NUROFENFLASH 400MG SUSPENSION BUVALE

NUROFENFLASH 400MG SUSPENSION BUVALE View larger

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Reckitt - Nurofen - Pharmacie Reckitt - Nurofen - Pharmacie

NurofenFlash 400 mg powder for oral solution is indicated for adults and adolescents over 40 kg (12 and over) in the symptomatic treatment of mild to moderate pain such as headache, toothache, menstrual pain and pains, and fever.
Drowsiness: Level 1

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For warnings, the precautions and cons-indications, please see the instructions.

Description

NurofenFlash 400 mg powder for oral solution is indicated for adults and adolescents over 40 kg (12 and over) in the symptomatic treatment of mild to moderate pain such as headache, toothache, menstrual pain and pains, and fever.
Drowsiness: Level 1

For adults and children over 40kg


Composition:

  • Each bag contains ibuprofen 400 mg ibuprofen
  • Excipients: betadex, lemon oil (consisting of maltodextrin, modified starch (corn) and tartrazine E102), saccharin sodium (E954), sodium cyclamate (E952), sodium citrate (E331), sucrose.
  • Excipients with known effects: glucose, tartrazine, sucrose

Dosage:

  • Adults and adolescents over 40 kg (12 and over): 1 packet up to three times a day if necessary. Space the doses of at least 6 hours. To be taken preferably with meals.

Do not take more than 3 sachets per day.

Cons-indications   :

  • Allergy to ibuprofen, tartrazine or any other ingredients in NurofenFlash 400 mg powder
  • History of shortness of breath, asthma, runny nose, swelling or hives after using aspirin or similar painkillers
  • History of bleeding or gastrointestinal perforation related to previous treatment with NSAIDs
  • Ulcer or bleeding from the stomach or changing old
  • Corocarienne severe disease, heart failure, liver or kidney
  • During pregnancy
  • Severe dehydration
  • Cerebrovascular bleeding or other bleeding evolving
  • Bleeding disorders or bleeding provision
  • Children less than 40 kg

Oral

Read carefully the instructions

Packaging   : Box of 10 sachets.

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

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Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

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NOTICE

ANSM - Last updated: 21/11/2016

Name of the medicinal product

NUROFENFLASH 400 mg powder for oral solution in sachet

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 or pharmacist.

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

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor or pharmacist. 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 teenagers

o 3 days for fever and 4 days for pain in adults.

Do not use this medication for children.

What is in this leaflet?

1. What is NUROFENFLASH 400 mg powder for oral solution in sache and in which cases it is used?

2. What information should I take before taking NUROFENFLASH 400 mg powder for oral solution in sache ?

3. How to take NUROFENFLASH 400 mg powder for oral solution in sache ?

4. What are the possible side effects?

5. How to store NUROFENFLASH 400 mg powder for oral solution in sache ?

6. Package contents and other information.

1. WHAT NUROFENFLASH 400 mg powder for oral solution in sachet AND WHAT IS IT USED FOR?

Pharmacotherapeutic group: anti-inflammatory and antirheumatic, non-steroidal; derivatives of propionic acid, ATC code: M01AE01.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medications provide relief by altering how the body responds to pain, edema and high temperature.

NUROFENFLASH 400 mg powder for oral solution is indicated in adults and adolescents over 40 kg (12 years and older) in the symptomatic treatment of:

· mild to moderate pain, such as headache, dental pain, painful menstrual periods

· fever.

2. BEFORE YOU TAKE NUROFENFLASH 400 mg powder for oral solution in sachet?

Never take NUROFENFLASH 400 mg powder for oral solution in sachets:

· hypersensitivity to ibuprofen, tartrazine or any of the other ingredients of NUROFENFLASH 400 mg powder for oral solution ( see section 6 );

· history of shortness of breath, asthma, runny nose, swollen face and / or hands or urticaria after using ibuprofen, aspirin or other similar painkillers (NSAIDs);

· history of bleeding or gastrointestinal perforation related to previous NSAID treatment;

· ulcer or bleeding of the active or former stomach (two or more episodes);

· severe cardiac, hepatic or renal failure;

· during the last three months of pregnancy ( see below );

· severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);

· cerebrovascular haemorrhage or other evolving hemorrhage;

· Unclear hematopoiesis disorders.

Do not give to children under 40 kg.

Warnings and Precautions

Talk to your doctor or pharmacist about taking NUROFENFLASH 400 mg powder for oral solution in sachets .

· if you suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease).

· If you suffer from severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrosis. The use of NUROFENFLASH should be discontinued immediately at the first signs of skin rash, mucosal lesions or any other signs of allergic reactions.

· If you have inherited disorders of blood formation (eg acute intermittent porphyria).

· If you suffer from bleeding disorders.

· If you have or have ever had an intestinal disease (ulcerative colitis or Crohn's disease). If your kidney functions are reduced.

· If you have liver problems.

· If you are trying to get pregnant.

· A oversight medical special East Requirements directly after major surgery.

· If you have or have had asthma or an allergic condition causing shortness of breath.

· If you suffer from hay fever, nasal polyps or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. These allergic reactions may occur as asthma attacks (known as analgesic asthma), angioedema or urticaria. Prolonged use of an analgesic treatment to treat headaches can aggravate them. If this situation is experienced or suspected, medical advice must be obtained and treatment must be discontinued. The diagnosis of overuse of headache medication should be suspected in patients with frequent or daily headache despite (or because) of regular use of medication for headaches.

· Older people are more likely to experience side effects.

· Adverse effects can be reduced by using the lowest effective dose for the shortest possible period of time.

· In the case of chicken pox (varicella), it is advisable to avoid the use of NUROFENFLASH In the case of a prolonged administration of NUROFENFLASH, regular monitoring of the liver and renal balance and of the blood form is necessary.

· Combination with other NSAIDs, including specific inhibitors of cyclooxygenase-2, increases the risk of adverse reactions ( see "Taking other medicines" ) and should be avoided.

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

· In general, the usual use of (several kinds) of analgesics can cause severe and lasting kidney problems. This risk can increase as a result of physical stress with loss of salt and dehydration. This is why it should be avoided.

· NSAIDs may mask the symptoms of infection and fever.

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 NUROFENFLASH 400 mg powder for oral solution in a sachet if you:

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

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

Consult a physician before using NUROFENFLASH if any of the above conditions apply to you.

Other medicines and NUROFENFLASH 400 mg powder for oral solution in sachet

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

NUROFENFLASH 400 mg powder for oral solution in sachet is likely to affect or be affected by certain other medicines. For example :

· anti-coagulant drugs (ie, which fluidize the blood / prevent the appearance of clots such as aspirin / acetylsalicylic acid, warfarin, ticlopidine)

· medicines 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 NUROFENFLASH 400 mg, powder for oral solution in sachet . Therefore, you should always consult your doctor or pharmacist before using NUROFENFLASH 400 mg powder for oral solution in a sachet along with other medicines.

Contact your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, inform them if you take:

Other NSAIDs including selective cyclooxygenase-2 inhibitors

This may increase the risk of ulcers or gastrointestinal bleeding.

Digoxin (for heart failure)

Because the effect of digoxin can be accentuated

Glucocorticoids (medicines containing cortisone or cortisone-related substances).

This may increase the risk of ulcers or gastrointestinal bleeding.

Antiplatelet agents:

This can increase the risk of bleeding

Aspirin (low dose):

Because ibuprofen can slow down the blood dilution effect of aspirin.

Blood-thinning drugs (such as warfarin)

Because ibuprofen can increase the effects of these drugs

Phenytoin (for epilepsy)

Because the effect of phenytoin can be accentuated

Selective serotonin reuptake inhibitors (drugs used for the treatment of depression)

Because they can increase the risk of gastrointestinal

Lithium (drug for manic depression and depression)

Because the effect of lithium can be accentuated

Probenecid and sulfinpyrazones (gout medications)

Because the excretion of ibuprofen can be delayed.

Medications for hypertension and diuretics

Because ibuprofen can decrease the effects of these drugs with a possible increased risk for the kidneys

Potassium-sparing diuretics:

This can cause hyperkalaemia

Methotrexate (a medicine for cancer or rheumatism)

Because the effect of methotrexate can be accentuated

Tacrolimus and ciclosporin (immunosuppressive drugs)

Because the kidneys can be damaged

Zidovudine (a drug for the treatment of AIDS)

Because with the use of NUROFENFLASH 400 mg powder for oral solution in sachet there is an increased risk of haemarthrosis and hematomas in hemophiliac patients with HIV.

Sulfonylureas (antidiabetic drugs)

Interactions are possible.

Quinolone antibiotics

The risk of convulsions may increase.

Cytochrome CYP2C Inhibitors

Because administration of ibuprofen in combination with cytochrome CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (inhibitor CYP2C9), an increase in exposure of ibuprofen S + of about 80 to 100% was shown. Reduced doses of ibuprofen should be considered when cytochrome CYP2C9 inhibitors are concomitantly administered, particularly when high doses of ibuprofen are administered in combination with voriconazole or fluconazole.

NUROFENFLASH 400 mg powder for oral solution in sachets with food and alcohol

Patients with gastric fragility should take NUROFENFLASH 400 mg powder for oral solution in sachet with food.

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

Do not take this medication during the last 3 months of pregnancy. This medication should not be taken during the first 6 months of pregnancy except on medical advice.

feeding

This drug passes into breast milk. This medication passes into breast milk, but it can be used during breastfeeding provided that the recommended dose is used for the shortest possible period of time.

Fertility

NUROFENFLASH 400 mg powder for oral solution belongs to a class of medicines (NSAIDs) that can alter female fertility. However, this effect is reversible upon discontinuation of treatment.

Sport

Not applicable.

Driving and using machines

For short-term treatment and at the recommended dosage, this medicine has no or little influence on the ability to drive and use machines. If dizziness and vision problems occur, do not drive or use machines. Alcohol consumption increases the risk of these side effects.

NUROFENFLASH 400 mg powder for oral solution in sachet contains:

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains tartrazine which may cause allergic reactions.

3. HOW TO TAKE NUROFENFLASH 400 mg powder for oral solution in sachet?

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist.

The recommended dose is:

Dosage

Adults and adolescents over 40 kg (12 years and over): 1 sachet (400 mg ibuprofen) up to three times daily if necessary. Space the doses for at least 6 hours.

Do not take more than 3 sachets (equivalent to a total of 1200 mg of ibuprofen) per 24 hours.

Method and route of administration

Oral use.

Dissolve the contents of the sachet in a glass of water, mix and drink immediately.

ONCE THE SOLUTION PREPARED, DRINK IT IMMEDIATELY.

Patients with a sensitive stomach are advised to take NUROFENFLASH 400 mg powder for oral solution during meals. If you take it shortly after eating, the onset of action of this medication may be delayed. In this case do not take more NUROFENFLASH 400 mg powder for oral solution than the dose that was recommended in this section until the exact end of the dose renewal time.

Duration of treatment

The occurrence of adverse reactions can be minimized by using the lowest dose possible during the shortest treatment time needed to relieve symptoms.

In the adolescent:

If treatment should be continued for more than 3 days or if symptoms worsen, consult a physician.

In adults:

The duration of treatment should not exceed 3 days in case of fever or 4 days in case of pain. If symptoms worsen or persist, consult your doctor.

Consult your doctor or pharmacist if you think the effect of this medication is stronger or weaker than you thought.

If you take more NUROFENFLASH 400 mg powder for oral solution in a sachet than you should:

Quickly see a doctor. . The following signs may occur: nausea, vomiting, stomach pain, or more rarely diarrhea. In addition, headache, gastrointestinal bleeding, dizziness, dizziness, drowsiness, nystagmus, vision problems, ringing in the ear, low blood pressure, arousal, disorientation, convulsions, coma, loss of consciousness, hyperkalaemia, metabolic acidosis, increased prothrombin time / INR, acute renal failure, liver damage, respiratory depression, cyanosis and exacerbation of asthma in asthmatics.

If you have any further questions about the use of this product, consult your doctor or pharmacist.

If you forget to take NUROFENFLASH 400 mg powder for oral solution in sachet:

Not applicable.

If you stop taking:

Not applicable.

If you have any further questions on the use of this medication, talk to your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, NUROFENFLASH 400 mg powder for oral solution in sachet is likely to have undesirable effects, although not everyone is subject to it.

The occurrence of adverse events can be minimized by the use of the minimal dose during the shortest treatment time necessary to relieve symptoms. Although side effects are rare, you may experience one of the known side effects of taking NSAIDs. If this is the case, or if you have any concerns about taking this medication, stop the medication and talk to your doctor as soon as possible. Elderly people taking this medication increase their risk of developing health problems related to side effects.

Stop taking this medication and seek immediate medical attention if you develop:

· signs of intestinal haemorrhage such as severe abdominal pain, tarry black stools, vomiting of blood or dark particles resembling ground coffee;

· signs of very rare but severe allergic reactions such as worsening of asthma, wheezing or unexplained breathlessness, swelling of the face, tongue or throat, difficulty breathing, tachycardia or a fall in blood pressure leading to collapse . Such reactions may occur even if this is the first time you are using this medication.

· severe skin reactions such as rashes covering the entire body, desquamation, vesication or detachment of the skin.

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.

Common: (can affect up to 1 in 10 people)

· stomach pain such as acid burning, stomach pain and nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation and slight loss of blood in the stomach and / or intestine which can cause anemia in exceptional cases.

Uncommon: (May affect up to 1 in 100 people)

• Gastrointestinal ulcers, perforation or haemorrhage, inflammation of the mucous membrane of the mouth with ulceration, aggravation of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue.
• visual impairment
• various rashes
• hypersensitivity reactions with urticaria and itching

Rare: (can affect up to 1 in 1,000 people)
• tinnitus (ringing in the ears)
• increased urea levels in the blood, pain in the flanks and / or abdomen, blood in the urine and fever may be signs of alteration of the kidneys (papillary necrosis) • increased urea concentrations in the blood,
• decreased hemoglobin levels

Very rare: (can affect up to 1 in 10,000 people)
• oesophagitis, pancreatitis and formation of intestinal stenosis with "diaphragm" type

• heart failure, heart attack and swelling of the face or hands (edema)
• decreased urination and swelling (especially in patients with arterial hypertension or decreased renal function), swelling (edema) and turbid urine (nephrotic syndrome); inflammatory diseases of the kidney (interstitial nephritis) which can lead to acute renal failure. If any of the above symptoms occur or if you have a feeling of general impairment, stop taking NUROFENFLASH 400 mg powder for oral suspension and see your doctor right away as this may be the first sign of impaired function renal or renal impairment.
• psychotic reactions, depression
• high blood pressure, vasculitis
• palpitations
• liver dysfunction, liver damage (early signs may be discolouration of the skin), especially during long-term treatment, liver failure, acute liver inflammation (hepatitis)
• Problems in the production of blood cells. The first signs are fever, sore throat, superficial buccal ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding and unexplained bruising. In these cases, you should stop treatment immediately and see a doctor. Any self-medication with analgesics or medicines that reduce fever (antipyretic drugs) should not be taken.
• severe skin infections and soft tissue complications during chickenpox (varicella)
• worsening of infection-related inflammations (eg, necrotizing fasciitis) associated with the use of certain analgesics (NSAIDs) has been described. If signs of infection occur or worsen, you should report this to your doctor. It is to be investigated whether there is any indication for antimicrobial / antibiotic therapy.
• symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or disorientation have been observed when using ibuprofen. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue diseases) are more likely to be affected. Contact a doctor immediately if these symptoms occur.
• severe forms of skin reactions such as rashes with redness and blisters (eg Stevens - Johnson syndrome, erythema multiforme, necrolysis / epidermal toxic Lyell syndrome), hair loss (alopecia).

Frequency not known: (can not be estimated from available data)

· reactivity of the respiratory tract including asthma, bronchospasm or dyspnea.

Drugs such as NUROFENFLASH 400 mg powder for oral solution in sachets may be associated with an increased risk of heart attack (myocardial infarction) or stroke.

NUROFENFLASH 400 mg powder for oral solution contains tartrazine which may cause an allergic reaction.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 NUROFENFLASH 400 mg powder for oral solution in sachet?

Keep this medicine out of the reach and sight of children.

Do not use NUROFENFLASH 400 mg powder for oral solution after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of the month.

No special storage conditions

Once the solution is prepared, drink it immediately.

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 NUROFENFLASH 400 mg contains, powder for oral solution in sachet?

· The active substance is:

Ibuprofen................................................. .................................................. 400 mg

In the form of ibuprofen lysinate

For a bag

· The other components are:

Betdex, lemon oil (composed of maltodextrin, modified starch (maize) and tartrazine E102), sodium saccharin (E954), sodium cyclamate (E952), sodium citrate (E331), sucrose.

What is NUROFENFLASH 400 mg powder for oral solution in sachet and contents of the pack

This medicinal product is in powder form for oral solution in sachets.

The powder is white in color.

The single-dose pouch consists of a heat-sealing paper / aluminum foil / polyethylene.

Box of 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 15 or 16 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

RECKITT BENCKISER HEALTHCARE FRANCE

15 RUE AMPERE

91748 MASSY CEDEX

LA FRANCE

Marketing Authorization Operator

RECKITT BENCKISER HEALTHCARE FRANCE

15 RUE AMPERE

91748 MASSY CEDEX

LA FRANCE

Maker

LABORATORIO DE APLICACIONES FARMACODINAMICAS, SA (FARDI)

GRASSOT

16 08025 BARCELONA

SPAIN

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with the regulations in force.

to be completed later by the holder

The last date on which this leaflet was revised is:

to be completed later by the holder

Other

Not applicable.

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 40 kg (12 years of age or older) : If the disorder is too troublesome, you can take a medication containing ibuprofen at the indicated dosage.

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

· 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.

Buy all drugs in the group Reckitt including Nurofen, Nureflex on Care and nature, your bio pharmacy online!

Cheap Nurofen your licensed pharmacy ARS Online  

Nurofen is a nonprescription drug in the family of nonsteroidal anti-inflammatory drugs (NSAIDs). He struggles against the pain and reduce fever. Nurofen is an effective painkiller to relieve most mild to moderate pain. Beware though, this medicine contains ibuprofen and therefore the high-dose pain. It should not be routinely used in case of pain and mundane is against-indicated in pregnant women from the sixth month of pregnancy.

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