Takeda Ibumetin forte 400 mg

One Ibumetin forte 400 mg film-coated tablet contains 400 mg ibuprofen as the active ingredient.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (non-steroidal analgesics/anti-inflammatory drugs (NSAIDs)). These drugs have analgesic, anti-inflammatory and antipyretic effects.

Ibumetin is used

• for the relief of mild to moderate pain (such as headache, toothache and menstrual pain);
• to relieve pain and fever associated with colds.

If you do not feel better or worse after 3-4 days, contact your doctor.

Contraindications

Ibumetin should not be taken

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid or other similar painkillers (NSAIDs).
• if you suffer from bleeding in the brain (cerebrovascular haemorrhage) or other active bleeding.
• if you have (or have had two or more episodes of) a gastrointestinal ulcer or gastrointestinal bleeding.
• if you have previously had gastrointestinal bleeding or perforation when taking NSAIDs.
• if you have severe liver, kidney or heart failure (severe functional disorders).
• if you suffer from an unexplained blood disorder.
• if you suffer from a tendency to uncontrolled bleeding (haemorrhage) or problems with blood clotting (coagulation).
• if you suffer from severe dehydration (dehydration of the body caused by vomiting, diarrhea or not drinking enough fluids).
• if you are in the last three months of pregnancy (see section Pregnancy, breast-feeding and fertility).
• of children under 6 years or 20 kg body weight 

interactions

What should you avoid while taking this medicine?
Ibumetin may affect or be affected by other medicines. For example:

• Medicines that have an anticoagulant effect (ie thin the blood/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines can also affect or be affected by treatment with ibumetin. You should therefore always seek the advice of your doctor or pharmacist before using Ibumetin with any other medicine.

Combination of ibuprofen (the active substance in Ibumetin 400) with: possible reactions:

• other NSAIDs, including salicylates Increased side effects, in particular the risk of gastrointestinal ulcers and bleeding (this combination should be avoided, see point 2 "Take special care with Ibumetin 400")
• Low-dose salicylates for “blood-thinning” The blood-thinning effect may be impaired (with prolonged use)
• Cardiac glycosides (a group of active substances that serve to strengthen the heart) increase in their concentration in the blood - appropriate controls and, if necessary, dose adjustment is recommended.
• Zidovudine (antiviral drug) There is evidence of an increased risk of bleeding into joints (haemarthrosis) and bruising in hemophiliac patients (bleeders).
• Glucocorticoids increase the risk of gastrointestinal ulcers or bleeding (see point 2 "Take special care with Ibumetin 400")
• Drugs that inhibit platelet aggregation Increase in the risk of gastrointestinal bleeding (see point 2 “Take special care with Ibumetin 400”)
• Acetylsalicylic acid (low dose) as an antiplatelet agent Inhibition of platelet aggregation may be impaired by concomitant use of Ibumetin 400
• Anticoagulants (medicines to inhibit blood clotting) NSAIDs can increase the effect of anticoagulants (see point 2 "Take special care when taking Ibumetin 400"); an increased risk of bleeding is possible. (Coagulation status check recommended)
• Phenytoin (medicine used to treat seizures) Possible increase in the concentration of this drug in the blood - appropriate monitoring and dose adjustment recommended if necessary.
• Selective serotonin reuptake inhibitors/SSRIs (certain antidepressants) Increased risk of gastrointestinal bleeding (see point 2 “Take special care with Ibumetin 400”
• Lithium (agent for the treatment of mental illnesses) Increase in the lithium concentration in the blood – monitoring and, if necessary, dose adjustment recommended.
• Probenecid, sulfinpyrazone (agents used to treat gout) Delay in the elimination of ibumetin 400 and this can lead to accumulation in the body with an increase in its undesirable effects (dose reduction of ibumetin 400 and monitoring recommended)
• Potassium-sparing diuretics Increased effect and risk of increased levels of potassium in the blood (hyperkalemia) (blood pressure and potassium levels checked)
• diuretics increase the risk of nephrotoxicity (kidney damage). Monitoring of kidney function recommended, ensure adequate hydration.
• Furosemide and other loop diuretics (certain water tablets) Reduction of their blood pressure lowering effect (blood pressure checks recommended)
• Blood pressure lowering drugs (antihypertensives) weakening of their blood pressure lowering effect (blood pressure checks recommended)
• ACE inhibitors (medicines used to treat heart failure and high blood pressure) Angiotensin II antagonists Increased risk of kidney damage and increased risk of increased potassium levels in the blood (hyperkalaemia). (Check of kidney function and potassium level recommended, ensure adequate hydration)
• Methotrexate (cancer drug) Administration of Ibumetin 400 within 24 hours before or after treatment with methotrexate can lead to an increase in blood levels of methotrexate and consequently increase the toxicity of this substance. (combination is to be avoided)
• Ciclosporin (agent used to prevent transplant rejection, but also in the treatment of rheumatism) Increased risk of damage to the gastrointestinal tract, kidney and liver damage from NSAIDs possible; cannot be ruled out for Ibumetin 400 either
• Tacrolimus (used to prevent transplant rejection) There is an increased risk of kidney damage
• Antidiabetics (medicines to lower blood sugar; for oral use) Fluctuations in blood sugar have been described in combination with NSAIDs (increased blood sugar checks recommended)

Taking ibumetin with food, drink and alcohol
It is recommended that patients with a sensitive stomach take ibumetin with food. Some side effects, such as those affecting the gastrointestinal system, are more likely to occur when alcohol is taken at the same time as ibumetin.

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 for advice before taking this medicine.

Pregnancy
Tell your doctor if you become pregnant while taking ibumetin. DO NOT take this medicine during the last 3 months of pregnancy. Avoid taking this medicine during the first 6 months of pregnancy unless your doctor tells you otherwise.

Breast-feeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. This medicine can be used during breast-feeding if taken at the recommended dose and for the shortest possible time.

Fertility Ibumetin
belongs to a group of medicines (NSAIDs = Non-Steroidal Anti-Inflammatory Drugs) which can impair fertility in women. This effect is reversible after stopping the drug.

Avoid taking this medicine if you are trying to conceive. 

application

The recommended dose is:

Adults and adolescents (from the age of 12):
body weight (age) ≥40 kg (adolescents from 12 years and adults)
single dose 1 tablet (equivalent to 400 mg ibuprofen)
max. daily dose 3 tablets (equivalent to 1200 mg ibuprofen)

Children (6 years and older):
Ibuprofen can only be given to children under 12 years of age if prescribed by a doctor. Ibumetin should not be used in children under 6 years of age. The tablet can be divided into equal doses.

Body weight (age) 20kg - 29 kg (children: 6 years -9 years)
single dose ½ (equivalent to 200 mg ibuprofen)
max. daily dose 1½ (equivalent to 600 mg ibuprofen)

Body weight (age) 30 kg -39 kg (children: 10 y - 12 y)
single dose ½ (equivalent to 200 mg ibuprofen)
max. daily dose 2 (equivalent to 800 mg ibuprofen)

Elderly (over 65 years of age)
No specific dose adjustment is required. Due to the possible side effects (see point 2 "Warnings and precautions"), elderly people should be monitored particularly carefully.

Impaired liver or kidney function
If you suffer from impaired liver or kidney function, talk to your doctor before taking ibumetin. See also Section 2.

Method of
administration For oral use.
Please take Ibumetin whole with plenty of liquid (e.g. a glass of water) during or after a meal.
There should be at least 6 hours between two doses.

Duration of use
This medicine is only intended for short-term treatment. You should only take the lowest dose for the shortest time necessary to relieve your symptoms. Consult your doctor if you need to take ibumetin for more than 3 days to treat fever, for more than 4 days to treat pain, or if symptoms worsen.

If children and adolescents need to take this medicine for more than 3 days or if symptoms worsen, seek medical advice.

Please talk to your doctor or pharmacist if you feel that the effect of this medicine is stronger or weaker than you expected.

side effects

The most frequently observed side effects involve the digestive tract.
Stomach/duodenal ulcers (peptic ulcers), perforation (perforation) or bleeding may occur, particularly in elderly patients (see section 2). Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, haematemesis, mouth ulcers, exacerbation of inflammatory bowel diseases such as colitis and Crohn's disease (see section 2) have been reported after use. Less frequently gastritis has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose range and the duration of use.

Fluid retention (oedema), high blood pressure and heart failure (heart failure) have been reported with NSAID treatment.

Using drugs like ibumetin may be associated with a small increased risk of heart attack or stroke.

Common (may affect up to 1 in 10 people)
Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and minor gastrointestinal blood loss, which in exceptional cases can cause anemia

Uncommon (may affect up to 1 in 100 people)
Hypersensitivity reactions with skin rash and itching and asthma attacks (possibly with drop in blood pressure); Visual disturbances, stomach/duodenal ulcers - possibly with bleeding and perforation, inflammation of the mouth with ulceration, worsening of inflammatory bowel disease (ulcerative colitis or Crohn's disease), inflammation of the stomach (gastritis), headache, dizziness, insomnia, agitation, irritability or tiredness, increased Water retention in the tissue (oedema) - especially in patients with high blood pressure or impaired kidney function, excessive protein excretion in the urine; inflammatory kidney disease, which can be associated with acute renal dysfunction.

Rare (may affect up to 1 in 1,000 people)
ringing in the ears (tinnitus), hearing problems

Very rare (may affect up to 1 in 10,000 people)
Disorders of blood formation, decrease in blood cells (e.g. red or white blood cells, blood platelets), severe general hypersensitivity reactions: They can manifest themselves as facial oedema, tongue swelling, inner larynx swelling with constriction of the airways, shortness of breath, tachycardia, drop in blood pressure to the point of threatening shock, disorders of perception and experience, depression; Palpitations, heart muscle weakness, heart attack, high blood pressure, inflammation of the esophagus or pancreas, narrowing of the small and large intestine, liver dysfunction, liver damage - especially with long-term therapy, liver failure, acute liver inflammation (hepatitis), severe skin reactions such as rash with reddening and blistering (e.g. Stevens Johnson Syndrome, Toxic Epidermal Necrolysis/Lyell Syndrome), Hair Loss,

Worsening of infection-related inflammations has been described very rarely in temporal relation to the use of NSAIDs, including ibumetin.

In exceptional cases, severe skin infections and soft tissue complications can occur during chickenpox.

Symptoms of meningitis (headache, nausea, vomiting, fever, stiff neck, clouding of consciousness) can very rarely occur in patients suffering from autoimmune diseases such as systemic lupus erythematosus or mixed collagen diseases.

Not known (cannot be estimated from the available data)
A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include a rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell)

Stop using this medicine and contact a doctor immediately if any of the following possible signs of a serious side effect occur:

• Stomach upset, heartburn or pain in the abdomen
• Vomiting blood or coffee grounds like vomiting
• Blackening of the stool or blood in the urine
• Skin reactions such as a rash or itching
• difficult breathing, shortness of breath or shortness of breath, swelling in the head area
• yellowing of the skin or eyes
• severe exhaustion with loss of appetite
• persistent sore throat, mouth sores, fatigue or fever
• Nosebleeds, skin bleeding
• Decreased urination with swelling and severe fatigue
• Swelling of the face, feet or legs
• severe headache or neck stiffness
• chest pain
• clouding of consciousness

composition

The active substance is: ibuprofen. One tablet contains 400 mg ibuprofen.

The other ingredients are:
Tablet core: microcrystalline cellulose, lactose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica
Tablet coating: hypromellose, talc, titanium dioxide E171