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DICLO-XL 100

Active substance(s): DICLOFENAC SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DICLO-XL 100

[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, health
care provider 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 Diclo-XL 100 are and what they are used for
2. Before you take Diclo-XL 100
3. How to take Diclo-XL 100
4. Possible side effects
5. How to store Diclo-XL 100
6. Further information
1. What Diclo-XL 100 are and what they are used for
Diclofenac is one of the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Diclo-XL 100 may be used for the relief of pain and swelling
in a wide range of chronic (long-term) (arthritis affecting
the joints) conditions including arthritis (swelling of a joint),
osteoarthritis and ankylosing spondylitis (arthritis affecting the
spine and pelvis).
Diclo-XL 100 is specially formulated to release the active
ingredient slowly, over a long period of time.
2. Before you take Diclo-XL 100
Do not take if you have a peptic ulcer (ulcer in your stomach
or duodenum) bleeding in your stomach, or have had two
or more episodes of peptic ulcers, stomach bleeding or
perforation.
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate
medical help:
• Pass blood in your faeces (stools/motions)
• Pass tarry black stools
• Vomit any blood or dark particles that look like coffee
grounds.
• STOP TAKING the medicine and tell your doctor if you
experience: indigestion or heartburn, abdominal pain
(pains in your stomach) or other abnormal stomach
symptoms.
Do not take Diclo-XL 100 and tell your doctor if you:

Have a history of stomach bleeding or perforation
which may be related to the use of NSAIDs (naproxen,
ibuprofen, diclofenac) or aspirin.

Are hypersensitive (allergic) to Diclofenac or any other
ingredients in this medicine (see section 6. Further
information).

Have a history of allergy to aspirin, ibuprofen or NSAIDs,
which includes attacks of asthma, swelling of the nose
and throat, skin rashes or a runny nose.

Have inflammatory bowel disease.

Suffer from severe kidney, heart or liver disease

Suffer from epilepsy

Are in the last trimester of pregnancy

Are taking medicines for blood clots (for example warfarin)

If you established heart disease and/ or cerebrovascular
disease e.g. if you have had a heart attack, stroke, ministroke (TIA) or blockages to blood vessels to the heart or
brain or an operation to clear bypass blockages

If you have or have had problems with your blood
circulation (peripheral arterial disease).
Take special care with Diclo-XL 100 and tell your doctor if
you:

Suffer from asthma

Are an older person

Have System Lupus Erythematous (SLE or ‘Lupus’) or
other connective tissue disorders

Have ulcerative colitis or Crohn’s disease

Have porphyria (enzyme deficiency affecting the
chemicals responsible for blood production in the body).

Make sure your doctor knows, before you are given
diclofenac:

If you smoke

If you have diabetes

If you have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides.
Medicines such as Diclo-XL 100 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.
Side effects may be minimised by using the lowest effective
dose for the shortest duration necessary.
If you go into hospital to see a doctor or you have a dental
appointment, tell them that you are taking Diclo-XL 100.
If you suffer from any blood or bleeding disorder your doctor
may ask you to have regular check ups while taking these
tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Especially:

Aspirin, ibuprofen or other non-steroidal anti inflammatory
drugs for pain relief (e.g naproxen, diclofenac)

Anticoagulants such as warfarin to prevent blood clots

Antihypertensives to treat high blood pressure

Methotrexate and ciclosporin used to treat rheumatoid
arthritis and psoriasis

Corticosteroids used as anti-inflammatory treatments

Mifepristone (now or at any time in last 12 days)

Lithium used in the treatment of depression

Diuretics (water tablets) used to treat blood pressure and
water retention

Digoxin used to treat heart problems

Phenytoin used to treat epilepsy

Sulphonylureas such as gliclazide or glibenclamide used
to treat diabetes

Probenecid used to treat gout

SSRIs (Selective serotonin reuptake inhibitors) used to
treat depression such as fluoxetine and paroxetine

Anti-platelet agents used to prevent blood clots from
forming that can lead to heart attack or stroke e.g aspirin,
clopidogrel, ticlopidine, dipyridamole

Tacrolimus used for immunosuppression

Zidovudine used in the treatment of AIDS and HIV
infection

Trimethoprim used to prevent or treat urinary tract
infections

Colestipol/cholestyramine used to lower cholesterol

Voriconazole used to treat fungal infections

Quinolone antibiotics used to treat infections.
Taking Diclo-XL 100 with food and drink
Always take the tablets with plenty of water, preferably with a
meal. Try to take them at the same times every day.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant, planning on becoming pregnant
or are breast-feeding.
Diclo-XL 100 should not be taken in the last 3 months of
pregnancy.
Diclofenac does pass into the mother’s milk; therefore breastfeeding should be avoided if taking Diclo-XL 100.
Diclo-XL 100 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
Undesirable effects such as dizziness, drowsiness and tiredness
and visual disturbances are possible after taking medicines of
this type. If you are affected do not drive or operate machinery.
Important information about some of the ingredients of
Diclo-XL 100
This medicine contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Diclo-XL 100

Always take Diclo-XL 100 exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure. The lowest effective dose should be used for the shortest
possible time.

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Very rare side effects (These may affect less than 1 in every
Adults (including older people):
The usual dose is 100mg (one tablet) daily, taken whole with 10,000 patients):
Effects on the nervous system:
plenty of water preferably with food or after food.
Older patients are more likely to experience side effects. Tingling or numbness in the fingers, tremor, blurred or double
Therefore treatment should be started on the lowest possible vision, hearing loss or impairment, tinnitus (ringing in the
dose for the shortest possible duration. Your doctor should ears), sleeplessness, nightmares, mood changes, depression,
anxiety, mental disorders, disorientation and loss of memory,
monitor your condition regularly.
fits, headaches together with a dislike of bright lights, fever and
Children: Not recommended
a stiff neck, impotence.
If you take more Diclo-XL 100 than you should
Effects on the stomach and digestive system:
If you accidently take too many Diclo-XL 100 tablets, tell your Constipation, inflammation of the tongue, mouth ulcers,
doctor at once. If you can’t do this, go to the nearest casualty inflammation of the inside of the mouth or lips, taste changes,
department. Take along any tablets that are left, the container lower gut disorders (including inflammation of the colon or
and the label so that the hospital staff can easily tell what worsening of ulcerative colitis or Crohn’s disease, inflammation
of the pancreas (pain, feeling sick and being sick).
medicine you have taken.
Effects on the heart, chest or blood:
If you forget to take Diclo-XL 100
If you forget to take a dose, take it as soon as you remember Palpitations (fast or irregular heart beat), chest pain,
unless it is time for your next dose. Do not take a double dose hypertension (high blood pressure), inflammation of blood
vessels (vasculitis), heart disorders, including congestive heart
to make up for a forgotten dose.
failure, hypotension (low blood pressure, symptoms of which
If you stop taking Diclo-XL 100
include faintness, giddiness or lightheadedness).
Continue to take the tablets for as long as your doctor tells
Effects on the liver or kidneys:
you to. Talk to your doctor if you have any concerns.
Kidney or severe liver disorders including liver failure, presence
of blood or protein in the urine.
4. Possible side effects
Like all medicines, Diclofenac can cause side effects, although Effects on skin or hair:
not everybody gets them.
Skin rashes which may be made worse by exposure to sunlight.
Hair loss, itching, facial swelling.
Serious side effects:
If you suffer from any of the following side effects, STOP Not known side effects (These cannot be estimated from
TAKING the tablets and seek immediate medical help:
the available data):
Pass blood in your faeces (stools/motions)
Confusion, hallucinations, malaise (general feeling of
Pass black tarry stools
discomfort), inflammation of the nerves in the eye, disturbances
Vomit any blood or dark particles that look like coffee in sensation.
grounds
STOP TAKING the medicine and tell your doctor if you Reporting of side effects
experience: Indigestion or heartburn, abdominal pain If you get any side effects, talk to your doctor, pharmacist or
(pains in your stomach) or other abnormal stomach nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
symptoms.
Card Scheme at: www.mhra.gov.uk/yellowcard
Medicines such as Diclofenac may be associated with a
small increased risk of heart attack (myocardial infarction) By reporting side effects you can help provide more information
on the safety of this medicine.
or stroke.
If you experience any of the following stop taking the tablets
and contact your doctor immediately:

All medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your doctor
straight away if you get any sudden wheeziness, difficulty
in breathing, swelling of the eye lids, face or lips, rash,
reddening of the skin or itching (especially affecting your
whole body)

Severe painful skin disorder with blisters and peeling skin.
You may also have flu-like symptoms such as fever or sore
throat (Steven’s Johnson Syndrome)

Jaundice with symptoms of yellowing of eyes and skin

Diarrhoea (stop taking Diclo-XL 100 and do not take it
again)

Blood disorders; you may have a persistent sore throat or
high temperature, anaemia (feeling tired after exercising,
giddiness, looking pale)

Respiratory problems: including inflammation of the
lungs which causes breathlessness, cough and raised
temperature and aggravated asthma.

5. How to store Diclo-XL 100

Keep out of the sight and reach of children.
Keep the tablets in a dry place at normal room temperature
(below 25° C) in the packaging they come in.
Do not use Diclo-XL 100 after the expiry date which is stated on
the label. The expiry date refers to the last day of that month.
Do not use Diclo-XL 100 if you notice visible signs of
deterioration.
Medicines should not be disposed of via waste water 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 Diclo-XL 100 contains.
The active substance(s) is Diclofenac sodium Ph Eur.
The other ingredients are:
Lactose Monohydrate
Magnesium Stearate
Hydrogenated vegetable
oil type IUSNF (Sterotex)
The side effects listed below have also been reported.
Povidone K30
Common side effects (These may affect between 1 and 10
Talc
in every 100 patients):

Nausea, vomiting, wind, loss of appetite
What Diclo-XL 100 looks like and contents of the pack

Headache, dizziness, vertigo
Description: White, circular, biconvex tablets

Skin rash or spots
Contents of pack: Prolonged release tablets; Packs of
28 tablets.

Raised levels of liver enzymes in the blood.
Marketing Authorisation Holder and Manufacturer
Co-Pharma Limited
Unit 4, Metro Centre,
Tolpits Lane, Watford, Herts, UK, WD18 9SS
Tel: 01923 255580
Fax: 01923 255581
This leaflet was last revised in 09/2015.

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1xxxxxx

Rare side effects (These may affect between 1 in every 1000
to 1 in every 10,000 patients):

Gastritis (inflammation, irritation or swelling of the stomach
lining)

Drowsiness, tiredness

Fluid retention, symptoms of which include swollen ankles

Liver function disorders, including hepatitis

Raised, itchy rash (Urticaria).

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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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