25 mg film-coated tablet
diclofenac potassium
1. WHAT EEZENEO IS AND WHAT IT IS USED FOR?
Eezeneo relieves pain and reduces inflammation. Eezeneo belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).
Eezeneo is used to treat temporary mild to moderate pain conditions, e.g. headaches including migraines, toothaches, muscle, and joint pain, back pain, and menstrual cramps.
The diclofenac potassium contained in Eezeneo may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. BEFORE YOU TAKE EEZENEO
Do not use Eezeneo
- if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of Eezeneo
- if you have or have had a recurring sore, bleeding, or broken wound in your stomach or duodenum a
- if you have an increased tendency to bleed
- if you have a history of bleeding or a broken wound in the gastrointestinal tract in connection with the use of painkillers ( NSAIDs )
- if you have porphyria (a metabolic disease)
- if you have severe liver or kidney function
- if you have a known heart disease and/or disease of the blood vessels of the brain, e.g. heart attack, stroke, “mini-stroke” ( transient chemical attack, TIA ).
- You may also have had narrowing of the blood vessels to the heart or brain, or have had surgery for such narrowing by clearing vessels one by one or via a bypass operation.
- if you have or have had problems with blood circulation ( peripheral vascular disease)
- if you have previously had an allergic reaction while taking painkillers containing acetylsalicylic acid, ibuprofen, or other pain/inflammation medicines in the NSAID group. Signs of a hypersensitivity reaction may include swelling of the face and mouth ( angioedema ), difficulty breathing, chest pain, runny nose, rash, or any other type of allergic reaction.
- during the last three months of pregnancy
Warnings and cautions
Side effects can be minimized by treating with the lowest effective dose for the shortest possible time. Higher doses than those recommended can lead to serious risks. This also means that the combination of several NSAIDs at the same dose should be avoided.
Consult your doctor before treatment, if you have or have had any of the following diseases:
- gastrointestinal upset, heartburn/discomfort in the stomach, or previously had a sore, bleeding, or broken wound in the stomach or intestine
- heart disease, liver disease, or kidney disease
- asthma, inflammation or swelling of the nasal mucosa, chronic obstructive pulmonary disease (COPD), or chronic respiratory infections
- SLE (a connective tissue disease)
- diseases with an increased tendency to bleed
- high blood pressure or heart disease (mild to moderate heart failure )
- angina, blood clots
- ulcerative colitis or Crohn’s disease
- diabetes
Before you get Eezeneo, tell your doctor
- if you smoke
- if you have high cholesterol or triglyceride levels (blood fats)
- if you have recently had surgery or are about to have surgery on your stomach or intestinal tract, Eezeneo can sometimes impair wound healing in the intestines after surgery.
For chickenpox, this medicine should not be used.
Elderly people should be aware of the increased risk of side effects that exist in old age.
NSAIDs including Eezeneo may in rare cases cause stomach ulcers which may occur at any time during treatment with or without warning symptoms. If you get problems with the gastrointestinal tract, especially if you are older, contact a doctor.
Like other NSAIDs, Eezeneo may mask signs or symptoms of infection.
In rare cases, Eezeneo can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.
Like other NSAIDs, diclofenac may in rare cases cause allergic reactions, including allergic shock reactions. Stop taking Eezeneo and contact a doctor immediately if swelling of e.g. a. face, tongue, and/or throat and/or difficulty swallowing or hives, which occur together with difficulty breathing ( angioedema ).
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Eezeneo and consult a doctor if you get a rash or damage to the mucous membranes.
Prolonged use of painkillers for headaches can worsen the headache. If you experience this or suspect it, you should discontinue treatment and consult a doctor.
Using Eezeneo can make it difficult for you to get pregnant. More information about this can be found in the section “Pregnancy and breastfeeding”.
Medicines such as Eezeneo may increase the risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time 3 days for migraines or 5 days for pain.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Eezeneo may be affected or affected by certain medicines containing the following active substances:
- anticoagulants (eg warfarin, ticlopidine, acetylsalicylic acid, heparin ).
- medicines for the treatment of diabetes, except insulin,
- lithium or selective serotonin reuptake inhibitors ( SSRIs ) (used in certain types of depression),
- digoxin (used for heart problems),
- tacrolimus (used in transplants and eczema ),
- ciclosporin (used in transplants, severe psoriasis, and rheumatism),
- certain medicines for high blood pressure (so-called beta-receptor blockers, angiotensin II antagonists, and ACE inhibitors ),
- diuretics ( diuretics also used for high blood pressure ),
- quinolone antibiotics (used in urinary tract infections),
- corticosteroids (used to treat inflammatory diseases),
- colestipol or cholestyramine (used in high blood fats),
- fluconazole or voriconazole (used for fungal infections),
- rifampicin ( antibiotics for tuberculosis ),
- carbamazepine (used in epilepsy ),
- barbiturates (sleeping pills),
- diazepam (sedatives),
- St. John’s wort (in case of depression),
- phenytoin (used in epilepsy )
- methotrexate (used in psoriasis, rheumatism, and certain cancers)
- sulfinpyrazone (used to treat gout )
- tenofovir (antiviral the HIV – infection )
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Eezeneo with food and drink
The tablets are swallowed whole along with the liquid. For best effect, the tablets should not be taken with or immediately after a meal.
Pregnancy, breastfeeding, and fertility
Pregnant women should not use Eezeneo during the last three months of pregnancy. Taking Eezeneo should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Small amounts of diclofenac pass into breast milk. Therefore, Eezeneo should not be used during breast-feeding.
Using Eezeneo can make it harder for you to get pregnant. Talk to your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant. The effect is temporary and stops when you stop taking this type of medicine.
Driving and using machines
If you experience side effects such as visual disturbances, dizziness, or difficulty sleeping during treatment with Eezeneo, you should refrain from driving or using machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. HOW TO TAKE EEZENEO
Migraine attacks
The usual dose for adults (over 18 years): 2 tablets are taken at the first sign of a migraine attack. If relief is not achieved within 2 hours, take another 2 tablets. This can be repeated once more after 4-6 hours, but not more than 6 tablets (150 mg) per day. Do not exceed the indicated dose one.
Contact a doctor if symptoms worsen or do not improve within 3 days in case of migraine.
Temporary mild to moderate pain conditions, e.g. headache, toothache, muscle and joint pain, back pain, and menstrual pain
The usual dose for adults (over 18 years): 1 tablet every 4 to 6 hours if needed. Do not take more than 3 tablets (75 mg) per day. Do not exceed the indicated dose one.
Contact a doctor if symptoms worsen or do not improve within 5 days in case of pain.
The tablets are swallowed whole along with the liquid. For best effect, tablets should not be taken with a meal.
Eezeneo should not be given to children and adolescents under 18 years of age without a doctor’s prescription.
If you are not sure, talk to your doctor or pharmacist. If you have the impression that the effect of Eezeneo is too strong or too weak, talk to your doctor or pharmacist.
If you take more Eezeneo than you should:
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Eezeneo can cause side effects, although not everybody gets them. Some side effects can be serious.
At the beginning of the treatment, gastrointestinal problems may occur. These side effects usually go away within a few days.
In rare cases, severe skin infections are associated with chickenpox.
Drugs such as diclofenac may cause a small increased risk of heart attack or stroke.
In rare cases, Eezeneo can affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). You must inform about your medication.
Stomach bleeding can occur at any time during treatment with or without warning symptoms. This generally has more serious consequences for the elderly. If this or other unexpected symptoms occur, consult a physician.
Stop using Eezeneo and tell a doctor immediately if you notice the following:
- Symptoms of angioedema, for example: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
- Chest pain, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome.
- Mild abdominal cramps and soreness, which begin shortly after the start of Eezeneo treatment and are followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain (reported, occurring in an unknown number users).
Other side effects are
Common (more than 1 in 100 patients): Stomach pain, nausea, vomiting, diarrhea, indigestion, decreased appetite, increased flatulence, headache, dizziness, dizziness, rash, elevated liver values.
Uncommon (less than one in 100 patients): Tracheal spasm, hepatic dysfunction (hepatitis, jaundice).
Rare (less than 1 in 1000 patients): Fatigue, swelling of the body due to fluid retention, hypersensitivity reactions ( hives, allergic shock reaction with a drop in blood pressure), stomach ulcers, stomach bleeding (blood vomiting, blood in the stool, bloody diarrhea), inflammation of the stomach, impotence (connection uncertain), asthma (including shortness of breath), severe liver effects.
Very rare (less than 1 in 10,000 patients including single reports) : Impact on vision (blurred vision, double vision) and hearing (hearing loss, tinnitus), intestinal problems (eg constipation, inflammation of the intestine), worsening of Crohn’s disease and ulcerative colitis , inflammation of the tongue, mouth or esophagus, pancreatitis, difficulty falling asleep, nightmares, irritability, anxiety, depression, memory disorders, confusion, disturbed perception of reality, ant crawls, tremors, convulsions, loss of sensation, taste changes and heartburn (pain) , high blood pressure , heart failure, myocardial infarction, vasculitis), blood clots (decreased number of platelets that can cause small bleeding in the skin and mucous membranes, decreased number of white blood cells that can impair the immune system ( agranulocytosis ), decay of red blood cells , anemia ), eczema , itching , skin redness, severe redness, Steven Johnson’s syndrome ( mucositis and dermatitis with blisters and high fever) and Lyell’s syndrome(such as Steven-Johnson syndrome but also with sudden skin detachment), hair loss, photosensitivity reactions, severe effects on the kidneys (eg decreased or stopped urine production and blood in the urine), meningitis or pneumonia without bacterial cause, stroke , angioedema (eg swelling of face, rash, difficulty breathing).
5. HOW TO STORE EEZENEO
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask at the pharmacy how to deal with medicines that are no longer used. These measures will help to protect the environment.
6. FURTHER INFORMATION
Content declaration
- The active substance is diclofenac potassium. One tablet contains 25 mg of diclofenac potassium.
- The other ingredients are potassium bicarbonate, mannitol, sodium lauryl sulfate, macrogol, crospovidone, magnesium stearate, hypromellose.
What the medicine looks like and the contents of the pack
The tablets are white, round, and biconvex.
Blister packs containing 10, 12, 18 and 20 tablets (over-the-counter) and 30, 40, 80, 100 and 120 tablets (prescription).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Meda OTC AB, Box 906, 170 09 Solna.
Manufacturer
Laboratorio Pharmacologico Milanese SRL
Via Monterosso, 273
21042 Caronno Pertusella (VA)
Italy.