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DICLOMAX SR

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM

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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
because it contains important information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor, pharmacist or nurse.
− This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
− If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Diclomax is and what it is used for
2. What you need to know before you take Diclomax
3. How to take Diclomax
4. Possible side effects
5. How to store Diclomax
6. Contents of the pack and other 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, osteoarthritis, low back pain and
sprains or broken bones, or to control pain and inflammation following
orthopaedic, dental and other minor surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOMAX
Do not take Diclomax if
− you are allergic (hypersensitive) to diclofenac sodium or any of the
other ingredients of Diclomax (listed in section 6 of this leaflet)
− you have ulcers in the stomach or small intestine (gastric or
duodenal ulcers) or bleeding in your stomach or intestines (this
can include blood in vomit, bleeding when emptying bowels, fresh
blood in stools or black, tarry stools)
− you have a history of ulcers or bleeding in your stomach or
intestines that has occurred at least twice
− you have any history of bleeding or perforation in your stomach or
intestines related to the use of any anti-inflammatory medicines
− you are allergic to aspirin, ibuprofen or any other anti-inflammatory
medicines used to treat painful conditions
− your doctor has told you that you have acute porphyria
− you are in your last three months of pregnancy
− 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)
− your doctor has told you that you have an intolerance to sugars
called lactose or sucrose.
− you have severe liver, kidney or heart failure
Diclomax Capsules are not recommended for children.
Talk to your doctor before taking this product if any of the above apply to you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Diclomax
− if you are elderly
− if you are taking any other NSAIDs (non-steroidal anti-inflammatory drugs)
− if you smoke
− if you have diabetes
− if you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
or if you suffer from any of the following conditions:
− stomach or bowel disorders including Crohn’s disease or ulcerative colitis
− heart problems
− liver or kidney disease
− if you have ever had asthma, hayfever or other allergies, polyps in
your nose, difficulty breathing (COPD) or long-term respiratory infections
− 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)
− 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.
Tell your doctor if you are about to have major surgery.
If you go into hospital or visit a dentist or any other doctor, tell them
that you are taking this medicine.

Other special warnings
− If you have a history of stomach problems when you take NSAIDs,
particularly if you are elderly, you must tell your doctor straight
away if you notice any unusual symptoms.
− Medicines such as Diclomax 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.
− Because it is an anti-inflammatory medicine, Diclomax can make
the symptoms of an infection (such as fever or pain) less noticeable.
Other medicines and Diclomax
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other 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 or
anti-platelet medicine (e.g. low dose aspirin) used to prevent blood
clots forming
− methotrexate – used in cancer and certain inflammatory diseases
like rheumatoid arthritis
− lithium – a medicine used to treat mental health problems
− 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
− oral 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)
− oral medicines for diabetes (e.g. hypoglycaemic agents)
− cardiac glycosides (e.g. digoxin) - medicines used to treat heart problems
− 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.
− phenytoin – a medicine used to treat seizures
− colestipol and colestyramine – medicines used to lower cholesterol
− voriconazole – a medicine used to treat fungal infections.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Abnormalities have been reported in babies whose mothers have
taken NSAIDs during pregnancy. You should not take diclofenac during the
last three months of pregnancy as it may affect the baby’s kidney
function and circulation, blood clotting in both the mother and baby,
and labour.
Diclofenac should be avoided if you are breast-feeding, as small
amounts of the medicine may pass into breast milk.
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
It is usually 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.
Diclomax contains 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.
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diclomax can cause side effects, although not
everybody gets them. Side effects may be minimised by using the
lowest effective dose for the shortest duration necessary.
If you get any of the following side effects after taking
Diclomax, STOP taking them and seek urgent medical
advice immediately:
• Allergic reactions which can include difficulty in breathing or
starting to wheeze, swelling of the face, lips, tongue or throat
• Stomach or intestinal ulcers, or intestinal bleeding (there have been
very rare reported cases resulting in death particularly in the elderly)
causing severe stomach pain, vomiting blood or dark coffee
ground-like material, passing bloody or black tar-like stools,
diarrhoea with blood in it
• Severe skin rash, itching, bruising, painful red areas, peeling or
blistering
• Yellowing of your skin or the whites of your eyes (jaundice)
• An unexpected change in the amount of urine produced and/or its
appearance or blood in your urine
• Bruising more easily than usual or frequent sore throats or infections
• Small red or purple spots on your skin
• Stiff neck, headache, disorientation, nausea and/or vomiting
associated with fever
• Medicines such as Diclomax may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke
• Mild cramping and tenderness of the abdomen, starting shortly after
the start of the treatment with Diclomax 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 side effects listed below have also been reported:
Common: may affect up to 1 in 10 people
− stomach pain
− nausea
− vomiting
− loss of appetite
− skin rash
− raised levels of liver enzymes in the blood
− diarrhoea
− flatulence (excess wind)
− heartburn (indigestion)
− headache
− dizziness
− vertigo (condition that affects balance)
Rare: may affect up to 1 in 1,000 people
− liver problems, including hepatitis (inflammation of the liver)
− gastritis (inflammation or irritation of the stomach lining)
− asthma (including shortness of breath)
− oedema (water retention/swelling)
− raised itchy rash
− sleepiness
Very rare: may affect up to 1 in 10,000 people
− problems with sight including blurred or double vision
− ringing in the ears (tinnitus)
− hearing loss
− depression
− disorientation
− sleeplessness
− nightmares
− irritability
− mental disorders
− loss of memory
− fits
− anxiety
− tremor
− taste changes
− “pins and needles” or numbness, tingling or itching of the skin
− various skin disorders including eczema, redness of the skin and
increased sensitivity to sunlight
− angioedema (swelling under the skin, particularly around the eyes
and lips)
− hair loss
− itch
− rapidly progressive hepatitis
− liver damage and failure
− kidney problems including kidney failure and presence of blood or
protein in the urine
− palpitations (fast or irregular heart beat)
− chest pain
− heart failure
− hypertension (high blood pressure)
− inflammation of blood vessels (vasculitis)
− inflammation of the lungs (pneumonitis)
− inflammation of the colon (including worsening of ulcerative
colitis or Crohn’s disease)
− constipation
− inflammation of the mouth (including mouth ulcers)
− inflammation of the tongue
− oesophageal disorders (causes symptoms such as difficulty
swallowing)
− narrowing of the intestine
− inflammation of the pancreas (pancreatitis)

Not known: frequency cannot be estimated from the available data
− confusion
− hallucination (imagining something that is not really there)
− low numbers of white blood cells
− inflammation of the nerves in the eye
− worsened asthma or wheeze
− tiredness
− general feeling of being unwell (malaise)
Reporting of 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 DICLOMAX
Keep this medicine out of the sight and reach of children.
Diclomax does 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.
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.
6. CONTENTS OF THE PACK AND OTHER 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 4 and 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 revised in November 2016.

Diclomax is a trademark

UK/933119
07/16

Client: Galen

Code: TBC

Job Title: Diclomax SR 75mg Capsules PIL
Revision: 10
Size: 210 x 360mm
Date: 1/12/16
Pharmacode: TBC
Barcode:
Keyline/Die Ref

Colours:

Black
2D Pharma Area

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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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