Diclofenac Sodium 50mg Gastro-Resistant Tablets
Very rare side effects (may affect up to 1 in 10,000people):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as blurred vision, 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, disturbances in sensation.
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).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, 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:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of the lining of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves of the eye.
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 Diclofenac Tablets
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 outer packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
6. Contents of the pack and other information What Diclofenac Tablets contain:
• The active ingredient is diclofenac sodium 50 mg
• The other ingredients are Lactose Monohydrate, Povidone (K30), Maize starch, Sodium Starch Glycolate (Type A), Microcrystalline Cellulose (PH-102), Colloidal Anhydrous Silica, Magnesium Stearate, Purified Talc, Hypromellose, Macrogolglycerol Hydroxystearate, Iron Oxide Yellow (E172), Iron Oxide Red (E172), Titanium Dioxide (E171), Methactylic Acid Ethylacrylate Copolymer (1:1) Dispersion 30% , Triethyl Citrate.
What Diclofenac Tablets look like and contents of the pack:
• The 50mg tablets are 7.80 to 8.20 mm in diameter, round, pale brown, enteric coated tablets, plain on both the sides.
• Diclofenac Sodium 50 mg Gastro-resistant tablets are available in packs of 28 & 84 tablets.
Not all pack sizes may be marketed This leaflet was last revised in 09/2015 IPOMI
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
4 121XXX-V2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac Sodium 50 mg Gastro-resistant Tablets
Diclofenac Sodium
Read all of these 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, asks your doctor, or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
• The name of this medicine is Diclofenac Sodium 50 mg Gastro-resistant Tablets but it will be referred to as Diclofenac Tablets throughout this leaflet
What is in this leaflet
1. What Diclofenac Tablets are and what they are used for
2. What you need to know before you take Diclofenac Tablets
3. How to take Diclofenac Tablets
4. Possible side effects
5. How to store Diclofenac Tablets
6. Contents of the pack and other information
1. What Diclofenac Tablets are and what they are used for
Diclofenac tablets contain the active ingredient Diclofenac Sodium, which is part of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are used to reduce pain and inflammation.
• Diclofenac Tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including:
- rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis
- backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures
- tendonitis, tenosynovitis, bursitis pain and inflammation associated with dental and minor surgery.
2. What you need to know before you take Diclofenac Tablets Do not take Diclofenac Tablets if you:
• are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Tablets (listed in section 6).
• 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)
• have had stomach or bowel problems after you have taken other NSAIDs
• have severe heart, kidney or liver 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 bypass blockages
• have or have had problems with your blood circulation (peripheral arterial disease)
• are more than six months pregnant.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Diclofenac Tablets if you:
• suffer from any stomach or bowel disorders such as ulcerative colitis or Crohn’s disease
• have a disease called porphyria (symptoms of porphyria are discolouration of the urine, serious skin disorders, anaemia, abdominal pains and severe mental disorders)
• have in the past suffered from asthma
• have serious illness with blistering of the skin, mouth, eyes and genitals or connective tissue disorders such as lupus (SLE) or any similar condition.
• have runny nose, nasal polyps, chronic lung disease or chronic lung infection
• have kidney or liver problems or if you are elderly or recovering from major surgery
• have heart problems, previous stroke or think you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker)
• any blood or bleeding disorder
• are in first six months of your pregnancy or are breast-feeding
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If you notice skin rash or appearance of lesions after starting this medicine, please seek medical advice immediately Other special warnings
• You should take the lowest dose of Diclofenac Tablets 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 Tablets. 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
• 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 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 Tablets
Diclofenac Sodium 50 mg Gastro-resistant Tablets are not suitable for children aged under 12.
Other medicines and Diclofenac Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even medicines bought without a prescription as some medicines can affect the way other medicines work.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Diclofenac Tablets work:
• Medicines to treat diabetes (such as Gliclazide or Tolbutamide)
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets) for example spironolactone
• Lithium (used to treat some mental problems)
• Methotrexate (for 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) for example ciprofloxacin, ofloxacin
• Any other NSAID or COX-2 (cyclo-oxgenase-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 used to treat depression called selective serotonin reuptake inhibitors (SSRIs)
• Oral steroids (an anti-inflammatory drug)
• Medicines used to treat heart conditions or high blood pressure, for example B-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)
Pregnancy and breast-feeding
• Are you pregnant or planning to become pregnant? Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. Do not take Diclofenac Tablets if you are in the last three months of your pregnancy as it may affect the baby’s circulation. Avoid these tablets if you are in first six months of your pregnancy or if you are breast-feeding, unless your doctor has advised you to take them
• Are you trying for a baby? Taking Diclofenac Tablets may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant
Driving and using machines
Diclofenac Tablets may cause dizziness, drowsiness, tiredness, and problems with your vision. Do not drive or operate machinery if you are affected
Diclofenac Tablets contains Lactose
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diclofenac Tablets.
3. How to take Diclofenac Tablets
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole preferably with a drink of water, before or with food. Do not crush or chew the tablets as the tablets have been coated with a substance, which allows them to pass through the stomach before dissolving. It is important that the coating is not damaged by chewing
Dosage
Your doctor will decide your dose, as it depends on your condition.
Adults
A typical dose is 75 mg to 150 mg daily divided into two or three doses Elderly and patients with kidney problems
Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly.
Children
Not recommended for children.
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 Tablets than you should Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the packaging with you so that the doctor knows what you have taken.
Symptoms of an overdose are headache, feeling sick, being sick, stomach pain, intestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, fits, ringing in the ears and fainting.
If you forget to take Diclofenac Tablets
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
Do not take more than 150 mg (three 50 mg tablets) in 24 hours.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. Possible Side effects
Like all medicines, Diclofenac can cause side effects, although not everybody gets them.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Some side effects can be serious
Stop taking Diclofenac Tablets and tell your doctor straight away if you notice:
• 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 swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction
• a serious skin reaction such as rash, blistering or peeling of the skin (Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis)
• Yellowing of your skin or the whites of your eyes (jaundice)
• An unexpected change in the amount of urine produced and/or its appearance
If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
The side effects listed below have also been reported.
Common side effects (may affect up to 1 in 10people):
• Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.
Rare side effects (may affect up to 1 in 1,000people):
• 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
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
• Skin rash and itching
• Fluid retention, symptoms of which include swollen ankles
• Liver function disorders, including hepatitis and jaundice
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