Document: leaflet MAH GENERIC_PL 10972-0038 change

• leaflet MAH BRAND_PL 10972-0038
• leaflet MAH GENERIC_PL 10972-0038

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Mercury Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

The name of your medicine is Phenindione 10 mg Tablets, Phenindione 25 mg Tablets, Phenindione 50 mg Tablets. It will be referred to as ‘Phenindione Tablets’ for ease hereafter. What is in this leaflet:

1.    What Phenindione Tablets are and what they are used for

2.    What you need to know before you take Phenindione Tablets

3.    How to take Phenindione Tablets

4.    Possible side effects

5.    How to store Phenindione Tablets

6.    Contents of the pack and other information

1. WHAT PHENINDIONE TABLETS ARE AND WHAT THEY ARE USED FOR

Phenindione tablets (either 10,25 or 50 mg) 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.

The tablets come in three strengths: 10 mg (creamy white); 25 mg (green) and 50 mg (creamy white).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENINDIONE TABLETS

Do not take Phenindione 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 Phenindione Tablets;

•    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 diarrhea

•    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 apply to you as they may alter the effect of Phenindione Tablets and require an adjustment of the dose.

Other medicines and Phenindione 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. Phenindione 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

•    joint and muscular pain (feprazone, oxyphenbutazone and phenylbutazone)

•    pain killers (dextropropoxyphene)

•    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 Phenindione 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 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. Phenindione Tablets with food, drink and alcohol

•    do not drink large amounts of alcohol when taking Phenindione 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

Phenindione 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. Phenindione 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

Phenindione tablets should not affect your ability to drive

or use machines.

Phenindione tablets contains 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.

3. HOW TO TAKE PHENINDIONE 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 Phenindione tablets to take, and how often to take them.

The recommended dose lor Phenindione tablets 10 mg is:

•    usual starting dose of 200 mg (20 tablets) on the first day

•    after the first day the dose is usually reduced to 100 mg (10 tablets) a day.

The recommended dose lor Phenindione tablets 25 mg is:

•    usual starting dose of 200 mg (8 tablets) on the first day

•    after the first day the dose is usually reduced to 100 mg (4 tablets) a day.

The recommended dose for Phenindione tablets 50 mg is:

•    usual starting dose of 200 mg (4 tablets) on the first day

•    after the first day the dose is usually reduced to 100 mg (2 tablets) a day.

From the third day of treatment, the doctor will adjust your dose up or down depending on the results of a 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

Phenindione 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 Phenindione tablets and ask them to contact your own doctor.

If you take more Phenindione tablets than you should

If you take too many Phenindione tablets, 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 Phenindione 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 Phenindione 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 Phenindione 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 Phenindione 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 Phenindione 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 a 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

•    feeling sick (nausea) or being sick (vomiting)

•    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 PHENINDIONE TABLETS

Keep this medicine out of the sight and reach of children. Store in original package/container in order to protect from light.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Phenindione tablets contain

The active substance is Phenindione. Each tablet contains 10 mg, 25 mg or 50 mg of Phenindione.

The other ingredients are maize starch, lactose, anhydrous citric acid powder, magnesium stearate, purified water.

The 25 mg tablets also contain dispersed green 14811 ansteads.

What Phenindione tablets looks like and contents of pack For Phenindione tablets 10 mg

Creamy white flat bevel edged uncoated tablets scored on one side engraved D10 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.

For Phenindione tablets 25 mg

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.

For Phenindione tablets 50 mg Creamy white flat bevel edged uncoated tablets scored on one side engraved D50 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 Ltd, 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 December 2015.

100198/LF/034/05 -100199/LF/034/05 -100200/LF/034/05