Eeze

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Eeze 25 mg film-coated tablet

Diclofenac potassium

Read all of this leaflet carefully before you start taking this medicine

Keep this leaflet. You may need to read it again.
If you have any further questions, 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 symptoms 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 Eeze is and what it is used for

2. What you nedd to know before you take Eeze

3. How to take Eeze

4. Possible side effects

5. How to store Eeze

6. Contents of the pack and other information

1. WHAT EEZE IS AND WHAT IT IS USED FOR

Eeze belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Eeze relieves pain and reduces inflammation.
Adults: Treatment ofmild to moderate pain, such as headache, including episodic pain associated with migraine, toothache, joint and muscle pain and back pain. Period pains.

Children and adolescents: Short-term treatment of pain related to inflammatory infections of the ear, nose or throat and of acute post-operative pain after minor surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EEZE

Do not take Eeze

- if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6)

- if you have or have a history of a recurrent stomach ulcer or duodenal ulcer, bleeding or perforation

- if you have an increased tendency to bleeding

- if you have a history of gastrointestinal bleeding/perforation related to previous use of painkillers (NSAIDs)

- if you have porphyria (metabolic disease)

- if you have severely reduced liver or kidney function

- if you previously have had an allergic reaction such as asthma, sneezing or a rash on taking painkillers containing acetylsalicylic acid or other drugs for pain/inflammation within the group of NSAIDs

- during the final three months of pregnancy

- 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)

Warning and precautions

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Higher doses than the recommended dose are generally associated with an increased risk of side effects.

Medicines such as Eeze 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.

Talk to your doctor before treatment,

if you have or have had any of the following diseases:

- gastrointestinal problems, heartburn/ discomfort in the stomachor a history of gastric or intestinal ulceration, bleeding or perforation

- heart disease, liver disease or kidney disease

- asthma, inflammation or swelling of the nasal mucous membranes, chronic obstructive pulmonary diseases or chronic infections of the respiratory tract

- SLE (connective tissue disease)

- diseases that result in an increased tendency to bleed

- high blood pressure,heart problems (mild to moderate heart failure),

- angina or blood clots

- ulcerative colitis or Crohn’s disease

- diabetes

Make sure your doctor knows, before you are given diclofenac

if you have raised cholesterol or raised triglyceride
if you smoke

During varicella it is advisable to avoid use of this drug.

Elderly persons should be aware of the greater risk of side effects that comes with increasing age.

Serious skin reactions have been reported very rarely in association with the use of NSAIDs. Stop using Eeze if you get any skin rash or any other sign of hypersensitivity and contact a doctor.

If you get gastrointestinal problems, discontinue to take Eeze and seek advice from a doctor.

Prolonged use of any type of painkiller for headaches can make the headache worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.

Like other anti-inflammatory agents, Eeze can mask the signs or symptoms of infection.

Like other anti-inflammatory agents, allergic reactions, including anaphylactic reactions can also occur in rare cases with diclofenac, without earlier exposure to the drug.

Eeze can make it more difficult to conceive, please refer to the section Pregnancy and breast-feeding for further information.

Other medicines and Eeze

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Certain medicines may affect or be affected by treatment with Eeze, for example:

medicines against blood clots (warfarin, ticlopidine, acetylsalicylic acid, heparin etc.),
medicines against tumours and disturbances of the immune system (such as methotrexate),
medicines for treating diabetes, except for insulin,
lithium (used for manic depression)
SSRIs (used for depression)
digoxin (used for heart problems)
ciclosporin (used during transplantations, for severe psoriasis and for rheumatism)
certain medicines for high blood pressure (beta-blockers, angiotensin II receptor antagonists and ACE inhibitors)
diuretics (agents to stimulate urine production, and used against high blood pressure)
quinolone antibiotics (used for urinary tract infection)
zidovudine (used in the treatment of HIV infection)
corticosteroids (used to treat inflammatory diseases)
colestipol or colestyramine (used to treat levels of blood fat)
fluconazole or voriconazole (used for fungal infections)
rifampicin (an antibiotic used for tuberculosis)
carbamazepine or phenytoin (used for epilepsy)
barbiturates (sleeping agents)
diazepam (a sedative)
pentoxifylline (an agent to dilate blood vessels)
tacrolimus (used for liver, kidney or heart transplant)
sulfinpyrazone (used for treatment of gout)
tenofovir (virus inhibitor for treatment of HIV-infection).

Never take several different pain-relief medicines, including other NSAIDs, at the same time without first consulting your doctor or pharmacist

Eeze with food and drink

The tablets should be swallowed whole with liquid. To obtain the best effect, they should not be taken with or directly after a meal.

Pregnancy and breast-feeding

Eeze must not be used during the last three months of the pregnancy.Eeze should be avoided by women who are trying to become pregnant or who are pregnant. Treatment with Eeze during any phase of pregnancy may only take place on the prescription of a doctor.

Diclofenacpasses into the breast-milkin small amounts. Therefore, Eeze shouldnot be used duringbreast-feeding.

Taking Eeze can make it more difficult to conceive. Seek advice from your doctor if you are planning to become pregnant or if you are having problems in becoming pregnant. The effect is temporary and ceases when you stop taking these types of drugs.

Driving and using machines

If you experience side effects such as visual disturbances, dizziness or somnolence while taking Eeze, you should refrain from driving or using machines.

Eeze contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE EEZE

The dose has been individually prescribed for you by a doctor. The dose and the duration of the treatment is depending of the pain condition.

Migraine attacks

Usual dose for adults and adolescents over 16 years: 2 tablets to be taken at the first signs of a migraine attack. 2more tablets to be taken if relief is not obtained within 2 hours.

This may be repeated once more after 4–6 hours, with a maximum dose of 150 mg (6 tablets) in a 24-hour period. Do not exceed the stipulated dose.

Other acute pain conditions, such as headache, toothache, muscle and joint pain or period pains

Usualdose for adultsand adolescents over 16 years: 1-2 tablets to be taken every 4-6 hours as required. Do not take more than 150 mg (6 tablets) in a 24-hour period.Do not exceed the stipulated dose.

Pain related to inflammatory infections of the ear, nose or throat or pain after minor surgery

Usual dose for adolescents 12-16 years (45-55 kg): 1 tablet to be taken as required, maximum 3-4 times in a 24-hours period.

Usual dose for children 9-11 years (35-44 kg): 1 tablet to be taken as required, maximum 3 times in a 24-hours period.

The tablets should be swallowed whole with liquid. To obtain the best effect, they should not be taken with a meal.

Seek advice from your doctor or pharmacist if you are unsure. Contact your doctor or pharmacist if you think that Eeze has too strong or weak an effect.

If you take more Eeze than you should

Always contact a doctor or a hospital if you take more Eeze than you should.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Eeze can cause side effects, although not everybody gets them. Some side effects can be serious.

You may experience gastrointestinal problems at the beginning of treatment. These side effects normally disappear within a few days.

Medicines such as Eeze may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Exceptional serious infections of the skin in case of varicella.

Stomach bleeding can occur at any time during treatment with or without warning symptoms. This generally has more serious consequences in elderly patients. A doctor must be contacted if this occurs, or if any other unexpected symptoms occur.

Eeze may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

Stop using Eeze and tell your doctor straight away if you notice:

If you experience symptoms of angioedema, such as: swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath.
Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Eeze 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).

Other side effects:

Common (occur in more than 1 patient in 100 patients):Epigastric pain, abdominalpain, nausea, vomiting, diarrhoea, dyspepsia, reduced appetite, flatulence, headache, dizziness, vertigo, rash,raised liver values.

Uncommon (occur in less than 1 patient in 100 patients, but by more than 1 patient in 1,000 patients): Tiredness, convulsions in the windpipe.

Rare (experienced by fewer than 1 patient in 1,000 patients): Hypersensitivity reactions (allergic shock reaction with a fall in blood pressure),drowsiness, disturbances of sensation, asthma, digestive problems,gastritis, stomach ulcer, stomach haemorrhage (vomit mixed with blood, blood in the stools, haemorrhagic diarrhoea),liver function disorders (liver inflammation, jaundice), urticaria, renal insufficiency, swelling of the body as a result of fluid retention, impotence (the association is uncertain).

Very rare (experienced by fewer than 1 patient in 10000 patients): Effects on blood composition (a reduced number of blood platelets, which can lead to small haemorrhages in the skin and mucous membranes, a reduced number of white blood cells, including agranulocytosis, which can degrade the immune response, breakdown of red blood cells, anaemia), disorientation, depression, difficulties in sleeping, nightmares, irritability, psychotic disorders, paraesthesia, memory disturbances, convulsions, anxiety, tremors, aseptic meningitis (with symptoms like i.e. fever, malaise and stiff neck), changes in the sense of taste, stroke, effects on vision (blurred vision, double vision) and hearing (reduced hearing, tinnitus), effects on the heart and blood vessels (such as chest pains, tachycardia, high blood pressure, heart failure or heart attack), inflammation of lung tissue, problems with the large intestine, constipation, inflammation of the tongue, mouth or oesophagus, inflammation of the pancreas, liver impairment, eczema, redness of the skin, itching, swelling (angioedema), hair loss, hypersensitivity to light, bullous skin reactions and rare skin syndromes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis,effects on the kidneys (which may lead to reduction or stoppage in urine production and blood in the urine), worsening of ulcerative colitis and Crohn’s disease (inflammatory disease of the intestines).

Reporting side effects

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

(To be completed nationally)

5. HOW TO STORE EEZE

Keep this medicine out of the reach and sight of children.

Do not use Eeze after the expiry date stated on the pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater 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 Eeze contains

The active substance is diclofenac potassium. Each tablet contains 25 mg diclofenac potassium.
The other ingredients are lactose monohydrate 27.2 mg, maize starch, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, hypromellose, macrogol, talc, simethicone,

sorbic acid, benzoic acid, macrogol palmitate, macrogol stearate, monoglycerides and diglycerides, octamethylcyclotetrasiloxane, titanium dioxide (colourant E171) and red iron oxide (colourant E172).

What Eeze looks like and contents of the pack

The Eeze tablets are pink, round and biconvex with a diameter of 6 mm.

Pack sizes: 6, 10, 12, 18, 20, 30, 40, 80, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Meda OTC AB, Box 906, 170 09 Solna, Sweden

Tel: +46 8 630 19 00

This leaflet was last authorised on:

2016-10-19