NOTICE
ANSM - Updated on: 08/12/2019
Name of the drug
CLIPTOL, gel
Levomenthol, Ibuprofen
Framed
Read all of this leaflet carefully before using this medicine because it contains important information for you.
You should always use this medicine by carefully following the information given in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 5 days.
What does this booklet contain ?
1. What is CLIPTOL, gel and in which cases it is used?
2. What should I know before using CLIPTOL, gel?
3. How to use CLIPTOL, gel?
4. What are the possible side effects?
5. How to store CLIPTOL, gel?
6. Contents of the pack and other information.
1. WHAT IS CLIPTOL, gel AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: TOPICAL FOR JOINT AND MUSCLE PAIN, ATC code: M02AA13.
CLIPTOL contains 2 active substances, ibuprofen and levomenthol:
· Ibuprofen belongs to a family of drugs called nonsteroidal anti-inflammatory drugs. It decreases inflammation and calms pain.
· Levomenthol soothes pain in muscles, tendons and joints.
CLIPTOL, gel is used to treat short-term pain and swelling caused by minor injuries such as sprains (strains), contusions or sports injuries.
This medication is reserved for adults and adolescents over 15 years old.
2. WHAT YOU NEED TO KNOW BEFORE USING CLIPTOL, gel?
Never use CLIPTOL, gel:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· From 6 th month of pregnancy.
· If you have ever had an allergy or asthma triggered by taking ibuprofen or another drug of the same family (non-steroidal anti-inflammatory drugs) such as aspirin for example.
· If you have a skin lesion, regardless of the lesion: eczema (red patches), weeping lesion (lesion with fluid leaking from it), infected lesion, burn or sore.
· At the same time as another product to be applied to the skin on the same painful area.
Warnings and Precautions
Talk to your doctor or pharmacist before using CLIPTOL, gel.
This medicine contains propylene glycol which can cause skin irritation.
You should not apply this medicine:
· on the eyes,
· on the mucous membranes (inside the mouth, nose, ears and on the genitals),
· under a waterproof and air-tight dressing (occlusive dressing).
Tell your doctor before using this medicine if you have kidney disease (renal failure) or if you have a stomach ulcer.
Stop treatment and contact a doctor immediately if, after applying CLIPTOL, gel, you have a rash on the skin. It may then be an allergy to this drug.
Children
Not applicable.
Other medicines and CLIPTOL, gel
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
CLIPTOL, gel with food and drink
Not applicable.
Pregnancy and breast feeding
Pregnancy
During the first 5 months of your pregnancy, you can use CLIPTOL gel only if your doctor considers it necessary.
From the 6th month of pregnancy, you should under no circumstances use this medicine. The effects on your child can have serious consequences, including on their heart, lungs and kidneys, even with just one application.
Ask your doctor or pharmacist for advice before taking any medicine.
Feeding with milk
Nonsteroidal anti-inflammatory drugs pass into breast milk. As a precaution, you should avoid using this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Driving and using machines
Not applicable.
CLIPTOL, gel contains propylene glycol.
(see section “Warnings and Precautions”).
3. HOW TO USE CLIPTOL, gel?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 application 2 to 3 times a day, with a minimum of 4 hours between each application. The amount of gel to use is:
· For 15 g tubes: 40 to 100 mm of gel per application.
· For tubes of 20, 30 or 50 g: approximately 10 to 40 mm of gel per application.
You should not exceed 3 applications per day.
Adverse effects are reduced by using the lowest effective dose for the shortest time possible. Take the dose indicated in this leaflet.
Method and route of administration
This medication is applied to the skin.
· Apply a thin layer of gel to the painful area and massage lightly until absorbed.
· Wash your hands well after each use (unless they are part of the area to be treated).
Duration of treatment
If there is no improvement after 5 days of treatment or if it worsens, consult your doctor.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Use in children
Not applicable
If you used more CLIPTOL, gel than you should:
Rinse thoroughly with water and consult your doctor or pharmacist immediately.
If you forget to use CLIPTOL, gel:
Do not take a double dose to make up for the dose you forgot to take.
If you stop using CLIPTOL, gel:
Not applicable.
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.
You should stop treatment immediately and consult your doctor if any of the following occurs:
Can occur allergic reactions:
· on the skin: a rash spread over the skin, itching, hives (sensation resembling a sting of nettles), redness, dryness, burning sensation, inflammation of the skin (contact dermatitis) , small red spots on the skin (purpura) and less frequently a peeling of the skin which can spread quickly and seriously all over the body,
· at the respiratory level: asthma, difficulty in breathing,
· in general: sudden swelling of the face and neck (angioedema).
You should tell your doctor if any of the following occur during your treatment:
Other general effects of nonsteroidal anti-inflammatory drugs (digestive and / or renal effects) may occur. They depend on the amount of gel applied, the surface treated and its condition, the duration of treatment and whether or not a closed dressing is used.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (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 CLIPTOL, gel?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or tube. The expiration date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What CLIPTOL contains, gel
· The active substances are:
Ibuprofen................................................. .................................................. ......................... 5 g
Levomenthol ................................................. .................................................. ...................... 3 g
For 100 g of gel.
· The other excipient components are:
propylene glycol, diisopropanolamine, carbomer 980, 96 percent ethanol and purified water.
What is CLIPTOL, gel and contents of the pack
This medication is in the form of a gel. Each tube contains 15, 20, 30 or 50 g of gel. Not all presentations may be marketed.
This gel is colorless with no visible particles with a mint smell.
Marketing authorization holder
PIERRE FABRE MEDICINE
45, place Abel-Gance
92100 Boulogne
Marketing authorization operator
PIERRE FABRE MEDICINE
45, place Abel-Gance
92100 Boulogne
Maker
PIERRE FABRE MEDICINE PRODUCTION
PROGIPHARM ESTABLISHMENT
Lycée Street
45502 Gien Cedex
Names of the drug 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 medication is available on the ANSM website (France).