Phenylbutazone 100mg Tablets
ESSENTIAL GENERICS
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
Phenylbutazone tablets contain phenylbutazone which is a non-steroidal anti-inflammatory drug (NSAID).
They can help to relieve pain and inflammation caused by ankylosing spondylitis when other medicines may not be suitable.
Ankylosing spondylitis is a disease causing inflammation of the joints affecting the backbone.
Do NOT take Phenylbutazone if you:
• are allergic to phenylbutazone, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or to any of the other ingredients (see Section 6)
• have, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach, intestines or bowel, or severe gastritis, especially if you have taken NSAIDs before
• have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), as phenylbutazone can make this worse
• have severe heart, liver or kidney problems
• lung problems, swelling or high blood pressure which may affect the heart
• have any disease of the thyroid gland
• have or have ever had a bleeding disorder, or any other disorder affecting the blood or cells in your blood
• have Sjogren's syndrome, which is a disorder in which the mouth and eyes become extremely dry
• are asthmatic and know that NSAIDs bring on an asthma attack, rash, swelling or inflammation of the nasal passage
• take any other non-steroidal anti-inflammatory drug (NSAID), (eg. ibuprofen, diclofenac)
• are more than 6 months pregnant.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Phenylbutazone
Before taking the tablets, tell your doctor if you:
• are taking any other anti-inflammatory medicines including steroids (eg. prednisolone)
• are taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel)
• are taking antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine)
• have kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment
• are elderly (see Section 3)
• are trying to become pregnant (see Section on Fertility)
• have stomach or digestive tract problems or if you ever had an ulcer or bleeding from the stomach after taking pain killers such as aspirin. Bleeding in the stomach or gut can occur in patients taking Phenylbutazone. Additional medicine i.e. an antacid (indigestion medicine) may be given
• have asthma, or a history of bronchial asthma, as this medicine may cause breathing difficulties
• have a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE)
• have ulcers or inflamed areas in the mouth such as cheek, gums, tongue or lips
• have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, fluid retention, diabetes or high cholesterol or are a smoker). Additional monitoring may be carried out by your doctor.
Medicines such as Phenylbutazone may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Regular tests will be carried out by your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Phenylbutazone or they may affect how well Phenylbutazone will work. Tell your doctor or pharmacist if you are taking:
• medicines that can increase a chance of getting ulcers or a bleed in the stomach or gut, such as:
- corticosteroids used to treat arthritis and inflammation
- medicines such as anti-platelet agents, used to thin the blood (e.g. warfarin, aspirin, clopidogrel). Your doctor may check your blood for a short period
- antidepressants called selective serotonin re-uptake inhibitors (SSRIs), (e.g. paroxetine)
- any other anti-inflammatory medicines (e.g. diclofenac, celecoxib)
• medicines used for high blood pressure (e.g. atenolol, ramipril, valsartan)
• diuretics (water tablets) or heart medicines (e.g. digoxin, sotalol, diltiazem)
• some diabetic medicines such as (e.g. glipizide, glibenclamide) or insulin
• medicines which suppress the immune system (e.g. ciclosporin, tacrolimus, methotrexate)
• lithium, a medicine used to treat mood swings and some types of depression
• a medicine usually prescribed through hospitals, called mifepristone (taken within the last 12 days)
• quinolone antibiotics (antibiotics used to treat infections)
• methylphenidate, a medicine used to treat hyperactivity conditions
• anabolic steroids, such as nandrolone
• misoprostol, a medicine used for treating ulcers in the stomach and intestine
• zidovudine, a medicine used for HIV (human immunodeficiency virus)
• alcohol
• a medicine used to treat epilepsy known as phenytoin
• medicines which affect liver enzymes - (check with your pharmacist). These include barbiturates, chorphenamine, promethazine, rifampicin
• cholestyramine, a medicine use to control cholesterol.
Pregnancy and breast-feeding Pregnancy
Phenylbutazone will be passed to your unborn baby. It is not known how much it will affect your unborn baby in the first 6 months of pregnancy.
DO NOT take the tablets in the last 3 months of pregnancy as they may delay the onset of labour and prolong its duration. They may also increase the likelihood of bleeding in the mother and in the baby.
If you need to take these tablets, your doctor can help you decide whether or not to take them during the first 6 months of pregnancy.
Breast-feeding
Phenylbutazone passes into breast milk and can affect the baby. You should not take the tablets while breast-feeding unless advised by your doctor.
Fertility
DO NOT take the tablets if you are trying to become pregnant, as they may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Phenylbutazone may cause drowsiness, dizziness, tiredness or affect your vision. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert.
Alcohol may increase these effects.
Important information about some of the ingredients of Phenylbutazone 100 mg Tablets
• sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Ponceau 4R
This may cause allergic reactions.
Continued over page
Always take Phenylbutazone tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
• Take the tablets with or immediately after a meal.
• Swallow the tablets whole with plenty of water. Your doctor may ask you to take an antacid (indigestion medicine) at the same time.
• Drinking alcohol while taking Phenylbutazone may cause the alcohol to have more effect than usual.
Doses
Adults: the usual starting dose for the first 48 hours is 400 mg to 600 mg daily in divided doses.
Your doctor will then reduce the dose to the minimum amount necessary, usually 200 mg to 300 mg daily in divided doses.
Elderly patients are at a higher risk of side effects and should take the lowest effective dose for the shortest possible time, with additional monitoring carried out by your doctor.
Children: this medicine is NOT suitable for children under 14 years.
Tests
If you are expected to take phenylbutazone for more than 1 week, your doctor will take tests for blood disorders, kidney and liver function before and during treatment.
If you have thyroid function tests - tell the doctor that you are taking these tablets, as they may affect the results.
If you take more than you should
If you take more tablets than you should you may cause serious damage to your body i.e. stomach, heart, liver, kidneys, lungs, blood and central nervous system. You may get the following symptoms: nausea, vomiting, diarrhoea, abdominal pain, bleeding in your stomach/intestines, headache, ringing in your ears, deafness, difficulty in breathing and seizures (fits). You may also feel drowsy, dizzy, or faint.
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the container and any remaining tablets with you so that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Phenylbutazone tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the skin, mouth, eyes, and genital region, and patchy areas of rash, peeling skin, burning sensation
or any of the following reactions
• passing blood in your stools (faeces/motions)
• passing black tarry stools
• vomiting any blood or dark particles that look like coffee grounds.
Seek immediate medical attention if you have any of the following symptoms:
• indigestion or heartburn, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting
• any unusual bruising or bleeding, for example nose-bleeds, pinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth
• signs of anaemia such as feeling tired, breathless, and looking pale
• fever, sore throat, mouth ulcers, anal ulcers, repeated infections or infections that will not go away. This may be due to a low level of white blood cells
• sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness, vomiting and muscle pain, with or without a rash
• fever, rash, swelling, nausea, aches and pains, loin pain, passing more or less urine than usual, passing red urine or passing urine at night, difficulty or inability to pass urine. This may be due to changes in your kidneys
• sudden or progressive loss or blurring of vision, loss of colour vision, eye pain which worsens with eye movement
• headache, in particular on waking in the morning. This may be due to high blood pressure
• chest pain, sometimes worse when lying down, difficulty breathing at rest or on exercising
• wheezing or gurgling sounds when you breathe, difficulty breathing, shortness of breath when lying down. This may be due to fluid on the lungs
• severe or worsening diarrhoea, abdominal cramps and/or swelling (cramps/swelling in your stomach)
• pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas
• yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to changes in your liver.
Tell your doctor if you get any of the following side effects:
• ringing or buzzing in the ears (tinnitus) • deafness
• head-spins (vertigo) • constipation or bloating
• depression • difficulty in swallowing
• hallucinations • blurred vision, bleeding in the eye
• mental confusion • feeling ill (malaise)
• dizziness, drowsiness, feeling lethargic and tired
• a feeling of numbness, tingling or burning in hands or feet
• asthma or asthma that is worse than usual (shortness of breath)
• swelling of your hands, feet (around the ankles) or abdomen
• sore mouth (pain or ulcers on the tongue, cheeks, lips, throat or gums)
• swollen salivary glands (in front of the ears, under the lower jaw and under the tongue) which may make chewing or swallowing painful, dry mouth
• a lump at the front of the neck, feeling tired and sensitive to the cold, weight gain, constipation. This may be due to changes in the thyroid gland
• reactions to the sun. Your skin may become red, painful and swollen - do not sunbathe, use a sun bed, or expose your skin to artificial UV light.
Medicines such as Phenylbutazone may be associated with a small increased risk of heart attack or stroke. (See Section 2 - end of 'Take special care').
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
What Phenylbutazone 100 mg Tablets contain •The active ingredient is phenylbutazone (100 mg).
• The other ingredients are:
potato starch, sodium laurilsulfate, gelatin, sucrose, colloidal anhydrous silica, purified talc, magnesium stearate, sodium starch glycollate.
The coating contains:
sucrose, purified talc, titanium dioxide, maize starch, Ponceau 4R (E124).
(See end of Section 2 for further information on sucrose and Ponceau 4R).
What Phenylbutazone Tablets look like and contents of the pack
Phenylbutazone Tablets are round red coated tablets.
They are available in containers of 84 or 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton BD23 2RW.
This leaflet was last revised in
June 2015
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