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Ibuprophen 400 mg Mylan 10 sticks of 10 ml
Over-the-counter medication

Ibuprophen 400 mg Mylan 10 sticks of 10 ml

Brand : Mylan Viatris Mylan Viatris

Ibuprofen MYLAN 400mg 10 sticks of 10ml is indicated for the short-term treatment of fever and or pain such as headaches, flu-like conditions, dental pain, body aches, and painful periods.

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What are the indications for Ibuprofen MYLAN 400mg 10 sticks of 10 ml?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Its active substance is used in many medicines, it helps to fight against pain and helps to lower fever .

Ibuprofen is therefore very frequently used in the event of conditions causing pain and a rise in body temperature. It is very effective against headaches and painful menstruation. It can also be administered to children over 30 kg. This medication is ideal for fever, pain and other migraine attacks.

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

In adults and children over 30 kg (about 11-12 years old), it is indicated for the short-term treatment of fever and/or pain such as headache, flu -like illness, dental pain, aches, and painful periods .

In adults, it is indicated for the treatment of mild to moderate migraine attacks with or without aura after at least medical advice.

How to take this painkiller properly?

Ibuprofen is taken with food. This instruction is often poorly followed, but ibuprofen is an anti-inflammatory that must be taken during a meal. Indeed, taking it while eating limits the risk of heartburn.

The occurrence of side effects can be minimized by using the lowest possible dose for the shortest treatment duration necessary to relieve symptoms.

Painful and/or feverish conditions suitable for adults and children from 30 kg (about 11-12 years old).

1 sachet of 400 mg per dose, to be renewed if necessary after 6 hours. In all cases, do not exceed 3 sachets of 400 mg per day (i.e. 1200 mg per day).

Oral route Homogenize the suspension before use by pressing with the fingers several times on the top and bottom of the sachet.

This medicine can be administered directly without water or diluted in water. The sachets are to be taken preferably during a meal.

Oral suspension in sachet. White viscous suspension with the characteristic smell of strawberries.

Comment on the recommendations for use and dosage of Ibuprofen MYLAN 400mg 10 sticks of 10ml with our partner Avis checked after your purchase .

What is the composition of these Sticks?

glycerol, sodium chloride, sodium citrate, citric acid anhydrous, hypromellose, xanthan gum, sodium saccharin, thaumatin, purified water

What are the side effects and contraindications?

Internal use. follow the dosage. Store in a clean, dry place. Keep out of reach of children. Not for use by pregnant women. Do not use in children under 30 kg. Do not hesitate to ask your doctor or pharmacist for advice.

Presentation - Packaging

Ibuprofen MYLAN 400mg is available in our online pharmacy in boxes of 10 sticks of 10ml.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated on : 17/01/2025

ATTENTION

IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet WHICH IS A NON-STEROIDIC ANTI-INFLAMMATORY (NSAID) MAY RESULT IN FTAL DEATH IF TAKEN FROM THE 6TH MONTH OF PREGNANCY (24 weeks of amenorrhea) EVEN AFTER A SINGLE TAKE.

Do not use if you are 6 months or more pregnant (24 weeks or more).

Before the 6th month or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary, as determined by your doctor.

Product name

IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet

Ibuprofen

Box

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist for any advice or information you may need.

- If you experience any 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 do not feel any improvement or if you feel less well after 3 days in the case of fever or migraine and 5 days in the case of pain.

What does this leaflet contain?

1. What isIBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet and what is it used for?

2. What do I need to know before taking IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet?

3. How should I take IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet?

4. What are the possible side effects?

5. How to store IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet?

6. Package contents and other information.

1. WHAT IS IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet AND WHAT IS IT USED FOR?

Pharmacotherapeutic class: other analgesics and antipyretics - ATC code: M01AE01.

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

It is indicated for adults and children weighing 30 kg or more (approx. 11-12 years), for the short-term treatment of fever and/or pain such as headaches, flu-like symptoms, toothache, aches and painful menstruation.

It is indicated in adults, after at least one medical opinion, for the treatment of mild to moderate migraine attacks, with or without aura.

2. WHAT DO I HAVE TO KNOW BEFORE TAKING IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet?

Never take IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet if you are 24 weeks or more pregnant (6 months or more of pregnancy) (see "Pregnancy, breast-feeding and fertility" below).

During the first 5 months of pregnancy, you should not take IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet, unless absolutely necessary, as determined by your doctor.

If you are planning a pregnancy and are taking an NSAID, talk to your healthcare professional.

Never take IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet:

- if you are allergic to libuprofen or any of the other ingredients listed in section 6;

- if you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea);

- if you have a history of allergy or asthma triggered by this or related drugs, notably other non-steroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin);

- if you have a history of gastrointestinal bleeding or ulcers associated with previous treatment with NSAIDs;

- if you have an evolving or recurrent stomach or intestinal ulcer or bleeding;

- if you have an ongoing gastrointestinal hemorrhage, cerebral hemorrhage or other hemorrhage;

- if you have a history of gastrointestinal ulcer or hemorrhage;

- if you have severe liver disease;

- if you have serious kidney disease;

- if you have severe heart disease;

- if you have systemic lupus erythematosus;

- if you are being treated with mifamurtide (a treatment for certain bone cancers).

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Warnings and precautions

Special precautions with IBUPROFENE VIATRIS CONSEIL

At high doses, in excess of 1200 mg/day, this drug has anti-inflammatory properties and may cause the sometimes serious side effects observed with non-steroidal anti-inflammatory drugs.

Drugs such asIBUPROFENE VIATRIS CONSEIL may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose, the greater the risk.

Do not exceed recommended doses or duration of treatment.

If you have heart problems including heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, arteriopathy of the lower limbs (poor circulation due to narrowing or blockage of the arteries), or any type of cerebrovascular accident (including minor stroke or transient ischemic attack "TIA"), or if you have risk factors for these conditions (e.g. high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you smoke), please talk to your doctor or pharmacist before taking IBUPROFENE VIATRIS CONSEIL.

Signs of allergic reaction to this drug, including breathing problems, swelling of the face and neck (angioedema), chest pain have been reported with libuprofen. Stop taking IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet immediately and contact your doctor or the nearest hospital emergency department if you notice any of these signs.

Be particularly careful with IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet.

Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), acute generalized exanthematous pustulosis (AGEP) have been reported in association with libuprofen therapy. Stop taking IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet and seek medical advice immediately if you experience any of the symptoms associated with the serious skin reactions described in section 4.

Infections

IBUPROFENE VIATRIS CONSEIL may mask signs of infection such as fever and pain. It is therefore possible that IBUPROFENE VIATRIS CONSEIL may delay adequate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and the symptoms of this infection persist or worsen, consult a physician immediately.

Special warnings

If you are a woman, IBUPROFENE VIATRIS CONSEIL may impair your fertility. Its use is not recommended in women who wish to conceive a child. In women who have difficulty conceiving or who are undergoing reproductive function tests, please talk to your doctor or pharmacist before taking IBUPROFENE VIATRIS CONSEIL.

This medicine should be used with caution in elderly patients.

Elderly subjects are at greater risk of adverse reactions, particularly gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac functions must be closely monitored. Dosage should be kept as low as possible for the shortest period necessary to relieve symptoms.

BEFORE USING THIS MEDICATION, CONSULT YOUR DOCTOR IN THE EVENT OF :

- a history of asthma associated with chronic rhinitis, chronic sinusitis or nasal polyps. Administration of this product may lead to an asthma attack, particularly in certain patients allergic to acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (see "Never take IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet");

- coagulation disorders or anticoagulant therapy. This medicine may cause serious gastrointestinal symptoms;

- digestive history (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer);

- heart, liver or kidney disease;

- chickenpox. This medicine is not recommended in exceptional cases of serious skin infections;

- non-steroidal anti-inflammatory drugs (NSAIDs);

- concomitant treatment with other drugs which increase the risk of peptic ulcer or bleeding, e.g. oral corticosteroids, antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), blood clot-preventing drugs such as aspirin, or anticoagulants such as warfarin. If you have any of these conditions, consult your doctor before taking IBUPROFENE VIATRIS CONSEIL (see "Other medicines and IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet");

- concomitant treatment with methotrexate at doses exceeding 20 mg per week or with pemetrexed (see "Other drugs and IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet").

DURING TREATMENT, IN THE EVENT OF :

- visual disturbances, PREVENT YOUR PHYSICIAN;

- gastrointestinal haemorrhage (blood in the mouth or stools, blood in vomit, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY;

- signs appear on the skin or mucous membranes resembling a burn (redness with bubbles or blisters, ulcerations), STOP TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY;

- signs suggestive of allergy to this drug, in particular an asthma attack or sudden swelling of the face and neck (see "What are the possible side effects?"), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY.

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

You must 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 medicine. Carefully read the package inserts of any other medicines you are taking to ensure that they do not contain non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid (aspirin).

Ask your doctor or pharmacist before taking IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet.

Children and adolescents

Not applicable.

Other medicines and IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet

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

Always tell your doctor, dentist or pharmacist if you are taking or have recently taken any of the following medicines in addition toIBUPROFENE VIATRIS CONSEIL :

- certain treatments for bone cancer (mifamurtide);

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

- corticosteroids;

- anticoagulants (such as anticoagulants/platelet antiaggregants like laspirin (acetylsalicylic acid), warfarin, ticlopidine, injectable heparin);

- lithium;

- methotrexate;

- drugs that reduce blood pressure (angiotensin-converting enzyme inhibitors such as captopril, diuretics, beta-blockers such as latenolol-containing drugs and angiotensin II antagonists such as losartan);

- certain antidepressants (selective serotonin reuptake inhibitors (increased risk of digestive bleeding));

- pemetrexed;

- ciclosporin, tacrolimus;

- tenofovir disoproxil.

IBUPROFENE VIATRIS CONSEIL 400 mg, oral suspension in sachet with food and drink

Not applicable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

From the beginning of the 6th month (24th week of amenorrhea) until the end of pregnancy, IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet is contraindicated. Under NO CIRCUMSTANCES should you take this medicine during this period, as its effects on your unborn child may be serious or even fatal. In particular, toxicity to the heart, lungs and/or kidneys has been observed, even with a single dose. It can also affect you and your baby, promoting bleeding and leading to a later or longer-than-expected delivery.

Before the beginning of the 6th month (up to the 24th week of amenorrhea) or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary. This will be determined by your doctor. In such cases, the dose should be as low as possible and the duration of treatment as short as possible.

NSAIDs, including IBUPROFENE VIATRIS CONSEIL 400 mg, oral suspension in sachet, can cause miscarriage and, in some cases, malformations after exposure in early pregnancy.

From 2 and a half months of pregnancy (12 weeks of amenorrhea), IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet may cause kidney problems in your baby, if taken for several days, which may result in a low level of amniotic fluid in the baby (oligohydramnios).

From the beginning of the 5th month of pregnancy (20 weeks of amenorrhea), a narrowing of the blood vessels in your baby's heart (constriction of the ductus arteriosus) may be observed. If treatment lasting several days is required during the 5th month of pregnancy (between 20 and 24 weeks' gestation), your doctor may recommend additional monitoring.

If you have taken this medicine while pregnant, tell your doctor immediately, so that you can be offered appropriate monitoring if necessary.

Breast-feeding

As this drug passes into breast milk, it is not recommended to use it while breast-feeding.

Female fertility

This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, leading to difficulties in becoming pregnant, which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.

Driving vehicles and using machines

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

IBUPROFENE VIATRIS CONSEIL 400 mg, suspension buvable en sachet contains sodium, benzoate salt and maltitol.

This medicine contains 58 mg sodium (main component of table salt) per sachet. This is equivalent to 2.9% of the maximum recommended daily allowance of sodium for an adult.

This medicine contains 10 mg benzoate salt per dose. Benzoate salt may increase the risk of dicterus (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).

If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.

3. HOW DO I TAKE IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet?

Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

The occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest duration necessary to relieve symptoms.

Dosage

Painful and/or febrile conditions

FOR ADULTS AND CHILDREN FROM 30 kg (approx. 11-12 years).

The usual dosage is 1 sachet (400 mg) per dose, repeated if necessary every 6 to 8 hours, up to a maximum of 3 sachets per day (i.e. 1200 mg).

The 400 mg sachet is reserved for pain or fever that is more intense or not relieved by a 200 mg sachet of ibuprofen.

Elderly patients are at greater risk of adverse reactions, so use the lowest possible dose for the shortest duration necessary to relieve symptoms.

Do not exceed recommended doses or treatment duration (3 days for fever, 5 days for pain).

The maximum dosage is 3 sachets per day (1200 mg).

For migraine attacks

FOR ADULTS ONLY

1 sachet (400 mg) as soon as possible after the onset of the attack.

If a patient is not relieved after the first dose, a second dose should not be taken during the same attack. However, the attack can be treated with another non-steroidal anti-inflammatory drug or aspirin.

If the pain recurs, a second dose may be taken, provided there is an 8-hour interval between the 2 doses.

If in doubt, ask your doctor or pharmacist for advice.

Method of administration

Oral administration.

IBUPROFENE VIATRIS CONSEIL is a suspension. It should be homogenized before use by repeatedly pressing the top and bottom of the sachet with the fingers. IBUPROFENE VIATRIS CONSEIL may be administered directly without water or diluted in water.

The sachets should preferably be taken with a meal.

Frequency of administration

Systematic administration avoids oscillations in pain or fever.

They should be taken at least 6 hours apart.

Duration of treatment

The duration of use is limited to :

- 3 days in case of fever ;

- 3 days in case of migraine;

- 5 days in case of pain.

If pain persists more than 5 days or fever more than 3 days, or if they worsen, or if a new condition develops, inform your doctor.

In the event of a migraine attack, the duration of treatment should not exceed 3 days.

If symptoms persist or worsen, or if new symptoms appear, ask your pharmacist or doctor for advice.

If you feel that the effect of IBUPROFENE VIATRIS CONSEIL is too strong or too weak, consult your doctor or pharmacist.

If you have taken more IBUPROFENE VIATRIS CONSEIL 400 mg, drinkable suspension in sachet, than you should have

If you have taken moreIBUPROFENE VIATRIS CONSEIL than you should have, or if children have accidentally taken the medicine, always contact a doctor or the nearest hospital for advice on the risk and what action to take.

Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, ringing in the ears, confusion and unsteady eye movements. Agitation, drowsiness, disorientation or coma may also occur. Occasionally, patients develop convulsions. At high doses, the following symptoms have been reported: drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, sensation of body cold and breathing problems. In addition, prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatics. In addition, arterial hypotension and reduced respiration may occur.

If you forget to take IBUPROFENE VIATRIS CONSEIL 400 mg, oral suspension in sachet

Do not take a double dose to make up for the one you forgot to take.

If you stop taking IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet

Not applicable.

If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, libuprofen may cause undesirable effects, but these do not always occur in everyone.

Stop taking libuprofen and consult a doctor immediately if you experience any of the following symptoms:

- reddish, non-elevated, target- or circle-shaped spots on the trunk, often accompanied by central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];

- generalized rash, elevated body temperature and swollen lymph nodes (DRESS or hypersensitivity syndrome);

- generalized red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms generally appear as soon as treatment is initiated (acute generalized exanthematous pustulosis).

-

Medicines such asIBUPROFENE VIATRIS CONSEIL may increase the risk of heart attack ("myocardial infarction") or stroke.

Allergic reactions may occur:

- skin: rash, itching, swelling, worsening of chronic urticaria, a severe skin reaction called hypersensitivity syndrome (DRESS syndrome) may occur. Hypersensitivity symptoms include rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);

- asthma-like breathing;

- generalized: sudden swelling of the face and neck with difficulty breathing (angioedema), anaphylactic reaction, hypersensitivity reaction.

In rare cases, bleeding, gastrointestinal perforation or digestive ulcer may occur (abdominal pain, upper abdominal pain, discharge of blood through the mouth ("hematemesis") or in the stools, black discoloration of the stools ("melaena")), exacerbation of inflammation of the intestine ("colitis") or Crohn's disease (see "Taking special precautions with IBUPROFENE VIATRIS CONSEIL"). The higher the dosage used, the more frequently these occur.

In exceptional cases, headaches accompanied by nausea, vomiting and stiff neck may be observed: symptoms of meningitis.

- Very rarely, bullous skin or mucous membrane manifestations may occur (burning sensation accompanied by redness with bullae, blisters, ulcerations ("Lyell syndrome" and "Stevens-Johnson syndrome").

The following other adverse reactions have been reported:

- widespread, scaly red rash with masses under the skin and blisters, mainly located in skin folds, on the trunk and upper extremities, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). If you develop these symptoms, stop using IBUPROFENE VIATRIS CONSEIL and consult a doctor immediately. See also section 2;

- skin sensitivity to light (frequency undetermined);

- exceptionally, severe skin infections have been observed with chickenpox;

- chest pain, which may be a sign of a potentially severe allergic reaction known as Kounis syndrome (frequency undetermined).

In all such cases, discontinue treatment immediately and inform your doctor.

During treatment, the following may occur:

- digestive disorders: stomach upset, vomiting, nausea, diarrhea, constipation, flatulence, difficult digestion ("dyspepsia"), gastritis;

- exceptionally, dizziness, headaches, rare visual disturbances, significant urine loss, abnormal blood in the urine ("hematuria"), kidney failure and other kidney diseases ("interstitial nephritis", "nephrotic syndrome", "papillary necrosis").

In all such cases, you should inform your doctor.

Exceptionally, changes in liver function or blood count (abnormal drop in blood cell count: white blood cells ("agranulocytosis", "leukopenia") or red blood cells ("anemia", "aplastic anemia", "hemolytic anemia", decrease in hematocrit and hemoglobin) or platelets ("thrombocytopenia")) may be serious.

Other very rare side effects:

- nervousness, ringing in the ears;

- mouth ulcers;

- abnormally high blood pressure ("hypertension");

- heart failure;

- liver problems: symptoms may include yellowing of the skin and whites of the eyes ("jaundice"), hepatitis;

- peripheral edema, swelling.

Reporting side effects

If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr

By reporting adverse reactions, you are helping to provide more information on drug safety.

5. HOW TO CONSERVE IBUPROFENE VIATRIS CONSEIL 400 mg, Oral suspension in sachet?

Keep out of sight and reach of children.

Do not use this medicine after the expiration date indicated on the packaging after "EXP". The expiration date refers to the last day of that month.

No special storage precautions are required.

Do not dispose of any medicine with your household waste . Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.

6. CONTENTS AND OTHER INFORMATION

What IBUPROFENE VIATRIS CONSEIL 400 mg oral suspension sachet contains

- The active substance is :

ibuprofen.................................................................................................................... 400 mg

per sachet.

- The other components are :

liquid maltitol, glycerol, sodium chloride, sodium citrate, citric acid anhydrous, hypromellose, xanthan gum, sodium benzoate, sodium saccharin, strawberry flavor, thaumatin, purified water.

What IBUPROFENE VIATRIS CONSEIL 400 mg, oral suspension in sachet is and what it contains

This medicine is available as a drinkable suspension in 10 mL sachets.

Box of 10 sachets of 10 mL suspension.

Marketing authorization holder

viatris sante

1 rue de turin

69007 lyon

Marketing authorization holder

viatris sante

1 rue de turin

69007 lyon

Manufacturer

KERN PHARMA, S.L.

POLIGONO INDUSTRIAL COLÓN II, VENUS, 72

08228 TERRASSA (BARCELONA)

SPAIN

Product names in member states of the European Economic Area

Not applicable.

The last date on which this leaflet was revised was :

[to be completed subsequently by the holder].

Other

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

ADVICE / HEALTH EDUCATION

WHAT TO DO IN CASE OF FEVER

Normal body temperature varies from one individual to another, and lies between 36.5°C and 37.5°C. A rise of more than 0.8°C is considered a fever.

Adults and children weighing over 30 kg (approx. 11-12 years): If the symptoms are too distressing, you can take a medication containing ibuprofen at the recommended dosage.

With this medication, fever should subside rapidly. Nevertheless:

- if other signs appear (such as a rash);

- if fever persists for more than 3 days or worsens;

- if headaches become severe, or if vomiting occurs;

CONSULT YOUR DOCTOR IMMEDIATELY.

WHAT TO DO IN CASE OF PAIN

- if no improvement after 5 days of treatment;

- if pain recurs regularly;

- if accompanied by fever;

- if it wakes you up at night;

CONSULT YOUR DOCTOR IMMEDIATELY.

WHAT TO DO IN THE EVENT OF A MIGRAINE

What is a migraine?

Migraine is an illness characterized by severe headaches, occurring in attacks lasting from 4 to 72 hours and recurring several times a month. It can sometimes be preceded by visual and/or sensory signs known as aura (impression of brightness or flickering in the visual field, illusion that a fly seems to be crossing the visual field).

Migraine or headache?

The term "migraine" is often used instead of "headache". The following questions can help you identify whether you have a migraine. You can complete them yourself or with the help of your pharmacist.

1. Your headache evolves in attacks lasting from a few hours to 3 days (without treatment).

Between attacks, you have no head pain. Yes □ No □

2. You have had at least 5 seizures in your life. Yes □ No □

3. Your headache has at least 2 of the following characteristics: Yes □ No □

- localized to one side of the head;

- pulsatile ("it taps");

- increased by exertion (climbing stairs, running, coughing);

- the painful intensity of the attack ranges from strong to very strong.

4. Your headache is accompanied by at least 1 of the following signs: Yes □ No □

- urge to vomit or vomiting ;

- discomfort with light (photophobia) and/or noise (phonophobia).

If you answered YES:

- to 4 questions: you probably have migraine;

- to 3 questions: you probably suffer from migraine;

- to 1 or 2 questions: you probably don't suffer from migraine.

Discuss these results with your doctor, so that he or she can confirm the diagnosis and agree with you on the most appropriate treatment.

How can I manage my attacks?

Certain factors, such as fatigue, stress, food (chocolate, alcohol), sensory factors (noise, flashing lights, perfumes, etc.) or physiological factors such as menstruation, are likely to trigger migraine attacks.

Knowing the triggers and warning signs that may precede an attack enables treatment to be started early (ideally within an hour of onset, while the attack is still mild). The earlier the treatment is taken, the more effective it is, and often the shorter its duration (early treatment limits migraine recurrence).

Noting in a diary or notebook the date and duration of your attacks, the intensity of the pain, any triggers and the medication used for each attack will help your doctor assess your migraine and its treatment.

Failure to treat the first attack does not necessarily mean failure to treat subsequent attacks. The efficacy of ibuprofen 400 mg should be evaluated over 2 or 3 attacks. To help you, answer the following questions and discuss them with your doctor and pharmacist.

Are you relieved 2 hours after taking ibuprofen? Yes □ No □

Do you experience any side effects (digestive or other)? Yes □ No □

Do you use a single dose of medication? Yes □ No □

Can you resume your usual activities 2 hours after taking it? Yes □ No □

In what cases should you consult your doctor?

While most headaches are benign in origin, you shouldn't ignore the fact that they can be a symptom of sometimes serious conditions requiring specialist treatment.

Consult your doctor in the following cases:

- first attack of headache;

- onset of headaches after age 50;

- triggered by physical exertion, sexual intercourse or coughing;

- installation of a "thunderclap" headache: sudden appearance of a headache from one second to the next;

- appearance of unusual signs accompanying the headache, such as :

o loss of balance,

o neck stiffness, making neck movements difficult or impossible,

o double vision, blurred vision,

o difficulty speaking,

o reduced muscle strength, numbness in arms and legs;

- body temperature > 38°C;

- worsening of headaches;

- headache not of usual character;

- continuous onset of headaches.

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