MEAIS

Diclofenac potassium 12.5mg tablets

PATIENT INFORMATION LEAFLET

In this leaflet:

1.    What Diclofenac potassium 12.5mg Tablets are and what they are used for

2.    Before you take Diclofenac potassium 12.5mg Tablets

3.    How to take Diclofenac potassium 12.5mg Tablets

4.    Possible side effects

5.    How to store Diclofenac potassium 12.5mg Tablets

6.    Further Information

1.    What Diclofenac potassium 12.5mg tablets are and what they are used for

Diclofenac potassium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce pain and inflammation in the following conditions:

•    Sprains, strains and other injuries

•    Pain and inflammation following surgery

•    Gout

•    Other painful conditions affecting the joints and muscles such as backache, rheumatoid arthritis, osteoarthritis, ankylosing spondylytis and pyrophosphate arthropathy.

The tablets can also be used to relieve the symptoms associated with migraine attacks in adults.

2.    Before you take Diclofenac potassium 12.5mg tablets

Do not take Diclofenac potassium 12.5mg 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.

Check with your doctor or pharmacist before taking Diclofenac potassium 12.5mg 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.

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.

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Diclofenac potassium tablets are not recommended for children under the age of 14.

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 this medicine 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 12.5mg 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 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) - the 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.

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

You should not take Diclofenac during the first 6 months of pregnancy unless directed by your doctor and must not 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 0.0374 mmol (1.46mg) potassium per tablet. This should be taken into account if you have reduced kidney function or are on a controlled potassium diet.

3. How To Take Diclofenac potassium 12.5mg tablets

Always take Diclofenac potassium 12.5mg tablets exactly as your doctor has told you. If you are unsure check with your doctor or pharmacist. Diclofenac potassium 12.5mg tablets must not be taken longterm, blood tests should be carried out if taken for more than a few days.

To minimise side effects, you should take the lowest effective dose for the shortest time necessary to relieve your symptoms.

The tablets must be swallowed whole with a glass of water, with or after food.

The usual dose is:

To treat pain and inflammation

Adults - 75 mg (6 tablets) to 150 mg (12 tablets) a day

in two or three doses.

Elderly patients - a lower dose may be used. If you are frail or have a low body weight, your doctor may ask you to go back to see him regularly for the first 4 weeks of treatment, to make sure that you are not experiencing any side effects.

Children over 14 years of age - 75mg (6 tablets) to 100mg (8 tablets) daily, in two or three doses.

• To treat the symptoms of migraine in adults

50mg (4 tablets) taken when the first signs of a migraine attack appear. Another 50mg (4 tablets) taken 2 hours after the first dose if needed and then every 4 to 6 hourly. You should not take more than 200mg (16 tablets) 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.

4. Possible side effects

Like all medicines, Diclofenac potassium 12.5mg tablets can cause side effects, although not everybody gets them.

If you suffer from any of the following at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:

•    pass blood in your faeces (stools / motions)

•    pass black tarry stools

•    vomit any blood or dark particles that look like coffee grounds

•    an allergic reaction such as itching, low blood pressure, swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing

•    a form of meningitis (aseptic) causing a combination of symptoms such as headache, fever, stiff neck, tiredness, muscle pain, sore throat and disorientation.

•    yellowing of the skin or the whites of your eyes

•    stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)

•    severe skin reactions such as:

-    round red patches on the skin

-    rash with flushing, fever, blisters and ulcers

-    rash with reddening, peeling and swelling of skin that looks like severe burns

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

•    Indigestion or heartburn

•    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms

•    Any type of fit or seizure

•    An unexpected change in the amount of urine produced and/or its appearance

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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, 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 12.5mg 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.

5. How to store Diclofenac potassium 12.5mg tablets

Keep out of the reach and sight of children Do not store above 25 °C

Do not use after the expiry date stated on the carton. Unused tablets should be taken back to the pharmacist for safe disposal.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Diclofenac potassium 12.5mg tablets contain

The active substance (the ingredient that makes the tablet work) is diclofenac. Each tablet contains 12.5mg 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 and Xanthan gum E415.

What Diclofenac potassium 12.5mg tablets look like and contents of the pack

The tablets are white, round, unscored, biconvex 5mm film coated tablets, with 'I' marked on one side Pack sizes 7, 10, 14, 28, 30, 50, 56, 98 and 100 film coated tablets.

(Not all packs sizes may be available)

Marketing Authorisation Holder

(-1 ehf, Reykjavikurvegur 78, 220 Hafnarfjordur,

Product Licence Number: PL 24702/0072

Manufacturer

Actavis hf., Reykjavikurvegi 78, PO Box 420, IS-222, Hafnarfjordur, Iceland.

This leaflet was last approved in {MM/YYYY}.

Revision date: July 2008