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DICLOFENAC POTASSIUM 50 MG TABLETS

Active substance(s): DICLOFENAC POTASSIUM

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Diclofenac potassium

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 only for you personally
and you should not pass it on to others. 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.

In this leaflet:

1. What AdaciumTM Rapid tablets are and what they
are used for
2. Before you take AdaciumTM Rapid tablets
3. How to take AdaciumTM Rapid tablets
4. Possible side effects
5. How to store AdaciumTM Rapid tablets
6. Further Information

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1.What AdaciumTM Rapid tablets
are and what they are used for

AdaciumTM Rapid tablets belong 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 AdaciumTM Rapid tablets

Do not take AdaciumTM Rapid 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
• suffer from severe kidney, heart or liver failure
• if you 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
• if you have, or have had, problems with your
blood circulation (peripheral arterial disease)
• are pregnant, and in the last three months (last
trimester) of pregnancy.
Make sure your doctor knows, before you are given
AdaciumTM Rapid tablets if you:
• smoke
• have diabetes
• have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides
• 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, COPD which affects
your breathing, a chest infection or hayfever
• suffer from liver porphyria (disorder of the red
blood pigment)
• have had or need to have surgery
• are elderly (over 65), particularly if you are frail or
underweight
• are being treated with diuretics (water tablets) or
COX-2 inhibitors such as celecoxib.
Medicines such as AdaciumTM Rapid tablets 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.

Important information about some of the ingredients
If you are allergic to peanut or soya do not take this
medicine, as it contains soya.

3. How To Take AdaciumTM Rapid tablets

Taking other medicines

Always take AdaciumTM Rapid tablets exactly as your
doctor has told you. If you are unsure check with
your doctor or pharmacist. AdaciumTM Rapid 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.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Especially:
• colestipol and cholestyramine – these may reduce
the effect of AdaciumTM Rapid tablets
• medicines to treat diabetes – a dose adjustment
of these medicines may be necessary as blood
sugar may drop too low
• anticoagulants and anti-platelet medicines –
(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 AdaciumTM Rapid tablets
• cytotoxic medicines (e.g. methotrexate to treat
cancers) – should not be taken less than 24 hours
before or after AdaciumTM Rapid tablets -the
blood levels of these medicines may be increased
if taken with AdaciumTM Rapid tablets
• ciclosporin – a dose adjustment may be necessary
as 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 AdaciumTM Rapid tablets
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 AdaciumTM Rapid tablets
may increase the risk of blood disorders
• Digoxin – the blood level of digoxin may be
increased if taken with AdaciumTM Rapid tablets
• Selective Serotonin Reuptake Inhibitors (SSRIs)
(medicines to treat depression) – may increase the
risk of bleeding in the stomach
• Phenytoin (an epilepsy medicine) – the blood level
of this medicine may be increased if taken with
AdaciumTM Rapid tablets
• Potent CYP2C9 Inhibitors (e.g. sulfinpyrazone and
voriconazole) – the blood level of diclofenac may
be increased if taken with these medicines.

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 over 14 years of age – 75mg to 100mg
daily, in two or three doses.
• 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 AdaciumTM Rapid tablets than
you should:

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AdaciumTM Rapid 50mg tablets

Some patients may experience side effects such as
dizziness, drowsiness, feel like you may fall asleep, fatigue
and visual disturbances which may affect their ability to
drive or operate machinery. Make sure you are not
affected before driving or operating machinery.

Contact your doctor, emergency room or pharmacist
if you have taken more AdaciumTM Rapid tablets
than stated in this leaflet or more than what your
doctor has prescribed (and you feel unwell).

If you forget to take AdaciumTM Rapid 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, AdaciumTM Rapid tablets can cause
side effects, although not everybody gets them.
If you suffer from any of the following rare, or very
rare, side effects at any time during your treatment,
STOP TAKING the medicine and seek immediate
medical help:
• chest pains
• drooping in your mouth or eye, unable to lift your
arms, blurred speech or unable to speak as these
are symptoms of a stroke
• 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, rash, 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.
• asthma or asthma that has been made worse by
this medicine.
• severe rash, sometimes seen as pinky red spots
with clear or violet centres.
• an unexpected change in the amount of urine
produced and/or its appearance.
Tell your doctor if you experience any of the
following symptoms:
Common (affecting up to 1 in 10 people)
• headache
• feeling, or being, sick
• diarrhoea
• pain or swelling of your stomach or abdomen, heartburn
• anorexia
• dizziness or feeling light-headed

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 AdaciumTM Rapid
tablets during the first 6 months of pregnancy as the risk of
miscarriage or impact on development of your baby is
increased. However, your doctor may prescribe AdaciumTM
Rapid tablets 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 AdaciumTM Rapid tablets during
the last 3 months of pregnancy as damage to the foetus
and reduced labour may occur.
Breastfeeding
Small amounts of diclofenac may pass into breast
milk and so AdaciumTM Rapid tablets should not be
used whilst breastfeeding.
Female fertility
AdaciumTM Rapid tablets 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.
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Driving and using machines

Side effects may be minimised by using the lowest
effective dose for the shortest duration necessary.
Medicines such as AdaciumTM Rapid tablets may very
rarely cause an allergic reaction (hypersensitivity) in
patients who have not taken the medicine before.
Taking AdaciumTM Rapid tablets may also mask the
symptoms of an infection.
Whilst you are taking these tablets, your doctor may
want to give you a check-up from time to time.
AdaciumTM Rapid tablets are not recommended for
children under the age of 14.

Rare (affecting up to 1 in 1000 people)
• reduced, blurred or double vision
• swelling of feet or ankles
• a feeling of no energy
• feeling sleepy or drowsy
• rash or raised lumps on your skin
• a feeling of being uncomfortable, general aches
and pains
Very Rare (affecting less than 1 in 10,000 people)
• constipation
• if you have an irritable bowel disease, such as colitis
or Crohn’s disease, the symptoms may get worse
• depression, anxiety, memory loss, or confusion
• anaemia making you feel tired or lethargic
• your heart beats too quickly or irregularly; chest pains
• impotence (difficulty getting an erection)
• ringing in the ears
• strange visions or sounds
• difficulty sleeping
• mouth ulcers or a sore mouth
• pins and needles or sensitivity to touch
• your blood does not clot easily
• low resistance to infections, fever
• spotting or unexplained bruising of the skin, nose bleeds
• hair loss
• taste disturbances
Unknown
• sudden loss of vision
• confusion
• hallucinations
• change in taste
• generally feeling unwell
Medicines such as AdaciumTM Rapid tablets may be
associated with a small increased risk of heart attack or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 AdaciumTM Rapid 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 AdaciumTM Rapid tablets contain

The active substance (the ingredient that makes the
tablet work) is diclofenac. Each tablet contains
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 AdaciumTM Rapid tablets look like and
contents of the pack

The 50mg tablets are reddish brown, round,
unscored, biconvex 9mm film coated tablets.
Pack sizes
Blister packs: 7, 12, 21, 28, 30, 50, 56, 60, 84 and 100
film coated tablets.
Plastic bottles: 100 and 500 film-coated tablets
(Not all packs sizes may be available)

Marketing Authorisation Holder

Focus Pharmaceuticals Limited, Unit 5 Faraday
Court, Centrum 100, Burton Upon Trent, Staffordshire,
DE14 2WX, United Kingdom

Manufacturer

Actavis hf., Reykjavikurvegi 78, PO Box 420, IS-222,
Hafnarfjordur, Iceland.
This leaflet was last revised in 07/2014.
Other sources of information

For information in large print, audio CD or
Braille please telephone 00 44 (0)1283 495 280
or email medinfo@focuspharma.co.uk.
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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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