RHUMALGAN XL 100 MG MODIFIED-RELEASE CAPSULES

Active substance: DICLOFENAC SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Rhumalgan® SR 75 mg Modified Release Capsules
Rhumalgan® XL 100 mg Modified Release Capsules

(diclofenac sodium)

What you need to know about Rhumalgan Capsules
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important
information.
• Keep the leaflet in a safe place because you may want to read it again.
• If you have any other questions, or if there is something you donʼt understand, please ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Never give it to someone else. It may not be the right
medicine for them even if their symptoms seem to be the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1. What Rhumalgan Capsules are and what they
are used for
2. Things to consider before you start to take
Rhumalgan Capsules
3. How to take Rhumalgan Capsules
4. Possible side effects
5. How to store Rhumalgan Capsules
6. Further Information

1

What Rhumalgan Capsules are
and what they are used for

2

Things to consider before you start
to take Rhumalgan Capsules

of the following:
• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets)
• Lithium (used to treat some mental problems)
• Methotrexate (for some inflammatory diseases
and some cancers)
• Ciclosporin and tacrolimus (used to treat some
inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or treat
urinary tract infections)
• Quinolone antibiotics (for infections)
• Any other NSAID or COX-2 (cyclo-oxgenase-2)
inhibitor, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate
pregnancy)
• Cardiac glycosides (for example digoxin), used to
treat heart problems
• Medicines known as SSRIs, and an SNRI,
venlafaxine, used to treat depression
• Oral steroids (anti-inflammatory drugs)
• Medicines used to treat heart conditions or high
blood pressure, for example beta blockers or
ACE inhibitors
• Voriconazole (a medicine used to treat fungal
infections)
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cholestryramine (used to lower
cholesterol)
• Ritonavir and zidovudine (used to treat HIV and
AIDS)
• Baclofen (a muscle relaxant often used in MS)
• Drospirenone (used in an oral contraceptive pill)
• Ketorolac (used to treat post-operative pain)
• Penicillamine (a treatment for rheumatoid arthritis)
• Erlotinib (for cancer)
• Iloprost, a treatment for pulmonary hypertension
(high blood pressure in the artery carrying blood
from the heart to the lungs)
• Pentoxifylline (used to treat circulation disorders)
• Sibutramine (for obesity).

Diclofenac sodium, the active ingredient in
Rhumalgan Capsules, is one of a group of
medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and
inflammation. Rhumalgan Capsules are specially
formulated to release the diclofenac sodium slowly.
This helps to reduce the number of capsules you
may need to take each day.
• Rhumalgan Capsules relieve pain, reduce
swelling and ease inflammation in a wide range
of conditions affecting the joints, muscles and
tendons including:
- Rheumatoid arthritis, osteoarthritis, acute gout,
ankylosing spondylitis
- Backache, sprains and strains, soft tissue
sports injuries, frozen shoulder, dislocations
and fractures
- Tendonitis, tenosynovitis, bursitis
• They are also used to treat pain and
inflammation associated with orthopaedic (bone
and joint surgery), dental and minor surgery.

Some people MUST NOT take Rhumalgan
Capsules. Talk to your doctor if:
• you think you may be allergic to diclofenac
sodium, aspirin, ibuprofen or any other NSAID, or
to any of the other ingredients of Rhumalgan
Capsules. (These are listed at the end of the
leaflet).
Signs of an allergic reaction include swelling of
the face and mouth (angioedema), breathing
problems, runny nose, skin rash or any other
allergic type reaction.
• you have now, or have ever had, a stomach
(gastric), duodenal (peptic) or intestinal ulcer, or
bleeding in the digestive tract (this can include
blood in vomit, bleeding when emptying bowels,
fresh blood in faeces or black, tarry faeces).
• 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.
• you have or have had problems with your blood
circulation (peripheral arterial disease).
• have had stomach or bowel problems after you
have taken other NSAIDs.
• have severe heart, kidney or liver failure.
• are more than six months pregnant.

Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines
you have bought yourself, including herbal
remedies, as well as medicines on prescription from
your doctor.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

Although not common, abnormalities have been
reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take
Rhumalgan Capsules during the last 3 months of
pregnancy as it may affect the babyʼs circulation.

You should also ask yourself these questions
before taking Rhumalgan Capsules:
• Do you suffer from any stomach or bowel
disorders including ulcerative colitis or Crohnʼs
disease?
• Do you have kidney or liver problems, or are you
elderly?
• Do you have a condition called porphyria?
• Do you suffer from any blood or bleeding
disorder? If you do, your doctor may ask you to
go for regular check-ups while you are taking
these capsules.
• Have you ever had asthma?
• Are you breast-feeding?
• Do you have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides?
• Do you have heart problems, or have had a
stroke, or think you might be at risk of these
conditions (for example, if you have high blood
pressure, diabetes or high cholesterol or are a
smoker)?
• Do you smoke?
• Do you have diabetes?
• Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES,
tell your doctor or pharmacist because
Rhumalgan Capsules might not be the right
medicine for you.

draft: 44004311, 44004310
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mat.no.: LF00000000

Are you taking other medicines?
Some medicines can interfere with your treatment.
Tell your doctor or pharmacist if you are taking any

Taking Rhumalgan Capsules may make it more
difficult for you to get pregnant. You should talk to
your doctor if you are planning to become pregnant
or if you have problems getting pregnant.

You should not take Rhumalgan Capsules if you are
breast-feeding.

Will there be any problems with driving or using
machinery?
Very occasionally people have reported that
Rhumalgan Capsules have made them feel dizzy,
tired or sleepy. Problems with eyesight have also
been reported. If you are affected in this way, you
should not drive or operate machinery.
Important information about some of the
ingredients of Rhumalgan Capsules
This product contains lactose and sucrose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.

Other special warnings
• You should take the lowest dose of Rhumalgan
for the shortest possible time, particularly if you
are underweight or elderly
• There is a small increased risk of heart attack or
stroke when you are taking any medicine like
Rhumalgan. The risk is higher if you are taking
high doses for a long time. Always follow the
doctorʼs instructions on how much to take and
how long to take it for

Continued on the next page >>

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• Drowsiness, tiredness
• Hypotension (low blood pressure, symptoms of
which may include faintness, giddiness or light
headedness)
• Skin rash and itching
• Fluid retention, symptoms of which include
swollen ankles
• Liver function disorders, including hepatitis and
jaundice.

• Whilst you are taking these medicines your
doctor may want to give you a check up from
time to time
• If you have a history of stomach problems when
you are taking NSAIDs, particularly if you are
elderly, you must tell your doctor straight away if
you notice any unusual symptoms
• Because it is an anti-inflammatory medicine,
Rhumalgan Capsules may reduce the symptoms
of infection, for example, headache and high
temperature. If you feel unwell and need to see a
doctor, remember to tell him or her that you are
taking Rhumalgan Capsules.

3

How to take Rhumalgan Capsules

Very rare side effects (These may affect less
than 1 in every 10,000 patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual
disturbances such as blurred or double vision,
hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes,
depression, anxiety, mental disorders, disorientation
and loss of memory, fits, headaches together with a
dislike of bright lights, fever and a stiff neck,
disturbances in sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth
ulcers, inflammation of the inside of the mouth or
lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of
ulcerative colitis or Crohnʼs disease).

Your doctor will tell you how many Rhumalgan
Capsules to take and when to take them. Always
follow his/her instructions carefully. The dose will be
on the pharmacistʼs label. Check the label carefully.
If you are not sure, ask your doctor or pharmacist.
Keep taking your capsules for as long as you have
been told, unless you have any problems. In that
case, check with your doctor.
Take the capsules with or after food.

Swallow the capsules whole with a drink of water.
Do not crush or chew them as this will affect the
special ʻslow releaseʼ system.

Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain,
hypertension (high blood pressure), inflammation of
blood vessels (vasculitis), inflammation of the lung
(pneumonitis), heart disorders including congestive
heart failure or heart attack, blood disorders
(including anaemia).

The usual doses are:

Adults
Rhumalgan SR 75 mg Capsules: One capsule,
taken once or twice daily.
Rhumalgan XL 100 mg Capsules: One capsule
daily.

Elderly
Your doctor may advise you to take a dose that is
lower than the usual adult dose if you are elderly.
Your doctor may also want to check regularly that
the Rhumalgan Capsules are not affecting your
stomach.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver
failure, presence of blood or protein in the urine.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson
syndrome, Lyellʼs syndrome and other skin rashes
which may be made worse by exposure to sunlight.
Hair loss.

These capsules are not suitable for children.

The doctor may also prescribe another drug to
protect the stomach to be taken at the same time,
particularly if you have had stomach problems
before, or if you are elderly, or taking certain other
drugs as well.

Other side effects that have also been reported
include:
Inflammation of the pancreas, impotence, facial
swelling, inflammation of the lining of the brain
(meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of
discomfort), inflammation of the nerves of the eye.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as
you remember. If it is nearly time for your next dose,
just take the next dose and forget about the one
you missed. Do not double up on the next dose to
make up for the one missed. Do not take more than
150 mg in 24 hours.

Do not be alarmed by this list – most people
take Rhumalgan Capsules without any
problems.
If any of the symptoms become troublesome, or
if you notice anything else not mentioned here,
please go and see your doctor. He/she may
want to give you a different medicine.

What if you take too many Capsules?
If you, or anyone else, accidentally takes too many
capsules, tell your doctor or your nearest hospital
casualty department. Take your medicine pack with
you so that people can see what you have taken.

4

5

Possible side effects

Store in the original package.

Keep out of the reach and sight of children.

Rhumalgan Capsules are suitable for most people,
but, like all medicines, they can sometimes cause
side effects. Side effects may be minimised by
using the lowest effective dose for the shortest
duration necessary.

Do not take Rhumalgan Capsules after the expiry
date which is printed on the outside of the pack.

If your doctor tells you to stop taking Rhumalgan
Capsules, please take any unused capsules back to
your pharmacist to be destroyed. Do not throw them
away with your normal household water or waste.
This will help to protect the environment.

Some side effects can be serious
Stop taking Rhumalgan Capsules and tell your
doctor straight away if you notice:
• Stomach pain, indigestion, heartburn, wind,
nausea (feeling sick) or vomiting (being sick)
• Any sign of bleeding in the stomach or intestine,
for example, when emptying your bowels, blood
in vomit or black, tarry faeces
• Allergic reactions which can include skin rash,
itching, bruising, painful red areas, peeling or
blistering
• Wheezing or shortness of breath
(bronchospasm)
• Swollen face, lips, hands or fingers
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• An unexpected change in the amount of urine
produced and/or its appearance.

6

Further information

What Rhumalgan Capsules contain
Rhumalgan SR 75 mg Capsules are white, opaque
hard capsules marked ʻDIC75ʼ, containing 75 mg of
the active ingredient, diclofenac sodium.
Rhumalgan XL 100 mg Capsules are pink, opaque
hard capsules marked ʻDIC100ʼ, containing 100 mg
of the active ingredient, diclofenac sodium.
The capsules also contain the inactive ingredients:
sucrose, maize starch, macrogol 6000, ammonia
methacrylate copolymer type A, talc, lactose
monohydrate, polysorbate 80, gelatin, titanium
dioxide (E171), shellac, iron oxide (E172) and
propylene glycol. Rhumalgan XL 100 mg Capsules
also contain red iron oxide and yellow iron oxide.

If you notice that you are bruising more easily than
usual or have frequent sore throats or infections, tell
your doctor.

The side effects listed below have also been
reported.
Common side effects (These may affect
between 1 and 10 in every 100 patients):
• Stomach pain, heartburn, nausea, vomiting,
diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.

Rhumalgan SR 75 mg Capsules come in blister
packs of 56.
Rhumalgan XL 100 mg Capsules come in blister
packs of 28.
Not all pack sizes may be marketed.

The Marketing Authorisation Holder and
manufacturer is
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Rare side effects (These may affect between 1 in
every 1000 to 1 in every 10,000 patients):
• Stomach ulcers or bleeding (there have been
very rare reported cases resulting in death,
particularly in the elderly)
• Gastritis (inflammation, irritation or swelling of the
stomach lining)
• Vomiting blood
• Diarrhoea with blood in it or bleeding from the
back passage
• Black tarry faeces or stools

draft: 44004311, 44004310
laetus code: supplier to add
mat.no.: LF00000000

How to store Rhumalgan
Capsules

This leaflet was revised in 10/2013.

SZ00000LT000

Artwork Proof Box
Ref: N034 - SPC & PIL referral updates
Proof no.
006.0

Date prepared:
23/10/2013

Colours:
Black
Dimensions: 146 x 420 mm

Font size:
7.5pt
Fonts:
Helvetica

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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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