NOTICE
ANSM - Updated on: 11/12/2018
Drug Name
KREOSOTUM COMPLEX No. 62, 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 after 10 days.
What is in this leaflet?
1. What is KREOSOTUM COMPLEX No. 62, oral solution in drops, and what is it used for?
2. What should you know before taking KREOSOTUM COMPLEX No. 62, oral solution in drops?
3. How should you take KREOSOTUM COMPLEX No. 62, oral solution in drops?
4. What are the possible side effects?
5. How should KREOSOTUM COMPLEX No. 62, oral solution in drops, be stored?
6. Package contents and other information.
1. WHAT IS KREOSOTUM COMPLEX No. 62, oral solution in drops, AND WHAT IS IT USED FOR?
KREOSOTUM COMPLEX No. 62, oral solution in drops, is a homeopathic medicine traditionally used for the symptomatic treatment of productive coughs.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING KREOSOTUM COMPLEX No. 62, oral solution in drops?
Never take KREOSOTUM COMPLEX No. 62, oral solution in drops:
· In children under 12 years of age.
· If you are allergic to the active ingredients or any of the other ingredients in this medicine, listed in section 6.
Warnings and Precautions
Consult your doctor or pharmacist before taking KREOSOTUM COMPLEX No. 62, oral solution in drops.
· This medicine contains 46% by volume of ethanol (alcohol), i.e., up to 181 mg per dose (20 drops), which is equivalent to 4.5 ml of beer or 1.8 ml of wine per dose.
· Dangerous if used by individuals with alcoholism.
· Use with caution in pregnant or breastfeeding women, children, and high-risk groups such as those with liver failure or epilepsy.
· If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medication.
· Given the presence of the SILICEA strain in the formula, this medication should not be used for otitis or sinusitis without medical advice.
Children
Not applicable.
Other medications and KREOSOTUM COMPLEX No. 62, oral solution in drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
KREOSOTUM COMPLEX No. 62, oral solution in drops with food and beverages
This medicine should preferably be taken between meals.
Pregnancy and breastfeeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Not applicable.
KREOSOTUM COMPLEX No. 62, oral solution in drops, contains ethanol and lactose.
3. HOW TO TAKE KREOSOTUM COMPLEX No. 62, 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:
For adults and children over 12 years of age only.
20 drops, 3 times a day.
Administration:
Take with a little water, preferably between meals. Hold the medicine under the tongue before swallowing.
Sublingual route.
Hold the bottle upright.
Frequency of administration:
Space out doses as symptoms improve and stop taking the medication once symptoms disappear.
Duration of treatment
Treatment should not exceed 10 days. Beyond that, medical advice is necessary.
If you have taken more KREOSOTUM COMPLEX No. 62, oral solution in drops, than you should have
Consult your doctor or pharmacist immediately.
If you forget to take KREOSOTUM COMPLEX No. 62, oral solution in drops
Do not take a double dose to make up for the dose you missed.
If you stop taking KREOSOTUM COMPLEX No. 62, 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 KREOSOTUM COMPLEX No. 62, 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 6 months 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 KREOSOTUM COMPLEX No. 62, oral solution in drops, contains
· The active ingredients are:
Kreosotum 3 DH................................................................................................................. 6 ml
Chelidonium majus 3 DH...................................................................................................... 6 ml
Terebinthina 3 DH................................................................................................................ 6 ml
Stannum metallicum 8 DH.................................................................................................... 6 ml
Silicea 8 DH........................................................................................................................ 6 ml
for a 30 ml bottle.
· Other ingredients are: ethanol, purified water, lactose.
What is KREOSOTUM COMPLEX No. 62, oral solution in drops, and contents of the outer packaging
KREOSOTUM COMPLEX No. 62, 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 website (France).