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DICLOFENAC POTASSIUM 25 MG TABLETS

Active substance(s): DICLOFENAC POTASSIUM / DICLOFENAC POTASSIUM / DICLOFENAC POTASSIUM

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PATIENT INFORMATION LEAFLET

Diclofenac potassium 25mg & 50mg 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,

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
1. What Diclofenac potassium tablets are and what
they are used for
Diclofenac potassium belongs to a group of medicines called nonsteroidal 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 tablets
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, in your
stomach (gastric) or small
intestine (duodenal) or
bleeding in your stomach,
or have had two or more
episodes of peptic ulcers,
stomach bleeding or
perforation
• have history of gastro-intestinal bleeding or perforation, relating
to previous NSAID therapy
• 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
• have established heart disease and /or cerebrovascular disease e.g. if
you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
• have or have had problems with your blood circulation (peripheral
arterial disease)
• 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)
• are being treated with diuretics (water tablets) or COX-2 inhibitors
such as celecoxib.
• have Systemic Lupus Erythematosus (SLE) and mixed connective
tissue disease

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

Make sure your doctor knows, before you are given diclofenac:
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised
cholesterol or raised triglycerides
Side effects may be minimised by using the lowest effective dose for
the shortest duration necessary.
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 you should discuss your
treatment with your doctor or pharmacist.
Diclofenac may mask the signs and symptoms of infection.
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
• phenytoin (a medicine used to treat seizures) - the blood level of
this medicine may be increased if taken with Diclofenac
• colestipol and cholestyramine – these may reduce the effect of
Diclofenac
• potent CYP2C9 Inhibitors (e.g. sulfinpyrazone and voriconazole)
- the blood level of Diclofenac may be increased if taken with these
medicines
• selective serotonin reuptake inhibitors (SSRIs)
• trimethoprim

Laboratory tests

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

Continued top of next column

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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.

3. How To Take Diclofenac potassium tablets
Always take Diclofenac potassium tablets exactly as your doctor has
told you. If you are unsure check with your doctor or pharmacist.
Diclofenac potassium tablets must not be taken long-term, 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 - 75mg to 150mg 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 aged 14 years and over – 75mg to 100mg daily, in two or
three doses.
• Not recommended for children under 14 years old.

Tell your doctor if you experience any of the following symptoms:
Common (affects up to 1 in 10 people):
headache, dizziness, ’spinning’ sensation, feeling or being sick,
diarrhoea, pain or swelling of your stomach or abdomen, indigestion,
heartburn, wind, loss of weight or poor appetite, abnormal liver
function tests, skin rashes.
Rare (may affect up to 1 in 1,000 people):
allergic reactions, tiredness, difficulty breathing, inflammation of
the stomach, stomach ulcers or bleeding, vomiting blood, blood in
the faeces, hepatitis, yellowing of the skin or whites of eyes, rash or
raised lumps on your skin, fluid retention (symptoms of which include
swollen ankles), drowsiness.
Very rare (may affect up to 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, seizures, aseptic meningitis, 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 or low 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 or failure, presence of
blood or protein in the urine, skin rash, itching, skin eruptions, eczema,
dermatitis, 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),
angioneurotic odema (swelling of the skin).
Unknown (frequency cannot be estimated from the data):
neutropenia (can lead to low resistance to infections), confusion,
hallucination, disturbances of sensation, generally feeling unwell,
sudden loss of vision.
Medicines such as Diclofenac potassium tablets may be associated
with a small increased risk of heart attack (“myocardial infarction”) or
stroke (very rare).

Reporting 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.

To treat the symptoms of migraine in adults

5. How to store Diclofenac potassium tablets

If you take more Diclofenac potassium tablets than you
should:

Keep out of the reach and sight of children.
This medicine has no special storage precautions.
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.

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.

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.

6. Further information
What Diclofenac potassium tablets contain

4. Possible side effects
Like all medicines, this medicine 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),
vomiting (being sick) or other abnormal stomach symptoms
• any type of fit or seizure
• an unexpected change in the amount of urine produced and/or its
appearance
• mild cramping and tenderness of the abdomen, starting shortly
after the start of the treatment with Diclofenac potassium tablets
and followed by rectal bleeding or bloody diarrhoea usually within
24 hours of the onset of abdominal pain (frequency not known,
cannot be estimated from the available data).
Continued top of next column

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 pack sizes may be available)
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78,
220 Hafnarfjördur, Iceland
Manufacturer
Specifar S.A.
1, 28 Octovriou str., 123 51 Ag. Varvara,
Athens, Greece
This leaflet was last updated in April 2017

BBBA0628

Diclofenac Potassium 25mg & 50mg Tablets PIL - UK
approved for print/date

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Item no:

BBBA0628

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
29.03.17
26.04.17
S.Anson

Date sent:
30.03.17
Date received: 11.04.17

Dimensions:
170 x 320
Min Body Text Size: 8pts
Supplier:
Specifar

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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