Skip to Content

DICLOFENAC SODIUM 25 MG GASTRO-RESISTANT TABLETS

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM / DICLOFENAC SODIUM

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

TEVA UK Ref:

231-30-84233-G LEA DICLOFENAC A/S TAB TUK
Version:

3

08 December 2016

BLACK
PANTONE® GREEN C
Template

DICLOFENAC SODIUM 25 mg AND Medicines such as diclofenac may be
with a small increased risk of heart
50 mg GASTRO-RESISTANT TABLETS associated
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.
Read all of this leaflet carefully before you
• If you have heart problems, previous stroke
start taking this medicine because it contains
or think that you might be at risk of these
important information for you.
conditions (for example if you have high
• Keep this leaflet. You may need to read it again.
blood pressure, diabetes, or high cholesterol
• If you have any further questions, ask your
or are a smoker) you should discuss your
doctor or pharmacist or nurse.
treatment with your doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
Other medicines and Diclofenac
harm them, even if their signs of illness are
Tell your doctor or pharmacist if you are taking
the same as yours.
• If you get any side effects, talk to your doctor or have recently taken or might take any other
medicines– even medicines you bought yourself
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. without a prescription. Medicines can
sometimes interfere with each other. Your doctor
See section 4.
may limit your use of a medicine or you may
What is in this leaflet:
need to take a different medicine. It is especially
important to mention any of the following:
1. What Diclofenac is and what it is used for
2. What you need to know before you take
• any other non-steroidal anti-inflammatory
Diclofenac
drug (NSAID) for pain relief such as
3. How to take Diclofenac
ibuprofen, aspirin or cyclooxygenase-2
4. Possible side effects
selective inhibitors. Taking two or more
5. How to store Diclofenac
NSAID medicines at the same time is not
6. Contents of the pack and other information
recommended, but your doctor may decide
that it is necessary for your treatment and
the benefits you will gain outweigh the risks
1 What Diclofenac is and what it is
used for
• aspirin in order to prevent blood clots
Diclofenac is a non-steroidal anti-inflammatory • medicines for high blood pressure e.g. betablockers or ACE inhibitors
(NSAID) drug.
• medicines for high blood sugar e.g. gliclazide
• diuretics ("water tablets") e.g. spironolactone
Diclofenac 25 mg and 50 mg Gastro-resistant
• cardiac glycosides e.g. digoxin
Tablets are used to relieve pain and
• lithium (used to treat some mental problems)
inflammation in conditions such as:
• methotrexate (for some inflammatory
• rheumatoid arthritis
diseases and some cancers)
• osteoarthrosis
• ankylosing spondylitis (arthritis of the spine) • mifepristone (a medicine used to terminate
pregnancy)
• low back pain
• other conditions affecting the muscles, joints, • corticosteroids, which are drugs given to
treat a variety of conditions such as allergies
tendons and bones e.g. strains, sprains,
and hormone imbalances e.g. prednisolone
fractures or dislocations
• anti-coagulants e.g. warfarin
• acute gout
• immunosuppressive agents e.g. ciclosporin,
• dental and other minor surgery.
tacrolimus
Diclofenac 25 mg Gastro-resistant Tablets may
• quinolone antibiotics e.g. ciprofloxacin,
also be used to relieve juvenile chronic arthritis.
ofloxacin
• drugs for depression called selective
Children aged 9 years and above
serotonin reuptake inhibitors (SSRIs)
Diclofenac 25 mg Gastro-resistant Tablets may
be used as a short treatment for fever, caused • zidovudine, used to treat HIV infection
• phenytoin (used to treat fits)
due to infections of the ear, nose or throat.
• colestipol, cholestyramine (used to reduce
Diclofenac 25 mg Gastro-resistant Tablets may
the amount of cholesterol and certain fatty
be used alone or as an additional therapy with
substances in your blood)
other pain killers to relieve pain caused due to • sulfinpyrazone (used to treat gout)
surgery.
• voriconazole (used to treat fungal infection).
Package leaflet:
Information for the user

2

What you need to know before
you take Diclofenac

Do not take Diclofenac:
• if you are allergic to diclofenac sodium or
any of the other ingredients of this medicine
(listed in section 6)
• if you have experienced asthma, an itchy or
runny nose, skin rashes or breathing
difficulties after taking any other NSAID
(Non-steroidal anti-inflammatory drugs)
e.g. aspirin or ibuprofen
• if you have, or have ever had, peptic
ulceration (ulcer in your stomach or
duodenum)
• if you have ever experienced stomach or
intestinal bleeding (black tarry stools or
vomiting blood) after taking any other
NSAID
• if you have severe liver, kidney or heart
problems
• if you are more than 6 months pregnant or
you are planning to become pregnant (see
‘Pregnancy, breast-feeding and fertility’)
• 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)
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking diclofenac gastro-resistant tablets:
• if you suffer from any stomach or bowel
disorders such as ulcerative colitis or
Crohn’s disease
• if you suffer from a disease called porphyria
(symptoms of porphyria are discolouration of
the urine, serious skin disorders, anaemia,
abdominal pains and severe mental disorders)
• if you suffer from or have in the past
suffered from asthma
• if you suffer from serious illness with
blistering of the skin, mouth, eyes and genitals
or connective tissue disorders such as lupus
• if you notice skin rash or appearance of
lesions after starting this medicine, please
seek medical advice immediately
• if you suffer from runny nose, nasal polyps,
chronic lung disease or chronic lung infection
• if you suffer from kidney, liver or heart
problems or if you are elderly or recovering
from major surgery
• if you smoke
• if you suffer from diabetes
• if you have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides.
Side effects may be minimised by using the
lowest effective dose for the shortest duration
necessary.
This medicine may mask the sign and
symptoms of infection.
Your doctor may decide to monitor your
kidney function, liver function, blood sugar
and blood cell counts whilst you are taking
diclofenac sodium.

REG0051904

Version 6.4

Diclofenac with food and drink
Take this medicine with or after food.
Pregnancy, breast-feeding and fertility
• DO NOT take Diclofenac if you are more than
6 months pregnant
• If you are less than 6 months pregnant, ask your
doctor for advice before taking this medicine
• 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.
• Diclofenac should not be taken if you are
breast-feeding, therefore please talk to your
doctor before taking this medicine.
Driving and using machines
• Diclofenac may cause dizziness, drowsiness,
tiredness, and problems with your vision.
• DO NOT drive or operate machinery if you
are affected.
Diclofenac tablet contains Lactose
• Patients who are intolerant to lactose should
note that Diclofenac tablets contain a small
amount of lactose. If your doctor has told you
that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
Diclofenac tablets contain Sunset yellow (E110)
Sunset yellow may cause allergic reactions

3

How to take Diclofenac

Always take this medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably
with a drink of water, with or after food. DO
NOT chew the tablets. The tablets have been
coated with a substance, which allows them to
pass through the stomach before dissolving. It
is important that the coating is not damaged
by chewing. The recommended dose is:
• Adults
75 – 150 mg a day, in divided doses. The
maximum daily dose is 150 mg.
• Elderly
Elderly patients should take the lowest
effective dose for the shortest possible time
to reduce the risk of side effects.
Use in children and adolescents
• Children 1 year old and over
The dose depends on the child’s body
weight. Your doctor will calculate the
appropriate dose for your child.
• Children under 1 year old
Diclofenac is not recommended for use in
children under 1 year old.
For treatment of surgical pain and fever
caused due to infections of the ear and nose in
children aged 9 years (with minimum 35 kg
bodyweight) or over and adolescents
• The dose depends on the bodyweight and
severity of the disorder. Your doctor will
decide the appropriate dose.
Diclofenac 50 mg Gastro-resistant Tablets
should not be used in children under 12 years
of age.

Approved

Page 1 of 3

If you take more Diclofenac than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately.
An overdose is likely to cause headache,
feeling sick, being sick, stomach pain, intestinal
bleeding, diarrhoea, breathing problems,
coma, drowsiness, dizziness, fits, ringing in the
ears and fainting.
Please take this leaflet, any remaining tablets,
and the container with you to the hospital or
doctor so that they know which tablets were
consumed.

• inflammation of lungs, symptoms you may feel
are like fever, shortness of breath, chills etc
• inflammation of colon causes abdominal
pain or diarrhoea, aggravation of existing
digestive problems such as colitis and
Crohn’s disease, constipation, inflammation
or ulceration of the mouth e.g. mouth ulcers
and cold sores, inflammation of the tongue.
• throat lesions, damage of colon, narrowing
of the intestine.
Not known: frequency cannot be estimated
from the available data
• optic nerve inflammation, sensation disorders
• difficulty in getting and maintaining an
erection.

If you forget to take Diclofenac
If you forget to take a tablet, take one as soon
as you remember, unless it is nearly time to
take the next one. DO NOT take a double dose
to make up for a forgotten dose.

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
If you have any further questions on the use of Yellow Card Scheme at:
this product, ask your doctor or pharmacist.
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
If you stop taking Diclofenac
more information on the safety of this medicine.
Do not suddenly stop taking your tablets as side
effects may occur. If treatment is to be stopped
5 How to store Diclofenac
your doctor will gradually reduce your dose.
Keep this medicine out of the sight and reach
If you have any further questions on the use of
of children.
this product, ask your doctor or pharmacist.
The tablets should be stored below 25°C, in a
dry place in the original package or container
Possible
side
effects
4
supplied. Keep the container tightly closed. Do
Like all medicines, this medicine can cause side not transfer them to another container.
Do not use this medicine after the expiry date
effects, although not everybody gets them.
that is stated on the outer packaging. The
Serious side effects:
expiry date refers to the last day of that month.
Stop taking the tablets and tell your doctor
Do not throw away any medicines via
immediately or go to the casualty department wastewater or household waste. Ask your
at your nearest hospital if the following
pharmacist how to throw away medicines you
happens at any time during your treatment:
no longer use. These measures will help
protect the environment.
Rare: may affect up to 1 in 1,000 people
• A severe allergic reaction (swelling of the
lips, face or neck leading to severe difficulty
in breathing; skin rash or spots, eczema,
redness of the skin, scaly skin, bruise like
rash, itching very low blood pressure or
shock and hives)
• passing blood in your faeces (stools/motions)
• yellowing of the skin or whites of the eyes,
blood problems, inflammation of liver, liver
disorders
• passing black tarry stools
• vomiting any blood or dark particles that
look like coffee grounds
Very rare: may affect up to 1 in 10,000 people
• a serious illness with blistering of the skin,
mouth, eyes and genitals (Stevens-Johnson
syndrome)
• ringing in the ears, hearing impairment
• blood disorders such as anaemia, reduction
in the number of white blood cells, which
may be characterised by fever or chills, sore
throat, ulcers in your mouth or throat and
infection
• a severe blistering rash in which the surface
layers of the skin may peel off (Lyell's
syndrome)
• symptoms which include stiff neck,
headache, feeling and being sick, fever or
disorientation, particularly in patients with
systemic lupus erythematosus (SLE) or
connective tissue disorders, signs of serious
inflammation of the linings of the brain
(Aseptic meningitis),
• palpitations, chest pain and heart failure
(myocardial infarction), stroke
• severe liver disorders including acute liver
failure.
• kidney failure, blood in the urine, increased
amount of protein in the urine, severe kidney
disorders
• inflammation of the pancreas (pancreatitis),
which causes severe pain in the abdomen
and back.
Not known: frequency cannot be estimated
from the available data
• mild cramping and tenderness of the
abdomen, starting shortly after the start of
the treatment with diclofenac and followed
by rectal bleeding or bloody diarrhoea
usually within 24 hours of the onset of
abdominal pain.

6

Contents of the pack and other
information

What Diclofenac Gastro-resistant Tablets
contain:
• The active ingredient is diclofenac sodium,
25 mg or 50 mg
• The other ingredients are lactose
monohydrate, maize starch, povidone
(E1201), sodium starch glycolate (Type A),
colloidal anhydrous silica and magnesium
stearate (E572). The gastro-resistant coating
contains hydroxypropyl methylcellulose
(E464), citric acid monohydrate (E330),
methacrylic acid copolymer, purified talc
(E553b), polyethylene glycol (E1520) and the
colours are titanium dioxide (E171), sunset
yellow (E110) and iron oxide yellow (E172).
The 50 mg tablets also contain iron oxide
red (E172). The 25 mg tablets also contain
quinoline yellow (E104). The black printing
ink contains shellac, iron oxide black (E172)
and propylene glycol (E1520).
What Diclofenac Gastro-resistant Tablets look
like and contents of the pack:
• The 25 mg tablets are yellow, round,
biconvex, bevel-edged, gastro-resistant
tablets. They are printed ‘25’ over ‘0518’ and
plain on the reverse.
• The 50 mg tablets are tan, round, biconvex,
bevel-edged, gastro-resistant tablets. They
are printed ‘50’ over ‘0519’ and plain on the
reverse.
• The product is available in pack sizes of 10,
20, 28, 30, 50, 56, 60, 84, 100, 250, 500, and
1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder: TEVA UK
Limited, Eastbourne, BN22 9AG.
Company Responsible for Manufacture: TEVA
Pharmaceutical Works Private Limited Company,
Pallagi street 13 Debrecen, H-4042, Hungary.
This leaflet was last revised in 12/2016
PL 00289/0738 and 0739

Other side effects
The following side effects have also been
reported. If you feel unwell with any of these
side effects tell you doctor:
Common: may affect up to 1 in 10 people
• headache, dizziness, spinning
• feeling sick, being sick, nausea, vomiting,
loose stools, abdominal pain, indigestion or
heartburn
• wind, loss of appetite
• abnormal liver function tests
Rare: may affect up to 1 in 1,000 people
• drowsiness, tiredness
• inflammation of the lining of the stomach,
vomiting blood, ulcers.
• nettle rash
• hypotension (low blood pressure, symptoms
of which may include faintness, giddiness or
light headedness)
• fluid retention resulting in swelling of the
ankles or feet.
Very rare: may affect up to 1 in 10,000 people
• abnormal sensation of skin (e.g. tingling,
numbness), memory impairment, fits,
anxiety, shaking, taste disorders, stroke
• depression, difficulty in sleeping,
nightmares, irritability and psychological
problems
• visual disturbances, blurred vision and
double vision
• loss of hair, sensitivity to light
• high blood pressure and inflammation of
blood vessels, often with skin rash

REG0051904

Version 6.4

Approved

84233-G

Page 2 of 3

Expand Transcript

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.

Hide