Skip to Content

DICLOFENAC POTASSIUM 25 MG TABLETS

Active substance(s): DICLOFENAC POTASSIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
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
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
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 nonsteroidal 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

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

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

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

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
Continued over page

Continued top of next column
AAAI1181

Diclofenac Potassium 25mg & 50mg Tablets PIL - UK
item no: AAAI1181

dimensions: 170 x 320mm

print proof no: 5

pharmacode:

origination date: 15-07-15

min pt size: 8pt

1. Black
2.
3.
4.
5.
6.

originated by: BW
approved for print/date

colours/plates:

revision date: 05-05-16

Technical Approval

revised by: BW

date sent: 15-07-15

supplier: Actavis Iceland

technically app. date: 29-07-15

Non Printing Colours
1.
2.
3.

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.

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:

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.

5. How to store Diclofenac potassium tablets

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

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.

4. Possible side effects

6. Further information

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

What Diclofenac potassium tablets contain

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

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

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)
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78,
220 Hafnarfjördur, Iceland
Manufacturer
Actavis hf., Reykjavikurvegi 78, PO Box 420, IS-222,
Hafnarfjordur, Iceland.

Continued top of next column

This leaflet was last updated in May 2016.

AAAI1181

Diclofenac Potassium 25mg & 50mg Tablets PIL - UK
item no: AAAI1181

dimensions: 170 x 320mm

print proof no: 5

pharmacode:

origination date: 15-07-15

min pt size: 8pt

1. Black
2.
3.
4.
5.
6.

originated by: BW
approved for print/date

colours/plates:

revision date: 05-05-16

Technical Approval

revised by: BW

date sent: 15-07-15

supplier: Actavis Iceland

technically app. date: 29-07-15

Non Printing Colours
1.
2.
3.

Expand view ⇕

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.

Hide