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

Package leaflet: Information for the user

Diclofenac potassium

Read all of this 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, please ask your doctor or pharmacist..

• – 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.

What is in this leaflet

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

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

• 3. How to take Diclofenac Potassium Tablets

• 4. Possible side effects

• 5. How to store Diclofenac Potassium Tablets

• 6. Contents of the pack and other information

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). NSAIDs reduce pain and inflammation.

Diclofenac Potassium Tablets relieve pain, reduce swelling and ease inflammation in:

• – Rheumatoid arthritis, osteoarthrosis, acute gout, low back pain, ankylosing spondolytis

• – Migraine

• – Conditions affecting the joints and muscles such as 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 orthopaedic, dental and other minor surgery.

2. what you need to know before you take diclofenac potassium tablets- are allergic to diclofenac potassium aspirin, ibuprofen or any other nsaids or any of the other ingredients in the tablet (listed in section 6)

• – have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.

• – have had stomach or bowel problems after you have taken other NSAIDs.

• – have previously had a reaction (asthma , hives or a cold ) caused by an allergy to salicylates (e.g. aspirin) or other non-steroidal pain killers.

• – suffer from severe kidney , severe heart or severe 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 or bypass blockages.

• – have or have had problems with your blood circulation (peripheral arterial disease) are pregnant , and in the last three months (last trimester ) of pregnancy. If you are allergic to peanut or soya.

Signs of a allergic (hypersensitive) reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction.

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 Potassium Tablets, as Diclofenac Potassium Tablets can sometimes worsen wound healing in your gut after surgery.

Warnings and precautions

Talk with your doctor or pharmacist before taking Diclofenac Potassium Tablets if you:

• – have a history of gastrointestinal disease e.g. ulcerative colitis or Crohn's disease.

• – have reduced heart , kidney , or liver function.

• – suffer from any blood clotting disorder.

• – have or have had asthma.

• – are breast-feeding.

• – have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

• – have heart problems, or have you had a stroke, or think you might beat risk of these conditions.

• – have diabetes.

• – suffer from liver porphyria (disorder of the red blood pigment).

• – have had or need to have surgery.

• – are elderly (over 65).

• – are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib.

• – Smoke.

• – have Lupus (SLE) or any similar condition.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary, particularly if you are underweight or elderly.

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 (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

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.

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. This includes 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 these medicines may be increased if taken with diclofenac.

• - cytotoxic medicines (e.g. methotrexate to treat cancers) – 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.

• - tacrolimus (an immunosuppressant) – these may increase the risk of kidney damage.

• - cholesterol lowering medication (e.g. colestipol and cholestyramine ) these medicines can delay or decrease the effect of diclofenac. It is recommended that diclofenac is taken at least 4 to 6 hours after taking these medicines.

• - SSRIs (medicine to treat depression e.g. citalopram) – these may increase the risk of bleeding in the stomach

• - 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 or COX-2 (cyclo-oxgenase-2) inhibitor (e.g. aspirin or ibuprofen ) – 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) – 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.

• - phenytoin (a medicine used to treat seizures).

• - sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections).

• - trimethoprim (a medicine used to prevent or treat urinary tract infections).

• - zidovudine (an antiretroviral drug used to treat HIV) – combination with Diclofenac may increase the risk of blood disorders.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

You should not take Diclofenac during the first 6 months of pregnancy unless directed by your doctor.

Do not take Diclofenac during the last 3 months of pregnancy as damage to the foetus and reduced labour may occur.

Breast-feeding

You should not take Diclofenac whilst breastfeeding.

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.

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.

Important information about the ingredients of Diclofenac Potassium Tablets

If you are allergic to peanut or soya, do not use this medicinal product.

Diclofenac Potassium Tablets contain sodium

This medicine contains less than 1mmol sodium (23mg) per 25 mg or 50 mg tablet, that is to say essentially ‘sodium-free’.

Diclofenac Potassium Tablets contain

This medicinal product has 0.075 mmol (2.92mg) potassium per 25mg tablet and 0.150 mmol (5.85mg) potassium per 50mg tablet. This should be taken into account if you have reduced kidney function or are on a controlled potassium diet.

3. how to take diclofenac potassium tablets

Always take Diclofenac potassium tablets exactly as your doctor has told you. If you are unsure, check with your doctor or pharmacist. 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.

The tablets must be swallowed whole with a glass of water, with or after food.

The recommended dose is:

Adults – 75 mg to 150 mg a day in two or three doses. The number of tablets you take will depend on the strength the doctor has given you.

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.

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 him regularly for the first 4 weeks of treatment, to make sure that you are not experiencing any side effects.

Use in children and adolescents

Children over 14 years of age – 75mg to 100mg daily, in two or three doses.

Diclofenac potassium Tablets are not recommended for children under the age of 14. They are not recommended for the treatment of migraine in children of any age.

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 Potassium Tablets than you should

If you, or anyone else, accidentally takes too much, contact your doctor, emergency room or pharmacist if you have taken more Diclofenac Potassium Tablets than stated in this leaflet or more than what your doctor has prescribed. Take your medicine pack with you so that people can see what you have taken.

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 tell your doctor straight away if you notice:

• – Sudden and crushing chest pain (signs of myocardial infarction or heart attack), especially if you have been taking a higher dose (150 mg per day) for a long period of time.

• – 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, 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 dark 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 or heartburn.

• – An unexpected change in the amount of urine produced and/or its appearance.

• – You are bruising more easily than usual or have frequent sore throats or infections.

• – Any type of fit or seizure.

• – A form of meningitis (aseptic) causing a combination of symptoms such as headache, tiredness, muscle pain, sore throat and disorientation.

• – Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Potassium Tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain.

• – 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: may affect up to 1 in 10 people

• – Headache, dizziness (vertigo).

• – Raised levels of liver enzymes in the blood.

• – Diarrhoea with blood in it or bleeding from the back passage.

• – Weight loss (anorexia).

Uncommon: may affect up to 1 in 100 people – Fast or irregular heart beat (palpitations),

Rare: may affect up to 1 in 1000 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

• – Drowsiness, tiredness.

• – Fluid retention, symptoms of which include swollen ankles.

• – Liver function disorders, including hepatitis and jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems which would lead to tiredness, loss of appetite, stomach pain, joint pain.

• – Asthma (symptoms may include wheezing, breathlessness, coughing and a tightness across the chest).

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, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), difficulty sleeping, nightmares, mood changes, depression, anxiety, mental disorders, disorientation and loss of memory, fits, fever and a stiff neck.

• – Unpleasant taste in the mouth

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 , lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease) inflammation of the pancreas.

Effects on the heart, 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 liver disorders including kidney failure and liver failure, presence of blood or protein in the urine.

Effects on skin or hair:

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.

Hair loss.

Fluid filled blisters on the skin that are itchy, reddish or darker than normal

Effects on the reproductive system:

Impotence.

Other effects that have also been reported include with unknown frequency include

Confusion, hallucinations, malaise (general feeling of discomfort), disturbances of sensation,inflam­mation of the nerves in the eye.

Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: 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 use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Unused tablets should be taken back to the pharmacist for safe disposal.

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- the active substance (the ingredient that makes the tablet work) 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 anhydrous, magnesium stearate, polyvinyl alcohol partially hydrolysed, titanium dioxide E171, talc, lecithin soya E322, Iron oxide red E172, Iron oxide yellow E172 and Xanthan gum E415.

What Diclofenac Potassium Tablets looks like and contents of the pack

The 25 mg tablets are pink, round, unscored, biconvex 6mm film coated tablets.

The 50 mg tablets are reddish brown, round, unscored, biconvex 9mm film coated tablets.

Pack sizes

Blister packs: 7, 12, 21, 28, 30, 50, 56, 60, 84 and 100 film coated tablets.

Plastic bottles: 100 and 500 film-coated tablets

(Not all packs sizes may be available)

Marketing Authorisation Holder

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building,

4 Gatwick Road,

Crawley,

West Sussex,

RH10 9BG,

United Kingdom

Manufacturer

APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th Floor, CP House, 97–107 Uxbridge Road, Ealing, London W5 5TL

This leaflet was last revised in November 2020.