NOTICE
ANSM - Updated on: 06/19/2017
Name of the medication
DROSERA COMPLEX No. 64, oral solution in drops
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
What is in this leaflet?
1. What is DROSERA COMPLEX No. 64, oral solution in drops, and what is it used for?
2. What should you know before taking DROSERA COMPLEX No. 64, oral solution in drops?
3. How should you take DROSERA COMPLEX No. 64, oral solution in drops?
4. What are the possible side effects?
5. How should DROSERA COMPLEX No. 64, oral solution in drops, be stored?
6. Package contents and other information.
1. WHAT IS DROSERA COMPLEX No. 64, oral solution in drops, AND WHAT IS IT USED FOR?
DROSERA COMPLEX No. 64, oral solution in drops is a homeopathic medicine traditionally used to treat dry or hacking coughs associated with rhinitis, nasopharyngitis, acute bronchitis, and uncomplicated tracheitis
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING DROSERA COMPLEX No. 64, oral solution in drops?
Never take DROSERA COMPLEX No. 64, oral solution in drops:
· If you are allergic (hypersensitive) to the active ingredients or any of the other ingredients in this medicine, listed in section 6.
· In children under 30 months of age.
Warnings and Precautions
Consult your doctor or pharmacist before taking DROSERA COMPLEX No. 64, oral solution in drops.
· Given the presence of the Pulsatilla strain in the formula, this medicine should not be used for otitis or sinusitis without medical advice.
· This medication contains a maximum of 45% vol. ethanol (alcohol), i.e., up to 178 mg per dose (20 drops), which is equivalent to 4.4 ml of beer, 1.8 ml of wine per dose for adults, and up to 44 mg per dose (5 drops), which is equivalent to 1.1 ml of beer or 0.4 ml of wine per dose for children.
· The use of this medication is dangerous in individuals with alcoholism and should be considered with caution in pregnant or breastfeeding women, children, and high-risk groups such as those with liver failure or epilepsy.
Children and adolescents
Not applicable.
Other medications and DROSERA COMPLEX No. 64, oral solution in drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
DROSERA COMPLEX No. 64, oral solution in drops with food
This medicine should be taken between meals.
Pregnancy and breastfeeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
Not applicable.
DROSERA COMPLEX No. 64, oral solution in drops, contains ethanol.
3. HOW TO TAKE DROSERA COMPLEX No. 64, oral solution in drops
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you have any doubts.
Dosage:
For adults and children over 30 months of age only.
Adults: 20 drops 3 times a day or 5 to 10 drops after each coughing fit, not to exceed 60 drops per day.
Duration of treatment: Do not exceed 15 days without medical advice.
Children 30 months and older: 5 drops per day. An interval of at least 4 hours between doses must be observed.
Maximum duration of treatment: 5 days.
Method of administration
Sublingual route.
Take with a small amount of water, preferably between meals.
Hold the medication under the tongue before swallowing.
Hold the dropper bottle upright.
Dosage frequency:
Space out doses as symptoms improve and stop taking the medication once symptoms have disappeared.
If you have taken more DROSERA COMPLEX No. 64, oral solution in drops, than you should have:
Consult your doctor or pharmacist immediately.
If you forget to take DROSERA COMPLEX No. 64, oral solution in drops:
Do not take a double dose to make up for the dose you missed.
If you stop taking DROSERA COMPLEX No. 64, oral solution in drops:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD DROSERA COMPLEX NO. 64, oral solution in drops, BE STORED?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the label and outer packaging. The expiration date refers to the last day of that month.
The medicine should be used within 1 year of opening.
Keep the bottle tightly closed.
No special storage precautions.
Do not use this medication if you notice any visible signs of deterioration.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DROSERA COMPLEX No. 64, oral solution in drops, contains
· The active ingredients are:
Drosera 2 DH............................................................................................................................ 3 ml
Ipeca 4 DH................................................................................................................................ 3 ml
Thymus vulgaris 3 DH................................................................................................................ 3 ml
Cuprum aceticum 4 DH.............................................................................................................. 3 ml
Pulsatilla 3 DH.......................................................................................................................... 3 ml
Lobelia inflata 3 DH................................................................................................................... 3 ml
Belladonna 3 DH....................................................................................................................... 3 ml
Viola odorata TM....................................................................................................................... 3 ml
Coccus cacti 3 DH.................................................................................................................... 3 ml
Veratrum album 8 DH................................................................................................................ 3 ml
for 30 ml of oral solution in drops.
· The other ingredients are: purified water, ethanol.
What is DROSERA COMPLEX No. 64, oral solution in drops, and contents of the outer packaging
DROSERA COMPLEX No. 64, oral solution in drops, is packaged in a 30-ml yellow glass bottle with a dropper inside a cardboard box.
Marketing Authorization Holder
Lehning Laboratories
3 rue du Petit Marais
57640 SAINTE BARBE
FRANCE
Marketing Authorization Holder
Lehning Laboratories
3 Petit Marais Street
57640 SAINTE BARBE
FRANCE
Manufacturer
Lehning Laboratories
3 Petit Marais Street
57640 SAINTE BARBE
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
To be completed later by the marketing authorization holder.
Other
Detailed information on this drug is available on the ANSM website (France).