NOTICE
ANSM - Updated on: 10/09/2020
Name of the medication
UVA URSI COMPLEX No. 9, 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 UVA URSI COMPLEX No. 9, oral solution in drops, and what is it used for?
2. What should you know before taking UVA URSI COMPLEX No. 9, oral solution in drops?
3. How should you take UVA URSI COMPLEX No. 9, oral solution in drops?
4. What are the possible side effects?
5. How should UVA URSI COMPLEX No. 9, oral solution in drops, be stored?
6. Package contents and other information.
1. WHAT IS UVA URSI COMPLEX No. 9, oral solution in drops, AND WHAT IS IT USED FOR?
UVA URSI COMPLEX No. 9, oral solution in drops, is a homeopathic medicine traditionally used in the treatment of cystitis, as an adjunct to anti-infective treatments.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING UVA URSI COMPLEX No. 9, oral solution in drops?
Never take UVA URSI COMPLEX No. 9, 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 before taking UVA URSI COMPLEX No. 9, oral solution in drops. As part of the management of cystitis, a medical consultation is required prior to taking this medication.
· This medication contains 45% by volume of ethanol (alcohol), 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.
· This should be taken into account when used by individuals with alcoholism.
· This should be taken into account in pregnant or breastfeeding women 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.
· Due to the presence of the PULSATILLA strain in the formula, this medication should not be used for otitis or sinusitis without medical advice.
Children
Not applicable.
Other Medications and UVA URSI COMPLEX No. 9, Oral Solution Drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
UVA URSI COMPLEX No. 9, oral solution in drops with food and beverages
This medicine should be taken with a little water, preferably 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.
UVA URSI COMPLEX No. 9, oral solution in drops, contains ethanol and lactose.
3. HOW TO TAKE UVA URSI COMPLEX No. 9, 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 intended for adults and children over 12 years of age.
20 drops 3 times a day.
Duration of treatment: maximum 15 days.
Route of administration
Sublingual route.
Take with a little water between meals; hold under the tongue for a few moments 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 UVA URSI COMPLEX No. 9, oral solution in drops, than you should have
Consult your doctor or pharmacist immediately.
If you forget to take UVA URSI COMPLEX No. 9, oral solution in drops
Do not take a double dose to make up for the dose you missed.
If you stop taking UVA URSI COMPLEX No. 9, 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.signalement-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD UVA URSI COMPLEX No. 9, 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 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 UVA URSI COMPLEX No. 9, oral solution in drops, contains
· The active ingredients are:
Uva ursi 1 DH...................................................................................................................... 6 ml
Pulsatilla 5 DH.................................................................................................................... 6 ml
Euphrasia officinalis 3 DH................................................................................................... 3 ml
Helleborus niger 4 DH.......................................................................................................... 3 ml
Belladonna 3 DH................................................................................................................. 3 ml
Argentum metallicum 8 DH................................................................................................... 3 ml
Aconitum napellus 3 DH...................................................................................................... 3 ml
Coccus cacti 2 DH.............................................................................................................. 3 ml
per 30 ml of oral solution in drops
· The other ingredients are: purified water, ethanol, lactose.
What is UVA URSI COMPLEX No. 9, oral solution in drops, and contents of the outer packaging
UVA URSI COMPLEX No. 9, 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 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
HYGIENE TIPS
To prevent the recurrence of cystitis, it is important that you follow each of the following recommendations:
· Drink plenty of fluids: 1.5 to 2 liters of fluid are needed per 24 hours (in the form of water, herbal tea, fruit juice, etc.).
· Urinate frequently: at least 4 to 5 times a day; avoid holding it in.
· If you are prone to constipation, eat a balanced diet (green vegetables, fruits, regular meals, and plenty of fluids).
· Avoid wearing clothes that are too tight.
· After urinating or having a bowel movement, always remember to wipe from front to back, not the other way around.
· If you have noticed that your episodes of cystitis may occur after sexual intercourse, make it a habit to urinate immediately afterward.
Detailed information about this medication is available on the ANSM (France) website.