IBUMETIN 400 TBL 400MG N100 (IBUPROFEN)

ATC code: M01AE01 

Active substances: Ibuprofenum

Vendor, principal: Nycomed Sefa As. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

IBUMETIN 200MG N100

Package leaflet: information for the user Ibumetin 200 mg film-coated tablets

Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
•   Keep this leaflet. You may need to read it again.
•   Ask your pharmacist if you need more information or advice.
•   You must talk to a doctor if you do not feel better or if you feel worse after 4 days.
•   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 Ibumetin is and what it is used for
2.   What you need to know before you use Ibumetin
3.   How to use Ibumetin
4.   Possible side effects
5.   How to store Ibumetin
6.   Contents of the pack and other information

1. What Ibumetin is and what it is used for

Ibumetin is a non-steroidal anti-inflammatory drug (NSAID), which possesses anti-inflammatory, analgesic, and antipyretic properties.
Ibumetin is used to treat mild to moderate pain, dysmenorrhoea (painful menstruation) and fever.

2. What you need to know before you use Ibumetin Do not use Ibumetin:

•   if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
•   if you are allergic to other NSAIDs or acetylsalicylic acid (e.g. asthma has been reported);
•   if you have, or have ever had, a gastric and/or duodenal ulcer, gastrointestinal haemorrhage or gastrointestinal perforation;
•   if you have a tendency to bruise (e.g. lack of platelets in the blood);
•   if you have severe heart, kidney or liver failure;
•   if you have hepatic cirrhosis (death of liver cells and liver fibrosis);
•   if you have uncontrolled high blood pressure;
•   from the third trimester of pregnancy.

Warnings and precautions

If you have:
•   impaired heart, liver or kidney function;
•   asthma;
•   a known infection;
•   coagulation disorders;
•   systemic lupus erythematosus or another connective tissue disease;
•   inflammatory bowel disease (ulcerative colitis or Crohn’s disease).
If you are concomitantly using other medicines, see section “Other medicines and Ibumetin”.
Patients with systemic lupus erythematosus or another connective tissue disease may be at an increased risk of developing aseptic meningitis.
Ibuprofen might impair fertility, which is why it is not recommended for women who wish to have a baby. Women with fertility problems and women undergoing fertility tests should consider discontinuing treatment with ibuprofen.
Side effects, especially gastrointestinal side effects are more common in the elderly.
Tell your doctor about any unusual gastrointestinal symptoms (such as gastrointestinal haemorrhage), especially if these occur at the beginning of treatment. If a gastrointestinal haemorrhage or ulcer occurs during treatment with ibuprofen, the treatment should be stopped immediately.
Anti-inflammatory / analgesic medicines, such as ibuprofen, may be associated with a slightly increased risk of infarction or stroke, especially when used in large doses. Do not exceed the recommended dose or duration of treatment.
Talk to your doctor or pharmacist before taking Ibumetin:
-   if you have heart problems, such as heart failure or angina (chest pain), or if you have had a heart attack, bypass, peripheral arterial disease (poor blood supply in the legs or feet due to narrowed or clogged arteries or any type of stroke (incl. mini-stroke or transient ischemic attack (TIA));
-   if you have high blood pressure, diabetes or high cholesterol levels, if heart disease or stroke has occurred in your family or if you smoke.
Very rarely, severe skin disorders have occurred when using NSAIDs. If you experience skin rash, mucosal lesion, or another symptom of hypersensitivity, discontinue using Ibumetin immediately and talk to your doctor.
Children and adolescents suffering from dehydration are at risk of renal failure.
Talk to your doctor or pharmacist before using Ibumetin.

Other medicines and Ibumetin

Ibumetin may influence the effect of other medicines and vice versa. These medicines include, for example:
•   anticoagulants (which thin the blood and prevent the formation of blood clots, e.g. aspirin or acetylsalicylic acid, warfarin, ticlopidine);
•   medicines to treat high blood pressure (ACE inhibitors, such as captopril; beta-blockers, such as atenolol; angiotensin II receptor antagonists, such as losartan).
Concomitant use of Ibuprofen and corticosteroids (hormones to treat severe inflammatory diseases), platelet aggregation inhibitors (aspirin), other NSAIDs or serotonin reuptake inhibitors (antidepressants) increases the risk of a gastrointestinal ulcer and haemorrhage.
Ibuprofen increases the effect of some medicines that inhibit blood clotting, which may increase the risk of bleeding.
Ibuprofen may decrease the effect of some diuretics (water tablets).
Ibuprofen may promote the toxicity of lithium preparations (used to treat depression), methotrexate (used to treat rheumatic diseases and tumours), cyclosporine (medicine supressing the activity of the immune system) and tacrolimus (medicine used after kidney transplantation).
Probenecid (medicine for gout) may prolong the excretion of ibuprofen from the body.
Some other medicines may also influence the use of Ibumetin or vice versa. Therefore, always tell your doctor or pharmacist before taking Ibumetin with other medicines.

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.
Ibuprofen is not recommended to be administered in the first and second trimester of pregnancy and is contraindicated starting from the third trimester of pregnancy.
Ibuprofen is excreted in breast milk. Breast-feeding should be discontinued in the case of a need for prolonged treatment.

Ibumetin contains lactose monohydrate

This medicine contains lactose monohydrate as an excipient. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Ibumetin

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Mild to moderate pain and fever. Adults 2 tablets (400 mg), followed by 1 tablet (200 mg) or 2 tablets (400 mg) according to need but no more than in every 4 hours. The maximum daily dose in the case of mild to moderate pain and fever should not exceed 1,200 mg.
Without a doctor’s prescription, Ibumetin should not be taken for more than 6 days in the case of pain; more than 3 days in the case of a fever of uncertain cause; and the recommended dose should not be exceeded.
You should talk to your doctor also if symptoms worsen after taking Ibumetin for more than 4 days.
Children 20-40 mg/kg per day divided into 3-4 doses. For children whose weight is 20 kg or more, a dose of 200 mg is administered 3 times a day; 200-400 mg 3 times a day for children weighing more than 30 kg; and 400 mg 3 times a day for children weighing more than 40 kg.
If children older than 6 months and adolescents require treatment for more than 3 days or if symptoms worsen, consult your doctor.
Symptomatic treatment of primary dysmenorrhea: the recommended dose is 2 tablets (400 mg). The dose may be administered every 4 hours according to need.
The tablets should be swallowed whole; if necessary, the tablets may also be chewed or crushed and washed down with water. To reduce the risk of an upset stomach, take the tablets with a meal.
If you feel that the effect of Ibumetin is too strong or too weak, consult your doctor or pharmacist.

If you take more Ibumetin than you should

If you have taken more Ibumetin than recommended or if children have accidentally taken this medicine, contact your doctor or nearest hospital immediately to get information on possible risks and necessary treatment options.
Symptoms of an overdose include nausea, abdominal pain, vomiting (may be blood-mixed), headache, ringing in the ears, confusion and flickering eye movements. At extremely high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mostly in children), weakness and dizziness, incoordination of movements, blood in the urine, chills in the body, breathing problems and abnormal liver and kidney function may occur. Blood clotting potential may decrease.
In the case of overdose symptoms, take the pack with you and consult your doctor.
If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (in more than 1 user in 10): diarrhoea, upper abdominal discomfort.
Common side effects (in more than 1 user in 100):
skin rash, mild and transient headache, dizziness, tinnitus (ringing in the ears), fluid retention, swelling, nausea, vomiting, indigestion, constipation, abdominal cramps or pain.
Uncommon side effects (in more than 1 user in 1,000):
abnormal liver function tests, congestive heart failure, insomnia, nervousness, increased blood pressure, asthma attacks, stomach or duodenal ulcer with bleeding and/or perforation, gastrointestinal haemorrhage, colitis and inflammatory bowel disease.
Rare and very rare side effects (in less than 1 user in 1,000):
various skin disorders (rash, redness, blistering, scaling, peeling), skin sensitivity to sunlight, blood disorders, coagulation disorders, sleepiness, depression, confusion, meningitis and extrapyramidal disorders (unusual face and body movements, restlessness, and tremors), severe hepatic and renal impairment, inability to concentrate and cognitive disorders, eye disorders - various visual disturbances and inflammation of the iris and ciliary body, hair loss, nail problems and inflammation of blood vessels.
A severe skin reaction called DRESS may occur. DRESS symptoms include skin rash, fever, swelling of the lymph nodes and an increase in the number of eosinophils (certain types of white blood cells).

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 www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibumetin

Do not store at a temperature higher than 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Ibumetin contains

-   The active substance is ibuprofen. One film-coated tablet contains 200 mg of ibuprofen.
-   The other excipients are potato starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose 15 (E 464), microcrystalline cellulose (E 460), propylene glycol, talc and colloidal anhydrous silica.

What Ibumetin looks like and contents of the pack

The Ibumetin 200 mg tablet is a white, round, film-coated tablet with curved surfaces.
100 tablets in a plastic bottle.

Marketing Authorisation Holder and Manufacturer

Takeda Pharma AS Jaama 55B 63308 Pölva Estonia
Telephone: +372 617 7669

The leaflet was last revised in April 2018.