Cliptol Gel

Cliptol gel is a medication recommended for adults. It is formulated with an anti-inflammatory (ibuprofen) and menthol. It is used topically as a short-term treatment for minor injuries such as minor sprains, bruises, or sports injuries.
The active ingredients are ibuprofen (5 g) and levomenthol (3 g) per 100 g of gel.
The excipients are propylene glycol, diisopropanolamine, carbomer 980, 96% ethanol, and purified water.
Cliptol gel dosage
Cliptol gel is recommended for adults only, with 2 to 3 applications per day, ensuring at least 4 hours between each application. Do not exceed 3 applications per day.
The duration of treatment is limited to 5 days. After this time, if no improvement is observed or if signs of worsening occur, you should seek medical advice.
Cliptol gel is applied topically to the affected area, massaging gently to ensure proper absorption of the medication.
It is very important to wash your hands thoroughly after each use. Use the lowest effective dose for the shortest possible time to avoid the risk of adverse effects.
Precautions for use of Cliptol gel
Use of Cliptol gel is contraindicated if you are allergic to ibuprofen or any of the ingredients in this medication.
It should not be used if you have had an asthma attack triggered by taking ibuprofen, aspirin, or any other anti-inflammatory.
It should not be applied to mucous membranes, eyes, broken, infected, or oozing skin, in cases of eczema, or under an occlusive dressing. You should consult your doctor before using this medication if you have kidney failure or a stomach ulcer.
Do not combine Cliptol gel with any other topical product.
This medication should not be used during the first 5 months of pregnancy without medical advice. Its use is prohibited from the 6th month of pregnancy.
You should avoid using Cliptol gel while breastfeeding.
If a rash occurs, if you have difficulty breathing, or if your face suddenly swells after applying the gel, you should stop using it immediately and consult your doctor.

Packaging: 50g tube.

To treat osteoarthritis, Pierre Fabre developed Structum capsules.








LEAFLET
ANSM - Updated on: 02/28/2024
Name of the medicinal product
CLIPTOL, gel
Levomenthol, Ibuprofen
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse after 5 days.
What is in this leaflet?
1. What is CLIPTOL, gel and what is it used for?
2. What you need to know before using CLIPTOL gel?
3. How to use CLIPTOL gel?
4. Possible side effects?
5. How to store CLIPTOL gel?
6. Contents of the pack and other information.
1. WHAT IS CLIPTOL gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: TOPICAL FOR JOINT AND MUSCLE PAIN, ATC code: M02AA13.
CLIPTOL contains two active ingredients, ibuprofen and levomenthol:
· Ibuprofen belongs to a family of medications called nonsteroidal anti-inflammatory drugs. It reduces inflammation and relieves pain.
· Levomenthol soothes pain in muscles, tendons, and joints. CLIPTOL gel is used for the short-term treatment of pain and swelling caused by minor injuries such as sprains (strains), bruises, or sports injuries.
This medication is for adults and adolescents over 15 years of age only.
You should consult a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE USING CLIPTOL gel?
Never use CLIPTOL gel:
· if you are allergic to the active substances or any of the other ingredients of this medication (listed in section 6).
· if you are in your third trimester of pregnancy.
· if you have ever had an allergy or asthma triggered by taking ibuprofen or another medication in the same family (nonsteroidal anti-inflammatory drugs), such as aspirin. If you have any type of skin lesion: eczema (red patches), weeping lesion (lesion with fluid leaking from it), infected lesion, burn, or wound.
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.
You should not apply this medicine:
On the eyes,
On mucous membranes (inside the mouth, nose, ears, and genitals),
Under a waterproof and breathable dressing (occlusive dressing).
Tell your doctor before using this medicine if you have kidney disease (renal failure) or a stomach ulcer.
Stop treatment and contact a doctor immediately if you develop a skin rash after applying CLIPTOL gel. This may be due to an allergy to this drug.
Serious skin adverse reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using CLIPTOL gel immediately and consult a doctor as soon as possible if any of the symptoms related to these serious skin adverse reactions described in section 4 appear.
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 Breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor before taking any medication. Inform your doctor if you become pregnant while taking CLIPTOL gel. This medication should not be used by women during the third trimester of pregnancy. During the first and second trimesters of pregnancy, use the product only on the recommendation of a doctor.
Breastfeeding
Ibuprofen is excreted in breast milk in minimal amounts, and no effects on the breastfed infant are expected. Topical ibuprofen alone can be used during breastfeeding.
However, there is insufficient information on the excretion of levomenthol, the second component of CLIPTOL gel, into breast milk. Therefore, due to the lack of sufficient data, the use of CLIPTOL gel during breastfeeding is not recommended.
Driving and Operating Machinery
Not applicable.
CLIPTOL gel contains propylene glycol.
· 100 mg of propylene glycol in 1 g of gel
· 300 mg of alcohol (ethanol) in 1 g of gel. This may cause a burning sensation on damaged skin.
3. HOW TO USE CLIPTOL gel?

WARNINGS:
Flammable product.
Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources.
Do not smoke while using or handling the tube.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
The recommended dose is 1 application 2 to 3 times a day, leaving at least 4 hours between each application. The amount of gel to use is:
For 15g tubes: 40 to 100 mm of gel per application.
For 20, 30, or 50g tubes: approximately 10 to 40 mm of gel per application.
You should not exceed 3 applications per day.
Side effects are reduced by using the lowest effective dose for the shortest possible time. Follow 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 gently until absorbed.
Wash your hands thoroughly 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 the condition worsens, consult your doctor.
Always use this medication exactly as directed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Use in children
Not applicable
If you use 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 a forgotten dose.
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.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them. You should immediately stop treatment and consult your doctor if any of the following occur:
Very rare side effects (may affect up to 1 in 10,000 people)
Skin-related:
Reddish, non-raised spots on the trunk, shaped like targets or circles, often with central blisters, peeling of the skin that can quickly spread to severe extent over the whole body, ulcers of the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis),

Side effects that may occur with an unknown frequency (frequency cannot be estimated from the available data):
Local or generalized allergic reaction (hypersensitivity); including a sudden, severe, and potentially fatal generalized allergic reaction if medical attention is not immediately sought (anaphylactic reaction), during which you may experience a skin rash (such as hives, itching), swelling, difficulty breathing, rapid heartbeat, dizziness, sweating, a drop in blood pressure, and/or loss of consciousness/fainting.
· at the site of CLIPTOL gel application to the skin: a rash (rash), itching (pruritus), itchy red patches (urticaria), dry skin, redness (erythema), a burning sensation,
· a rash (rash), itching (pruritus), itchy red patches of skin (urticaria),
· the appearance of small purple spots or patches on the skin, like bruises (purpura), inflammation of the skin (contact dermatitis). · Rapid swelling of the tissues under the skin and certain mucous membranes, often occurring in the face, neck, and throat, can block the airways and be fatal if not immediately medically treated (angioedema). It can also affect the arms, legs, back, digestive system, and genitals, and may also be accompanied by hives (red, itchy patches).
· An abnormal skin reaction to light, similar to sunburn (photosensitivity reaction),
· A severe allergic reaction that may include a widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome),
· A widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms generally appear upon initiation of treatment (acute generalized exanthematous pustulosis or AGEP),

· asthma (or worsening of asthma),
· difficulty breathing, including excessive and prolonged contraction of the airway muscles (bronchospasm and dyspnea) in patients suffering from these conditions or with a history of allergies.
You should inform your doctor if any of the following side effects occur during your treatment:
Other general effects of nonsteroidal anti-inflammatory drugs may occur: digestive side effects such as abdominal pain, indigestion (dyspepsia); and/or renal effects such as kidney dysfunction (renal failure). These depend on the amount of gel applied, the area treated and its condition, the duration of treatment, and whether or not a closed dressing is used.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-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?

Flammable product. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. Do not smoke.
Close the tube after use.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the carton or tube. The expiry date refers to the last day of that month. Store at a temperature not exceeding 25°C.
Do not use after 6 months of first opening.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What CLIPTOL gel contains
· The active ingredients are:
Ibuprofen............................................................................................................................. 5 g
Levomenthol.......................................................................................................................... 3 g
Per 100 g of gel.
· Other excipients are:
Propylene glycol, diisopropanolamine, carbomer 980, 96 percent ethanol, and purified water. What CLIPTOL gel looks like and what are the contents of the outer packaging?
This medicine is in gel form. Each tube contains 15, 20, 30, or 50 g of gel. Not all pack sizes may be marketed.
This gel is colorless, with no visible particles, and a mint odor.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
Parc Industriel de la Chartreuse
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
ETABLISSEMENT PROGIPHARM
Rue du Lycée
45502 Gien Cedex
Names of the medicinal product in the Member States of the European Economic Area
Not applicable. This leaflet was last revised:
[To be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM (France) website.