ADACIUM RAPID 50 MG TABLETS, DICLOFENAC POTASSIUM 50 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take adacium™ rapid tablets

Do not take AdaciumTM Rapid tablets:

• if you are allergic to diclofenac potassium or any of the

'............­...........■ other ingredients of this

! medicine (listed section

: 6)

• ■ if you have a peptic

I 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

• t............­...........■ if you 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

• if you suffer from severe kidney, heart or liver failure
• if 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
• if you have, or have had, problems with your blood circulation (peripheral arterial disease)
• if you are pregnant, and in the last three months (last trimester) of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Adacium ™ Rapid tablets if you:

• smoke
• you have had an ulcer or some other problem affecting your stomach or intestines
• have diabetes
• have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• 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
• you have mixed connective tissue disorders and systemic lupus erythematosus – SLE (which results in joint pain, skin change and disorders of other organs)
• have or have had asthma, COPD which affects your breathing, a chest infection or hayfever
• suffer from liver porphyria (disorder of the red blood pigment)
• have had or need to have surgery
• are elderly (over 65) , particularly if you are frail or underweight
• are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib.
• you had a previous episode of vomiting blood or blood in stools
• you experience skin rash, itching, painful red areas, peeling or blistering of the skin or any other allergic reaction within the first few days of treatment with diclofenac.

.............­.............­.............­........ E

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3. How To Take Adacium

TM Rapid tablets Always take Adacium™ Rapid tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adacium™ Rapid 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:

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

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

• 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 hourly. 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 Adacium™ Rapid tablets than you should:

Contact your doctor, emergency room or pharmacist if you have taken more Adacium™ Rapid tablets than stated in this leaflet or more than what your doctor has prescribed (and you feel unwell).

If you forget to take Adacium™ Rapid tablets

Do not take a double dose to make up for forgotten dose. Continue the treatment as advised by your doctor.

4. Possible side effects

Like all medicines, Adacium™ Rapid tablets can cause side effects, although not everybody gets them.

If you suffer from any of the following rare, or very rare, side effects at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:

• mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Adacium™ Rapid tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data)
• ulcers in GI tract (with or without bleeding or perforation sometimes fatal particularly in the elderly)
• chest pains
• drooping in your mouth or eye, unable to lift your arms, blurred speech or unable to speak as these are symptoms of a stroke
• pass blood in your faeces (stools / motions)
• pass black tarry stools
• vomit any blood or dark particles that look like coffee grounds
• an allergic reaction such as itching, rash, low blood pressure, swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing
• a form of meningitis (aseptic) causing a combination of symptoms such as headache, fever, stiff neck, tiredness, muscle pain, sore throat and disorientation.
• yellowing of the skin or the whites of your eyes due to liver problems, inflammation of liver which could be fatal, necrosis of liver
• decreased urinary output, fluid retention due to sudden loss of kidney function
• kidney disorder and kidney damage
• stomach pain, indigestion, heartburn, wind, nausea (feeling sick), vomiting (being sick) or other abnormal stomach symptoms.
• asthma or asthma that has been made worse by this medicine.
• severe rash, sometimes seen as pinky red spots with clear or violet centres.
• severe flaking or scaling of skin
• an unexpected change in the amount of urine produced and/or its appearance.

Tell your doctor if you experience any of the following symptoms:

Common: may affect up to 1 in 10 people

• headache
• diarrhoea
• pain or swelling of your stomach or abdomen, heartburn
• loss of appetite (anorexia)
• dizziness or feeling light-headed
• raised levels of liver enzymes in the blood
• skin rash.

Rare: may affect up to 1 in 1000 people

• gastritis (inflammation, irritation or swelling of the stomach lining)
• swelling of feet or ankles
• a feeling of no energy
• feeling sleepy or drowsy
• rash or raised lumps on your skin

Very Rare: may affect less than 1 in 10,000 people

• reduced, blurred or double vision
• constipation
• if you have an irritable bowel disease, such as colitis or Crohn’s disease, the symptoms may get worse

• depression, anxiety, irritability, memory loss, or confusion I

• your heart beats too quickly or irregularly; chest pains I

• inflammation of the blood vessels
• shortness of breath with dry cough (pneumonitis) ;

• impotence (difficulty getting an erection)

• hearing impaired
• difficulty sleeping, nightmare

• pins and needles or sensitivity to touch
• your blood does not clot easily

• spotting or unexplained bruising of the skin, nose bleeds ■

5. How to store Adacium™ Rapid tablets

Keep this medicine out of the sight and reach of children. This medicine has no special storage precautions. Do not use after the expiry date stated on the carton. Unused tablets should be taken back to the pharmacist for safe disposal.

Medicines should not be...........­.............

disposed of via ;

wastewater or household ■ waste. Ask your I

pharmacist how to ; dispose of medicines no ■ longer required. These I measures will help to ;

protect the environment. ■

6. Contents of the pack and other information

What Adacium™ Rapid tablets contains

The active substance (the ingredient that makes the tablet work) is diclofenac. Each tablet contains 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, iron oxide yellow and xanthan gum E415.

What Adacium™ Rapid tablets looks like and contents of the pack

The 50mg 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

Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom.

Manufacturer

Actavis hf., Reykjavikurvegi 78, PO Box 420, IS-222, Hafnarfjordur, Iceland.

This leaflet was last revised in June 2021.

Other sources of information

For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email .