NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
HEMOCLAR 0.5 PERCENT, cream
Sulfuric Polyester of Pentosan
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
· DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Review summary
In this notice :
1. WHAT HEMOCLAR 0.5 PERCENT, cream AND WHAT IT IS USED FOR?
2. BEFORE YOU USE HEMOCLAR 0.5%, cream?
3. HOW TO USE HEMOCLAR 0.5 PER CENT, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HEMOCLAR 0.5%, cream?
6. ADDITIONAL INFORMATION
1. WHAT HEMOCLAR 0.5 PERCENT, cream AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
LOCAL PRODUCT FOR MUSCULAR AND ARTICULAR PAIN
Therapeutic indications
This medication is recommended as an adjunct to local treatment of benign traumas (blues, strokes) in adults and children from one year.
2. BEFORE YOU USE HEMOCLAR 0.5%, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use HEMOCLAR 0.5 PERCENT, cream in the following cases:
· History of allergy or decline in platelet counts in blood following anticoagulant therapy with heparin or heparin-like products.
· Known allergy (hypersensitivity) to other constituents (methyl parahydroxybenzoate and propylene glycol).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with HEMOCLAR 0.5 PERCENT, cream:
Precautions for use
For external use only. Do not swallow.
· This medicine contains propylene glycol and may cause skin irritation.
· This medicine contains "Parahydroxybenzoate" and may cause allergic reactions.
· Stop treatment in case of allergic skin reactions.
· Do not apply in the immediate vicinity of the eyes, mucous membranes, wounds, burns, infected lesions or oozing skin diseases. |
· Wash hands thoroughly after each use (to avoid contact with eyes or mucous membranes).
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Use of other medicines
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy and lactation.
If you discover that you are pregnant, consult your doctor, alone can judge the need to continue treatment.
GENERALLY, DURING PREGNANCY OR BREASTFEEDING, ALWAYS ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST BEFORE TAKING A MEDICINE.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect:
Propylene glycol (E1520), methyl parahydroxybenzoate (E218).
3. HOW TO USE HEMOCLAR 0.5 PER CENT, cream?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Apply 2 to 4 times a day to the area to be treated by massaging very slightly to facilitate penetration.
Method and route of administration
Dermal. Local application.
Symptoms and Instructions for Overdose
If you have used more than 0.5% Hemoclar, you should not have any creams and you should feel the effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Excessive use may result in worsening of adverse reactions, including skin irritation.
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, HEMOCLAR 0.5 PERCENT, cream is likely to have unwanted effects, although not everyone is subject to it.
Possibility of localized allergic reactions at the point of application.
Due to the presence of propylene glycol, this medication may cause skin irritation.
Due to the presence of methyl parahydroxybenzoate, this drug may cause allergic reactions (possibly delayed).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE HEMOCLAR 0.5%, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use HEMOCLAR 0.5 PERCENT, cream after the expiry date stated on the carton.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible 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 HEMOCLAR contains 0.5%, cream?
The active substance is:
Sulfuric Polyester of Pentosan .............................................. .................................................. ..... 0.500 g
For 100 g of cream.
The other components are:
Non-ionic emulsifying wax with ketostearomacrogol, polyglycolysed maize oil, glycerol, propylene glycol (E1520), methyl parahydroxybenzoate (E218), levulinic acid, sodium hydroxide, purified water.
Pharmaceutical form and content
What is HEMOCLAR 0.5 PERCENT, cream and contents of the pack?
This medication is in the form of a cream. Tube of 30 g.
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
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
SANOFI WINTHROP INDUSTRIE
196 RUE DU MARECHAL JUIN
45200 AMILLY
or
UNITHER LIQUID MANUFACTURING
1-3, ALLEE OF NESTE
31770 COLOMIERS
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Contact your pharmacist or doctor: If you need more information or advice. If you are not sure whether this medication is appropriate for you, in particular: · If you are pregnant or nursing; · If you have, besides what you want to treat with this medicine, another disease; · If you are taking other medicines at the same time, even if they are sold without a prescription; · If you have ever been allergic to a drug. |
Prevention tips to combine
Accidents could be prevented by appropriate preventive measures:
· Arrange your home to avoid falls,
· Wear appropriate protective gear during various activities (DIY, sports activities: gloves, helmet, shin guard, knee pads, ankle brace, etc.).
Warning signs, requiring medical consultation
Do not try to take care of yourself if:
· the pains are violent, extended or cause a cessation of activity,
· it is impossible to walk or use the affected limb,
· the wounded area becomes red, hot and painful,
· it seems that a liquid pouch has formed,
· the impact has touched the eye or the proximity of the eye,
· the signs appeared without obvious cause, in the absence of a shock,
· your signs persist or worsen.
These signs may be the symptoms of a more serious illness / condition for which medical advice is required.