DICLOMAX SR

Active substance: DICLOFENAC SODIUM

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Diclomax TEST 190x254 UK/932437:Layout 1 19/04/2012 13:42 Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diclomax SR 75mg Capsules and
Diclomax Retard 100mg Capsules
(Diclofenac Sodium)
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, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are 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 Diclomax is and what it is used for
2. Before you take Diclomax
3. How to take Diclomax
4. Possible side effects
5. How to store Diclomax
6. Further information

1. WHAT DICLOMAX IS AND WHAT IT IS USED FOR
The name of this medicine is Diclomax SR 75mg Capsules or Diclomax Retard
100mg Capsules. The active substance in them is diclofenac sodium which
belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs).
They are used to relieve pain and inflammation or swelling and can be used in the
treatment of painful conditions affecting the joints and muscles, e.g. rheumatoid
arthritis, osteoarthrosis, low back pain and sprains or broken bones, or to control
pain and inflammation following orthopaedic, dental and other minor surgery.

2. BEFORE YOU TAKE DICLOMAX
Do not take Diclomax if
- you are allergic (hypersensitive) to diclofenac sodium or any of the other
ingredients of Diclomax
- you are allergic to aspirin, ibuprofen or any other anti-inflammatory medicines
used to treat painful conditions
- you currently have, or have ever had, ulcers in the stomach or small intestine
(peptic ulceration) or bleeding in your stomach or intestines
- your doctor has told you that you have an intolerance to sugars called lactose
or sucrose
- your doctor has told you that you have acute porphyria
- you have severe liver, kidney or heart failure
- you are taking any other NSAIDs (non-steroidal anti-inflammatory drugs)
- you are pregnant or breast-feeding
Diclomax Capsules are not recommended for children.
Talk to your doctor before taking this product if any of the above apply to you.
Take special care with Diclomax
- if you have asthma
- if you have, or have ever had, bloody diarrhoea
- if you are elderly
or if you suffer from any of the following conditions:
- heart, liver or kidney disease
- systemic lupus erythematosus (SLE) (a chronic inflammatory disease affecting
many systems of the body) or other mixed connective tissue disorders (if so
you may have an increased risk of aseptic meningitis if you take this medicine)
- Crohn’s disease or ulcerative colitis (bowel disorders)
- any blood disorders where you bleed or bruise easily
If any of the above apply to you, it is important that you tell your doctor or
pharmacist before taking this medicine and they will decide what to do. It may
still be safe for you to take Diclomax.
If you go into hospital or visit a dentist or any other doctor, tell them that you are
taking this medicine.

Warnings
Medicines such as Diclomax Capsules 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, 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
medicines, including those medicines obtained without a prescription.
This is especially important if you are taking any of the following:
- quinolone antibiotics (such as ciprofloxacin) used to treat certain bacterial
infections
- warfarin (to thin the blood) or any other anticoagulant medicines
- methotrexate – used in cancer and certain inflammatory diseases like
rheumatoid arthritis
- lithium – a medicine for depression
- zidovudine – a medicine used to treat HIV
- a group of medicines called selective serotonin reuptake inhibitors that are
commonly referred to as SSRIs and used to treat depression
- steroids (e.g. prednisolone)
- other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin and
ibuprofen)
- water tablets (diuretics)
- medicines that affect your immune system (e.g. ciclosporin or tacrolimus)
- medicines for diabetes (e.g. hypoglycaemic agents)
- medicines to treat heart problems (e.g. digoxin)
- medicines to treat high blood pressure
- a medicine called mifepristone used for the termination of pregnancy. It is
important to tell your doctor if you have taken mifepristone within the last
12 days.
Taking Diclomax with food and drink
Diclomax should be taken with or after food.
Pregnancy and breast-feeding
If you are pregnant, think you might be or are breast-feeding you should ask your
doctor or pharmacist for advice before taking Diclomax.
Diclomax 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
It is safe to drive while taking Diclomax, however, you may experience dizziness,
tiredness or problems with your sight.
If you are affected by any of these, do not drive or operate machinery.
Important information about some of the ingredients of Diclomax Capsules
These capsules contain lactose and sucrose. If your doctor has told you that you
have an intolerance to some sugars, contact your doctor before taking this
medicine.

3. HOW TO TAKE DICLOMAX
Always take Diclomax exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure. The label on the carton will tell you
how many capsules you should take and when.
Diclomax SR 75mg Capsules:
The normal dose of Diclomax SR for adults is one or two 75mg capsules daily,
swallowed whole with or after food. Do not chew the capsule(s) or remove the
contents.
Diclomax Retard 100mg Capsules:
The normal dose of Diclomax Retard for adults is one 100mg capsule daily,
swallowed whole with or after food. Do not chew the capsule or remove the
contents.
If you take more Diclomax than you should
If you take too many capsules contact your nearest hospital casualty department
or tell your doctor or pharmacist immediately. Take this leaflet and any remaining
capsules with you.

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If you forget to take Diclomax
If you forget to take a dose, take it as soon as you remember unless it is almost
time for your next dose. Do not take a double dose to make up for a forgotten
dose.

Do not use Diclomax if you notice that the packaging or any of the capsules are
damaged.
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
Like all medicines, Diclomax can cause side effects, although not everybody gets
them.
If you get any of the following side effects after taking Diclomax, stop taking them
and contact your doctor immediately:
- difficulty in breathing
- starting to wheeze
- any unusual swelling or a blistering skin rash
- vomiting blood or dark coffee ground like material
- passing bloody or black tar like stools
- bloody diarrhoea
- swelling of the face, lips, tongue or throat
If you get any of the following symptoms contact your doctor as soon as
possible:
- heartburn (indigestion)
- pains in your stomach or any other unusual stomach problems
- small red or purple spots on your skin
- stiff neck, headache, nausea and/or vomiting associated with fever
The following side effects have been reported most commonly:
- stomach ulcers
- diarrhoea
- stomach pain or irritation
- flatulence (excess wind)
- nausea
- constipation
- vomiting
- oedema (water retention /
- skin rash or itching
swelling)
The following side effects have also been reported less commonly:
- certain blood disorders which
- mouth ulcers
may increase the risk of
- inflammation of the liver
bleeding, bruising or infections
(hepatitis)
- headache
- yellowing of the skin and
- problems with sight
eyes (jaundice)
- depression
- kidney problems
- confusion
- general feeling of being
- hallucination (imagining
unwell (malaise)
something that is not really
- tiredness or drowsiness
there)
- ringing in the ears (tinnitus)
- “pins and needles” or
- vertigo (condition that
numbness, tingling or itching
affects balance)
of the skin
- sensitivity to light
- dizziness

6. FURTHER INFORMATION
What Diclomax SR 75mg Capsules contain
The active substance is diclofenac sodium. Each Diclomax SR capsule contains
75mg of diclofenac sodium. The other ingredients are sucrose, maize starch,
polyethylene glycol 6000, ammonio methacrylate copolymer type A, talc, lactose,
polysorbate 80, gelatin, yellow iron oxide (E172), titanium dioxide (E171) and
imprinting ink (shellac, black iron oxide (E172) and propylene glycol).
What Diclomax Retard 100mg Capsules contain
The active substance is diclofenac sodium. Each Diclomax Retard capsule
contains 100mg of diclofenac sodium. The other ingredients are sucrose, maize
starch, polyethylene glycol 6000, ammonio methacrylate copolymer type A, talc,
lactose, polysorbate 80, gelatin, titanium dioxide (E171) and imprinting ink
(shellac, black iron oxide (E172) and propylene glycol).
What Diclomax Capsules look like and contents of the pack
Diclomax SR 75mg Capsules are yellow capsules with “Diclomax SR 75mg”
printed on them in black ink. They are available in blister packs of 4 and 56
capsules.
Diclomax Retard 100mg Capsules are white capsules with “Diclomax Retard”
printed on them in black ink. They are available in blister packs of 28 capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturers
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
Mipharm SpA
Via Bernardo Quaranta 12
20141- Milan
Italy
This leaflet was last approved in April 2012.
Diclomax is a trademark

Medicines such as Diclomax may be associated with a small increased risk of
heart attack (“myocardial infarction”) or stroke.
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.

5. HOW TO STORE DICLOMAX
Keep out of the reach and sight of children.
Store Diclomax SR 75mg Capsules between 10˚C and 25˚C. Do not refrigerate.
Store in the original packaging to protect the capsules from moisture.
Diclomax Retard 100mg Capsules do not require any special storage conditions.
Do not use Diclomax after the expiry date which is stated on the carton and
blister foil. The expiry date refers to the last day of that month.

UK/932437
08/03/12

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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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