NOTICE
ANSM - Updated on : 04/11/2019
Name of medicinal product
ARKOGELULES MILLEPERTUIS, capsule
St John's wort (dried extract of the flowering top)
Box
Please read this leaflet carefully before taking this medicine as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 15 days.
Keep out of the reach of children.
What does this leaflet contain?
1. What is ARKOGELULES MILLEPERTUIS, capsule and what is it used for?
2. What do I need to know before taking ARKOGELULES MILLEPERTUIS, capsule?
3. How do I take ARKOGELULES MILLEPERTUIS, capsule?
4. What are the possible side effects?
5. How to store ARKOGELULES MILLEPERTUIS, capsule?
6. Package contents and other information.
1. WHAT IS ARKOGELULES MILLEPERTUIS, capsule AND WHAT IS IT USED FOR?
Herbal medicine.
Other antidepressants, ATC code: N06AX.
Herbal medicine for short-term treatment of mild depressive symptoms.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ARKOGELULES MILLEPERTUIS, capsule?
This medicine is not an antidepressant and is not indicated for the treatment of major depression. If your troubles persist and you feel, most of the time :
- significant suffering that disrupts your personal, social and professional life,
great sadness and/or loss of interest in activities and hobbies you used to enjoy, combined with some of the following symptoms : insomnia, memory problems, loss of energy, irritability, unusual guilt, dark thoughts, loss of zest for life, loss of appetite, "fidgeting", other appetite and sleep disorders, consult your doctor.
St. John's Wort preparations can adversely affect the effects of many drugs. If you are taking other medicines, particularly prescription medicines, do not take ARKOGELULES MILLEPERTUIS without consulting your doctor or pharmacist.
Never take ARKOGELULES MILLEPERTUIS:
- if you are under 18 years of age,
- if you are allergic (hypersensitive) to St John's Wort (Hypericum perforatum L.) or to any of the other ingredients of this medicine, as listed in section 6.
- in association with : anti-coagulants, anti-epileptics, hormonal contraceptives (estroprogestogens and progestogens), digoxin (used to treat heart disease), immunosuppressants (used in organ transplants), antiproteases (used in the treatment of HIV infection), antidepressants (used in the treatment of diabetes).infection), anti-tyrosine kinases (used in the treatment of certain cancers), irinotecan, telaprevir, theophylline and aminophylline (used in the treatment of certain cancers).aminophylline (used in the treatment of asthma and certain respiratory diseases), verapamil (used in the treatment of heart disease).
Warnings and precautions
- You should seek medical advice before starting treatment if you are taking other medicines.
- The antidepressant properties of ARKOGELULES MILLEPERTUIS usually become apparent within the first 4 weeks of treatment. If clinical symptoms persist or worsen, or if suicidal ideation appears, you should consult your doctor.
- Although St. John's wort extract has been prescribed for many years, no specific safety data are available on its use in patients with impaired liver or kidney function. Inform your doctor if you suffer from liver or kidney disease.
- Avoid prolonged exposure to the sun during treatment, due to the risk of skin reactions resembling sunburn (photosensitivity).
- If you are due to undergo surgery, inform your doctor if you are taking ARKOGELULES MILLEPERTUIS.
Children and teenagers
ARKOGELULES MILLEPERTUIS should not be used in children and adolescents under 18 years of age.
Other medicines and ARKOGELULES MILLEPERTUIS
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist as ARKOGELULES MILLEPERTUIS may reduce the therapeutic effect of other medicines.
ARKOGELULES MILLEPERTUIS should never be taken in combination with :
- anti-coagulants,
- anti-epileptics
- contraceptives (estroprogestogens and progestogens),
- digoxin (used to treat heart disease),
- immunosuppressants (used for organ transplants),
- antiproteases (used to treat HIV infection),
- antityrosine kinases (used to treat certain cancers),
- irinotecan (used in the treatment of certain cancers),
- telaprevir (used to treat hepatitisC),
- theophylline and aminophylline (used to treat asthma and certain respiratory diseases),
- verapamil (used to treat heart disease),
Taking St. John's Wort in combination with hormonal contraceptives may result in reduced efficacy or even cancellation of the effect, with potentially serious consequences (e.g. pregnancy). In such cases, additional contraceptive methods (particularly mechanical ones such as IUDs or condoms) should be used.
ARKOGELULES MILLEPERTUIS, capsule is not recommended in association with :
- carbamazepine (used to treat epilepsy),
- benzodiazepines (used to treat occasional insomnia),
- propafenone (used to treat tachycardia),
-cyproterone (used to treat certain hormonal disorders),
-dronedarone (used to treat heart rhythm disorders),
-ivabradine (used to treat angina),
-simvastatin (used to lower blood lipid and cholesterol levels),
-telithromycin (antibiotics),
-ulipristal(emergencycontraceptive).
- Iariprizole (used in antipsychotic treatment).
ARKOGELULES MILLEPERTUIS may cause undesirable effects such as: nausea, dizziness, headache, anxiety, abdominal pain, agitation, mental confusion in association with :
- serotonin reuptake inhibitor antidepressants (sertraline, paroxetine, nefazodone),
- anti-migraine drugs of the triptan family,
- buspirone (anxiolytic).laripiprazole (antipsychotic).
If you are due to undergo surgery, please inform your doctor that you are taking.
ARKOGELULES MILLEPERTUIS. If necessary, stop taking it (risk of interaction with products used for local or general anaesthesia).
ARKOGELULES MILLEPERTUIS with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
ARKOGELULES MILLEPERTUIS should not be used during pregnancy of any term, by women of childbearing age not using contraception, or during breastfeeding, due to the lack of data on administration in this context.
Driving and use of machinery
Not applicable.
ARKOGELULES MILLEPERTUIS contains :
Not applicable.
3. HOW TO TAKE ARKOGELULES MILLEPERTUIS, capsule?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults :
2 capsules morning and evening.
Preferably taken at the same time each day.
Use in children and adolescents
ARKOGELULES MILLEPERTUIS is not recommended for children and adolescents under 18 years of age.
Method of administration
Take by mouth. Swallow capsule with a large glass of water.
Duration of treatment
6 weeks.
Effects generally appear within 4 weeks. If symptoms persist during treatment, consult a doctor or pharmacist.
If you have taken more ARKOGELULES MILLEPERTUIS than you should have :
Consult your doctor or pharmacist immediately.
Overdose may cause convulsions and confusion.
After ingesting large doses of this drug, protect yourself from sunlight and other sources of UV radiation for 1-2 weeks.
If you forget to take ARKOGELULES MILLEPERTUIS:
Do not take a double dose to make up for the one you forgot to take.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects of varying degrees of discomfort may be expected, the frequency of which is unknown:
- gastrointestinal disorders (such as nausea, abdominal pain, diarrhea),
- allergic-type skin reactions,
- fatigue or restlessness,
- excessive sensitivity to sunlight (photosensitivity), with skin reactions resembling sunburn if exposed to the sun during treatment.
- sensitivity disorders such as tingling or burning sensations.
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 Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE ARKOGELULES MILLEPERTUIS, capsule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after "EXP". The expiration date refers to the last day of the month.
Store at temperatures not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to remove any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ARKOGELULES MILLEPERTUIS contains
- The active substance is :
St John's wort(Hypericum perforatum L.) (dried extract of the flowering top of)..175 mg
Extraction solvent: ethanol 60% m/m.
Drug/extract ratio: 3.5-6:1.
For one capsule.
- Other components are :
microcrystalline cellulose, magnesium stearate, hydrophobic silica.
Extract additive: maltodextrin.
Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).
What ARKOGELULES MILLEPERTUIS is and what it contains
Box of 42 or 45 capsules (brown PVC) with oxygen-absorbing sachet.
Not all presentations may be marketed.
Marketing authorization holder
ARKOPHARMA
LABORATOIRES PHARMACEUTIQUES
BP 28
06511 CARROS CEDEX
Marketing authorization holder
ARKOPHARMA
PHARMACEUTICAL LABORATORIES
BP 28
06511 CARROS CEDEX
Manufacturer
ARKOPHARMA
LABORATOIRES PHARMACEUTIQUES
LID DE CARROS LE BROC
1ERE AVENUE 2709 M
06510 CARROS
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM website