NUROFENPRO 20mg/ml SUSPENSION WITHOUT SUGAR

NOTICE

ANSM - Last updated: 10/05/2017

Name of the medicinal product

NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension

sweetened with liquid maltitol and sodium saccharin

Ibuprofen

framed

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

You should always use 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 your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if your infant (3 months to 2 years old) feels worse, or feels no improvement after 24 hours .

· You should contact your doctor if your child (2 to 12 years) feels less well, or feels no improvement after 3 days .

Do not use this medication for children.

What is in this leaflet?

1. What is NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium and in which cases it is used?

2. What information should I take before taking NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and saccharin sodium?

3. How to take NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, sweetened oral suspension with liquid maltitol and saccharin sodium?

4. What are the possible side effects?

5. How to store NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium?

6. Package contents and other information.

1. WHAT IS NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and sodium saccharin AND WHAT IS IT USED FOR?

Pharmacotherapeutic group: ANALGESICS AND ANTIPYRETICS - ATC code: M0AE01

You should talk to your doctor if your child feels worse or no improvement:

· after 24 hours in infants (3 months to 2 years)

· after 3 days in children over 6 months of age.

This medicine contains ibuprofen. It is indicated in infants over 5 kg (and over 3 months) and in children under 12 (about 30 kg), in the symptomatic treatment:

· fever and / or pain such as headache, flu-like conditions, dental pain, muscle aches,

· of chronic juvenile arthritis.

2. BEFORE YOU TAKE NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium?

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

Never take NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium :

· if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medication.

· 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,

· 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.

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

Warnings and Precautions

Take special care with NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension:

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.

Drugs such as NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and sodium saccharin may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose, the longer the treatment time, the greater the risk.

Drugs such as NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and sodium saccharin may cause bronchospasm in patients with or with a history of bronchial asthma or allergic disease.

Do not exceed recommended dosage or treatment time.

If you have heart problems, have had a stroke, or if you think you have risk factors for this type of illness (eg high blood pressure, diabetes, high cholesterol, or please contact your doctor or pharmacist.

Drugs such as NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and sodium saccharin may cause kidney failure in dehydrated infants and children.

Special warnings

If you are a woman, NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and saccharin sodium can impair 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 tell your doctor or pharmacist before taking NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, water-sweetened oral suspension liquid maltitol and sodium saccharin.

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.

This medicine contains glycerol and can cause headaches and digestive disorders (diarrhea).

The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).

This medicine contains sodium. This medicine contains 1.85 mg sodium / ml solution or about 0.9 mg sodium / kg. To be taken into account in patients controlling their sodium dietary intake.

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. Administration of this specialty may lead to an asthma attack, particularly in some people who are allergic to acetylsalicylic acid (aspirin) or to a non-steroidal anti-inflammatory drug ( see section "Never take NUROFENPRO 20 mg / ml CHILDREN AND INFANTS WITHOUT SUGAR, drinkable suspension sweetened with liquid maltitol and sodium saccharin in the following cases " ).

· coagulation disorders, and anticoagulant therapy. This medicine 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 any of these conditions, consult your doctor before taking NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium ( see section "Take or use other medicines" ,

· concomitant therapy with methotrexate at doses greater than 20 mg per week or with pemetrexed ( see section "Take or use other medicinal products" ).

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 including asthma attack or abrupt swelling of the face and neck ( see section 4. "WHAT ARE POSSIBLE SIDE EFFECTS?" ), STOP TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR EMERGENCY MEDICAL SERVICE.

Other medicines and NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and saccharin sodium

PLEASE INDICATE YOUR DOCTOR OR YOUR PHARMACIST IF YOU TAKE OR RECENTLY TAKE ANY OTHER MEDICINE, EVEN IF ANY MEDICINE IS OBTAINED WITHOUT ORDER.

CERTAIN MEDICINAL PRODUCTS MAY NOT BE USED AT THE SAME TIME, WHILE OTHER MEDICINES REQUIRE SPECIFIC CHANGES (DOSE, FOR EXAMPLE).

Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and sodium saccharin:

· aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors

· corticosteroids

· oral anticoagulants such as warfarin, injectable heparin, antiplatelet agents or other thrombolytics such as ticlopidine

· lithium

· methotrexate

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

· some antidepressants (selective serotonin reuptake inhibitors)

· pemetrexed

· ciclosporin, tacrolimus.

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

· Medicines for high blood pressure (ACE inhibitors, eg captopril, beta-blockers, angiotensin II antagonists) and even other types of medications that may affect or affect their action treatment with ibuprofen.

· Cardiac glycosides such as digoxin which are drugs used in many cardiac pathologies.

· Mifepristone (a drug used for termination of pregnancy).

· Zidovudine (a drug for the treatment of AIDS).

· Quinolones (antibiotics).

NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and sodium saccharin with food and beverages 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 or pharmacist for advice before taking this medicine.

This medication is for infants and children. However, when used in exceptional circumstances by a woman likely to be pregnant, the following points should be recalled:

During the first trimester of pregnancy (12 weeks of gestation is 12 weeks ¹ day of your last menstrual period), your doctor may prescribe this medication if necessary.

2.5 to 5 months of pregnancy (12-24 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 (in excess of 24 weeks of amenorrhea), you should NOT take this medication because its effects on your child can have serious consequences especially on a cardiopulmonary and renal plan, 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

Fertility

Not applicable

Sport

Not applicable.

Driving and using machines

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

NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, sweetened oral suspension with liquid maltitol and sodium saccharin contains glycerol, maltitol and sodium.

3. HOW TO TAKE NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium?

Reserved for infants over 5 kg (and over 3 months) and children under 12 years (about 30 kg).

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

The occurrence of adverse reactions can be minimized by using the lowest possible dose for the shortest duration necessary to alleviate the symptoms.

Dosage

Infants under 5 kg (or less than 3 months)

This medication should not be used in children less than 5 kg (or less than 3 months). Talk to your doctor or pharmacist.

Infants over 5 kg (and more than 3 months) and children under 12 (about 30 kg)

Pain and / or fever :

The usual dosage is 20 to 30 mg / kg / day in 3 doses per day (not to exceed 30 mg / kg / day).
Systematic catches, spaced 8 hours apart, avoid peaks of pain or fever.

You should talk to your doctor if your child feels worse or no improvement:

· after 24 hours in infants (3 months to 2 years)

· after 3 days in children over 6 months of age.

Chronic Juvenile Arthritis:

The usual dosage is 30 to 40 mg / kg / day in 4 doses per day.

Administration mode

Oral use.

The drug is administered via the syringe for oral administration (graduated in kg), which delivers a dose of 10 mg / kg per dose.

The use of the syringe for oral administration is strictly reserved for the administration of NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS.

The dose to be administered for intake is obtained by aspirating the suspension by pulling the plunger of the syringe for oral administration to the graduation corresponding to the weight of the child.

For each outlet:

· 5 to 10 kg: fill the syringe up to the scale indicating the weight of the child;

· in excess of 10 kg: first fill the syringe up to the 10 kg graduation and then a second time until reaching a total equal to the child's weight (example for a 15 kg child: fill a first times the syringe up to the 10 kg graduation and then a second time up to 5 kg);

· more than 30 kg (about 12 years): there are more suitable dosage forms.

1) Shake well before use

2) Open the bottle by turning the child-resistant cap by pressing.

3) Fully insert the syringe into the sampling nozzle.

4) To fill the syringe, hold the bottle "head down". Keep the syringe in place. Gently and regularly pull the plunger up to the required scale.

5) Replace the bottle "head up" and remove the syringe.

6) Insert the syringe into the child's mouth without pushing it in and administer the suspension by gently pressing the plunger.

After each use, disassemble the syringe for oral administration, rinse and dry.

Check with your doctor or pharmacist if in doubt.

If you take more NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS than you should:

In case of accidental overdose or poisoning, STOP THE TREATMENT AND QUICKLY SEE YOUR 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 give NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and saccharin sodium:

Do not give a double dose to make up for a missed dose

If you stop giving NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension sweetened with liquid maltitol and sodium saccharin :

Not applicable.

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, other side effects 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, asthma attacks and breathing difficulties. You should stop taking Nurofenpro 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, dizziness

Very rare: aseptic meningitis

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 and gastrointestinal haemorrhage, tarry black stools, blood vomiting 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.

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's 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.

If you notice any side effects not listed in this leaflet, please tell 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 NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and saccharin sodium?

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

Do not use NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, drinkable suspension after the expiry date stated on the bottle.

Store at a temperature not exceeding 25 ° C.

After first opening the bottle, the suspension is kept for a maximum of 6 months.

Do not use this medication if you notice any visible signs of deterioration of the product.

Do not throw any medication into drains or household waste. 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 NUROFENPRO contains 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and saccharin sodium

· The active substance is:

Ibuprofen................................................. .................................................. 20.00 mg

For 1 ml oral suspension.

· The other components are:

Polysorbate 80, glycerol, liquid maltitol, sodium saccharin, citric acid monohydrate, sodium citrate, xanthan gum, sodium chloride, orange flavoring 2M 16014, domiphene bromide, purified water.

What is NUROFENPRO 20 mg / ml SUGAR-FREE CHILDREN AND INFANTS, oral suspension sweetened with liquid maltitol and saccharin sodium and contents of the pack

Suspension sweetened with liquid maltitol and saccharin sodium. Bottle of 100 or 150 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder

RECKITT BENCKISER HEALTHCARE FRANCE

38 RUE VICTOR BASCH

CS 11018

91305 MASSY CEDEX

Marketing Authorization Operator

RECKITT BENCKISER HEALTHCARE FRANCE

38 RUE VICTOR BASCH

CS 11018

91305 MASSY CEDEX

Maker

BCM LIMITED

1 THANE ROAD WEST

NOTTINGHAM

NG2 3AA

UK

or

RECKITT BENCKISER HEALTHCARE (UK) LIMITED

INN LANE

HULL

EAST YORKSHIRE

HU8 7DS

UK

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 infants (under 2 years of age):

o Fever can be dangerous:

§ it entails a risk of convulsion if it rises too much and above all too quickly,

§ it causes a risk of dehydration.

o What has to be done:

§ undressing the child (a naked child in a room at 20 ° C risks nothing),

§ often drinking (some children drink very little but very often),

§ possibly, bathe it in water whose temperature is 2 ° C below that of the child,

§ have the person take a fever medication, after ensuring that the medication is appropriate to the infant's weight, in accordance with the indicated doses.

o What you should not do:

§ cover the child, increasing the risk of convulsion and dehydration,

§ put it "on the diet".

o Consult a physician:

In the following hours, if the temperature is raised to more than 38.5 ° C and accompanied by other abnormalities: unusual behavior (screams, crying, drowsiness), vomiting, diarrhea.

In children over 2 years:

If the disorder is too troublesome, you can give a fever medication, after making sure that the medication is appropriate to the child's weight, according to the doses indicated.
However:

o if there are other signs (such as a rash), or if the temperature persists for more than 3 days or if it gets worse, see a doctor

o if headache becomes violent, in case of vomiting, consult a doctor immediately.

"WHAT TO DO IN CASE OF PAIN"

Consult a physician:

· In the absence of improvement after:

o 24 hours in infants less than 2 years of age;

o 3 days for children over 2 years.

· If the pain returns regularly,

· If they are accompanied by fever,

· If they awaken your child at night.

VIDAL OF THE FAMILY

NUROFENPRO Child and Infant