Patient leaflet - DIFLUNISAL 250 MG FILM-COATED TABLETS
Diflunisal Diflunisal
250 mg 500 mg
Film-coated Tablets Film-coated Tablets
WHAT IS IN YOUR TABLETS?
Active ingredient
The active ingredient in your Diflunisal Tablets is diflunisal. Two strengths of Diflunisal Tablets are available: peach-coloured, capsule-shaped, film-coated tablets, marked ‚MSD 675‘ containing 250 mg diflunisal; and orange-coloured, capsule-shaped, film-coated tablets, marked ‚MSD 697‘ containing 500 mg diflunisal.
Other ingredients
Diflunisal 250 mg and 500 mg Tablets contain the following inactive ingredients: microcrystalline cellulose E460, hydroxypropylcellulose E463, pregelatinised maize starch, magnesium stearate E572, sunset yellow aluminum lake E110, talc, titanium dioxide E171, methylhydroxypropylcellulose E464. In addition, the peach-coloured 250 mg tablets contain carnauba wax E903.
Diflunisal tablets are supplied in blister packs of 60 tablets.
HOW DO YOUR TABLETS WORK?
The active ingredient in your tablets is diflunisal. Diflunisal is one of a group of medicines known as non-steroidal anti-inflammatory drugs or ‚NSAl Ds‘. NSAIDs work as painkillers and also reduce inflammation in joints, muscles, and ligaments. These medicines may do this by decreasing the production of naturally occurring chemicals in your body, called prostaglandins, which can cause inflammation.
WHO MAKES YOUR TABLETS?
Your tablets are made by Merck Manufacturing Division, Merck Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland NE23 3JU, UK. The Marketing Authorisation is held by Chemidex Pharma Ltd, trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
WHY DO YOU NEED TO TAKE THESE TABLETS?
Your doctor has probably prescribed Diflunisal for you for one of the following reasons which he will have explained to you: – to relieve pain
– to relieve pain and inflammation of joints or tendons caused by a condition called rheumatoid arthritis or osteoarthritis
– to relieve period pains.
ARE THERE PATIENTS WHO SHOULD NOT TAKE THESE TABLETS?
Do not take the tablets if:
– you are in the last three months of pregnancy – you are breast-feeding
– you have had a bad or allergic reaction to this or similar medicines, or to any of the ingredients in the past
– you have had difficulty breathing, including asthma, itchy rashes, localized swelling or hay fever, after taking aspirin, ibuprofen or other NSAIDs
– you have, or have ever had an ulcer in your stomach or intestine
– you have, or have ever had active bleeding in your digestive system – symptoms of this would be abdominal pain, vomiting blood, or if your faeces are black or contain blood.
– you have severe liver, kidney or heart disease.
In addition, Diflunisal is not recommended for use in children.
If you think any of these apply to you, do not take the tablets, go and talk to your doctor first and follow his advice.
WHAT ELSE SHOULD YOU KNOW BEFORE TAKING YOUR TABLETS?
You should check with your doctor before taking Diflunisal if:
– you have a problem with your blood clotting
– in the past you have had ulcers in your stomach or intestine or had any bleeding from your digestive system, or Crohn's disease.
– you suffer from heart, asthma, liver or kidney problems, particularly if you are elderly.
– you suffer from high blood pressure, fluid retention, or diabetes
– you are dehydrated
– you have a viral or bacterial infection.
Medicines such as Diflunisal may be associated with a small increased risk of heart attack („myocardial infarction“) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Diflunisal may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
In addition, if you have problems with your eyes, you should inform your doctor.
WHAT ABOUT DRIVING AND OPERATING MACHINERY?
Diflunisal can cause dizziness, drowsiness, fatigue and visual disturbances in some people. If this happens to you, avoid activities which require you to be alert, for example, driving a car or operating machinery.
CAN YOU TAKE DIFLUNISAL TABLETS WITH OTHER MEDICINES?
There are a few other medicines which may not mix with Diflunisal. Your doctor knows about these and will alter your treatment as needed. It is important that you tell your doctor about all the medicines you are taking, including any drugs you are taking without a doctor's prescription.
If you are taking any of the following medicines, you should talk to your doctor about them before taking Diflunisal:
– antiplatelet agents such as aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin, sulindac, naproxen, or cyclooxygenase-2 inhibitors
– the following painkillers: paracetamol and codeine – diuretics, sometimes known as water tablets, called frusemide or hydrochlorothiazide
– aluminum hydroxide antacid suspension, or other antacids
– anti-clotting or blood thinning medicines – for example, warfarin or nicoumalone
– ciclosporin, used in patients with transplants – methotrexate, used in severe skin diseases, severe rheumatoid arthritis and as anti-cancer therapy
– gold salts, used in the treatment of arthritis
– cardiac glycosides such as digoxin, a medicine used to treat heart failure and alterations of heart rhythm
– antihypertensive medicines for the treatment of high blood pressure.
– lithium for treatment of mental disorders
– corticosteroid drugs, including anti-inflammatory and replacement therapies
– mifepristone, a treatment used in emergency for termination of pregnancy
– antibiotics from the quinolone group of antibiotics.
– tacrolimus, used in treatment of immunosupression
– selective serotonin-reuptake inhibitors (SSRIs), used to treat depression
HOW SHOULD YOU TAKE DIFLUNISAL?
Diflunisal tablets must be swallowed whole and must not be crushed or chewed. You should preferably take your tablets with or after food, exactly as advised by your doctor or pharmacist. The number of tablets you take each day will depend on your condition. The usual doses are:
For relief of pain: an initial dose of 1000 mg followed by 500 mg every 12 hours is recommended for most patients. Following the first dose your doctor may tell you to take 500 mg every 8 hours, if the pain is more severe. After the first day the daily dose should not exceed 1500 mg per day.
For osteoarthritis and rheumatoid arthritis: the recommended dose is 500 mg to 1000 mg a day, taken once or twice a day.
For period pain: the recommended dose is 1000 mg at the start of cramps or bleeding, then 500 mg every 12 hours for as long as symptoms last. After the first day the daily dose should not exceed 1500 mg per day. The tablets should not usually be taken for more than five days.
WHAT IF YOU FORGET TO TAKE A TABLET OR TAKE TOO MANY?
If you miss a dose just carry on with the next one as normal. Do not take an extra one to make up.
If you take too many tablets by mistake, contact your doctor immediately.
WHAT UNWANTED EFFECTS COULD YOUR TABLETS HAVE?
Like all medicines, Diflunisal may occasionally cause side effects in some patients. The most frequently reported side effects are stomach or abdominal pain, indigestion, nausea, diarrhoea, rash, headache.
Less frequent side effects that have occurred are vomiting, constipation, wind, dizziness, sleepiness, sleeplessness, ringing in the ears, tiredness.
The following rare side effects have also occurred: Effects on the digestive system such as stomach or intestinal ulcer, a hole in the lining of the intestines or bleeding from the stomach or intestine, loss of appetite, inflammation of the stomach.
Effects on the liver, the symptoms of which may be pale faeces and dark urine, flu-like symptoms, and yellowing of the skin and/or eyes.
Effects on the skin, such as a reaction to light, itchiness, hives, sweating, dry and sore mouth, more severe skin disorders, symptoms of which may include redness, blisters, peeling skin, ulcerated mouth, eyes and genitals.
Kidney problems including kidney damage, kidney inflammation, changes in urine output, pain when passing urine and blood stained urine.
Nervous system effects, including vertigo, lightheadedness, pins and needles, nervousness, depression, confusion and hallucinations.
Blood disorders, the symptoms of which could include a combination of pallor, tiredness, fever, sore throat and mouth, bruising and prolonged bleeding after injury.
Eye disorders, including blurred vision and other temporary disturbances in vision. If you develop eye problems during treatment with Diflunisal, contact your doctor immediately.
In addition, weakness and fluid retention have occurred. Breathlessness, palpitation, fainting, chest pain and muscle cramps have also been reported rarely.
Medicines such as Diflunisal may be associated with a small increased risk of heart attack („myocardial infarction“) or stroke.
If you notice any of the above effects, or you have any other unusual symptoms or feelings, seek medical assistance.
Serious allergic reactions to Diflunisal have been reported and include fever, chills, difficulty in breathing and swallowing, collapse, swollen lips, face, tongue and throat, rash, and swollen glands. This may also include problems with liver, kidneys, or blood cells (see above for symptoms of each). If you notice any of these effects, stop taking the tablets and contact your doctor immediately.
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: By reporting side effects you can help provide more information on the safety of this medicine.
HOW SHOULD YOUR TABLETS BE KEPT?
Do not take the tablets after the expiry date, which is clearly marked on the pack.
Keep your tablets out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not put the tablets into another container as they might get mixed up. If you have any tablets left over when your doctor tells you to stop taking them, return them to the pharmacist.
REMEMBER this medicine is for you. Do not share it with anyone else. It may not suit them.
Date of revision: June 2015
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT DIFLUNISAL TABLETS?
This leaflet gives you some important patient information about Diflunisal. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.
ARTHRITIS CARE
(Arthritis Care is an organisation which helps arthritis patients and their relatives, and is not associated with Chemidex Pharma Ltd.)
Patients requiring further independent information or advice should contact Arthritis Care, the UK's largest voluntary organisation working with people with arthritis. Arthritis Care works with and for all people with arthritis to promote their health, well-being and independence, through services, support, self-help, influence, and information.
Address: 18 Stephenson Way, London NW1 2HD. Telephone: 0207–380–6500.
Freephone Helpline: 0808 800 4050, 12 noon to
4 p.m., Monday to Friday.
ESSENTIAL GENERICS
124–125/L/a/2