Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet are: PL 14017/0019, PL 14017/0018.
Diclofenac Sodium 50mg Gastro-Resistant Tablets
Diclofenac Sodium 50 mg
Gastro-resistant tablets
1. What DICLOFENAC SODIUM 50mg is and what it is used for
2. What you need to know before you take DICLOFENAC SODIUM 50mg
3. How to take DICLOFENAC SODIUM 50mg
4. Possible side effects
5. How to store DICLOFENAC SODIUM 50mg
6. Contents of the pack and other information
Diclofenac sodium, the active ingredient in DICLOFENAC SODIUM 50mg, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
DICLOFENAC SODIUM 50mg tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including:
They are also used to treat pain and inflammation associated with dental and minor surgery.
Talk to your doctor or pharmacist before taking Diclofenac:
Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking DICLOFENAC SODIUM 50MG, as DICLOFENAC can sometimes worsen wound healing in your gut after surgery.
Tell your doctor or pharmacist if you have any of these conditions because Diclofenac Sodium 50mg might not be the right medicine for you.
These tablets are not suitable for children aged under 12.
Some medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are taking any of the following:
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Take this medicine with or after food.
Very occasionally people have reported that diclofenac sodium tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.
These tablets are not suitable for children aged under 12.
Diclofenac Sodium 50mg tablets contains lactose:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Diclofenac Sodium 50mg tablets contains a colouring agent, sunset yellow (E110). Sunset yellow (E110) may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
The doctor will tell you how many Diclofenac Sodium 50mg tablets to take and when to take them. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take the tables with or after food.
Swallow the tablets whole with a glass of water. DO NOT crush or chew the tablets.
The recommended dose is:
Adults 75 to 150 mg daily in two or three divided doses. The number of tablets which you take will depend on the strength the doctor has given you.
Elderly
The lowest effective dose should be used. Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Diclofenac Sodium tablets are not affecting your stomach.
Children
These tablets are not suitable for children aged under 12.
The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.
If you, or anyone else, accidentally take too much Diclofenac Sodium, tell your doctor or go to your nearest hospital casualty department immediately. Take your medicine pack with you so that people can see what you have taken.
Symptoms of an overdose can include: headache, nausea (feeling sick), vomiting, abdominal pain, stomach or intestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ringing in the ears, fainting, or occasionally convulsions (seizures, uncontrolled fits).
It is important that you do not miss a dose. If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, just take the next dose and forget about the one you missed. Do NOT take a double dose to make up for a forgotten tablet. Do not take more than 150 mg in 24 hours. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING Diclofenac Sodium tablets and tell your doctor straight away if you notice:
If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
Tell your doctor immediately if you notice the following:
The side effects listed below have also been reported.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Effects on the nervous system:
Inflammation of the lining of the brain (meningitis), tingling or numbness in the fingers, tremor, visual disturbances such as blurred or double vision, taste changes, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, irritability, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease), inflammation of the pancreas.
Effects on the chest or blood:
Hypertension (high blood pressure), hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), blood disorders (including anaemia).
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:
Facial swelling, serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.
Hair loss
Effects on the reproductive system:
Impotence.
Throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances of sensation.
Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.
Do not be alarmed by this list - most people take Diclofenac Sodium Tablets without any problems.
If any of the side effects becomes serious, or if you notice side effects not listed in this leaflet, please tell your doctor. He/she may want to give you a different medicine.
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’.
Do not store above 25°C. Keep the tablets in their original pack.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
The name of your medicine is Diclofenac Sodium 50mg.
Diclofenac Sodium 50mg: The active substance is diclofenac sodium. Each gastro-resistant tablet contains 50 mg of diclofenac sodium. The other ingredients are: tablet core: copolyvidone, microcrystalline cellulose, colloidal anhydrous silica, lactose, maize starch, magnesium stearate, crospovidone. Tablet enteric coat: triethyl citrate, methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%, talc. Tablet film coat: hydroxypropylmethylcellulose, polyethylene glycol, iron oxide yellow (E172), iron oxide red (E172), sunset yellow (E110), titanium dioxide (E171). Polish: carnauba wax.
Diclofenac Sodium 50mg gastro-resistant tablets are marked DICL50 on one side and are reddish-brown in colour. Diclofenac Sodium 50mg gastro-resistant tablets are packed in cartons containing 28, 84 or 100 tablets in foil blister strips.
Not all pack sizes may be marketed.
This leaflet was last revised in September 2022