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DICLO-XL 100

Active substance(s): DICLOFENAC SODIUM

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F.P.O
PACKAGE LEAFLET: INFORMATION FOR THE USER

DICLO-XL 100

[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 Diclo-XL 100 are and what they are used for
2. What you need to know 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. Contents of the pack and other information

2. What you need to know before you take Diclo-XL 100
Do not take Diclo-XL 100 if:
• You are allergic to diclofenac sodium or any of the other
ingredients of this medicine (listed in section 6)
• You have ever had an allergic reaction to other NSAIDs
(e.g. ibuprofen, aspirin, naproxen), symptoms can include
asthma, swelling of the nose and throat, skin rashes or a
runny nose
• You have now, or have ever had, a stomach (gastric) or
duodenal (peptic) 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 had stomach or bowel problems after you have
taken other NSAIDs
• You have severe heart, kidney or liver failure
• You have 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 or bypass blockages
• You have or have had problems with your blood circulation
(peripheral arterial disease)
• You are in the last trimester of pregnancy.
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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Diclo-XL
100 if you:

Suffer from asthma, or any other breathing condition

Are an elderly person

Have System Lupus Erythematous (SLE or ‘Lupus’) or
other connective tissue disorders

Suffer from any stomach or bowel disorders including
ulcerative colitis or Crohn’s disease

Have porphyria (enzyme deficiency affecting the chemicals
responsible for blood production in the body)

Suffer from any blood or bleeding disorders

Are a female attempting to conceive

Have kidney or liver problems.

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Other medicines and Diclo-XL 100
Tell you doctor, pharmacist or nurse if you are taking, have
recently taken or might take any other medicines.
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 and other medicines used to treat heart problems
• Phenytoin used to treat epilepsy
• Sulphonylureas such as gliclazide or glibenclamide used
to treat diabetes
• 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.

F.P.O

1. What Diclo-XL 100 are and what they are used for
Diclo-XL 100 contains the active substance diclofenac sodium.
Diclofenac sodium 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.

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.

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
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.
Diclofenac does pass into the mother’s milk; therefore breastfeeding should be avoided if taking Diclo-XL 100.
Diclo-XL 100 should not be taken in the last 3 months of
pregnancy.
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 visual disturbances, dizziness,
vertigo, drowsiness and tiredness are possible after taking
medicines of this type. If you are affected do not drive or
operate machinery.
Diclo-XL 100 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 this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure. The
lowest effective dose should be used for the shortest possible
time.
Use in adults and the elderly:
The recommended dose is 100mg (one tablet) daily, taken
whole with plenty of water preferably with food or after food.

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Elderly patients are more likely to experience side effects.
Therefore treatment should be started on the lowest possible
dose for the shortest possible duration. Your doctor should
monitor your condition regularly.
Use in children:
Diclo-XL 100 is not recommended for use in children.
If you take more Diclo-XL 100 than you should
If you accidently take too many Diclo-XL 100 tablets, tell your
doctor at once. If you can’t do this, go to the nearest casualty
department. Take along any tablets that are left, the container
and the label so that the hospital staff can easily tell what
medicine you have taken.
If you forget to take Diclo-XL 100
If you forget to take a dose, take it as soon as you remember
unless it is time for your next dose. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Diclo-XL 100
Continue to take the tablets for as long as your doctor tells
you to. Talk to your doctor if you have any concerns.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Very rare (may affect up to 1 in 10,000 people):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, 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, impotence.
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 Crohn’s disease, inflammation
of the pancreas (pain, feeling sick and being sick).
Effects on the heart, chest or blood:
Hypertension (high blood pressure), inflammation of blood
vessels (vasculitis), hypotension (low blood pressure, symptoms
of which include faintness, giddiness or lightheadedness).
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:
Skin rashes which may be made worse by exposure to sunlight.
Hair loss, itching, facial swelling.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
Not known (frequency cannot be estimated from the
not everybody gets them.
available data):
Confusion, hallucinations, malaise (general feeling of discomfort),
Serious side effects:
If you suffer from any of the following side effects, STOP inflammation of the nerves in the eye, disturbances in sensation,
injury to the large intestine due to poor blood flow (ischaemic
TAKING the tablets and seek immediate medical help:
colitis).
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
Reporting of side effects
- Vomit any blood or dark particles that look like coffee If you get any side effects, talk to your doctor, pharmacist or
grounds
nurse. This includes any possible side effects not listed in this
- Indigestion or heartburn, abdominal pain (pains in your leaflet. You can also report side effects directly via the Yellow
stomach) or other abnormal stomach symptoms.
Card Scheme at: www.mhra.gov.uk/yellowcard or search for
Medicines such as Diclofenac may be associated with a MHRA Yellow Card in the Google Play or Apple App Store.
small increased risk of heart attack (myocardial infarction) By reporting side effects you can help provide more information
or stroke.
on the safety of this medicine.

6. Contents of the pack and other information
What Diclo-XL 100 contains
The active substance is diclofenac sodium. Each tablet contains
100mg diclofenac sodium.
The other ingredients are:
Lactose (see section 2)
Magnesium Stearate
Hydrogenated vegetable
oil type I USNF (Sterotex)
Povidone K30
Talc
What Diclo-XL 100 looks like and contents of the pack
Description: White, circular, biconvex tablets
Contents of pack: Prolonged release tablets; Packs of
28 tablets.

Marketing Authorisation Holder and Manufacturer
Uncommon (may affect up to 1 in 100 people):
Co-pharma
• Palpitations (fast or irregular heart beat)
Unit 4, Metro Centre,
• Chest pain
Tolpits Lane, Watford, Herts, WD18 9SS, UK
• Heart disorders, including congestive heart failure.
Tel: 01923 255580
These symptoms are generally associated in those on longFax: 01923 255581
term treatment with a high dose (150mg per day).
This leaflet was last revised in 12/2017.
Rare (may affect up to 1 in 1,000 people):
• 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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The side effects listed below have also been reported
Common (may affect up to 1 in 10 people):
• Nausea, vomiting, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.

5. How to store Diclo-XL 100
Keep this medicine out of the sight and reach of children.
Store between 15°C and 25°C in a dry place.
Do not use this medicine after the expiry date which is stated
on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

F.P.O

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 (Stevens-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
• An unexpected change in the amount of urine produced
and/or its appearance.

F.P.O
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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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