NOTICE
ANSM - Updated on: 02/11/2020
Name of the drug
NUROFENPLAST 200 mg, medicated plaster
Reserved for adults or adolescents 16 and over
Ibuprofen
Box
Read all of this leaflet carefully before using this medicine as it contains important information for you.
You should always use this medicine by carefully following the information provided 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 get any side effects, talk to your doctor, or pharmacist. This also applies to any side effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 5 days.
What does this booklet contain ?
1. What is NUROFENPLAST 200 mg, medicated plaster and in which cases it is used?
2. What you need to know before you use NUROFENPLAST 200 mg, medicated plaster?
3. How to use NUROFENPLAST 200 mg, medicated plaster?
4. What are the possible side effects?
5. How to store NUROFENPLAST 200 mg, medicated plaster?
6. Contents of the pack and other information.
1. WHAT IS NUROFENPLAST 200 mg, medicated plaster AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Non-steroidal anti-inflammatory drugs for topical use - ATC code: M02AA13
The active substance is ibuprofen. Ibuprofen belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). These drugs work by changing the way the body reacts to pain, edema, and fever. The medicated plaster delivers ibuprofen locally and continuously to the painful region during the 24 hours of application.
NUROFENPLAST 200mg, medicated plaster is indicated for the short-term symptomatic treatment of local pain in cases of mild trauma: strains, sprains or bruises located near the upper or lower limb joint in adults or adolescents 16 years of age and more.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUROFENPLAST 200 mg, medicated plaster?
Never use NUROFENPLAST 200 mg, medicated plaster:
· If you are allergic to ibuprofen , acetylsalicylic acid, any other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine, listed in section 6.
· If you have a history of allergy after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or acetylsalicylic acid: asthma, wheezing, itching, runny nose, rash or swelling.
· During the last three months of pregnancy .
Do not use NUROFENPLAST 200 mg, medicated plaster on injured skin (abrasions, cuts, burns), on infected skin lesions , or on skin affected by exudative dermatitis , eczema , on the eyes , lips or mucous membranes .
Warnings and precautions
Talk to your doctor or pharmacist before using NUROFENPLAST 200 mg, medicated plaster if:
· You have or have had asthma or an allergy .
· You have a peptic ulcer, or bowel, heart, kidney, or liver problems.
· You are less than 6 months pregnant or breastfeeding.
When using NUROFENPLAST 200 mg, medicated plaster:
· At the first sign of skin reaction (rash, peeling of the skin, blisters) or any other sign of allergic reaction, stop using the medicated plaster and consult your doctor immediately.
· Report any unusual abdominal symptoms (especially bleeding) to your doctor.
· If you are an elderly person, you are more at risk of having side effects.
· If your health does not improve, or if it gets worse, or if you develop new symptoms, talk to your doctor.
· To reduce the risk of photosensitivity, avoid exposure of the treated area to strong natural and / or artificial sunlight (for example, UV booths) for the duration of the treatment and one day after removal of the patch.
Children and adolescents
This medication should not be used in children and adolescents under 16 years of age.
Other medicines and NUROFENPLAST 200 mg, medicated plaster:
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, especially if you are taking:
· A drug that lowers blood pressure ;
· Or a blood thinning medication (such as warfarin).
· Aspirin or another NSAID - to treat inflammation and pain
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medication during the last 3 months of pregnancy .
If you are less than 6 months pregnant, tell your doctor before using this medicine.
No harmful effects related to the use of this drug in lactating women are known. However, as a precaution, this medicated plaster should not be applied directly to the breasts of nursing mothers.
Driving and using machines
Not applicable.
NUROFENPLAST 200 mg, medicated plaster contains:
Not applicable.
3. HOW TO USE NUROFENPLAST 200 mg, medicated plaster?
Always use this medication exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Recommended dose:
In adults and adolescents 16 years of age and older.
One dose consists of a medicated plaster. The maximum dose that can be used is one medicated plaster per 24 hours.
Do not use this medication in children or adolescents under 16 years of age.
For skin application on intact skin.
It is recommended to thoroughly clean and dry the area to be treated before applying the medicated plaster.
The plaster can be applied at any time of the day or night, but it must be removed at the same time the next day and a new plaster can then be applied.
The medicated plaster is flexible and adaptable. It can be applied if necessary on or near a joint without hampering normal movements.
Do not :
· Cut out the plaster. It must be used in its entirety.
· Apply to damaged or injured skin.
· Cover with other plasters or non-breathable bandages / bandages.
· Put the plaster in contact with water
Mode of application:
|
1. To remove a medicated plaster from the sachet, tear or cut the sachet along the dotted lines. 2. Remove the plastic film noted (A) and place the adhesive strip in the middle of the painful area. 3. Remove the plastic film noted (B) and stretching slightly, smooth this part of the medicated plaster on your skin. 4. Remove the plastic film noted (C). 5. Slightly stretching, smooth the rest of the medicated plaster over your skin. |
Duration of treatment :
This medication should be used for the shortest time necessary to relieve symptoms. Do not use this medication for more than 5 days . If symptoms persist for more than 5 days, consult a doctor.
If you use more NUROFENPLAST 200 mg, medicated plaster than you should:
Accidental overdose with a medicated plaster is unlikely.
Consult your doctor. Signs of overdose may include feeling or being unwell, upset stomach or more rarely diarrhea. Ringing in the ears, headache, or digestive bleeding is also possible.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and consult your doctor immediately and if you notice:
· Signs of an allergic reaction, such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or rashes.
· Signs of hypersensitivity and skin reactions such as redness, edema, swelling, blistering, peeling or ulceration of the skin.
If any of the following side effects occur, or if you notice any effects not listed here, please tell your doctor or pharmacist:
Frequency not known (cannot be estimated from the available data)
· Skin reactions such as redness, burning, itching, blisters, skin condition or oozing lesion
· Asthma, difficulty breathing, shortness of breath
· Abdominal pain or other digestive issues
· Kidney problems
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NUROFENPLAST 200 mg, medicated plaster?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and the carton after EXP . The expiration date refers to the last day of this month.
Store at a temperature not exceeding 25ºC (2 plasters per sachet).
Store at a temperature not exceeding 30ºC (4 plasters per sachet).
Store in the original packaging, protect from light.
After first opening of the sachet: will keep for 6 months.
Do not throw used plasters down the toilet.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What NUROFENPLAST 200 mg contains, medicated plaster
· The active substance is:
Ibuprofen................................................. .................................................. ............ 200 mg
· The other components are:
Adhesive layer:
Macrogol 400, macrogol 20,000, levomenthol, triblock styrene-isoprene-styrene copolymer,
Polyisobutylene, Ester of hydrogenated rosin glycerol, liquid paraffin
Support layer:
Woven polyethylene terephthalate (PET)
Protective film:
Polyethylene terephthalate (PET) coated with silicone
What is NUROFENPLAST 200 mg, medicated plaster and contents of the pack
The medicated plaster is composed of a transparent self-adhesive layer, surmounted by a woven and flexible flesh-colored support of 10 cm by 14 cm, with a protective film.
Each sachet contains 2 or 4 medicated plasters.
Box of 2, 4, 6, 8, or 10 medicated plasters.
Not all presentations 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
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
NOTTINGHAM SITE
THANE ROAD
NOTTINGHAM
NG90 2DB
United Kingdom
Or
RB NL Brands BV .
WTC Schiphol Airport
Schiphol Boulevard 207
1118 BH Schiphol
NETHERLANDS
Names of the drug in the member states of the European Economic Area
This medicine 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.