DICLOFENAC SODIUM TABLETS 25 MG - patient leaflet, side effects, dosage

1. what diclofenac sodium is and what it is used for

Diclofenac sodium, the active ingredient in DICLOFENAC SODIUM 25mg, is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

DICLOFENAC SODIUM 25mg tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including:

• Rheumatoid arthritis, osteoarthritis, acute gout (painful inflammation of the joints especially in the feet and hands), ankylosing spondylitis (form of spinal arthritis).
• Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures
• Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis.

They are also used to treat pain and inflammation associated with dental and minor surgery.

In children aged 1–12 years DICLOFENAC SODIUM 25mg tablets are used to treat juvenile chronic arthritis.

In children aged 9 years and above DICLOFENAC SODIUM 25mg tablets are used for short term treatment of fever related to infections of the ear, nose or throat, and for relief of acute post-operative pain.

2. what you need to know before you take diclofenac sodium 25mg

Do not take DICLOFENAC SODIUM 25mg if:

• you are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of DICLOFENAC SODIUM 25mg tablets (these are listed under section 6 „CONTENTS OF THE PACK AND OTHER INFORMATION“ 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.
• 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, mini-stroke (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 more than six months pregnant

Warnings and precautions

Talk to your doctor or pharmacist before taking Diclofenac if:

• you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease
• you have kidney or liver problems, or you are elderly
• you have a condition called porphyria
• you suffer from any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets.
• you ever had asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic pulmonary diseases or infections of the respiratory tract.
• you are breast feeding
• you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• you have heart problems or if you had a stroke or you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker)
• you have diabetes
• you smoke
• you have Systemic Lupus Erythematosus SLE (inflammatory, auto-immune disorder which causes symptoms such as joint pain, joint inflammation, skin rashes, fever) or any similar condition
• you have an intolerance to some sugars such as lactose (these tablets contain lactose)

Tell your doctor if you recently had or you are going to have a surgery

III

Tell your doctor or pharmacist if you have any of these conditions because Diclofenac Sodium might not be the right medicine for you.

Children

In children aged 1–12 years DICLOFENAC SODIUM 25mg tablets are used to treat juvenile chronic arthritis.

Other medicines and Diclofenac Sodium 25mg

Some medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are taking any of the following:

• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets)
• Lithium (used to treat some mental problems)
• Methotrexate (for treatment of some inflammatory diseases and some cancers)
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or treat urinary tract infections)
• Quinolone antibiotics (for infections)
• Any other NSAID or COX-2 (cyclo-oxygenase-2) inhibitor, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate pregnancy)
• Cardiac glycosides (for example digoxin), used to treat heart problems
• Medicines known as SSRIs (used to treat depression)
• Oral steroids (an anti-inflammatory drug)
• Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors
• Voriconazole (a medicine used to treat fungal infections).
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cho­lestyramine (used to lower cholesterol)

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.

Diclofenac Sodium 25mg with food and drink

Take this medicine with or after food.

• Pregnancy and breast-feeding Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take DICLOFENAC SODIUM 25mg tablets during the last 3 months of pregnancy as it may affect the baby's circulation.
• You should advise your doctor or pharmacist if you think you might be pregnant or are up to 6 months pregnant.
• Taking Diclofenac Sodium 25mg tablets may make it more difficult to become pregnant. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
• You should avoid taking Diclofenac Sodium whilst breast feeding.

Driving and using machines

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.

Other special warnings

• You should take the lowest effective dose of Diclofenac Sodium for the shortest possible time particularly if you are underweight or elderly.
• There is a small increased risk of heart attack or stroke when you are taking any medicine like Diclofenac Sodium. The risk is higher if you are taking high doses for a long time. Always follow the doctor’s instruc­tions on how much to take and how long to take it for.
• If at any time while taking Diclofenac Sodium you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness or slurring of speech, contact your doctor immediately.
• Whilst you are taking these medicines your doctor may want to give you a check-up from time to time.
• If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
• Because it is an anti-inflammatory medicine, Diclofenac Sodium tablets may reduce the symptoms of infection, for example, headache, and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac Sodium tablets.

Diclofenac Sodium tablets contains

Diclofenac Sodium 25 mg 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 25 mg contains a colouring agent, sunset yellow (E110), which may cause allergic reactions.

3. how to take diclofenac sodium

The doctor will tell you how many Diclofenac Sodium 25 mg 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 and children over 12 years old 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 aged 1 to 12 years

Doses vary with the age and weight of the child. These tablets may be given to children but not to infants, where applicable, within the daily dose range of 1–3 mg per kilogram of body weight in two or three separate doses.

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 take more Diclofenac Sodium than you should

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).

If you forget to take Diclofenac Sodium

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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Diclofenac Sodium can cause side effects, although not everybody gets them.

Some side effects can be serious

STOP TAKING Diclofenac Sodium tablets and tell your doctor straight away if you notice:

• Sudden and crushing chest pain (signs of myocardial infarction or heart attack)
• Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• Sudden weakness or numbness in the face, arm or leg especially on one side of the body, sudden loss or disturbance of vision; sudden difficulty in speaking or ability to understand speech; sudden migraine-like headaches which happen for the first time, with or without disturbed vision. These symptoms can be an early sign of a stroke
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
• Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces
• Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering
• Wheezing or shortness of breath (bronchospasm)
• Swollen face, lips, hands or fingers
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• An unexpected change in the amount of urine produced and/or its appearance.
• Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Sodium and followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal pain.
• Stevens Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals)

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:

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

The side effects listed below have also been reported.

Common side effects (These may affect between 1 and 1 in 10 in every 100 patients):

• Stomach pain, heartburn, nausea, vomiting, diarrhea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood

Uncommon side effects (These may affect between 1 and 10 in every 1000 patients):

• 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 side effects (These may affect between 1 in every 1,000 to

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1 in every 10,000 patients):

• 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 including wheezing, breathlessness, coughing and a tightness across the chest

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:

5. how to store diclofenac sodium

Keep out of the sight and reach of children.

Do not use Diclofenac Sodium tablets after the expiry date which is printed after ‘Exp’ on the carton.

Do not store above 25°C. Keep the tablets in their original pack. 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 Diclofenac Sodium 25mg tablets contain

The name of your medicine is Diclofenac Sodium 25mg.

Diclofenac Sodium 25mg: Each gastro-resistant tablet contains 25 mg of the active ingredient diclofenac sodium, and also contains the following inactive ingredients: 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), sunset yellow (E110), titanium dioxide (E171). Polish: carnauba wax.

What Diclofenac Sodium 25mg tablets look like and contents of the pack

Diclofenac Sodium 25mg gastro-resistant tablets are marked D25 on one side and are yellowish-brown in colour. Diclofenac Sodium 25mg gastro-resistant tablets are packed in cartons containing 84 tablets or 100 tablets in foil blister strips.

Not all pack sizes may be marketed.

Marketing Authorisation Holder/Manufac­turer:

Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK.

This leaflet was last revised in February 2020

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