NOTICE
ANSM - Updated on: 04/12/2019
Name of the medication
LACHESIS COMPLEX No. 122, 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 package insert?
1. What is LACHESIS COMPLEX No. 122, oral solution in drops, and what is it used for?
2. What information should you know before taking LACHESIS COMPLEX No. 122, oral solution in drops?
3. How should you take LACHESIS COMPLEX No. 122, oral solution in drops?
4. What are the possible side effects?
5. How should LACHESIS COMPLEX No. 122, oral solution in drops, be stored?
6. Package contents and other information.
1. WHAT IS LACHESIS COMPLEX No. 122, oral solution in drops, AND WHAT IS IT USED FOR?
LACHESIS COMPLEX No. 122, oral solution in drops, is a homeopathic medicine traditionally used for functional menopausal disorders (hot flashes, mood swings, headaches, and palpitations).
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING LACHESIS COMPLEX No. 122, oral solution in drops?
Never take LACHESIS COMPLEX No. 122, oral solution in drops:
· if you are allergic to the active ingredients or any of the other ingredients in this medicine, listed in Section 6.
·Do not give LACHESIS COMPLEX No. 122 to children.
Warnings and Precautions
Consult your doctor or pharmacist before taking LACHESIS COMPLEX No. 122, oral solution in drops.
· This medicine contains 45% ethanol (alcohol) by volume, i.e., up to 178 mg per dose (20 drops), which is equivalent to 4.4 ml of beer or 1.8 ml of wine per dose.
· Dangerous if used by people with alcoholism.
· Should be used 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 LACHESIS COMPLEX No. 122, oral solution in drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LACHESIS COMPLEX No. 122, oral solution in drops with food
This medication should preferably be taken between meals.
Pregnancy and breastfeeding
This medication is indicated for postmenopausal women. Consult your doctor or pharmacist before taking any medication.
Driving and operating machinery
Not applicable.
LACHESIS COMPLEX No. 122, oral solution in drops, contains ethanol.
3. HOW TO TAKE LACHESIS COMPLEX No. 122, oral solution in drops
Always take this medication exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you have any questions.
Dosage
This medicine is for adults only.
20 drops 3 times a day.
Duration of treatment: 1 month, renewable upon medical advice.
Administration
Take with a little water between meals; hold under the tongue for a few moments before swallowing.
Sublingual route.
Hold the dropper bottle upright.
Frequency of administration:
Space out doses as symptoms improve and stop taking the medication once symptoms have disappeared.
If you have taken more LACHESIS COMPLEX No. 122, oral solution in drops, than you should have
Consult your doctor or pharmacist immediately.
If you forget to take LACHESIS COMPLEX No. 122, oral solution in drops
Do not take a double dose to make up for the dose you missed.
If you stop taking LACHESIS COMPLEX No. 122, 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 the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD LACHESIS COMPLEX NO. 122, 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 must be used within 2 years 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 LACHESIS COMPLEX No. 122, oral solution in drops, contains
· The active ingredients are:
Lachesis mutus 10 DH......................................................................................................... 6 ml
Kalium carbonicum 6 DH..................................................................................................... 6 ml
Bryonia 4 DH...................................................................................................................... 6 ml
Cactus grandiflorus 3 DH..................................................................................................... 6 ml
Glonoinum 8 DH.................................................................................................................. 6 ml
for 30 ml of oral solution in drops.
· The other ingredients are: purified water, ethanol.
What is LACHESIS COMPLEX No. 122, oral solution in drops, and contents of the outer packaging
LACHESIS COMPLEX No. 122, oral solution in drops, is packaged in a 30-ml amber glass bottle with a dropper inside a cardboard box.
Marketing Authorization Holder
LABORATOIRES LEHNING
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Marketing Authorization Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
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 (France) website.