In this manual :
1. WHAT IS HEMOCLAR 0.5 PER CENT, cream AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING HEMOCLAR 0.5 PER CENT CREAM
3. HOW DO I USE HEMOCLAR 0.5 PER CENT, Cream?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW DO I USE HEMOCLAR 0.5 PER CENT CREAM?
6. ADDITIONAL INFORMATION
1. WHAT IS HEMOCLAR 0.5 PER CENT CREAM AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
TOPICAL PRODUCT FOR MUSCLE AND JOINT PAIN
This medicine is recommended as an adjunct to local treatment of minor trauma (bruises, blows) in adults and children aged one year and over.
2. WHAT YOU SHOULD KNOW BEFORE USING HEMOCLAR 0.5 PER CENT, cream
List of information needed before taking the medicine
Not applicable.
Never use HEMOCLAR 0.5 PER CENT cream in the following cases:
- A history of allergy or low blood platelet count following anticoagulant therapy with heparins or heparin-like products.
- Known allergy (hypersensitivity) to other constituents (methyl parahydroxybenzoate and propylene glycol).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special care with Hemoclar 0.5 per cent cream:
Precautions for use
For external use only. Do not swallow.
- This medication contains propylene glycol and may cause skin irritation.
- This medication contains "Parahydroxybenzoate" and may cause allergic reactions.
- Discontinue use if allergic skin reactions occur.
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- Do not use in the immediate vicinity of the eyes, on mucous membranes, on wounds, on burns, on infected lesions or on oozing skin diseases.
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- Wash hands thoroughly after each use (to avoid contact with eyes or mucous membranes).
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Use of other medicines
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy and breastfeeding.
If you discover that you are pregnant, consult your doctor.
IN GENERAL, IT IS ADVISABLE DURING PREGNANCY OR BREASTFEEDING TO ALWAYS ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICINE.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:
Propylene glycol (E1520), methyl parahydroxybenzoate (E218).
3. HOW TO USE HEMOCLAR 0.5 PER CENT, cream
Instructions for proper use
Not applicable.
Dosage, Method 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, massaging very gently to facilitate penetration.
Method and route of administration
Dermal route. Local application.
Symptoms and instructions in case of overdose
If you have used more HEMOCLAR 0.5 PERCENT cream than you should have and you experience any effects not listed in this leaflet, please tell your doctor or pharmacist.
Excessive use may lead to worsening of the side effects, including skin irritation.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, HEMOCLAR 0.5 PERCENT cream may have side effects, although not everyone is susceptible.
Localized allergic reactions at the site of application may occur.
Due to the presence of propylene glycol, this medicine may cause skin irritation.
Due to the presence of methyl parahydroxybenzoate, this medicine may cause allergic reactions (possibly delayed).
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW DO I USE HEMOCLAR 0.5 PER CENT, cream?
Keep out of the reach and sight of children.
Do not use HEMOCLAR 0.5 PERCENT cream after the expiry date stated on the carton.
Store 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 HEMOCLAR 0.5 PER CENT cream contain?
The active substance is:
Pentosan Polyester Sulfate ..................................................................................................... 0.500 g
Per 100 g of cream.
The other components are:
Non-ionic cetostearomacrogol emulsifying wax, polyglycolysed corn oil, glycerol, propylene glycol (E1520), methyl paraben (E218), levulinic acid, sodium hydroxide, purified water
Pharmaceutical form and content
What is HEMOCLAR 0.5 PER CENT cream and what does it contain?
This medicine is in the form of a cream. Tube of 30 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13 BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
1-13 BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
SANOFI WINTHROP INDUSTRIE
196 RUE DU MARECHAL JUIN
45200 AMILLY
or
UNITHER LIQUID MANUFACTURING
1-3, ALLEE DE LA NESTE
31770 COLOMIERS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
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Ask your pharmacist or doctor:
If you need further information or advice.
If you are not sure whether this medicine is suitable for you, in particular
- If you are pregnant or breastfeeding;
- If you have any other illnesses besides the one you want to treat with this medicine;
- 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 any medication.
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Prevention tips to combine
Accidents can be avoided by taking appropriate preventive measures:
- Arrange your home to avoid the risk of falls,
- Wear appropriate protective equipment during various activities (DIY, sports activities: gloves, helmet, shin guards, knee pads, ankle pads, etc.).
Warning signs requiring medical attention
Do not try to take care of yourself if:
- the pain is severe, widespread, or causes you to stop activity,
- it is impossible to walk or use the affected limb,
- the injured area becomes red, hot and painful,
- a fluid pocket appears to have formed,
- the shock has affected the eye or the vicinity of the eye,
- the signs appeared without an obvious cause, in the absence of a shock,
- your signs persist or worsen.
These signs may be symptoms of a more serious illness/situation, for which medical advice is required.
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