NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
REPAIR, GEL
Aescine / diethylamine salicylate
framed
· This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
· Please read this manual carefully as it contains important information for you. Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist or doctor.
Review summary
In this notice :
1. WHAT REPAIR, GEL AND WHAT IT IS USED FOR?
2. BEFORE YOU USE REPAIR, GEL?
3. HOW TO USE REPAIR, GEL?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE REPAIR, GEL?
6. ADDITIONAL INFORMATION
1. WHAT DOES REPAIR, GEL AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTI-INFLAMMATORY NON-STEROID (M: locomotor system)
Therapeutic indications
This medication is indicated in adults for short-term local treatment in case of benign trauma: sprain (bruising), contusion.
2. BEFORE YOU USE REPAIR, GEL?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use REPARIL, gel in the following cases:
· allergy to any of the constituents;
· injured skin, whatever the lesion: oozing lesion, eczema, infected lesion, burn or wound;
· history of allergy to salicylates or a related drug, including other non-steroidal anti-inflammatory drugs, aspirin;
· from the 25th week of gestation (early 6th month of pregnancy).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR AND YOUR PHARMACIST
Precautions for use; special warnings
Take special care with REPARIL, gel:
Precautions for use
· This medication is for adults only.
· Do not apply in the immediate vicinity of the eyes, mucous membranes, wounds or infected lesions, injured skin, oozing dermatoses.
· This medication is to be applied only in the painful area.
· This medication should not be used as an occlusive dressing.
It is recommended to wash hands thoroughly after each application.
If there is no improvement after 5 days of treatment or in case of aggravation, it is imperative to consult your doctor.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
This gel contains a non-steroidal anti-inflammatory drug: diethylamine salicylate. You should not take other medicines for skin application containing diethylamine salicylate and / or non-steroidal anti-inflammatory drugs. Read the leaflets carefully for other medicines you are taking to ensure that diethylamine salicylate and / or non-steroidal anti-inflammatory drugs are not present. |
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
1) Up to 24 weeks of amenorrhea (5 months of age pregnancy) your doctor may, if necessary, to prescribe this drug in a timely manner.
2) From the 25th week of gestation (early 6 th month of pregnancy), you should IN NO EVENT OF YOURSELF take this drug because its effect on your child can have serious consequences, including a cardiopulmonary and renal plan, even with a single application.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
As NSAIDs pass through breast milk, as a precaution, they should be avoided in breastfeeding women.
In case of breast-feeding, the gel should not be applied to the chest.
GENERALLY, DURING PREGNANCY AND BREASTFEEDING, ALWAYS REQUEST NOTICE TO YOUR DOCTOR AND YOUR PHARMACIST BEFORE TAKING A MEDICINE.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable
List of excipients with known effect
Not applicable.
3. HOW TO USE REPAIR, GEL?
Instructions for proper use
IF YOU HAVE A DOUBT, DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR AND YOUR PHARMACIST.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Reserved for adults
Dosage
The usual dosage is 1 application, 1 to 3 times a day, on the painful area.
Apply the gel in a thin layer with a soft, prolonged massage on the painful or inflammatory area.
Wash hands thoroughly after each use.
IF YOU HAVE THE PRINTING THAT THE EFFECT OF REPAIR, GEL, IS TOO STRONG OR TOO LOW, TALK TO YOUR DOCTOR OR YOUR PHARMACIST
Method and route of administration
Dermal
Duration of the treatment
Treatment is limited to 5 days.
If the pain persists beyond 5 days or any other signs, do not continue treatment without your doctor's advice.
Symptoms and Instructions for Overdose
Not applicable.
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, this medicine may cause side effects, although not everybody gets them.
Exceptionally, allergic skin manifestations (very rare) can occur, mainly localized eczema. These skin reactions can sometimes extend beyond the site of application.
Other general effects of non-steroidal anti-inflammatory drugs, depending on the amount of gel applied, the surface area treated and its condition, the duration of treatment, and the use or not of a closed dressing may also occur .
In all cases, stop treatment immediately and notify your doctor.
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 REPAIR, GEL?
Keep out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date stated on the outer packaging.
The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Do not use this medication if you notice any 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 REPARIL contain?
The active substances are:
Aescine ................................................. .................................................. ......................................... 1.00 g
Diethylamine Salicylate ............................................... .................................................. ................. 5.00 g
For 100 g of gel.
The other components are:
Lavender essential oil, neroli essential oil, carbomers, macrogol 6 glycerol caprylocaprate, disodium edetate, trometamol, isopropyl alcohol, purified water.
Pharmaceutical form and content
What is REPARIL, gel and contents of the pack?
This medication is in the form of a gel. Tube of 20, 40 or 100 g.
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
ROTTAPHARM
40-44 WASHINGTON STREET
75008 PARIS
exploiting
MYLAN MEDICAL SAS
40-44 Washington Street
75008 PARIS
Maker
MADAUS GMBH
51101 KOLN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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
Not applicable.
Other
Health Education Council: |
You just have a trauma or a bruise, you can use the gel to relieve your pain but:
In case of ankle sprain
Mild sprain or sprain, does not cause cracking or dislocation.
The initial pain is quickly improved by resting (24 h to 48 h).
Functional impotence is almost non-existent, even if walking is slightly painful. Any signs of immediate, persistent or secondary seriousness such as: pulsating pain, severe hematoma, foot foot ecchymosis, should prompt you to see your doctor promptly.
In practice :
· if you are over 55,
· if you absolutely can not put yourself in support on the leg to take a few steps,
· or if a hematoma (blue) occurs within 24 hours to 48 hours, or if there is a significant distortion or edema (swelling), you should consult your doctor who will judge the need for x-rays and orthopedic treatment.
In case of knee injury
· if you are over 55,
· in case of severe swelling of the knee with or without hematoma and / or inability to support, you should also consult your doctor.
In all cases
If there is a complete functional impairment, ie if you can not use the upper limb or the lower limb and in case of a large (blue) hematoma, you should also consult your doctor immediately