Patient leaflet - Diclofenac Potassium 50 mg tablets
1. What Diclofenac potassium tablets are and what they are used for
Diclofenac potassium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce pain and inflammation in the following conditions:
- Sprains, strains and other injuries
- Pain and inflammation following surgery
- Gout
- Other painful conditions affecting the joints and muscles such as backache, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and pyrophosphate arthropathy.
The tablets can also be used to relieve the symptoms associated with migraine attacks in adults.
2. What you need to know before you take Diclofenac potassium tablets
Do not take Diclofenac potassium tablets if you:
- are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6), aspirin, ibuprofen or other related painkillers. 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
- have had a heart attack, a stroke, a mini-stroke (TIA), blood clots or had a heart bypass
- have or have ever had a stomach ulcer, perforation or bleeding
- are taking other NSAID painkillers, or aspirin
- suffer from severe kidney or liver failure
- have or have had problems with your blood circulation (peripheral arterial disease)
- are more than 6 months pregnant.
Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac potassium tablets if:
- you have asthma, diabetes, high cholesterol, angina, high blood pressure, liver, kidney or bowel problems
- there is a chance you may be pregnant
- you are breast-feeding
- you smoke
- you suffer from any blood clotting disorder
- you suffer from liver porphyria (disorder of the red blood pigment)
- you have had or need to have surgery
- you are elderly (over 65)
- you are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib
- you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease
- you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Diclofenac potassium tablets or other pain medications.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
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.
If you have heart problems, have had a previous stroke or think that you might be at risk of these conditions, you should discuss your treatment with your doctor or pharmacist.
Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking Diclofenac potassium tablets, as Diclofenac potassium tablets can sometimes worsen wound healing in your gut after surgery.
Diclofenac may mask the signs and symptoms of infection.
Whilst you are taking these tablets, your doctor may want to give you a check-up from time to time.
Other medicines and Diclofenac potassium tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Especially:
- medicines to treat diabetes. A dose adjustment of these medicines may be necessary as blood sugar may drop too low
- anticoagulants (e.g. warfarin). These may increase the risk of bleeding
- diuretics (water tablets). The effect of these may be decreased. Potassium-sparing diuretics may increase the potassium levels in the blood
- lithium (medicine to treat depression). The blood levels of lithium may be increased if taken with Diclofenac
- cytotoxic medicines (e.g. methotrexate to treat cancers). These should not be taken less than 24 hours before or after Diclofenac potassium tablets - the blood levels of these medicines may be increased if taken with Diclofenac
- ciclosporin. This may harm kidney function
- quinolones (to treat infections, e.g. ciprofloxacin and levofloxacin). These may cause convulsions (fits)
- steroid tablets. These may increase the risk of bleeding in the stomach
- other NSAIDs (e.g. aspirin). These may increase the risk of side effects
- medicines to treat high blood pressure (ACE-inhibitors, beta blockers). The blood pressure lowering effect may be reduced
- mifepristone (used to induce abortion). The effect of mifepristone may be reduced by NSAIDs
- cardiac glycosides (e.g. digoxin) used to treat heart failure. Use with Diclofenac may worsen heart failure or increase blood levels of these medicines
- tacrolimus (an immunosuppressant). These may increase the risk of kidney damage
- zidovudine (an antiretroviral drug used to treat HIV). Taking with Diclofenac may increase the risk of blood disorders
- phenytoin (a medicine used to treat seizures). The blood level of this medicine may be increased if taken with Diclofenac
- colestipol and cholestyramine. These may reduce the effect of Diclofenac
- potent CYP2C9 Inhibitors (e.g. sulfinpyrazone and voriconazole). The blood level of Diclofenac may be increased if taken with these medicines
- selective serotonin reuptake inhibitors (SSRIs) (antidepressants)
- trimethoprim (to treat infections).
Laboratory tests
Frequent liver and kidney function tests and monitoring of blood counts are necessary if taken for more than a few days.
Pregnancy, breast-feeding and fertility
Pregnancy
Do not take Diclofenac potassium tablets 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 potassium tablets 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 potassium tablets 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.
Breast-feeding
You should only take Diclofenac whilst breast-feeding if advised by your doctor.
Female fertility
Diclofenac 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.
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.
Driving and using machines
Some patients may experience side effects such as dizziness, drowsiness and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery.
Diclofenac potassium tablets contain lecithin soya
If you are allergic to peanut or soya, do not take this medicinal product.
Information on sodium content
This medicine contains less than 1mmol sodium (23mg) per 25mg or 50mg tablet, that is to say essentially ‘sodium-free’.
3. How to take Diclofenac potassium tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Diclofenac potassium tablets must not be taken long-term, blood tests should be carried out if taken for more than a few days.
To minimise side effects, you should take the lowest effective dose for the shortest time necessary to relieve your symptoms.
Take the tablets with or after food. Swallow the tablets whole with a drink of water. Do not crush or chew them.
The usual dose is:
To treat pain and inflammation
- Adults - 75mg to 150mg a day in two or three doses.
- Elderly patients – a lower dose may be used. If you are frail or have a low body weight, your doctor may ask you to go back to see them regularly for the first 4 weeks of treatment, to make sure that you are not experiencing any side effects.
Children aged 14 years and over – 75mg to 100mg daily, in two or three doses.
- Not recommended for children under 14 years old.
To treat the symptoms of migraine in adults
50mg taken when the first signs of a migraine attack appear. Another 50mg taken 2 hours after the first dose if needed and then every 4 to 6 hours. You should not take more than 200mg in 24 hours.
These tablets are not suitable for the treatment of migraine in children.
If you take more Diclofenac potassium tablets than you should
Contact your doctor, nearest hospital or pharmacist if you have taken more Diclofenac potassium tablets than stated in this leaflet or more than what your doctor has prescribed.
If you forget to take Diclofenac potassium tablets
Do not take a double dose to make up for a forgotten dose. Continue the treatment as advised by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Diclofenac potassium tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- 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).
Stop taking Diclofenac potassium tablets and contact a doctor straight away if you notice:
Uncommon (may affect up to 1 in 100 people):
- Sudden and crushing chest pain (signs of myocardial infarction or heart attack), especially if you have been taking a higher dose (150mg per day) for a long period of time.
- Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).
Rare (may affect up to 1 in 1,000 people):
- Any sign of bleeding in the stomach or intestine (e.g. having black tarry stools or blood in your vomit). Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac potassium tablets and followed by bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain. Gastritis (inflammation, irritation or swelling of the stomach lining).
- Stomach ulcers (there have been very rare reported cases resulting in death, particularly in the elderly).
- Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering. Facial swelling, serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Wheezing or shortness of breath (bronchospasm). Swollen face, lips, hands or fingers.
- Yellowing of your skin or the whites of your eyes.
Very rare (may affect up to 1 in 10,000 people):
- 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.
- An unexpected change in the amount of urine produced and/or its appearance.
- Inflammation of the lining of the brain (meningitis).
- Fits.
- Persistent sore throat or high temperature. If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
Not known (frequency cannot be estimated from the available data):
- Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
Tell your doctor if you experience any of the following:
Common (may affect up to 1 in 10 people):
- Stomach pain, heartburn, nausea (feeling sick), vomiting (being sick), diarrhoea, indigestion, wind, loss of appetite.
- Headache, dizziness, vertigo.
- Skin rash or spots.
- Raised levels of liver enzymes in the blood.
Uncommon (may affect up to 1 in 100 people):
- Fast or irregular heartbeat (palpitations), chest pain, heart disorders.
Rare (may affect up to 1 in 1,000 people):
- Drowsiness, tiredness.
- Skin rash and itching.
- Fluid retention, symptoms of which include swollen ankles.
- Liver function disorders, including hepatitis and jaundice, inflammation of the pancreas.
- Asthma (symptoms may include wheezing, breathlessness, coughing and a tightness across the chest).
Very rare (may affect up to 1 in 10,000 people):
- 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, headaches together with a dislike of bright lights, fever and a stiff neck.
- 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).
- 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).
- Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine.
- Hair loss.
- Impotence.
Not known (frequency cannot be estimated from the available data):
- Throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances of sensation.
- 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.
Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.
Reporting 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 Website: 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 potassium tablets
Keep this medicine out of the sight and reach of children.
This medicine has no special storage precautions.
Do not take this medicine after the expiry date which is stated on the carton/bottle. The expiry date refers to the last day of that month.
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 potassium tablets contain
The active substance is Diclofenac. Each tablet contains 25mg or 50mg Diclofenac potassium.
The tablets also contain silica colloidal anhydrous, sodium starch glycollate, povidone, maize starch, calcium hydrogen phosphate, magnesium stearate, polyvinyl alcohol partially hydrolysed, titanium dioxide E171, talc, lecithin soya E322, iron oxide red, iron oxide yellow and xanthan gum E415.
What Diclofenac potassium tablets look like and contents of the pack
The 25mg tablets are pink, circular, biconvex 6mm film-coated tablets.
The 50mg tablets are reddish brown, circular, biconvex 9mm film-coated tablets.
Pack sizes
Blister packs: 28 film-coated tablets.
Plastic bottles: 100 and 500 film-coated tablets.
(Not all pack sizes may be available).
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Specifar S.A.
1, 28 Octovriou str., 123 51 Ag. Varvara, Athens, Greece