”.
How to use the Waran
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor who adjusts it individually for you. The full dose should be taken at the same time each day.
If you used too much Waran
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.
If the dose of Waran is too high, you may have an increased tendency to bleed, for example, blood in the urine or stool, skin bleeding (bruises), or bleeding in the gums.
If you forgot to use Waran
Do not take a double dose to make up for a missed tablet.
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.
Talk to your doctor immediately if you experience any of the following side effects:
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.
Very common ( may affect more than 1 in 10 users):
Bleeding from various organs. Always contact a doctor if you experience bleeding.
Common ( may affect up to 1 in 10 users ):
Increased sensitivity to warfarin during long-term treatment.
Uncommon ( may affect up to 1 in 100 users ):
Anemia, vomiting, nausea, diarrhea.
Rare ( may affect up to 1 in 1,000 users):
Skin rash, hives, itching, hair loss, liver damage, jaundice, local vascular inflammation in the skin, tissue damage, tissue damage in the skin.
Very rare ( may affect up to 1 in 10,000 users ):
Hypersensitivity reaction, blue toe syndrome (painful, bluish discoloration of the toes), dark or black stools.
No known frequency ( occurs in an unknown number of users ):
Abdominal pain (due to bleeding), accumulation of calcium in the blood vessel wall (which leads to enlarging and painful sores on the skin). Impaired kidney function in severe anticoagulation and the presence of blood in the urine (anticoagulation-related nephropathy ).
How the Warrant is to be stored
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 medicines 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 warfarin sodium 2.5 mg per tablet.
- Other ingredients are lactose monohydrate 50 mg per tablet, corn starch, calcium hydrogen phosphate dihydrate, povidone, magnesium stearate, and indigo carmine (dye E 132).
Appearance and package sizes of the medicine
The tablets are blue and round with a gross score.
The tablet can be divided into two equal doses (but not into four equal doses ).
Package sizes:
100 tablets in a plastic jar
98 x 1 tablet in the single-dose blister
Marketing Authorisation Holder
Orifarm Healthcare A/S
Energizer 15
5260 Odense S
Denmark
info@orifarm.com
Local Representative
Orifarm Healthcare Box 56048 102 17 Stockholm
Manufacturer
Orifarm Manufacturing Poland Sp. z o. o
Ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland