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 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
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.

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

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
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.

Continued top of next column

Continued over page

AAAJ1687

Diclofenac Potassium 25mg & 50mg Tablets PIL - UK
item no: AAAJ1687

dimensions: 170 x 320

print proof no: 2

pharmacode:

origination date: 19.07.16

min pt size: 8

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

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 09.08.16

Technical Approval

revised by: S.Anson

date sent: 19.07.16

supplier: Actavis Iceland

technically app. date: 09.08.16

Non Printing Colours
1.
2.
3.

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 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 - 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:

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

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
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.

6. Further information
What Diclofenac potassium tablets contain

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)

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.
This leaflet was last updated in August 2016.

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
Continued top of next column
AAAJ1687

Diclofenac Potassium 25mg & 50mg Tablets PIL - UK
item no: AAAJ1687

dimensions: 170 x 320

print proof no: 2

pharmacode:

origination date: 19.07.16

min pt size: 8

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

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 09.08.16

Technical Approval

revised by: S.Anson

date sent: 19.07.16

supplier: Actavis Iceland

technically app. date: 09.08.16

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