NUROFENCAPS 400 MG

NOTICE

ANSM - Last updated: 10/05/2017

Name of the medicinal product

NUROFENCAPS 400 mg soft capsule

Ibuprofen

framed

Please read this manual carefully as it contains important information for you.

· This medication is given without a prescription. However, you should use NUROFENCAPS carefully to get the best results.

· Keep this leaflet. You may need to review it again.

· For more information, ask your pharmacist for advice.

· If symptoms worsen or persist for more than 3 days in case of fever and after 4 days in case of pain, contact your doctor.

· If any of the side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Review summary

In this notice :

1. What is NUROFENCAPS 400 mg, soft capsule and in which cases is it used?

2. What information should I take before taking NUROFENCAPS 400 mg soft capsule ?

3. How to take NUROFENCAPS 400 mg, soft capsule ?

4. What are the possible side effects?

5. How to store NUROFENCAPS 400 mg, soft capsule ?

6. Additional information.

1. WHAT NUROFENCAPS 400 mg, soft capsule AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

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.

Therapeutic indications

NUROFENCAPS 400 mg, soft capsule 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, painful menstruation, dental pain, flu and fever.

2. BEFORE YOU TAKE NUROFENCAPS 400 mg soft capsule.

List of information needed before taking the medication

Not applicable.

Cons-indications

Never take NUROFENCAPS 400 mg soft capsules in the following cases:

· allergy to ibuprofen, red culvert 4R (E124) or any of the other ingredients of NUROFENCAPS 400 mg soft capsule (see section 6 "Additional Information");

· history of shortness of breath, asthma, runny nose, swelling or urticaria after using aspirin or other similar painkillers (NSAIDs);

· ulcer or bleeding of the stomach or duodenum (peptic ulcer), whether progressive or old (two or more episodes);

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

· patients with hematopoiesis disorders.

· bleeding disorders or bleeding disorders (haemorrhage);

· 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;

· child under 40kg or under 12 years of age.

Precautions for use; special warnings

Take special care with NUROFENCAPS 400 mg soft capsule:

· In case of systemic lupus erythematosus or mixed connective tissue disease (state of the immune system responsible for joint pain, rash and fever).

· If you suffer from hereditary disorders of hematopoiesis (acute intermittent porphyria) or coagulation disorders.

· If you have or have ever had an intestinal disease (ulcerative colitis or Crohn's disease).

· If you have problems with high blood pressure and / or heart failure.

· If your kidney function is reduced

· If you have liver problems.

· 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 airway disease, there is an increased risk of allergic reactions. These allergic reactions can manifest in the form of asthma attacks (called analgesic asthma). Angioedema or urticaria.

· Taking medicines that may increase the risk of ulceration or bleeding, such as: oral corticosteroids, anticoagulants (eg warfarin), selective serotonin (antidepressant) reuptake inhibitors, or antiplatelet agents (eg, aspirin).

Other Warnings:

· Prolonged use of analgesics for headaches can aggravate them. If this happens or is suspected, stop treatment and contact a doctor.

· Drugs such as NUROFENCAPS 400 mg, soft capsule may be associated with an increased risk of heart attack (myocardial infarction) or stroke. The higher the dose and the longer the duration of treatment, the greater the risk. Do not exceed the recommended dose or treatment time (3 days for fever and 4 days for pain).

· If you have a heart condition, history of stroke, or if you think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are smoker) you should discuss your treatment with your doctor or pharmacist.

· In case of varicella, it is recommended not to use NUROFENCAPS 400 mg, soft capsule.

· In the case of prolonged administration of NUROFENCAPS 400 mg, soft capsule, regular monitoring of liver and kidney function and blood count 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.

· the usual use of several kinds of analgesics can cause severe and long-lasting kidney problems and should be avoided. This risk may increase as a result of dehydration.

Adverse effects can be reduced by using the lowest effective dose for the shortest possible period of time. Older people are more likely to experience side effects.

Consult a physician before using NUROFENCAPS 400 mg soft capsule if any of the above conditions apply to you.

Interaction with other medicines

Taking 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:

· Blood coagulation inhibitors (eg acetylsalicylic acid, warfarin, ticlopidine), medicines for high blood pressure (ACE inhibitors, eg captopril, beta-blockers, antagonists of angiotensin II) and even other types of medications that may affect or affect their action may be affected by treatment with ibuprofen. Therefore, you should always seek advice from your doctor before taking ibuprofen in combination with other medicines.

· Do not take NUROFENCAPS 400 mg soft capsule if you are taking acetylsalicylic acid (aspirin) at daily doses greater than 75 mg.

· If you are taking low-dose acetylsalicylic acid (up to 75 mg daily) seek advice from your doctor or pharmacist before taking NUROFENCAPS 400 mg soft capsule.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially if you take:

· other NSAIDs (non-steroidal anti-inflammatory drugs) may increase the risk of gastrointestinal ulceration or bleeding;

· digoxin (for heart failure), because the effect of digoxin may be accentuated;

· glucocorticoids (medicines containing cortisone or cortisone-related substances as these drugs may increase gastrointestinal or bleeding risk;

· antiplatelet agents, as they may increase the risk of gastrointestinal ulcer or bleeding;

· blood thinners (such as warfarin, acetyl salicylic acid or ticlopidine) because ibuprofen may increase the effects of these drugs;

· of phenytoin (for epilepsy), because the effect of phenytoin may be accentuated;

· selective serotonin reuptake inhibitors (drugs used for nerve depression) as they may increase the risk of bleeding;

· lithium (drug for manic depressive illness and depression), because the effect of lithium may be accentuated;

· probenecid and sulfinpyrazone (medication for gout), as excretion of ibuprofen may be delayed;

· medicines for high blood pressure (ACE inhibitors, eg captopril, beta-blockers, angiotensin II antagonists) and diuretics because ibuprofen can decrease the effects of these drugs with increased risk possible for the kidneys;

· potassium-sparing diuretics as this may lead to elevated blood potassium concentration (hyperkalaemia);

· methotrexate (a medicine for cancer or rheumatism) because the effect of methotrexate may be accentuated;

· tacrolimus and ciclosporin (immunosuppressive drugs), as the kidneys may be damaged;

· zidovudine (a drug for the treatment of AIDS) because with the use of NUROFENCAPS 400 mg, soft capsule, there is an increased risk of hemarthrosis and hematomas in hemophiliac patients with HIV;

· sulphonylureas (antidiabetic medicines), because interactions are possible;

· quinolones (antibiotics), since their use may increase the risk of convulsions;

· of mifepristone (use to interrupt pregnancy) because the effect of mifepristone may be reduced.

Always seek the advice of your doctor before taking ibuprofen with other medicines.

Interactions with food and beverages

Food and drinks

Swallow the capsule with a large glass of water. It is recommended for patients with gastric sensitivity, to take NUROFENCAPS 400 mg, soft capsule during a meal. Adverse reactions such as those affecting the gastrointestinal tract may occur when alcohol is taken at the same time as NUROFENCAPS 400 mg soft capsule.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Pregnancy

You should tell your doctor if you are pregnant during treatment with NUROFENCAPS 400 mg soft capsule. 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

Small amounts of ibuprofen and its metabolites pass into breast milk. This medication may be used during breast-feeding if the recommended dose is used for the shortest possible period of time.

Female fertility

NUROFENCAPS 400 mg soft capsule belongs to the class of drugs likely to alter female fertility. However, this effect is reversible upon discontinuation of treatment. Avoid taking this medication if you are trying to get pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

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.

Patients with dizziness, drowsiness, dizziness or visual disturbances when taking NUROFENCAPS 400 mg soft capsule should avoid driving or using machines. These effects can be accentuated when taking alcohol.

List of excipients with known effect

Important information about some of the ingredients of NUROFENCAPS 400 mg soft capsule

This medicine contains sorbitol. If your doctor has told you about an intolerance to some sugar, contact your doctor before taking this medicine.

This medication contains an azo dye, 4R (E124) culvert red and may cause allergic reactions.

3. HOW TO TAKE NUROFENCAPS 400 mg, soft capsule?

Instructions for proper use

Always take NUROFENCAPS 400 mg, soft capsule strictly following the instructions given in this leaflet. You can check with your doctor or pharmacist in case of doubt.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Unless otherwise prescribed by your doctor, the usual dosage is as follows:

Dosage

Adults and adolescents over 40 kg (12 years and over): 1 capsule (400 mg ibuprofen) taken with a large glass of water up to three times daily if necessary. Space the doses of at least 6 hours between each dose.

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

Do not give NUROFENCAPS 400 mg, soft capsule to adolescents under 40 kg or children under 12 years of age.

Method and route of administration

Oral use. Do not chew.

Patients with a sensitive stomach are advised to take NUROFENCAPS 400 mg, soft capsule 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 NUROFENCAPS 400 mg, soft capsule than the dose that was recommended to you in this section until the exact end of the dose renewal time.

Duration of treatment

This medication should be used only for a short period of time. The occurrence of adverse reactions can be minimized by using the lowest dose possible during the shortest treatment time needed to relieve symptoms.

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.

Symptoms and Instructions for Overdose

If you take more NUROFENCAPS 400 mg, soft capsule than you should:

Seek immediate medical attention. Signs of nausea, stomach upset, diarrhea, tinnitus, headache, blood in the stool or blood in the vomit (gastrointestinal bleeding), dizziness, drowsiness, confusion, disorder of orientation. Rarely loss of consciousness.

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

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, NUROFENCAPS 400 mg, soft capsule is likely to have side 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. You may have one of the known side effects of taking NSAIDs (see below). 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.

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: affects 1 to 10 users in 1,000

· 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

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 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 skin 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.

Frequent

· Gastrointestinal pain such as heartburn, abdominal pain, nausea and indigestion, vomiting, gas (flatulence), diarrhea, constipation and mild blood loss in the stomach and / or intestine which can cause anemia in exceptional cases.

Rare

· Gastric or intestinal ulcers, sometimes accompanied by hemorrhage or perforation, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), aggravation of colitis and Crohn's disease.

· Central nervous system disorders such as: headache, dizziness, insomnia, restlessness, irritability or fatigue.

· Disorders of vision.

· Allergic reactions, such as rash, itching and asthma attacks. In such cases, you should discontinue the treatment with NUROFENCAPS 400 mg soft capsule and inform your doctor immediately.

Rare

· Tinnitus (ringing of ears).

· Renal involvement (papillary necrosis) and elevated levels of uric acid in the blood.

Very rare

· Swelling (edema), high blood pressure and heart failure have been reported in association with NSAID therapy.

· Inflammation of the esophagus or pancreas, formation of a narrowing of the membrane type in small and large intestines (stenosis intestinal diaphragm type).

· Severe skin infections and complications related to soft tissue during chickenpox appear.

· Less than normal urine and swelling (especially in patients with high blood pressure or reduced renal function); swelling (edema) and urine disorders (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that can lead to acute renal failure. If you experience any of the above symptoms, or if you are feeling depressed in general, stop taking NUROFENCAPS 400 mg soft capsule immediately and see your doctor as they may be the first signs kidney disease or impairment.

· Hematopoietic disorders (the first signs are fever, sore throat, superficial oral ulcers, flu-like symptoms, intense fatigue, nosebleed and cutaneous hemorrhage). In such cases, you should immediately stop this treatment and see a doctor. Refrain from any self-medication with analgesics or antipyretics (medicines to reduce fever).

· Psychotic reactions and depression.

· Exacerbation of inflammations associated with an infection (eg, necrotizing fasciitis) associated with the use of certain analgesics (NSAIDs) has been described. If signs of infection develop or if the infection worsens during treatment with NUROFENCAPS 400 mg, soft capsule, you should go to the doctor without delay. It should be investigated whether an anti-infectious / antibiotic treatment is indicated in this case.

· Hypertension, palpitations, heart failure and heart attack.

· Hepatic function abnormalities, hepatic impairment, especially during long-term treatment, liver failure, acute liver inflammation (hepatitis).

· Symptoms of aseptic meningitis accompanied by neck stiffness, headache, nausea, vomiting, fever or obstruction have been observed during treatment with ibuprofen. Patients with autoimmune diseases (SLE, mixed connective tissue disease) are more likely to be affected. If this happens, tell your doctor immediately.

· Severe forms of skin reactions such as rash with redness and ves- tification (eg Stevens-Johnson syndrome, bullous erythrodermia with epidermolysis / Lyell's syndrome), hair loss (alopecia).

· Severe allergic reaction.

· Aggravation of asthma and bronchospasm.

NUROFENCAPS 400 mg, soft capsule contains an azo dye, 4R red pellet (E124) and can cause allergic reactions.

Drugs such as NUROFENCAPS 400 mg, soft capsule may be associated with an increased risk of heart attack (myocardial infarction) or stroke.

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 NUROFENCAPS 400 mg, soft capsule?

Keep out of the reach and sight of children.

Expiration date

Do not use NUROFENCAPS 400 mg soft capsule after the expiry date stated on the carton and the blister. The expiry date refers to the last day of the month indicated.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Store in the original package in order to protect from moisture.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does NUROFENCAPS 400 mg contain, soft capsule?

The active substance is :

Ibuprofen ................................................. .................................................. ................................ 400.00 mg

For a soft capsule.

The other components are :

Macrogol 600, potassium hydroxide, purified water.

Envelope of the capsule : partially dehydrated liquid sorbitol (E420), gelatin, red culvert 4 R (E124)

Printing ink : titanium dioxide (E171), propylene glycol, hypromellose (E464)

Pharmaceutical form and content

What is NUROFENCAPS 400 mg, soft capsule and contents of the pack?

This medication is in the form of a red and transparent oval-shaped soft capsule with a "Nurofen" logo printed in white. Box of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 or 50 soft capsules.

Not all pack sizes may be marketed.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

RECKITT BENCKISER HEALTHCARE FRANCE

15 RUE AMPERE

91748 MASSY CEDEX

LA FRANCE

exploiting

RECKITT BENCKISER HEALTHCARE France

38 RUE VICTOR BASCH

CS 11018

91305 MASSY CEDEX

Maker

Reckitt Benckiser Healthcare International

Thane Road, Nottingham

NG90 2DB

UK

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.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

The following information is intended exclusively for healthcare professionals:

Other

ADVICE / HEALTH EDUCATION

"WHAT TO DO IN CASE 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 can be considered a fever.

· In adults and children over 40 kg (about 12 years of age and older), if the condition is too troublesome, you may take this medicine which contains ibuprofen at the indicated dosage.

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

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

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

o 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.

VIDAL OF THE FAMILY

NUROFENCAPS