MIG 400. 400 mg. 10 tablets

MIG 400. 400 mg. 10 tablets
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MIG-400 is an anti-inflammatory and analgesic drug (NSAID NSAID) with temperature (antipyretic) properties. 

MIG 400. 400 mg. 10 tablets

What is MIG- 400 and what it is used
MIG- 400 is an anti-inflammatory and analgesic drug ( NSAID NSAID) with temperature ( antipyretic ) properties.

Use of MIG- 400
Symptomatic treatment of :
mild to moderate pain;
high temperature.

2 . Before you take MIG- 400
Do not take MIG- 400 :
if you are allergic (hypersensitive) to ibuprofen or any of the excipients ;
if you have had an allergic reaction after taking aspirin or other NSAIDs , such as:
asthma attacks ;
edema of the nasal mucosa ;
skin reactions (eg erythema, urticaria or similar);
in unexplained disorders of hematopoiesis ;
with active or a history of recurring ulcers of the stomach / duodenum ( peptic ulcers) or haemorrhage ( two or more distinct episodes of proven ulceration or bleeding ) ;
with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
with bleeding in the brain ( cerebrovascular haemorrhage) or other active bleeding ;
in severe renal or hepatic function ;
in severe heart failure ;
in the last 3 months of pregnancy.
MIG- 400 should not be used in children under 6 years of age or weighing less than 20 kg, because the concentration is not appropriate.

Take special care with MIG- 400
Side effects can be minimized as to control the symptoms , the lowest effective dose for the shortest time .

Consult your doctor before taking this medicine if you have any of the following conditions.
Notice with respect to the gastrointestinal tract
Should avoid concomitant use of MIG- 400 with other NSAIDs , including so-called COX- 2 inhibitors (selective cyclooxygenase -2).

Elderly patients exhibit an increased incidence of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Therefore, in elderly patients need particularly close monitoring by a doctor .
Gastrointestinal bleeding , ulceration or perforation , which can be fatal, has been reported with the use of all NSAIDs at any time during treatment , with or without warning symptoms or serious GI events in the past.
The risk of gastrointestinal bleeding , ulceration or perforation is higher with increasing NSAID doses , in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 2 "Do not take MIG- 400 " ) and in the elderly . These patients should start treatment with the lowest possible dose .
For these patients, and for patients who need treatment with acetylsalicylic acid or other active substances which increase the risk of gastrointestinal complications , it is recommended that a combination therapy with protective agents ( e.g., misoprostol or proton pump inhibitors ) .
If you have a history of gastrointestinal side effects , especially if you are elderly , should report any unusual abdominal symptoms ( especially bleeding from the gastrointestinal tract) , particularly in the early stages of treatment.
Caution is required if administered concomitantly with drugs that may increase the risk of ulceration or bleeding such . oral corticosteroids, anticoagulants such as warfarin, selective inhibitors of serotonin reuptake , which are used together with other medicines to treat depressive illness or antiplatelet drugs such as aspirin (see section 2, "Taking other medicines" ) .
The occurrence of gastrointestinal ulceration or hemorrhage during therapy with LAG -400 treatment should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4 . " Possible side effects").

Effects on the cardiovascular system
Drugs such as MIG- 400 can be associated with a small increased risk of heart attack (myocardial infarction ) or stroke. Any risk is more likely with high doses and prolonged use. Do not exceed the recommended dose and duration of treatment ( maximum 4 days ) .
If you have heart problems, previous stroke or if you think you are at increased risk of these conditions (eg if you have high blood pressure, diabetes or high cholesterol or are a smoker ) you should consult your treatment with your doctor or pharmacist.

skin reactions
Very rarely in association with the use of NSAIDs , severe skin reactions with redness and blistering , some of them fatal ( exfoliative dermatitis , Stevens -Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome ) (see section 4 . " possible side effects ").
The risk for the occurrence of these reactions in patients being highest early in the course of treatment: beginning of the reaction is in most cases within the first month of treatment.
MIG- 400 should stop and consult a doctor immediately at the first appearance of skin rash, mucosal ulceration or other signs of hypersensitivity.

other comments
In some autoimmune disorders ( systemic lupus erythematosus and mixed connective tissue disease) , MIG -400 can be used only after a rigorous assessment of the benefit / risk ratio . There is increased risk for symptoms of non-infectious inflammation of the meninges ( aseptic meningitis ) (see section 4 ) .

Particularly careful monitoring by a physician is required :
in the gastro -intestinal disorders or a history of chronic inflammatory bowel disease ( ulcerative colitis, Crohn's disease) ;
high blood pressure or heart failure ;
with impaired renal or hepatic function;
immediately after surgery ;
Allergies (eg skin reactions to other medications , asthma , urticaria) , chronic swelling of the nasal mucosa or chronic respiratory diseases that narrow the airways.
Severe acute hypersensitivity reactions ( eg, anaphylaxis ) occur rarely . At the first sign of severe acute hypersensitivity reaction while taking MIG- 400, you should stop immediately and consult a doctor.
Ibuprofen , the active ingredient of MIG- 400 may temporarily inhibit the function of coagulation ( platelet aggregation ) . Therefore, patients with bleeding disorders should be carefully monitored .
Coadministration of ibuprofen -containing drugs , the anticoagulant effect of acetylsalicylic acid given at a low dose (ie, prevent the formation of blood clots ) can be violated.
You should not use medicines containing ibuprofen without the express instructions of the doctor.
If at the same time taking drugs to reduce blood clotting or decrease in blood sugar as a precaution should be a study of blood clotting or blood sugar .
With prolonged use of MIG -400 requires regular monitoring of liver function , renal function , and blood count.
You should consult and inform your doctor or dentist if you are taking MIG- 400 before surgery .
Upon continued administration of analgesics may occur headache , which should not be treated with higher doses of the drug. Ask your doctor if despite use of LAG -400 regularly suffer from headaches.
In general , the regular application of analgesics , particularly of a combination of analgesics active substances can lead to irreversible kidney damage with the risk of kidney failure ( analgesic nephropathy) .
You should avoid use of MIG- 400 in chicken pox .

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some anticoagulant ( anti- clotting drugs ) (e.g. acetylsalicylic acid / aspirin , warfarin , ticlopidine ), certain drugs used to treat high blood pressure (ACE - inhibitors , e. Captopril, and beta receptor blocking agents, angiotensin II antagonists) , or even some other medicines may affect or be affected by treatment with ibuprofen . Therefore, always before the concomitant use of ibuprofen and other drugs, consult your doctor.
The effect of the active substances or medicinal products listed below, may be affected by co-administration of MIG- 400 .

Enhancing the effect and / or side effects
If at the same time , the following drugs , their concentration in the blood can be increased :
digoxin (a medicine for enhancing the pumping function of the heart) ;
phenytoin ( a drug for the treatment of seizures) ;
lithium (a medicine used to treat mental illness) .
Generally do not require the testing of serum lithium , digoxin and phenytoin if MIG- 400 is used correctly ( for maximum 4 days ) ;
substances that inhibit blood clotting ;
methotrexate ( a drug for the treatment of cancer or certain rheumatic diseases ) . Do not take MIG- 400 24 hours before and after administration of methotrexate. This can lead to an increase in the concentration of methotrexate in the blood and an increase of unwanted effects ;
acetylsalicylic acid or other anti-inflammatory analgesics , including COX -2 inhibitors ( NSAIDs ), selective inhibitors of serotonin reuptake inhibitors ( drugs for the treatment of depressive mood ) and cortisone drugs ( glucocorticoids ) . There is an increased risk of bleeding and ulceration of the gastrointestinal tract ;
medicines containing probenecid or sulfinpyrazone ( medicines for gout ) . This may delay transmission of ibuprofen . May occur accumulation of ibuprofen in the body and enhancement of the adverse effects.
Weakening effect
drugs promote fluid excretion ( diuretics) , and drugs for high blood pressure ( antihypertensives ) ;
ACE inhibitors ( drugs for the treatment of heart failure and hypertension ) . Risk of impaired kidney function is increased;
aspirin in low doses : the effect of low-dose aspirin on platelets responsible for blood clotting may be impaired (see section 2 'Take special care with MIG- 400 " ) .
Other possible interactions
zidovudine (a medicine to treat AIDS ): in hemophiliacs with HIV infection have an increased risk of joint bleeding and bruising ;
cyclosporin ( a medicament for suppressing an immune response , e. after transplantation and in the treatment of rheumatism ) : there is a risk of renal failure;
Tacrolimus: There is a risk of renal impairment ;
potassium-sparing agents, promote fluid excretion ( certain diuretics ): if taken at the same time may increase potassium level ;
sulfonylurea (medicines to lower blood sugar ): Although not described interactions between ibuprofen and sulfonylurea drugs , unlike other NSAIDs , if taken at the same time as a precautionary measure should be monitored blood glucose values ;
anticoagulants and drugs : there have been isolated reports of interaction between ibuprofen and anticoagulant drugs : when coadministration analysis is recommended coagulation .
Taking MIG- 400 with food and drink
If possible, you should not take alcohol during the administration of MIG- 400, as it may intensify adverse effects, particularly those affecting the gastrointestinal tract and central nervous system.

Pregnancy and lactation
If during the use of MIG- 400 you find that you are pregnant , you should tell your doctor.
You can use the MIG- 400 only during the first 6 months of pregnancy after consulting your doctor .
Due to the risk of complications for mother and child , MIG -400 should not be applied in the last 3 months of pregnancy.
MIG- 400 belongs to a group of medicines ( NSAIDs ) , which can reduce a woman's fertility . This effect is reversible upon discontinuation of the drug.

The active substance ibuprofen and its metabolites pass into breast milk in small amounts. Since at present there are no known negative consequences for the child stop breastfeeding generally not required for short-term use . However, if the prescribed continuous application or administration of higher doses must be given to early discontinuation of breast feeding .
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Since high doses of LAG -400 may experience reactions of central nervous system fatigue and dizziness , in isolated cases, the reactions can be changed and the opportunity to actively participate in traffic and use machines may be broken. This applies to a greater extent when used in combination with alcohol . Then you can react quickly and purposefully unexpected and sudden incidents. In this case, do not drive cars and other vehicles ! Do not operate equipment or machinery ! Do not operate without proper support for the feet !

3 . How to take MIG- 400
Always take MIG- 400 exactly as directed in this leaflet. If you are not sure, ask your doctor or pharmacist.

The usual dose is:
Body weight (age) single dose Maximum daily dose
20 kg - 29 kg 6-9 years 1/2 tablet (equivalent to 200 mg of ibuprofen) 1 1/2 tablets (equivalent to 600 mg ibuprofen )
30 kg - 39 kg 10-12 years 1/2 tablet (equivalent to 200 mg of ibuprofen) 2 tablets (equivalent to 800 mg ibuprofen )
> 40 kg ( adolescents 12 years and older) 1/2 -1 tablet (equivalent to 200-400 mg ibuprofen) 3 tablets (equivalent to 1200 mg ibuprofen)
If you take the maximum single dose , wait at least 6 hours to the next dose .

Elderly and patients with previous gastric ulcer or duodenal
These patients should be started on the lowest dose (see section 2 'Take special care with MIG- 400 " ) .

Impaired renal or hepatic function
Not require dose reduction in mild to moderate renal or hepatic function.

Method and route of administration
Oral administration ( p.o.) .
Please swallow the film-coated tablets without chewing , with plenty of liquid ( eg a glass of water ) during or after meals.

Instructions for dividing the tablet
Hold the tablet with the thumbs and forefingers of both hands , scored downward and break the tablet in half along the score line by pressing the thumbs down.

Duration of use
Only for short-term use .
Do not take MIG- 400 for more than four days without consulting a doctor.

Please consult your doctor if you think that the effect of MIG- 400 is too strong or too weak.

If you take more than the amount of MIG- 400
Take MIG- 400 as directed by the doctor or the dosing instructions in this leaflet. If you think there is not enough pain relief , do not increase your dose alone and consult a doctor .

Possible symptoms of overdose are :
disorders of the central nervous system, such as headache , vertigo , dizziness and loss of consciousness ( and in children and seizures) ;
gastrointestinal disorders such as stomach pain , nausea and vomiting , bleeding from the gastrointestinal tract ;
impaired hepatic or renal function ;
drop in blood pressure;
weakened breathing ( respiratory depression ) ;
bluish - red discoloration of the skin and mucous membranes ( cyanosis ) .
There is no specific antidote .

If you suspect an overdose of MIG- 400, tell a doctor immediately ! Depending on the severity of intoxication , the doctor will determine what measures may be necessary .

If you forget to take MIG- 400
Do not take a double dose to make up for a missed dose.

If you have any questions about using this medicine, consult your doctor or pharmacist !

4 . Possible side effects
Like all medicines, MIG- 400 can cause side effects, although not everybody gets them. If you notice any of these side effects, consult your doctor who will decide what measures to take.

As the basis for assessment of adverse reactions taken the following frequencies :
Very common: affects more than 1 in 10 patients ;
Common: affects 1 to 10 of 100 patients ;
Uncommon: affects 1 to 10 users in 1,000 ;
Rare: affects 1 to 10 of 10 000 patients ;
Very rare: affects less than 1 in 10 000 patients ;
Not known: frequency can not be estimated from the available data.
Possible side effects
The list of adverse reactions following covers all side effects known in the treatment of ibuprofen, including those in the administration of high doses for long periods of time in patients with rheumatism . The frequency of an event outside , very rare cases , it refers to short-term doses to a maximum of 1200 mg ibuprofen oral dosage forms ( tablets = 3 MIG- 400 ) and the maximum 1800 mg suppository ( suppository ) .
It should be borne in mind that these side effects are mainly dose-dependent and may vary among patients.
The most commonly observed adverse events are gastrointestinal . There may be ulcers of the stomach or duodenum ( peptic ulcers) , perforation or gastrointestinal haemorrhage , sometimes fatal , particularly in the elderly ( see section 2 'Take special care with MIG- 400 " ) .
After administration have been reported nausea , vomiting , diarrhea, gas, constipation , digestive complaints , abdominal pain, jet-black stools, vomiting blood , ulcerative stomatitis (inflammation of the oral mucosa with ulceration ), worsening of intestinal diseases ulcerative colitis and Crohn's disease (see section 2 'Take special care with MIG- 400 " ) .
More rarely seen is inflammation of the gastric mucosa . The risk of experiencing gastrointestinal hemorrhage depends on dose and duration of use.
Oedema , hypertension and heart failure in relation to treatment with NSAIDs.
Drugs such as MIG- 400 can be associated with a small increased risk of heart attack ( myocardial infarction) or stroke.

cardiac disorders
very rare
Heartbeat ( palpitations) , heart failure, heart attack ( myocardial infarction) .

Blood and lymphatic system
very rare
Abnormalities in hematopoiesis (anemia , leukopenia , thrombocytopenia, pancytopenia, agranulocytosis) .
The first signs may be fever, sore throat, superficial sores in the mouth, flu-like symptoms , severe fatigue , bleeding from the nose and skin.
In these cases, the drug should be discontinued immediately and see a doctor .
You should not apply any self painkillers and lower fever medications.

Nervous System Disorders
Disorders of the central nervous system such as headache, vertigo , dizziness, agitation, irritability or fatigue .

Eye disorders
Visual disturbances .

Ear and labyrinth
Ringing in the ears ( tinnitus) .

Gastrointestinal Disorders
Gastrointestinal symptoms such as burning, stomach pain, nausea , vomiting, gas, diarrhea , constipation and mild gastrointestinal bleeding , which exceptionally can lead to a reduction in red blood cells ( anemia).

Ulcers of the stomach or duodenum ( peptic ulcers) , with possible perforation or hemorrhage , inflammation of the oral mucosa with ulceration (ulcerative stomatitis ) , deterioration of ulcerative colitis or Crohn's disease, gastric mucosal inflammation ( gastritis ) .

very rare
Inflammation of the esophagus ( esophagitis ) and pancreas (pancreatitis ) , form a membranous constrictions in the small intestine and the large intestine ( bowel , like a diaphragm , the narrowed ) .
In case of severe pain in the upper abdomen , vomiting blood , blood in the stool or black discoloration of feces , stop taking MIG- 400 and inform the doctor immediately !

Renal and urinary disorders
very rare
Increased fluid retention in the tissues ( edema) , especially in patients with high blood pressure or renal function , nephrotic syndrome ( the water retention in the body [ edema ] , and increased excretion of protein in the urine , kidney inflammation ( nephritis ) which may be accompanied by acute renal dysfunction .
Renal tissue ( papillary necrosis) and increased concentration of uric acid in the blood may also occur .
Decreased urine output , water retention in the body ( edema) , and a sense of malaise, may be a sign of renal disease to renal failure .

If these symptoms occur or worsen , then you should stop taking MIG- 400 and contact a doctor immediately .

Skin and subcutaneous tissue disorders
very rare
Severe skin reactions such as skin rash with redness and blistering (eg, Stevens- Johnson syndrome, toxic epidermal necrolysis / Lyell 's syndrome ) , hair loss ( alopecia ) .
As an exception may lead to serious skin infections and soft tissue complications of chickenpox or shingles (see also " Infections and infestations " ) .

Infections and infestations
very rare
Very rarely described deterioration associated with infectious inflammation (eg the development of necrotising fasciitis ) in the application of certain anti-inflammatory drugs ( NSAIDs to which it belongs and MIG- 400) .
Observed symptoms of inflammation of the meninges ( aseptic meningitis) as severe headache , nausea, vomiting , fever, neck stiffness or reduced consciousness . There is an increased risk for patients who are already suffering from certain autoimmune diseases ( systemic lupus erythematosus, mixed connective tissue disease ) .
The onset or worsening of the signs of infection (eg, redness, swelling , fever, chills and pain ) during the use of MIG- 400, you should consult a doctor without delay.

vascular disorders
very rare
High blood pressure (hypertension ) .

Immune system disorders ( hypersensitivity )
Hypersensitivity reactions with skin rash and itching , as well as asthma attacks ( possible drop in blood pressure).
In which case, you should inform the doctor and should not take more MIG- 400 .

very rare
Heavy general hypersensitivity reactions
May appear as swollen face, swollen tongue , laryngeal edema with narrowing of the airways , shortness of breath , palpitations, low blood pressure to life-threatening shock.
If any of these symptoms occur , which can happen even in the first application, require immediate medical attention .

Hepatobiliary disorders
very rare
Liver function disorders , liver damage, especially during prolonged treatment , liver failure , acute liver inflammation (hepatitis) .
With prolonged use should be carefully monitored parameters of liver function.

Psychiatric disorders
very rare
Psychotic reactions , depression .

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.

5 . How to store MIG- 400
Keep out of reach of children!
Do not use MIG- 400 after the expiry date stated on the blister and carton after " EXP" date refers to the last day of that month.

Storage Conditions
This medicinal product does not require any special storage conditions .
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 . Additional information
What does MIG- 400
The active substance is ibuprofen .
Each tablet contains 400 mg ibuprofen .

Other ingredients:
Corn starch , silica , colloidal anhydrous , sodium starch glycolate ( type A), magnesium stearate.

Film coating :
Hypromellose , macrogol 4000 , povidone K 30 , titanium dioxide (E 171).
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