Consumer medicine information

Marevan

Warfarin sodium

BRAND INFORMATION

Brand name

Marevan

Active ingredient

Warfarin sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Marevan.

MAREVAN®

MAREVAN®


 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


 1. Why am I using MAREVAN?

MAREVAN contains the active ingredient warfarin. MAREVAN is used to prevent blood from excessive clotting or forming harmful clots. For more information, see Section 1. Why am I using MAREVAN? in the full CMI.

 2. What should I know before I use MAREVAN?

Do not use if you have ever had an allergic reaction to MAREVAN or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use MAREVAN? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with MAREVAN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

 4. How do I use MAREVAN?
  • Follow your doctor's directions exactly about how much MAREVAN to take. Different people require different amounts of this medicine, and the dosage is adjusted to suit you. Your doctor will determine how much to take through blood tests.
  • MAREVAN should be taken at about the same time each day.

More instructions can be found in Section 4. How do I use MAREVAN? in the full CMI.

 5. What should I know while using MAREVAN?

Things you should do

  • Remind any doctor, dentist or pharmacist you visit that you are using MAREVAN.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
  • If you become pregnant while taking this medicine, tell your doctor immediately.
  • If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Things you should not do

  • Do not stop taking your medicine or lower the dosage without checking with your doctor.
  • There are two brands of warfarin called MAREVAN and COUMADIN. Do not swap from one brand to the other.

Driving or using machines

  • Be careful before you drive or use any machines or tools until you know how MAREVAN affects you.

Drinking alcohol

  • Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.
  • Keep your tablets in a cool dry place where the temperature stays below 30°C.

For more information, see Section 5. What should I know while using MAREVAN? in the full CMI.

 6. Are there any side effects?

Speak to your doctor as soon as possible if you notice any of the following side effects, bruising, nosebleeds, and bleeding from gums after brushing. Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of the following serious side effects, blood in urine, chest pain, difficulty breathing or swallowing and severe skin wounds.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.


MAREVAN®

Active ingredient(s): warfarin sodium


 Consumer Medicine Information (CMI)

This leaflet provides important information about using MAREVAN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using MAREVAN.

Where to find information in this leaflet:

1. Why am I using MAREVAN?
2. What should I know before I use MAREVAN?
3. What if I am taking other medicines?
4. How do I use MAREVAN?
5. What should I know while using MAREVAN?
6. Are there any side effects?
7. Product details

1. Why am I using MAREVAN?

MAREVAN contains the active ingredient warfarin. MAREVAN is an anticoagulant. Some people refer to anticoagulant medicines as “blood thinners”.

MAREVAN is used to prevent blood from excessive clotting or forming harmful clots. Excessive clotting sometimes occurs when physical mobility is low. If excessive clotting is not treated, it can lead to serious health problems such as strokes or heart attacks.

There are two brands of warfarin. They are called MAREVAN and COUMADIN. Do not swap from one brand to the other.

This medicine is only available with a doctor's prescription.

2. What should I know before I use MAREVAN?

Warnings

Do not use MAREVAN if:

  • you are allergic to warfarin, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue or other parts of the body
    - rash, itching or hives on the skin
  • Always check the ingredients to make sure you can use this medicine.
  • Do not take MAREVAN if you tend to bleed easily, have any active ulcers or have abnormal blood cells. This medicine may make bleeding tendencies worse.
  • Do not take MAREVAN if you have moderate to severe high blood pressure. The risk of bleeding may be increased by taking this medicine.
  • Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor if you:

  • have or have had any of the following medical conditions:
    - liver or intestinal disease such as coeliac disease
    - kidney disease or impaired kidney function
    - high blood pressure
    - a deficiency in Protein C
    - an ulcer in your stomach or small intestine (duodenum)
    - red or black bowel motions
    - bleeding tendencies
    - fits or convulsions
    - thyroid problems
    - heart problems
    - psychiatric problems
    - severe diabetes
    - long-lasting infections, diarrhoea, vomiting or fever
    - alcoholism
    - severe allergies.
  • take any medicines for any other condition
  • have allergies to any other medicines, foods, preservatives or dyes.
  • are going to have any dental treatment
  • have recently had or are going to undergo any surgical procedures or operations
  • are starting any sporting activities that may result in traumatic injury

If you have not told your doctor about any of the above, tell them before you start taking MAREVAN.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not take MAREVAN if you are pregnant.

It may affect your developing baby.

Do not breast-feed if you are taking this medicine.

The active ingredient in MAREVAN passes into breast milk and there is a possibility that your baby may be affected.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and foods may interfere with MAREVAN and affect how it works. These include:

  • aspirin
  • any medication used to treat arthritis (including glucosamine and chondroitin)
  • some medications used to treat blood clots, heart attacks or angina
  • antihistamines or any cough or cold preparations
  • some antibiotics
  • laxatives
  • vitamin C
  • vitamin E
  • vitamin K
  • St John's Wort
  • other herbal preparations (such as garlic, ginseng, feverfew, gingko biloba and ginger)
  • drinking alcohol
  • cranberry and grapefruit juice
  • eating large amounts of green leafy vegetables and/or drastic changes in dietary habits.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MAREVAN.

4. How do I use MAREVAN?

How much to take

  • Follow your doctor's directions exactly about how much MAREVAN to take.
  • Different people require different amounts of this medicine, and the dosage is adjusted to suit you.
  • Your doctor will determine how much to take through blood tests. It is important to keep all your doctor's appointments so that your progress can be checked.
  • Follow the instructions provided by your doctor or pharmacist and use MAREVAN until your doctor tells you to stop.
  • They may differ from the information contained in this leaflet.
  • If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
  • This medicine helps to control your condition, but does not cure it.
  • Do not stop taking MAREVAN or reduce your dose unless your doctor tells you to.

When to take MAREVAN

  • MAREVAN should be taken at about the same time each day.
  • Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
  • It does not matter if you take this medicine before or after food.

How to take MAREVAN

  • Swallow the tablets whole with a glass of water.
  • Do not crush or chew the tablets.

If you forget to use MAREVAN

MAREVAN should be used regularly at the same time each day.

If you miss your dose, take it as soon as you remember on the same day, and then take your next dose at the usual time on the next day.

If you do not remember until the next day, skip the dose you missed and wait to take your next scheduled dose as normal. Do not take a double dose to make up for the dose you missed.

  • This may increase the chance of you getting an unwanted side effect.
  • If you are not sure what to do, ask your doctor or pharmacist.
  • If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much MAREVAN

If you think that you have used too much MAREVAN, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Possible signs of overdose include bleeding. Blood may also be seen in stools or urine. Abnormal bruising or abnormal menstrual bleeding may also be experienced.

5. What should I know while using MAREVAN?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking MAREVAN.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

Try to eat a balanced diet.

This minimises the possibility of the food you eat interfering with MAREVAN.

Call your doctor straight away if you:

  • do not feel well while you are taking MAREVAN.

Remind any doctor, dentist or pharmacist you visit that you are using MAREVAN.

Things you should not do

  • Do not take MAREVAN to treat any other complaints unless your doctor tells you to.
  • Do not start or stop taking any other medicines whilst you are taking MAREVAN unless you have spoken to your doctor.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not stop taking your medicine or lower the dosage without checking with your doctor.
  • There are two brands of warfarin called MAREVAN and COUMADIN. Do not swap from one brand to the other.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how MAREVAN affects you.

MAREVAN may cause dizziness in some people

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.
  • Keep your tablets in a cool dry place where the temperature stays below 30°C.
  • Keep the tablets away from light.
  • A locked cupboard at least one-and a-half metres above the ground is a good place to store medicines.

Follow the instructions on the bottle on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

  • bruising
  • nosebleeds
  • bleeding from gums after brushing
  • increased menstrual flow or heavier periods
  • purplish & mottled toes
  • prolonged bleeding from cuts
  • swollen ankles
  • painful swelling or discomfort
  • stomach pain
  • joint pain
  • persistent headache or fever
  • non-healing wounds or lesions or mottling of skin

Speak to your doctor as soon as possible if you notice any of the following

Serious side effects

Serious side effects

What to do

  • red or dark brown urine
  • symptoms related to a condition called anticoagulant-related nephropathy: blood in urine, reduced urine output, swelling of the legs, ankles and feet, increased time for blood to clot (high INR test values), heavy bleeding
  • persistent diarrhoea
  • red or black bowel motions
  • vomiting or coughing up blood
  • chest pain
  • difficulty breathing or swallowing
  • severe skin wounds
  • a serious fall or injury

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What MAREVAN contains

Active ingredient

(main ingredient)

MAREVAN 1 mg -

1 mg warfarin sodium

MAREVAN 3 mg -

3 mg warfarin sodium

MAREVAN 5 mg -

5 mg warfarin sodium

Other ingredients

(inactive ingredients)

lactose monohydrate

magnesium stearate

maize starch

pregelatinised maize starch

sodium starch glycollate

indigo carmine (1 mg and 3 mg only)

iron oxide red (1 mg only)

iron oxide yellow (1 mg only)

erythrosine (5 mg only)

Potential allergens

sulfites and sugars as lactose

Do not take this medicine if you are allergic to any of these ingredients.

What MAREVAN looks like

MAREVAN 1 mg tablets are fawn, scored and bevel edged with “M” embossed above the score and “1” below. The other side is plain (AUST R 12511).

MAREVAN 3 mg tablets are blue, scored and bevel edged with “M” embossed on one side above the score and “3” below. Other side is plain (AUST R 12513).

MAREVAN 5 mg tablets are pink, scored and bevel edged with “M” embossed on one side above the score and “5” below. Other side is plain (AUST R 12514).

MAREVAN is available in bottles containing 50 tablets.

Who distributes MAREVAN

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in April 2023.

MAREVAN® is a Viatris company trade mark

MAREVAN_cmi\Apr23/00

Published by MIMS May 2023

BRAND INFORMATION

Brand name

Marevan

Active ingredient

Warfarin sodium

Schedule

S4

 

1 Name of Medicine

Warfarin sodium.

2 Qualitative and Quantitative Composition

Each Marevan tablet contains 1 mg, 3 mg or 5 mg of warfarin sodium as the active ingredient.
Excipients of known effect. Sugars as lactose and sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Marevan 1 mg tablets are a flat fawn coloured tablet with bevelled edge, scored and embossed with "M" above and "1" below.
Marevan 3 mg tablets are flat blue coloured tablet with bevelled edge, scored and embossed with "M" above and "3" below.
Marevan 5 mg tablets are flat pink coloured tablet with bevelled edge, scored and embossed with "M" above and "5" below.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. Suspected or overt abnormal bleeding (e.g. appearance of blood in stools or urine, haematuria, excessive menstrual bleeding, melaena, petechiae, excessive bruising or persistent oozing from superficial injuries) are early manifestations of excessive anticoagulation beyond a safe and satisfactory level.
Treatment and warfarin reversal. The treatment of excessive anticoagulation is based on the INR level, the presence or absence of bleeding and clinical circumstances.
Consult local clinical guidelines on warfarin reversal.
For patients with elevated INR, no bleeding and no high risk of bleeding, reversal of excessive anticoagulation may be achieved by discontinuing warfarin and if necessary, by administration of oral or parenteral vitamin K1.
For immediate reversal of excessive anticoagulation, prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) may be considered to replace the low levels of factors II, VII, IX and X induced by warfarin. Administration of Vitamin K1 is necessary for sustaining the reversal achieved by PCC or FFP.
Use of vitamin K1 reduces response to subsequent warfarin therapy. Patients may return to a pre-treatment thrombotic status following the rapid reversal of a prolonged INR. Resumption of warfarin administration reverses the effect of vitamin K and a therapeutic INR can again be obtained by careful dosage adjustment. If rapid anticoagulation is indicated, heparin may be preferable for initial therapy.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Carcinogenesis and mutagenesis. Carcinogenicity and mutagenicity studies have not been performed with Marevan.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSWARSOD.gif Marevan (warfarin sodium) is a vitamin K dependent factor anticoagulant. Warfarin is 4-hydroxy-3-(3-oxo-1-phenylbutyl) coumarin which is present as a racemic mixture.
Warfarin sodium is a white hygroscopic powder, very soluble in water and in alcohol.
Molecular formula: C19H15NaO4.
Molecular weight: 330.3.
CAS number. 129-06-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MAREVAST.gif

References

1. Yasar U, Eliasson E, Dahl M, Johansson I, Ingelman-Sundberg,M, Sjoqvist F. Validation of methods for CYP2C9 genotyping: Frequencies of mutant alleles in Swedish population. Biochem Biophys Res Comm. 1999; 254:628-631.
2. Herman D, Locatelli I, Grabnar I, et al. Influence of CYP2C9 polymorphisms, demographic factors and concomitant drug therapy on warfarin metabolism and maintenance dose. Pharmacogenomics J. 2005;5:193-202.
3. Sanderson S, Emery J, Higgins J. CYP2C9 gene variants, drug dose, and bleeding risk in warfarin-treated patients: A HuGEnet systemic review and meta-analysis. Genet Med. 2005;7:97-104.
4. Lindh JD, Lundgren S, Holm L, Alfredsson L, Rane A. Several-fold increase in risk of overanticoagulation by CYP2C9 mutations. Clin Pharmacol Ther. 2005;78:540-550.
5. Wadelius M, Chen LY, Downes K, et al. Common VKORC1 and GGCX polymorphisms associated with warfarin dose. Pharmacogenomics J. 2005;5:262-270.
6. Veenstra DL, You JHS, Rieder MJ, et al. Association of Vitamin K epoxide reductase complex 1 (VKORC1) variants with warfarin dose in a Hong Kong Chinese patient population. Pharmacogenet Genomics. 2005;15-687-691.
7. Takahashi H, Wilkinson GR, Nutescu EA, et al. Different contributions of polymorphisms in VKORC1 and CYP2C9 to intra- and inter-population differences in maintenance doses of warfarin in Japanese, Caucasians and African Americans. Pharmacogenet Genomics. 2006;16:101-110.