Ibuprofen 200 MG TABLETS 20 Biogaran

Ibuprofen 200 MG TABLETS 20 Biogaran View larger

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Ibuprofen 200 mg Biogaran contains a nonsteroidal anti-inflammatory: ibuprofen. It is indicated in adults and children over 20 kg (about 6 years), in the treatment of acute fever and / or pain such as headache, flu symptoms, dental pain, aches and painful periods.

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Ibuprofen 200 MG TABLETS 20 Biogaran

 

 

Description ibuprofen 200 MG Biogaran 20 tablets

 

Biogaran 200mg Ibuprofen is a nonsteroidal anti-inflammatory: ibuprofen. It is indicated in adults and children over 20 kg (about 6 years), in the treatment of acute fever and / or pain such as headache, flu symptoms, dental pain, aches and painful periods.

 

This medicine is a nonsteroidal anti-inflammatory drugs (NSAIDs). He struggles against the pain and reduce fever. Its anti-inflammatory properties are manifested in high doses.
It is used in the treatment of acute fever and pain (headache, toothache, flu symptoms, aches, painful periods ...).

 

Prolonged treatment or overdose of NSAIDs suffer serious adverse effects.
Some situations should lead to no further treatment after a medical opinion:

  • significant heartburn or black, foul-smelling stools may result in irritation or bleeding of the digestive tract;
  • rash no obvious cause;
  • asthma attack;
  • unusual and severe fatigue, or sudden and significant drop in the volume of urine in a person with heart failure, dehydrated or treated with a diuretic.

Caution is necessary in the elderly or in patients with a history of stomach ulcer or duodenal ulcer or bleeding risk, especially gastrointestinal (Crohn's disease, ulcerative colitis).
The use of NSAIDs is not recommended in children with chickenpox: they could increase the risk of infectious complications exceptional but potentially serious.
Some doctors believe that anti-inflammatory drugs can reduce the effectiveness of IUDs and exposed to a risk of unwanted pregnancy. This risk is currently controversial.
Driver: This medication may be responsible, in rare cases, dizziness or blurred vision.

 

Using advice and opinion on ibuprofen 200mg 20 tablets Biogaran

 

Do not exceed the dose or duration of treatment recommended by your doctor or pharmacist to limit adverse effects.
This medication may be freely available in some pharmacies; However, do not hesitate to ask your pharmacist for advice.


Ibuprofen composition Biogaran 200mg 20 tablets

 

p cp
Ibuprofen200 mg
Sucrose+

 

Introducing ibuprofen 200mg cpr 20 Biogaran

 

20 Tablets

 

VIDAL OF THE FAMILY

IBUPROFÈNE BIOGARAN CONSEIL

Non-steroidal anti-inflammatory drug

The 200 mg tablets are generic of NUREFLEX 200 mg (which is no longer marketed).
400 mg tablets are generic of ADVILMED.

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

IBUPROFEN BIOGARAN TIP 200 mg: tablet; box of 20.
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IBUPROFEN BIOGARAN TIP 400 mg: tablet; box of 10.
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Biogaran Laboratory

COMPOSITION (summary)
p cp p cp
Ibuprofen 200 mg 400 mg

INDICATIONS (summary)
This drug is a non- steroidal anti-inflammatory drug ( NSAID ). It combats pain and lowers the fever. Its anti-inflammatory properties manifest in high doses.
It is used in the short-term treatment of fever and pain (headaches, dental pain, muscle aches, painful periods ...).
The 400 mg dosage is also used in the treatment of migraine attack in adults after at least medical advice.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
Prolonged treatment or overdosage of NSAIDs may result in serious adverse reactions.
Some situations should lead to further treatment only after medical advice:
  • severe heartburn or black and foul-smelling stools that may indicate irritation or bleeding of the digestive tract;
  • rash without obvious cause;
  • asthma attack ;
  • unusual and intense fatigue, or a sharp and significant decrease in the volume of urine in a person suffering from heart failure , dehydration or diuretic treatment.
Precautions are necessary in the elderly or in case of a history of stomach or duodenal ulcer or haemorrhagic risk, especially digestive ( Crohn 's disease , ulcerative colitis ).
The use of NSAIDs is not recommended in children with varicella: it may increase the risk of infectious, exceptional but potentially serious complications.
NSAIDs have an inhibitory effect on ovulation and are likely to decrease fertility in women. This effect is reversible upon discontinuation of treatment.
Some doctors consider that anti-inflammatories can decrease the effectiveness of intrauterine devices (IUDs) and expose them to an unwanted pregnancy risk. This risk is highly controversial.
Conductor: This medication may be responsible, in rare cases, for dizziness or disturbances of vision.
DRUG INTERACTIONS (summary)
This medication may interact with other medicines, including: Inform your doctor or pharmacist if you are taking a diuretic , an ACE inhibitor , an angiotensin II inhibitor , a beta-blocker, or a medicine containing ciclosporin.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Adverse effects to the unborn child have been demonstrated when NSAIDs are used during the last 4 months of pregnancy; the risk exists even with a single intake and even if the pregnancy is over term. The use of this medication is contraindicated during this period.
During the first 5 months, the effect of this medication is poorly understood: only your doctor can evaluate the possible risk of its use in your case.

Breastfeeding:
Ibuprofen is low in breast milk: however, as a precaution, it is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
In order to limit the occurrence of digestive disorders , this medication can be taken during meals. However, in the case of acute pain, the fasting catch ensures a faster effect.
The tablets should be swallowed as they are with a glass of water, without being chewed.

Usual dosage:

Pain and fever:
  • Adults and children over 30 kg (approximately 11 years): 1 to 2 200 mg tablets or 1 400 mg tablet per dose, to be renewed if necessary after a minimum of 6 hours, not to exceed 6 tablets to 200 mg or 3 tablets at 400 mg per day.
  • Child 20 to 30 kg (approximately 6 to 11 years): 1 tablet 200 mg, to be renewed if necessary after 6 hours. Do not exceed 3 tablets per day.
In the absence of medical advice, the duration of treatment should be limited to 5 days in case of pain and 3 days in case of fever.
Migraine attack :
  • Adult: 1 tablet 400 mg, to be taken at the beginning of the crisis. There is no need to take a capsule or tablet if the effect is insufficient. On the other hand, if the symptoms reappear, it is possible to take 1 additional tablet within a minimum delay of 8 hours between the 2 catches. Do not exceed 3 days of treatment.
TIPS (summary)
The 400 mg dosage is intended for use when ibuprofen 200 mg is insufficiently effective. It can nevertheless be used from the outset in the treatment of severe pain.
Do not exceed the recommended dosage or duration of treatment recommended by your doctor or pharmacist to limit side effects.
Taking this medication does not dispense with the usual measures to help cede the migraine attack: lie down in a dark room.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Nausea, vomiting, gastritis .
Rarely:

GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


anemia
Reduction in the level of hemoglobin in the blood, which usually results in a decrease in the number of red blood cells. Iron is essential for the synthesis of hemoglobin. Iron deficiency during pregnancy, a vegetarian diet, abundant or repeated haemorrhage (menstruation) is a common cause of anemia. Other causes, more rare, are related to vitamin deficiencies of group B.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


antiplatelet agents
Medication that prevents the platelets from clumping and therefore the clots from forming. The oldest platelet antiaggregant is aspirin taken in small doses.
Anti-aggregants should not be confused with anticoagulants with a different mechanism of action.


anti coagulants
Medication that prevents blood from coagulating and therefore prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also prevent the formation of clots in the heart during rhythm disorders such as atrial fibrillation or in the case of an artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: INR (formerly TP);
  • injectable anticoagulants derived from heparin, the efficacy of which can be controlled by the blood assay of anti-Xa activity, Howell's Time (TH) or Cephalin Kaolin Time (TCK) depending on the products used. A regular dosage of blood platelets is necessary throughout the life of a heparin derivative.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


beta blockers
Family of drugs used primarily in cardiology. They block the action of adrenaline (and other related hormones) on the heart, vessels and bronchi.


Crohn
inflammation of the intestine, which can cause ulcers and narrowing. It often becomes chronic and can be accompanied by persistent diarrhea and malnutrition.


diuretic
Medication allowing increased kidney water removal. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other rarer ailments.
These drugs cause loss of sodium and potassium (except for some of them called "potassium-sparing"). Their prolonged administration therefore requires regular blood potassium control, to avoid heart problems that may result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible but less frequent consequence of the prolonged use of diuretics; it is also detected by a blood test.


duodenum
A part of the intestine into which food from the stomach penetrates.


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatory drugs.


hemorrhage
Loss of blood from an artery or vein. Hemorrhage can be external, but also internal and go unnoticed.


angiotensin II inhibitor
These drugs are sometimes called sartans, for the names of the molecules belonging to this family end with sartan (losartan, candesartan, etc.).
This family of drugs blocks the action of angiotensin II, a substance that increases blood pressure and tires the heart.
Angiotensin II inhibitors are used to treat high blood pressure.


ACE inhibitor
This family of drugs blocks the action of an enzyme, which converts angiotensin I (naturally inactive substance) to angiotensin II. This last substance increases blood pressure and fatigue the heart.
ACE inhibitors are used to treat high blood pressure, heart failure or myocardial infarction.


heart failure
Inability of the heart to fulfill its function as a pump. The main symptoms of heart failure are fatigue and shortness of breath during an effort.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


lupus erythematosus
Skin disease causing redness of the central part of the face. There are two main forms: discoid lupus (only cutaneous) and disseminated lupus (associated with lesions of the deep organs).


migraine
Special headache usually affecting the right or left half of the head, often associated with a fear of light and noise.


blood count
The count measures the number of red blood cells (red blood cells), white blood cells (leukocytes) and platelets in the blood. The blood formula specifies the percentage of different white blood cells: neutrophils, eosinophils, basophils, lymphocytes, monocytes.
Abbreviation: NFS.


edema
Accumulation of water or lymph causing localized swelling.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


ulcerative colitis
Inflammatory disease of the rectum and colon, which evolves by flare-ups. Each flare is accompanied by fever, bloody stools.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


crisis management
As opposed to long-term treatment, short-term and episodic treatment in the context of seizure or outbreak diseases.


transaminases
Enzymes dosed in the blood, which rate rises during some hepatitis. They are included in blood tests as SGOT and SGPT or ASAT and ALAT.


digestive disorders
Set of symptoms indicating irritation or malfunction of the digestive tract. One or more disorders may be present: nausea, vomiting, aerophagia, abdominal pain, heartburn, bloating, flatulence, diarrhea or constipation, etc. Antibiotics can promote candidiasis, often responsible for digestive disorders.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).

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NOTICE

ANSM - Updated on: 25/08/2017

Name of the medicinal product

IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet

Ibuprofen

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after:

o 3 days for children and adolescents

o 3 days in case of fever and over 5 days in case of pain in adults.

What is in this leaflet?

1. What is IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet and in which cases is it used?

2. What information should I take before taking IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet?

3. How to take IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet?

4. What are the possible side effects?

5. How to store IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet?

6. Package contents and other information.

1. WHAT IS IBUPROFENE BIOGARAN COUNCIL 200 mg film-coated tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS - ATC code: M0AE01. / N02B.

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. In adults and children over 20 kg (about 6 years), it is indicated in the short-term treatment of fever and / or pain such as headache, flu-like conditions, dental pain, aches and pains.

2. BEFORE YOU TAKE IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet?

Do not take IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablets:

· if you are allergic to ibuprofen or any of the other ingredients of this medication mentioned in section 6,

· after 5 months of pregnancy (24 weeks of amenorrhea),

· a history of allergy or asthma triggered by the use of this drug or a related drug, including other non-steroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin), rhinitis, swelling or urticaria,

· antecedent allergy to the other constituents of the tablet,

· history of gastrointestinal bleeding or ulcers associated with previous NSAID treatments,

· ulceration or bleeding of the stomach or intestine in progress or recurrence,

· gastrointestinal haemorrhage, cerebral hemorrhage or other ongoing hemorrhage,

· severe liver disease,

· severe kidney disease,

· serious heart disease,

· systemic lupus erythematosus,

· child under 6 years old because it can swallow and choke.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet .

In high doses, greater than 1200 mg / day, this drug has anti-inflammatory properties and can cause serious disadvantages that are observed with non-steroidal anti-inflammatory drugs.

Anti-inflammatory / analgesic drugs such as ibuprofen are likely to be associated with a slightly increased risk of heart attack or stroke, especially when used at high doses. Do not exceed recommended dosage or treatment time.

Discuss your treatment with your doctor or pharmacist before taking IBUPROFENE BIOGARAN TIP if you:

· have heart problems, heart failure, angina pectoris (chest pain), or if you have had a heart attack, surgical bypass, peripheral arterial disease (poor circulation in the legs or feet due to narrowed arteries or stroke) or any type of stroke (including "mini-stroke" or transient ischemic attack (TIA)),

· have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke or if you are a smoker.

There is a risk of renal failure in dehydrated children and adolescents.

If you are a woman, IBUPROFENE BIOGARAN TIP can alter your fertility. Its use is not recommended in women who wish to conceive a child. For women who have reproductive difficulties or who are undergoing reproductive function tests, please talk to your doctor or pharmacist before taking IBUPROFENE BIOGARAN CONSEIL.

Elderly patients have a higher risk of adverse effects, particularly for gastrointestinal haemorrhage, ulcers and perforations. Renal, hepatic and cardiac functions should be closely monitored. The dosage should be as low as possible for the shortest time needed to relieve symptoms.

BEFORE YOU USE THIS MEDICINE, CONSULT YOUR DOCTOR IN CASE:

· a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose.

The administration of this specialty may lead to an asthma attack, especially in some people allergic to acetylsalicylic acid (aspirin) or a non-steroidal anti-inflammatory drug (see section "Do not take IBUPROFENE BIOGARAN CONCIL 200 mg film-coated tablet ")

· coagulation disorders, and anticoagulant therapy. This medication may cause severe gastrointestinal symptoms,

· digestive antecedents (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer),

· heart disease, liver or kidney disease,

· of varicella. This medication is not recommended because of exceptional severe infections of the skin,

· concomitant treatment with other drugs that increase the risk of peptic ulcer or haemorrhage, eg, oral corticosteroids, antidepressants (SSRIs, ie, Selective Serotonin Recapture Inhibitors), medicines preventing the formation of blood clots such as aspirin or anticoagulants such as warfarin. If you are in one of these cases, consult your doctor before taking IBUPROFENE BIOGARAN COUNCIL (see section " Other medicines and IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablets "),

· concomitant therapy with methotrexate at doses greater than 20 mg per week or with pemetrexed (see section " Other medicines and IBUPROFENE BIOGARAN TIP 200 mg, film-coated tablet. ").

DURING TREATMENT, IN CASE OF:

· of vision problems, PREVENT YOUR DOCTOR,

· gastrointestinal haemorrhage (discharge from the mouth or stool, stool coloration in black), STOP TREATMENT AND IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE,

· of appearances of cutaneous or mucosal signs that resemble a burn (redness with bubbles or blisters, ulcerations), STOP THE TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR AN EMERGENCY MEDICAL SERVICE,

· of allergy-related signs of asthma, such as an asthma attack or abrupt swelling of the face and neck (see section "What are the possible side effects?")

STOP TREATMENT AND IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE.

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen.

You should not take other medicines containing non-steroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and / or acetylsalicylic acid (aspirin) at the same time as this medication. Read carefully the instructions for other medicines you are taking to ensure that there are no nonsteroidal anti-inflammatory drugs and / or acetylsalicylic acid (aspirin).

Children and Youth

Not applicable.

Other medicines and IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to IBUPROFENE BIOGARAN TIP:

· aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs

· corticosteroids

· lithium

· methotrexate

· angiotensin converting enzyme inhibitors, diuretics, beta-blockers and angiotensin II antagonists

· some antidepressants (selective serotonin reuptake inhibitors)

· pemetrexed

· ciclosporin, tacrolimus

· other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors

· medicines used to treat pain and inflammation (example) acetylsalicylic acid unless low doses have been advised by the doctor

IBUPROFENE BIOGARAN COUNCIL is likely to affect or be affected by certain other medicines. for example

· anticoagulant medications (ie, which fluidize the blood / prevent the appearance of clots such as aspirin / acetylsalicylic acid, warfarin, ticlopidine)

· drugs that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines are also likely to affect or be affected by treatment with IBUPROFENE BIOGARAN CONSULTING. Therefore, you should always seek advice from your doctor or pharmacist before using IBUPROFENE BIOGARAN CONSEIL together with other medicines.

· Cardiac glicosides such as digoxin which are drugs used in many cardiac pathologies because their effects can be increased.

· Mifepristone (a drug used for termination of pregnancy). IBUPROFENE BIOGARAN CONSEIL should not be used within 8-12 days after taking mifepristone because the effect of mifepristone may be reduced.

· Zidovudine (a drug for the treatment of AIDS) because with the use of IBUPROFENE BIOGARAN COUNCIL there is an increased risk of hemarthrosis and hematomas in hemophiliac patients with HIV.

IBUPROFENE BIOGARAN TIP 200 mg, film-coated tablets with food, drinks and alcohol

Not applicable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.

Pregnancy

During the first trimester (12 weeks of gestation is 12 weeks after the 1st day of your last period), your doctor may, if necessary, to prescribe the drug.

For 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medication will only be used on the advice of your doctor and in brief dosage. Prolonged use of this medication is strongly discouraged.

After 5 months of pregnancy (beyond 24 weeks of amenorrhea), you should NOT take this medication because its effects on your child can have serious consequences, especially on the cardiopulmonary level and renal, even with a single dose.

If you are taking this medication when you are more than five months pregnant, please speak to your obstetrician gynecologist for appropriate monitoring.

feeding

This drug passes into breast milk. As a precaution, it should be avoided during breastfeeding.

Female fertility

IBUPROFENE BIOGARAN COUNCIL belongs to the class of medicines that can alter female fertility. However, this effect is reversible upon discontinuation of treatment. Avoid taking this medication if you are trying to get pregnant.

Driving and using machines

In rare cases, taking this medicine may cause dizziness and blurred vision.

IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet contains

Not applicable.

3. HOW TO TAKE IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor or pharmacist or nurse if in doubt.

Dosage

ADULTS TO THE ADULT AND THE CHILD FROM 20 KG (about 6 years).

Painful and / or febrile conditions

In children, the usual dosage is 20 to 30 mg / kg / day in 3 doses per day (not to exceed 30 mg / kg / day).

In children from 20 to 30 kg (approximately 6 to 11 years): 1 tablet (200 mg), to be renewed if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (600 mg).

In adults and children over 30 kg (approximately 11-12 years): 1 to 2 tablets (200 mg), to be renewed if necessary after 6 hours. In all cases, do not exceed 6 tablets per day (1200 mg).

The elderly with an increased risk of adverse effects should use the lowest dose possible for the shortest time necessary to relieve symptoms.

Do not exceed the recommended doses or the duration of treatment (3 days in case of fever, 5 days in case of pain).

The maximum dosage is 6 tablets per day (1200 mg).

Method and route of administration

Oral use.

Swallow the tablet without chewing it with a large glass of water , preferably during meals .

Frequency of Administration

Systematic catch can help prevent fever or pain.

They should be spaced at least 6 hours.

Duration of treatment

The duration of use is limited to:

· 3 days in case of fever,

· 5 days in case of pain

In children and adolescents:

If the treatment is to be followed for more than 3 days or if the symptoms worsen, it is advisable for the patient to consult a doctor

In the adult

If the pain persists more than 5 days or the fever more than 3 days , or if they worsen or in the event of another disorder, inform your doctor.

If you feel that the effect of IBUPROFENE BIOGARAN TIP, is too strong or too weak: talk to your doctor or pharmacist.

If you take more IBUPROFENE BIOGARAN TIP 200 mg, film-coated tablet than you should

In case of accidental overdose or poisoning, STOP TREATMENT AND QUICKLY CONSULT A DOCTOR.

The following signs may occur: Nausea, vomiting, stomach pain, and more rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding are possible. In cases of more severe poisoning, dizziness, somnolence, rarely excitement, disorientation, convulsions and loss of consciousness may occur. Hyperkalemia, metabolic acidosis and bleeding can occur in very severe poisoning. Acute renal impairment, hepatic involvement, hypotension, respiratory depression, cyanosis rarely occur. Aggravation of asthma in asthmatics is possible.

If you forget to take IBUPROFENE BIOGARAN TIP 200 mg, film-coated tablet

Do not take a double dose to make up for the single dose that you have forgotten to take.

If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following list of side effects may occur if you are being treated with ibuprofen in the short term. For long-term treatment or if your doctor prescribes a higher dose, adverse event benefits may occur than those described below.

In order to evaluate the side effects, the following frequencies are used:

· Very common: Touch more than 1 user out of 10

· Common: key 1 to 10 users out of 100

· Uncommon: key 1 to 10 users in 1000

· Rare: Touch 1 to 10 users out of 10,000

· Very rare: affects less than 1 user in 10,000

· Not known: Frequency is impossible to estimate based on available data

If any of the following side effects occur, or if any of them worsen or if you notice any effects not listed here, please inform your doctor,

Blood disorders

Very rare : Problems in the production of blood cells, the first signs are: Fever, sore throat, superficial ulcers of the mouth, flu symptoms, extreme fatigue, nasal and cutaneous bleeding. In these cases, you should stop treatment immediately and see a doctor. Avoid self-medication of painkillers or medicines that lower fever (antipyretic drugs).

Immune System Problems

Uncommon : Allergic reactions with itching and urticaria as well as asthma attacks. You must stop taking IBUPROFENE BIOGARAN COUNCIL and inform your doctor immediately.

Very rare : Severe allergic reactions, signs may include: edema of the face, tongue and throat, shortness of breath, accelerated heart rhythm, low blood pressure, severe shock. If any of these symptoms occur, which can happen even when first used, immediate medical assistance is required.

Nervous System Disorders

Uncommon : Headache

Very rare : aseptic meningitis

Not known : dizziness

Eye disorders

Not known : Visual Disorders

Cardiac disorders

Not known : heart failure, edema,

Vascular disorders

Not known : Hypertension

Digestive and intestinal disorders

Uncommon : Abdominal pain, nausea and dyspepsia

Rare : diarrhea, flatulence, constipation and vomiting

Very rare : peptic ulcer, perforation, gastrointestinal haemorrhage, black tarry stools, vomiting of blood or dark particles resembling ground coffee, ulcerative stomatitis, gastritis.

Not known : aggravation of colitis and Crohn's disease

Hepatic Disorders

Very rare : Liver damage (the first signs can be a discoloration of the skin),

Not known : hepatitis, increased transaminases.

Skin disorders

Uncommon : various skin rashes

Very rare : Severe forms of skin reactions such as bullous reaction including Stevens-Johnson syndrome, erythema multiforme and Lyell syndrome.

Not known : infectious complication of skin and soft tissues during chicken pox

Kidney disorders:

Very rare : Renal involvement, papillary necrosis specifically during long-term treatment associated with increased uremia and edema.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet?

Keep this medicine out of the reach and sight 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.

Store at a temperature not exceeding 25 ° C.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What IBUPROFENE BIOGARAN CONSEIL 200 mg contains: film-coated tablet

· The active substance is:

Ibuprofen................................................. .................................................. 200 mg

For a film-coated tablet.

· The other components are:

Pregelatinized starch, sodium carboxymethyl starch (type A), stearic acid, povidone K90, anhydrous colloidal silica.

Laminating:

SEPIFILM [hypromellose (E464), macrogol 400 stearate], SEPISPERSE [hydroxypropylcellulose, titanium dioxide (E171)].

What is IBUPROFENE BIOGARAN CONSEIL 200 mg film-coated tablet and contents of the pack

This drug is in the form of film-coated tablet. Box of 20 or 30 tablets.

Marketing Authorization Holder

BIOGARAN

15, BOULEVARD CHARLES DE GAULLE

92700 COLOMBES

Marketing Authorization Operator

BIOGARAN

15, BOULEVARD CHARLES DE GAULLE

92700 COLOMBES

Maker

DELPHARM BRETIGNY

USINE OF PETIT PARIS

91731 BRETIGNY SUR ORGE

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Health Education Council:

"WHAT TO DO IN THE EVENT OF FEVER":

The normal temperature of the body is variable from one individual to another and between 36.5 ° C and 37.5 ° C.

An increase of more than 0.8 ° C is considered a fever.

In adults and children over 20 kg (approx. 6 years) : If the disorder is too troublesome, you can take a medicine containing ibuprofen at the indicated dosage.

With this medication, the fever should drop rapidly. However :

· if other signs appear (such as a rash),

· if the fever persists for more than 3 days or if it worsens,

· if the headache becomes violent, or in case of vomiting,

CONSULT YOUR DOCTOR IMMEDIATELY.

"WHAT TO DO IN CASE OF PAIN":

· In the absence of improvement after 5 days of treatment,

· If the pain returns regularly,

· If accompanied by fever,

· If she wakes you up at night,

CONSULT YOUR DOCTOR IMMEDIATELY.

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