PACKAGE LEAFLET
Read this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you notice any side effects not listed in this leaflet, or side effects (see section 4) get serious please tell your doctor or pharmacist.
In this leaflet:
1. What IBUMAX is and what it is used for
2. Before you use IBUMAX-tablets
3. How to use IBUMAX-tablets
4. Possible side effects
5. How to store IBUMAX-tablets
6. Further information
1. WHAT IBUMAX IS AND WHAT IT IS USED FOR
IBUMAX contains ibuprofen, which is so-called anti-inflammatory painkiller.
Ibuprofen reduces synthesis of endogenic compounds, which mediate pain sensation and inflammation. Pain is relieving and burning, redness and swelling decrease with aid of ibuprofen. Ibuprofen reduces also fever.
IBUMAX-tablets are used:
rheumatoid arthritis, children rheumatoid arthritis, degenerative arthritis, rheumatoid spondylitis and other connective tissue disorders.
for inflammation and pain after operations and measures (also tooth measures)
pain concerning accidents and injuries
gout pain, migrant, menstrual pain
heavy menstrual bleeding for women who use spiral
temporarily in conditions with pain and fever,
A physician could have been prescribed IBUMAX-tablets to you for other symptoms also.
2. BEFORE YOU USE IBUMAX
Do not use IBUMAX-tablets
if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of the product (see section 6)
if you have previously received allergic symptoms or worsening of asthma when using acetyl salicylic acid or other painkiller
if you have severe heart failure
if you have active gastric or duodenal ulceration
if you have had previously gastric or duodenal ulceration, which has re-occurred once or many times
if you have previously had gastrointestinal perforation or bleeding (eg. black or bloody stools, vomiting of blood, anemia) when using painkillers
if you have a bleeding disease (hemophilia) or have low thrombocyte count (thrombosytopenia) or
during the last trimester of pregnancy (weeks 28-40).
Take special care with IBUMAX-tablets
Discuss with your doctor before using this medicine
if you have hypertension or cardiac insufficiency,
if you have angina pectoris,
if you have disorders in circulation of brain or extremities
if you have renal or liver dysfunction,
If you have some gastrointestinal disease, such as ulcerative colitis (Colitis ulcerosa) or Crohn's disease,
if you have had previously abdominal pain, get easily bruises or bleeding from nose, or
if you have bronchial asthma.
Tell your doctor also if you have other diseases or allergies.
When using painkillers, such as IBUMAX-tablets, risk to myocardial infarction and stroke may increase. This risk increases when the dose is increased and treatment is prolonged. Do not take the medicine longer time than is recommended.
If you have a cardiac disease or have had previously a stroke, or if you have risk factors to these diseases (eg. high blood pressure, diabetes mellitus, elevated cholesterol level in blood, or if you smoke), you should consult your doctor or pharmacist about your medicine.
Using other medicines concomitantly
Tell your doctor about all medicines you are using, from those under prescription, and also from those which can get without prescription and from herbal and natural health products. Remember to mention if you have recently used some medication.
IBUMAX-tablets may alter action of some medicines, if they are used at the same time. In such a case, the doctor can change your medication or dosage recommendations.
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captorpil, betareceptor blocking medicines, angiotensin II antagonists) and even some other medicines may affect or be affected by the treatment of ibuprofen. Seek therefore always advice of a doctor before you use ibuprofen with other medicines.
Other medicines influence on the efficacy and safety of IBUMAX-tablets:
Other painkillers should not be used simultaneously with IBUMAX-tablets - only undesirable effects increase, not potency.
Effects of the drugs inhibiting coagulation (eg. warfarin) can be changed significantly, and risk for bleeding increases. Concomitant use should be avoided.
Antithrombotic medicines (eg. acetyl salisylic acid, ticlopidine or clopidogrel) - increased risk to gastrointestinal bleeding. If you are using small dose of acetyl salisylic acid daily (eg. 100 mg) to reduce risk for thrombosis, you have to take it at least one hour before taking IBUMAX-tablets.
Certain anti-depressive medicines (eg. citalopram, fluoxetine, paroxetine, sertraline) which belong in so-called serotonin-selective re-uptake inhibitors (SSRI), increase risk to bleedings.
Some anti-cholesterol medicines (colestipole and cholestyramine) should be taken preferably over 4 hours later than IBUMAX-tablets so that they would not inhibit absorption of ibuprofen.
Anti-epilepsy drugs phenytoin and phenobarbital, and anti-tuberculotic drug rifampicin may impair effect of IBUMAX-tablets.
Anti-fungal medicines fluconazole and miconazole may increase adverse effects of IBUMAX- tablets.
Lithium levels may elevate too much if used concomitantly with ibuprofen.
Digoxin, because digoxin levels in blood can elevate too much in those patients who have renal insufficiency.
Oral corticosteroid can increase risk to abdominal adverse effects and gastrointestinal bleeding, if used concomitantly.
Adverse effect of methotrexate which is used in treatment of rheumatic and dermal diseases may increase when used concomitantly with IBUMA- tablets. Do not use IBUMAX-tablets on those days when you take methotrexate.
Adverse effects of cyclosporin can increase in concomitant use.
Effects of some antihypertensive medicines and diuretics may decrease due to action of IBUMAX-tablets. Tell your doctor, if your blood pressure is followed up or if you are using antihypertensive medication.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. IBUMAX-tablets may use during pregnancy according to physician's instructions. IBUMAX must not be used during the last trimester of pregnancy in other words after 28. pregnancy weeks.
IBUMAX-tablets may be used during lactation since only insignificant amounts of ibuprofen is secreted to breast milk.
IBUMAX belongs to painkillers which use can make it difficult to become pregnant. This effect disappears when IBUMAX treatment is stopped.
Driving and using machines
IBUMAX-tablets do not usually affect ability to drive or to operate machinery. Sometimes adverse effects can appear, such as sleepiness and vertigo (see section 4); then you should abstain from driving and using of machines.
3. HOW TO USE IBUMAX-TABLETS
Always take IBUMAX-tablets exactly as your doctor has told you. If you are uncertain, check the dosage from your doctor or pharmacist.
For prolonged use only by physician's prescription.
The tablet should be taken with sufficient amount of fluid, eg. with glass of water.
Adults and children over 12 years of age:
The dosage is individual. The average dosage is 400-600 mg 3-4 times a day. In more severe cases or in treatment of an acute phase 800 mg 3-4 times per day.
In treatment of any illness, single dose 1600 mg should not exceed.
Usually the total daily dose 2400 mg is sufficient. Do not exceed the total daily dose 3200 mg.
If the older patient or patient with renal or liver dysfunction is in question, the physician usually prescribes smaller dosages.
Children (under 12 years of age):
Only by physician's prescription.
If you take more IBUMAX-tablets than you should
In case of over dosage and poisoning contact immediately a physician, hospital emergency room or poison information centre. (tel. 09-471 977 or 09-4711 exchange).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, IBUMAX-tablets may cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (appear over 1 of 100 patients) adverse effects have been reported:
increase risk to bruises and nasal bleeding (due to impairment of function of thrombocytes)
depression of mood or sleepiness
dizziness and headache
deterioration of cardiac insufficiency (oedema and dyspnoea)
heartburn, abdominal pain, nausea or diarrhoea
rash, itch or swelling of skin and mucous membranes.
Uncommon (appear less than 1 of 100 patients) adverse effects have been reported:
dizziness, nightmares, cognitive disorders, hallucinations, paranoid disorders
pricking or tingling of skin with no apparent physical cause (parestesias)
inflammation of mouth, ulceration and bleeding of gastrointestinal system, bloody stools
Rare (appear less than 1 of 1000 patients) adverse effects have been reported:
decreased number of thrombocytes (with increased risk to bruises and nasal bleeding)
decreased number or disappearance of white cells in blood (connected to fever without clear reason, flu-like symptoms and pain in throat)
blurring of vision or corneal disorders
deterioration of angina pectoris (increased pain in the chest), arrhythmia
dyspnoea, deterioration of asthma
gastrointestinal perforations, hematemesis, deterioration of ulcerative colitis and proctitis, other colitis, parotitis, pancreatitis
elevation of liver enzymes, cholestatic hepatitis
severe papular or exfoliative eczema in skin or mucous membranes, photohypersensitivity, deterioration of acne or psoriasis
renal failure
severe hypersensitivity reactions (anaphylaxis).
Use of painkillers, such as IBUMAX-tablets, increase slightly risk to myocardial infarction or stroke.
Stop using the medicine and contact immediately your doctor or nearest hospital if following symptoms appear:
difficulties to breath or dyspnoea
severe swelling of skin or mucous membranes
swelling of tongue or larynx
vertigo or collapse
acute, severe abdominal pain or vomiting of blood.
Contact your doctor as soon as possible if you have following symptoms:
heartburn and other stomach disorders
black stools
increased tendency to bruises and nasal bleeding
swelling of legs and hands
symptoms on skin which develop slowly
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious please tell your doctor or pharmacist.
5. HOW TO STORE IBUMAX-TABLETS
Keep out of the reach and sight of children.
No special instructions for storage.
Do not use the tablets after the expiry date, which is stated on the carton.
Medicines should not be disposed of via drain or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What IBUMAX-tablets contains
The active substance is ibuprofen 400 mg, 600 mg or 800 mg in one film-coated tablet.
The other ingredients are:
Core: pregelatinised starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, stearic acid, anhydrous colloidal silicon oxide.
Coating: hypromellose, macrogol 4000, polydextrose, colour (titanium dioxide E 171).
IBUMAX-tablets are unsweetened and lactose free.
What IBUMAX-tablets looks like
IBUMAX 400 mg: a white, capsule-shaped, film-coated tablet with score which width is 7.5 mm and length 18 mm.
IBUMAX 600 mg: a white, capsule-shaped, film-coated tablet with score which width is 9.0 mm and length 22.5 mm.
IBUMAX 800 mg: a white, capsule-shaped, film-coated tablet with score which width is 10.0 mm and length 21 mm.
Pack sizes
IBUMAX 200 mg: 100 tablets.
IBUMAX 400 mg: 100 tablets.
IBUMAX 600 mg and 800 mg: 10, 30 and 100 tablets.
All package sizes are not necessary in market.
Marketing authorisation holder and Manufacturer
Vitabalans Oy
Varastokatu 8
FI-13500 Hδmeenlinna
Finland
Tel. + 358 3 615 600
Fax: + 358 3 618 3130
This leaflet was last approved in 21.11.2008
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