Skip to Content

DICLO-SR 75

Active substance(s): DICLOFENAC SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

DICLO-SR 75
[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-SR 75 is and what it is used for
2. What you need to know before you take Diclo-SR 75
3. How to take Diclo-SR 75
4. Possible side effects
5. How to store Diclo-SR 75
6. Contents of the pack and other information
1. What Diclo-SR 75 is and what it is used for
Diclofenac is one of the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Diclo-SR 75 may be used for the relief of pain and swelling in
a wide range of conditions including arthritis, musculoskeletal
disorders or gout and pain caused by injury or minor surgery.
Diclo-SR 75 is specially formulated to release the active
ingredient slowly, over a long period of time.
2.What you need to know before you take Diclo-SR 75
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-SR 75 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. Contents of
the pack and other 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)

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 bypass blockages

If you have or have had problems with your blood
circulation (peripheral arterial disease).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Diclo-SR 75 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

Suffer from heart problems

Suffer from liver or kidney problems

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-SR 75 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-SR 75.
If you suffer from any blood or bleeding disorder your doctor
may ask you to have regular check ups while taking these
tablets.
Other medicines and Diclo-SR 75
Tell your 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 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.
Diclo-SR 75 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
breast-feeding should be avoided if taking Diclo-SR 75.
Diclo-SR 75 should not be taken in the last 3 months of
pregnancy.
Diclo-SR 75 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.
Diclo-SR 75 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-SR 75

Always take Diclo-SR 75 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.

--- 180 x 280mm --- FRONT PAGE

DICLO-SR 75
CO-PHARMA

Pack Insert

180 x 280mm - Same Size
1027299
Black
***
Front & Back Printing. To be supplied in unfolded size.
60 GSM Paper.
Printing clarity to be clear & sharp.

-1026207
1
2.0

Older 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.
Children: Not recommended
If you take more Diclo-SR 75 than you should
If you accidently take too many Diclo-SR 75 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-SR 75
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-SR 75
Continue to take the tablets for as long as your doctor tells
you to. Talk to your doctor if you have any concerns.

4. Possible side effects

Like all medicines, Diclofenac can cause side effects, although
not everybody gets them.
Serious side effects:
If you suffer from any of the following side effects, STOP
TAKING the tablets and seek immediate medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry 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.
Medicines such as Diclofenac may be associated with a
small increased risk of heart attack (myocardial infarction)
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 (Stevens Johnson Syndrome)

Jaundice with symptoms of yellowing of eyes and skin

Diarrhoea (stop taking Diclo-SR 75 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.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10
in every 100 patients):

Nausea, vomiting, wind, loss of appetite

Headache, dizziness, vertigo

Skin rash or spots

Raised levels of liver enzymes in the blood.
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).

Very rare side effects (These may affect less than 1 in every
10,000 patients):
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:
Palpitations (fast or irregular heart beat), chest pain,
hypertension (high blood pressure), inflammation of blood
vessels (vasculitis), heart disorders, including congestive heart
failure, 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.
Not known side effects (These cannot be estimated from
the available data):
Confusion, hallucinations, malaise (general feeling of
discomfort), inflammation of the nerves in the eye, disturbances
in sensation.
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 Diclo-SR 75

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-SR 75 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-SR 75 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. Contents of the pack and other information
What Diclo-SR 75 contains.
The active substance(s) is Diclofenac sodium Ph Eur.
The other ingredients are:
Ethanol
Lactose Monohydrate
Magnesium Stearate
Methylhydroxpropylcellulose
Microcrystalline cellulose
Iron oxide red (E172)
Povidone
Talc

What Diclo-SR 75 looks like and contents of the pack
Description: Light-pink, round convex tablets
Contents of pack: Prolonged release tablets; Packs of 28 and
56 tablets.
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

1027299

Adults (including older people):
The usual dose is one tablet once or twice daily, taken whole
with plenty of water preferably with food or after food.

Leaflet was last revised in 09/2015.

--- 180 x 280mm --- BACK PAGE

DICLO-SR 75
CO-PHARMA

Pack Insert

180 x 280mm - Same Size
1027299
Black
***
Front & Back Printing. To be supplied in unfolded size.
60 GSM Paper.
Printing clarity to be clear & sharp.

-1026207
1
2.0

Expand view ⇕

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