Diclofenac Potassium 50 mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you have any of the side effects, or if you notice any not listed, please tell your doctor or pharmacist

In this leaflet:

1. What Diclofenac potassium tablets are and what they are used for
2. Before you take Diclofenac potassium tablets
3. How to take Diclofenac potassium tablets
4. Possible side effects
5. How to store Diclofenac potassium tablets
6. Further Information

In children aged 9 years and above:

25mg tablets may be used in the short term treatment of fever related infections of the ear, nose or throat such as tonsillitis and inflammation of the ear drum. It may also be used either individually or in combination with morphine (or other opiates) for pain relief after surgery.

Do not take Diclofenac potassium tablets if you:

• are allergic (hypersensitive) to diclofenac potassium or any of the other ingredients in the tablet (see section 6)
• have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
• have previously had a reaction (asthma, hives or a cold) caused by an allergy to salicylates (e.g. aspirin) or other non-steroidal pain killers
• suffer from severe kidney, heart or liver failure
• are pregnant, and in the last three months (last trimester) of pregnancy.

Check with your doctor or pharmacist before taking Diclofenac potassium tablets if you:

• have a history of gastrointestinal disease e.g. ulcerative colitis or Crohn’s disease
• have reduced heart, kidney, or liver function
• suffer from any blood clotting disorder
• have or have had asthma
• suffer from liver porphyria (disorder of the red blood pigment)
• have had or need to have surgery
• are elderly (over 65)
• if you are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib.

Medicines such as diclofenac 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, have had a 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.

Whilst you are taking these tablets, your doctor may want to give you a check-up from time to time.

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.

Especially:

• medicines to treat diabetes – a dose adjustment of these medicines may be necessary as blood sugar may drop too low
• anticoagulants – (e.g. warfarin) - these may increase the risk of bleeding
• diuretics (water tablets) – the effect of these may be decreased. Potassium-sparing diuretics may increase the potassium levels in the blood
• lithium (medicine to treat depression) the blood levels of these medicines may be increased if taken with Diclofenac
• cytotoxic medicines (e.g. methotrexate to treat cancers) – should not be taken less than 24 hours before or after Diclofenac potassium tablets - the blood levels of these medicines may be increased if taken with Diclofenac
• ciclosporin – this may harm kidney function
• quinolones (to treat infections, e.g. ciprofloxacin and levofloxacin) – these may cause convulsions (fits)
• steroid tablets – these may increase the risk of bleeding in the stomach
• other NSAIDs (e.g. aspirin) – these may increase the risk of side effects
• medicines to treat high blood pressure (ACE-inhibitors, beta blockers) – the blood pressure lowering effect may be reduced
• mifepristone (used to induce abortion) – effect of mifepristone may be reduced by NSAIDs
• cardiac glycosides (e.g. digoxin) used to treat heart failure. Use with Diclofenac may worsen heart failure or increase blood levels of these medicines.
• tacrolimus (an immunosuppressant) - these may increase the risk of kidney damage.
• zidovudine (an antiretroviral drug used to treat HIV) - combination with Diclofenac may increase the risk of blood disorders.

Laboratory tests

Frequent liver and kidney function tests and monitoring of blood counts are necessary if taken for more than a few days.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

It is not recommended that you take Diclofenac during the first 6 months of pregnancy. However, your doctor may prescribe Diclofenac for you during the first six months of pregnancy if he/she feels the benefit to you outweighs the risk. You must not however take Diclofenac during the last 3 months of pregnancy as damage to the foetus and reduced labour may occur.

Breastfeeding

You should only use Diclofenac whilst breastfeeding if advised by your doctor.

Female fertility

Diclofenac 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.

Driving and using machines

Some patients may experience side effects such as dizziness, drowsiness and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery.

Important information about some of the ingredients

If you are allergic to peanut or soya do not take this medicine, as it contains soya. This medicine contains 0.075 mmol (2.92mg) potassium per 25mg tablet and 0.150 mmol (5.85mg) potassium per 50mg tablet. This should be taken into account if you have reduced kidney function or are on a controlled potassium diet.

To treat the symptoms of migraine in adults

50mg taken when the first signs of a migraine attack appear.

Another 50mg taken 2 hours after the first dose if needed and then every 4 to 6 hourly. You should not take more than 200mg in 24 hours.

These tablets are not suitable for the treatment of migraine in children.

If you take more Diclofenac potassium tablets than you should:

Contact your doctor, emergency room or pharmacist if you have taken more Diclofenac potassium tablets than stated in this leaflet or more than what your doctor has prescribed (and you feel unwell)

If you forget to take Diclofenac potassium tablets

Do not take a double dose to make up for forgotten dose. Continue the treatment as advised by your doctor.

STOP TAKING the medicine and tell your doctor if you experience:

• Any type of fit or seizure
• An unexpected change in the amount of urine produced and/or its appearance

Tell your doctor if you experience any of the following symptoms:

Common (occurs in less than 1 in 10 people): headache, dizziness, ’spinning’ sensation, diarrhoea, loss of weight or poor appetite, abnormal liver function tests, skin rashes

Rare (occurs in less than 1 in 1000 people): drowsiness, tiredness, stomach ulcers or bleeding, hepatitis, itching, fluid retention (symptoms of which include swollen ankles)

Very rare (occurs in less than 1 in 10 000 people: ‘pins and needles’, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), difficulty sleeping, nightmares, depression, irritability, anxiety, psychotic reactions, disorientation, loss of memory, numbness, sensitivity to light, taste disturbance, constipation, inflammation of the tongue, mouth ulcers, ulcers of the gullet, lower gut disorders (including inflammation of the colon causing diarrhoea and stomach pains), palpitations (fast or irregular heart beat), chest pain, high blood pressure, inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia, making you tired and more prone to minor infections or bleeding), kidney or liver disorders, presence of blood or protein in the urine, skin rash, itching, skin eruptions, eczema, Erythema Multiforme (round red patches on the skin), Stevens-Johnson-Syndrome (severe skin rash with flushing, fever, blisters and ulcers), or Lyell’s Syndrome (severe rash with reddening, peeling and swelling of skin that looks like severe burns), hair loss, pancreatitis (inflammation of the pancreas), worsening of ulcerative colitis or Crohn’s disease, impotence (difficulty getting an erection).

Medicines such as Diclofenac potassium tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. If you have any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

What Diclofenac potassium tablets contain

The active substance (the ingredient that makes the tablet work) is Diclofenac. Each tablet contains 25mg or 50mg Diclofenac potassium.

The tablets also contain silica colloidal anhydrous, sodium starch glycollate, povidone, maize starch, calcium hydrogen phosphate anhydrous, magnesium stearate, polyvinyl alcohol partially hydrolysed, titanium dioxide E171, talc, lecithin soya E322, iron oxide red, iron oxide yellow and xanthan gum E415.

What Diclofenac potassium tablets look like and contents of the pack

The 25mg tablets are pink, round, unscored, biconvex 6mm film coated tablets.

The 50mg tablets are reddish brown, round, unscored, biconvex 9mm film coated tablets.

Pack sizes

Blister packs: 28 film- coated tablets.

Plastic bottles: 100 and 500 film-coated tablets (Not all packs sizes may be available)

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