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DICLOFENAC POTASSIUM 12.5MG TABLETS

Active substance(s): DICLOFENAC POTASSIUM

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Diclofenac potassium 12.5mg tablets
PATIENT INFORMATION LEAFLET

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 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.

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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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
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

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

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.

Common (occurs in less than 1 in 10
people):

12.5mg tablets

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

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

Medis ehf, Reykjavikurvegur 78, 220 Hafnarfjordur,
Iceland.
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
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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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