NOTICE
ANSM - Updated: 24/09/2013
Name of the drug
SEDOPAL capsule
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, 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, talk to your pharmacist.
· If the symptoms get worse or persist, consult a doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT SEDOPAL, capsule AND WHAT IT IS USED FOR
2. WHAT IS THE INFORMATION BEFORE YOU TAKE SEDOPAL, capsule?
3. HOW TO TAKE SEDOPAL, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SEDOPAL, capsule?
6. ADDITIONAL INFORMATION
1. WHAT SEDOPAL, capsule AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Herbal medicine.
Therapeutic indications
Traditionally used to reduce the nervousness of adults and children, especially in case of sleep disorders.
2. WHAT IS THE INFORMATION BEFORE YOU TAKE SEDOPAL, capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take SEDOPAL , capsule:
· If you are allergic (hypersensitive) to any of the ingredients in SEDOPAL Capsule.
Precautions for use; special warnings
Not applicable.
Interactions with other drugs
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
There is insufficient data on taking this medication during pregnancy and lactation. Therefore, as a precaution, it is best not to take SEDOPAL, capsule without medical advice.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE SEDOPAL, capsule?
Instructions for a good use
Capsule to swallow with a large glass of water before meals.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Administration mode
Oral way.
Dosage
Adults: 1 to 2 capsules, 2 times daily to take morning and evening.
Children from 5 years old: 1 capsule per day and per age group of 5 years. If necessary, it is possible to open the capsule and mix its contents with a food.
Frequency of administration
Not applicable.
Duration of treatment
Not applicable.
Symptoms and instructions in case of overdose
If you take more SEDOPAL, capsule than you should:
Consult your doctor or your pharmacist.
Instructions for omitting one or more doses
If you forget to take SEDOPAL, capsule:
Do not take a double dose to make up for the dose you forgot to take. Continue your treatment normally.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, SEDOPAL capsules can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SEDOPAL, capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use SEDOPAL Capsule after the expiry date which is stated on the carton or on the blister. The expiry date refers to the last day of the month.
Storage conditions
Store away from light, moisture and temperatures below 25 ° C.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does SEDOPAL contain, capsule?
The active substances are:
Hawthorn (powder of flowered head of) ......................................... .................................................. ... 120 mg
Eschscholtzia (flower powder of aerial part of) ........................................ ....................................... 120 mg
Sweet clover (powder of flowered head of) .......................................... .................................................. .... 120 mg
For a capsule.
The other components are:
Composition of the tunic : yellow iron oxide, indigotine, titanium dioxide, gelatin.
Pharmaceutical form and content
What is SEDOPAL, capsule and contents of the pack?
Capsule. Box or case 40 capsules.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
exploiting
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
Maker
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (www.ansm.sante.fr).
Information reserved for health professionals
Not applicable.
Other
Not applicable.