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PACKAGE LEAFLET: INFORMATION FOR THE USER
AdaciumTM Rapid 50mg tablets
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
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.
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Taking AdaciumTM Rapid tablets may also mask the Driving and using machines Tell your doctor if you experience any of the
symptoms of an infection. Some patients may experience side effects such as following symptoms:
Whilst you are taking these tablets, your doctor may dizziness, drowsiness and visual disturbances which Common (affecting up to 1 in 10 people)
want to give you a check-up from time to time. may affect their ability to drive or operate • headache
AdaciumTM Rapid tablets are not recommended for machinery. Make sure you are not affected before • feeling, or being, sick
children under the age of 14. driving or operating machinery.
• diarrhoea
Important information about some of the
Taking other medicines • pain or swelling of your stomach or abdomen,
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
ingredients
If you are allergic to peanut or soya do not take this
heartburn
• anorexia
including medicines obtained without a prescription. medicine, as it contains soya.
• dizziness or feeling light-headed
Especially: Rare (affecting up to 1 in 1000 people)
• colestipol and cholestyramine – these may reduce 3. How To Take AdaciumTM Rapid • reduced, blurred or double vision
the effect of AdaciumTM Rapid tablets
tablets • swelling of feet or ankles
• medicines to treat diabetes – a dose adjustment
of these medicines may be necessary as blood Always take AdaciumTM Rapid tablets exactly as your • a feeling of no energy
doctor has told you. If you are unsure check with
sugar may drop too low • feeling sleepy or drowsy
your doctor or pharmacist. AdaciumTM Rapid tablets
• anticoagulants and anti-platelet medicines – • rash or raised lumps on your skin
must not be taken long-term, blood tests should be
(e.g.warfarin) - these may increase the risk of • a feeling of being uncomfortable, general aches
carried out if taken for more than a few days.
bleeding and pains
To minimise side-effects, you should take the lowest
• diuretics (water tablets) – the effect of these may effective dose for the shortest time necessary to Very Rare (affecting less than 1 in 10,000 people)
be decreased. Potassium-sparing diuretics may relieve your symptoms. • constipation
increase the potassium levels in the blood The tablets must be swallowed whole with a glass of • if you have an irritable bowel disease, such as
• lithium (medicine to treat depression) the blood water, with or after food. colitis or Crohn’s disease, the symptoms may get
levels of these medicines may be increased if
The usual dose is: worse
taken with AdaciumTM Rapid tablets • depression, anxiety, memory loss, or confusion
• cytotoxic medicines (e.g. methotrexate to treat • To treat pain and inflammation
Adults - 75mg to 150mg a day in two or three doses. • anaemia making you feel tired or lethargic
cancers) – should not be taken less than 24 hours
Elderly patients – a lower dose may be used. If you • your heart beats too quickly or irregularly; chest
before or after AdaciumTM Rapid tablets -the
are frail or have a low body weight, your doctor may pains
blood levels of these medicines may be increased
if taken with AdaciumTM Rapid tablets ask you to go back to see him regularly for the first 4 • impotence (difficulty getting an erection)
• ciclosporin – a dose adjustment may be necessary weeks of treatment, to make sure that you are not • ringing in the ears
as this may harm kidney function experiencing any side effects. • strange visions or sounds
• quinolones (to treat infections, e.g. ciprofloxacin Children over 14 years of age – 75mg to 100mg • difficulty sleeping
and levofloxacin) – these may cause convulsions daily, in two or three doses. • mouth ulcers or a sore mouth
(fits) • To treat the symptoms of migraine in adults • pins and needles or sensitivity to touch
• steroid tablets – these may increase the risk of 50mg taken when the first signs of a migraine attack • your blood does not clot easily
bleeding in the stomach appear. Another 50mg taken 2 hours after the first • low resistance to infections, fever
• other NSAIDs (e.g. aspirin) – these may increase dose if needed and then every 4 to 6 hourly. You • spotting or unexplained bruising of the skin, nose
the risk of side effects should not take more than 200mg in bleeds
• medicines to treat high blood pressure 24 hours.
• hair loss
(ACE-inhibitors, beta blockers) – the blood pressure These tablets are not suitable for the treatment of
lowering effect may be reduced • taste disturbances
migraine in children.
• mifepristone (used to induce abortion) – effect of Unknown
If you take more AdaciumTM Rapid tablets than
mifepristone may be reduced by NSAIDs • sudden loss of vision
you should:
• cardiac glycosides (e.g. digoxin) used to treat Contact your doctor, emergency room or Medicines such as AdaciumTM Rapid tablets may be

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
• are pregnant, and in the last three months (last
trimester) of pregnancy.
Check with your doctor or pharmacist before taking
AdaciumTM Rapid 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, 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
• if you 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.
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.
Medicines such as AdaciumTM Rapid tablets may very
rarely cause an allergic reaction (hypersensitivity) in
patients who have not taken the medicine before.
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heart falure. 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.
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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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.
associated with a small increased risk of heart attack
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 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 updated in July 2012.

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