1. WHAT IS CLIPTOL, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
What is CLIPTOL, gel?
CLIPTOL, gel contains two active ingredients, ibuprofen and levomenthol:
Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory drugs. It reduces inflammation and calms pain.
Levomenthol relieves pain in muscles, tendons and joints.
Therapeutic indications
What is it used for?
CLIPTOL gel is used for the short-term treatment of pain and swelling caused by minor injuries such as sprains, bruises or sports injuries.
This medicine is for adults and adolescents over 15 years of age.
2. WHAT YOU SHOULD KNOW BEFORE USING CLIPTOL, gel
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use CLIPTOL, gel
From the 6th month of pregnancy.
If you are allergic (hypersensitive) to any of the active ingredients (ibuprofen and/or levomenthol) or to any of the other components contained in this medicine. For a list of ingredients, see section 6.
If you have ever had an allergy or asthma triggered by ibuprofen or another medicine of the same family (non-steroidal anti-inflammatory drugs), such as aspirin.
If you have any kind of skin injury, such as eczema (red patches), an oozing lesion (a lesion with fluid draining from it), an infected lesion, a burn or a wound.
At the same time as another product to be applied to the skin on the same painful area.
Precautions for use; special warnings
Be careful with CLIPTOL, gel
This medicine contains propylene glycol which may cause skin irritation.
You should not apply this medicine :
on the eyes,
on mucous membranes (inside the mouth, nose, ears and genitals),
under a waterproof and airtight dressing (occlusive dressing).
Tell your doctor before using this medicine if you have kidney disease (kidney failure) or if you have a stomach ulcer.
Stop treatment and contact a doctor immediately if you get a rash on your skin after using CLIPTOL. This may be an allergy to this medicine.
Interactions 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.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
During the first 5 months of your pregnancy, you may use CLIPTOL, gel only if your doctor considers it necessary.
From the 6th month of pregnancy onwards, you must not use this medicine under any circumstances. The effects on your child can be serious, especially on the heart, lungs and kidneys, even with a single application.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
Non-steroidal anti-inflammatory drugs pass into breast milk. As a precautionary measure, you should not use this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some of the ingredients of CLIPTOL, gel
This medicine contains propylene glycol (see section "Take care with CLIPTOL, gel").
3. HOW TO USE CLIPTOL, gel
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
The usual dose is 1 application 2 to 3 times a day, with a minimum of 4 hours between each application. The quantity of gel to be used is :
For 15 g tubes: 40 to 100 mm of gel per application.
For 20, 30 or 50 g tubes: about 10 to 40 mm of gel per application.
You should not exceed 3 applications per day.
Undesirable effects are reduced by using the minimum effective dose for the shortest possible time. Observe 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 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 the condition worsens, consult your doctor.
Symptoms and instructions in case of overdose
If you have used more CLIPTOL, gel than you should have
Rinse with plenty of water and consult your doctor or pharmacist immediately.
Instructions in case of missed doses
If you forget to use CLIPTOL, gel
Do not use a double dose to make up for the one you forgot to use.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, CLIPTOL, gel is likely to have side effects, although not everyone is susceptible.
You should stop treatment immediately and consult your doctor if any of the following effects occur:
Allergic reactions may occur:
-ontheskin: a widespread rash on the skin, itching, hives (nettle-like sensation), redness, dryness, burning sensation, inflammation of the skin (contact dermatitis), small red spots on the skin (purpura) and less commonly a peeling of the skin that can rapidly spread severely over the whole body,
on therespiratory level: asthma, difficulty in breathing,
ingeneral: a sudden swelling of the face and neck (angioedema).
You should tell your doctor if any of the following effects occur during your treatment:
Other general effects of non-steroidal anti-inflammatory drugs may occur (digestive and/or renal effects). 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 side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres.
Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.
5. HOW TO USE CLIPTOL, gel
Keep out of the reach and sight of children.
Expiry date
Do not use after the expiry date on the box or tube. The expiry date refers to the last day of the month.
Storage conditions
This medicine should be stored at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does CLIPTOL gel contain?
The active substances are :
Ibuprofen ............................................................................................. ................................................ 5 g
Levomenthol .......................................................................................... ................................................ 3 g
For 100 g of gel.
Other components are: propylene glycol, di-isopropanolamine, carbomer 980, 96 percent ethanol and purified water.
Pharmaceutical form and content
What is CLIPTOL gel and what does it contain?
This medicine 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 colourless with no visible particles and a minty odour.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL-GANCE
92100 BOULOGNE
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