Patient leaflet - Diclofenac tablets BP 25 mg

1. What Diclofenac Tablets are and what they are used for

2. What you need to know before you take Diclofenac Tablets

medicines to thin the blood/prevent clotting (anti-coagulants or antiplatelet drugs) such as warfarin, clopidogrel
How to take Diclofenac Tablets
Possible side effects
How to store Diclofenac Tablets
aspirin or other NSAIDs e.g. ibuprofen, naproxen, COX-2 inhibitors such as celecoxib
Contents of the pack and other information
What Diclofenac Tablets are and what they are used for
any medicines for diabetes e.g. glibenclamide, gliclazide, metformin
medicines to treat high blood pressure or heart problems including water tablets (diuretics) such as furosemide, ACE inhibitors (e.g. enalapril), beta-blockers (e.g. atenolol) or cardiac glycosides (e.g. digoxin)

Diclofenac Tablets belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). It is most commonly used for relief of pain and stiffness and to reduce swelling in a variety of conditions including: rheumatoid arthritis, osteoarthritis, low back pain, sprains, strains, dislocations, fractures, ankylosing spondylitis, inflammation of tendons and tendon sheaths, stiff joints and frozen shoulder, bursitis (e.g. housemaid’s knee), acute gout, and pain following orthopedic, dental and other minor surgical procedures. Diclofenac Tablets of 25 mg strength only, may also be used in children with juvenile chronic arthritis, and may be used in children aged 9 years and above (and with a minimum body weight of 35 kg) for the short term treatment of fever due to ear, nose or throat infections, or together with another painkiller to relieve pain following an operation.

lithium or a selective serotonin reuptake inhibitor (SSRI) to treat depression e.g. citalopram, fluoxetine, sertraline
methotrexate (a cancer drug which can also be used for treating psoriasis)
ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow transplants)
trimethoprim (used to prevent and treat urinary tract infections)
oral steroids (used in hormone replacement therapy and to treat inflammation) e.g. hydrocortisone, prednisolone
What you need to know before you take Diclofenac Tablets
mifepristone (used to terminate a pregnancy)
quinolone antibiotics (for infections) e.g. ciprofloxacin, ofloxacin

Do not take these tablets if you:

zidovudine (to treat HIV infection)
are allergic to diclofenac or to any of the other ingredients in the tablets (see section 6)
phenytoin (used to treat epilepsy)
colestipol or cholestyramine (used lo lower cholesterol)
have had any form of allergic reaction (such as asthma, blocked or runny nose, swelling of the face or throat, skin rash or itching) to aspirin or any other non-steroidal anti-inflammatory drugs (NSAIDs) or painkillers e.g. ibuprofen, naproxen
medicines known as CYP2C9 inhibitors such as voriconazole (used to treat fungal infections). Other special warnings:
have a stomach ulcer, perforation or bleeding (this can include blood in vomit, bleeding when emptying bowel, fresh blood in faeces or black, tarry faeces), or have previously had two or more episodes of these in the past
Medicines such as diclofenac 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.
have ever had stomach bleeding or perforation caused by taking NSAIDs
Diclofenac may reduce the symptoms usually seen as a result of an infection such as fever or headache, so it you feel unwell and need to see a doctor make sure you tell the doctor you are taking this medicine.
have severe heart, liver or kidney failure
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
Your doctor may want to monitor you whilst you are taking this medicine, particularly if you are taking it for a long time.
have or have had problems with your blood circulation (peripheral arterial disease)
Pregnancy and breastfeeding:
Do not take diclofenac if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take diclofenac during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, diclofenac can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring, Diclofenac may make it more difficult to become pregnant. You should inform your doctor it you are planning to become pregnant or if you have problems becoming pregnant. Effects on driving or operating machinery:
are more than 6 months pregnant (see pregnancy and breastfeeding section).

Check with your doctor before taking these tablets if you:

are elderly, as you may be more likely to suffer side effects (see section 4) and you may be prescribed a lower dose than the usual adult dose
have, or have ever had asthma, as diclofenac might bring on an attack
suffer from hay fever or other allergies, polyps in your nose, breathing problems (COPD) or long-term respiratory infections
have heart, liver or kidney problems
have problems with the way your blood clots
have a history of problems with your stomach or intestines, e.g. ulcerative colitis or Crohn’s disease
have systemic lupus erythematosus (SLE) or mixed connective tissue disorder (an immune system disorder)
have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
have ever had high blood pressure or previously had heart failure
Sometimes these tablets can make you feel dizzy, tired, drowsy, sleepy or might affect your vision. If you think this medicine has affected you, do not drive or operate machinery.
have liver porphyria
are recovering from major surgery
are a smoker
have diabetes
Important information about some of the ingredients of Diclofenac Tablets:
have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking diclofenac or other pain medications
The tablets contain lactose. It you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The tablets also contain methyl and propyl parahydroxybenzoates (E216, E218) which may cause allergic reactions (possibly delayed) and the 25mg tablets also contain tartrazine (E102) which may cause allergic reactions.
tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before receiving/taking/using Diclofenac Tablets, as Diclofenac Tablets can sometimes worsen wound healing in your gut after surgery
you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Tablets. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction.
This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.

3. How to take Diclofenac Tablets

Swallow the tablets whole with a little water. Do not chew the tablets or break them. Take with or after food. Always take the medicine exactly as directed by your doctor. Your doctor will decide the dose that is best

Product: Diclofenac 25mg & 50mg Tablets

Crescent R&D

Amendment Date

for you.

The pharmacist’s label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

Adults:

The usual adult dose is 75 to 150 mg a day, taken in 2 or 3 divided doses. The recommended maximum daily dose is 150 mg.

Elderly:

Your doctor may have told you to take a lower dose than the usual adult dose stated above.

Follow your doctor’s instructions. Your doctor may want to do some tests after you start taking these tablets to check you are not bleeding in your stomach or intestines. Children aged between 1 to 12 years, for juvenile chronic arthritis:

Using Diclofenac Tablets 25 mg, the usual dose is 1-3 mg per kg of bodyweight per day, taken in divided doses.

Children aged 9 years or over (and weighing at least 35 kg), for fever or pain following an operation:

Using Diclofenac Tablets 25 mg, the dose is up to 2 mg per kg of bodyweight per day in 3 divided doses. Diclofenac Tablets 50 mg should NOT be used in children under 14 years of age.

If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

If you forget to take a dose:

Take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSE. Do not take more than 150 mg (three 50 mg tablets or six 25 mg tablets) in 24 hours.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may be minimized by using the lowest effective dose for the shortest duration necessary.

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 black tarry stools, vomit any blood or dark particles that look like coffee granules. These may be signs of a stomach ulcer or bleeding in your stomach.
Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset or abdominal pain.

STOP TAKING the medicine and tell your doctor as soon as possible if you experience:

indigestion or heartburn
abdominal pain (pains in your stomach) or other abnormal stomach symptoms
allergic reactions such as skin rash, itching, bruising, painful red areas, peeling or blistering, dizziness, difficulty in breathing, wheezing or shortness of breath, swollen face, throat, lips, hands or fingers
blistering of skin when exposed to sunlight
yellowing of your skin or the whites of your eyes and/or pale stools, dark urine, loss of appetite as these may be signs of liver problems
passing more or less urine than normal, cloudy or foamy urine, blood or protein in the urine, pain in the back, swelling (particularly of the ankles) as these may be signs of kidney problems
a serious allergic skin reaction which may include large widespread red and/or dark patches, swelling of the skin, blisters, and itching (Generalised bullous fixed drug eruption).

If you get any of the following very rare effects (may affect less than 1 in 10,000 people) stop taking the tablets and tell your doctor as soon as possible:

inflammation of the pancreas causing severe pain in the abdomen and back
Stevens-Johnson syndrome or toxic epidermal necrolysis (serious illnesses causing blistering of the skin, mouth, eyes and genitals)
aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck, muscle pain, feeling or being sick, eyes being very sensitive to bright light or disorientation.

Tell your doctor or pharmacist it you suffer from any of the following other side effects:

Common (may affect up to 1 in 10 people):

feeling or being sick, loss of appetite, heartburn, nausea, vomiting, diarrhoea, flatulence (wind), changes in blood enzymes, headache, skin rash or spots feeling of dizziness or “spinning”.

Uncommon (may affect up to 1 in 100 people):

Fast or irregular heart beat (palpitations), chest pain, heart disorders, including heart attack or breathlessness, difficulty breathing when lying down, or swelling of the feet or legs (signs of heart failure), especially if you have been taking a higher dose (150 mg per day) for a long period of time. Rare (may affect up to 1 in 1,000 people):
Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)
Gastritis (inflammation, irritation or swelling of the
stomach lining).
- Vomiting blood.
- Diarrhoea with blood in it or bleeding from the back passage.
- Black, tarry faeces or stools.
- Drowsiness, tiredness
- Skin rash and itching
- Fluid retention, symptoms of which include swollen ankles
- Liver function disorders, including hepatitis and jaundice
- Asthma (symptoms may include wheezing, breathlessness, coughing and a tightness across the chest).

Very rare (may affect up to 1 in 10,000 people):

high blood pressure, heart failure (which can cause shortness of breath or swollen ankles)
constipation, sore, swollen or inflamed mouth or throat, lower gut disorders including worsening of the symptoms of colitis and Crohn’s disease, or in isolated cases damage to/problems with the colon.
blood disorders including severe reduction in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising, or make infections more likely
eczema, reddening or scaling of the skin, increased sensitivity to sunlight or loss of hair
ringing in the ears or impaired hearing
eyesight problems (such as blurred, double, partial or complete loss of vision, blind spots, halos around lights)
convulsions, tremor, tingling and numbness in the hands or feet, changes in memory or taste
difficulty sleeping, depression, anxiety, irritability, mood changes, nightmares
palpitations, chest pain
low blood pressure (symptoms include feeling faint and light-headed) or shock
inflammation of the blood vessels or of the lung tissue
medicines such as diclofenac may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Not known (frequency cannot be estimated from the available data)

an allergic skin reaction, that may include round or oval patches of redness and swelling of the skin, blistering, and itching (Fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is taken again.

Other side effects include:

tiredness, confusion, inflammation of the optic nerve in the eye, changes in sensation, hallucinations or impotence
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diclofenac Tablets

Do not store above 25°C. Store in the original package. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6. Contents of the pack and other information

Ingredients:

Diclofenac tablets are available in two strengths and contain either 25 or 50mg of diclofenac sodium as the active ingredient.

The tablets are gastro-resistant which means it has a coating which prevents it from dissolving until it has passed through the stomach. The tablets also contain the following other ingredients: lactose, maize starch, magnesium stearate and purified talc. The 25mg tablets also contain sodium starch glycollate and microcrystalline cellulose, and the 50mg tablets also contain povidone. The tablet coating contains methacrylic acid ethyl acrylate copolymer, hypromellose, triethyl citrate, talc, yellow iron oxide (E172), titanium dioxide (E171) and macrogol/PEG. The 25 mg tablet coating also contains polydextrose, and the 50 mg tablet coating also contains polyvinyl alcohol,

yellow iron oxide (E172) and black iron oxide (E172). What the medicine looks like:

Diclofenac Tablets 25mg are yellowish-mustard film coated shallow biconvex tablets.

Diclofenac Tablets 50mg are light-brown film coated shallow biconvex tablets.

The tablets are available in pack sizes of 28, 50, 84 or 100 tablets. (Not all pack sizes may be marketed). Marketing Authorisation Holder and Manufacturer

Crescent Pharma Ltd., Key House,

Sarum Hill, Basingstoke, RG21 8SR, UK.

Date leaflet revised: May 2026.

If you would like this leaflet in a different format please contact the licence holder at the above address.

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