NOTICE
ANSM - Updated on: 07/11/2017
Drug Name
LERGYPAX, orodispersible tablet
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 LERGYPAX, orodispersible tablet, and what is it used for?
2. What should you know before taking LERGYPAX, orodispersible tablet?
3. How should you take LERGYPAX, orodispersible tablet?
4. What are the possible side effects?
5. How should LERGYPAX orodispersible tablets be stored?
6. Package contents and other information.
1. WHAT IS LERGYPAX, ORAL DISPERSIBLE TABLET, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code:
Not applicable.
LERGYPAX, orodispersible tablet is a homeopathic medicine traditionally used for the adjunctive treatment of certain allergic conditions: spasmodic rhinitis (periodic or aperiodic), hay fever, allergic conjunctivitis.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING LERGYPAX, orodispersible tablet?
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Never take LERGYPAX, orodispersible tablet:
· in children under 30 months 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
The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (rare hereditary diseases).
Children
Not applicable.
Other medicines and LERGYPAX, orodispersible tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LERGYPAX, orodispersible tablet with food and beverages
This medicine should be taken between meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
In the absence of experimental and clinical data, and as a precaution, the use of this medication should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
Not applicable.
ERGYPAX, orodispersible tablet contains lactose.
3. HOW TO TAKE LERGYPAX, orodispersible tablet?
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 are unsure.
Dosage
This medicine is intended for adults and children over 30 months of age.
For prevention: 2 tablets twice daily, starting the month before and throughout the seasonal allergy season.
For acute attacks: 2 tablets 5 times a day for 3 days, then 2 tablets 3 times a day for 8 days, then 2 tablets twice a day throughout the exposure period.
Method and route of administration
For adults and children over 6 years of age: allow the tablet to dissolve under the tongue, between meals.
For children aged 30 months to 6 years: dissolve the tablet in a small amount of water before administration, due to the risk of choking.
Sublingual route.
If you have taken more LERGYPAX orodispersible tablets than you should have
Not applicable.
If you forget to take LERGYPAX, orodispersible tablet
Do not take a double dose to make up for the dose you missed.
If you stop taking LERGYPAX, orodispersible tablet
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 LERGYPAX, orodispersible tablet, 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 blister pack and on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not use this medicine 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 LERGYPAX, orodispersible tablet contains
· The active ingredients are:
Allium cepa 6 DH.......................................................................................................... 5.000 mg
Euphrasia officinalis 2 DH.............................................................................................. 5,000 mg
Histaminum 6 DH......................................................................................................... 5,000 mg
Sabadilla 6 DH............................................................................................................. 5,000 mg
Arsenicum iodatum 6 DH............................................................................................... 5,000 mg
Arundo donax 2 DH....................................................................................................... 5,000 mg
Per 250 mg tablet
· The other ingredients are: mannitol, lactose monohydrate, croscarmellose sodium, magnesium stearate, lemon flavoring.
What is LERGYPAX, orodispersible tablet, and contents of the outer packaging
LERGYPAX, orodispersible tablet is a 250 mg orodispersible tablet.
Box of 40 or 60 tablets packaged in 2 or 3 blister packs of 20 tablets (PVC/PVDC/Aluminum).
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
Detailed information on this drug is available on the ANSM (France) website.