NOTICE
ANSM - Last updated: 12/04/2017
Name of the medicinal product
NIFLUGEL 2.5%, gel
Niflumic acid
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 side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is NIFLUGEL 2.5%, gel and when is it used?
2. What should I know before taking NIFLUGEL 2.5%, gel?
3. How to take NIFLUGEL 2.5%, gel?
4. What are the possible side effects?
5. How to store NIFLUGEL 2.5%, freeze?
6. Package contents and other information.
1. WHAT IS NIFLUGEL 2.5%, GEL AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: TOPICS FOR ARTICULAR AND MUSCULAR PAIN - ATC code: M02AA17
You should talk to your doctor if you do not feel better or feel less well.
This medication contains a nonsteroidal anti-inflammatory drug: niflumic acid.
It is indicated in adults (over 15 years), in short-term treatment of trauma like tendinitis, benign sprain (strain), contusion.
2. BEFORE YOU TAKE NIFLUGEL 2.5%, freeze?
Do not take NIFLUGEL 2.5%, gel:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· if you are over 5 months pregnant (24 weeks of amenorrhea),
· if you have a history of asthma to this drug or to a related drug, including other non-steroidal anti-inflammatory drugs, aspirin,
· if you have an injured skin, whatever the lesion: oozing lesions, eczema, infected lesion, burn or wound.
Warnings and Precautions
Talk to your doctor or pharmacist before taking NIFLUGEL 2.5%, gel.
Observe the instructions for use:
· never apply a dose higher than recommended (see section Dosage),
· do not apply over an extended surface of the body,
Medications such as NIFLUGEL 2.5%, gel may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose, the longer the treatment time, the greater the risk.
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.
Blood pressure should be closely monitored at the beginning and throughout the treatment.
Patients should be advised of signs of serious cardiovascular adverse reactions (eg, chest pain, shortness of breath, weakness, slurred speech) and what to do if they occur.
Caution should be exercised when using NIFLUGEL, 2.5%, gel, in patients undergoing coronary artery bypass graft (CABG) or immediately before or after cardiac surgery, including concomitant medications.
THIS MEDICINE MUST BE TAKEN ONLY UNDER MEDICAL SURVEILLANCE.
BEFORE TREATMENT,
PREVENT YOUR DOCTOR IN CASE:
· digestive antecedents (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer),
· concomitant anticoagulant or anticoagulant therapy, which may cause serious gastrointestinal events,
· heart disease, liver or kidney disease,
· a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this specialty may lead to an asthma attack, particularly in some people allergic to acetylsalicylic acid (aspirin) or a non-steroidal anti-inflammatory drug (see section "Never take NIFLUGEL 2.5%, gel" )
· of varicella. This medication is not recommended because of exceptional severe infections of the skin.
DURING TREATMENT, IN CASE OF:
· gastrointestinal haemorrhage, (discharge from the mouth or stool, stool coloration black), STOP TREATMENT AND IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE.
· signs of an allergy to this medication, including asthma attack or abrupt swelling of the face and neck (see section 4. " What are the possible side effects?"), STOP TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR EMERGENCY MEDICAL SERVICE.
· onset of abnormal skin reaction during treatment: STOP IMMEDIATELY TREATMENT AND WARN YOUR DOCTOR.
· Asymptomatic increases in the values of liver function tests and, in rare cases, increases in liver function tests three times the upper limit of normal with or without severe liver adverse effects may occur in a reduced percentage of patients receiving NSAID therapy.
Patients taking NIFLUGEL 2.5% gel should be monitored for signs or symptoms of clinically significant liver reactions. If such signs or symptoms develop, treatment with NIFLUGEL 2.5% gel should be discontinued.
In case of infection, surveillance should be strengthened.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
This medication contains a nonsteroidal anti-inflammatory drug: niflumic acid.
You should not take other medicines containing non-steroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and / or acetylsalicylic acid (aspirin) or its derivatives at the same time as this medication.
Read the leaflets for other medicines you are taking to ensure that there are no nonsteroidal anti-inflammatory drugs and / or acetylsalicylic acid.
Children and Youth
This medicine is reserved for adults (over 15 years), in the absence of data in children.
Other medicines and NIFLUGEL 2.5%, gel
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, even if it is a non-prescription medication because there are certain medicines that should not be taken together and other medicines which may require dose modification when taken together.
You should always tell your doctor or pharmacist if you are using or receiving any of the following medicines before taking NIFLUGEL 2.5%, gel:
· aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs
· 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.
· tenofovir disoproxil
· deferasirox
· pentoxifylline
Concomitant use of NIFLUGEL 2.5%, gel with other topical gels is not recommended.
NIFLUGEL 2.5%, gel with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Pregnancy
During the first quarter is large (12 weeks of gestation is 12 weeks after the 1st day of your last period), your doctor may, if necessary, to prescribe the drug.
For 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medication will only be used on the advice of your doctor and in brief dosage. Prolonged use of this medication is strongly discouraged.
Epidemiological evidence suggests an increased risk of miscarriages, congenital abnormalities, genitourinary defects and gastroschisis
After 5 months of pregnancy (beyond 24 weeks of amenorrhea), you should NOT take this medication because its effects on your child can have serious consequences, especially on a cardiopulmonary level and renal, even with a single dose.
If you have taken this medication while you are more than five months pregnant, talk to your obstetrician gynecologist for appropriate monitoring.
feeding
This drug passes into breast milk. As a precaution, it should be avoided during breastfeeding.
Fertility
If you are a woman, NIFLUGEL 2.5%, gel can alter your fertility. Its use is not recommended in women who wish to conceive a child. For women who have reproductive difficulties or who are undergoing reproductive function tests, please talk to your doctor or pharmacist before taking NIFLUGEL 2.5%, gel.
NIFLUGEL 2.5% gel contains
Not applicable
3. HOW TO TAKE NIFLUGEL 2.5%, freeze?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
RESERVED FOR THE ADULT (MORE THAN 15 YEARS).
Dosage
The usual dosage is 1 application 3 times a day.
Administration mode
Local track.
Allow the gel to penetrate through a gentle, prolonged massage on the painful or inflammatory area.
Wash hands thoroughly and prolonged after each use.
Frequency of Administration
Duration of treatment: if there is no improvement after 5 days of treatment, consult your doctor.
If you used more than 2.5% NIFLUGEL, you should not have frozen
Rinse thoroughly with water and consult your doctor or pharmacist immediately.
If you forget to use NIFLUGEL 2.5% gel
Do not take a double dose to make up for a missed dose .
If you stop using NIFLUGEL 2.5% gel
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Some effects are rare but serious.
It is essential to stop treatment immediately and to inform your doctor if:
o of allergic reactions:
§ skin rashes on the skin, erythema, itching associated with the route of administration. , strong skin reaction when exposed to sunlight or UV light; rarely, bullous lesions (such as blisters) on the mucous membranes or the skin. Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
§ respiratory asthma attack type,
§ general allergic shock type, angioedema.
o other general effects of non-steroidal anti-inflammatory agents, depending on the amount of gel applied, the surface area treated and its condition, duration of treatment and whether or not a closed dressing is used.
o of digestive hemorrhage (discharge of blood through the mouth or in the stools, coloring of the stools in black). This is all the more frequent when the dosage used is high.
o Exceptionally, severe skin infections have been observed in cases of chicken pox.
In addition, cases of duodenal ulcer or perforation were observed.
· Some other effects only require to notify your doctor. He alone can judge of the conduct to be taken in case:
o digestive disorders of the abdominal pain type, vomiting, nausea, transit disorders.
o Cases of bone damage after treatment for several years at high doses (fluorosis) were observed.
o Some biological changes may require blood, hepatic and renal monitoring.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE NIFLUGEL 2.5%, freeze?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after the abbreviation used for the expiration date. The expiry date refers to the last day of that month.
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 NIFLUGEL 2.5% contains, gel
· The active substance is:
Niflumic acid ................................................ .................................................. .................. 2,500 g
· The other components are: di-isopropanolamine, carbomer (SYNTHALEN K), 96% ethanol, purified water.
What is NIFLUGEL 2.5%, gel and contents of the pack
This medication is in the form of a gel. Tube of 60g.
Marketing Authorization Holder
UPSA SAS
3, RUE JOSEPH MONIER
92500 Rueil-Malmaison
Marketing Authorization Operator
UPSA SAS
3, RUE JOSEPH MONIER
92500 Rueil-Malmaison
Maker
UPSA SAS
304, AVENUE OF DOCTOR JEAN BRU
47000 AGEN
Or
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
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]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).