SUMMARY OF PRODUCT FEATURES
1. NAME OF THE MEDICINAL PRODUCT
ELUSANES HARPAGOPHYTON, capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
HARPAGOPHYTON(Harpagophytum procumbens D.C.) (hydroalcoholic dry extract of root of) .......200 mg
on maltodextrin
For one capsule.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Capsule.
4. CLINICAL DATA
4.1. therapeutic indications
Herbal medicine.
Traditionally used in the symptomatic treatment of minor painful joint manifestations.
4.2. Dosage and method of administration
Oral use. For adults only.
1 capsule morning and evening, to be taken with a large glass of water.
Duration of treatment: 4 weeks
4.3. Contraindications
This medicine is contraindicated in the event of hypersensitivity to the active substance or to one of the excipients.
4.4 Special warnings and precautions for use
In case of joint pain accompanied by swelling, redness or fever, medical advice is required.
Use with caution:
- In patients with cardiac pathologies
- in case of gastric or duodenal ulcer
If symptoms worsen, medical advice is required.
Special warnings
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
4.5. Interactions with other medicinal products and other forms of interaction
No interactions have been reported.
4.6. Pregnancy and lactation
There are no reliable data on teratogenesis in animals.
Clinically, no specific malformative or fetotoxic effects have been observed to date.
However, the follow-up of exposed pregnancies is insufficient to exclude any risk.
Therefore, as a precautionary measure, the use of this drug is not recommended during pregnancy.
In the absence of data on the passage into breast milk, the use of this medicinal product is not recommended during breastfeeding.
4.7. Effects on ability to drive and use machines
The effects on the ability to drive and use machines have not been studied.
4.8. Undesirable effects
The following adverse reactions may occur:
- gastrointestinal disorders (such as nausea, vomiting, diarrhea, abdominal pain)
- neurological disorders (such as headache, dizziness)
- skin reactions (such as allergic reactions)
4.9. Overdose
No cases of overdose have been described.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Not applicable.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Lactose monohydrate, talc, colloidal anhydrous silica, magnesium stearate.
Composition of the capsule shell: gelatin, titanium dioxide.
6.Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of packaging
30 or 60 capsules in a white high density polyethylene bottle with a white polypropylene cap.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
8. MARKETING AUTHORIZATION NUMBER(S)
- 34009 360 424-7 6 or 360 424-7: 30 capsules in bottle (PE/PP).
- 34009 360 425-3 7 or 360 425-3: 60 capsules in bottle (PE/PP).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
17 April 1990 - 17 April 2005
10. DATE OF UPDATE OF THE TEXT
19 August 2010
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Not subject to medical prescription.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Name of the medicinal product
ELUSANES HARPAGOPHYTON, capsule
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
- Keep this leaflet, you may need to read it again.
- If you need more information and advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor
- If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
In this leaflet :
1. WHAT IS ELUSANES HARPAGOPHYTON, capsule AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING ELUSANES HARPAGOPHYTON, capsule?
3. HOW DO I TAKE ELUSANES HARPAGOPHYTON, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE ELUSANES HARPAGOPHYTON, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS ELUSANES HARPAGOPHYTON, capsule and WHAT IS IT USED FOR?
Pharmacotherapeutic class
Herbal medicinal product.
Traditionally used in minor painful joint manifestations.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ELUSANES HARPAGOPHYTON, capsule?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Do not take ELUSANES HARPAGOPHYTON, capsule:
- if you are hypersensitive to the active substance or to any of the other components contained in ELUSANES HARPAGOPHYTON, capsule
Precautions for use; special warnings
Be careful with ELUSANES HARPAGOPHYTON, capsule:
- If you have joint pain with swelling, redness or fever, consult your doctor.
- If you have heart disease, contact your doctor before taking this medicine.
- If you have a gastric or duodenal ulcer, contact your doctor before taking this medicine.
Special warnings
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance. Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
If symptoms worsen, consult a doctor.
Interactions with other drugs
No interactions have been reported.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
The use of this medicine should be avoided during pregnancy and lactation.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue the treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Lactose.
3. HOW TO TAKE ELUSANES HARPAGOPHYTON, capsule
Instructions for proper use
Not applicable.
Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment
Dosage
For adults only.
1 capsule morning and evening, to be taken with a large glass of water.
Method of administration
Take by mouth.
Duration of treatment
The duration of use is limited to 4 weeks.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ELUSANES HARPAGOPHYTON, capsule is likely to have undesirable effects, although not everyone is subject to them, such as
- gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain.
- neurological disorders such as headaches, dizziness
- skin reactions (allergic reactions)
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE ELUSANES HARPAGOPHYTON, capsule
Keep out of the reach and sight of children.
Do not use ELUSANES HARPAGOPHYTON, capsule after the expiry date stated on the box. The expiry date refers to the last day of the month.
Store below 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does ELUSANES HARPAGOPHYTON, capsule contain?
The active substance is :
HARPAGOPHYTON(Harpagophytum procumbens DC.) (hydroalcoholic dry extract of root) ......200 mg
on maltodextrin
For one capsule.
Other components are:
Lactose monohydrate, talc, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide.
Pharmaceutical form and content
What is ELUSANES HARPAGOPHYTON, capsule and what does it contain?
This medicine comes in capsule form. Boxes of 30 or 60.
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
Operator
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
45, PLACE ABEL GANCE
92100 BOULOGNE
Names of the medicinal product in the member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on 19 August 2010.
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.
Not applicable.
Français
English
