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DINDEVAN 25MG TABLETS

Active substance(s): PHENINDIONE / PHENINDIONE / PHENINDIONE

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Package leaflet: Information for the user
Dindevan 25mg Tablets
Phenindione
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Dindevan 25mg Tablets. It will be referred to as ‘Dindevan Tablets’ for
ease hereafter.
What is in this leaflet
1. What Dindevan Tablets are and what they are used for
2. What you need to know before you take Dindevan Tablets
3. How to take Dindevan Tablets
4. Possible side effects
5. How to store Dindevan Tablets
6. Contents of the pack and other information
1. WHAT DINDEVAN TABLETS ARE AND WHAT THEY ARE USED FOR
Phenindione belongs to a group of medicines called anticoagulants. These medicines increase the time it
takes for your blood to clot. Phenindione is used to prevent and treat blood clots in the veins and arteries,
for example, clots in the legs, lungs, brain or heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DINDEVAN TABLETS
Do not take Dindevan Tablets
• if you are allergic to Phenindione or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver or kidney problems
• if you are pregnant or trying for a baby
• if you within the last 72 hours have had an operation or you have given birth within the last 48 hours
• if you are currently breast-feeding
• if you suffer from any unusual bruising or bleeding
• if you suffer from uncontrolled high blood pressure
• if you have an infection of the tissues lining the heart called bacterial endocarditis
• if you have a rare problem of sugar intolerance
• if your doctor has told you that you have bleeding within the brain (hemorrhagic stroke).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Dindevan Tablets

if you have a painful skin rash. On rare occasions Dindevan Tablets can cause serious skin
conditions, including one called calciphylaxis that can start with a painful skin rash but can lead to serious
complications. This adverse reaction occurs more frequently in patients with chronic kidney disease
• if you are elderly



















if you have recently lost or gained a lot of weight
if you have any short term illness
if you have a problem with your kidneys, or liver which is not classed as severe
if you are being sick or have diarrhoea
if you are changing your diet which may result in an increase or decrease of Vitamin K
if you have protein C or S deficiency (blood clotting disorders)
if you have a disease of the brain and blood vessels (cerebrovascular disease)
if you have major heart disease
if you have low levels of iron in the blood (which may lead to pale appearance of the eyes and skin)
if you have had a major injury
if you have ulcers in your stomach
if you have bleeding in the stomach or intestines
if you have either an increase or decrease in the levels of thyroid hormone
if you have cancer
if you have decreased blood supply to a part of the brain (ischemic stroke)
if you are going to have surgery. The doctor may have to change your dose or stop your phenindione
treatment
if you have stopped smoking.

Tell your doctor if any of the above applies to you as they may alter the effect of Dindevan Tablets and
require an adjustment of the dose.
Other medicines and Dindevan Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription or herbal remedies. Dindevan Tablets may affect or
be affected by any of the medicines below which are used to treat the following conditions:



















Heart problems e.g. amiodarone and propafenone
Prevent the formation of blood clots e.g. clopidogrel, bivalirudin, dabigatran, heparin, fondaparinux,
rivaroxaban, danaparoid
Clot dissolving medications (e.g. streptokinase, alteplase)
Problems with platelet aggregation (blood cells sticking together) e.g. dipyridamole, eptifibatide,
tirofiban and abciximab, prostacyclin
Depression e.g. amitriptyline, nortriptyline, citalopram, venlafaxine
Pain and inflammation e.g. paracetamol, aspirin, ibuprofen, piroxicam, flurbiprofen, indometacin,
sulindac, azapropazone, diflunisal, corticosteroids
High levels of lipids (fats) in the blood and drugs which lower cholesterol levels e.g. clofibrate
Infection e.g. antibiotics such as ciprofloxacin, metronidazole, norfloxacin, co-trimoxazole,
erythromycin, tetracyclines, cefamandole, chloramphenicol, rifampicin, neomycin, aztreonam,
sulfamethoxazole
Fungal infections, e.g. miconazole
Stomach ulcers or excessive production of stomach acid e.g. cimetidine, sucralfate, cholestyramine.
Diabetes e.g. tolbutamide, phenformin and glucagon
Various inflammatory problems such as asthma e.g. prednisolone, zafirlukast
Gout e.g. allopurinol, sulfinpyrazone
Cancer e.g. ipilimumab, dasatinib and imatinib
Difficulty in sleeping e.g. phenobarbital
Osteoarthritis pain (glucosamine)
Chronic alcoholism e.g. disulfiram
Thyroid problems e.g. thyroxine







Epilepsy e.g. barbiturates, carbamazepine, primidone, phenytoin
Pain killers (Dextropropoxyphene)
Joint and muscular pain (Feprazone, oxyphenbutazone and phenylbutazone)
Obesity e.g. orlistat
Stress (ACTH, released in the body in response to biological stress).

If you are taking the following, tell your doctor
• Oral contraceptives
• Anabolic steroids such as stanozolol (used to promote muscle growth)
• Vitamin supplements e.g. Vitamin K or Cod Liver Oil (or other dietary intake high in fats or oils).
The dose of Dindevan Tablets will need to be checked regularly if any other medicines are also used at
the same time. Many medications interact with Phenindione, so please inform your doctor if you are
taking any other medicines including over the counter medicines, herbal (St. John's Wart) or vitamin
preparations.
Regular blood tests:
You will have regular blood tests to see how long it takes for your blood to clot. These blood tests are
very important to make sure you are taking the right dose. Blood tests will be more frequent if you have
had your dose of phenindione changed, if you have started or stopped taking other medicines or have liver
or kidney problems.
Dindevan Tablets with food, drink and alcohol
• Do not drink large amounts of alcohol when taking Dindevan Tablets. Discuss this with your
doctor if you are worried about anything
• Avoid drinking Cranberry juice
• Some foods like liver, broccoli, brussels sprouts and green leafy vegetables may interfere with the
action of Phenindione
• Avoid taking any food supplements when taking Phenindione.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
Dindevan Tablets should not be taken if you are pregnant, think you are pregnant or are planning to
become pregnant.
If you think you may have become pregnant, contact your doctor as soon as possible. Dindevan Tablets
can have an adverse effect on the unborn child, and alternative medicines are available.
Breast-feeding
Speak to your doctor before taking this medicine if you are breast-feeding.
Driving and using machines
Dindevan Tablets should not affect your ability to drive or use machines.
Dindevan Tablets contain lactose which is a form of sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine also contains tartrazine (E102) which may cause allergic reactions.

3. HOW TO TAKE DINDEVAN TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Read the label on the container to see how many Dindevan Tablets to take,
and how often to take them.
The recommended dose is:
Adults:
• Usual starting dose of 200mg (8 tablets) on the first day
• After the first day, the dose is usually reduced to 100mg (4 tablets) a day.
• From the third day of treatment, the doctor will adjust your dose up or down depending on the
results of the blood test which will be performed at the start and at regular intervals during your
treatment.
Method of Administration
• Swallow the tablets whole with a drink of water
• Try to take the tablets at the same time each day
• Do not take more tablets than the doctor tells you to.
The dose recommendations are for adults only.
Use in children
Dindevan Tablets are not suitable for use in children.
If you have to go to another doctor, to hospital or to a dentist, tell them that you are being treated with
Dindevan Tablets and ask them to contact your own doctor.
If you take more Dindevan Tablets than you should
If you take too many Dindevan Tablets, you may experience bruising, lump of blood, blood in the
urine, rectal bleeding and bleeding into any internal organ. Tell your doctor or go to your nearest
Hospital Casualty/Accident and Emergency Department immediately. Take any remaining tablets and
this leaflet with you so that the medical staff will know what you have taken.
If you forget to take your Dindevan Tablets
If you miss a dose and remember within two or three hours, you can still take that dose. If you forget for a
longer time, do not take that dose to catch up, but take your next dose when it is due. Remember to tell
your doctor when you see him/her next and have your blood test. Do not take a double dose to make up
for a forgotten tablet.
If you stop taking Dindevan Tablets
Do not stop taking your tablets except on your doctor’s advice as your condition may worsen.
Keep healthcare professionals informed
Carry your anticoagulant record card with you at ALL times. Always tell any doctors, surgeons, nurses,
dentists or pharmacists that you go to, that you are taking Dindevan Tablets.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Dindevan Tablets and tell your doctor immediately if you experience any of the
following side effects, because you may need urgent medical treatment:
• Allergic reactions: the signs may include swelling of your face, lips, tongue or throat, difficulty
breathing or swallowing, skin rashes, dark red or black areas on the skin as the skin may be dying or
scaling of the skin. Also bluish discolouration of the skin including toes may occur. This is a rare
complication, most likely to occur during the first several days of therapy with Dindevan Tablets and
often in association with large starting doses
• Unusual bleeding or bruising more easily, getting more infections, feeling weak or tired more than
usual, jaundice (yellowing of the skin or whites of the eyes), problems with your kidneys or liver and hair
loss.
The following side-effects have been reported:
Not known (frequency cannot be estimated from the available data)















Blood disorders (your doctor will do tests to check this).
Loose stools (Diarrhoea)
Loss of consciousness, fits, numbness, headache, dizziness, feeling or being sick, slurred speech,
blurred vision. These could be signs that there is bleeding or formation of blood clots in your brain
Difficulty in breathing and chest pain due to collection of blood in the chest
Bleeding from cuts and wounds or the nose
Vomiting of blood
Black or red stools which might be due to bleeding from the stomach, intestine or rectum
Severe stomach or back pain
Taste disturbance
Fever
Unusual bleeding from the stomach, intestine or rectum
Pancreatitis presenting as severe stomach or back pain
Dark red or brown coloured urine which might be due to bleeding in your kidneys or bladder.
Your urine may turn pink or orange

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DINDEVAN TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the "Use Before" date which is stated on the carton and label. The "Use
Before" date refers to the last day of that month.
Store in original package/container in order to protect from light.
Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dindevan Tablets contain
The active substance is Phenindione. Each tablet contains 25mg of Phenindione. The other ingredients are
maize starch, lactose, anhydrous citric acid powder, magnesium stearate, dispersed green 14811 ansteads,
purified water.
What Dindevan Tablets look like and contents of pack
Green flat, bevel edged uncoated tablets scored on one side, engraved D25 on the scored side. The tablets
are packaged in either plastic pots (polypropylene containers) containing 28, 100 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharma Group Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer
Custom Pharmaceuticals Ltd., Conway Street, Hove, East Sussex, BN3 3LW, UK
This leaflet was last revised in March 2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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